目的 观察馥感啉口服液治疗小儿感冒气虚风热证的临床疗效和安全性。方法 采用区组随机、双盲双模拟、阳性药平行对照、多中心临床研究的方法。467例患者随机分为对照组(117例)和治疗组(350例),对照组服用小儿解表口服液和馥感啉口服液模拟剂,治疗组服用小儿解表口服液模拟剂和馥感啉口服液,疗程为1周。观察两组的临床疗效、中医证候疗效、单项症状消失率,并对其依从性和安全性进行评价。结果 对照组和治疗组临床疗效的总有效率分别为82.91%、98.29%,中医证候疗效的总有效率分别为84.62%、98.29%,两组比较差异均有统计学意义(P<0.01)。两组的发热、恶风、咽红肿痛、咳嗽的单项症状消失率比较差异均有统计学意义(P<0.05),两组鼻塞、流浊涕的单项症状消失率比较差异均无统计学意义。两组不良事件/不良反应发生率比较差异均无统计学意义。结论 馥感啉口服液治疗小儿感冒气虚风热证具有较好疗效,且安全性较好,具有一定的临床推广应用价值。

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.