阿奇霉素序贯疗法治疗社区获得性肺炎138例临床评价

Clinical evaluation of azithromycin sequential therapy in the treatment of 138 patients with community-acquired pneumonia

目的 :评价阿奇霉素序贯疗法治疗社区获得性肺炎的疗效与安全性。方法 :本研究为多中心、开放、随机对照试验 ,社区获得性肺炎患者被随机分配为试验组接受阿奇霉素 ,对照组接受头孢呋辛 ,均先静脉给药继以口服序贯治疗 ,对照组中疑为非典型病原感染者需全程联合琥乙红霉素口服治疗。结果 :(1)试验组和对照组临床有效率分别为 88.9% (5 6 / 6 3)和92 .2 % (5 9/ 6 4 ) ,临床痊愈率分别为 79.4 % (5 0 / 6 3)和 6 5 .6 % (4 2 / 6 4 )。上述结果经统计学分析差异无显著性。但试验组疗程较对照组显著为短 (P <0 .0 1)。 (2 )试验组 6 3例中病原阳性者 38例 ,其中细菌培养阳性者 32例 ,非典型病原体检测阳性者14例 ,非典型病原体与细菌的混合感染 8例。对照组 6 4例中病原阳性者 4 2例 ,其中细菌培养阳性者 31例 ,非典型病原体检测阳性者 19例 ,非典型病原体与细菌的混合感染 8例。经治疗两组总的细菌清除率分别为 96 .8% (31/ 32 )和 96 .9% (30 /31) ,两组差异无显著性。 (3)试验组不良反应发生率为 2 6 .1% (18/ 6 9) ,显著高于对照组 (8.7% ,6 / 6 9) ,主要表现为试验组发生静脉注射部位局部反应者较多 (11/ 18) ,除 1例中途停药外 ,均系轻度 ,患者可耐受 ,且减缓静脉滴注速度后 ,局部反应明显减少。实?

Objective: To evaluate the efficacy and safety of injectable azithromycin in the treatment of community-acquired pneumonia. Methods:In this multicenter, open-labeled randomized comparative study, patients with community-acquired pneumonia were allocated randomly to azithromycin monotherapy group or cefuroxime with or without erythromycin ethylsuccinate group. Results:(1) The clinical efficacy rates (azithromycin vs cefuroxime with or without erythromycin ethylsuccinate) were 88.9% (56/63) vs 92.2% (59/64), the clinical cure rates were 79.4% (50/63) vs 65.6%(42/64). There was no statistically significant difference between these two groups. (2) The bacterial eradication rates were 96.8%(31/32) vs 96.9%(30/31). There was no statistically significant difference between the two groups. (3) Drug-related adverse effects were 26.1%(18/69) in azithromycin group, higher than that in cefuroxime with or without erythromycin ethylsuccinate group 8.7%(6/69). This is due to more patients with local reactions in azithromycin group than those in cefuroxime with or without erythromycin ethylsuccinate group. These drug-related events could be alleviated by slowing down the speed of infusion; most of these adverse effects of both groups were mild and tolerable. Drug-related abnormal laboratory findings occurred in both groups were 21.7% (15/69), all were mild and transient. Conclusions:The clinical efficacy of azithromycin is as good as cefuroxime with or without erythromycin ethylsuccinate, furthermore, the duration of therapy is shorter in azithromycin group. The adverse reaction rates of azithromycin are higher than those of cefuroxime with or without erythromycin ethylsuccinate, however, most adverse reaction are mild and tolerable.