真实世界疑似清开灵注射液致肾功能异常患者临床特征分析

The Real World of Qingkailing Injection by Clinical Characteristics of Suspected Patients with Abnormal Renal Function Analysis

目的:分析真实世界疑似清开灵注射液致肾功能异常患者的临床特征,探索使用清开灵注射液后出现肾功能异常的高危影响因素。方法:基于中国中医科学院中医临床基础医学研究所构建的医院信息系统(hospital information system,HIS)的医疗电子数据仓库,提取使用清开灵注射液后疑似出现肾功能异常患者的临床特征,采用SOMTE抽样与logistic回归相结合的方法进行挖掘分析。结果:使用清开灵注射液的患者患肝硬化或伴有电解质紊乱,或合并使用胸腺肽、硝苯地平、胰岛素时疑似易导致肾功能异常。结论:清开灵注射液与上述疑似危险因素联合使用时应加强观察,一旦发现异常应及时处理,以确保患者的用药安全,本研究结果尚需进一步开展机制探索与临床验证。

Objective： To analyze the clinical features of patients with abnormal renal function Suspicion were caused by Qingkailing Injection in real world,and to explore the risk factors of abnormal renal function after the use of Qingkailing injection. Methods： Based on the medical electronic data warehouse of hospital information system（HIS）,which was constructed by Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,the clinical features of patients with suspected renal dysfunction after the use of Qingkailing injection were extracted,the method of SOMTE sampling and logistic regression were used for mining data analysis. Results： Patients who were treated with Qingkailing injection were susceptible to abnormal renal function when they suffered from liver cirrhosis or electrolyte disorders,or with thymosin,nifedipine,and insulin. Conclusion： when the Qingkailing injection is combined with the suspected risk factors,the observation should be strengthened. Once the abnormal treatment is found,doctors must be in time to ensure the safety of the patients,the results of this study need to be further mechanism exploration and clinical validation.