Sasaki J, Yamada Y, Morihana K, Kaneko A, Takai H, Ohmura H, Abe H, Ikeshima K, Sesimo Y, Mishina M
Jpn J Antibiot. 1985 May;38(5):1389-419.
Clinical efficacy and safety of TMS-19-Q.GC tablet (TMS), a new macrolide antibiotic preparation, were compared with those of josamycin (JM) in the treatment of acute odontogenic infection under multicentered double-blind controlled study at the daily dosage of 600 mg of TMS or 1,200 mg of JM. The results obtained were as follows: The patients entered into the study were 265 cases and 112 in TMS group and 111 in JM group were adopted to evaluate for the efficacy. The evaluation was made by 2 ways i.e. changes in total clinical scores of the symptom and the doctors assessment. Efficacy rating of TMS and JM were 81.3 and 82.0% judged by the score and 73.2 and 77.5% judged by doctors in charge respectively. In the cases with 15 to 20 of total scores at the initial visit, considered to be suitable for the evaluation of antibiotics, the efficacy rating of both drugs were 86.7% in TMS and 84.6% in JM. Organisms were isolated from 34 cases in TMS and 40 in JM and the clinical effectiveness in those cases were almost the same. Slight adverse reactions were observed in 6 cases (4.6%) of TMS group and 1 (0.8%) of JM. In 3 cases (4 incidences) of TMS group and 1 of JM slightly abnormal laboratory findings were found. On the statistical analysis of the data regarding efficacy, safety and usefulness, both drugs had no significant difference. From these results, TMS was considered as effective as JM in the treatment of acute odontogenic infection at a daily half doses of JM.
在多中心双盲对照研究中，比较了新型大环内酯类抗生素制剂TMS-19-Q.GC片（TMS）与交沙霉素（JM）在治疗急性牙源性感染方面的临床疗效和安全性，TMS的日剂量为600mg，JM的日剂量为1200mg。结果如下：纳入研究的患者共265例，采用TMS组112例、JM组111例进行疗效评估。评估采用两种方式，即症状总临床评分的变化和医生评估。根据评分判断，TMS和JM的有效率分别为81.3%和82.0%，根据主治医生判断分别为73.2%和77.5%。初诊时总分在15至20分、被认为适合评估抗生素疗效的病例中，两种药物的有效率TMS为86.7%，JM为84.6%。TMS组34例、JM组40例分离出微生物，这些病例的临床疗效几乎相同。TMS组6例（4.6%）出现轻微不良反应，JM组1例（0.8%）出现轻微不良反应。TMS组3例（4人次）、JM组1例实验室检查结果略有异常。对疗效、安全性和实用性的数据进行统计分析，两种药物无显著差异。从这些结果来看，TMS在日剂量为JM一半的情况下，治疗急性牙源性感染的效果与JM相当。
