Gooch W M, Blair E, Puopolo A, Paster R Z, Schwartz R H, Miller H C, Smyre H L, Yetman R, Giguere G G, Collins J J
University of Utah School of Medicine, Salt Lake City, USA.
Pediatr Infect Dis J. 1996 Feb;15(2):157-64. doi: 10.1097/00006454-199602000-00013.
In recent years there has been considerable interest in reducing the duration of antibiotic treatment regimens in patients with common bacterial infections. We conducted two independent, investigator-blinded, multicenter, randomized clinical trials, one of which included microbiologic evaluation of middle ear fluid obtained by tympanocentesis, comparing the efficacy and safety of 5 or 10 days of treatment with cefuroxime axetil suspension (CAE) with that of 10 days of treatment with amoxicillin/clavulanate suspension (AMX/CL) in children with acute otitis media.
A total of 719 pediatric patients from the ages of 3 months to 12 years were enrolled in the 2 studies. Patients received CAE for either 5 or 10 days at 30 mg/kg/day in 2 divided doses (n = 242 and 235, respectively) or AMX/CL for 10 days at 40 mg/kg/day in 3 divided doses (n = 242). Patients in the CAE (5 days) group received placebo on Days 6 through 10. In the study that included tympanocentesis, bacteriologic assessments were based on middle ear fluid cultures obtained pretreatment and, when possible, after treatment in patients with an unsatisfactory clinical outcome.
Organisms were isolated from the pretreatment middle ear fluid specimens of 177 of 244 (73%) patients undergoing tympanocentesis, with the primary pathogens being Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis (37, 35 and 12% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 92% (24 of 26), 84% (32 of 38) and 95% (36 of 38) of bacteriologically evaluable patients treated with CAE for 5 or 10 days or with AMX/CL, respectively. A satisfactory clinical outcome (cure or improvement) occurred in 69% (101 of 147), 70% (121 of 173) and 74% (131 of 177) of clinically evaluable patients treated with CAE (5 days), CAE (10 days) or AMX/CL, respectively. Treatment with AMX/CL was associated with a significantly higher incidence of drug-related adverse events than was treatment with CAE for either 5 or 10 days (P < 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (34% vs. 17 and 12%, respectively; P < 0.001), particularly diarrhea.
Treatment with CAE given twice daily for 5 days is equivalent to treatment for 10 days either with the same regimen of CAE or with AMX/CL given three times daily in pediatric patients with acute otitis media.
近年来，人们对缩短常见细菌感染患者的抗生素治疗疗程兴趣浓厚。我们开展了两项独立、研究者设盲、多中心、随机临床试验，其中一项试验包括对通过鼓膜穿刺术获取的中耳液进行微生物学评估，比较头孢呋辛酯混悬液（CAE）5天或10天治疗方案与阿莫西林/克拉维酸混悬液（AMX/CL）10天治疗方案在急性中耳炎儿童患者中的疗效和安全性。
两项研究共纳入719例年龄在3个月至12岁的儿科患者。患者分别按30mg/kg/天分2次给药接受CAE治疗5天或10天（分别为n = 242和235），或按40mg/kg/天分3次给药接受AMX/CL治疗10天（n = 242）。CAE（5天）组患者在第6至10天接受安慰剂治疗。在包括鼓膜穿刺术的研究中，细菌学评估基于治疗前获取的中耳液培养结果，对于临床结局不理想的患者，尽可能在治疗后再次进行培养。
在244例接受鼓膜穿刺术的患者中，177例（73%）患者的治疗前中耳液标本分离出微生物，主要病原体为肺炎链球菌、流感嗜血杆菌和卡他莫拉菌（分别占分离株的37%、35%和12%）。在接受CAE治疗5天或10天或AMX/CL治疗的可进行细菌学评估的患者中，病原体被根除或推测被根除的比例分别为92%（26例中的24例）、84%（38例中的32例）和95%（38例中的36例）。在可进行临床评估的患者中，接受CAE（5天）、CAE（10天）或AMX/CL治疗的患者中，临床结局满意（治愈或改善）的比例分别为69%（147例中的10.1例）、70%（173例中的.121例）和74%（177例中的131例）。与CAE治疗5天或10天相比，AMX/CL治疗的药物相关不良事件发生率显著更高（P < 0.001），主要表现为药物相关胃肠道不良事件发生率更高（分别为34% vs. 17%和12%；P < 0.001），尤其是腹泻。
对于急性中耳炎儿科患者，每天两次给予CAE治疗5天与每天相同方案的CAE治疗10天或每天三次给予AMX/CL治疗1.0天疗效相当。
