目的 對(duì)益宮顆粒治療產(chǎn)后惡露不絕的臨床價(jià)值進(jìn)行綜合評(píng)價(jià)。方法 應(yīng)用循證醫(yī)學(xué)、藥物經(jīng)濟(jì)學(xué)、衛(wèi)生技術(shù)評(píng)估等定性與定量研究相結(jié)合的評(píng)價(jià)方法，從安全性、有效性、經(jīng)濟(jì)性、創(chuàng)新性、適宜性、可及性、藥品質(zhì)量保障性和中醫(yī)藥特色“7＋1”個(gè)維度開展益宮顆粒臨床綜合評(píng)價(jià)。結(jié)果 （1）安全性：益宮顆粒未見明顯急、慢毒性，上市后統(tǒng)計(jì)2019年1月—2022年6月益宮顆粒藥品不良反應(yīng)的粗略發(fā)生率為2.9/100 000人/年，Meta分析結(jié)果顯示，益宮顆粒/益宮顆粒聯(lián)合用藥組與對(duì)照組的不良反應(yīng)發(fā)生率差異無(wú)統(tǒng)計(jì)學(xué)意義（P＞0.05）。（2）有效性：Meta分析結(jié)果顯示，益宮顆粒/益宮顆粒聯(lián)合用藥組與對(duì)照組相比，可提高產(chǎn)后惡露不絕的總有效率[RR＝1.15，95%CI（1.12～1.19），Z＝8.62，P＜0.000 01]、術(shù)后泌乳改善率[RR＝0.20，95%CI（0.14～0.27），Z＝6.21，P＜0.000 01]、術(shù)后7 d陰道止血率[RR＝0.18，95%CI（0.12～0.24），Z＝5.68，P＜0.000 01]，降低術(shù)后28 d陰道未止血率[RR＝-0.07，95%CI（-0.12～-0.01），Z＝2.41，P＝0.02]，降低術(shù)后14 d宮腔深度[MD＝-1.25，95%CI（-1.39～-1.11），Z＝18.05，P＜0.000 01]，縮小子宮三徑和[MD＝-37.57，95%CI（-45.21～-29.87），Z＝9.59，P＜0.000 01]。（3）經(jīng)濟(jì)性：藥物經(jīng)濟(jì)學(xué)研究顯示，與產(chǎn)復(fù)康顆粒相比，益宮顆粒是具有經(jīng)濟(jì)性的方案。（4）創(chuàng)新性：調(diào)研結(jié)果顯示，益宮顆粒為獨(dú)家專利品種，具有理論創(chuàng)新性，能滿足臨床未滿足的、關(guān)鍵的需求。（5）適宜性：益宮顆粒說(shuō)明書信息完整，儲(chǔ)存方便，患者依從性較高，調(diào)研結(jié)果顯示，在藥品信息和藥品臨床使用方面其均具有較好的適宜性。（6）可及性：益宮顆粒價(jià)格水平（0.57）較低，可負(fù)擔(dān)性（13.42%）較好。（7）藥品質(zhì)量保障性：益宮顆粒的中藥材具有基源道地性，鑒定、貯存和使用等符合國(guó)家標(biāo)準(zhǔn)和藥典要求，近3年抽檢無(wú)不合格情況。（8）中醫(yī)藥特色：益宮顆粒源于民間驗(yàn)方，上市后被廣泛應(yīng)用，頗具中醫(yī)藥特色。結(jié)論 益宮顆粒治療產(chǎn)后惡露不絕的臨床價(jià)值較好，可為臨床合理用藥與科學(xué)決策提供循證參考。

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?；究蒲袠I(yè)務(wù)專項(xiàng)資助項(xiàng)目（2020-JYB-ZDGG-072）