Baba S, Kinoshita H, Mori Y, Sanbe B, Ueda R, Kawamura S, Sugita R, Fujimaki Y, Nomura Y, Kawabata I
Jpn J Antibiot. 1985 May;38(5):1368-88.
In order to compare the clinical efficacy and safety of TMS-19-Q.GC tablet (TMS) with josamycin tablet (JM) in acute tonsillitis, the double blind trial was carried out with the daily dosage of 200 mg X 3 in TMS and 400 mg X 3 in JM. Number of cases evaluated for clinical efficacy were 154 cases (73 treated with TMS and 81 treated with JM). The effective rating of TMS and JM were 89.0% and 88.9% judged by doctors in charge, and 82.2% and 85.2% judged by committee respectively. Bacteriological effects were satisfactory to yield the eradication rates of 93.8% in TMS and 94.7% in JM. Number of cases evaluated for safety were 199 cases (101 treated with TMS and 98 treated with JM). The incidence of side effect was 4.0% (4/101) in TMS and 5.1% (5/98) in JM and most of them were mild gastro-intestinal disorders. Number of cases evaluated for utility were 156 cases (74 treated with TMS and 82 treated with JM). The usefulness rates were 85.1% in TMS and 86.6% in JM. There was no significant difference between TMS and JM, in clinical effect, bacteriological effect, safety and utility. From these results, daily 600 mg dosage of TMS was as useful as daily 1,200 mg dosage of JM in the treatment for acute tonsillitis.
为比较TMS - 19 - Q.GC片（TMS）与交沙霉素片（JM）治疗急性扁桃体炎的临床疗效及安全性，进行了双盲试验，TMS每日剂量为200mg×3，JM每日剂量为400mg×3。评估临床疗效的病例数为154例（73例接受TMS治疗，81例接受JM治疗）。主管医生判断TMS和JM的有效率分别为89.0%和88.9%，委员会判断分别为82.2%和85.2%。细菌学效果良好，TMS和JM的根除率分别为93.8%和94.7%。评估安全性的病例数为199例（101例接受TMS治疗，98例接受JM治疗）。TMS的副作用发生率为4.0%（4/101），JM为5.1%（5/98），大多数为轻度胃肠道紊乱。评估实用性的病例数为156例（74例接受TMS治疗，82例接受JM治疗）。TMS的有用率为85.1%，JM为86.6%。TMS和JM在临床疗效、细菌学效果、安全性和实用性方面无显著差异。根据这些结果，TMS每日600mg剂量在治疗急性扁桃体炎方面与JM每日1200mg剂量同样有效。
