复方左炔诺孕酮片避孕有效性与安全性的Meta分析

Meta-analysis for the Contraceptive Efficacy and Safety of Compound Left Acetylene Progesterone Tablets

关键词:  复方左炔诺孕酮片  避孕  有效性  安全性  Meta分析

Key words:  compound left acetylene progesterone tablets  contraception  efficacy  safety  Meta-analysis

摘要:

目的 系统评价复方左炔诺孕酮片——左炔诺孕酮/炔雌醇100/20 μg（levonorgestrel/ethinyl estradiol 100/20 μg，LNG/EE 100/20 μg）避孕的有效性及安全性。方法 计算机检索中国知网、维普、万方、Pubmed、Web of science、EMbase以及Cochrane图书馆等数据库，査找有关复方左炔诺孕酮片（LNG/EE 100/20 μg）用于避孕的随机对照试验（RCT），检索时间均从建库至2015年8月30日。对资料进行数据提取和质量评价，釆用RevMan 5.3软件进行Meta分析。结果 纳入7项研究，共1 786例患者。Meta分析结果显示，与复方左炔诺孕酮片（LNG/EE 150/30 μg）等几个复方口服避孕药相比，复方左炔诺孕酮片（LNG/EE 100/20 μg）在避孕有效率[OR=1.08，95% CI（0.29，4.04），P=0.91]和不良事件发生率[OR=0.99，95% CI（0.81，1.21），P=0.92]方面差异均无统计学意义，周期控制有效率差异有统计学意义[OR=1.75，95% CI（1.28，2.38），P=0.000 4]，复方左炔诺孕酮片（LNG/EE 100/20 μg）对周期控制的效果更优。结论 根据现有的临床数据，复方左炔诺孕酮片（LNG/EE 100/20 μg）避孕有效率与不良事件发生率与复方左炔诺孕酮片（LNG/EE 150/30 μg）等几个复方口服避孕药相当，而周期控制有效率效果明显。由于纳入的随机对照试验样本量小，部分文献质量偏低，本评价结果还需通过严格设计的大样本临床试验加以验证。

Abstract:

OBJECTIVE To evaluate the efficacy and safety of compound left acetylene progesterone tablets (Levonorgestrel/ethinyl estradiol 100/20 μg, LNG/EE 100/20 μg) for contraception. METHODS Searched medical databases including CNKI, VIP Database, Wangfang Database, Pubmed, Web of science, EMbase and Cochrane library by computer. Extracted and evaluated data then performed the meta-analysis by using RevMan 5.3 software. RESULTS A total of 7 RCTs including 1 786 subjects were recruited for meta-analysis. Compared with like compound left acetylene progesterone tablets(LNG/EE 150/30 μg) and other seveal compound oral contraceptives, compound left acetylene progesterone tablets (LNG/EE 100/20 μg) were no significant differences in contraception efficacy[OR=1.08, 95% CI(0.29, 4.04), P=0.91] and safety[OR=0.99, 95% CI(0.81, 1.21), P=0.92], however, it is better on cycle control efficacy[OR=1.75, 95% CI(1.28, 2.38), P=0.000 4]. CONCLUSION Compound left acetylene progesterone tablets (LNG/EE 100/20 μg) are better than compound left acetylene progesterone tablets(LNG/EE 150/30 μg) and other seveal compound oral contraceptives on cycle control, no significant differences in the efficacy and safety. Due to the limited quantity and quality of the included studies, these results need to be further confirmed by a more large-sample and well-designed clinical trials.