基于真实世界氢溴酸樟柳碱注射液治疗急性缺血性脑卒中的有效性及药物经济学评价

Efficacy and Pharmacoeconomic Evaluation of Anisodine Hydrobromide Injection in the Treatment of Acute Ischemic Stroke:Based on Real World

目的评价氢溴酸樟柳碱注射液治疗急性缺血性脑卒中的有效性和经济性,为临床治疗急性缺血性脑卒中及政府决策提供医学依据。方法本研究为真实世界的回顾性队列研究,采用分层随机抽样的方法,选择2018年2月至2020年7月,全国31家医院2298例急性缺血性脑卒中住院患者为研究对象,其中暴露组和非暴露组各1149例。选择美国国立卫生研究院卒中量表(NIHSS)评分和改良Rankin量表(m RS)评分为有效性评价指标。采用成本-效果和成本-效用分析方法,对暴露组采用常规治疗基础上加用氢溴酸樟柳碱注射液和非暴露组采用常规方式治疗急性缺血性脑卒中的经济性进行比较。结果暴露组较非暴露组NIHSS评分多降低0.34分,差异有统计学意义(P<0.05);暴露组较非暴露组m RS评分≥2的比例降低多近10%,差异有统计学意义(P<0.05)。暴露组较非暴露组,每降低1个百分点的残障比例,增量成本不足300元。暴露组1年内获得的QALYs为0.1024年,高于非暴露组的0.0813年,差异有统计学意义(P<0.05)。暴露组人均每多获得1个QALY的成本低于世界卫生组织(WHO)推荐阈值。敏感性分析支持结果的稳健性。结论氢溴酸樟柳碱注射液可有效改善急性缺血性脑卒中患者的神经功能,降低残障程度,提高生命质量,药物经济学优势明显。

Objective To evaluate the efficacy and economy of anisodine hydrobromide injection in the treatment of acute ischemic stroke,and to provide a medical basis for clinical treatment of acute ischemic stroke and government decision-making.Methods This project is a real-world retrospective cohort study.A stratified random sampling method was used to select 2298 hospitalized patients with acute ischemic stroke from 31 hospitals across the country from February 2018 to July 2020 as the research subjects,including 1149 cases in the exposed group and 1149 in the non-exposed group.The NIHSS score and mRS score were selected as the efficacy evaluation indicators.The cost-effectiveness and cost-utility analysis methods were used to compare the economics of adding anisodine hydrobromide injection on the basis of conventional treatment in the exposed group and conventional treatment for acute ischemic stroke in the non-exposed group.Results Compared with the non-exposed group,the NIHSS of the exposed group decreased by 0.34 points,and the difference was statistically significant(P<0.05).Compared with the non-exposed group,the proportion of mRS≥2 in the exposed group decreased by nearly 10%,and the difference was statistically significant(P<0.05).Compared with the non-exposed group,the incremental cost of each 1 percentage point reduction in the disability ratio is less than 300 yuan.The QALYs obtained within 1 year in the exposed group was 0.1024 years,which was higher than that in the non-exposed group,which was 0.0813 years,and the difference was statistically significant(P<0.05).The cost of each additional QALY per person in the exposed group was lower than the WHO recommended threshold.Sensitivity analyses supported the robustness of the results.Conclusion Anisodine hydrobromide injection can effectively improve the neurological function of patients with acute ischemic stroke,reduce the degree of disability,improve the quality of life,and has obvious advantages in pharmacoeconomics.