超常规剂量半枝莲和白花蛇舌草治疗恶性肿瘤安全性的回顾性队列研究  

Safety of supranormal dose of Scutellaria barbata and Hedyotis diffusa in treating malignant tumor:a retrospective cohort study

作　　者：念家云 高宇 陈宇晗 张佳慧 李晓晓 代存芳 马云飞[1] 丁彤晶 王笑民[1] NIAN Jia-yun;GAO Yu;CHEN Yu-han;ZHANG Jia-hui;LI Xiao-xiao;DAI Cun-fang;MA Yun-fei;DING Tong-jing;WANG Xiao-min(Oncology Department,Beijing Hospital of Traditional Chinese Medicine Affiliated to the Capital Medical Universityy,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院肿瘤科,北京100010

出　　处：《北京中医药》2022年第12期1355-1359,共5页Beijing Journal of Traditional Chinese Medicine

基　　金：北京市科技计划项目(Z191100008319006)。

摘　　要：目的 评价超常规剂量半枝莲和白花蛇舌草治疗恶性肿瘤的安全性。方法 采用回顾性队列研究方法,连续纳入535例恶性肿瘤患者,超常规剂量半枝莲和白花蛇舌草暴露组365例,非暴露组170例,详细记录研究时间窗内所有用药及不良反应事件情况。比较暴露组和非暴露组之间不良事件OR值。将服药剂量及服药时间进行加权计算累计暴露值,比较暴露组内不同累计暴露值之间不良事件发生率。结果 由于2组之间存在混杂因素,为使组间基线资料相对均衡,进一步采用倾向评分匹配法进行2∶1匹配,匹配后暴露组和非暴露组之间不良事件差异无统计学意义(OR=1.25,95%CI0.63~2.47,P>0.05);暴露组内,随着累计暴露值增大,不良事件发生率呈增加趋势(χ^(2)=18.544,P<0.001),高累计暴露值组不良事件发生率高于低累计暴露值组。结论 本研究数据暂不支持超常规剂量半枝莲/白花蛇舌草治疗恶性肿瘤可以诱发更多不良事件,但是超大剂量、长时间使用潜在诱发肝功能异常及胃肠道不适的风险趋势。Objective To evaluate the safety of supranormal dose of scutellaria barbata and hedyotis diffusa in the treatment of malignant tumor.Methods A retrospective cohort study was conducted in this study in which 535 patients with malignant tumor were continuously enrolled,including 365 patients in exposure group and 170 patients in non-exposure group.All drugs and adverse events were recorded in detail in the study time window.The adverse event OR values between the exposed group and the non-exposed group were compared.The cumulative exposure values was calculated by weighting the dosage and time of taking medicine,and the incidence of adverse events among different cumulative exposure values in the exposure group was compared.Results Because of the confounding factors between the two groups,propensity score matching method was further used for 2:1 matching in order to make the baseline data of the two groups relatively balanced.After matching,the difference was not statistically significant between the exposed group and the non-exposed group(OR=1.25,95% CI 0.63~2.47,P>0.05).In the exposure group,with the increase of cumulative exposure,the incidence of adverse events increased (χ^(2)=18.544,P<0.001).The incidence of adverse events in the high cumulative exposure group was significantly higher than that in the low cumulative exposure group.Conclusion The data in this study could not support the evidence that supranormal dose of scutellaria barbata and hedyotis diffusa may induce more adverse events in treating malignant tumors.However,the risk of abnormal liver function and gastrointestinal discomfort may be caused by ultra-large dosages and long-term use.

关 键 词：超常规剂量 半枝莲 白花蛇舌草 恶性肿瘤 安全性 回顾性队列研究 

分 类 号：R273[医药卫生—中西医结合]