|国家科技期刊平台
首页|期刊导航|现代妇产科进展|地诺孕素治疗子宫腺肌病疗效与安全性meta分析

地诺孕素治疗子宫腺肌病疗效与安全性meta分析OACSTPCD

Meta-analysis of efficacy and safety of dienogest in the treatment of adenomyosis

中文摘要英文摘要

目的:系统评价地诺孕素治疗子宫腺肌病的疗效及安全性,为临床用药提供循证依据.方法:计算机检索PubMed、EMbase、Cochrane Library、中国生物医学文献数据库、CNKI和万方数据库,检索时限均为建库至2023 年7 月30 日,纳入地诺孕素(试验组)对比阳性药物或安慰剂(对照组)治疗子宫腺肌病的随机对照研究(RCT).筛选文献、提取资料后采用Cochrane 5.1.0 偏倚风险评估工具对纳入文献质量进行评价,采用Rev Man 5.3 统计软件进行meta分析.结果:纳入10 篇RCT研究,共820 例患者.Meta分析结果显示,试验组较对照组VAS 评分显著降低(SMD=-2.50,95%CI 为-4.73~-0.27,P=0.03),对于子宫体积变化疗效相当(MD=0.24,95%CI为-0.87~1.36,P= 0.67),试验组的临床有效率显著高于对照组(RR = 1.30,95%CI 为 1.19~1.41,P<0.01),患者的CA125 水平两者差异不大(MD =-4.25,95%CI 为-13.16~4.66,P = 0.35),两者的潮热副反应发生率(RR=0.72,95%CI为 0.03~15.53,P=0.83)、异常子宫出血发生率(RR=2.11,95%CI为0.87~5.15,P=0.10)相当.结论:地诺孕素组的疼痛缓解较安慰剂组有明显优势,与阳性对照组相比,疗效差别不大;临床有效率显著高于阳性对照组,子宫体积变化、CA125 水平与阳性对照组和安慰剂组疗效均相当;安全性方面,潮热副反应发生率与阳性对照组和安慰剂组均相当,异常子宫出血的发生率与阳性对照组相当,但显著高于安慰剂组,因此应用地诺孕素时要警惕子宫出血的风险.未来仍需大规模随机对照研究去验证.

Objective:To systematically evaluate the efficacy and safety of dienogest in the treatment of adenomyosis,so as to provide an evidence-based basis for the treatment of ade-nomyosis.Methods:Retrieved from PubMed,Embase,Cochrane Library,CBM,CNKI and Wan-fang database(searched from inception to July 30,2023),randomized controlled trials(RCTs)about dienogest(trial group)versus positive drugs or placebo(control group)in the treatment of adenomyosis were collected.The quality of included literature was screened,extracted and eval-uated by Cochrane 5.1.0 risk of bias assessment tool,and meta-analysis was performed using Rev Man 5.3 software.Results:A total of 10 RCTs were included,including 820 patients.Meta-analysis showed that the VAS score of trial group was significantly lower than that of control group(SMD=-2.50,95%CI:-4.73~-0.27,P=0.03).There was no statistical significance in the changes of uterine volume between dienogest group and control group(MD=0.24,95%CI:-0.87~1.36,P=0.67),the clinical response rate in trial group was significantly higher than that in control group(RR=1.30,95%CI:1.19~1.41,P<0.01).There was little differ-ence in CA125 levels between the two groups(MD =-4.25,95%CI:-13.16~4.66,P = 0.35).The incidence of hot flashes(RR=0.72,95%CI:0.03~15.53,P=0.83)and abnor-mal uterine bleeding(RR=2.11,95%CI:0.87~5.15,P=0.10)were similar between the two groups.Conclusion:Compared with the control group,the trial group had better pain relief and higher clinical response,comparable changes in uterine volume and CA125 levels.In terms of safety,the incidence of side effects of hot flushes was similar.The incidence of abnormal uterine bleeding was comparable to that of the positive control group,but was significantly higher than that of the placebo group,so the risk of uterine bleeding should be vigilant when using dinorg-estrel.Large-scale RCTs are needed to evaluate the effect in the future.

张毅;张瑞;张俊珂;郝洁;刘克锋

郑州大学第一附属医院药学部,郑州 450052郑州大学第一附属医院药学部,郑州 450052||河南省药品临床综合评价中心,郑州 450052

临床医学

地诺孕素子宫腺肌病Meta分析

DienogestAdenomyosisMeta-analysis

《现代妇产科进展》 2024 (005)

345-351 / 7

10.13283/j.cnki.xdfckjz.2024.05.033

评论