中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 525-531.
DOI: 10.19803/j.1672-8629.2021.06.07

• 中药药物警戒实践创新专栏 • 上一篇    下一篇

斑蝥类制剂治疗原发性肝癌的效益-风险评估

姜皓1,2, 章之琪1,2, 张冰1,2,*, 张晓朦1,2, 耿可欣1,2   

  1. 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
  • 收稿日期:2020-03-09 出版日期:2021-06-15 发布日期:2021-07-02
  • 通讯作者: *张冰,女,博士,教授·博导,主任医师,中药药物警戒与合理用药研究、中药药性理论与名老中医传承研究、中药防治代谢性疾病研究。E-mail：zhangbing6@263.net
  • 作者简介:姜皓,男,在读硕士,中药药物警戒与合理用药研究。
  • 基金资助:
    国家自然科学基金资助项目(81874349); 国家中医药领军人才支持计划“岐黄学者”项目; 第三批国家高层次人才特殊支持计划（万人计划）教学名师项目

Benefit-Risk Assessment of Mylabris Preparations in the Treatment of Primary Hepatic Carcinoma

JIANG Hao1,2, ZHANG Zhiqi1,2, ZHANG Bing1,2,*, ZHANG Xiaomeng1,2, GENG Kexin1,2   

  1. 1School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China;
    2Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China
  • Received:2020-03-09 Online:2021-06-15 Published:2021-07-02

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摘要： 目的 定量评估斑蝥类制剂（MPs）治疗原发性肝癌（PHC）的效益与风险,为临床安全有效使用MPs提供依据。方法 检索中国知网、万方数据、维普网、SinoMed、Pubmed、Web of Science等中英文数据库,获取自建库至2020年9月9日MPs治疗PHC的随机对照试验（RCT）。建立MPs治疗PHC的多准则决策（MCDA）模型,采用SWING法赋予效益指标与风险指标的权重,分别为70%和30%。纳入文献报道的、符合评估标准的临床随机对照试验（RCT）,借助Meta分析方法合并RCT结果,结合 MCDA模型算出患者的效益值、风险值与效益-风险值。结果 检索到4种MPs,纳入相关RCT 76项。相较于肝动脉化疗栓塞术（TACE）,静脉MPs联用肝动脉化疗栓塞术（TACE）的效益-风险值为59,口服MPs为55,差异值为4,95% CI[-2.4,10.4],概率为85.76%;艾迪注射液联合TACE治疗PHC的效益-风险值为63.4,艾易舒注射液为62.7,差异值为0.7,95% CI[-6.4,7.8],概率为54.43%。结论 现有证据表明,MPs是一种治疗PHC获益较好、风险较低的药物。静脉MPs联合TACE治疗PHC的效益-风险可能优于口服MPs,艾迪注射液治疗PHC的效益-风险与艾易舒注射液相当。

关键词: 斑蝥类制剂, 原发性肝癌, 效益, 风险, 评估, 多准则决策

Abstract: Objective This study aims to quantitatively evaluate the benefits and risks of Mylabris Preparations (MPs) in the treatment of primary hepatic carcinoma (PHC). It can provide an intuitive basis for using MP safely and effectively in clinic. Methods This study searched for randomized controlled trials(RCTs) of MPs treatment for PHC in CNKI, Wanfang, VIP, SinoMed, Pubmed, Web of Science and other Chinese and English databases. The search time was from the establishment of the database to September 9, 2020. The multi-criteria decision-making analysis (MCDA) model for MPs treatment of PHC was established. The SWING method was used to assign weights to benefit indicators and risk indicators. Their weights were 70% and 30% respectively. With the help of Meta-analysis method to combine the RCT results, it used the MACD model to calculate the patient's benefit value, risk value and benefit-risk value. Results In total, 4 MPs were retrieved in the study, and 76 related RCTs were included. Compared with Transcatheter arterial chemoembolization(TACE), the benefit-risk value of intravenous MPs combined with TACE for PHC treatment was 59, while the benefit-risk value of oral MPs combined with TACE treatment of PHC was 55. The benefit-risk difference between the two types of MPs was 4, 95% CI [-2.4,10.4], and the probability of difference was 85.76%.The benefit-risk value of Aidi injection combined with TACE in the treatment of PHC was 63.4, and the benefit-risk value of Aiyishu injection combined with TACE in the treatment of PHC was 62.7. The benefit-risk difference of the two kinds of MPs was 0.7, 95% CI [-6.4,7.8], and the probability of difference is 54.43%. Conclusion The current evidence shows that MPs are a type of drug with better benefits and lower risks in the treatment of PHC. The benefit-risk of intravenous MPs combined with TACE in the treatment of PHC may be better than that of oral MPs, and the benefit-risk of Aidi injection combined with TACE in the treatment of PHC is equivalent to that of Aiyishu injection.

Key words: Mylabris Preparations, primary hepatic carcinoma, benefit, risk, assessment, multi-criteria decision-making analysis

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