摘要
该文严格遵守循证医学原则,贴近疾病临床实际,突出中医药特色,梳理流行性感冒临床试验方案"PICOS原则"设计关键点,优化中成药治疗流行性感冒临床试验方案。以"柴银颗粒治疗轻症流行性感冒的随机、双盲、阳性药平行对照研究设计"为例,从研究类型、研究对象、干预措施、对照措施、结局指标、常见问题思考等6个方面,具体探讨了中成药治疗流行性感冒临床试验设计要点。从方法学建议,在中成药治疗流行性感冒有效性和安全性临床试验设计方案中,研究类型应首选随机对照研究,纳入标准在确定西医诊断标准同时应明确中医证候,排除标准需全面地列出混淆因素和导致研究结果偏倚的特殊情况,干预措施应有依据地合理设定给药方案,对照措施以国际公认阳性药物或者指南对照为佳,以中位退热时间为主要结局指标,疗效评价可设定疾病症状量化表,谨慎使用中医证候积分量表进行疗效评价,疗效评价标准需设定时间节点,合并用药、禁止用药规定中需全面且明确的书写药物全称。
To sort out the key points in "PICOS" design of clinical trial scheme for influenza, and optimize the clinical trial scheme of Chinese patent medicine in the treatment of influenza by strictly following the principle of evidence-based medicine, focusing on the clinical practice of the disease, and highlighting the characteristics of traditional Chinese medicine. "The design of a randomized, double-blind, positive parallel control study of a certain herbal preparation for the treatment of non-severe influenza" was taken as an example in this study, and the key points in the clinical trial design of Chinese patent medicine for the treatment of influenza were specifically discussed from six aspects, including the type of study, object of study, intervention measures, control measures, outcome indicators and frequently asked questions in test design. From methodological suggestions, in the design scheme of clinical trial on efficacy and safety of Chinese patent medicine in the treatment of influenza, the randomized controlled study should be the first choice for type of study;the inclusion criteria should define both the diagnostic criteria of Western medicine and the syndromes of traditional Chinese medicine(TCM);the exclusion criteria should include a comprehensive list of confounding factors and special circumstances lea-ding to bias in the study results;the interventions should be based on a well-defined dosing programme;internationally recognized positive drugs or guidelines should be used as control measures, with median antipyretic time as the main outcome indicator. For the evalua-tion of curative effect, disease symptom scale can be set, and the TCM syndrome scoring scale was carefully used in this study, with time nodes set for the efficacy evaluation standard. The full name of the drugs should be written in the regulations on combined drug use and prohibited drug use.
作者
李珍萱
赵国桢
郭玉红
李博
刘清泉
LI Zhen-xuan;ZHAO Guo-zhen;GUO Yu-hong;LI Bo;LIU Qing-quan(Capital Medical University,Beijing 100069,China;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Beijing University of Chinese Medicine,Beijing 100029,China;Beijing Institute of Traditional Chinese Medicine,Beijing 100010,China;Beijing Hospital of Traditional Chinese Medicine Yanqing Branch,Capital Medical University,Beijing 100191,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第7期1706-1710,共5页
China Journal of Chinese Materia Medica
基金
国家“重大新药创制”科技重大专项(2019ZX09734001)
国家自然科学基金项目(81774146)。
关键词
循证医学
流行性感冒
试验方案
evidence-based medicine
influenza
trial scheme
