天智颗粒联合多奈哌齐治疗血管性痴呆肝阳上亢证31例

Study on the Present Situation of Off-label Use of Drugs and Countermeasures in Pediatric Department

目的:研究天智颗粒联合多奈哌齐治疗血管性痴呆肝阳上亢证的临床效果。方法:将62例血管性痴呆肝阳上亢证患者随机分为观察组和对照组各31例,对照组患者采用多奈哌齐治疗,观察组患者采用天智颗粒联合多奈哌齐治疗,比较两组患者的总有效率、治疗前后QOL评分、ADL评分及不良反应情况。结果:经过治疗,观察组患者总有效率为87.10%(27/31),显著高于对照组的64.52%(20/31),差异具有统计学意义(P<0.05)。观察组患者治疗后QOL、ADL评分均显著高于对照组,差异具有统计学意义(P<0.05)。两组患者不良反应发生率比较差异无统计学意义(P>0.05)。结论:采用天智颗粒联合多奈哌齐治疗血管性痴呆肝阳上亢证可提高患者生活质量和日常生活能力,显著改善患者智力状态,具有一定的临床推广价值。

Objective：To realize the off-label use of drugs present situation in pediatric departmentanalyze its reason and risk, and to provide countermeasures for the ration drug use in children. Methods ： Select reference pediatric off-label use of drugs data reported in the literature,and statistical analysis was conducted on the incidence and types of off-label use of drugs, incidence of off-label use of drugs in children at different age stages and the drugs categories, etc. Results ： The incidence rate of off-label use of drugs were 43.9 %. The types of off-label use of drugs was over optimal application groups（44.3 %）. Super instruction was the age of the highest incidence of drug infancy（64.2 % ）. The off-label use of drugs was microbe and mineral drugs （58. 9 %）. Conclusion ： Off-label use of drugs is a widely existing phenomena,have higher risk, which needs the clinical physicians to have a good knowledge of drug introductions, as much as possible and reduce the incidence of the off-label use of drugs, so as to ensure the safe and effective medication in children.