Kiani R, Johnson D, Nelson B
Department of Medicine, University of Illinois Hospital, Chicago 60612.
Am J Med. 1988 Sep 16;85(3A):6-13. doi: 10.1016/0002-9343(88)90457-3.
A total of 560 patients were treated in two double-blind, randomized multicenter studies to compare the safety and efficacy of cefixime (400 mg administered once daily) and amoxicillin (250 or 500 mg administered three times daily) for the treatment of bacterial respiratory tract infections. Eighty percent of the 244 patients treated in the lower respiratory tract infections (LRTI) study had acute bronchitis. Streptococcus pneumoniae (13 percent), Haemophilus influenzae (28 percent), and Escherichia coli (10 percent) were the pathogens most frequently isolated from sputum in these patients. Among evaluable patients with positive bacterial culture results at baseline, a favorable clinical response (cured or improved) was obtained in 100 percent of the cefixime-treated patients (22 of 22) and in 96 percent of the amoxicillin-treated patients (23 of 24). Bacteriologic eradication rates were 100 percent and 83 percent for cefixime and amoxicillin, respectively. In the upper respiratory tract infections (URTI) study, 316 patients with pharyngitis (80 percent) or tonsillitis (14 percent) were treated. Group A, beta-hemolytic Streptococcus (69 percent) and H. influenzae (8 percent) were the pathogens most frequently isolated from the throat culture specimens of these patients. Favorable clinical results were obtained in 99 percent of the evaluable cefixime-treated group (n = 73) and in 98 percent of the amoxicillin-treated group (n = 66). The bacteriologic eradication rates were 93 percent and 100 percent, respectively. The adverse experiences reported during both studies were similar in nature and frequency to those reported for other beta-lactam antibiotics with the exception of a higher incidence of altered bowel movement (diarrhea and stool changes) with both drugs. These episodes usually resolved without remedial medication when the treatment was withdrawn. No significant adverse laboratory findings were observed. Results of these trials demonstrate that cefixime at a dosage of 400 mg once daily is an effective and safe oral antibiotic for the treatment of acute respiratory tract infections.
在两项双盲、随机多中心研究中，共对560例患者进行了治疗，以比较头孢克肟（每日一次服用400毫克）和阿莫西林（每日三次服用250或500毫克）治疗细菌性呼吸道感染的安全性和疗效。在下呼吸道感染（LRTI）研究中接受治疗的244例患者中，80%患有急性支气管炎。肺炎链球菌（13%）、流感嗜血杆菌（28%）和大肠杆菌（10%）是这些患者痰液中最常分离出的病原体。在基线细菌培养结果呈阳性的可评估患者中，头孢克肟治疗组（22例中的22例）100%获得了良好的临床反应（治愈或改善），阿莫西林治疗组（24例中的23例）为96%。头孢克肟和阿莫西林的细菌清除率分别为100%和83%。在上呼吸道感染（URTI）研究中，对316例咽炎（80%）或扁桃体炎（14%）患者进行了治疗。A组β溶血性链球菌（69%）和流感嗜血杆菌（8%）是这些患者咽喉培养标本中最常分离出的病原体。可评估的头孢克肟治疗组（n = 73）中99%获得了良好的临床结果，阿莫西林治疗组（n = 66）中为98%。细菌清除率分别为93%和100%。两项研究中报告的不良事件在性质和频率上与其他β-内酰胺类抗生素报告的相似，但两种药物导致的排便改变（腹泻和大便变化）发生率较高。当停止治疗时，这些症状通常无需药物治疗即可缓解。未观察到明显的不良实验室检查结果。这些试验结果表明，每日一次服用400毫克的头孢克肟是治疗急性呼吸道感染的一种有效且安全的口服抗生素。
