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[重新审视细菌性前列腺炎临床评估标准——替马沙星临床研究数据分析]

[Re-examination of the criteria for clinical evaluation on bacterial prostatitis--analysis of the data of the clinical study of temafloxacin].

作者信息

Arakawa S, Kamidono S, Hirose T, Kumamoto Y, Suzuki K, Ito Y, Ban Y, Kawada Y, Kumon H, Ohmori H

机构信息

Department of Urology, Kobe University School of Medicine.

出版信息

Hinyokika Kiyo. 1994 May;40(5):455-66.

PMID:8023771
Abstract

The clinical efficacy of temafloxacin (TMFX) was evaluated in the patients with acute prostatitis (AP: 31 cases) and chronic prostatitis (CP: 75 cases), and the criteria for clinical evaluation on bacterial prostatitis by the Japanese UTI Committee were re-examined. The clinical efficacy of TMFX on prostatitis was examined. The number of the evaluable cases by doctors in charge were 30 and 68 for AP and CP, respectively. The efficacy rates were as high as 96.7% for AP and 80.9% for CP. In the patients whose efficacy could be evaluated by the Committee, the efficacy rates were as high as 100% (15/15) for acute bacterial prostatitis (ABP) and 66.7% (18/27) for chronic bacterial prostatitis (CBP). The bacteriological eradication rates were 100% (15/15) for ABP and 81.5% (22/27) for CBP. Adverse drug reactions were observed in 8 of 100 cases (total evaluable cases) but they clinically did not consist any problems. Abnormal laboratory test findings were observed in 9 of 71 cases (total evaluable cases), whose changes were all slight and did not clinically cause any problem. Therefore, TMFX was concluded to be highly useful in the treatment of ABP and CBP. The criteria for clinical evaluation on bacterial prostatitis were re-examined. Concerning the treatment period, comparison of the evaluation at Day 7 with that at Day 14 in ABP revealed that the efficacy was evaluable at Day 7. In the same way, comparison of the evaluation at Day 14 with that at Day 28 in CBP revealed that the efficacy was evaluable at Day 14. Concerning the pathogens, in ABP, the major pathogens were considered to be GNR as well as E. coli. On the other hand, in CBP, GNR and E. faecalis, that were generally authorized to be pathogens, were detected in less than half of the patients, and CNS were detected in the other patients. Among the CNS cases, there were some cases that showed no relationship between improvement of clinical symptoms and bacterial response. Therefore, it is necessary to perform further studies on this matter. In conclusion, regarding the criteria for clinical evaluation on bacterial prostatitis proposed by the Japanese UTI committee, the treatment period for evaluation of efficacy was appropriate, and it is necessary to perform further studies in order to determine the pathogens in bacterial prostatitis.

摘要

对31例急性前列腺炎(AP)和75例慢性前列腺炎(CP)患者评估了替马沙星(TMFX)的临床疗效,并重新审视了日本泌尿道感染委员会关于细菌性前列腺炎的临床评估标准。研究了TMFX对前列腺炎的临床疗效。负责医生可评估的AP和CP病例数分别为30例和68例。AP的有效率高达96.7%,CP的有效率为80.9%。在委员会可评估疗效的患者中,急性细菌性前列腺炎(ABP)的有效率高达100%(15/15),慢性细菌性前列腺炎(CBP)的有效率为66.7%(18/27)。ABP的细菌清除率为100%(15/15),CBP的细菌清除率为81.5%(22/27)。100例(总可评估病例)中有8例观察到药物不良反应,但临床上无任何问题。71例(总可评估病例)中有9例观察到实验室检查结果异常,其变化均轻微,临床上未引起任何问题。因此,得出结论,TMFX在ABP和CBP的治疗中非常有用。重新审视了细菌性前列腺炎的临床评估标准。关于治疗期,ABP中第7天与第14天评估结果的比较显示,第7天即可评估疗效。同样,CBP中第14天与第28天评估结果的比较显示,第14天即可评估疗效。关于病原体,在ABP中,主要病原体被认为是革兰氏阴性菌(GNR)以及大肠杆菌。另一方面,在CBP中,通常被认定为病原体的GNR和粪肠球菌在不到一半的患者中被检测到,其他患者中检测到凝固酶阴性葡萄球菌(CNS)。在CNS病例中,有一些病例显示临床症状改善与细菌反应之间无关联。因此,有必要对此进行进一步研究。总之,对于日本泌尿道感染委员会提出的细菌性前列腺炎临床评估标准,评估疗效的治疗期是合适的,有必要进行进一步研究以确定细菌性前列腺炎中的病原体。

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