目的 觀察馥感啉口服液治療小兒感冒氣虛風(fēng)熱證的臨床療效和安全性。方法 采用區(qū)組隨機(jī)、雙盲雙模擬、陽性藥平行對照、多中心臨床研究的方法。467例患者隨機(jī)分為對照組(117例)和治療組(350例),對照組服用小兒解表口服液和馥感啉口服液模擬劑,治療組服用小兒解表口服液模擬劑和馥感啉口服液,療程為1周。觀察兩組的臨床療效、中醫(yī)證候療效、單項(xiàng)癥狀消失率,并對其依從性和安全性進(jìn)行評價。結(jié)果 對照組和治療組臨床療效的總有效率分別為82.91%、98.29%,中醫(yī)證候療效的總有效率分別為84.62%、98.29%,兩組比較差異均有統(tǒng)計學(xué)意義(P<0.01)。兩組的發(fā)熱、惡風(fēng)、咽紅腫痛、咳嗽的單項(xiàng)癥狀消失率比較差異均有統(tǒng)計學(xué)意義(P<0.05),兩組鼻塞、流濁涕的單項(xiàng)癥狀消失率比較差異均無統(tǒng)計學(xué)意義。兩組不良事件/不良反應(yīng)發(fā)生率比較差異均無統(tǒng)計學(xué)意義。結(jié)論 馥感啉口服液治療小兒感冒氣虛風(fēng)熱證具有較好療效,且安全性較好,具有一定的臨床推廣應(yīng)用價值。

Objective To explore the causes and characteristics of adverse drug reactions (ADR) caused by traditional Chinese medicine injections in Shanghai Jiading District Central Hospital, and to provide reference for improving clinical rational drug use. Methods ADR reports (65 cases) induced by traditional Chinese medicine injections in Shanghai Jiading District Central Hospital from 2013 to 2015 were analyzed statistically. Results Among ADR reports (65 cases), women with ADR induced by traditional Chinese medicine injections were more than men, and more were focused on 50 - 60 years old. There were 49 cases of patients without history of allergies, accounting for 75.38%. The drugs most easily triggering ADR were Xueshuantong Injection, Shenmai Injection, and Ossotide Injection. The most cases occured during 1 - 7 d after the intravenous drip. The main ADR were skin and its appendages injury (61.54%) and systemic injury (20.00%). There were 59 cases (90.77%) of ADR caused by combination with other drugs. Conclusion More attention should be paid on the ADR monitoring and reporting of traditional Chinese medicine injections to promote clinical rational use and safe medication.