Zhang Min, Chu Jiashuai, Xiu Chang, Bai Jing, Fan Lei
Discipline Inspection Commission Office, The Third Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China.
Graduate School, Heilongjiang University of Chinese Medicine, Harbin, China.
Medicine (Baltimore). 2025 Sep 12;104(37):e44483. doi: 10.1097/MD.0000000000044483.
This study aims to systematically assess the efficacy of Zhizi Qinggan Decoction combined with methimidazole tablets for the treatment of hyperthyroidism through a systematic review and meta-analysis, to provide evidence for clinical practice.
A computer search of both Chinese and English databases, including CNKI, WangFang, VIP, CBM, PubMed, Cochrane Library, Embase, and Web of Science, was conducted. The search period was from the establishment of the database to August 2024. Randomized controlled trials (RCTs) related to the treatment of hyperthyroidism with Zhizi Qinggan Decoction were collected. Two independent researchers conducted the literature search, selection, and quality assessment. A meta-analysis was conducted using Stata 14.0 software to evaluate various outcome indicators, including thyroid hormone levels, clinical effectiveness, and traditional Chinese medicine syndrome scores.
A total of 16 RCTs were included, involving 1320 patients with hyperthyroidism with an average age of 39.3 years. The meta-analysis results indicated that Zhizi Qinggan Decoction combined with Western medicine significantly improved outcomes in the treatment of hyperthyroidism compared to Western medicine alone. Specifically, the results for free triiodothyronine (standardized mean difference [SMD] = -0.79; 95% confidence interval [CI]: -1.11, -0.47; P < .0001), free thyroxine (SMD = -2.09; 95% CI: -2.91, -1.28; P < .0001), thyroid-stimulating hormone (SMD = 1.99; 95% CI: 1.00, 2.99; P < .0001), thyroid volume (SMD = -1.22; 95% CI: -1.84, -0.60; P < .001), clinical efficacy (odds ratio = 6.05; 95% CI: 3.85, 9.51; P < .0001), adverse reactions (odds ratio = 2.61; 95% CI: 1.52, 4.45; P < 0.001), and traditional Chinese medicine syndrome score (SMD = -1.85; 95% CI: -2.41, -1.28; P < .001) all showed statistically significant improvements (P < .001).
Current evidence suggests that the combination of Zhizi Qinggan Decoction and methimazole tablets provides good clinical therapeutic outcomes. However, further efforts are needed to strengthen the evidence supporting its clinical application through rigorous large-sample RCTs.
本研究旨在通过系统评价和荟萃分析，系统评估栀子清肝汤联合甲巯咪唑片治疗甲状腺功能亢进症的疗效，为临床实践提供依据。
对中国知网、万方、维普、中国生物医学文献数据库、PubMed、Cochrane图书馆、Embase和Web of Science等中英文数据库进行计算机检索。检索时间为各数据库建库至2024年8月。收集与栀子清肝汤治疗甲状腺功能亢进症相关的随机对照试验（RCT）。由两名独立研究人员进行文献检索、筛选和质量评估。使用Stata 14.0软件进行荟萃分析，以评估各项结局指标，包括甲状腺激素水平、临床疗效和中医证候评分。
共纳入16项RCT，涉及1320例甲状腺功能亢进症患者，平均年龄39.3岁。荟萃分析结果表明，与单纯西药治疗相比，栀子清肝汤联合西药治疗甲状腺功能亢进症的疗效显著提高。具体而言，游离三碘甲状腺原氨酸（标准化均数差[SMD]=-0.79；95%置信区间[CI]：-1.11，-0.47；P<0.0001）、游离甲状腺素（SMD=-2.09；95%CI：-2.91，-1.28；P<0.0001）、促甲状腺激素（SMD=1.99；95%CI：1.00，2.99；P<0.0001）、甲状腺体积（SMD=-1.22；95%CI：-1.84，-0.60；P<0.001）、临床疗效（比值比=6.05；95%CI：3.85，9.51；P<0.0001）、不良反应（比值比=2.61；95%CI：1.52，4.45；P<0.001）和中医证候评分（SMD=-1.85；95%CI：-2.41，-1.28；P<0.001）均显示有统计学意义的改善（P<0.001）。
现有证据表明，栀子清肝汤与甲巯咪唑片联合应用具有良好的临床治疗效果。然而，需要通过严格的大样本RCT进一步加强支持其临床应用的证据。
