摘要
该研究旨在对治疗肺癌的口服中成药药物基本应用信息和临床研究证据的分布和发展情况。通过检索相关药物目录、指南及药物信息网获得有关药物的功能、主治、组成信息、价格信息,筛选出相关中成药;同时中英文数据库获得口服中成药治疗肺癌的临床研究,检索时间从建库至2021年8月22日。对相关专家共识、系统评价、随机对照试验研究、非随机对照试验研究和非对照临床试验研究概况进行概况性综述分析。最终,研究共纳入104种口服中成药,包括31种胶囊剂、16种颗粒剂、20种口服液体制剂、17种片剂、17种丸剂和3种膏剂,共涉及198味中药;单次服药价格高于100元的有2种,在10~100元的有36种,10元以下的有66种。有48种中成药能够检索到对应的410篇临床研究文献,发表于1986年至2021年,包括1篇专家共识,21篇口服中成药治疗肺癌的临床随机对照试验的系统评价研究,277篇随机对照试验研究,87篇非随机对照研究和24篇非对照临床研究。临床研究中,中成药联合的一线治疗方案中以放疗和化疗为主,结局指标涉及近期疗效、生活质量评价和不良反应发生率等9个方面。该研究表明口服中成药对肺癌治疗有明显的中医优势,临床试验研究数量逐年增多,结局指标涉及多个方面,未来需要对中成药开展更全面、更规范的临床研究。
This scoping review aimed to summarize the application information and clinical studies of oral Chinese patent medicines.The oral Chinese patent medicines in treating lung cancer were screened out by searching pf the drug directory,related guidelines,and medical information websites.The data including functions,application,ingredients,and prices of these medicines were collected.Six public databases were searched with the time interval of establishment to August 22,2021 for collection of the clinical studies of oral Chinese patent medicines in the treatment of lung cancer.The expert consensuses,systematic reviews,randomized controlled trials,non-randomized controlled trials,and non-controlled trials were selected for analysis.A total of 104 oral Chinese patent medicines were screened out,including 31 capsules,16 granules,20 oral liquids,17 tablets,17 pills,and 3 ointments,in which altogether 198 herbal medicines were involved.The single-dose prices of 2,36,and 66 medicines were>CNY 100,CNY 10-100,and<CNY 10,respectively.There were 410 clinical studies associated with 48 oral Chinese patent medicines,which were published from1986 to 2021.These publications included 1 expert consensus,21 systematic reviews,277 randomized controlled trials,87 non-randomized controlled trials,and 24 non-controlled trials.In the clinical studies,the Chinese patent medicines were usually applied in combination with radiotherapy and chemotherapy.The evaluation of primary outcomes focused on 9 indicators including clinical efficacy,quality of life,and incidence of side effects.In conclusion,the oral Chinese patent medicines demonstrated significant advantages in the treatment of lung cancer,and the relevant clinical trials were increasing year by year,with multiple outcome indicators being evaluated.More comprehensive and standardized clinical studies need to be designed for oral Chinese patent medicines in treating lung cancer in the future.
作者
王娟
韩旭
姜淼
郭洪涛
顾浩
廖星
WANG Juan;HAN Xu;JIANG Miao;GUO Hong-tao;GU Hao;LIAO Xing(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2022年第8期204-213,共10页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家自然科学基金面上项目(82174239,81873181,81603401)
中国中医科学院科技创新工程项目(CI2021A00701-3)
中国中医科学院基本科研业务·优秀青年科技人才(创新类)培养专项(ZZ13-YQ-078,ZZ13-YQ-075)
中国中医药循证医学中心“业务研究室主任专项”(2020YJSZX-2)。
关键词
口服中成药
肺癌
临床研究
概况性评价
oral Chinese patent medicine
lung cancer
clinical research
scoping review
