Ishibashi T, Harada Y, Takamoto M, Ebihara M, Sugiyama M, Shimazu K, Iwanaga T, Kishikawa R, Makie T, Tsurutani H, Kisanuki K, Mitsuno T, Hirota N, Furuno T, Hiraoka T, Tsumori Y, Matsuura Y, Namba K, Oe T, Inuyama M, Chifu S, Fukunaga H, Ueno Y, Matsukizono K, Genka K
Department of Internal Medicine, National Ohmuta Hospital.
Jpn J Antibiot. 1998 Dec;51(12):746-58.
Clinical efficacy and safety of pareteral sulbactam/ampicillin (SBT/ABPC) was compared with cefotiam (CTM) in a randomized clinical trial of pneumonia in the elderly at 13 National Hospitals of Kyushu island. 37 patients received SBT/ABPC 3 g i.v., b.i.d., and 31 patients received CTM 1 g i.v., b.i.d. for 7 to 14 days. 1. 68 patients (37 for SBT/ABPC and 31 for CTM) were evaluated for safety. No statistical differences were noted in the patients' backgrounds of either group. 2. The clinical efficacy of SBT/ABPC was 96.3% (26/27 cases) while CTM was 75.2% (17/23 cases). This was found to be statistically significant (Fisher's exact test: p < 0.05). 3. 100% of evaluated cases (10 for SBT/ABPC and 4 for CTM) showed bacterial elimination. 4. No side effects were observed in the study. 5. Abnormal laboratory findings were noted in 10.8% (4/37 cases) for SBT/ABPC and 3.2% (1/31 cases) for CTM. The major adverse events were mild elevation of GOT, GPT and A1-P for SBT/ABPC, and mild platelets overproduction for CTM. No statistical differences were noted in both groups. These results are consistent with SBT/ABPC as a highly effective antibiotic in the treatment of elderly patients with pneumonia.
在九州岛13家国立医院对老年人肺炎进行的一项随机临床试验中,比较了注射用舒巴坦/氨苄西林(SBT/ABPC)与头孢替安(CTM)的临床疗效和安全性。37例患者静脉注射SBT/ABPC 3 g,每日2次,31例患者静脉注射CTM 1 g,每日2次,疗程7至14天。1. 对68例患者(SBT/ABPC组37例,CTM组31例)进行了安全性评估。两组患者的背景无统计学差异。2. SBT/ABPC的临床有效率为96.3%(26/27例),而CTM为75.2%(17/23例)。发现差异有统计学意义(Fisher精确检验:p<0.05)。3. 100%的评估病例(SBT/ABPC组10例,CTM组4例)显示细菌清除。4. 研究中未观察到副作用。5. SBT/ABPC组10.8%(4/37例)和CTM组3.2%(1/31例)出现实验室检查异常。主要不良事件为SBT/ABPC组谷草转氨酶、谷丙转氨酶和碱性磷酸酶轻度升高,CTM组血小板轻度过度生成。两组均未发现统计学差异。这些结果表明SBT/ABPC是治疗老年肺炎患者的一种高效抗生素。