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目的系统评价复方左炔诺孕酮片——左炔诺孕酮/炔雌醇100/20μg(levonorgestrel/ethinyl estradiol 100/20μg,LNG/EE 100/20μg)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 100/20μg)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Rev Man 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 150/30μg)等几个复方口服避孕药相比,复方左炔诺孕酮片(LNG/EE 100/20μg)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 100/20μg)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 100/20μg)避孕有效率与不良事件发生率与复方左炔诺孕酮片(LNG/EE 150/30μg)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。
Objective To evaluate the efficacy and safety of levonorgestrel / levonorgestrel 100 / 20μg (LNV / EE 100 / 20μg) contraceptives. Methods The databases of CNKI, VIP, Wanfang, Pubmed, Web of Science, EMbase and Cochrane Library were searched for randomized controlled trials on levonorgestrel (LNG / EE 100 / 20μg) for contraception (RCT), search time from the database to August 30, 2015. The data extraction and quality evaluation of data, preclude the use of Rev Man 5.3 software for meta-analysis. Results Seven studies were enrolled in a total of 1 786 patients. Meta-analysis showed that compared with several compound oral contraceptives such as levonorgestrel (LNG / EE 150 / 30μg), the combination of levonorgestrel (LNG / EE 100 / 20μg) There were no significant differences between the two groups (OR = 1.08,95% CI 0.29,4.04, P = 0.91) and incidence of adverse events [OR = 0.99,95% CI (0.81,1.21), P = 0.92] The control efficacy rate was statistically significant (OR = 1.75, 95% CI (1.28, 2.38), P = 0.0004], and the combination of levonorgestrel tablets (LNG / EE 100 / 20μg) . Conclusions According to the available clinical data, the effective rate of contraceptives and the incidence of adverse events of levonorgestrel (LNG / EE 100 / 20μg) and compound levonorgestrel tablets (LNG / EE 150 / 30μg) Compound oral contraceptives, and cycle control efficiency is obvious. Due to the small sample size of the included randomized controlled trials and the low quality of some of the articles, the results of this review need to be validated through rigorous design of large sample clinical trials.