虫类中成药辅助抗肿瘤有效性及安全性的Meta分析

朱燃培; 张华; 闫晓宇; 赵方方; 董嘉楠; 郑玉玲

doi:10.13748/j.cnki.issn1007-7693.20251007

虫类中成药辅助抗肿瘤有效性及安全性的Meta分析

Efficacy and Safety of Insect-based Chinese Patent Medicines in Adjunctive Cancer Treatment: A Meta-analysis

摘要

摘要:
目的系统评价虫类中成药辅助治疗肿瘤的疗效和安全性，为临床应用提供循证依据。
方法检索中国知网(CNKI)、万方数据知识服务平台(Wanfang)、维普中文期刊(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Embase、Cochrane Library、Web of Science，从建库至2024年7月20日收录的虫类中成药治疗恶性肿瘤的随机对照试验(randomized controlled trial，RCT)。使用ROB 2.0对纳入文献进行偏倚风险评估，RevMan 5.3进行meta分析，Stata 15进行敏感性分析和发表偏倚检测，GRADEprofiler 3.6评价结局指标证据质量等级。
结果共纳入62个RCTs，8823例患者(治疗组4604例，对照组4219例)，包含11种虫类抗肿瘤中成药。Meta分析结果显示：与常规抗肿瘤治疗相比，联合虫类抗肿瘤中成药可显著提高肿瘤患者客观缓解率(RR=1.34，95%CI1.28，1.39)、疾病控制率(RR=1.16，95%CI1.13，1.18)、1年生存率(RR=1.33，95%CI1.23，1.44)、2年生存率(RR=1.72，95%CI1.35，2.18)、延长总生存率(MD=2.11，95%CI0.85，3.36)、无进展生存期(MD=2.31，95%CI1.07，3.56)，并提高生活质量改善率(RR=1.19，95%CI1.13，1.25)、CD4⁺/CD8⁺比值(MD=0.24，95%CI0.14，0.35)、NK细胞水平(MD=2.85，95%CI2.39，3.31)，降低不良事件发生率消化道不良反应(RR=0.72，95%CI0.66，0.77)、白细胞下降(RR=0.72，95%CI0.63，0.82)、血红蛋白下降(RR=0.82，95%CI0.73，0.91)、血小板下降(RR=0.66，95%CI0.59，0.73)、粒细胞减少(RR=0.65，95%CI0.54，0.79)、肝功能异常(RR=0.67，95%CI0.58，0.77)、肾功能异常(RR=0.62，95%CI0.49，0.79)，以上指标均有统计学意义；但在延长患者中位生存期中(MD=3.26，95%CI−3.04，9.56)，差异无统计意义。敏感性分析和发表偏倚检测提示结果稳健。GRADE证据评价提示以上结局指标证据级别为极低级至高级，其中，1年生存率、消化道不良反应发生率、血小板降低发生率、肝功能异常发生率为高级证据。
结论联合虫类中成药对瘤体的控制作用更佳，可提高近期疗效和生存率、延长无病生存时间、改善生活质量，且未发现有增加不良反应的风险，安全性高，推荐临床应用。

Abstract: OBJECTIVE To systematically evaluate the efficacy and safety of insect proprietary Chinese medicine in the adjuvant treatment of tumor, and provide evidence-based evidence for clinical application.
METHODS Searches were conducted in CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, Cochrane Library, and Web of Science for randomized controlled trials(RCTs) on insect-based Chinese patent medicines treating malignant tumors from database inception to July 20, 2024. The ROB 2.0 tool was used for bias risk assessment of included studies, RevMan 5.3 for meta-analysis, Stata 15 for sensitivity analysis and publication bias detection, and GRADEprofiler 3.6 for grading the quality of evidence of outcome indicators.
RESULTS A total of 62 RCTs involving 8 823 patients(4 604 in the experimental group and 4 219 in the control group) and 11 types of insect-based anti-tumor Chinese patent medicines were included. Meta-analysis results showed that, compared with conventional anti-tumor treatment, the combination of insect-based Chinese patent medicines significantly improved the objective response rate(RR=1.34, 95%CI1.28, 1.39), disease control rate(RR=1.16, 95%CI1.13, 1.18), 1-year survival rate(RR=1.33, 95%CI1.23, 1.44), 2-year survival rate(RR=1.72, 95%CI1.35, 2.18), extended overall survival(MD=2.11, 95%CI0.85, 3.36), progression-free survival(MD=2.31, 95%CI1.07, 3.56), improved quality of life(RR=1.19, 95%CI1.13, 1.25), CD4⁺/CD8⁺ ratio(MD=0.24, 95%CI0.14, 0.35), and NK cell levels(MD=2.85, 95%CI2.39, 3.31), and reduced adverse event ratesgastrointestinal adverse reactions(RR=0.72, 95%CI0.66, 0.77), leukopenia(RR=0.72, 95%CI0.63, 0.82), hemoglobin decrease(RR=0.82, 95%CI0.73, 0.91), thrombocytopenia(RR=0.66, 95%CI0.59, 0.73), neutropenia(RR=0.65, 95%CI0.54, 0.79), abnormal liver function(RR=0.67, 95%CI0.58, 0.77), abnormal kidney function(RR=0.62, 95%CI0.49, 0.79), all of which were statistically significant. However, there was no statistically significant difference in extending median survival time(MD=3.26, 95%CI−3.04, 9.56). Sensitivity analysis and publication bias detection indicated that the results were robust. GRADE evidence evaluation suggested that the evidence levels of the above outcome measures ranged from very low to high, with the 1-year survival rate, incidence of gastrointestinal adverse reactions, incidence of thrombocytopenia, and incidence of abnormal liver function being of high quality evidence.
CONCLUSION The combination of insect-based Chinese patent medicines provides better control over tumors, improves short-term efficacy and survival rates, prolongs disease-free survival, and enhances quality of life, all without increasing the risk of adverse reactions. It is considered safe and recommended for clinical application.

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