益宫颗粒治疗产后恶露不绝的临床综合评价  

Clinical comprehensive evaluation of Yigong Granules in treatment of postpartum lochia

作　　者：杨倩 魏嘉茵 潘婕 韩千禧 张欣颖 朱文涛[1] YANG Qian;WEI Jiayin;PAN Jie;HAN Qianxi;ZHANG Xinying;ZHU Wentao(School of Management,Beijing University of Chinese Medicine,Beijing 102488,China;Medical Insurance Office,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China;School of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学管理学院,北京102488 [2]首都医科大学附属北京胸科医院医疗保险办公室,北京101149 [3]北京中医药大学中医学院,北京102488

出　　处：《药物评价研究》2025年第1期167-179,共13页Drug Evaluation Research

基　　金：中央高校基本科研业务专项资助项目(2020-JYB-ZDGG-072)。

摘　　要：目的对益宫颗粒治疗产后恶露不绝的临床价值进行综合评价。方法应用循证医学、药物经济学、卫生技术评估等定性与定量研究相结合的评价方法,从安全性、有效性、经济性、创新性、适宜性、可及性、药品质量保障性和中医药特色“7+1”个维度开展益宫颗粒临床综合评价。结果(1)安全性:益宫颗粒未见明显急、慢毒性,上市后统计2019年1月—2022年6月益宫颗粒药品不良反应的粗略发生率为2.9/100000人/年,Meta分析结果显示,益宫颗粒/益宫颗粒联合用药组与对照组的不良反应发生率差异无统计学意义(P>0.05)。(2)有效性:Meta分析结果显示,益宫颗粒/益宫颗粒联合用药组与对照组相比,可提高产后恶露不绝的总有效率[RR=1.15,95%CI(1.12~1.19),Z=8.62,P<0.00001]、术后泌乳改善率[RR=0.20,95%CI(0.14~0.27),Z=6.21,P<0.00001]、术后7 d阴道止血率[RR=0.18,95%CI(0.12~0.24),Z=5.68,P<0.00001],降低术后28 d阴道未止血率[RR=-0.07,95%CI(-0.12~-0.01),Z=2.41,P=0.02],降低术后14 d宫腔深度[MD=-1.25,95%CI(-1.39~-1.11),Z=18.05,P<0.00001],缩小子宫三径和[MD=-37.57,95%CI(-45.21~-29.87),Z=9.59,P<0.00001]。(3)经济性:药物经济学研究显示,与产复康颗粒相比,益宫颗粒是具有经济性的方案。(4)创新性:调研结果显示,益宫颗粒为独家专利品种,具有理论创新性,能满足临床未满足的、关键的需求。(5)适宜性:益宫颗粒说明书信息完整,储存方便,患者依从性较高,调研结果显示,在药品信息和药品临床使用方面其均具有较好的适宜性。(6)可及性:益宫颗粒价格水平(0.57)较低,可负担性(13.42%)较好。(7)药品质量保障性:益宫颗粒的中药材具有基源道地性,鉴定、贮存和使用等符合国家标准和药典要求,近3年抽检无不合格情况。(8)中医药特色:益宫颗粒源于民间验方,上市后被广泛应用,颇具中医药特色。结论益宫颗粒治疗产后恶露不绝的临床价值较好,可为临Objective To evaluate the clinical value of Yigong Granules in treatment of postpartum lochiorrhea.Methods Evidence-based medicine,pharmacoeconomics,health technology evaluation and other qualitative and quantitative evaluation methods were used to carry out clinical comprehensive evaluation of Yigong Granules from the“7+1”dimensions of safety,effectiveness,economy,innovation,suitability,accessibility,drug quality assurance and TCM characteristics.Results(1)Safety:No obvious acute or chronic toxicity was found in Yigong Granules,and the crude incidence of adverse drug reactions of Yigong Granules from January 2019 to June 2022 was 2.9/100000 persons/year.Meta-analysis results showed that there was no statistical significance in the incidence of adverse drug reactions between Yigong Granules/Yigong Granules combined treatment group and control group(P>0.05).(2)Validity:The results of Meta-analysis showed that compared with the control group,the combined treatment group of Yigong Granules/Yigong Granules could improve the total effective rate of postpartum lochia incontinence[RR=1.15,95%CI(1.12-1.19),Z=8.62,P<0.00001]and the improvement rate of postoperative milk[RR=0.20,95%CI(0.14-0.27),Z=6.21,P<0.00001],hemostasis rate within 7 d[RR=0.18,95%CI(0.12-0.24),Z=5.68,P<0.00001],decreased the rate of non-hemostasis after 28 d[RR=−0.07,95%CI(−0.12-−0.01),Z=2.41,P=0.02],decreased the depth of uterine cavity 14 d after surgery[MD=−1.25,95%CI(−1.39-−1.11),Z=18.05,P<0.00001],and reduced the size of the triaxial diameter of uterus[MD=−37.57,95%CI(−45.21-−29.87),Z=9.59,P<0.00001].(3)Economy:Pharmacoeconomic studies had shown that compared with Chanfukang Granule group,Yigong Granule group was an economical regimen.(4)Innovation:The research results showed that Yigong Granule was an exclusive patented variety with theoretical innovation and can meet the unmet and key clinical needs.(5)Suitability:The instruction manual information of Yigong Granules was complete,convenient to store,and the patient complian

关 键 词：益宫颗粒 产后恶露不绝 临床价值 综合评价 META分析 

分 类 号：R984[医药卫生—药品]