目的 對兒瀉停顆粒治療小兒急性腹瀉（濕熱瀉）進行臨床綜合評價，判斷其臨床價值，為臨床合理用藥提供參考。方法 通過課題組專家討論，圍繞安全性、有效性、經(jīng)濟性、適宜性、可及性、創(chuàng)新性6個維度，選擇《兒童中成藥臨床綜合評價指標框架》中的評價指標，基于文獻資料（公開/未公開）、證據(jù)性信息、臨床調(diào)查問卷等，通過現(xiàn)存統(tǒng)計資料分析法、內(nèi)容分析法、系統(tǒng)性文獻綜述法等收集證據(jù)，應用《兒童中成藥臨床綜合評價工具》進行綜合價值判斷，對兒瀉停顆粒開展評價。結果 （1）安全性維度：兒瀉停顆粒的不良反應發(fā)生率較低，未發(fā)現(xiàn)嚴重不良反應，安全性良好且風險可控，證據(jù)充分，得分 24.47分。（2）有效性維度：Meta分析和前瞻性隊列研究結果均提示，本品治療小兒急性腹瀉，具有顯著療效，在同類品種中成藥療效排序為第2位，得分31.94分；（3）經(jīng)濟性維度：本品日藥品費用為3.1～24.6元，每增加1個單位有效率，僅需多花費0.40～3.14元，具有經(jīng)濟學優(yōu)勢，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：本品在可負擔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：本品在技術創(chuàng)新方面，優(yōu)化了工藝、提高和修訂質(zhì)量標準；并獲得多項國家專利，具有良好創(chuàng)新性，得分2.73分。（7）綜合評價結果：兒瀉停顆粒的綜合價值指數(shù)為76.98。結論 兒瀉停顆粒綜合價值指數(shù)≥75，其治療小兒急性腹瀉（濕熱瀉）臨床綜合價值較好。

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)藥學會求實項目（兒科專項）“兒童中成藥臨床綜合評價技術及示范案例研究”（2020ZX09201-008）；天津市教委科研計劃項目（2021KJ138）