氯碳头孢与阿莫西林/克拉维酸随机对照洽疗下呼吸道感染临床研究

A Randomized Controlled Clinical Trial of Loracarbef and Amoxicillin/Clavulanate in the Treatment of Lower Respiratory Tract Infection

本项研究旨在通过随机对照临床试验对美国礼来公司提供的氯碳头孢的安全性及有效性进行临床评价。本组临床试验选用氯碳头孢作试验药，按照每次400mm，q12h给药；阿莫西林／克拉维酸钾作对照药按照每次375－750mm，q8h给药，疗程10－14d。试验组可进行疗效评价病例为65例，药物不良反应评价病例69例;对照组可进行疗效评价病例为62例，药物不良反应评价病例69例。试验组有效率为93.8％，β-酰酸胺酶产生菌有效率为94．4％，细菌清除率为88.9％；对照组分别为90．3％、83．8％和87．3％。结果经统计学处理无显著性差异（P＞0．05）。试验组药物不良反应发生率为2．90％，对照组为11.59％，经统计学处理有显著性差异（P＜0.05）。

In order to evaluate its efficacy and safety in the treatment of lower respiratorytract infections, a randomized controlled open labelled multicenter clinical trial wasconducted for the treatment of 127 hospitalized patients with lower respiratory tractinfections. Amoxicillin/clavulanate was chosen as the controlled drug. The dosage ofIoracarbef was 400mg twice a day and for the controlled drug it was 375mg to 750mgthree times a day. The duration of treatment was 10~14 days in both groups. In therandomized controlled study, 69 patients were enrolled in loracarbef group, 69 were assessedfor safety and 65 for effcacy while 69 patients were enrolled in the controlled group, 69were assessed for safety and 62 for effcacy. The results showed that the overall efficacyrates were 93.8% for the Loracarbef group and 90.3% for the controlled group; whereasthe bacterial efficacy rates for β-lactamase-producing strains were 94.4% and 83.8%, theoverall bacterial clearance rates were 88.9% and 87.3%, respectively. The results showedthat there was no statisticaI difference between two groups(P>0.05). The incidence ofadverse drug reaction rates was 2.90% and 11 .59%, respectively. There was statisticaldifference between the two groups (P<0.05).