多中心评价银杏内酯注射液治疗缺血性脑卒中药物经济学

Multicenter evaluation on pharmacoeconomics of Ginkgolide Injection in treatment of ischemic stroke

目的研究多中心常规方法加银杏内酯注射液治疗缺血性脑卒中的临床疗效、经济性、安全性,评价药物经济价值。方法采用前瞻性队列研究的试验方法,收集各中心2013年8月—2014年12月缺血性脑卒中患者,以银杏内酯注射液加常规治疗的患者为治疗组;对照组患者在常规治疗基础上可使用其他活血化瘀类药物,治疗组354例,对照组180例;在出院后3、6、12个月对两组患者进行电话随访,获取药效指标:日常生活活动能力评价(ADL)评分、生活自理患者比例、痊愈率、复发率、全因死亡率;经济学指标:患者工作恢复率、成本效果比(CER);以及不良事件发生率、严重程度,评估患者不同治疗方案的远期获益差异。结果出院后3、6、12个月,治疗组的ADL评分、痊愈率、自理率、工作恢复率均优于对照组,且差异显著(P<0.05);出院后12个月,治疗组复发率和死亡率优于对照组,且差异显著(P<0.05);出院后6、12个月,治疗组的CER均小于对照组(P<0.05);两组不良反应发生率均较低。结论远期评估发现,经银杏内酯注射液治疗患者较未接受其治疗患者临床效果更佳,CER更优,证明了银杏内酯注射液治疗脑卒中的有效性及经济性。

Objective To study the clinical efficacy,safety,and economic efficiency of ginkgolide injection and conventional therapy of patients with cerebral arterial thrombosis in multi center,and to evaluate the economic value of drugs.Methods A prospective cohort study was conducted in this study,patients with ischemic stroke were collected from August 2013 to December 2014.Patients （354 cases） in treatment group were treated with Ginkgolide Injection and routine treatment,and patients （180 cases） in control group could be treated with other drugs for activating blood circulation to dissipate blood stasis on the basis of routine treatment.The patients were telephone followed-up visited 3,6,and 12 months after discharge for pharmacodynamic indexes：evaluation of activities of daily living （ADL） score,self-care rate,cure rate,recurrence rate,and all-cause mortality;economic indicators：the patient work recovery rate,cost effectiveness ratio （CER）,and the incidence,and severity of adverse events,to assess the differences in the long-term benefits of different treatment regimens.Results Follow-up in 3,6,and 12 months showed that ADL score,cure rate,self-care rate,and work recovery rate of the treatment group were better than those of control group,and the difference was statistically significant.Follow-up in 12 months showed that,recurrence rate and mortality rate in the treatment group was better than that in the control group,with statistical difference.Follow-up in 6 and 12 months showed that CER of treatment group was smaller than that of the control group.The incidence of adverse reactions was low in the two groups.Conclusion Long term evaluation showed that patients treated with Ginkgolide Injection had better clinical outcomes and better CER than those without it,which proved the effectiveness and economic efficacy of Ginkgolide Inj ection in the treatment of stroke.