刘萍　张宸宇　夏长军　王宙　吴峰　陈剑　安秋冬　张艳

摘要：目的 系统评价小金胶囊治疗甲状腺结节的疗效及安全性。方法 检索CNKI、VIP、Wangfang、CBM、Cochrane Library、PubMed及EMBase中小金胶囊联合左甲状腺素钠片（优甲乐）治疗甲状腺结节的随机对照研究（RCT）。采用RevMan5.3软件对纳入研究进行Meta分析。结果 纳入9项RCT，共计779例研究对象。Meta分析结果显示小金胶囊联合优甲乐治疗甲状腺结节在提高总有效率和缩小最大结节直径方面均优于对照组，差异具有统计学意义;在sTSH、TSH方面，小金胶囊联合优甲乐治疗与单用优甲乐相比无明显差异。小金胶囊组不良反应主要是恶心呕吐、失眠等，经减少优甲乐剂量及对症治疗后均可好转，未发生严重不良反应。结论 小金胶囊能够提高甲状腺结节患者的临床疗效，安全性较好。

关键词：小金胶囊;甲状腺结节;Meta分析

中图分类号：R285.6   文献标志码：A   文章编号：1007-2349（2021）10-0045-07

【Abstract】Objective： To systematically evaluate the efficacy and safety of Xiaojin Capsules in the treatment of thyroid nodules patients. Methods： A randomized controlled study of CNKI， VIP， Wangfang， CBM， Cochrane Library， PubMed and EMBase was conducted to search Xiaojin Capsules combined with levothyroxine sodium tablets （Euthyrox） in the treatment of thyroid nodules. RevMan5.3 software was used to conduct Meta analysis of the included studies. Results： 9 RCTs were included， with a total of 779 subjects. The Meta analysis results showed that Xiaojin Capsule combined with Euthyrox in the treatment of thyroid nodules was superior to the control group in terms of increasing the total effective rate and reducing the maximum nodule diameter， and the difference was statistically significant. In terms of sTSH and TSH， Xiaojin Capsule combined with Euthyrox， there was no significant difference in the treatment compared with the single use of levothyroxine sodium tablets. The adverse reactions of the Xiaojin Capsule group were mainly nausea， vomiting， insomnia， etc.， and these reactions improved after reducing the dose of Euthyrox and symptomatic treatment， and no serious adverse reactions occurred. Conclusion： Xiaojin Capsule can improve the clinical effect of patients with thyroid nodules and has good safety.

【Key words】Xiaojin Capsule; Thyroid Nodules; Meta Analysis

甲状腺结节是一种常见的甲状腺疾病，我国大陆地区成人甲状腺结节发病率为24.0%～48.7%[1]，其中甲状腺癌占10%～15%[2]。甲状腺结节多为良性，但研究报道89%的患者未经治疗5年后结节体积增大至少15%[3]。结节较大时会对颈部美观产生影响，甚至压迫毗邻气管、食管及周围神经，从而出现呼吸/吞咽困难、声嘶等症状[4]。目前，口服优甲乐抑制TSH水平是临床中治疗甲状腺结节的主要手段[5-6]，但不良反应明显，患者依从性差[7]，而中医药治疗本病疗效显著，且可以减少不良反应的发生[8]。

小金胶囊是由《外科证治全生集》中记载的方剂小金丹化裁而成，由人工麝香、木鳖子（去壳去油）、制草乌、白胶香、醋乳香、醋没药、五灵脂（醋炙）、酒当归、地龙、香墨10种药物组成，具有消肿散结、化瘀止痛的功效[9]。……