Baba S, Wada K, Hatano T, Murai K, Kinoshita H, Kawamura S, Sugita R, Fujimaki Y, Sanbe B, Ueda R
Jpn J Antibiot. 1985 Mar;38(3):595-614.
The clinical study for TMS-19-Q.O tablet was performed with multicenter trial. The results obtained were as follows; Final global improvement rating in 332 cases of otorhinolaryngological infections were excellent in 99, good in 142, fair in 40 and poor in 51 and the effective rate was 72.6%. Those of 266 cases with acute infection were excellent in 93 and good in 121 and the effective rate was 80.5%. Optimum daily doses would be 600 mg based on the analysis of 144 cases of the acute infection with sensitive bacteria (MIC: less than or equal to 3.13 micrograms/ml). In acute infection, major causative bacteria were Gram-positive cocci (GPC) indicating the frequency of 72.0% in total isolates and 87.5% in singly isolated cases. In chronic infection, although GPC were also dominant, Gram-negative bacilli were observed in 31.9%. Clinical and bacteriological effective rates of 160 cases of acute infection with single species were 80.6% and 90.3%, and those of 43 cases in chronic infection were 44.2% and 72.7%, respectively. The resistant rates of isolates in acute infection to TMS-19-Q were 13.3% in S. aureus, 7.7% in S. epidermidis, 6.0% in S. pyogenes and 0% in S. pneumoniae. Those in chronic infection were 20.0% in S. aureus and 25.0% in S. epidermidis. Slight adverse reactions, such as skin eruption or gastrointestinal disorders were observed in 14 cases and no severe one was observed. Slight elevation of GOT, GPT, Al-P, BUN, S-Cr. or eosinophil were observed in 12 cases. These results suggest that TMS-19-Q would be useful antibiotic for otorhinolaryngological infections.
对TMS - 19 - Q.O片剂进行了多中心临床试验。获得的结果如下：332例耳鼻咽喉感染患者的最终总体改善评级为：优99例，良142例，中40例，差51例，有效率为72.6%。266例急性感染患者中，优93例，良121例，有效率为80.5%。根据对144例急性感染敏感菌（MIC：小于或等于3.13微克/毫升）病例的分析，最佳日剂量应为600毫克。在急性感染中，主要致病菌为革兰氏阳性球菌（GPC），在总分离株中的出现频率为72.0%，在单一分离株病例中的出现频率为87.5%。在慢性感染中，虽然GPC也占主导，但革兰氏阴性杆菌的出现率为31.9%。160例单一菌种急性感染的临床和细菌学有效率分别为80.6%和90.3%，43例慢性感染的临床和细菌学有效率分别为44.2%和72.7%。急性感染分离株对TMS - 19 - Q的耐药率在金黄色葡萄球菌中为13.3%，表皮葡萄球菌中为7.7%，化脓性链球菌中为6.0%，肺炎链球菌中为0%。慢性感染中，金黄色葡萄球菌为20.0%，表皮葡萄球菌为25.0%。14例患者出现轻微不良反应，如皮疹或胃肠道不适，未观察到严重不良反应。12例患者出现GOT、GPT、Al - P、BUN、S - Cr或嗜酸性粒细胞轻度升高。这些结果表明，TMS - 19 - Q对耳鼻咽喉感染将是一种有用的抗生素。
