盐酸头孢他美酯胶囊单独或序贯治疗急性支气管炎和肺炎的疗效观察

Cefetamet pivoxil hydrochloride alone versus sequential therapy for acute bronchitis and pneumonia

目的:观察单纯口服盐酸头孢他美酯胶囊(力欣美)或静脉滴注头孢曲松联合口服盐酸头孢他美酯胶囊序贯治疗急性支气管炎和肺炎临床疗效。方法:采用开放性、多中心的临床研究方法,共入选急性支气管炎和肺炎患者99例,有效病例88例。根据病情的严重程度分为口服组和序贯组。口服组49例予头孢他美酯(0.5g,每天2次),序贯组39例予静脉点滴头孢曲松1～2g/d,3～5d待病情改善后改为头孢他美酯0.5g每天2次序贯治疗,两组总疗程均为5～14d。结果:两组治疗急性支气管炎和肺炎的总有效率为95.5%,其中急性支气管炎口服组和序贯组的有效率均为100.0%。肺炎口服组有效率为88.0%,序贯组为96.8%。细菌培养的总阳性率35.2%,主要菌种为流感和副流感嗜血杆菌。两组细菌总的清除率为87.1%。与治疗前相比,两组患者治疗第4天与治疗后全身症状和体征评分、呼吸系统的症状和体征评分以及临床试验总评分较治疗前的评分都有明显的下降,具有显著的临床和统计学差异(P=0.000)。两组不良事件发生率为6.1%,与药物相关的不良反应总发生率为5.1%,不良反应较轻微可耐受。结论:盐酸头孢他美酯胶囊口服和联合头孢曲松序贯治疗均对急性支气管炎和肺炎具有显著的临床疗效,且不良反应发生率低,有较好的耐受性和安全性。

Objective To explore the efficacy of oral cefetamet pivoxil capsule alone versus that of sequential therapy with ceftriaxone and cefetamet pivoxial for acute bronchitis and pneumonia. Methods We conducted an openlable, muhicenter clinical trial among 88 patients. Based on the severity of infection, the patients were randomized to receive oral cefetamet pivoxil of 0.5g twice daily （49 patients with mild to moderate infection, monotherapy group）, or intravenous eeftriaxone of 1 to 2g daily for 3 to 5 days, followed by oral cefetamet pivoxil 0.5g twice daily （39 patients with moderate to severe infection, sequential therapy group） and both therapies lasted 5 to 14 days. Results The overall efficacy was 95.5 % in all the patients and 100% in those with acute bronchitis who received monotherapy or sequential therapy, tn patients with pneumonia, the efficacy was 88% for monotherapy and 96.8% for sequential therapy. The total positive rate of sputum culture was 35.2%, with the main isolates being Haemophilies influenzae and Haemophilus parainfluenzae. The overall bacterial eradication rate was 87.1%. On day 4 and completion of therapy, the general and respiratory symptoms and signs were significantly improved in both groups （P = 0.000）, so were the laboratory findings. The overall incidence of adverse events was 6.1%; the drug-related adverse events were mild and well-tolerated, with an incidence of 5.1%. Conclusions Either cefetamet pivoxil monotherapy or sequential therapy is effective, well-tolerated, and safe in the treatment of acute bronchitis and penumia and has fewer adverse events.