Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China.
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China.
Explore (NY). 2024 Mar-Apr;20(2):158-167. doi: 10.1016/j.explore.2023.08.003. Epub 2023 Aug 22.
Irinotecan is a novel first-line therapy for colorectal cancer, but the toxicity and side effects include diarrhea without satisfactory treatments. Chinese herbal decoction (CHD) is an effective complementary and alternative prevention and therapy for irinotecan induced diarrhea (IID). This systematic review and meta-analysis of randomized controlled trials (RCTs) aims to assess the preventive effect of CHD in the treatment of IID.
Seven databases (PubMed, COCHRANE, EMBASE, CNKI, VIP, Wanfang, and CBM) were screened for random controlled trials on the prevention and treatment of IID by CHD from January 1980 to May 2022. The Cochrane Collaboration Risk of Bias (ROB 2.0) was applied for bias risk assessment, and the Grading Recommendation Assessment, Development, and Evaluation (GRADE) for quality of evidence. Meta-analysis was conducted with RevMan 5.3 software. In addition, a subgroup analysis was conducted on different grades of diarrhea, the incidence and duration of diarrhea, the selection of specific Chinese herbal medicine decoction, and the incidence of adverse reactions. Risk ratios (RR) and 95% confidence intervals (CIs) were calculated for all data by combining the meta-analysis with fixed or random-effects models based on outcome heterogeneity.
Fourteen RCTs involving 1056 participants were included. The study results displayed that the incidence of IID was lower with the use of CHD than the no-treatment group (RR = 0.55, 95% CI = 0.40-0.75, P = 0.0002). CHD in combination with western medicine (WM) was more effective than WM alone for IID (RR = 0.44, 95% CI 0.23-0.84, P = 0.01). This protective effect was more pronounced for severe grade III-V diarrhea (RR = 0.41, 95% CI = 0.26-0.64, P < 0.0001). In the specific Chinese herbal medicine decoction, the Banxia Xie Xin decoction presented better effectiveness (RR = 0.18, 95% CI: 0.05-0.63, P = 0.007) than WM alone. The Huangqin decoction was the most widely studied interventional scheme (n = 5). The relative risk (RR) of the Huangqin decoction was 0.56. No obvious adverse reactions were observed.
This study demonstrated that CHD has a preventive effect on IID and could be used as a complementary therapy with few side effects. However, additional large-sample, high-quality, randomized, double-blind trials are needed to guide the clinical practice scientifically.
www.crd.york.ac.uk/prospero (NO: CRD42020189506).
伊立替康是一种新型的结直肠癌一线治疗药物，但它的毒性和副作用包括没有满意治疗方法的腹泻。中药方剂（CHD）是一种有效的、针对伊立替康引起的腹泻（IID）的补充和替代预防和治疗方法。本系统评价和荟萃分析旨在评估 CHD 在治疗 IID 中的预防效果。
从 1980 年 1 月至 2022 年 5 月，通过对 PubMed、COCHRANE、EMBASE、CNKI、VIP、万方和 CBM 这 7 个数据库进行筛选，检索 CHD 预防和治疗 IID 的随机对照试验（RCT）。应用 Cochrane 协作风险偏倚（ROB 2.0）评估偏倚风险，并采用 Grading of Recommendations Assessment, Development, and Evaluation（GRADE）评估证据质量。采用 RevMan 5.3 软件进行荟萃分析。此外，还对不同等级的腹泻、腹泻的发生率和持续时间、特定中药方剂的选择以及不良反应的发生率进行了亚组分析。基于结局异质性，采用固定或随机效应模型，结合荟萃分析计算所有数据的风险比（RR）和 95%置信区间（CI）。
纳入了 14 项 RCT，涉及 1056 名参与者。研究结果显示，与不治疗组相比，使用 CHD 可降低 IID 的发生率（RR=0.55，95%CI=0.40-0.75，P=0.0002）。CHD 联合西药（WM）比 WM 单独治疗 IID 更有效（RR=0.44，95%CI 0.23-0.84，P=0.01）。这种保护作用在严重 III-V 级腹泻时更为显著（RR=0.41，95%CI=0.26-0.64，P<0.0001）。在特定的中药方剂中，半夏泻心汤的疗效更好（RR=0.18，95%CI：0.05-0.63，P=0.007），优于 WM 单独治疗。黄芩汤是干预方案中研究最多的方剂（n=5）。黄芩汤的相对风险（RR）为 0.56。未观察到明显的不良反应。
本研究表明，CHD 对 IID 有预防作用，可作为副作用少的辅助治疗方法。然而，还需要更多的大样本、高质量、随机、双盲试验来科学指导临床实践。
