目的 開展小兒肺熱咳喘口服液（FRKC）治療小兒急性支氣管炎（風(fēng)熱犯肺證）的臨床綜合評(píng)價(jià)，為臨床合理用藥和藥事決策提供參考依據(jù)。方法 基于文獻(xiàn)資料、相關(guān)數(shù)據(jù)平臺(tái)、臨床調(diào)查等信息，采用循證醫(yī)學(xué)、藥物經(jīng)濟(jì)學(xué)、臨床調(diào)研等定性與定量相結(jié)合的方法，圍繞安全性、有效性、經(jīng)濟(jì)性、適宜性、創(chuàng)新性、可及性 6 個(gè)維度，依據(jù)基于多準(zhǔn)則決策分析構(gòu)建的兒童中成藥臨床綜合評(píng)價(jià)技術(shù)體系對(duì) FRKC 進(jìn)行臨床綜合評(píng)價(jià)。結(jié)果 （1）安全性：FRKC 在處方、非臨床安全性、質(zhì)量監(jiān)管等方面均未體現(xiàn)安全性風(fēng)險(xiǎn)，臨床安全性方面，尚未發(fā)現(xiàn)嚴(yán)重不良反應(yīng)，一般不良反應(yīng)發(fā)生率較低，程度輕且短暫?？傮w安全性良好且可控。（2）有效性：Meta 分析顯示，F(xiàn)RKC 聯(lián)合西醫(yī)常規(guī)治療對(duì)于小兒急性支氣管炎的總有效率優(yōu)于單用西醫(yī)常規(guī)治療；同類品種的網(wǎng)狀 Meta 分析顯示，F(xiàn)RKC 在咳嗽消失時(shí)間、退熱時(shí)間、啰音消失時(shí)間方面，均排名第 1 位。臨床調(diào)研結(jié)果顯示，醫(yī)生和患者對(duì) FRKC 治療小兒急性支氣管炎的療效認(rèn)可度較高。（3）經(jīng)濟(jì)性：藥物經(jīng)濟(jì)學(xué)研究顯示，與西醫(yī)常規(guī)治療相比，F(xiàn)RKC 聯(lián)合常規(guī)治療更具有成本-效果優(yōu)勢(shì)。（4）適宜性：FRKC 說明書內(nèi)容完整、更新及時(shí)，患兒對(duì)劑型和口味可接受程度較高，運(yùn)輸和存儲(chǔ)方便，可滿足各年齡段整包裝服藥，在藥物信息和藥品使用方面都具有較好的適宜性。（5）創(chuàng)新性：FRKC 為中藥第四類新藥，臨床研究和指南、共識(shí)推薦其用于治療流感、毛細(xì)支氣管炎、病毒性肺炎、支氣管肺炎、支原體肺炎、慢性咳嗽、蕁麻疹等，外溢效應(yīng)較好。（6）可及性：FRKC 銷售范圍廣，市場(chǎng)占有率高；療程費(fèi)用占家庭可支配收入比例較低，不含瀕危、貴細(xì)藥材，可及性和可負(fù)擔(dān)性方面均較好。結(jié)論 綜合 6 個(gè)維度證據(jù)，采用兒童中成藥臨床綜合評(píng)價(jià)工具計(jì)算，F(xiàn)RKC 的臨床價(jià)值評(píng)分為 75.578 分，說明其治療小兒支氣管炎（風(fēng)熱犯肺證）臨床價(jià)值較好，其評(píng)價(jià)結(jié)果可為臨床合理用藥與藥事決策提供循證參考依據(jù)。

Objective To comprehensively evaluate the clinical application value of Xiaoer Feire Kechuan Oral Liquid (FRKC) in the treatment of acute bronchitis (syndrome of wind-heat invading lung), so as to provide evidence for clinical rational use and regulatory decision-making. Method Based on literature, relevant data platform, clinical investigation and other information, evidence-based medicine, pharmacoeconomics, clinical investigation and other qualitative and quantitative methods were adopted to focus on the six dimensions of safety, effectiveness, economy, suitability, innovation, and accessibility. According to the clinical comprehensive evaluation technology system of children's proprietary Chinese medicine based on multi-criteria decision analysis, the clinical comprehensive evaluation of FRKC was carried out. Result (1) Safety: FRKC does not reflect safety risks in terms of prescription, non-clinical safety, quality supervision, etc. In terms of clinical safety, no serious adverse reactions have been found, and the incidence of adverse reactions is generally low, the degree is mild and short. Overall safety is good and controllable. (2) Effectiveness: Meta-analysis showed that the total effective rate of FRKC combined with conventional western medicine was better than that of conventional Western medicine alone in treating acute bronchitis in children. Network meta-analysis of similar varieties showed that this product ranked first in terms of cough disappearance time, fever reduction time and rales disappearance time. The results of clinical investigation showed that doctors and patients recognized the efficacy of this product in the treatment of acute bronchitis in children.(3) Economy: Pharmacoeconomic studies showed that FRKC combined with conventional treatment has more cost-effectiveness advantages.(4) Suitability: The contents of the FRKC manual are complete and updated in a timely manner, the dosage form and taste are acceptable to children, and the transportation and storage are convenient, which can meet the whole packaging of medicine for all ages, and has good suitability in terms of drug information and drug use.(5) Innovation: FRKC is the fourth new drug of Chinese medicine. Clinical research and guidelines and consensus recommend it for the treatment of influenza, bronchiolitis, viral pneumonia, bronchoppneumonia, mycoplasma pneumonia, chronic cough, urticaria, etc., with good spillover effect. (6) Accessibility: FRKC has a wide sales range and a high market share. The cost of treatment is relatively low in the proportion of household disposable income, does not contain endangered and expensive fine herbs, and has good accessibility and affordability. Conclusion Based on six dimensions of evidence, the clinical value score of FRKC was 75.578 points by using the clinical comprehensive evaluation tool of children's proprietary Chinese medicine. It is indicated that it has good clinical value in the treatment of pediatric bronchitis (syndrome of wind-heat invading lung), and the evaluation results can provide evidence-based reference for clinical rational drug use and drug decision-making.

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中華中醫(yī)藥學(xué)會(huì)求實(shí)項(xiàng)目（兒科專項(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）