蟾酥类注射液治疗肝癌的风险评价与预警研究  

Risk assessment and pre-warning of injection within Bufonis Venenum in the treatment of liver cancer

作　　者：张晓朦[1,2] 吕锦涛 张冰 林志健[1,2] 刘荣雪 ZHANG Xiaomeng;LYU Jintao;ZHANG Bing;LIN Zhijian;LIU Rongxue(School of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China;Center for Pharmacovigilance and Rational use of Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]北京中医药大学中药药物警戒与合理用药研究中心,北京102488

出　　处：《中国药物警戒》2022年第5期469-474,492,共7页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(81874349);国家中医药管理局-国家中医药领军人才支持计划“岐黄学者”项目;北方中医药大学基本科研业务经费重点攻关计划(课题级)(2020-JYB-20GG-047)。

摘　　要：目的探索蟾酥类注射液治疗肝癌的风险评价与预警模式,为临床提供示范研究。方法检索中国知网、万方数据、Sino Med、Pub Med等期刊文献数据库,检索时间为建库至2022年1月31日,收集蟾酥类注射液(华蟾素注射液、得力生注射液、蟾酥注射液),治疗肝癌的随机对照试验,采用多准则决策模型评价其在不同应用条件下的效益-风险(BRA),基于评价结果采用熵权可拓物元模型预测该类药物应用的风险响应等级。结果共纳入64项蟾酥类注射液治疗肝癌的随机对照试验,评价结果显示,未联用经动脉化疗栓塞术治疗手段的组别BRA值81.55%高于联用者;应用华蟾素注射液的组别BRA值100%高于蟾酥注射液、得力生注射液;常规剂量组优于超说明书用量组;28 d内短疗程组BRA值优于长疗程19[95%CI(9.42,28.88)]。疗程因素需作为一级预警响应,临床给予特别关注。结论多准则决策联合熵权可拓物元模型可作为中药风险评价与预警的研究基础,为临床开展中药药物警戒提供依据。Objective To explore the risk assessment and pre-warning model of injection within Venenum Bufonis(VBI)in the treatment of liver cancer,so as to demonstration research for clinical practice.Methods The randomized controlled trials(RCTs)of VBI in the treatment of liver cancer were collected by searching comprehensively and systematically in journal literature databases such as CNKI,Wanfang Database,SinoMed,PubMed since the establishment of the database until January 31,2022.By using the multi-criteria decision analysis model,the benefit-risk assessment(BRA)of VBI in the treatment of liver cancer under different kinds of medication conditions was taken.Then based on BRA values,the VBI risk pre-warning level could be predicted by the entropy weight and matter-element extension model.Results 64RCTs of VBI in the treatment of liver cancer were included.The BRA value of the treatment method without transarterial chemoembolization was 81.55%higher than that of combined use;the BRA value of Cinobufasu injection was 100%higher than the Chansu injection or Delisheng injection;the conventional dose group was better than the off-label dose group;and the difference between 28 days and long course of treatment was 19[95%CI(9.42,28.88)].Based on the BRA results,the course of treatment need to be first-level pre-warning response.Conclusion Multi-criteria decisionmaking and entropy weight matter-element extension model can be used as risk assessment and pre-warning model for herbs,which provide basis for traditional Chinese medicine pharmacovigilance.

关 键 词：华蟾素注射液 得力生注射液 蟾酥注射液 肝癌 风险评价 风险预警 药物警戒 

分 类 号：R969.3[医药卫生—药理学] R994.11[医药卫生—药学]