舒巴坦－头孢哌酮与头孢噻肟随机对照治疗细菌性感染207例多中心临床试验

A RANDOMIZED CONTROLLED CLINICAL TRIAL OF SULPERAZONE AS COMPARED WITH CE- FOTAXIME IN THE TREATMENT OF BACTERIAL INFECTIONS

本项临床试验旨在评价舒巴坦与头孢哌酮联合制剂（ｓｕｌｐｅｒａｚｏｎｅ，舒普深）的安全性与有效性。试验方法为区组随机化开放式平行对照多中心试验设计，并选用头孢噻肟作为对照药。本次试验共治疗细菌性感染２０７例，其中联合制剂组与头孢噻肟组分别为１０３与１０４例。两组痊愈率分别为７３．７９％和６６．３５％；有效率分别为９５．１５％和９０．３８％；细菌清除率分别为８４．７１％和８０．６４％。不良反应发生率分别为７．７７％和８．６５％，差异均无显著性；但临床分离到的致病菌对联合制剂敏感率为９０．９０％，显著高于对头孢噻肟的敏感率（６９．３２％）。表明该联合制剂治疗细菌性感染安全有效，可提供临床广泛应用。

randomized controlled clinical trial of sulperazone as compared with efotaxime was conducted.207 patients with bacterial infections entered the study.The overall clinical efficacy rate of sulperazone and ce- fotaxime was 95.15% and 90.38% respectively. The bacterial clearance rate in the two groups was 84.7%and 80.6%respectively. The adverse drug reactions in both groups were mild with the rate of 7.77%and 8.65% respectively;there was no statistical difference between the two groups. The results of disc susceptibility test showed that the sensitive rate of the clinical isolates to sulperazone was 90.9%,be-ing significantly higher than that of cefotaxime 69.3%(P<0.001).