摘要
目的:监测与评价肾康注射液上市后临床使用安全性。方法:采用非干预主动监测研究方法,结合自发报告系统数据和文献研究数据对肾康注射液临床安全性、有效性进行评价。通过对本市5家三级甲等医院2013年3月至2016年4月临床使用肾康注射液的患者进行监测,监测周期15 d,将用药情况及不良反应发生情况进行统计分析。结果:共监测病例3391例,未发生不良反应。结论:肾康注射液临床应用安全有效,未见药品不良反应(ADR)。
Objective：To monitor and evaluate the clinical safety of ShenKang Injection. Methods： The non-intervention active moni- toring methods were applied to the study, combined with spontaneous reporting system data and published literatures, to evaluate clinical safety and effectiveness for Shenkang injection. From March 2013 to April 2016, patients who had be treated with tested drug were moni- tored in five three level of first-class hospitals with a large amount dosage of Shenkang injection in Tianjin. The information for medications and adverse reactions were observed and recorded focally from the beginning to treatment for 15 d and were carried out a statistical analy- sis. Results：A total of 3391 cases were monitored, no adverse reactions were found. Conclusion： ShenKang Injection has a good security and effective clinical efficacy,
出处
《中国药物评价》
2017年第2期121-125,共5页
Chinese Journal of Drug Evaluation
关键词
肾康注射液
中药注射剂
上市后安全性
监测与评价
Shenkang injection
Traditional Chinese medicine injection
Post-marketing safety
Monitoring and evaluation
