中国女性患者溴隐亭阴道给药治疗高催乳素血症有效性和安全性的Meta分析(1)
中圖分类号 R984 文献标志码 A 文章编号 1001-0408(2018)01-0111-06
DOI 10.6039/j.issn.1001-0408.2018.01.28
摘 要 目的：系统评价中国女性患者溴隐亭阴道给药治疗高催乳素血症的有效性和安全性，为临床提供循证参考。方法：计算机检索PubMed、The Cochrane Liabrary、Excerpta Media Database、中国期刊全文数据库(CJFD)、万方数据库、中国生物医学文献数据库(CBMdisc)，收集中国女性患者采用溴隐亭口服片阴道给药(试验组)对比溴隐亭口服给药(对照组)治疗高催乳素血症的随机对照试验(RCT)。对符合纳入标准的研究提取资料并按照Cochrane 系统评价员手册5.1.0评价纳入研究的方法学质量后，采用Rev Man 5.1统计软件对血清泌乳素(PRL)水平、月经改善率、妊娠恢复率、溢乳消失率、消化道不良反应发生率、神经系统不良反应发生率指标进行Meta分析。结果：共纳入16项RCT，合计1 175例患者。Meta分析结果显示，试验组患者消化道不良反应发生率[OR=0.14，95%CI(0.09，0.23)，P<0.001]、神经系统不良反应发生率[OR=0.32，95%CI(0.11，0.90)，P=0.03]显著低于对照组，差异均有统计学意义；两组患者血清PRL水平[MD=0.24，95%CI(-0.94，1.41)，P=0.69]、月经改善率[RD=0.04，95%CI(-0.04，0.11)，P=0.32]、妊娠恢复率[RD=0.01，95%CI(-0.08，0.10)，P=0.84]、溢乳消失率[RD=0.05，95%CI(-0.03，0.13)，P=0.20]比较，差异均无统计学意义。结论：溴隐亭阴道给药与口服给药相比，在疗效方面无显著差异，在消化道不良反应率、神经系统不良反应率方面存在明显优势，安全性更高，建议开发阴道给药的溴隐亭制剂。
关键词 溴隐亭；阴道给药；口服给药；系统评价；有效性；安全性；Meta分析
ABSTRACT OBJECTIVE： To evaluate the effectiveness and safety of bromocriptine by vaginal delivery in the treatment of hyperprolactinemia in Chinese female patients， and to provide evidence-based reference for clinic. METHODS： Retrieved from PubMed， The Cochrane Liabrary， Excerpta Medica Database， Chinese Journal Full-text Database， Wanfang Database and China Bxdxiology Medicine disc， randomized controlled trials (RCTs) about bromocriptine oral tablets by vaginal delivery (trial group) vs. bromocriptine by oral administration (control group) in the treatment of bromocriptine in Chinese female patients were collected. After data extraction， quality evaluation of included studies with Cochrane system evaluator manual 5.1.0， Meta-analysis of serum level of Prolactin levels， the rate of menstruation improvement， the rate of pregnancy recovery， the rate of galactorrhea disappearance， the incidence of ADR in digestive tract and the incidence of ADR in nervous system was conducted by using Rev Man 5.1 statistical software. RESULTS： A total of 16 RCTs were included， involving 1 175 patients. The results of Meta-analysis showed that the incidence of ADR in digestive tract [OR=0.14，95%CI(0.09， 0.23)，P<0.001] and ADR in nervous system [OR=0.32，95%CI(0.11， 0.90)，P=0.03] in trial group were significantly lower than control group， with statistical significance. There was no statistical significance in serum level of PRL [MD=0.24，95%CI (-0.94， 1.41)，P=0.69]， the rate of menstruation improvement [RD=0.04，95%CI (-0.04， 0.11)，P=0.32]， the rate of pregnancy recovery [RD=0.01，95%CI (-0.08， 0.10)，P=0.84] or the rate of galactorrhea disappearance [RD=0.05，95%CI (-0.03， 0.13)，P=0.20] between 2 groups. CONCLUSIONS： Compared with oral administration， bromocriptine by vaginal delivery has no significant difference in therapeutic efficacy but has obvious advantages in the incidence of ADR in digestive tract and in nervous system and better safety. It is suggested to development the special vaginal delivery preparation of bromocriptine., http://www.100md.com(袁洪波 张伶俐 杨春松 刘砚韬)
DOI 10.6039/j.issn.1001-0408.2018.01.28
摘 要 目的：系统评价中国女性患者溴隐亭阴道给药治疗高催乳素血症的有效性和安全性，为临床提供循证参考。方法：计算机检索PubMed、The Cochrane Liabrary、Excerpta Media Database、中国期刊全文数据库(CJFD)、万方数据库、中国生物医学文献数据库(CBMdisc)，收集中国女性患者采用溴隐亭口服片阴道给药(试验组)对比溴隐亭口服给药(对照组)治疗高催乳素血症的随机对照试验(RCT)。对符合纳入标准的研究提取资料并按照Cochrane 系统评价员手册5.1.0评价纳入研究的方法学质量后，采用Rev Man 5.1统计软件对血清泌乳素(PRL)水平、月经改善率、妊娠恢复率、溢乳消失率、消化道不良反应发生率、神经系统不良反应发生率指标进行Meta分析。结果：共纳入16项RCT，合计1 175例患者。Meta分析结果显示，试验组患者消化道不良反应发生率[OR=0.14，95%CI(0.09，0.23)，P<0.001]、神经系统不良反应发生率[OR=0.32，95%CI(0.11，0.90)，P=0.03]显著低于对照组，差异均有统计学意义；两组患者血清PRL水平[MD=0.24，95%CI(-0.94，1.41)，P=0.69]、月经改善率[RD=0.04，95%CI(-0.04，0.11)，P=0.32]、妊娠恢复率[RD=0.01，95%CI(-0.08，0.10)，P=0.84]、溢乳消失率[RD=0.05，95%CI(-0.03，0.13)，P=0.20]比较，差异均无统计学意义。结论：溴隐亭阴道给药与口服给药相比，在疗效方面无显著差异，在消化道不良反应率、神经系统不良反应率方面存在明显优势，安全性更高，建议开发阴道给药的溴隐亭制剂。
关键词 溴隐亭；阴道给药；口服给药；系统评价；有效性；安全性；Meta分析
ABSTRACT OBJECTIVE： To evaluate the effectiveness and safety of bromocriptine by vaginal delivery in the treatment of hyperprolactinemia in Chinese female patients， and to provide evidence-based reference for clinic. METHODS： Retrieved from PubMed， The Cochrane Liabrary， Excerpta Medica Database， Chinese Journal Full-text Database， Wanfang Database and China Bxdxiology Medicine disc， randomized controlled trials (RCTs) about bromocriptine oral tablets by vaginal delivery (trial group) vs. bromocriptine by oral administration (control group) in the treatment of bromocriptine in Chinese female patients were collected. After data extraction， quality evaluation of included studies with Cochrane system evaluator manual 5.1.0， Meta-analysis of serum level of Prolactin levels， the rate of menstruation improvement， the rate of pregnancy recovery， the rate of galactorrhea disappearance， the incidence of ADR in digestive tract and the incidence of ADR in nervous system was conducted by using Rev Man 5.1 statistical software. RESULTS： A total of 16 RCTs were included， involving 1 175 patients. The results of Meta-analysis showed that the incidence of ADR in digestive tract [OR=0.14，95%CI(0.09， 0.23)，P<0.001] and ADR in nervous system [OR=0.32，95%CI(0.11， 0.90)，P=0.03] in trial group were significantly lower than control group， with statistical significance. There was no statistical significance in serum level of PRL [MD=0.24，95%CI (-0.94， 1.41)，P=0.69]， the rate of menstruation improvement [RD=0.04，95%CI (-0.04， 0.11)，P=0.32]， the rate of pregnancy recovery [RD=0.01，95%CI (-0.08， 0.10)，P=0.84] or the rate of galactorrhea disappearance [RD=0.05，95%CI (-0.03， 0.13)，P=0.20] between 2 groups. CONCLUSIONS： Compared with oral administration， bromocriptine by vaginal delivery has no significant difference in therapeutic efficacy but has obvious advantages in the incidence of ADR in digestive tract and in nervous system and better safety. It is suggested to development the special vaginal delivery preparation of bromocriptine., http://www.100md.com(袁洪波 张伶俐 杨春松 刘砚韬)