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目的 对于小儿咽喉痛患者,应用青霉素治疗3天和7天,并与安慰剂相对照,以评价青霉素的疗效。 设计 随机、双盲、安慰剂对照试验。 设置 荷兰的43所全科医疗诊所。 对象 156例4～15岁的患儿,具咽喉痛症状<7天;至少符合4项主要诊断标准中的2项(有发热病史;无咳嗽;颈前淋巴结轻度肿大;扁桃体可见分泌物)。 干预措施 将病人随机分为3组:青霉素治疗7天组、青霉素治疗3天继而服用安慰剂4天组、安慰剂服用7天组。 衡量结局的主要指标 症状持续的时间;平均使用止痛剂的时间;因病休课的天数;链球菌感染后遗症的发生率;对病原体的根除率及6个月后咽痛的再发率。 结果 应用青霉素治疗咽喉痛患儿,与安慰剂比较并无明显优势,无论是对参与试验的所有患儿还是对有A组链球菌感染的96名患儿。随机分到青霉素治疗7天组有1名患儿出现了链球菌感染后遗症;青霉素治疗3天后继用安慰剂组有2例,而服用安慰剂7天组有8例患儿出现链球菌感染后遗症。 结论 在小儿咽喉疼痛平均持续时间方面,青霉素治疗并无明显优势。但是,它可能降低链球菌感染后遗症的发生率。
PURPOSE For pediatric patients with sore throat, penicillin is administered for 3 days and 7 days, compared with placebo, to evaluate the efficacy of penicillin. Randomized, double-blind, placebo-controlled trial was designed. Set up 43 general practice clinics in the Netherlands. Subjects 156 children aged 4 to 15 years with symptoms of sore throat <7 days; at least 2 of the 4 major diagnostic criteria (history of fever; no cough; slight enlargement of anterior cervical lymph nodes; tonsil visible secretions ). Interventions Patients were randomized to 3 groups: penicillin for 7 days, penicillin for 3 days followed by placebo for 4 days and placebo for 7 days. Time to symptom duration; duration of analgesic use on average; number of days due to sick leave; incidence of sequelae of streptococcal infection; eradication rate of pathogens and recurrence rate of sore throat after 6 months. Results The use of penicillin for the treatment of children with sore throat had no significant advantage over placebo, whether for all children participating in the trial or for 96 children with group A streptococcal infection. One patient in the 7-day group randomized to penicillin developed sequelae of streptococcal infection; 2 received placebo after 3 days of penicillin treatment and 8 sequelae of streptococcal infection in the 7-day placebo group . Conclusion There is no obvious advantage of penicillin in the average duration of sore throat in children. However, it may reduce the incidence of sequelae of streptococcal infections.