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2.9/100 000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＜0.000 01]、术后泌乳改善率[RR＝0.20，95%CI（0.14～0.27），Z＝6.21，P＜0.000 01]、术后7 d阴道止血率[RR＝0.18，95%CI（0.12～0.24），Z＝5.68，P＜0.000 01]，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＜0.000 01]，缩小子宫三径和[MD＝-37.57，95%CI（-45.21～-29.87），Z＝9.59，P＜0.000 01]。（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，可为临床合理用药与科学决策提供循证参考。

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 2.9/100 000 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 < 0.000 01] and the improvement rate of postoperative milk [RR = 0.20, 95%CI (0.14—0.27), Z = 6.21, P < 0.000 01], hemostasis rate within 7 d [RR = 0.18, 95%CI (0.12—0.24), Z = 5.68, P < 0.000 01], 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 < 0.000 01], and reduced the size of the triaxial diameter of uterus [MD = -37.57, 95%CI (-45.21—-29.87), Z = 9.59, P < 0.000 01]. (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 compliance was high. Research results showed that it had good suitability in terms of drug information and clinical use of drugs. (6) Accessibility: The price level of Yigong Granules was low (0.57 < 1), and the affordability (13.42%) aws good. (7) Drug quality assurance: The Chinese medicinal materials of Yigong Granules had the basic source and local nature, and the identification, storage and use meet the requirements of national standards and pharmacopoeia, and there were no qualified cases in the past three years. (8) TCM characteristics: Yigong Granules originated from folk prescriptions and had been widely used after listing, with TCM characteristics. Conclusion The clinical value of Yigong Granules is good, and it can provide evidence-based reference for clinical rational drug use and scientific decision-making.

R984

中央高校基本科研业务专项资助项目（2020-JYB-ZDGG-072）