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系统评价和网络荟萃分析干预措施预防抗结核药物性肝损伤的疗效和安全性。

Systematic review and network meta-analysis of efficacy and safety of interventions for preventing anti-tuberculosis drug induced liver injury.

机构信息

Master Degree of Clinical Pharmacy, Faculty of Pharmacy, Mahasarakham University, MahaSarakham, Thailand.

Clinical Trials and Evidence-Based Syntheses Research Unit (CTEBs RU), Mahasarakham University, MahaSarakham, Thailand.

出版信息

Sci Rep. 2023 Nov 14;13(1):19880. doi: 10.1038/s41598-023-46565-3.

Abstract

Anti-tuberculosis drug induced liver injury (Anti-TB DILI) is the most common adverse events (AEs) necessitating therapy interruption but there is no preventing regimen. This study aimed to examine the efficacy and safety of herbs/alternative medicines for preventing anti-TB DILI. Relevant articles were identified through a systematic search in 5 international databases from inception till March 2022. All randomized controlled trials (RCT) assessing the effects of herbal or alternative medicines against anti-TB DILI were included. The network meta-analysis (NMA) was used to synthesize the evidence for preventing hepatotoxicity using a random-effects model. A total of 3423 patients from 14 RCTs were included. The NMA indicated that supplementation of Turmeric plus Tinospora cordifolia (RR 0.07; 95% CI 0.02 to 0.28), and N-acetyl cysteine (NAC) (RR 0.09; 95% CI 0.01 to 0.75) significantly reduced the incidence of anti-TB DILI compared with placebo. In addition, poly herbal product significantly reduced alkaline phosphatase (ALP) (MD - 21.80; 95% CI - 33.80 to - 9.80) and total bilirubin (Tbil) compared with placebo (MD - 0.51; 95% CI - 0.76 to - 0.26). There was no statistically significant difference in the occurrence of AEs in any intervention. In conclusion, Turmeric plus Tinospora cordifolia, NAC and poly-herbal product may provide benefit for preventing anti-TB DILI in TB patients. However, these findings are based on a small number of studies. Additional studies are warranted to confirm the findings.

摘要

抗结核药物性肝损伤(Anti-TB DILI)是最常见的需要中断治疗的不良事件(AEs),但目前尚无预防方案。本研究旨在评估草药/替代药物预防抗结核药物性肝损伤的疗效和安全性。通过系统检索 5 个国际数据库,从建库至 2022 年 3 月,确定了相关文章。纳入评估草药或替代药物对抗结核药物性肝损伤影响的随机对照试验(RCT)。使用随机效应模型的网络荟萃分析(NMA)来综合预防肝毒性的证据。共纳入来自 14 项 RCT 的 3423 例患者。NMA 表明,姜黄加三叶鬼针草(RR 0.07;95%CI 0.02 至 0.28)和 N-乙酰半胱氨酸(NAC)(RR 0.09;95%CI 0.01 至 0.75)与安慰剂相比,显著降低抗结核药物性肝损伤的发生率。此外,与安慰剂相比,复方草药产品显著降低碱性磷酸酶(ALP)(MD -21.80;95%CI -33.80 至 -9.80)和总胆红素(Tbil)(MD -0.51;95%CI -0.76 至 -0.26)。任何干预措施的不良反应发生率均无统计学差异。总之,姜黄加三叶鬼针草、NAC 和复方草药产品可能对预防结核病患者的抗结核药物性肝损伤有益。然而,这些发现基于少数研究。需要更多的研究来证实这些发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecb8/10645982/e086e4548c74/41598_2023_46565_Fig1_HTML.jpg

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