妈富隆与敏定偶避孕效果及安全性比较的系统评价

Contraceptive Effect and Safety of Ethinyl Estradiol versus Desogestrel: A Systematic Review

目的系统评价口服避孕药物妈富隆(30μg炔雌醇+150μg去氧孕烯)与敏定偶(30μg炔雌醇+75μg孕二烯酮)的避孕效果和安全性。方法计算机检索MEDLINE(1990～2007),POPLINE(1990～2007),Cochran Central Register of Controlled Trials(CENTRAL)(2007年第2期),EMbase(1990～2007)和Cochrane图书馆(2007年第2期),并手工检索4种相关杂志,纳入妈富隆与敏定偶比较的随机对照试验。由两名评价员独立进行质量评价和资料提取。采用RevMan4.2进行Meta分析。结果共纳入6篇符合纳入标准的已发表文献,包括3143例受试者。Meta分析结果显示,妈富隆和敏定偶避孕有效性的差异无统计学意义(P>0.05);随访6个月妈富隆不规则出血率高于敏定偶,其差异有统计学意义[RR=1.50,95%CI(1.27,1.78);P<0.00001];随访6个月妈富隆除呕吐不良反应率较低外[RR=0.18,95%CI(0.04,0.78);P=0.02],其余不良反应率(头痛、乳房胀痛、紧张、静脉曲张、性交不适、黄褐斑、水肿)均高于敏定偶;随访6个月两者停药率差异无统计学意义。结论妈富隆和敏定偶避孕有效性相当,但使用后者对月经的影响和其他不良反应相对较少。由于观察例数和时间有限,上述结论仍需高质量的随机对照试验来证实。

Objective To compare and evaluate the effectiveness and safety of 30 μg ethinyl estradiol/150 μg desogestrel versus 30 μg ethinyl estradiol/75 μg gestodene. Methods We searched MEDLINE （1990 to 2007）, EMBASE （1990 to 2007）, POPLINE （1990 to 2007）, Cochrane Central Register of Controlled Trials （Issue 2, 2007）, EMBASE （1990 to 2007） and The Cochrane Library （Issue 2, 2007）. Four relevant journals were also hand searched. Randomized controlled trials （RCTs） comparing ethinyl estradiol with desogestrel were collected. The quality of the included studies was assessed and data were collected by two reviewers independently. Meta-analyses were performed with The Cochrane Collaboration＇s RevMan 4.2.10 software. Results Six studies involving 3,143 patients were included. Meta-analyses found no significant difference in contraceptive effect between 30μg ethinyl estradiol/150 μg desogestrel and 30μg ethinyl estradiol/75 μg gestodene （P〉0.05）. During six months of follow-up, patients receiving 30 μg ethinyl estradiol/150 μg desogestrel had a higher incidence of irregular bleeding （RR 1.50, 95%CI 1.27 to 1.78; P〈0.000 01）; and a lower incidence of vomiting （RR 0.18, 95%CI 0.04 to 0.78; P=0.02]; but higher incidences of breast tenderness, nervousness, headache, chloasma, edema, dyspareunia and varicose （RR 1.23 to 2.69; 95%CI 1.02 to 6.37, P〈0.05）. No significant differences were noted in discontinuation between 30 μg ethinyl estradiol/150 μg desogestrel and 30 μg ethinyl estradiol/75 μg gestodene. Conclusion Ethinyl estradiol was similar to desogestrel in terms of the contraceptive effect, while the use of desogestrel might be associated with less irregular bleeding and other common adverse events. As the existing data have a high risk of bias, the current evidence is insufficient and further high-quality randomized controlled trials are needed.