益母草注射液药物经济学评价  

Pharmacoeconomic evaluation of motherwort injection

作　　者：万峰[1,2] 张学斌 刘兴会 刘国恩[5] 成云芳[6] 彭成 WAN Feng;ZHANG Xuebin;LIU Xinghui;LIU Guoen;CHENG Yunfang;PENG Cheng(State Key Laboratory of Southwestern Chinese Medicine Resources,Chengdu University of Traditional Chinese Medicine,Chengdu 610072,Sichuan;School of Basic Medicine,Chengdu University of Traditional Chinese Medicine,Chengdu 610072,Sichuan;Beijing Compete Pharmaceutical Research And Clinical Evaluation Center,Beijing 100012,China;West China Second University Hospital of Sichuan University,Chengdu 610041,Sichuan;China Health Economics Research Center,Peking University,Beijing 100871,China;Beijing Gongcuo Pharmaceutical R&D Co.,Ltd.,Beijing 100101,China)

机构地区：[1]成都中医药大学西南特色中药资源国家重点实验室,四川成都610072 [2]成都中医药大学基础医学院,四川成都610072 [3]北京康派特药物研究与临床评价中心,北京100012 [4]四川大学华西第二医院,四川成都610041 [5]北京大学中国卫生经济研究中心,北京100871 [6]北京攻错医药研发有限公司,北京100101

出　　处：《中药与临床》2024年第4期88-94,99,共8页Pharmacy and Clinics of Chinese Materia Medica

基　　金：四川省科技成果转化示范项目(2018CC0108);四川省科学技术厅支撑项目(2021YFQ0033);国家自然科学基金重大项目(81891012);国家自然科学基金区域创新发展联合基金重点项目(U19A 2010);国家中医药多学科交叉创新团队项目(ZYYCXTD-D-202209);四川省中医药科技产业创新团队(2022C001);四川省中医药管理局科学技术研究专项(2024ZD02)。

摘　　要：目的:通过成本-效果和成本-效用分析评价益母草注射液联合缩宫素与缩宫素单独使用在预防产后出血和促进子宫复旧的经济学优劣,为医疗保险、药品支付制度改革以及缩宫产品等临床应用提供参考依据。方法:采用前瞻性队列研究设计,根据益母草注射液销售的地区和不同等级医院分布,随机选取全国25家医院2270例分娩产妇,其中自然分娩1100例,剖宫产1170例。根据生产过程中缩宫产品实际使用情况,不同分娩方式产妇均分为缩宫素单独使用和益母草注射液与缩宫素联合使用两个队列,自然分娩组中缩宫素单独使用队列578例,益母草注射液与缩宫素联合使用队列522例;剖宫产组中缩宫素单独使用队列601例,益母草注射液与缩宫素联合使用队列569例。以产后出血率、子宫复旧不良发生率、产后72 h宫底高度和恶露持续时间为效果指标,质量调整生命年(QALYs)为效用指标,进行成本-效果和成本-效用分析。结果:自然分娩组中缩宫素单独使用队列和益母草注射液与缩宫素联合使用队列产妇产后出血率分别为3.11%和2.49%,剖宫产组相应队列分别为2.33%和2.28%。与胎儿娩出时相比,无论何种分娩方式,益母草注射液与缩宫素联合使用队列产妇产后72 h宫底高度改善程度均优于缩宫素单独使用队列(自然分娩组4.0 vs.5.0,P=0.0005;剖宫产组4.93 vs.5.16,P=0.0567)。自然分娩和剖宫产组缩宫素单独使用队列子宫复旧不良发生率分别为11.94%和10.98%,均高于益母草注射液与缩宫素联合使用队列的8.62%和7.03%。采用生存分析方法对不同分娩方式中不同队列产妇恶露消失时间进行分析,自然分娩组和剖宫产组中益母草注射液与缩宫素联合使用队列产妇恶露中位消失时间均比缩宫素单独使用队列少1 d,log-rank检验P值分别为0.0159和0.8578。益母草注射液联合缩宫素使用效果优于缩宫素单独使用,但治疗成Objective: Through cost-effectiveness and costeffectiveness analysis, the economic advantages and demerits of using motherwort injection combined with oxytocin and oxytocin alone in preventing postpartum hemorrhage and promoting uterine involvment were evaluated, which provided reference for medical insurance, drug payment system reform and clinical application of uterine contraction products. Methods: A prospective cohort study was conducted. 2 270 parturient women(1 100 natural deliveries and 1 170 cesarean deliveries) coming from 25 different regions and different hospitals were selected according to the sales distribution of motherwort injection. According to the actual use of uterine contraction products in the process of production, women with different delivery methods were divided into two groups: oxytocin alone and motherwort injection combined with oxytocin. In the natural delivery group, 578 cases were given oxytocin alone, and 522 cases were given motherwort injection combined with oxytocin. In the cesarean section group, 601 cases were treated with oxytocin alone, 569 cases were treated with motherwort injectioncombined with oxytocin. The postpartum hemorrhage rate, the heights of fundus of uterus after postpartum 72h, the incidence of subinvolution of uterus and lochia duration were chosen as the effect indexes and quality-adjusted life years(QALYs) as the utility index. The cost-effectiveness and costeffectiveness analyses were conducted. Results: The postpartum hemorrhage rates of oxytocin cohort and motherwort injection combined oxytocin cohort were 3.11% and 2.49% respectively in natural deliveries group, and 2.33% and 2.28% respectively in cesarean deliveries group. Compared with fetal delivery, no matter what kind of delivery, the degree of improvement of height of fundus of uterus after postpartum 72h in oxytocin cohort was better than that in motherwort injection combined oxytocin cohort(natural delivery group 4.0 vs.5.0, P=0.000 5;cesarean section group 4.93 vs. 5.16, P=0.056 7). The incide

关 键 词：益母草注射液 自然分娩 剖宫产 成本-效果分析 成本-效用分析 药物经济学评价 

分 类 号：R956[医药卫生—药学]