丹参注射液临床应用风险分析与风险控制

Risk Analysis of Clinical Use of Danshen Injections and Risk Control

目的:探讨丹参注射液在临床应用中的风险影响因素和特点,为临床应用提供风险控制依据。方法:通过对丹参注射液不良反应的详细病例资料进行统计、分析,找出引起不良反应的相关影响因素,探讨风险控制措施。结果:丹参注射液产生不良反应的因素与剂型、剂量、给药浓度、配伍用药、患者年龄及健康状况、制剂纯度等有关,并提出了相应的控制方法和措施。结论:临床药剂、医务人员只要重视了丹参注射液的临床应用风险、影响因素及消除、控制的方法,临床应用风险是可防可控的。

OBJECTIVE:To investigate influencing factors and characteristics of the risks in clinical application of Danshen injections in order to provide references for risk control in clinical application.METHODS:Through a detailed statistical analysis on the case records of the adverse reactions of Danshen injections,the related influencing factors of the adverse drug reactions were probed and the risk control measures were discussed.RESULTS:The factors accountable for the adverse reaction of Danshen injection were related to dosage form,dosage,concentrations,combined drug use,patient's age and health status,purity of the preparations,and so on.The corresponding control method and measures have been proposed.CONCLUSION:The risks in clinical application of Danshen injections are controllable so long as clinical pharmacists and medical personnel pay attention to the risk and the influencing factors a well as the risk elimination and control method in clinical application of Danshen injections.