左炔诺孕酮宫内释放系统用于治疗子宫内膜异位症的疗效和安全性Meta分析

Levonorgestrel Releasing Intrauterine System for the Treatment of Endometriosis: A Meta-Analysis

摘要: 目的：采用循证医学方法评价左炔诺孕酮宫内释放系统节育器(levonorgestrel-releasing intrauterine system, LNG-IUS)治疗子宫内膜异位症的安全性及有效性。方法：通过计算机检索pubmed、embase、cochrane library等英文数据库及中国生物文献数据库、中国知网、维普、万方等中文数据库，检索时间由各大数据库建立至2021年2月，同时辅助其他检索方式，所检索文献由两名系统评价者独立评价纳入研究并提取资料，并用Revman软件进行meta分析。结果：共纳入14项研究，通过meta分析显示，与短效口服避孕药相比，LNG-IUS可明显缓解患者痛经程度(MD = −1.37, 95% CI = −2.17~−0.57, P = 0.0008)，降低血清CA125水平(MD = −4.76, 95% CI = −7.21~−2.32, P = 0.0001)，缩小子宫体积(SMD = −1.14, 95% CI = −2.24~−0.05, P = 0.04)，两者均有改善月经量的作用(MD = −10.64, 95% CI = −30.01~8.74, P > 0.05)，但没有统计学差异；与促性腺激素释放激素激动剂相比，均有改善患者痛经和缩小子宫体积的作用(MD = −0.57, 95% CI = −1.34~0.2, P = 0.14; MD = −26.92, 95% CI = −28.03~20.85, P = 0.77)，但两者作用相当，没有明显统计学差异。但是GnRH-a在使用过程中出现不良反应的概率明显高于LNG-IUS (OR = 0.19, 95% CI = 0.09~0.44, P < 0.00001)，且在减少月经量方面没有LNG-IUS有效(MD = −13.39, 95% CI = −22.2~−4.58, P = 0.003)；而在与孕三烯酮对比过程中发现，LNG-IUS在改善痛经程度(MD = −0.63, 95% CI = −0.95~−0.31, P = 0.001)、缩小子宫体积(SMD = −1.38, 95% CI = −2.31~−0.46, P = 0.003)、减少月经量(MD = −20.27, 95% CI = −26.1~−14.52, P < 0.00001)方面均优于孕三烯酮，且不良反应更少(OR = 0.19, 95% CI = 0.09~0.44, P < 0.00001)。结论：LNG-IUS对子宫内膜异位症的治疗效果较其他药物治疗更为显著，不良反应减少，在暂无生育要求且无LNG-IUS禁忌症患者中可作为首选。

Abstract: Objective: To evaluated the safety and efficacy of levonorgestrel releasing intrauterine system (LNG-IUS) in the treatment of endometriosis by evidence-based medicine. Methods: English databases such as PubMed, EMBASE, Cochrane Library and Chinese databases such as China biological literature database, CNKI, VIP, Wanfang were searched by computer. The retrieval time is from the establishment of major databases to February 2021. The retrieved articles were independently evaluated by two reviewers. The data were extracted and meta-analysis was performed by Revman software. Results: There are 14 studies were included. Meta analysis showed that compared with oral contraceptives, LNG-IUS could significantly relieve dysmenorrhea (MD = −1.37, 95% CI = −2.17~−0.57, P = 0.0008), reduce serum CA125 level (MD = −4.76, 95% CI = −7.21~−2.32, P = 0.0001), reduce uterine volume (SMD = −1.14, 95% CI = −2.24~−0.05, P = 0.04). And both of them could improve menstrual volume with no statistical difference (MD = −1.14, 95% CI = −2.24~−0.05, P = 0.04). Compared with gonadotropin-releasing hormone, LNG-IUS had the same effect of improvin dysmenorrhea and reducing uterine volume (MD= −0.57, 95% CI= −1.34~0.2, P= 0.14; MD= −26.92, 95% CI = −28.03~20.85, P = 0.77), lower incidence of adverse reactions (OR = 0.19, 95% CI = 0.09~0.44, P < 0.00001) and better effect of reducing menstruation (MD = −13.39, 95% CI = −22.2~−4.58, P = 0.003). Compared with gestrinone, LNG-IUS was superior to gestrinone in improving dysmenorrhea (MD = −0.63, 95% CI = −0.95~−0.31, P = 0.001), reducing uterine volume (SMD = −1.38, 95% CI = −2.31~−0.46, P = 0.003) and reducing menstrual volume (MD = −20.27, 95% CI = −26.1~−14.52, P < 0.00001) with fewer adverse reactions (OR = 0.19, 95% CI = 0.09~0.44, P < 0.00001). Conclusion: LNG-IUS was more effective than other drugs in the treatment of endometriosis, with less adverse reactions. It could be used as the first choice in patients with no fertility requirements or no contraindications of LNG-IUS.