目的 對黃莪膠囊進行臨床綜合評價，探索其臨床優(yōu)勢，以推進臨床合理用藥。方法 采用文獻研究及問卷調(diào)研的方式，全面收集黃莪膠囊在安全性、有效性、經(jīng)濟性、創(chuàng)新性、適宜性和可及性的證據(jù)及相關(guān)資料，利用多準則決策分析對黃莪膠囊的臨床價值進行綜合評價。結(jié)果 近5年有8部臨床指南、專家共識或?qū)Ｖ惺珍浟它S莪膠囊，推薦用于氣虛血瘀證、濕熱阻滯證患者。文獻研究顯示，單用或與其他陽性藥物聯(lián)用，均可有效提高良性前列腺增生癥患者的臨床總有效率、最大尿流率，降低國際前列腺癥狀評分（I-PSS），減少夜尿次數(shù)，有效性評定為A級。不良反應發(fā)生率為0～12.7%，多為一般不良反應，未見嚴重不良反應報道，安全性評為A級。相比于安慰劑治療，使用黃莪膠囊每提高1%有效率，需多花費33.04元，經(jīng)濟性評為A級；具有很好的臨床創(chuàng)新性和服務創(chuàng)新性，創(chuàng)新性評為A級；無特殊保存條件、藥材成分和其他限制條件，臨床使用符合用藥指南規(guī)范，適宜性評為A級；黃莪膠囊與同西醫(yī)適應癥的中成藥相比，價格相對偏高，日費用為39.3元，可及性評為B級。結(jié)論 綜合定量與定性2種方法，以循證醫(yī)學證據(jù)為主，結(jié)合調(diào)查問卷、官網(wǎng)數(shù)據(jù)信息、人用經(jīng)驗、藥物經(jīng)濟學評價等研究方法，對黃莪膠囊進行綜合評估：可及性評定為B級，有效性、安全性、經(jīng)濟性、創(chuàng)新性及適宜性均為A級。

Objective To evaluate the clinical effectiveness of Huang'e Capsules, aiming to clarify its clinical advantages and promote rational drug use. Methods Based on literature and questionnaire research, comprehensive evidence and related data on shexiang tongxin were collected in the dimensions of safety, effectiveness, economy, innovation, suitability and accessibility. And multi-criteria decision analysis (MCDA) was used to comprehensively evaluate the clinical value of Huang'e Capsules. Results Based on the eight clinical guidelines, expert consensus or monographs publishd in the past five years, Huang'e Capsules are recommended for patients with qi deficiency, blood stasis and damp heat blockade. Alone, or combination with other positive drugs, Huang'e Capsules can effectively improve the total clinical response rate, maximum urine flow rate, reduce I-PSS score, reduce the frequency of nocturia, and rate the effectiveness as A. Adverse reactions are mostly general adverse reactions and the incidence of adverse reactions was 0—12.7%. No serious adverse reactions have been reported, the risk is known to be small, and the safety is rated A. Compared with placebo, increase 1% effective rate would extra cost 33.04 yuan for Huang'e capsule, economic rating of grade A. It has good clinical innovation and service innovation, and innovation is rated as A. There are no special storage conditions, medicinal material ingredients and other restrictions, and the clinical use meets the specifications of the medication guidelines, and the suitability is rated as A; Compared with proprietary Chinese medicines with Western medical indications, the price of Huang'e Capsules are relatively highwith the daily cost of 39.3 yuan, and the accessibility is rated as B. Conclusion A comprehensive evaluation of Huang'e Capsules was conducted using two methods, quantitative and qualitative, with evidence-based medicine as the main method. Research methods such as survey questionnaires, official website data, user experience, and pharmacoeconomic evaluation were combined to evaluate the accessibility of Huange Capsules. The accessibility was rated as B level, while the effectiveness, safety, economy, innovation, and suitability were all rated as A.

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