摘要
安慰剂的制作成功与中医药临床试验的整体质量以及成功直接相关,因此可靠的质量评价标准可以为成功制备安慰剂提供更有力的证据。保障中药安慰剂的正常制作以及进行质量评价对于保护患者和试验顺利进行至关重要。就不同剂型中药安慰剂的制作(中药汤剂、中药颗粒、中药丸剂安慰剂)、中药安慰剂的质量评价方法(人工打分法、电子仿生测评法),中药安慰剂的临床使用和注意问题等进行综述,以期为提高中药安慰剂的制作工艺及评价方法提供一定的参考。
The success of placebo preparation is directly related to the overall quality and success of traditional Chinese medicine clinical trials.Therefore,reliable quality evaluation criteria can provide a stronger argument for the successful preparation of placebo.It is very important for patients to ensure the normal preparation of Chinese medicine placebos and carry out corresponding quality evaluation.The preparation of Chinese medicine placebos with different dosage forms(Chinese medicine decoction,Chinese medicine particles,and Chinese medicine pill placebos)and quality evaluation methods of Chinese medicine placebos,including artificial scoring method,electronic bionic evaluation method,clinical use of Chinese medicine placebos,and problems needing attention,were reviewed,in order to provide some references for the preparation process and evaluation of clinical Chinese medicine placebos.
作者
邵靖渊
胡薏慧
元唯安
史万忠
刘瑾
SHAO Jingyuan;HU Yihui;YUAN Weian;SHI Wanzhong;LIU Jin(Clinical Research Center,Shuguang Hospital,Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《药物评价研究》
CAS
2023年第5期1125-1130,共6页
Drug Evaluation Research
基金
上海市中医药“三年行动计划”[ZY(2021-2023)-0211、ZY(2021-2023)-0601]
上海市教委协同创新中心中西医结合-中成药临床评价平台(A1-U21-205-0103)
上海市申康中心示范性研究型病房建设(SHDC2022CRW010)
上海市申康中心医企融合创新协同专项(SHDC2022CRT018)
上海市慢性筋骨病临床医学研究中心项目(20MC1920600)。
关键词
中药安慰剂
临床试验
制作工艺
评价方法
质量评价
Chinese medicine placebo
clinical trials
manufacturing process
evaluation methods
quality assessment
