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作 者:阮洁 朱青梅[1] 李静[1] 李红玲[1] 赵军[1] RUAN Jie;ZHU Qingmei;LI Jing;LI Hongling;ZHAO Jun(The First Affiliated Hospital of Xinjiang Medical University,Urumqi,Xinjiang,China 830011)
机构地区:[1]新疆医科大学第一附属医院,新疆乌鲁木齐830011
出 处:《中国药业》2023年第10期109-116,共8页China Pharmaceuticals
基 金:国家重点研发计划[2017YFC0910001]。
摘 要:目的系统评价桂枝茯苓胶囊(丸/汤)联合孕三烯酮治疗子宫内膜异位症(EMT)的临床疗效及安全性。方法计算机检索PubMed、Embase、The Cochrane Library,中国知网(CNKI)、维普(VIP)、万方(WanFang)数据库,中国生物医学文献数据库(CBM),收集该联合治疗的随机对照试验(RCT)文献,检索时限为各数据库自建库起至2022年3月31日。采用RevMan 5.3软件对纳入文献进行Meta分析,并采用GRADE证据质量分级系统对结局指标的证据质量进行评级。结果共纳入17篇文献,涉及患者1623例。总有效率、复发率、妊娠率、糖类抗原125(CA125)水平和不良反应发生率为中等质量证据,其余指标均为极低质量证据。Meta分析结果显示,桂枝茯苓胶囊(丸/汤)联合孕三烯酮相较单用孕三烯酮,可明显提高总有效率、妊娠率(P<0.01),明显降低视觉模拟量表(VAS)评分、复发率、雌二醇水平、CA125水平、不良反应发生率(P<0.01),但不同疗法患者的卵泡刺激素(FSH)和黄体生成素(LH)水平相当(P=0.43,0.09)。结论桂枝茯苓胶囊(丸/汤)联合孕三烯酮治疗EMT的疗效优于单用孕三烯酮,且不良反应发生率低,用于改善患者的临床症状和提高生活质量安全有效。但该结论仍需更多高质量的随机双盲试验验证。Objective To evaluate systematically the clinical efficacy and safety of Guizhi Fuling Capsules(Pills/Decoction)combined with gestrinone in the treatment of endometriosis(EMT).Methods Randomized controlled trials(RCTs)of Guizhi Fuling Capsules(Pills/Decoction)combined with gestrinone in the treatment of EMT in the PubMed,Embase,The Cochrane Library,CNKI,VIP,WanFang and CBM databases from the inception to March 31,2022 were searched.The RevMan 5.3 software was used to do Meta-analysis for the included RCTs,and the GRADE evidence quality grading system was used to evaluate the evidence quality of outcome indicators.Results A total of 17 RCTs were included,involving 1623 patients.The total effective rate,relapse rate,pregnancy rate,carbohydrate antigen 125(CA125)level and incidence of adverse drug reaction(ADR)were evaluated as the medium-quality evidence,while the other indicators were evaluated as the very low-quality evidence.The results of Meta-analysis showed that compared with those in patients treated by gestrinone alone,the total effective rate and pregnancy rate in patients treated by Guizhi Fuling Capsules(Pills/Decoction)combined with gestrinone increased significantly(P<0.01),the Visual Analogue Scale(VAS)score,relapse rate,estradiol(E_(2))level,CA125 level and incidence of ADR in patients treated by Guizhi Fuling Capsules(Pills/Decoction)combined with gestrinone decreased significantly(P<0.01).However,the levels of follicle stimulating hormone(FSH)and luteinizing hormone(LH)in patients treated by different treatment methods were similar(P=0.43,0.09).Conclusion Compared with gestrinone alone,Guizhi Fuling Capsules(Pills/Decoction)combined with gestrinone is more effective and safer(lower incidence of ADR)in the treatment of EMT,which can improve the clinical symptoms and the quality of life of patients.However,these conclusions still need to be confirmed by more high-quality randomized double-blind trials.
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