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 Original Articles |
| A Randomized, Phase II, Dose-Ranging Trial of
Metampicillin/sulbactam(Mepicinⓡ) in the Treatment of Acute Pyelonephritis |
| Jang-Wook Sohn, M.D., Chul-Hyun Kim, M.D., Ok Park, M.D., Hee-Jin Cheong, M.D.,
Woo-Joo Kim, M.D., Min-Ja Kim, M.D., Seoung-Chul Park, M.D.,
Seong-Il Kim, B.S.* and Young-Ki Kim, M.D.* |
| Department of Internal Medicine and Clinical Pathology,
College of Medicine, Korea University, Seoul, Korea. |
Vol.32 Num.2 (p135~140)
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Background:Mepicin is a new product of β- lactamase inhibitors, comprised of metampicillin and sulbactam. A randomized, phase II, dose-ranging pilot study was performed to compare the safety and efficacy of Mepicin in the treatment of acute pyelonephritis.
Methods:A total of 92 adult patients with acute pyelonephritis were enrolled and randomized into one of the three treatment arms:3, 4.5 and 6 g/day of Mepicin. Thirty-two patients were excluded according to the exclusion criteria, and the rest 60 patients were eligible for the study, with 20 subjects in each of the three treatment arms. All subjects received the Mepicin intravenously for 7 to 10 days. Clinical and bacteriological responses were evaluated at entry and during the study period. Toxicity was monitored by daily examinations of the patients and the periodic evaluations of laboratory findings. Statistical analysis was done by Chi- square test, paired t-test, ANOVA, and repeated measures ANOVA.
Results:Overall clinical response rate was 93.3% (56/60). There were three relapses (5%) and one treatment failure. The bacteriological eradication was 88.3% (53/60). Most commonly isolated organism was E. coli (98%). There were no significant differences in clinical and bacteriological responses among the three treatment arms. Adverse drug reactions by Mepicin occurred in 58.7% (54/92) of all subjects evaluated. However, they appeared not to be dose-related and subsided without any specific treatment, except that one patient received antihistamine against urticaria. All adverse events includedeosinophilia (33.7%), abnormal liver function (26.1%), leukopenia (9.8%), rash (3.3%), urticaria (1.1%), phlebitis (1.1%), nausea(1.1%), vomiting(1.1%), thrombocytopenia (1.1%), increased BUN (1.6%), and total bilirubin (1.6%).
Conclusion:The data indicate that Mepicin is similarly effective and safe in the treatment of acute pyelonephritis among the treatment arms of 3, 4.5 and 6 g/day, and the dosage of 3 g/day of Mepicin appears to be mostly cost-effective. Further study needs to include a large scale of subjects |
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Keywords : Metampicillin/sulbactam, Mepicin, Acute pyeolnephritis, Efficacy, Safety |
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