【摘要】：目的觀察馥感啉口服液治療小兒急性上呼吸道感染在廣泛應(yīng)用條件下的有效性和安全性。方法采用多中心、觀察性研究的方法,收集2 124例急性上呼吸道感染的患兒,服用馥感啉口服液,療程為1周。分別從不同劑量、年齡段、辨證/辨病以及治療手段方面,觀察各組的痊愈率、繼發(fā)下呼吸道感染/呼吸道并發(fā)癥的情況,并對(duì)其安全性進(jìn)行評(píng)價(jià)。結(jié)果馥感啉口服液治療感冒總?cè)蕿?5.12%;倍增劑量與標(biāo)準(zhǔn)劑量、辨證(氣虛風(fēng)熱證、風(fēng)熱證)與辨病的痊愈率比較,差異無(wú)統(tǒng)計(jì)學(xué)意義;不同年齡段和不同治療方式的痊愈率比較,差異有統(tǒng)計(jì)學(xué)意義,其中以1歲年齡段患者及單獨(dú)服用馥感啉的患者痊愈率較高。并發(fā)癥總發(fā)生率為0.24%;倍增劑量與標(biāo)準(zhǔn)劑量、不同年齡段、辨證(氣虛風(fēng)熱證、風(fēng)熱證)與辨病的并發(fā)癥發(fā)生率比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義;單獨(dú)用藥的并發(fā)癥發(fā)生率低于聯(lián)合用藥。整體總臨床不良事件及不良反應(yīng)發(fā)生率分別為1.37%、1.04%。;臨床不良事件及不良反應(yīng)發(fā)生率比較,除不同劑量組外,差異均有統(tǒng)計(jì)學(xué)意義。結(jié)論馥感啉口服液治療小兒急性上呼吸道感染具有較高的臨床痊愈率和較低的并發(fā)癥發(fā)生率,療效較好;對(duì)于氣虛風(fēng)熱證、風(fēng)熱證,甚至辨病治療,有著較好而接近的療效;年齡越小治療痊愈率稍高。臨床不良事件/不良反應(yīng)的總發(fā)生率較低,倍增劑量未顯示出較標(biāo)準(zhǔn)劑量更高的安全風(fēng)險(xiǎn)。提示該品種有著較好的臨床應(yīng)用前景。
[Abstract]:Objective to observe the efficacy and safety of Fuganlin oral liquid in the treatment of acute upper respiratory tract infection in children. Methods A multicenter, observational study was used to collect 2 124 children with acute upper respiratory tract infection. The recovery rate, secondary lower respiratory tract infection and respiratory complications were observed from different dosage, age, syndrome differentiation / disease differentiation and treatment methods, and their safety was evaluated. Results the total cure rate of Fuganlin oral liquid in treating cold was 95.12.The difference between double dose and standard dose, syndrome differentiation (qi deficiency wind heat syndrome, wind heat syndrome) and disease differentiation was not statistically significant. There was significant difference in the cure rate between different age groups and different treatment methods, among which the cure rate was higher in the patients aged 1 years old and those who took fulminate alone. The total incidence of complications was 0.24. There was no significant difference in the incidence of complications between double dose and standard dose, different age groups, syndrome differentiation (qi deficiency, wind heat syndrome, wind heat syndrome) and disease differentiation. The incidence of complications of single medication was lower than that of combined medication. The overall incidence of clinical adverse events and adverse reactions were 1.37 and 1.044.There were significant differences in the incidence of clinical adverse events and adverse reactions except for different dosage groups. Conclusion Fuganlin oral liquid has higher clinical cure rate and lower incidence of complications in the treatment of acute upper respiratory tract infection in children, and has good curative effect on qi deficiency, wind-heat syndrome and even disease differentiation. The younger the age, the higher the cure rate. The overall incidence of clinical adverse events / adverse reactions was low, and the multiplying dose did not show a higher safety risk than the standard dose. It is suggested that this variety has a good clinical application prospect.
【作者單位】： 天津中醫(yī)藥大學(xué)第一附屬醫(yī)院;天津中醫(yī)藥大學(xué);
【分類(lèi)號(hào)】：R272

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