Lebel M H, Mehra S
Hôpital Sainte-Justine, University of Montreal, Montreal, Canada.
Pediatr Infect Dis J. 2001 Dec;20(12):1149-54. doi: 10.1097/00006454-200112000-00011.
Pertussis is still a prevalent public health problem, and antibiotic therapy may decrease disease severity and limit communicability. Erythromycin is the recommended antibiotic for treatment and prophylaxis of pertussis; however, side effects of erythromycin limit its usefulness in some patients. Clarithromycin, a newer macrolide, has good in vitro activity against Bordetella pertussis and a better side effect profile.
To compare the microbiologic and clinical efficacy and the clinical safety of a 7-day course of clarithromycin vs. a 14-day course of erythromycin in children with pertussis.
Prospective, randomized, single blind (investigator), parallel group trial.
Children from 1 month to 16 years of age presenting with a clinically defined pertussis syndrome were eligible for the study. After obtaining informed written consent, we randomized patients to receive either clarithromycin (7.5 mg/kg/dose twice a day for 7 days) or erythromycin (13.3 mg/kg/dose three times a day for 14 days). Nasopharyngeal cultures for B. pertussis were performed at enrollment and after end of treatment. Clinical assessments were performed at enrollment, at end of treatment and at a 1-month follow-up visit. Adverse event data were collected throughout the study.
The clarithromycin (n = 76) and erythromycin (n = 77) groups were well-matched for age and previous pertussis immunization. Microbiologic eradication and clinical cure rates were 100% (31 of 31) for clarithromycin and 96% (22 of 23) for erythromycin. The clarithromycin group had significantly fewer adverse events [45% (34 of 76) for clarithromycin vs. 62% (48 of 77) for erythromycin; P = 0.035], and compliance with the medication regimen was significantly higher in these patients.
A 7-day regimen of clarithromycin and a 14-day course of erythromycin were equally effective for treatment of pertussis. Clarithromycin was better tolerated than conventional erythromycin therapy.
百日咳仍是一个普遍存在的公共卫生问题，抗生素治疗可降低疾病严重程度并限制传染性。红霉素是治疗和预防百日咳的推荐抗生素；然而，红霉素的副作用限制了其在某些患者中的应用。克拉霉素是一种新型大环内酯类抗生素，对百日咳博德特氏菌具有良好的体外活性，且副作用较小。
比较7天疗程的克拉霉素与14天疗程的红霉素治疗百日咳患儿的微生物学和临床疗效以及临床安全性。
前瞻性、随机、单盲（研究者）、平行组试验。
年龄在1个月至16岁、临床表现为百日咳综合征的儿童符合研究条件。在获得知情书面同意后，我们将患者随机分为两组，分别接受克拉霉素（7.5mg/kg/剂量，每日两次，共7天）或红霉素（13.3mg/kg/剂量，每日三次，共14天）治疗。在入组时和治疗结束后进行百日咳博德特氏菌的鼻咽培养。在入组时、治疗结束时和1个月随访时进行临床评估。在整个研究过程中收集不良事件数据。
克拉霉素组（n = 76）和红霉素组（n = 77）在年龄和既往百日咳免疫接种方面匹配良好。克拉霉素的微生物学清除率和临床治愈率为100%（31例中的31例），红霉素为96%（23例中的22例）。克拉霉素组的不良事件明显较少[克拉霉素组为45%（76例中的34例），红霉素组为62%（77例中的48例）；P = 0.03），且这些患者对药物治疗方案的依从性明显更高。
7天疗程的克拉霉素和14天疗程的红霉素治疗百日咳同样有效。克拉霉素的耐受性优于传统的红霉素治疗。
