上海市浦东新区医疗机构中药制剂区内多点临床验证的实践和探索

Practice and exploration on clinical evaluations of hospital-made Chinese herbal formulas in the Pudong New Area of Shanghai

中药制剂能体现中医简、便、廉、验的特点,但因其生产成本高,医院制剂室纷纷关闭,又由于相关法律法规的制约,中药制剂的发展陷入了困境。上海市浦东新区作为国家中医药发展综合改革试验区,积极探索医疗机构中医制剂规范化研究及区内推广应用。新区卫生局依托曙光医院,设立浦东新区医疗机构中药制剂区内多点规范化临床验证评价中心,通过筛选制剂、生产、质控及统一调配、多点规范化临床验证等流程,进行药物的配伍和稳定性评价,多中心临床疗效确证和安全性评估以及不良反应的监测,探索筛选、集中生产、调配使用、多点临床验证的长效机制。

Chinese herbal formulas can well present the characteristics of traditional Chinese medicine （TCM） with their simple, convenient, inexpensive and effective uses. However, due to the high cost of production, manufacturing pharmacies inside the hospital closed down one after another, which rendered the difficult situation of developing preparation of Chinese herbal formulas. The Pudong New Area of Shanghai, as a pilot region for comprehensive reforms on national development of TCM, vigorously explores the standardized research on and application of hospital-made Chinese herbal formulas. The Health Bureau of the Pudong New Area, based on the Shuguang Hospital, has established a clinical evaluation center for hospital-made Chinese herbal formulas. Through screening, manufacturing, quality control, unified allocation, and standardized clinical evaluation, the clinical evaluation center has summarized its experience on these processes.