目的 對(duì)兒瀉停顆粒治療小兒急性腹瀉（濕熱瀉）進(jìn)行臨床綜合評(píng)價(jià)，判斷其臨床價(jià)值，為臨床合理用藥提供參考。方法 通過(guò)課題組專(zhuān)家討論，圍繞安全性、有效性、經(jīng)濟(jì)性、適宜性、可及性、創(chuàng)新性6個(gè)維度，選擇《兒童中成藥臨床綜合評(píng)價(jià)指標(biāo)框架》中的評(píng)價(jià)指標(biāo)，基于文獻(xiàn)資料（公開(kāi)/未公開(kāi)）、證據(jù)性信息、臨床調(diào)查問(wèn)卷等，通過(guò)現(xiàn)存統(tǒng)計(jì)資料分析法、內(nèi)容分析法、系統(tǒng)性文獻(xiàn)綜述法等收集證據(jù)，應(yīng)用《兒童中成藥臨床綜合評(píng)價(jià)工具》進(jìn)行綜合價(jià)值判斷，對(duì)兒瀉停顆粒開(kāi)展評(píng)價(jià)。結(jié)果 （1）安全性維度：兒瀉停顆粒的不良反應(yīng)發(fā)生率較低，未發(fā)現(xiàn)嚴(yán)重不良反應(yīng)，安全性良好且風(fēng)險(xiǎn)可控，證據(jù)充分，得分 24.47分。（2）有效性維度：Meta分析和前瞻性隊(duì)列研究結(jié)果均提示，本品治療小兒急性腹瀉，具有顯著療效，在同類(lèi)品種中成藥療效排序?yàn)榈?位，得分31.94分；（3）經(jīng)濟(jì)性維度：本品日藥品費(fèi)用為3.1～24.6元，每增加1個(gè)單位有效率，僅需多花費(fèi)0.40～3.14元，具有經(jīng)濟(jì)學(xué)優(yōu)勢(shì)，得分3.63分。（4）適宜性維度：本品藥物信息和藥品使用方面都具有較好的適宜性，得分 7.87 分。（5）可及性維度：本品在可負(fù)擔(dān)性與可獲得性方面均具有較好的可及性，得分6.34分。（6）創(chuàng)新性維度：本品在技術(shù)創(chuàng)新方面，優(yōu)化了工藝、提高和修訂質(zhì)量標(biāo)準(zhǔn)；并獲得多項(xiàng)國(guó)家專(zhuān)利，具有良好創(chuàng)新性，得分2.73分。（7）綜合評(píng)價(jià)結(jié)果：兒瀉停顆粒的綜合價(jià)值指數(shù)為76.98。結(jié)論 兒瀉停顆粒綜合價(jià)值指數(shù)≥75，其治療小兒急性腹瀉（濕熱瀉）臨床綜合價(jià)值較好。

Objective To evaluate the clinical value of Erxieting Granule in treating acute pediatric diarrhea and to provide reference for rational drug use.Methods Through the discussion of experts in the research group, the evaluation indicators in the Clinical Comprehensive Evaluation Index Framework of proprietary Chinese Medicines for Children were selected based on six dimensions including safety, effectiveness and economy, and the evidence was collected based on literature (open/undisclosed), evidential information, clinical questionnaires, etc., by means of existing statistical data analysis, content analysis, systematic literature review, etc. The evaluation of Erxieting Granules was carried out by using Clinical Comprehensive Evaluation Tool of Children's proprietary Chinese Medicine. Result (1) Security dimension. The incidence of adverse reactions of Erxieting Granules was low, no serious adverse reactions were found, and the safety was good and the risk was controllable, with sufficient evidence, and the score was 24.466 points. (2) Validity dimension. The results of meta-analysis and prospective cohort study both suggested that this product had significant efficacy in the treatment of acute diarrhea in children, ranking second in the efficacy of similar varieties of proprietary Chinese medicines, with a score of 31.94 points. (3) The daily drug cost of this product is 3.1—24.6 yuan, and each additional unit of efficiency costs 0.40—3.14 yuan, which has an economic advantage, and the score is 3.63 points. (4) Suitability dimension. This product has good suitability in terms of drug information and drug use, with a score of 7.87. (5) Accessibility dimension. This product has good accessibility in terms of affordability and availability, scoring 6.34 points. (6) Innovation dimension. In terms of technological innovation, the product has optimized the process, improved and revised the quality standards. And obtained a number of national patents, with good innovation, score 2.73 points. (7) Comprehensive evaluation results. The comprehensive value index of Erxieting Granules is 76.98.Conclusion The comprehensive value index of Erxieting Granules is ≥75, and its clinical comprehensive value is better in the treatment of acute diarrhea in children (damp-heat diarrhea).

R975

中華中醫(yī)藥學(xué)會(huì)求實(shí)項(xiàng)目（兒科專(zhuān)項(xiàng)）“兒童中成藥臨床綜合評(píng)價(jià)技術(shù)及示范案例研究”（2020ZX09201-008）；天津市教委科研計(jì)劃項(xiàng)目（2021KJ138）