Curtin Correne D, Casey Janet R, Murray Patrick C, Cleary Carolyn T, Hoeger William J, Marsocci Steven M, Murphy Marie Lynd, Francis Anne B, Pichichero Michael E
Elmwood Pediatric Group, Rochester, New York 14642, USA.
Clin Pediatr (Phila). 2003 Jul-Aug;42(6):519-26. doi: 10.1177/000992280304200606.
The purpose of this study was to compare the bacteriologic and clinical efficacy of oral cephalexin twice vs. three times daily vs. cefadroxil once daily as therapy for group A beta-hemolytic streptococcal (GABHS) tonsillopharyngitis. A prospective open-label, observational cohort study was conducted over 18 months (January 2000-June 2001). Children enrolled had an acute onset of symptoms and signs of a tonsillopharyngeal illness and a laboratory-documented GABHS infection. Follow-up examination and laboratory testing occurred 21 +/- 4 days following enrollment. Two hundred seventy-one patients were enrolled (intent to treat group): 63 received cephalexin twice daily, 124 received cephalexin three times daily, and 84 received cefadroxil once daily. Fifty-three children did not return for the follow-up visit, leaving 218 patients in the per-protocol group: 54 cephalexin twice-daily treated, 94 cephalexin 3-times daily treated, and 70 cefadroxil once-daily treated. In the per-protocol group, bacteriologic cure for those treated with cephalexin twice daily was 87%, for cephalexin 3 times daily, it was 81% and for cefadroxil once daily it was 81% (p = 0.61). The clinical cure rate for cephalexin twice-daily treatment was 91%; for three-times daily, it was 86%; and for cefadroxil once daily, it was 84% (p = 0.56). Because treatment allocation was not randomized, logistic regression analysis was used to adjust for treatment group differences. Younger age of patient was significantly associated with bacteriologic (p = 0.04) and clinical (p = 0.01) failure independent of treatment group but in the adjusted logistic model no differences were found among the 3 treatment regimens. Cephalexin dosed twice daily or three times daily and cefadroxil dosed once daily appear equivalent in bacteriologic and clinical cure of GABHS tonsillopharyngitis.
本研究的目的是比较口服头孢氨苄每日两次、每日三次与头孢羟氨苄每日一次治疗A组β溶血性链球菌(GABHS)扁桃体咽炎的细菌学疗效和临床疗效。一项前瞻性开放标签观察性队列研究进行了18个月(2000年1月至2001年6月)。纳入的儿童有扁桃体咽炎疾病的急性症状和体征,且实验室确诊为GABHS感染。在入组后21±4天进行随访检查和实验室检测。共纳入271例患者(意向性治疗组):63例每日接受两次头孢氨苄治疗,124例每日接受三次头孢氨苄治疗,84例每日接受一次头孢羟氨苄治疗。53名儿童未返回进行随访,因此符合方案组有218名患者:54例接受每日两次头孢氨苄治疗,94例接受每日三次头孢氨苄治疗,70例接受每日一次头孢羟氨苄治疗。在符合方案组中,每日两次服用头孢氨苄的患者细菌学治愈率为87%,每日三次服用头孢氨苄的患者为81%,每日一次服用头孢羟氨苄的患者为81%(p = 0.61)。每日两次服用头孢氨苄的临床治愈率为91%;每日三次服用为86%;每日一次服用头孢羟氨苄的为84%(p = 0.56)。由于治疗分配未随机化,因此使用逻辑回归分析来调整治疗组差异。患者年龄较小与细菌学(p = 0.04)和临床(p = 0.01)治疗失败显著相关,且与治疗组无关,但在调整后的逻辑模型中,三种治疗方案之间未发现差异。每日两次或三次服用头孢氨苄以及每日一次服用头孢羟氨苄在GABHS扁桃体咽炎的细菌学和临床治愈方面似乎等效。