Data_Sheet_1_Effect and safety of drospirenone and ethinylestradiol tablets (II) for dysmenorrhea: A systematic review and meta-analysis.pdf

AimThis systematic review aimed to assess the efficacy and safety of Drospirenone and Ethinylestradiol Tablets (II) in the treatment of dysmenorrhea.
MethodsElectronic databases, namely PubMed, Embase, Cochrane Controlled Register of Trials (CENTRAL), Scopus, Science, CBM, CNKI, Wanfang, and VIP, were searched before September 2022. Randomized controlled trials (RCTs), non-randomized controlled trials, cohort studies, case-control studies, and single-arm studies were included. Furthermore, the Cochrane Risk of Bias Tool for Systematic Reviews version 1 was used for the risk of bias assessment on RCTs. The Risk of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool was used for risk of bias assessment on non-randomized studies. The risk ratio (RR) was calculated for dichotomous data. Mean difference (MD) or standardized MD (SMD) were used as the effect size for continuous data.
ResultsA total of 11 studies involving 2,251 participants with dysmenorrhea were included. When Drospirenone and Ethinylestradiol Tablets (II) conventional 24/4-day regimen was compared with placebo, the total efficiency rate (defined as pain symptom disappearing or being relieved) in Drospirenone and Ethinylestradiol Tablets (II) 24/4-day regimen group was higher than in placebo group (RR = 5.55, 95%CI: 2.48–12.39, P < 0.0001). No clear differences were found on risk of overall adverse events or specific adverse events. When Drospirenone and Ethinylestradiol Tablets (II) was compared with active control drugs, no clear differences were found on the total efficiency rate or visual analog scale (VAS) scores for dysmenorrhea and other related pain. The risk of overall adverse events decreased in Drospirenone and Ethinylestradiol Tablets (II) conventional 24/4-day regimen (13/53 vs. 66/148, RR = 0.55, 95%CI: 0.33–0.91) when compared with active control drugs group. When Drospirenone and Ethinylestradiol Tablets (II) flexible extended regimen was compared with conventional 24/4-day regimen, the number of days of dysmenorrhea (MD=−3.98, 95%CI: −5.69 to −2.27), and dysmenorrhea associated with unscheduled bleedings (MD = −1.6, 95%CI: −2.8 to −0.5), were fewer in flexible extended regimen. In addition, there were no differences found on risk of adverse events (including mood changes, spotting, headache, breast pain, nausea, and vomiting) between compared groups (P > 0.05).
ConclusionDrospirenone and Ethinylestradiol Tablets (II) could improve symptoms of dysmenorrhea and decrease other related pain symptoms. More high-quality evidence is needed to confirm the advantages.
Systematic review registration[https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021271605], identifier [CRD42021271605].

目的：本系统综述旨在评估屈螺酮炔雌醇片(II)（Drospirenone and Ethinylestradiol Tablets (II)）治疗痛经的有效性与安全性。
方法：本研究于2022年9月前检索PubMed、Embase、Cochrane对照试验注册库（Cochrane Controlled Register of Trials, CENTRAL）、Scopus、Science、中国生物医学文献数据库（CBM）、中国知网（CNKI）、万方数据知识服务平台及维普资讯（VIP）等电子数据库。纳入随机对照试验（randomized controlled trials, RCTs）、非随机对照试验、队列研究、病例对照研究及单臂研究。针对随机对照试验，采用Cochrane系统综述偏倚风险工具1.0版进行偏倚风险评估；针对非随机干预研究，采用非随机干预研究偏倚风险工具（Risk of Bias In Non-randomized Studies of Interventions, ROBINS-I）开展偏倚风险评价。二分类数据采用风险比（risk ratio, RR）进行效应量计算，连续性数据则采用均数差（mean difference, MD）或标准化均数差（standardized mean difference, SMD）作为效应指标。
结果：本研究共纳入11项研究，涉及2251名痛经受试者。将屈螺酮炔雌醇片(II)常规24/4天给药方案与安慰剂对照时，试验组总有效率（定义为疼痛症状消失或缓解）显著高于安慰剂组（RR=5.55，95%CI：2.48~12.39，P<0.0001）。两组总体不良事件及特定不良事件发生风险无显著差异。将屈螺酮炔雌醇片(II)与阳性对照药物对比时，两组总有效率、痛经及其他相关疼痛的视觉模拟评分（visual analog scale, VAS）均无显著差异。与阳性对照组相比，屈螺酮炔雌醇片(II)常规24/4天给药方案的总体不良事件发生风险降低（13/53 vs. 66/148，RR=0.55，95%CI：0.33~0.91）。将屈螺酮炔雌醇片(II)灵活延长给药方案与常规24/4天给药方案对比时，灵活延长组的痛经发作天数（MD=-3.98，95%CI：-5.69~-2.27）及非计划出血相关痛经次数（MD=-1.6，95%CI：-2.8~-0.5）均更少。两组不良事件发生风险（包括情绪改变、点滴出血、头痛、乳房胀痛、恶心及呕吐）无显著差异（P>0.05）。
结论：屈螺酮炔雌醇片(II)可改善痛经症状并减轻其他相关疼痛症状，尚需更多高质量研究证据验证其临床优势。
系统综述注册信息：[https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021271605]，注册号[CRD42021271605]。