益母草注射液药物经济学评价

Pharmacoeconomic evaluation of motherwort injection

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,但治疗成本相应提高(自然分娩组3842.8元vs.3901.14元;剖宫产组6106.7元vs.6510.5元),自然分娩组产后产后出血率、产后72 h宫底高度改善、子宫复旧不良发生率和恶露持续时间增量成本效果比(ICER)分别为94.11、58.35、17.58和58.35元;剖宫产组产后产后出血率、产后72 h宫底高度改善、子宫复旧不良发生率和恶露持续时间增量成本效果比(ICER)分别为8003、1755、101和400元。结论:在分娩中,益母草注射液与缩宫素联合使用相比于缩宫素单独使用,不但能减少缩宫素的使用次数和使用剂量,同时在降低产后出血率、子宫复旧等方面更有优势,具有一定的成本-效益。

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 incidence of uterine involution in oxytocin cohort and motherwort injection combined oxytocin cohort were 11.94% and 10.98% respectively, which were higher than 8.62% and 7.03% in the cohort of motherwort injection combined oxytocin. Lochia duration in different cohorts was analyzed by survival analysis. The median of lochia duration in motherwort injection combined oxytocin cohort was 1 day less than that of oxytocin cohort. The P value of log-rank test were 0.015 and 0.857. Although the effect of motherwort injection combined with oxytocin was better than oxytocin alone, but it's treatment cost was higher(3 842.8 yuan vs. 3 901.14 yuan in natural deliveries group;6 106.7 yuan vs. 6 510.5 yuan in cesarean deliveries group). In natural deliveries group, the incremental cost-effectiveness ratio( ICER) of the postpartum hemorrhage rate, the heights of fundus of uterus after postpartum 72 h, the incidence of subinvolution of uterus and lochia duration were 94.11, 58.35, 17.58 and 58.35 yuan respectively.In the cesarean section group, the rate of postpartum hemorrhage, the improvement of fundal height 72 hours after delivery, the incidence of adverse uterine involusion and the incremental cost-effectiveness ratio(ICER) of lochia duration were 8 003, 1 755, 101 and 400 yuan,respectively. Conclusion: In delivery, motherwort injection combined oxytocin not only can decrease the dosage of oxytocin, but also have more advantages in reducing the rate of postpartum hemorrhage, promoting uterine involution and so on, and is a certain cost-effectiveness solution.