Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial

Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Wen-Jing Li [verfasserIn] Chun-Xiu Gong [verfasserIn] Mei-Jie Guo [verfasserIn] Jie Xing [verfasserIn] Tang Li [verfasserIn] Wen-Hui Song [verfasserIn] Xiao-Ping Luo [verfasserIn] Di Wu [verfasserIn] Jian-Ping Liang [verfasserIn] Bing-Yan Cao [verfasserIn] Yi Gu [verfasserIn] Chang Su [verfasserIn] Xue-Jun Liang [verfasserIn] Min Liu [verfasserIn] Rui Wang [verfasserIn] Feng-Ting Li [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2015

Schlagwörter:	Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin

Übergeordnetes Werk:	In: Chinese Medical Journal - Wolters Kluwer, 2004, 128(2015), 10, Seite 1314-1320
Übergeordnetes Werk:	volume:128 ; year:2015 ; number:10 ; pages:1314-1320

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.4103/0366-6999.156773

Katalog-ID:	DOAJ012000531

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245	1	0	\|a Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial
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520			\|a Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin.
650		4	\|a Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin
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700	0		\|a Chun-Xiu Gong \|e verfasserin \|4 aut
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700	0		\|a Tang Li \|e verfasserin \|4 aut
700	0		\|a Wen-Hui Song \|e verfasserin \|4 aut
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700	0		\|a Feng-Ting Li \|e verfasserin \|4 aut
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allfields	10.4103/0366-6999.156773 doi (DE-627)DOAJ012000531 (DE-599)DOAJ9570a260cf274d2a9a8cb4bda420c3ec DE-627 ger DE-627 rakwb eng Wen-Jing Li verfasserin aut Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin. Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin Medicine R Chun-Xiu Gong verfasserin aut Mei-Jie Guo verfasserin aut Jie Xing verfasserin aut Tang Li verfasserin aut Wen-Hui Song verfasserin aut Xiao-Ping Luo verfasserin aut Di Wu verfasserin aut Jian-Ping Liang verfasserin aut Bing-Yan Cao verfasserin aut Yi Gu verfasserin aut Chang Su verfasserin aut Xue-Jun Liang verfasserin aut Min Liu verfasserin aut Rui Wang verfasserin aut Feng-Ting Li verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 128(2015), 10, Seite 1314-1320 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:128 year:2015 number:10 pages:1314-1320 https://doi.org/10.4103/0366-6999.156773 kostenfrei https://doaj.org/article/9570a260cf274d2a9a8cb4bda420c3ec kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2015;volume=128;issue=10;spage=1314;epage=1320;aulast=Li kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 128 2015 10 1314-1320
spelling	10.4103/0366-6999.156773 doi (DE-627)DOAJ012000531 (DE-599)DOAJ9570a260cf274d2a9a8cb4bda420c3ec DE-627 ger DE-627 rakwb eng Wen-Jing Li verfasserin aut Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin. Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin Medicine R Chun-Xiu Gong verfasserin aut Mei-Jie Guo verfasserin aut Jie Xing verfasserin aut Tang Li verfasserin aut Wen-Hui Song verfasserin aut Xiao-Ping Luo verfasserin aut Di Wu verfasserin aut Jian-Ping Liang verfasserin aut Bing-Yan Cao verfasserin aut Yi Gu verfasserin aut Chang Su verfasserin aut Xue-Jun Liang verfasserin aut Min Liu verfasserin aut Rui Wang verfasserin aut Feng-Ting Li verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 128(2015), 10, Seite 1314-1320 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:128 year:2015 number:10 pages:1314-1320 https://doi.org/10.4103/0366-6999.156773 kostenfrei https://doaj.org/article/9570a260cf274d2a9a8cb4bda420c3ec kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2015;volume=128;issue=10;spage=1314;epage=1320;aulast=Li kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 128 2015 10 1314-1320
allfields_unstemmed	10.4103/0366-6999.156773 doi (DE-627)DOAJ012000531 (DE-599)DOAJ9570a260cf274d2a9a8cb4bda420c3ec DE-627 ger DE-627 rakwb eng Wen-Jing Li verfasserin aut Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin. Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin Medicine R Chun-Xiu Gong verfasserin aut Mei-Jie Guo verfasserin aut Jie Xing verfasserin aut Tang Li verfasserin aut Wen-Hui Song verfasserin aut Xiao-Ping Luo verfasserin aut Di Wu verfasserin aut Jian-Ping Liang verfasserin aut Bing-Yan Cao verfasserin aut Yi Gu verfasserin aut Chang Su verfasserin aut Xue-Jun Liang verfasserin aut Min Liu verfasserin aut Rui Wang verfasserin aut Feng-Ting Li verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 128(2015), 10, Seite 1314-1320 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:128 year:2015 number:10 pages:1314-1320 https://doi.org/10.4103/0366-6999.156773 kostenfrei https://doaj.org/article/9570a260cf274d2a9a8cb4bda420c3ec kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2015;volume=128;issue=10;spage=1314;epage=1320;aulast=Li kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 128 2015 10 1314-1320
allfieldsGer	10.4103/0366-6999.156773 doi (DE-627)DOAJ012000531 (DE-599)DOAJ9570a260cf274d2a9a8cb4bda420c3ec DE-627 ger DE-627 rakwb eng Wen-Jing Li verfasserin aut Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin. Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin Medicine R Chun-Xiu Gong verfasserin aut Mei-Jie Guo verfasserin aut Jie Xing verfasserin aut Tang Li verfasserin aut Wen-Hui Song verfasserin aut Xiao-Ping Luo verfasserin aut Di Wu verfasserin aut Jian-Ping Liang verfasserin aut Bing-Yan Cao verfasserin aut Yi Gu verfasserin aut Chang Su verfasserin aut Xue-Jun Liang verfasserin aut Min Liu verfasserin aut Rui Wang verfasserin aut Feng-Ting Li verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 128(2015), 10, Seite 1314-1320 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:128 year:2015 number:10 pages:1314-1320 https://doi.org/10.4103/0366-6999.156773 kostenfrei https://doaj.org/article/9570a260cf274d2a9a8cb4bda420c3ec kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2015;volume=128;issue=10;spage=1314;epage=1320;aulast=Li kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 128 2015 10 1314-1320
allfieldsSound	10.4103/0366-6999.156773 doi (DE-627)DOAJ012000531 (DE-599)DOAJ9570a260cf274d2a9a8cb4bda420c3ec DE-627 ger DE-627 rakwb eng Wen-Jing Li verfasserin aut Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin. Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin Medicine R Chun-Xiu Gong verfasserin aut Mei-Jie Guo verfasserin aut Jie Xing verfasserin aut Tang Li verfasserin aut Wen-Hui Song verfasserin aut Xiao-Ping Luo verfasserin aut Di Wu verfasserin aut Jian-Ping Liang verfasserin aut Bing-Yan Cao verfasserin aut Yi Gu verfasserin aut Chang Su verfasserin aut Xue-Jun Liang verfasserin aut Min Liu verfasserin aut Rui Wang verfasserin aut Feng-Ting Li verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 128(2015), 10, Seite 1314-1320 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:128 year:2015 number:10 pages:1314-1320 https://doi.org/10.4103/0366-6999.156773 kostenfrei https://doaj.org/article/9570a260cf274d2a9a8cb4bda420c3ec kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2015;volume=128;issue=10;spage=1314;epage=1320;aulast=Li kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 128 2015 10 1314-1320
language	English
source	In Chinese Medical Journal 128(2015), 10, Seite 1314-1320 volume:128 year:2015 number:10 pages:1314-1320
sourceStr	In Chinese Medical Journal 128(2015), 10, Seite 1314-1320 volume:128 year:2015 number:10 pages:1314-1320
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin Medicine R
isfreeaccess_bool	true
container_title	Chinese Medical Journal
authorswithroles_txt_mv	Wen-Jing Li @@aut@@ Chun-Xiu Gong @@aut@@ Mei-Jie Guo @@aut@@ Jie Xing @@aut@@ Tang Li @@aut@@ Wen-Hui Song @@aut@@ Xiao-Ping Luo @@aut@@ Di Wu @@aut@@ Jian-Ping Liang @@aut@@ Bing-Yan Cao @@aut@@ Yi Gu @@aut@@ Chang Su @@aut@@ Xue-Jun Liang @@aut@@ Min Liu @@aut@@ Rui Wang @@aut@@ Feng-Ting Li @@aut@@
publishDateDaySort_date	2015-01-01T00:00:00Z
hierarchy_top_id	363772693
id	DOAJ012000531
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ012000531</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230501175546.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230225s2015 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.4103/0366-6999.156773</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ012000531</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJ9570a260cf274d2a9a8cb4bda420c3ec</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Wen-Jing Li</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2015</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Medicine</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">R</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Chun-Xiu Gong</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Mei-Jie Guo</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Jie Xing</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" 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author	Wen-Jing Li
spellingShingle	Wen-Jing Li misc Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin misc Medicine misc R Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial
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topic_title	Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin
topic	misc Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin misc Medicine misc R
topic_unstemmed	misc Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin misc Medicine misc R
topic_browse	misc Central Precocious Puberty; Gonadotropin-releasing Hormone Analog; Idiopathic Central Precocious Puberty; Leuprorelin misc Medicine misc R
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title	Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial
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title_full	Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial
author_sort	Wen-Jing Li
journal	Chinese Medical Journal
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author_browse	Wen-Jing Li Chun-Xiu Gong Mei-Jie Guo Jie Xing Tang Li Wen-Hui Song Xiao-Ping Luo Di Wu Jian-Ping Liang Bing-Yan Cao Yi Gu Chang Su Xue-Jun Liang Min Liu Rui Wang Feng-Ting Li
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doi_str_mv	10.4103/0366-6999.156773
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title_sort	efficacy and safety of domestic leuprorelin in girls with idiopathic central precocious puberty: a multicenter, randomized, parallel, controlled trial
title_auth	Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial
abstract	Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin.
abstractGer	Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin.
abstract_unstemmed	Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio <0.6, the improvements of secondary sexual characteristics, gonadal development and sex hormone levels, the change of growth rate of bone age (BA) and growth velocity, and drug adverse effects between two groups were compared. Results: After the treatment, the percentage of children with a suppressed LH response to GnRH, defined as a peak LH ≤3.3 U/L, at 6 months in test and control groups were 96.80% and 96.20%, respectively, and the percentage of children with peak LH/FSH ratio ≤0.6 at 6 months in test and control groups were 93.60% and 93.70%, respectively. The sizes of breast, uterus and ovary of children and the levels of estradiol (E 2 ) were significantly reduced, and the growth rate of BA was also reduced. All the differences between pre- and post-treatment in each group were statistically significant (P < 0. 05), but the differences of the parameters between two groups were not significant (P < 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin.
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title_short	Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial
url	https://doi.org/10.4103/0366-6999.156773 https://doaj.org/article/9570a260cf274d2a9a8cb4bda420c3ec http://www.cmj.org/article.asp?issn=0366-6999;year=2015;volume=128;issue=10;spage=1314;epage=1320;aulast=Li https://doaj.org/toc/0366-6999
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author2	Chun-Xiu Gong Mei-Jie Guo Jie Xing Tang Li Wen-Hui Song Xiao-Ping Luo Di Wu Jian-Ping Liang Bing-Yan Cao Yi Gu Chang Su Xue-Jun Liang Min Liu Rui Wang Feng-Ting Li
author2Str	Chun-Xiu Gong Mei-Jie Guo Jie Xing Tang Li Wen-Hui Song Xiao-Ping Luo Di Wu Jian-Ping Liang Bing-Yan Cao Yi Gu Chang Su Xue-Jun Liang Min Liu Rui Wang Feng-Ting Li
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up_date	2024-07-03T23:16:56.595Z
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Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial

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