Takamoto M, Ishibashi T, Toyoshima H, Tanaka H, Tamaru N, Watanabe K, Yoshida M, Tokunaga N, Ichikawa Y, Oizumi K
Department of Internal Medicine, Ohmuta National Hospital.
Jpn J Antibiot. 1994 Sep;47(9):1131-44.
In the present study, we used the envelope method to divide patients with respiratory infections into two groups: a monotherapy group given imipenem/cilastatin sodium (IPM/CS) and a combination therapy group given imipenem/cilastatin sodium plus amikacin sulfate (AMK). We then compared the clinical efficacy and safety between groups. 1. Safety was evaluated in 83 patients in the IPM/CS group and 88 in the IPM/CS + AMK group while clinical efficacy was evaluated in 77 and 80 patients in the respective groups. 2. The overall efficacy rate was 84.4% in the IPM/CS group. Among the main infections, the efficacy rates were 82.7% in 52 cases of pneumonia (including lung abscess), 100% in cases of infected bronchiectasis, 66.7% in six cases of secondary infection of chronic respiratory disease, and 100% in four cases of chronic bronchitis. The overall efficacy rate was 83.8% in the IPM/CS + AMK group. Among the main infections, the efficacy rates were 88.1% in 59 cases of pneumonia (including lung abscess), 83.3% in 12 cases of infected bronchiectasis, and 60.0% in five cases of secondary infection of chronic respiratory disease. No significant differences in efficacies were seen between groups. 3. In the IPM/CS group, the efficacy rates were 92.3% for patients without prior antibiotic therapy in the IPM/CS group and 68.0% for those with prior therapy; in the IPM/CS + AMK group, the respective rates were 83.7% and 83.9%. In the IPM/CS group, there was a significant difference in the responses of patients with and without prior antibiotic therapy (P < 0.05). 4. Side effects were observed in six patients in the IPM/CS group (7.2%) and two patients in the IPM/CS + AMK group (2.3%). Abnormal laboratory test results were noted in 5 patients in the IPM/CS group (6.0%) and in 10 in the IPM/CS + f1p4group (11.4%). There was no significant difference in the incidence of side effects between groups and no severe adverse reactions in either group. These results indicate that IPM/CS alone produces of good response in moderate to severe respiratory infections while IPM/CS combined with AMK is useful in intractable respiratory infections.
在本研究中，我们采用信封法将呼吸道感染患者分为两组：单药治疗组给予亚胺培南/西司他丁钠（IPM/CS），联合治疗组给予亚胺培南/西司他丁钠加硫酸阿米卡星（AMK）。然后我们比较了两组之间的临床疗效和安全性。1. IPM/CS组83例患者和IPM/CS + AMK组88例患者进行了安全性评估，而相应组分别有77例和80例患者进行了临床疗效评估。2. IPM/CS组的总有效率为84.4%。在主要感染中，52例肺炎（包括肺脓肿）的有效率为82.7%，感染性支气管扩张病例的有效率为100%，6例慢性呼吸道疾病继发感染的有效率为66.7%，4例慢性支气管炎的有效率为100%。IPM/CS + AMK组的总有效率为83.8%。在主要感染中，59例肺炎（包括肺脓肿）的有效率为88.1%，12例感染性支气管扩张的有效率为83.3%，5例慢性呼吸道疾病继发感染的有效率为60.0%。两组之间的疗效无显著差异。3. 在IPM/CS组中，未接受过抗生素治疗的患者有效率为92.3%，接受过治疗的患者有效率为68.0%；在IPM/CS + AMK组中，相应的有效率分别为83.7%和83.9%。在IPM/CS组中，接受过和未接受过抗生素治疗的患者反应存在显著差异（P < 0.05）。4. IPM/CS组有6例患者（7.2%）出现副作用，IPM/CS + AMK组有2例患者（2.3%）出现副作用。IPM/CS组有5例患者（6.0%）实验室检查结果异常，IPM/CS + AMK组有10例患者（11.4%）出现异常。两组之间副作用发生率无显著差异，两组均未出现严重不良反应。这些结果表明，单用IPM/CS对中重度呼吸道感染有良好反应，而IPM/CS联合AMK对难治性呼吸道感染有效。
