溴隐亭不同给药方式治疗高泌乳素血症的Meta-分析

Meta-analysis of bromocriptine in treatment of hyperprolactinemia by different administration methods

目的系统评价溴隐亭不同给药方式治疗高泌乳素血症的疗效与安全性。方法计算机检索Pubmed、Embase、The Cochrane Liabrary、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库(WangFang)和维普中文科技期刊数据库(VIP)等数据库关于溴隐亭不同给药方式治疗高泌乳素血症的随机对照试验(RCT),检索时限均由建库至2018年10月31日。观察指标为血清泌乳素(PRL)水平、月经情况、妊娠率、溢乳情况、胃肠道不良反应(ADR)、循环系统及神经系统ADR。对符合要求的文献进行数据提取及方法学质量评价,采用RevMan 5.2软件进行Meta-分析。结果共纳入23项RCTs,计1 964例患者。Meta-分析结果示:溴隐亭阴道给药组与口服给药组相比,阴道给药组降低血清PRL [MD=-2.11,95%CI (-3.85,-0.37),P=0.02]、改善月经率[RD=0.08,95%CI (0.03,0.14),P=0.002]、溢乳消失率[RD=0.06, 95%CI (0.01, 0.10), P=0.02]效果更好,胃肠道ADR发生率更低[OR=0.18,95%CI(0.12,0.26),P<0.000 01]、循环系统及神经系统ADR发生率更低[OR=0.29,95%CI(0.17,0.49),P<0.000 01],这些指标均优于口服给药组。但用药后妊娠率方面两组差异无统计学意义。溴隐亭经直肠给药与口服给药比较,疗效无明显差异,但在ADR发生率方面[OR=0.10,95%CI(0.05,0.19),P<0.000 01],直肠给药低于口服给药,差异有统计学意义。结论现有证据显示溴隐亭阴道给药较口服给药效果显著,安全性更高;在不宜使用阴道给药的情况下,溴隐亭直肠给药较口服给药安全性更高,两种给药方式均值得临床推广。

Objective To evaluate the efficacy and safety of different administration methods of bromocriptine in the treatment of patients with hyperprolactinemia. Methods Randomized controlled trials(RCTs) about bromocriptine tablets by vaginal administration or rectal administration(trial group) vs bromocriptine by oral administration(control group) in the treatment of patients with hyperprolactinemia were retrieved from PudMed, Embase, the Cochrane Library, CNKI, CBM, WanFang Database,and VIP Database. After data extraction, quality evaluation of included studies with Cochrane system evaluator manual 5.1.0, Metaanalysis of serum level of prolactin levels, the rate of menstruation improvement, the rate of pregnancy recovery, the rate of galactorrhea disappearance, the incidence of adverse drug reaction(ADR) in digestive tract and the incidence of ADR in circulatory system and nervous system was conducted by RevMan 5.2 statistical software. Results A total of 23 RCTs were included, involving1 964 patients. The results of Meta-analysis showed that the decreasing serum level of prolactin levels [MD=22.11, 95%CI(-3.85,-0.37), P=0.02], the rate of menstruation improvement [RD=0.08, 95%CI(0.03, 0.14), P=0.002], the rate of galactorrhea disappearance[RD=0.06, 95%CI(0.01, 0.10), P=0.02], the incidence of ADR in digestive tract [OR=0.18, 95%CI(0.12, 0.26), P<0.000 01] and the incidence of ADR in circulatory system and nervous system [OR=0.29, 95%CI(0.17, 0.49), P<0.000 01] in vaginal administration group were better than those in control group, with statistical significance. But there was no statistical significance in pregnancy rate between vaginal administration group and control group. Moreover, there was also no statistical significance in efficacy between rectal administration group and control group. But the incidences of ADR [OR=0.10, 95%CI(0.05,0.19), P<0.000 01] in rectal administration group were lower than control group. Conclusion Compared with oral administration,bromcriptine by vaginal administration and rectal administration were with better safety, they deserve to be clinically promoted.