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用于HIV/AIDS患者药物性肝损伤的中草药:随机对照试验的系统评价

Chinese herbal medicine for drug-induced liver injury in patients with HIV/AIDS: A systematic review of randomized controlled trials.

作者信息

Zhang Xiao-Wen, Li Jing, Hou Wen-Bin, Jiang Yue, Zheng Ruo-Xiang, Xu De-Hao, Shen Chen, Robinson Nicola, Liu Jian-Ping

机构信息

Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China.

Beijing Key Laboratory of the Innovative Development of Functional Staple and the Nutritional Intervention for Chronic Disease, China National Research Institute of Food & Fermentation Industries co,.ltd, Beijing 100015, China.

出版信息

Integr Med Res. 2023 Mar;12(1):100918. doi: 10.1016/j.imr.2022.100918. Epub 2022 Dec 23.

Abstract

BACKGROUND

To explore the effectiveness and safety of Chinese herbal medicine (CHM) for drug-induced liver injury (DILI) in patients with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS).

METHODS

A systematic search was made of eight databases (Pubmed, Cochrane Library, Web of Science, Embase, CNKI, Wanfang, VIP, Sinomed) and two trial registries (WHO ICTRP, ClinicalTrials.gov) from inception to September 2022. The effect size was presented as risk ratio (RR) or mean difference (MD) with their 95% confidence interval (CI). The Cochrane Risk of Bias and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tools were used for quality appraisal.

RESULTS

Ten randomized controlled trials (RCTs) involving 732 participants were included. Comparing CHM alone with routine treatment, the CHM group showed lower aspartate aminotransferase (MD=-11.47 U/L, 95%CI[-13.05, -9.89], low certainty), lower alanine aminotransferase (MD=-2.68 U/L, 95%CI[-4.27, -1.08], low certainty), lower total bilirubin (MD=-4.31 mmol/L, 95%CI[-5.66, -2.96], low certainty), lower bilirubin direct (MD=-3.19 mmol/L, 95%CI[-3.87, -2.51], low certainty), and higher effective rate (assessed by symptoms and liver indicators) (RR=1.13, 95%CI[1.06, 1.20], low certainty). A significant difference was also found in CHM plus routine treatment versus routine treatment in the previous outcomes. No significant difference was found on helper T cells among these comparisons. Only one RCT reported safety of CHM and found no adverse reaction during the trial.

CONCLUSIONS

CHM may improve the liver function indices and effective rate for HIV/AIDS patients with DILI. However, the sample size was small and quality was low. Larger-samples of high-quality trials are needed.

摘要

背景

探讨中药治疗人类免疫缺陷病毒(HIV)/获得性免疫缺陷综合征(AIDS)患者药物性肝损伤(DILI)的有效性和安全性。

方法

对8个数据库(PubMed、Cochrane图书馆、科学网、Embase、中国知网、万方、维普、中国生物医学文献数据库)和2个试验注册库(世界卫生组织国际临床试验注册平台、美国国立医学图书馆临床试验注册库)进行系统检索,检索时间从建库至2022年9月。效应量以风险比(RR)或均值差(MD)及其95%置信区间(CI)表示。采用Cochrane偏倚风险评估工具和推荐意见分级、评估、制定与评价(GRADE)工具进行质量评价。

结果

纳入10项随机对照试验(RCT),共732例参与者。单独使用中药与常规治疗相比,中药组天门冬氨酸氨基转移酶较低(MD=-11.47 U/L,95%CI[-13.05, -9.89],低确定性),丙氨酸氨基转移酶较低(MD=-2.68 U/L,95%CI[-4.27, -1.08],低确定性),总胆红素较低(MD=-4.31 mmol/L,95%CI[-5.66, -2.96],低确定性),直接胆红素较低(MD=-3.19 mmol/L,95%CI[-3.87, -2.51],低确定性),有效率较高(根据症状和肝脏指标评估)(RR=1.13,95%CI[1.06, 1.20],低确定性)。在上述结局方面,中药联合常规治疗与常规治疗相比也存在显著差异。这些比较中辅助性T细胞无显著差异。仅1项RCT报告了中药的安全性,试验期间未发现不良反应。

结论

中药可能改善HIV/AIDS合并DILI患者的肝功能指标和有效率。然而,样本量小且质量低。需要开展更大样本量的高质量试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b2d8/9826828/04160b0c56b0/gr1.jpg

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