Long Zilin, Zhao Houyu, Liu Fengqi, Zhang Meng, Sun Feng
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China; Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing, China; Peking University Center for Evidence-based Medical and Clinical Research, Beijing, China.
Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing, China; Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.
J Ethnopharmacol. 2025 Jun 12;349:119969. doi: 10.1016/j.jep.2025.119969. Epub 2025 May 13.
Adverse events of anticancer treatment were common and debilitating in cancer patients. Traditional Chinese medicine injection (TCMI) plays an important role in the comprehensive treatment of cancer in China.
To explore whether TCMI can reduce adverse events of anticancer treatment in patients with cancer.
Ten databases (i.e., Embase, Web of Science, PubMed, ClinicalTrials.gov, the Cochrane Library, CBM, Scoups, CNKI, Wangfang Database and VIP) were searched up to July 2, 2024. RCT was included if it assessed TCMI in cancer patients and reported any type of adverse events. Data were extracted from eligible studies, and risk of bias was assessed using the RoB2 tool. Certainty of evidence was evaluated by the GRADE tool. Meta analysis was conducted by using random effects model. Subgroup and sensitivity analyses were performed for primary outcomes. The publication bias was evaluated for outcomes reported by more than 10 trials using funnel plots and Egger's test.
A total of 76 eligible RCTs involving 9862 patients with cancer and 45 type of adverse events were included. Meta-analysis revealed that compared with anticancer therapy alone, combination treatment with TCMI had lower risk for adverse events in bone marrow suppression (RR 0.60; 95 % CI,0.51, 0.70) and gastrointestinal issues (RR 0.69; 95 % CI, 0.63, 0.76). Also, TCMI was associated with decreased risk of leukopenia (RR 0.67; 95 % CI, 0.61, 0.74), thrombocytopenia (RR 0.66; 95 % CI, 0.57, 0.77), hemoglobin reduction (RR 0.76; 95 % CI, 0.68, 0.86), neutropenia (RR 0.74; 95 % CI,0.59, 0.93), anemia (RR 0.57; 95 % CI, 0.48, 0.68), liver adverse events (RR 0.63; 95 % CI, 0.54, 0.74), renal adverse events (RR 0.55; 95 % CI, 0.43, 0.70), neurotoxicity (RR 0.70; 95 % CI, 0.61, 0.81), cardiovascular toxicity (RR 0.42; 95 % CI, 0.23, 0.77), radiation-induced injuries (RR 0.43; 95 % CI, 0.34, 0.54]), oral mucositis (RR 0.46; 95 % CI, 0.36, 0.58), fatigue (RR 0.66; 95 % CI, 0.48, 0.90), fever (RR 0.52; 95 % CI, 0.32, 0.85), infection (RR 0.48; 95 % CI, 0.32, 0.72) and chemotherapy toxicity (RR 0.95; 95 % CI, 0.36, 0.86). GRADE assessment indicated high certainty for evidence in bone marrow suppression, hemoglobin reduction, liver adverse events, renal adverse events and oral mucositis.
TCMI can reduce adverse events of anticancer treatment and serve as an adjuvant therapy. It is necessary to strengthen the mechanism research of TCMI and carry out more large-scale, multi-center and well-designed clinical studies to evaluate the synergistic effects of TCMI in the future.
抗癌治疗的不良事件在癌症患者中很常见且令人虚弱。中药注射剂（TCMI）在中国癌症综合治疗中发挥着重要作用。
探讨中药注射剂是否能降低癌症患者抗癌治疗的不良事件。
检索截至2024年7月2日的10个数据库（即Embase、Web of Science、PubMed、ClinicalTrials.gov、Cochrane图书馆、CBM、Scoups、CNKI、万方数据库和维普数据库）。如果随机对照试验（RCT）评估了癌症患者的中药注射剂并报告了任何类型的不良事件，则纳入该试验。从符合条件的研究中提取数据，并使用RoB2工具评估偏倚风险。通过GRADE工具评估证据的确定性。采用随机效应模型进行荟萃分析。对主要结局进行亚组分析和敏感性分析。使用漏斗图和Egger检验对超过10项试验报告的结局进行发表偏倚评估。
共纳入76项符合条件的随机对照试验，涉及9862例癌症患者和45种不良事件。荟萃分析显示，与单纯抗癌治疗相比，中药注射剂联合治疗在骨髓抑制（RR 0.60；95%CI，0.51，0.70）和胃肠道问题（RR 0.69；95%CI，0.63，0.76）方面发生不良事件的风险较低。此外，中药注射剂与白细胞减少（RR 0.67；95%CI，0.61，0.74）、血小板减少（RR 0.66；95%CI，0.57，0.77）、血红蛋白降低（RR 0.76；95%CI，0.68，0.86）、中性粒细胞减少（RR 0.74；95%CI，0.59，0.93）、贫血（RR 0.57；95%CI，0.48，0.68）、肝脏不良事件（RR 0.63；95%CI，0.54，0.74）、肾脏不良事件（RR 0.55；95%CI，0.43，0.70）、神经毒性（RR 0.70；95%CI，0.61，0.81）、心血管毒性（RR 0.42；95%CI，0.23，0.77）、放射性损伤（RR 0.43；95%CI，0.34，0.54）、口腔黏膜炎（RR 0.46；95%CI，0.36，0.58）、疲劳（RR 0.66；95%CI，0.48，0.90）、发热（RR 0.52；95%CI，0.32，0.85）、感染（RR 0.48；95%CI，0.32，0.72）和化疗毒性（RR 0.95；95%CI，0.36，0.86）的风险降低相关。GRADE评估表明，骨髓抑制、血红蛋白降低、肝脏不良事件、肾脏不良事件和口腔黏膜炎的证据具有高确定性。
中药注射剂可降低抗癌治疗的不良事件，可作为辅助治疗。未来有必要加强中药注射剂作用机制的研究，并开展更多大规模、多中心、设计良好的临床研究，以评估中药注射剂的协同作用。
