Straus W L, Qazi S A, Kundi Z, Nomani N K, Schwartz B
Centers for Disease Control and Prevention, Public Health Service, Department of Health and Human Services, Atlanta, USA.
Lancet. 1998 Jul 25;352(9124):270-4. doi: 10.1016/s0140-6736(97)10294-x.
Co-trimoxazole is widely used in treatment of paediatric pneumonia in developing countries, but drug resistance may decrease its effectiveness. We studied the effectiveness of co-trimoxazole compared with that of amoxycillin in pneumonia therapy, and assessed the clinical impact of co-trimoxazole resistance.
We recruited 595 children, aged 2-59 months, with non-severe or severe pneumonia (WHO criteria) diagnosed in the outpatient wards of two urban Pakistan hospitals. Patients were randomly assigned on a 2:1 basis co-trimoxazole (n=398) or amoxycillin (n=197) in standard WHO doses and dosing schedules, and were monitored in study wards. The primary outcome was inpatient therapy failure (clinical criteria) or clinical evidence of pneumonia at outpatient follow-up examination.
There were 92 (23%) therapy failures in the co-trimoxazole group and 30 (15%) in the amoxycillin group (p=0.03)-26 (13%) versus 12 (12%) among children with non-severe pneumonia (p=0.856) and 66 (33%) versus 18 (18%) among those with severe pneumonia (p=0.009). For patients with severe pneumonia, age under 1 year (p=0.056) and positive chest radiographs (p=0.005) also predicted therapy failure. There was no significant association between antimicrobial minimum inhibitory concentration and outcome among bacteraemic children treated with co-trimoxazole.
Co-trimoxazole provided effective therapy in non-severe pneumonia. For severe, life-threatening pneumonia, however, co-trimoxazole is less likely than amoxycillin to be effective.
复方新诺明在发展中国家被广泛用于治疗小儿肺炎，但耐药性可能会降低其疗效。我们研究了复方新诺明与阿莫西林在肺炎治疗中的有效性，并评估了复方新诺明耐药性的临床影响。
我们招募了595名年龄在2至59个月之间、在巴基斯坦两家城市医院门诊病房被诊断为非重症或重症肺炎（按照世界卫生组织标准）的儿童。患者按2:1的比例随机分配接受标准世界卫生组织剂量和给药方案的复方新诺明（n = 398）或阿莫西林（n = 197）治疗，并在研究病房接受监测。主要结局是住院治疗失败（临床标准）或门诊随访检查时肺炎的临床证据。
复方新诺明组有92例（23%）治疗失败，阿莫西林组有30例（15%）（p = 0.03）——非重症肺炎儿童中分别为26例（13%）和12例（12%）（p = 0.856），重症肺炎儿童中分别为66例（33%）和18例（18%）（p = 0.009）。对于重症肺炎患者，1岁以下年龄（p = 0.056）和胸部X光片阳性（p = 0.005）也预示着治疗失败。在接受复方新诺明治疗的菌血症儿童中，抗菌药物最低抑菌浓度与结局之间无显著关联。
复方新诺明对非重症肺炎提供了有效的治疗。然而，对于严重的、危及生命的肺炎，复方新诺明比阿莫西林有效的可能性更小。
