摘要
目的评价连花清瘟胶囊治疗流行性感冒的临床疗效和安全性。方法采用随机双盲、阳性药平行对照、多中心临床试验设计。共入组240例,入组条件为符合流行性感冒诊断及中医毒热袭肺证辨证,体温≥38.0℃,年龄18～50岁,病程在48h之内。合格的受试者随机接受连花清瘟胶囊(4粒/次)或羚羊感冒胶囊(2粒/次)治疗,每日3次,共3d。结果证实为流感患者(即ITTI总体)有152例,试验组76例,对照组76例。ITTI总体中医证候疗效试验组显效率73.7%,明显高于对照组(55.3%)(P=0.018)。ITTI总体24h体温疗效试验组显效率71.1%,明显高于对照组(53.9%)(P=0.029)。共有233例可进行安全性分析,试验组未见不良反应发生。结论连花清瘟胶囊在流感发病后早期使用可以明显减轻症状的严重程度,未发现毒副作用。
Objective To evaluate the therapeutic effect and safety of Lianhua Qingwen Capsules (LHQC) in the treatment of influenza. Methods A multi- center, randomized, double- blind, positive- controlled, parallel group trial was designed. A total of 240 cases, which were diagnosed with influenza and classified as the syndrome of toxic heat invading lung, aged from 18 to 50 years old, with body temperature over 38.0 ℃ and disease course with 48 hours, was recruited. The intent- to- treat infected (ITTI) population was 152 cases , among which 76 were treated with LHQC (4 capsules thrice daily for 3 days) and other 76 with Lingyang Ganmao Capsules (2 capsules thrice daily for 3 days). Results In the ITTI population, the effective rate for subsiding fever was 71.1 % and 53.9 % (P=0.029), and that for relieving TCM symptoms was 73.7 % and 55.3 % (P=0.018) in LHQC group and Lingyang Ganmao Capsules group, respectively. A safety analysis was conducted in 233 cases. No adverse action was found in LHQC group while two adverse events (allergic dermatitis and diarrhea) in Lingyang Ganmao Capsules group. Conclusion Early application of LHQC is effective and safe in treating infuenza.
出处
《中药新药与临床药理》
CAS
CSCD
2005年第4期290-293,共4页
Traditional Chinese Drug Research and Clinical Pharmacology
关键词
连花清瘟胶囊
流行性感冒
毒热袭肺证
中药疗法
Lianhua Qingwen capsule
Infuenza
syndrome of toxic heat invading lung TCD therapy
