Arthur Margaret, McAdoo Michael, Guerra Javier, Maloney Robert, McCluskey Dennis, Giguere Gregory, Gomez Gema, Collins Jeffrey J.
Vincent, AL.
Am J Ther. 1996 Sep;3(9):622-629. doi: 10.1097/00045391-199609000-00004.
Acute bronchitis is the ninth most common outpatient illness seen by physicians in the United States. Oral antibiotic treatment is usually directed empirically against the most common bacterial pathogens associated with acute bronchitis, such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Although cefuroxime axetil and cefixime are both approved in the United States for treatment of acute bronchitis, currently they have not undergone direct clinical comparison for this indication. This randomized, investigator-blind, multicenter study was designed to compare the efficacy and safety of 250 mg cefuroxime axetil administered twice daily with that of 400 mg cefixime administered once daily in the treatment of acute bronchitis. Outpatients had to be greater-than-or-equal12 years of age and have signs and symptoms of acute bronchitis to be eligible for this study. Patients were randomly assigned to receive 10 days of oral treatment with either 250 mg cefuroxime axetil taken twice daily or 400 mg cefixime taken once daily. Patients were assessed for both clinical and bacteriologic responses once during treatment (3--5 days) and twice after treatment (1--3 days and 14 days). Bacteriologic assessments were based on sputum specimen cultures obtained pretreatment and posttreatment when possible. Of 465 patients with acute bronchitis who were enrolled in the study, 227 received cefuroxime axetil and 238 received cefixime. Organisms were isolated from the pretreatment sputum specimens in 172 of the 465 (37%) patients, with the primary pathogens being Haemophilus influenzae, Streptococcus pneumoniae, Morazella catarrhalis, and Staphylococcus aureus (30%, 14%, 14%, and 14% of isolates, respectively). A satisfactory clinical outcome (cure or improvement) was achieved in 88% (130 of 148) and 91% (152 of 167) of the clinically evaluable patients who had received cefuroxime axetil or cefixime, respectively (p = 0.36). Regarding the eradication of bacterial pathogens, a satisfactory outcome (cure or presumed cure) was obtained in 89% (47 of 53) and 91% (41 of 45) of bacteriologically evaluated patients who had received cefuroxime axetil or cefixime, respectively (p = 0.75). Treatment with cefixime was associated with a significantly higher incidence of drug-related gastrointestinal adverse events than was treatment with cefuroxime axetil (18% versus 10%, respectively; p = 0.01). This difference primarily reflects a higher incidence of drug-related diarrhea (15% versus 5%, p = 0.001). These results indicated the cefuroxime axetil taken twice daily is as effective as cefixime taken once daily in the treatment of acute bronchitis and that cefuroxime axetil produces fewer gastrointestinal adverse events, particularly diarrhea.
急性支气管炎是美国医生门诊中第九大常见疾病。口服抗生素治疗通常是经验性地针对与急性支气管炎相关的最常见细菌病原体，如肺炎链球菌、流感嗜血杆菌和卡他莫拉菌。虽然头孢呋辛酯和头孢克肟在美国均被批准用于治疗急性支气管炎，但目前它们尚未针对该适应症进行直接的临床比较。这项随机、研究者盲法、多中心研究旨在比较每日两次服用250mg头孢呋辛酯与每日一次服用400mg头孢克肟治疗急性支气管炎的疗效和安全性。门诊患者年龄须大于或等于12岁且有急性支气管炎的体征和症状才有资格参加本研究。患者被随机分配接受10天的口服治疗，每日两次服用250mg头孢呋辛酯或每日一次服用400mg头孢克肟。在治疗期间（3 - 5天）评估一次患者的临床和细菌学反应，治疗后（1 - 3天和14天）评估两次。细菌学评估尽可能基于治疗前和治疗后获得的痰标本培养结果。在纳入该研究的465例急性支气管炎患者中，227例接受了头孢呋辛酯治疗，238例接受了头孢克肟治疗。在465例患者中的172例（37%）治疗前痰标本中分离出了病原体，主要病原体为流感嗜血杆菌、肺炎链球菌、卡他莫拉菌和金黄色葡萄球菌（分别占分离株的30%、14%、14%和14%）。在分别接受头孢呋辛酯或头孢克肟治疗的可进行临床评估的患者中，88%（148例中的130例）和91%（167例中的152例）取得了满意的临床结局（治愈或改善）（p = 0.36）。关于细菌病原体的根除，在分别接受头孢呋辛酯或头孢克肟治疗的经细菌学评估的患者中，89%（53例中的47例）和91%（45例中的41例）取得了满意的结局（治愈或推定治愈）（p = 0.75）。与头孢呋辛酯治疗相比，头孢克肟治疗导致的药物相关胃肠道不良事件发生率显著更高（分别为18%和10%；p = 0.01）。这种差异主要反映了药物相关腹泻的发生率更高（15%对5%，p = 0.001）。这些结果表明，每日两次服用头孢呋辛酯在治疗急性支气管炎方面与每日一次服用头孢克肟同样有效，且头孢呋辛酯产生的胃肠道不良事件更少，尤其是腹泻。
