Evaluation of Evidence Grades and Reflections on 9 Commonly Used Chinese Patent Medicines for Treating Hashimoto's Thyroiditis Based on the Integrated Evidence Chain

doi:10.12114/j.issn.1007-9572.2025.0350

Chinese General Practice ›› 2026, Vol. 29 ›› Issue (36): 5401-5408.DOI: 10.12114/j.issn.1007-9572.2025.0350

• Original Research·Research Trends of Traditional Chinese Medicine • Previous Articles

Evaluation of Evidence Grades and Reflections on 9 Commonly Used Chinese Patent Medicines for Treating Hashimoto's Thyroiditis Based on the Integrated Evidence Chain

1. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
2. Beijing University of Chinese Medicine, Beijing 100029, China
3. Thyroid Disease Hospital, Sun Simiao Hospital of Beijing University of Chinese Medicine, Tongchuan 727100, China
4. Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China
5. Hainan Medical University, Haikou 571199, China

Received:2025-04-10 Revised:2025-11-20 Published:2026-12-20 Online:2026-10-30
Contact: DING Zhiguo

基于整合证据链评价9种常用中成药治疗桥本甲状腺炎证据等级及思考

1．100700　北京市，北京中医药大学东直门医院
2．100029　北京市，北京中医药大学
3．727100　陕西省铜川市，北京中医药大学孙思邈医院甲状腺病院
4．100102　北京市，中国中医科学院望京医院
5．571199　海南省海口市，海南医科大学

通讯作者: 丁治国
作者简介:
作者贡献：
邓洪枭负责研究整体方案设计，完成论文初稿的撰写与修改；司新颖负责文献筛选标准制订、临床经验类证据的梳理与分级；魏光成负责提供整合证据链评价方法的技术指导；焦格娜、李奇、陈智、户蕊负责文献数据的录入；祁烁负责研究文献质量评估；丁治国负责主导研究方向，对文章整体负责。
基金资助:
陕西省科学技术厅项目(2024JC-YBMS-676); 陕西省卫生健康委员会陕西省卫生健康高层次人才（团队）培育计划项目(陕卫人函〔2024〕192号)

Abstract

Abstract:

Background

At present, there are no specific drugs targeting the immune-dysregulation mechanisms underlying Hashimoto's thyroiditis (HT). Although Chinese patent medicines are widely used in the adjuvant therapy of HT, the grade of evidence-based evidence for their efficacy has not been systematically and standardizedly evaluated.

Objective

To evaluate the evidence grades of 9 commonly used CPMs for HT using the integrated evidence chain based effectiveness evaluation of traditional Chinese medicine (Eff-iEC), and provide evidence-based basis for HT treatment with traditional Chinese medicine.

Methods

Literatures on CPMs for HT were retrieved from CNKI, VIP and Wanfang Data (from database establishment to June 15, 2025). After screening by criteria, CPMs mentioned ≥5 times were identified as common ones. Their evidence grades were evaluated via Eff-iEC from three aspects: clinical experience (Grade A-D), experimental research (Grade A-D) and clinical trials (Grade A-D).

Results

A total of 178 literatures were initially screened, 69 were finally included, and 9 common CPMs were confirmed. Eff-iEC evaluation showed: Prunella vulgaris preparations were high-level evidence (AA+B), Tripterygium wilfordii preparations were intermediate-level evidence (BAB); Bailing Capsules (BB+B), Jinshuibao Capsules (BB+B), Xiaojin preparations (ACB), Huobahuagen Tablets (CDB), Yougui preparations (ADB), Buyuan Capsules (CDB) and Jinkui Shenqi Pills (ADB) were all low-level evidence.

Conclusion

Eff-iEC is an innovative tool for efficacy evaluation of traditional Chinese medicine. Among the 9 CPMs, Prunella vulgaris preparations have the highest evidence grade, followed by Tripterygium wilfordii preparations, and the rest have low grades. In addition, the Eff-iEC evaluation criteria need further improvement to enhance scientificity and clinical applicability.

Key words: Hashimoto's thyroiditis, Chinese patent drugs, Integrated evidence chain, Evidence grade, Evidence-based medicine

摘要：

背景

桥本甲状腺炎（HT）目前尚无针对其免疫紊乱发病机制的特效药物，中成药虽在HT辅助治疗中应用广泛，但其疗效的循证证据等级尚未经系统规范地评估。

目的

应用整合证据链（Eff-iEC）评价9种治疗HT常用中成药的证据等级，为HT中医药治疗提供循证依据。

方法

检索中国知网、维普网、万方数据知识服务平台（建库至2025-06-15）中中成药治疗HT的文献，按标准筛选后，统计提及频次≥5次的常用中成药，基于Eff-iEC从临床经验（A~D级）、实验研究（A~D级）、临床试验（A~D级）三方面评价证据等级。

结果

初筛178篇文献，最终纳入69篇，确定9种常用中成药。Eff-iEC评价显示：夏枯草制剂为高级证据（AA+B），雷公藤制剂为中级证据（BAB），百令胶囊（BB+B）、金水宝胶囊（BB+B）、小金制剂（ACB）、火把花根片（CDB）、右归制剂（ADB）、补元胶囊（CDB）、金匮肾气丸（ADB）均为低级证据。

结论

Eff-iEC是中医药疗效评价创新工具，9种中成药中夏枯草制剂证据等级最高，雷公藤制剂次之，其余证据等级较低。此外，Eff-iEC评价标准需进一步完善以提升科学性与临床适用性。

关键词: 桥本甲状腺炎, 中成药, 整合证据链, 证据等级, 循证医学

CLC Number:

R 581.4

DENG Hongxiao,SI Xinying,WEI Guangcheng, et al. Evaluation of Evidence Grades and Reflections on 9 Commonly Used Chinese Patent Medicines for Treating Hashimoto's Thyroiditis Based on the Integrated Evidence Chain[J]. Chinese General Practice, 2026, 29(36): 5401-5408. DOI: 10.12114/j.issn.1007-9572.2025.0350.
邓洪枭,司新颖,魏光成等. 基于整合证据链评价9种常用中成药治疗桥本甲状腺炎证据等级及思考[J]. 中国全科医学, 2026, 29(36): 5401-5408. DOI: 10.12114/j.issn.1007-9572.2025.0350.

Figures/Tables 3

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Evaluation of Evidence Grades and Reflections on 9 Commonly Used Chinese Patent Medicines for Treating Hashimoto's Thyroiditis Based on the Integrated Evidence Chain

基于整合证据链评价9种常用中成药治疗桥本甲状腺炎证据等级及思考

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药物名称	诊疗方案/指南/综述/Meta分析（篇）	临床/基础研究（篇）	合计（篇）
夏枯草制剂	26	14	40
百令胶囊	20	6	26
金水宝胶囊	14	2	16
小金制剂	8	2	10
火把花根片	9	0	9
右归制剂	7	0	7
补元胶囊	5	1	6
雷公藤多制剂	6	0	6
金匮肾气丸	5	1	6

药物名称	评价结果	证据等级
夏枯草制剂	AA+B	高级证据
百令胶囊	BB+B	低级证据
金水宝胶囊	BB+B	低级证据
小金制剂	ACB	低级证据
火把花根片	CDB	低级证据
右归制剂	ADB	低级证据
补元胶囊	CDB	低级证据
雷公藤制剂	BAB	中级证据
金匮肾气丸	ADB	低级证据

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