抗妇炎胶囊治疗盆腔炎性疾病后遗症-慢性盆腔痛药物经济学评价

Economic evaluation of Kangfuyan capsules in the treatment of sequelae of pelvic inflammatory diseaseschronic pelvic pain

目的通过成本-效果和成本-效用分析,比较抗妇炎胶囊与宫炎平胶囊治疗盆腔炎性疾病后遗症(SPID)-慢性盆腔痛(CPP)的经济学优劣。方法2014年9月至2015年11月,采用随机、双盲、阳性药平行对照设计,筛选10家研究中心262例受试者,最终240例SPID-CPP患者按照1:1比例随机分配到抗妇炎胶囊组(研究组)和宫炎平胶囊组(对照组)。2023年1月至2023年12月,对两组患者进行电话随访。以下腹痛视觉模拟评分法(VAS)评分、中医证候愈显率、疾病愈显率、盆腔痛复发率和盆腔炎性疾病发生率作为效果指标,以质量调整生命年(QALYs)为效用指标,治疗3个月经周期后进行成本-效果和成本-效用分析。结果研究组人均总成本981.96元,略高于对照组的860.64元(P<0.05)。与对照组相比,研究组受试者下腹痛人均每多降低1分,需多花费131.87元;疾病治愈和显效率每增加1个百分点,需多花费6.33元;中医证候治愈和显效率每增加1个百分点,需多花费8.42元;CPP复发率每减少1个百分点,人均需多花费5.37元。与对照组相比,研究组人均每多获得1个QALY需多花费12132元。结论在SPID-CPP患者的治疗中,抗妇炎胶囊显示出良好的安全性和有效性,与宫炎平胶囊相比,具有一定的经济学优势。

Objective To compare the economic advantages and disadvantages of Kangfuyan Capsules and Gongyanping Capsules in the treatment of pelvic inflammatory disease sequelae(SPID)-chronic pelvic pain(CPP)through cost-effectiveness and cost-effectiveness analysis.Methods From September 2014 to November 2015,262 subjects from 10 research centers were selected by a randomized,double-blind,positive-drug parallel control design.Finally,240 SPID-CPP patients were randomly assigned to the anti gynecological inflammation capsule group(study group)and the Gongyanping capsule group(control group)in a 1:1 ratio.Patients in both groups were followed up by telephone from January 2023 to December 2023.The following visual analogue scale(VAS)for abdominal pain,the recovery rate of traditional Chinese medicine syndromes,the recovery rate of diseases,the recurrence rate of pelvic pain,and the incidence rate of pelvic inflammatory diseases are used as effectiveness indicators.Quality adjusted life years(QALYs)were used as efficacy indicators,and cost-effectiveness and cost-effectiveness analyses were conducted after three menstrual cycles of treatment.Results The total cost per capita in the research group was 981.96 yuan,slightly higher than the control group's 860.64 yuan(P<0.05).Compared with the control group,the lower abdominal pain per person in the study group decreased by 1 point,which more cost 131.87 yuan.Increase of 1 percentage point in disease recovery rate,an additional cost of 6.33 yuan is required;For every 1 percentage point increase in the recovery rate of traditional Chinese medicine syndromes,an additional cost of 8.42 yuan is required;For every 1 percentage point decrease in CPP recurrence rate,an additional cost of 5.37 yuan per person is required.Compared with the control group,the study group spent an additional 12132 yuan per person for every additional QALY obtained.Conclusions In the treatment of SPID-CPP patients,Kangfuyan Capsules shows good safety and efficacy,and has certain economic advantages compared with Gongyanping Capsules.