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当归六黄汤联合抗甲状腺药物治疗甲状腺功能亢进症的疗效和安全性:一项系统评价与Meta分析

Efficacy and safety of Danggui Liuhuang Decoction combined with antithyroid drugs for hyperthyroidism: A systematic review and meta-analysis.

作者信息

Wei Maoying, Jia Weiyu, Jiang Yijia, Dong Chenlu, Wang Churan, Tang Yiting, Zhang Wenhua, Yin Dan, Guo Jingyi, Li Aijing, Gong Yanbing

机构信息

Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.

Beijing University of Chinese Medicine, Beijing, 100029, China.

出版信息

J Ethnopharmacol. 2025 Feb 11;341:119253. doi: 10.1016/j.jep.2024.119253. Epub 2024 Dec 26.

DOI:10.1016/j.jep.2024.119253
PMID:39732298
Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Hyperthyroidism is a prevalent clinical endocrine disorder. Danggui Liuhuang Decoction (DGLHD), a traditional Chinese herbal medicine formula, has shown potential benefits for patients with hyperthyroidism in recent studies. However, the clinical efficacy and safety of DGLHD have not been systematically evaluated. To address this, a systematic review and meta-analysis are necessary to comprehensively evaluate its efficacy and safety in treating hyperthyroidism.

AIM OF THE STUDY

To evaluate the efficacy and safety of DGLHD in treating hyperthyroidism.

MATERIALS AND METHODS

A comprehensive search of eight databases was conducted from their inception to November 2023 to identify randomized controlled trials (RCTs) comparing DGLHD combined with antithyroid drugs (ATDs) to ATDs alone. The quality of the included studies was assessed using the Cochrane Risk of Bias Assessment Tool. A meta-analysis was conducted using Revman 5.3 software, while publication bias was evaluated with Stata 16.0 software. The certainty of the evidence was assessed using the GRADE system.

RESULTS

Overall, 20 RCTs involving 1757 patients with hyperthyroidism were included in this analysis. The methodological quality was generally low. The meta-analysis revealed that, compared to ATDs alone, the combination of DGLHD with ATDs was more effective in reducing free triiodothyronine (FT3) [standardized mean difference (SMD) = -0.80, 95% confidence interval (CI): -1.31 to -0.28, P = 0.002], free thyroxine (FT4) [SMD = -1.47, 95% CI: -1.99 to -0.94, P < 0.00001], Traditional Chinese Medicine (TCM) syndrome scores [mean difference (MD) = -3.65, 95% CI: -4.68 to -2.62, P < 0.00001], and adverse events [relative risk (RR) = 0.23, 95% CI: 0.15 to 0.36, P < 0.00001]. Additionally, combining DGLHD with ATDs led to an improvement in thyroid-stimulating hormone (TSH) levels [SMD = 2.75, 95% CI: 1.37 to 4.13, P < 0.0001] and increased the effectiveness rate of TCM syndrome [RR = 1.20, 95% CI: 1.08 to 1.34, P = 0.001]. However, other outcomes, such as recurrence rates and quality of life scores, could not be analyzed through meta-analysis owing to the limited number of included studies.

CONCLUSION

Combining DGLHD with ATDs may alleviate clinical symptoms, enhance thyroid function, and reduce adverse events in patients with hyperthyroidism. Moreover, this treatment appears to be safe for clinical use. However, owing to the limited quantity and quality of the included studies, these conclusions require further validation through more large-sample, multicenter, high-quality RCTs.

摘要

民族药理学相关性

甲状腺功能亢进症是一种常见的临床内分泌疾病。当归六黄汤(DGLHD),一种传统的中药配方,在最近的研究中已显示出对甲状腺功能亢进症患者的潜在益处。然而,当归六黄汤的临床疗效和安全性尚未得到系统评价。为解决这一问题,有必要进行系统评价和荟萃分析,以全面评估其治疗甲状腺功能亢进症的疗效和安全性。

研究目的

评估当归六黄汤治疗甲状腺功能亢进症的疗效和安全性。

材料与方法

对八个数据库从建库至2023年11月进行全面检索,以识别比较当归六黄汤联合抗甲状腺药物(ATD)与单纯抗甲状腺药物的随机对照试验(RCT)。使用Cochrane偏倚风险评估工具对纳入研究的质量进行评估。使用Revman 5.3软件进行荟萃分析,同时使用Stata 16.0软件评估发表偏倚。使用GRADE系统评估证据的确定性。

结果

总体而言,本分析纳入了20项涉及1757例甲状腺功能亢进症患者的RCT。方法学质量普遍较低。荟萃分析显示,与单纯抗甲状腺药物相比,当归六黄汤联合抗甲状腺药物在降低游离三碘甲状腺原氨酸(FT3)[标准化均数差(SMD)=-0.80,95%置信区间(CI):-1.31至-0.28,P=0.002]、游离甲状腺素(FT4)[SMD=-1.47,95%CI:-1.99至-0.94,P<0.00001]、中医证候评分[均数差(MD)=-3.65,95%CI:-4.68至-2.62,P<0.00001]和不良事件[相对危险度(RR)=0.23,95%CI:0.15至0.36,P<0.00001]方面更有效。此外,当归六黄汤联合抗甲状腺药物可使促甲状腺激素(TSH)水平得到改善[SMD=2.75,95%CI:1.37至4.13,P<0.0001],并提高中医证候有效率[RR=1.20,95%CI:1.08至1.34,P=0.001]。然而,由于纳入研究数量有限,无法通过荟萃分析分析其他结局,如复发率和生活质量评分。

结论

当归六黄汤联合抗甲状腺药物可能减轻甲状腺功能亢进症患者的临床症状,改善甲状腺功能,并减少不良事件。此外,这种治疗方法在临床使用中似乎是安全的。然而,由于纳入研究的数量和质量有限,这些结论需要通过更多大样本、多中心、高质量的RCT进一步验证。

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