淋菌感染症の疫学的治療学的研究 T-2588による検討―

Abstract

第3世代セファロスポリン系抗生物質の経口剤であるT-2588を用い, 淋菌感染症に対する治験を, 男子尿道炎140例, 女子子宮頸管炎6例の計算146例について行なった.分離淋菌の110株中23株(20.9%)はβ-lactamase産生淋菌(PPNG)であった.T-2588の分離菌に対する抗菌力(MIC)は, 接種菌量106 CFU/mlで0.1～0.0125 μg/ml (peak 0.025 μg/ml)であった.PPNGでもpeakは0.025 μg/mlで, 最高値はnon-PPNGより1管高い0.2 μg/mlであった.C. trachomatis感染合併例は男子20.9%, 女子33.3%であった.男子症例に対する有効率は, 1日2回400 mg投与法で3日目90.5%, 7日目95.3%, PPNG分離例に限っては3日目73.3%, 7日目80.0%であった.1日3回300 mg投与では3日目93.3%, 7日目100%, 1日3回600 mg投与では3日目100%, 7日目100%であり, PPNGに対しても3日目, 7日目共に100%であった.女子症例は例数が少ないので結論づけられなかったが, やはり600 mg(分3)投与がよい成績(100%)であった.副作用は軽度のものを3例(1.7%)に認めたが, そのまま治療を続行した.以上の成績から, 淋菌感染症に対するT-2588による治療は, 1日分3投与600 mg 3日間投与でPPNGと関係なく, 充分な臨床効果を期待できると考えている

T-2588, a new oral cephalosporin antibiotic, for gonorrheal infections, was administered to 146 patients with gonorrheal infection cases (140 urethritis cases in males, 6 cervicitis cases in females). Twenty three strains (20.9%) out of 110 clinically isolated gonococci were PPNG. The MICs of T-2588 for the clinically isolated gonococci strains showed a distribution peak at 0.025 microgram/ml and ranged between 0.0125 microgram/ml to 0.1 microgram/ml when an inoculum size of 10(6)/CFU/ml was used. The distribution of MICs of PPNG also showed a peak at 0.025 microgram/ml and the maximum MIC was 0.2 microgram/ml, which is one dilution tube higher than the maximum MIC of non-PPNG. The rate of complication by Chlamydia trachomatis was 20.9% in male and 33.3% in female. At the dose of 400 mg given 2 times a day, the efficacy rate for the males on the 3rd and 7th day was 90.5% (efficacy rate against PPNG, 73.3%) and 95.3% (80.0%), respectively. At the dose of 300 mg given 3 times a day, it was 93.3% and 100%, respectively, and at the dose of 600 mg given 3 times a day, it was 100% and 100%, respectively. Therefore, the administration of T-2588 3 times a day resulted in a higher efficacy rate than that given 2 times a day. This effect was extremely marked in the case of patients with PPNG. The best clinical results were obtained at a daily dose of 600 mg t.i.d. Although the female patients were few, in number and no conclusion can be drawn, the best results were obtained with a daily dose of 600 mg t.i.d. (100%). There were three mild side effects (1.7%), which could not be attributed to the administration of T-2588 in the present study. In conclusion, T-2588 can be to be expected sufficiently clinically effective against gonorrheal infections, including PPNG, at a daily dose of 600 mg t.i.d. for 3 days.