Johnson H W, Anderson J D, Chambers G K, Arnold W J, Irwin B J, Brinton J R
Department of Surgery, University of British Columbia, Vancouver, Canada.
Pediatrics. 1994 May;93(5):752-5.
Because there is no evidence for the effectiveness of antibiotic prophylaxis in children with neurogenic bladder, the value of once-daily nitrofurantoin macrocrystals was assessed in a selected population with neurogenic bladder due to meningomyelocele. METHODS AND TRIAL POPULATION: Children with significant urinary tract abnormalities other than neurogenic bladder were excluded. A urinary tract "infection" was defined as > or = 10(8) colony forming units of bacteria/L of urine together with pyuria of > or = 50 x 10(6) leukocytes/L, and/or symptoms consistent with an urinary tract infection. Fifty-six children participated in a 24-week double-blinded, placebo-controlled cross-over study. The infection status was assessed at two weekly intervals or if relevant clinical manifestations occurred.
For the whole trial the average percentage of "infections" per urine sample for each patient was reduced from 39% on placebo to 19% on single daily dose prophylaxis (P < .0003). For the first 12 weeks of the trial corresponding figures were 45% on placebo and 22% on prophylaxis (P < .0018). There was evidence for a marked carryover protective effect of nitrofurantoin into the placebo arm of the trial.
Nitrofurantoin is an effective prophylactic agent during a 3-month period. Long-term studies are needed to confirm the reasonable expectation of a beneficial effect on urinary tract damage.
由于尚无证据表明抗生素预防对神经源性膀胱患儿有效，因此在一组因脊髓脊膜膨出导致神经源性膀胱的特定人群中评估了每日一次的呋喃妥因大晶体的价值。
排除患有除神经源性膀胱外的明显泌尿系统异常的儿童。泌尿系统“感染”定义为每升尿液中细菌菌落形成单位≥10⁸ ，同时脓尿≥50×10⁶白细胞/升，和/或有与泌尿系统感染相符的症状。56名儿童参与了一项为期24周的双盲、安慰剂对照交叉研究。每隔一周评估一次感染状况，或在出现相关临床表现时进行评估。
在整个试验中，每位患者每次尿液样本的“感染”平均百分比从安慰剂组的39%降至每日单剂量预防组的19%（P<0.0003）。在试验的前12周，相应的数据分别为安慰剂组45%和预防组22%（P<0.0018）。有证据表明呋喃妥因对试验的安慰剂组有显著的延续性保护作用。
呋喃妥因在3个月期间是一种有效的预防药物。需要进行长期研究以证实对泌尿系统损害有益效果的合理预期。
