Bu Zhijun, Xu Yaoyu, Zhou Xian, Wang Xuefeng, Liu Shuyuan, Wang Linyan, Yang Bei, Zhou Xiaodie, Lu Guanhang, Liu Jianping, Liu Zhaolan
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
The First Clinical College, Hubei University of Traditional Chinese Medicine, Wuhan, China.
Front Pharmacol. 2024 May 13;15:1359866. doi: 10.3389/fphar.2024.1359866. eCollection 2024.
This study aimed to conduct the first meta-analysis to comprehensively evaluate the clinical effectiveness and safety of Xiaochaihu Decoction in treating Cancer-related Fever (CRF). Eight databases were systematically searched in September 2023. The risk of bias (ROB) 2.0 tool recommended by Cochrane Handbook was applied to evaluate the ROB of the included randomized controlled trials (RCTs). Additionally, the quality of evidence was assessed using the Grading of recommendations assessment, development and evaluation (GRADE) tool. We included 18 RCTs involving 1,424 patients. Compared to Western medicine or Xinhuang Tablets, Xiaochaihu Decoction significantly improved clinical effectiveness in CRF patients (risk ratio [RR] = 1.24, 95% confidence interval [CI]: 1.17, 1.32) and expedited the normalization of body temperature (mean difference [MD] = -5.29, 95%CI: -5.59, -4.99). It also demonstrated a reduction in tumor necrosis factor-α (TNF-α) levels (MD = -0.63, 95%CI: -0.84, -0.41) and an increase in IL-2 levels (MD = 1.42, 95%CI: -1.09, 1.74). Analysis of Karnofsky Performance Status (KPS) scores showed that the use of Xiaochaihu Decoction improved the quality of life in CRF patients (RR = 1.57, 95%CI: 1.11, 2.22) and reduced the incidence of adverse events. However, it is important to note that the majority of included studies showed "some concerns" in risk of bias based on ROB 2.0, and the evidence quality assessed by GRADE method was rated as "low". While this study suggests the clinical effectiveness and safety of Xiaochaihu Decoction in treating patients with CRF, confirming these findings will necessitate additional high-quality, large-scale RCTs in future research. https://www.crd.york.ac.uk/prospero/, identifier CRD42023484068.
本研究旨在进行首次荟萃分析，以全面评估小柴胡汤治疗癌性发热（CRF）的临床疗效和安全性。2023年9月对八个数据库进行了系统检索。应用Cochrane手册推荐的偏倚风险（ROB）2.0工具评估纳入的随机对照试验（RCT）的偏倚风险。此外，使用推荐分级评估、制定和评价（GRADE）工具评估证据质量。我们纳入了18项涉及1424例患者的RCT。与西药或新癀片相比，小柴胡汤显著提高了CRF患者的临床疗效（风险比[RR]=1.24，95%置信区间[CI]：1.17，1.32），并加快了体温恢复正常（平均差[MD]=-5.29，95%CI：-5.59，-4.99）。它还显示肿瘤坏死因子-α（TNF-α）水平降低（MD=-0.63，95%CI：-0.84，-0.41），白细胞介素-2水平升高（MD=1.42，95%CI：-1.09，1.74）。卡诺夫斯基功能状态（KPS）评分分析表明，使用小柴胡汤改善了CRF患者的生活质量（RR=1.57，95%CI：1.11，2.22），并降低了不良事件的发生率。然而，需要注意的是，根据ROB 2.0，大多数纳入研究在偏倚风险方面显示出“一些担忧”，并且采用GRADE方法评估的证据质量被评为“低”。虽然本研究表明小柴胡汤治疗CRF患者具有临床疗效和安全性，但在未来研究中证实这些发现需要更多高质量、大规模的RCT。https://www.crd.york.ac.uk/prospero/，标识符CRD42023484068。
