Pichichero M E, Gooch W M
Elmwood Pediatric Group and University of Rochester Medical Center, NY, USA.
Pediatr Infect Dis J. 2000 Dec;19(12 Suppl):S171-3. doi: 10.1097/00006454-200012001-00007.
Group A beta-hemolytic streptococcal (GABHS) tonsillopharyngitis continues to be a prevalent pediatric infectious disease that requires prompt treatment for relief of symptoms and to prevent complications.
To compare the efficacy/tolerability of cefdinir and penicillin V in the treatment of pediatric GABHS tonsillopharyngitis as demonstrated in two clinical trials of similar design.
Multicenter, randomized, investigator-blinded trials.
Children < or =12 years of age with sore throat, pharyngeal erythema and positive rapid streptococcal antigen test results.
In Study A patients took cefdinir 7 mg/kg twice daily or 14 mg/kg once daily or penicillin V 10 mg/kg 4 times daily (all regimens for 10 days). In Study B patients took cefdinir 7 mg/kg twice daily for 5 days or penicillin V 10 mg/kg 4 times daily for 10 days.
Clinical and microbiologic evaluations were conducted at multiple times during and after therapy.
Of 1274 patients 1122 were evaluable (679 patients received cefdinir; 443 received penicillin V). Clinical cure and microbiologic eradication rates were superior in the combined cefdinir treatment groups (94.9 and 92.7%, respectively), whether given once or twice daily for 10 days or twice daily for 5 days, compared with the penicillin treatment group (88.5 and 70.9%, respectively; P<0.001 for both). Adverse event rates were comparable in the 2 groups.
Cefdinir is a reliable and well-tolerated drug for the management of GABHS tonsillopharyngitis in children.
A组β溶血性链球菌(GABHS)扁桃体咽炎仍然是一种常见的儿科传染病,需要及时治疗以缓解症状并预防并发症。
在两项设计相似的临床试验中比较头孢地尼和青霉素V治疗儿科GABHS扁桃体咽炎的疗效/耐受性。
多中心、随机、研究者设盲试验。
年龄≤12岁、有咽痛、咽部红斑且快速链球菌抗原检测结果呈阳性的儿童。
在研究A中,患者每日两次服用7mg/kg头孢地尼,或每日一次服用14mg/kg头孢地尼,或每日四次服用10mg/kg青霉素V(所有方案均为10天)。在研究B中,患者每日两次服用7mg/kg头孢地尼,持续5天,或每日四次服用10mg/kg青霉素V,持续10天。
在治疗期间及治疗后多次进行临床和微生物学评估。
1274例患者中,1122例可评估(679例患者接受头孢地尼治疗;443例接受青霉素V治疗)。联合头孢地尼治疗组的临床治愈率和微生物清除率更高(分别为94.9%和92.7%),无论每日给药一次或两次,持续10天,还是每日两次,持续5天,相比之下,青霉素治疗组分别为88.5%和70.9%(两者P均<0.001)。两组的不良事件发生率相当。
头孢地尼是治疗儿童GABHS扁桃体咽炎的一种可靠且耐受性良好的药物。