静配中心规范化管理对降低中药注射剂不良反应发生率的作用分析

Analysis of the effect of standardized management of static distribution center on reducing adverse reaction rate of traditional Chinese medicine injection

目的:研究静脉药物配置中心通过规范化管理对减少中药注射剂不良反应(ADR)发生率的作用。方法:收集2010~2013年规范化管理前ADR共50例,设为规范前组,2014~2016年规范化管理后ADR共11例,设为规范后组。对比两组ADR发生原因、涉及药品,分析静脉药物配置中心规范化管理对减少临床中药ADR的作用。结果:规范前组红花注射液出现ADR 6例,血栓通注射液出现ADR 7例、痰热清注射液出现ADR 12例,其他注射液出现ADR25例。规范后组ADR数量明显下降,血栓通注射液出现ADR 3例,痰热清注射液出现ADR 2例,红花注射液出现ADR 0例,其他注射液出现ADR 6例。规范后组用法用量不适宜、配伍禁忌、溶媒不适宜所致ADR较规范前组明显减少(44%VS 36%,8%VS 0%,14%VS 0%)。结论:通过静脉药物配置中心审方药师对临床不合理处方的及时干预,亦通过药物冲配人员在无菌洁净间进行规范的技术操作,减少了外界环境对药物冲配过程的影响,从而有效降低了中药注射剂ADR的发生率,保证用药安全。

Objective： To study the effect of standardized management of pharmacy intravenous admixture services to reduce the incidence of adverse reactions in traditional Chinese medicine injection.Methods： 50 cases of ADR were collected from 2010 to 2013 before standardization, set to the Pre-specification group, 11 cases of ADR were collected from 2014 to 2016 after standardization, set to the Post specification group. Results： There were 50 cases of adverse reactions in the Pre-specification group, including Xueshuantong injection ADR in 7 cases, safflower injection ADR in 6 cases , Tanreqing injection ADR in 12 cases, other injection ADR in 25 cases. The number of ADRs in the the Post specification group decreased significantly , include Xueshuantong injection ADR in 3 cases, Tanreqing injection ADR in 2 cases,safflower injection ADR in 0 cases, other ADR injection in 6 cases. After the standardized the usage is not appropriate, incompatible, solvent is not appropriate due to ADR significantly reduced （44% VS 36%, 8% VS 0%, 14% VS 0%）. Conclusion： Clinical unreasonable prescriptions was reviewed by pharmacists of PIVAS , and drug mating personnel in the sterile clean room to regulate the technical operation. Can reduce the external environment on the impact of drug matching process. Thus effectively reducing the incidence of traditional Chinese medicine injections ADR, ensure the safety of patients with medication.