de Groot H G, Hustinx P A, Lampe A S, Oosterwijk W M
Department of Surgery, Leyenburg Municipal Hospital, The Hague, The Netherlands.
J Antimicrob Chemother. 1993 Sep;32(3):491-500. doi: 10.1093/jac/32.3.491.
The clinical safety and efficacy of imipenem/cilastatin in the treatment of intra-abdominal infections was compared with the combination of aztreonam and clindamycin in a randomized prospective trial. The severity of illness was determined by means of the Apache II score and a fixed outcome reporting scheme was used. One hundred and four patients were entered into the study, of whom 80 were evaluable. Forty-two patients were treated with imipenem/cilastatin (500 + 500 mg qds) and 38 with aztreonam (600 tds) and clindamycin (1000 mg tds). The study groups were comparable for age and sex. The imipenem/cilastatin group differed from the aztreonam and clindamycin group in having significantly more patients with the diagnosis of acute appendicitis (P < 0.01) and a significantly lower mean Apache score (P < 0.05). The predominate microorganisms isolated in both groups were Escherichia coli and Bacteroides fragilis. Treatment with imipenem/cilastatin proved successful in 71% and failed in 24%, and initial success only was seen in 5%. The numbers in the group treated with aztreonam and clindamycin were 64%, 29% and 7% respectively. Severity of illness, as measured by Apache II score, had no influence on the study outcome. Imipenem/cilastatin as well as the combination of aztreonam and clindamycin were effective in the treatment of abdominal infections and no major adverse reactions were seen.
在一项随机前瞻性试验中，对亚胺培南/西司他丁治疗腹腔内感染的临床安全性和有效性与氨曲南和克林霉素的联合用药进行了比较。通过急性生理与慢性健康状况评分系统（Apache II）来确定疾病的严重程度，并采用固定的结果报告方案。104例患者进入该研究，其中80例可进行评估。42例患者接受亚胺培南/西司他丁治疗（500 + 500毫克，每日四次），38例患者接受氨曲南（600毫克，每日三次）和克林霉素（1000毫克，每日三次）治疗。研究组在年龄和性别方面具有可比性。亚胺培南/西司他丁组与氨曲南和克林霉素组的不同之处在于，诊断为急性阑尾炎的患者明显更多（P < 0.01），且平均Apache评分显著更低（P < 0.05）。两组中分离出的主要微生物均为大肠杆菌和脆弱拟杆菌。亚胺培南/西司他丁治疗成功的比例为71%，失败的比例为24%，仅初次治疗成功的比例为5%。氨曲南和克林霉素治疗组的相应比例分别为64%、29%和7%。以Apache II评分衡量的疾病严重程度对研究结果没有影响。亚胺培南/西司他丁以及氨曲南和克林霉素的联合用药在治疗腹腔感染方面均有效，且未观察到重大不良反应。
