[關(guān)鍵詞]
[摘要]
目的 通過(guò)循證醫(yī)學(xué)的方法對(duì)3個(gè)不同廠家利妥昔單抗進(jìn)行超說(shuō)明書(shū)用藥病種藥品遴選量化評(píng)估,為醫(yī)療機(jī)構(gòu)合理用藥及藥品遴選提供依據(jù)。方法 參考《中國(guó)醫(yī)療機(jī)構(gòu)藥品評(píng)價(jià)與遴選快速指南》,通過(guò)收集3個(gè)不同廠家的利妥昔單抗(商品名:美羅華®、漢利康®、達(dá)伯華®)藥學(xué)特性、有效性、安全性、經(jīng)濟(jì)性、醫(yī)保屬性、基本藥物、貯藏條件、藥品有效期、全球使用情況和生產(chǎn)企業(yè)狀況等數(shù)據(jù),對(duì)利妥昔單抗在類風(fēng)濕性關(guān)節(jié)炎(RA)、免疫性血小板減少癥(ITP)、肉芽腫性/顯微鏡下多血管炎(GPA/MPA)中的應(yīng)用進(jìn)行遴選量化評(píng)估。結(jié)果 3種利妥昔單抗治療RA中,美羅華®得分64,達(dá)伯華®得分70,漢利康®得分為72,治療RA時(shí)可優(yōu)選漢利康®;3種利妥昔單抗治療ITP及GPA/MPA中,達(dá)伯華®得分最高,分別為68及71,治療ITP及GPA/MPA可優(yōu)選達(dá)伯華。結(jié)論 3種利妥昔單抗均可進(jìn)入醫(yī)院用藥目錄,治療RA推薦漢利康®,治療GPA/MPA推薦達(dá)伯華®,治療ITP弱推薦達(dá)伯華®。
[Key word]
[Abstract]
Objective Through the method of evidence-based medicine to quantitative evaluation of off-label disease selection of three rituximab biosimilar. Methods Referring to the "A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions", through the collection of rituximab pharmaceutical characteristics, efficacy, safety, economy, medical insurance attributes, base medicine attributes, storage conditions, drug expiration dates, global usage and production enterprise status and other data from three different manufacturers (trade names: Rituxan, Hanlikang, Dabohua), the application of rituximab in rheumatoid arthritis, immune thrombocytopenia (ITP), and granulomatous/microscopic polyangiitis was evaluated for quantitative evaluation. Results Among the three kinds of rituximab in the treatment of rheumatoid arthritis, the score of Rituximab was 64, the score of Dabohua was 70, and the score of Hanlikang was 72. For rheumatoid arthritis, Hanlikang was the best choice. In the treatment of thrombocytopenia and granulomatous/microscopic polyangiitis, Dabohua had the highest scores, 68 and 71, respectively. Dabohua was the best choice for the treatment of thrombocytopenia and granulomatous/microscopic polyangiitis. Conclusion Three kinds of rituximab could enter the drug catalogue of medical institutions. Hanlikang is recommended for the treatment of rheumatoid arthritis. Dabohua is recommended for the treatment of granulomatous/microscopic polyangiitis and weakly recommended for the treatment of thrombocytopenia.
[中圖分類號(hào)]
R979.1
[基金項(xiàng)目]