하기도 감염 치료에 있어서 Dirithromycin(LY237216)의 효과에 대한 비교 임상연구

Abstract

Macrolides are often prescribed in the treatment of acute bronchitis, acute exacerbation of chronic bronchitis or pneumonia.Dirithromycin, a new macrolide antibiotic derived from erythromycin, is characterized by a long half-life which permits once-daily dosage. A randomized controlled clinical trial was performed to compare the efficacy and safety of dirithromycin with midecamycin over a 2~3 week observation period in patients with lower respiratory tract infections from October 1995 to May 1996 in Severance hospital, Seoul, Korea. Sixty-one patients(27 men, 34 women) were randomly assigned to receive 500mg of dirithromycin once a day or 200mg of midecamycin three times a day for seven days in patients with acute bronchitis and acute exacerbation of chronic bronchitis and for fourteen days in patients with bacterial pneumonia. Theresults of study were as follows: Significant improvement in symptoms such as cough, sputum expectoration, dyspnea, tachypnea, chest pain, chills and abnormal signs on auscultantion were noted. Clinical and bacteriological responses were assessed in 31 dirithromycin-treated and 30 midecamycin-treated patients. Evaluations were performed within 72 hours following the completion of treatment(post-therapy) and at 10~14 days following the completion of treatment (late post-therapy). Both drugs were effective with clinical success rates of 93.5% and 86.7% at post-therapy, and 93.5% and 86.7% at late post-therapy for dirithromycin and midecamycin, respectively. Pathogen eradication rates at post-therapy and late post-therapy were 77.4% and 96.7% for the dirithromycin group and 76.7% and 86.7% for the midecamycin group, respectively. There were no significant differences in clinical and bacteriological results in both treatment groups. There were no early discontinuations because of adverse events in both groups. Both drugs were well tolerated and side effects were negligible. In conclusion, dirithromycin is effective and safe in the treatment of lower respiratory tract infections.