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雷公藤制剂治疗特应性皮炎的疗效评价:基于随机对照试验的贝叶斯分析

Tripterygium agents for the treatment of atopic eczema: A Bayesian analysis of randomized controlled trials.

机构信息

Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.

Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China.

出版信息

Phytomedicine. 2019 Jun;59:152914. doi: 10.1016/j.phymed.2019.152914. Epub 2019 Apr 4.

DOI:10.1016/j.phymed.2019.152914
PMID:30991183
Abstract

BACKGROUND

Atopic eczema is a common and recrudescent skin disorder. Tripterygium agents (TA), extracted from Tripterygium wilfordii hook F, a traditional Chinese medicine, have been used as a supplemental therapy for treating eczema empirically in recent years.

PURPOSE

To investigate the efficacy and safety of TA for treating atopic eczema.

STUDY DESIGN

Systematic review and Bayesian analysis.

METHODS

PubMed, Embase, Cochrane Central Register of Controlled Trials, CNKI, Chinese Scientific Journals Database, the Wan Fang Database, and Chinese Biomedicine databases were systematically searched from their respective inception dates to October 2, 2018. Randomized controlled trials (RCTs) related to TA used alone or in combination with other drugs were included. Meta-analysis was conducted by RevMan 5.3 software, and Bayesian analysis was performed in Stata 15.0 and R (V.3.4.0) package gemtc software. The Cochrane risk-of-bias tool and Jadad score were applied to assess the quality of all trials.

RESULTS

Thirteen trials involving 1385 patients were analyzed. Meta-analysis showed that, when treating atopic eczema patients, TA combined with other drugs were strongly synergistic (p < 0.00001). Among all combinations, the efficacy of TA combined with Diyin tablet (DYP) and topical glucocorticoids (TG) (RR: 0.06, 95%CI [0.01, 0.53]), as well as with compound glycyrrhizin (CG) (RR: 0.36, 95%CI [0.14,0.94]) was superior. Among the different combined medications, the best curative effect was achieved with TA combined with DYP and TG (98.2%), followed by TA combined with CG (85.3%), with TG (51.0%), or with Fuyang granule (FG) (49.9%). Reproductive system dysfunction was the main adverse events in patients treated with TA (RR: 6.23, 95%CI [1.12, 34.62]). Immunoglobulin E (IgE) levels were significantly decreased, after treatment with TA (p = 0.04). Subgroup analysis indicated no statistically significant difference in eczema-related cytokines (p = 0.44). Recurrence rates of using TA and other drugs were similar (p = 0.40).

CONCLUSION

TA appear to be effective in some therapies when treating patients with atopic eczema, but with apparent side effects. It cannot be concluded that TA can be generally used for eczema in the clinic, because of the small sample size. Further multi-center studies with large samples, and high-quality RCTs should be conducted to clarify the efficacy and safety of TA for treating eczema.

摘要

背景

特应性皮炎是一种常见且易复发的皮肤疾病。雷公藤制剂(TA)是从中药雷公藤中提取的,近年来已被用作治疗湿疹的辅助治疗方法。

目的

研究 TA 治疗特应性皮炎的疗效和安全性。

研究设计

系统评价和贝叶斯分析。

方法

系统检索 PubMed、Embase、Cochrane 对照试验中心注册数据库、中国知网、中国科学期刊数据库、万方数据库和中国生物医学文献数据库,检索时间均从建库至 2018 年 10 月 2 日。纳入 TA 单独或联合其他药物治疗特应性皮炎的随机对照试验(RCT)。采用 RevMan 5.3 软件进行荟萃分析,采用 Stata 15.0 和 R(V.3.4.0)包 gemtc 软件进行贝叶斯分析。采用 Cochrane 偏倚风险工具和 Jadad 评分评价所有试验的质量。

结果

共纳入 13 项研究,涉及 1385 例患者。荟萃分析结果显示,TA 联合其他药物治疗特应性皮炎患者时具有较强的协同作用(p<0.00001)。在所有联合用药中,TA 联合地榆片(DYP)和外用糖皮质激素(TG)(RR:0.06,95%CI [0.01,0.53])以及 TA 联合复方甘草酸苷(CG)(RR:0.36,95%CI [0.14,0.94])的疗效优于其他联合用药。不同联合用药中,以 TA 联合 DYP 和 TG(98.2%)的疗效最佳,其次是 TA 联合 CG(85.3%)、TG(51.0%)或扶阳颗粒(FG)(49.9%)。生殖系统功能障碍是 TA 治疗患者的主要不良事件(RR:6.23,95%CI [1.12,34.62])。TA 治疗后,免疫球蛋白 E(IgE)水平显著降低(p=0.04)。亚组分析结果显示,湿疹相关细胞因子无统计学差异(p=0.44)。TA 组和其他药物组的复发率无统计学差异(p=0.40)。

结论

TA 治疗特应性皮炎患者可能有效,但存在明显的副作用。不能得出 TA 可普遍用于临床治疗湿疹的结论,因为样本量较小。需要进一步开展多中心、大样本、高质量的 RCT 以明确 TA 治疗湿疹的疗效和安全性。

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