2013-2016年天津市中医药研究院附属医院肾康注射液的上市后安全性再评价

目的：评价肾康注射液上市后用药安全性，探索中药注射剂上市后安全性再评价的方法和模式。方法选取2013年4月—2016年3月天津市中医药研究院附属医院肾病科慢性肾脏病第2、3、4期且使用肾康注射液的住院患者为研究对象，共观察317例。从用药开始至用药后15 d为观察期，填写评价筛选表，发生不良反应患者纳入为病例组，进行统计分析。结果全部48个批次的肾康注射液在317名患者用药和随访期间均未发生明显药品不良反应。结论肾康注射液药品的质量稳定性良好，临床疗效确切，但仍需对中药注射剂进行上市后安全性再评价，加强不良反应监测。

Re-evaluation of post-marketing safety of Shenkang Injection in Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital from 2013 to 2016

Objective To evaluate the post-marketing safety of Shenkang Injection, and explore the methods and models of safety re-evaluation of traditional Chinese medicine injections.Methods Patients (317 case) with chronic kidney disease in the stageⅡ —Ⅳ in Department of Nephropathy of Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital from April 2013 to March 2016 were tracked from the beginning to treatment for 15 d. Meanwhile, the evaluation and screening scale were filled, and patients with adverse reactions were included in the case group for statistical analysis.Results There were no significant adverse reactions of patients (317 case) treated with 48 batches of Shenkang Injection in the treatment and follow-up periods.Conclusion Shenkang Injection has good quality and effective clinical efficacy, but safety re-evaluation of traditional Chinese medicine injections should be carried out, and the monitoring of adverse reactions should be strengthen.