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一、总则;慢性肺原性心脏病(简称肺心病)是一种多发病、常见病,严重危害人民健康.因此研制有效新药是必要的,为了正确评价治疗肺心病新药的疗效、在临床试验和验证过程中,必须按照统一的标准,选择病例,判定疗效,其基本指导原则是必须保持中医药特色,体现理法方药的一致性,使新药确有疗效高、毒性低的优点,为此制定本原则为肺心病的临床试验和验证的技术依据.
First, the general rule; Chronic pulmonary heart disease (referred to as pulmonary heart disease) is a frequently-occurring disease, common disease, seriously endangering people’s health. Therefore, the development of effective new drugs is necessary, in order to correctly evaluate the efficacy of new drugs in the treatment of pulmonary heart disease, clinical trials In the process of verification, the cases must be selected according to a uniform standard to determine the curative effect. The basic guiding principle is to maintain the characteristics of traditional Chinese medicine and reflect the consistency of traditional Chinese medicine, so as to make the new medicine have the advantages of high curative effect and low toxicity. The principles of pulmonary heart disease clinical trials and verification of technical basis.