古子娟 卢如玲 袁烁 邓高丕

[摘要] 目的 評价散结镇痛胶囊联合左炔诺孕酮宫内节育系统（曼月乐）治疗子宫腺肌病的效果及安全性。 方法 计算机检索中国知网、万方、维普、CBM、Pubmed、The Cochrane Library、The Web of Science中英文数据库关于散结镇痛胶囊联合曼月乐治疗子宫腺肌病的随机对照试验，各个数据库检索时间均由建库至2017年12月10日。分为散结镇痛胶囊联合曼月乐组、单用曼月乐组两组，观察指标：总有效率、病灶缩小率、痛经评分、子宫内膜厚度、血清CA125水平。对符合纳入和排除标准的文献进行数据提取及方法学质量评价，并采用RevMan 5.3软件作Meta分析。结果 共纳入文献6篇，包括602例患者。Meta分析结果示：散结镇痛胶囊联合曼月乐组与单用曼月乐组对比，联合用药组总有效率更高（OR=5.38，95%CI：[3.01，9.63]，P < 0.000 01），病灶缩小率（OR=17.94，95%CI：[7.47，43.10]，P < 0.000 01）、痛经评分（MD =-1.72，95%CI：[-3.37，-0.07]，P = 0.04）、子宫内膜厚度（MD=-1.52，95%CI：[-1.77，-1.27]，P < 0.000 01）、血清CA125水平（MD =-5.74，95%CI：[-8.12，-3.35]，P < 0.000 01）等指标改善程度均优于单药组，且未出现明显不良反应。 结论 现有证据显示散结镇痛胶囊联合曼月乐治疗子宫腺肌病效果显著，能明显改善患者的痛经评分、病灶大小、子宫内膜厚度、血清CA125等指标，提高总有效率，可供临床参考借鉴。

[关键词] 散结镇痛胶囊；曼月乐；子宫腺肌病；Meta分析

[中图分类号] R711.71 [文献标识码] A [文章编号] 1673-7210（2018）02（c）-0088-06

Meta analysis of the efficacy of San Jie Zhen Tong Capsules combined with Levonorgestrel Intrauterine System in treatment of adenomyosis

GU Zijuan1 LU Ruling2 YUAN Shuo2 DENG Gaopi2

1.Guangzhou University of Traditional Chinese Medicine， Guangdong Province， Guangzhou 510405， China； 2. Women and Children Center the second Department of Gynecology， the First Affiliated Hospital of Guangzhou University of Chinese Medicine， Guangdong Province， Guangzhou 510405， China

[Abstract] Objective To evaluate the clinical efficacy and safety of San Jie Zhen Tong Capsules combined with Levonorgestrel Intrauterine System in the treatment of adenomyosis. Methods Published papers about randomized controlled trials （RCTs） of San Jie Zhen Tong Capsules combined with Levonorgestrel Intrauterine System in the treatment of adenomyosis from the establishment of the database till December 10， 2017 with language restriction of Chinese and English were searched from various databases， which included PubMed， the Cochrane Library， Web of Science， CBM， Wanfang Data， CNKI， VIP. The subjects were divided into two groups， including Sanjie Zhentong capsules combined with Levonorgestrel Intrauterine System group and mere Levonorgestrel Intrauterine System group. Moreover， the observations including the total efficiency and the indexes of Lesion reduction rate and dysmenorrhea score and endometrial thickness and serum CA125 levels. In addition， a Meta-analysis was conducted with Review Manager 5.3 software. Results Six articles involving 602 patients were included. The Meta-analysis showed that there was a significantly positive effect of San Jie Zhen Tong Capsules combined with Levonorgestrel Intrauterine System in the treatment of adenomyosis. Conclusion San Jie Zhen Tong Capsules combined with Levonorgestrel Intrauterine System can improve not only the indexes of Lesion reduction rate （OR=17.94， 95%CI： [7.47， 43.10]， P < 0.000 01）， Dysmenorrhea score （MD=-1.72， 95%CI： [-3.37， -0.07]， P=0.04）， Endometrial thickness （MD =-1.52， 95%CI： [-1.77， -1.27]， P < 0.000 01）， Serum CA125 levels （MD =-5.74， 95%CI： [-8.12， -3.35]， P < 0.000 01）， but also the total efficiency （OR=5.38， 95%CI： [3.01， 9.63]， P < 0.000 01） and it seems to have no obvious adverse reactions. Conclusion The evidences support that San Jie Zhen Tong Capsules combined with Levonorgestrel Intrauterine System have potential advantages compared to mere Levonorgestrel Intrauterine System therapy in the treatment of adenomyosis.

[Key words] San Jie Zhen Tong Capsules； Levonorgestrel Intrauterine System； Adenomyosis； Meta-analysis

子宫腺肌病是育龄期女性常见而难治的疾病之一，临床主要表现为继发性渐进性加重的痛经、月经量过多、经期延长[1]。对无生育要求或症状严重或药物保守治疗无效者，切除子宫可达到根治的目的。但对于年轻、有生育要求的患者则需要选择安全有效的保守治疗措施。左炔诺孕酮宫内节育系统属于宫腔内孕激素释放系统装置，又称为曼月乐，呈T型支架样，主要含有左炔诺孕酮成分，能降低子宫内膜对血液循环中雌二醇的敏感性，从而起到强力的拮抗内膜增生的作用，起到减少性激素分泌、减少月经量、调节性激素水平的作用[2]。……