舒巴坦/头孢哌酮与头孢噻肟随机对照多中心临床研究

Multicenter randomized controlled clinical trial on sulbactam/cefoperazone versus cefotaxime

目的 :用舒巴坦 /头孢哌酮与头孢噻肟随机对照治疗各种中、重度急性细菌性感染 ,评价前者的安全性及有效性。方法 :多中心区组随机平行试验及开放试验 ,舒巴坦 /头孢哌酮 (1∶ 1) 4～ 8g/ d,分 2～ 4次静滴 ,疗程 7～ 14d;头孢噻肟 4～ 8g/ d,用法同上。结果 :共完成 16 7例 (试验组 6 0例 ,对照组 6 1例 ,开放组 46例 ) ,不同感染病种者试验组痊愈率和有效率为 81.7%和 93.3% ,对照组者为 6 7.2 %和 90 .2 % ,开放组者的80 .4%和 95 .6 % ,无显著性差异 (P>0 .0 5 )。试验组和开放组共 10 6例 ,两组总的痊愈率和有效率分别为81.1%和 94.3%。不同细菌感染者各组药物疗效与不同感染病种者临床疗效一致。三组细菌培养阳性率分别为 90 .0 %、95 .2 %及 87.0 % ,细菌β-内酰胺酶产生率分别为 6 6 .7%、5 8.6 %及 6 7.5 % ,细菌清除率 (阴转率 )分别为 98.2 % (98.2 % )、96 .6 % (96 .4% )与 95 .0 % (94.8% ) ,无显著性差异 (P>0 .0 5 )。纸片敏试结果显示临床分离菌对舒巴坦 /头孢哌酮高敏率为 96 .7% ,高于头孢噻肟 6 7.1%、头孢哌酮 6 0 .5 %、头孢曲松 6 0 .5 %、头孢他啶 77.6 %及头孢唑林 44 .1% ,有显著性差异 (P<0 .0 5 )。舒巴坦 /头孢哌酮的 MIC值较其它头孢菌素类低。

Objective: The safty and efficacy of sulbactam/cefoperazone versus cefotaxime were evaluated through multicenter clinical study in treating acute bacterial infections. Method: Sulbactam/cefoperazone (A trial group, C open group) 4~8g daily, 2~4 times per day for 7~14 days versus cefotaxime (B control) 4~8g daily, 2~4 times per day for 7~14 days. Results: One hundred sixty seven patients were enrolled. Cure and effective rates were 81.7% & 93.3% in group A ( n =60), 67.2% & 90.2% in group B ( n =61), 81.1% & 95.6% in group C ( n =46), P >0.05. The rates of β lactamase producing strains were 60.5%, 59.6% & 67.5% respectively in the three groups. Bacterial eradication rates were 98.2%, 96.6%, 95.0%. The rate of clincal isolates sensitive to sulbactam/cefoperazone was 96.7%, much higher ( P <0.05) than that to cefoperazone (60.5%), cefotaxime (67.1%), cefotriaxone (60.5%), ceftazidime (77.6%) and cefazolin (44.1%). The MIC values of sulbactam/cefoperazone were lower than that of others. Adverse reactions were 4 (6.6%) in group A (skin rash, pruritus, nausea and vomiting), 1 (1.6%) in group B (ALT AST elevated), 1 (2.2%) in group C (skin rash). Conclusion: The results suggested that sulbactam/cefoperazone is an effective and safe agent for treating moderate and severe bacterial infections.