[关键词]
[摘要]
目的 系统评价保守性手术围术期应用亮丙瑞林治疗子宫腺肌病(AM)的临床有效性和安全性。方法 检索Cochrane Library、PubMed、Web of Science、Embase、ClinicalTrials.gov、中国临床试验注册中心(ChiCTR)、中国学术期刊全文数据库(CNKI)、万方数据库(Wanfang Data)、维普中文期刊全文数据库(VIP)和中国生物医学文献数据库(CBM),搜集围术期应用亮丙瑞林治疗AM的临床随机对照试验(RCT),检索时限为各数据库建库至2022年1月8日,两位研究者独立进行文献筛选、偏倚风险评价和资料提取,采用ReviewManager5.4.1软件进行Meta分析。结果 共纳入11项RCTs、包括1088例患者。Meta分析结果显示:术前应用亮丙瑞林能够减轻术后3个月痛经[SMD=-1.61,95%CI(-2.60,-0.63),P=0.001],减小术后3个月月经量[SMD=-1.02,95%CI(-1.43,-0.60),P<0.00001]和术后12个月月经量[SMD=-1.07,95%CI(-1.36,-0.79),P<0.00001],两组术后12个月痛经[SMD=-2.88,95%CI(-5.89,0.13),P=0.06]差异无统计学意义;术后应用亮丙瑞林能够减轻术后3个月痛经[SMD=-2.94,95%CI(-3.59,-2.29),P<0.00001]和12个月痛经[SMD=-1.53,95%CI(-2.51,-0.55),P<0.00001],减小术后3个月月经量[SMD=-0.62,95%CI(-1.06,-0.18),P=0.006]和12个月月经量[SMD=-7.93,95%CI(-9.12,-6.74),P<0.00001],差异有统计学意义。结论 术前应用亮丙瑞林可以提高手术安全性和有效率、促进术后康复,术后短期应用亮丙瑞林疗效显著并能够减少复发,术前或术后应用亮丙瑞林均可能出现药品不良反应,尚需开展更多高质量研究予以验证。
[Key word]
[Abstract]
Objective To systematically evaluate the clinical efficacy and safety of perioperative leuprolide application in conservative surgery for adenomyosis (AM).Methods Cochrane Library, PubMed, Web of Science, Embase, ClinicalTrials. gov, ChiCTR, CNKI, WanFang Data, VIP and CBM for related randomized controlled trials (RCTs) published before 8 January 2022 were searched. Two reviewers independently screened literature, assessed the risk of bias, and extracted data of included studies. Then meta-analysis was performed using ReviewManager 5.4.1 software.Results A total of 11 RCTs involving 1 088 patients were included. Compared with simple conservative surgical therapy, preoperative leuprolide application can moderate postoperative dysmenorrhea at 3rd month [SMD = -1.61, 95%CI (-2.60, -0.63), P = 0.001], reduce menstrual flow at 3rd month [SMD = -1.02, 95%CI (-1.43, -0.60), P <0.00001] and at 12th month [SMD = -1.07, 95%CI (-1.36, -0.79), P <0.00001], the difference was statistically significant. There was no significant difference in dysmenorrhea at 12th months [SMD = -2.88, 95%CI (-5.89, 0.13), P = 0.06] between the two groups after surgery; postoperative leuprolide application can moderate postoperative dysmenorrhea at 3rd month [SMD = -2.94, 95%CI (-3.59, -2.29), P <0.00001] and at 12th month [SMD = -1.53, 95%CI (-2.51, -0.55), P<0.00001], reduce menstrual flow at 3rd month [SMD = -0.62, 95%CI (-1.06, -0.18), P = 0.006] and 12th month [SMD = -7.93, 95%CI (- 9.12, - 6.74), P<0.000 01].Conclusions Preoperative leuprolide application safely improve the surgical efficacy and promote rehabilitation, short-term postoperative application of leuprolide has significant efficacy and can reduce recurrence, adverse drug reactions may occur in both protocols. More high-quality studies are required to verify the above conclusions.
[中图分类号]
R984;R969.3
[基金项目]
国家自然科学基金青年基金资助项目(81403321);江苏省中医药科技发展专项(2020ZX14);江苏省中医药科技发展计划项目(YB2020018);南京市玄武区兰园社区服务中心工作站建设项目(18-G2S-G22-003)