目的 評價腎康注射液上市后用藥安全性，探索中藥注射劑上市后安全性再評價的方法和模式。方法 選取2013年4月-2016年3月天津市中醫(yī)藥研究院附屬醫(yī)院腎病科慢性腎臟病第2、3、4期且使用腎康注射液的住院患者為研究對象，共觀察317例。從用藥開始至用藥后15 d為觀察期，填寫評價篩選表，發(fā)生不良反應(yīng)患者納入為病例組，進(jìn)行統(tǒng)計分析。結(jié)果 全部48個批次的腎康注射液在317名患者用藥和隨訪期間均未發(fā)生明顯藥品不良反應(yīng)。結(jié)論 腎康注射液藥品的質(zhì)量穩(wěn)定性良好，臨床療效確切，但仍需對中藥注射劑進(jìn)行上市后安全性再評價，加強不良反應(yīng)監(jiān)測。

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 stage Ⅱ-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.