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炔雌醇和依托孕烯避孕阴道环的疗效及副作用概况:一项系统评价和荟萃分析

Efficacy and side-effects profile of the ethinylestradiol and etonogestrel contraceptive vaginal ring: a systematic review and meta-analysis.

作者信息

López-Picado Amanda, Lapuente Oihane, Lete Iñaki

机构信息

a Araba Research Unit , Araba University Hospital , Vitoria , Spain.

b Bioaraba Research Institute , Vitoria , Spain.

出版信息

Eur J Contracept Reprod Health Care. 2017 Apr;22(2):131-146. doi: 10.1080/13625187.2017.1287351. Epub 2017 Feb 14.

Abstract

OBJECTIVE

To assess the efficacy and tolerability (side-effects profile), and compliance of the combined contraceptive vaginal ring (CCVR) compared with combined oral hormonal contraceptives (COC).

DATA SOURCES

The PubMed, Embase, POPLINE, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, ClinicalTrials.gov, Clinical Trials Registry Platform (ICTRP) and CINAHL databases were searched.

METHODS OF STUDY SELECTION

Electronic databases were searched for randomised clinical trials comparing the CCVR with COC with a duration of at least 3 months between 01 December and 15 December 2015. The primary outcome was efficacy. The secondary outcomes were compliance, absence of withdrawal bleeding, breakthrough bleeding, nausea and headache. Heterogeneity was assessed using I statistic and Cochran's Q statistic. Results were expressed as odds ratios (OR) with 95% confidence intervals (CIs) using random-effects models or fixed-effects models depending on the heterogeneity.

RESULTS

4368 records were identified, 2844 of which were removed after duplicates and 1524 records were screened. Of these, 1503 were excluded and 21 full text articles were assessed for eligibility. After removing another 7 articles, 14 records were finally included in the qualitative and quantitative analysis. The results show a trend to higher efficacy for the CCVR in preventing pregnancy (Peto OR: 0.52 [95% CI: 0.26-1.04]) and a significantly lower presence of nausea (Peto OR: 0.66 [95% CI: 0.46-0.93]). More cycles were compliant in the CCVR group (Peto OR: 1.22 [95% CI: 1.12-1.32]) and fewer women reported breakthrough bleeding (Peto OR: 0.68 [95% CI: 0.51-0.91]).

CONCLUSIONS

Our findings demonstrate that the CCVR is as effective and tolerable as the COC but with a better bleeding profile.

摘要

目的

评估复方避孕阴道环(CCVR)与复方口服激素避孕药(COC)相比的有效性、耐受性(副作用情况)及依从性。

数据来源

检索了PubMed、Embase、POPLINE、Cochrane对照试验中心注册库(CENTRAL)、拉丁美洲和加勒比卫生科学数据库(LILACS)、ClinicalTrials.gov、临床试验注册平台(ICTRP)及护理学与健康领域数据库(CINAHL)。

研究选择方法

检索电子数据库,查找2015年12月1日至12月15日期间比较CCVR与COC且持续时间至少3个月的随机临床试验。主要结局为有效性。次要结局为依从性、无撤退性出血、突破性出血、恶心和头痛。使用I统计量和 Cochr an Q统计量评估异质性。根据异质性,结果以随机效应模型或固定效应模型的比值比(OR)及95%置信区间(CI)表示。

结果

共识别出4368条记录,其中重复记录2844条被剔除,1524条记录被筛选。其中,1503条被排除,21篇全文文章被评估是否符合纳入标准。再剔除7篇文章后,最终14条记录被纳入定性和定量分析。结果显示,CCVR在预防妊娠方面有疗效更高的趋势(Peto OR:0.52 [95% CI:0.26 - 1.04]),恶心发生率显著更低(Peto OR:0.66 [95% CI:0.46 - 0.93])。CCVR组有更多周期的依从性良好(Peto OR:1.22 [95% CI:1.12 - 1.32]),报告突破性出血的女性更少(Peto OR:0.68 [95% CI:0.51 - 0.91])。

结论

我们的研究结果表明,CCVR与COC一样有效且耐受性良好,但出血情况更佳。

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