Watanabe S, Kukita A, Miura Y, Tsukinaga I, Tagami H, Tanita Y, Nonami E, Shishiba T, Fujita K, Shigeno Y
Jpn J Antibiot. 1985 May;38(5):1331-54.
Clinical efficacy and safety of TMS-19-Q.GC tablet (TMS), a new macrolide preparation, were compared with those of midecamycin (MDM) in superficial suppurative skin and soft tissue infections. The study was made by the double-blind controlled trial at the dosage of daily 600 mg in TMS group and 1,200 mg in MDM group. Total 218 cases (106 in TMS, 112 in MDM) were analyzed and the final global improvement rating were 82.1% in TMS and 83.9% in MDM. The clinical effectiveness of TMS was favorable and significantly different from MDM in the aged patients (greater than or equal to 60 years old) and the patients infected with susceptible strains (MIC less than or equal to 3.13) of Staphylococcus aureus. TMS is prepared with a specific formulation to make the absorption easier in the patients with lower acidity of gastric juice, and the favorable effect of TMS is considered to be a contribution of the devise in older patients. Slight adverse reactions were observed at 5.0% (6 cases) in TMS and 2.4% (3 cases) in MDM. In conclusion, TMS at the daily half dose of MDM is as effective as MDM in superficial suppurative skin and soft tissue infections.
将新型大环内酯制剂TMS-19-Q.GC片（TMS）与麦迪霉素（MDM）在浅表化脓性皮肤和软组织感染方面的临床疗效及安全性进行了比较。该研究采用双盲对照试验，TMS组每日剂量为600mg，MDM组为1200mg。共分析了218例病例（TMS组106例，MDM组112例），最终总体改善率TMS组为82.1%，MDM组为83.9%。在老年患者（年龄大于或等于60岁）以及感染金黄色葡萄球菌敏感菌株（MIC小于或等于3.13）的患者中，TMS的临床疗效良好，且与MDM有显著差异。TMS采用特定配方制备，使胃液酸度较低的患者更易吸收，TMS的良好效果被认为得益于该设计对老年患者的作用。TMS组轻微不良反应发生率为5.0%（6例），MDM组为2.4%（3例）。总之，TMS每日剂量为MDM的一半，在浅表化脓性皮肤和软组织感染中的疗效与MDM相当。
