Table3_Exploring the therapeutic potential of “Xiaochaihu Decoction”: a systematic review and meta-analysis on the clinical effectiveness and safety in managing cancer-related fever.docx

Objective: 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).
Methods: 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.
Results: 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”.
Conclusion: 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.
Systematic Review Registration:https://www.crd.york.ac.uk/prospero/, identifier CRD42023484068.

目的：本研究旨在开展首个荟萃分析，全面评估小柴胡汤治疗癌性发热（Cancer-related Fever, CRF）的临床疗效与安全性。
方法：本研究于2023年9月系统检索了8个数据库。采用《Cochrane手册》推荐的偏倚风险（Risk of Bias, ROB）2.0工具，对纳入的随机对照试验（Randomized Controlled Trial, RCT）进行偏倚风险评估；同时采用推荐分级的评估、制定与评价（Grading of Recommendations Assessment, Development and Evaluation, GRADE）工具对证据质量进行评价。
结果：本研究共纳入18项随机对照试验，涉及1424例患者。与西药或新癀片（Xinhuang Tablets）相比，小柴胡汤可显著改善癌性发热患者的临床疗效（风险比[RR]=1.24，95%置信区间[CI]：1.17~1.32），并加快体温恢复正常（均数差[MD]=-5.29，95%CI：-5.59~-4.99）；同时可降低肿瘤坏死因子-α（Tumor Necrosis Factor-α, TNF-α）水平（MD=-0.63，95%CI：-0.84~-0.41），提升白细胞介素-2（Interleukin-2, IL-2）水平（MD=1.42，95%CI：-1.09~1.74）。对卡氏功能状态评分（Karnofsky Performance Status, KPS）的分析显示，使用小柴胡汤可改善癌性发热患者的生活质量（RR=1.57，95%CI：1.11~2.22），并降低不良事件发生率。但需注意，纳入的多数研究基于ROB 2.0工具评估显示存在“部分担忧”的偏倚风险，且经GRADE方法评估的证据质量被评为“低”。
结论：尽管本研究提示小柴胡汤治疗癌性发热具有一定临床疗效与安全性，但要验证上述结论，仍需未来开展更多高质量、大规模的随机对照试验。
系统评价注册：https://www.crd.york.ac.uk/prospero/，标识符CRD42023484068。