Safran C
Roussel-Uclaf Institute, Romainville, France.
J Antimicrob Chemother. 1990 Dec;26 Suppl E:93-101. doi: 10.1093/jac/26.suppl_e.93.
The efficacy of cefpodoxime proxetil has been studied in ten clinical trials conducted in adults suffering from lower respiratory tract infections (pneumonia, acute bronchitis or acute on chronic bronchitis) and upper respiratory tract infections (tonsillitis/pharyngitis or sinusitis). All the trials were controlled, randomized, multicentre and international and seven were double-blind, double-dummy designed. Over a period of 18 months from July 1988 to December 1989, 2448 patients were included. Among them, 2429 (99%) were evaluated for tolerance, 2101 (86%) for tolerance and clinical efficacy and 1018 (42%) for tolerance and clinical and bacteriological efficacy. The clinical response was judged satisfactory in 1205/1263 (95.4%) patients treated with cefpodoxime proxetil and in 788/838 (94%) patients treated with comparative antibiotics. The bacteriological response was judged satisfactory for 662/699 (95%) pathogens for cefpodoxime proxetil treatment versus 427/463 (92, 2%) for comparators. Cefpodoxime proxetil has been given to 7351 patients in the course of its international development with no severe side-effect being observed. Common reactions have been noted with a similar frequency to that seen with the other beta-lactams. No pseudomembranous colitis has been observed during clinical trials. On this basis, cefpodoxime proxetil appears to be efficacious and well tolerated and could be an antibiotic of first choice in the treatment of lower and upper respiratory tract infections in adults and adolescents.
已在10项临床试验中研究了头孢泊肟酯对患有下呼吸道感染(肺炎、急性支气管炎或慢性支气管炎急性发作)和上呼吸道感染(扁桃体炎/咽炎或鼻窦炎)的成人的疗效。所有试验均为对照、随机、多中心和国际性试验,其中7项采用双盲、双模拟设计。在1988年7月至1989年12月的18个月期间,共纳入2448例患者。其中,2429例(99%)进行了耐受性评估,2101例(86%)进行了耐受性及临床疗效评估,1018例(42%)进行了耐受性及临床和细菌学疗效评估。接受头孢泊肟酯治疗的1263例患者中有1205例(95.4%)临床反应令人满意,接受对照抗生素治疗的838例患者中有788例(94%)临床反应令人满意。头孢泊肟酯治疗的699例病原体中有662例(95%)细菌学反应令人满意,而对照药物治疗的463例中有427例(92.2%)细菌学反应令人满意。在其国际研发过程中,已有7351例患者使用了头孢泊肟酯,未观察到严重副作用。已注意到常见反应的发生频率与其他β-内酰胺类药物相似。临床试验期间未观察到伪膜性结肠炎。在此基础上,头孢泊肟酯似乎疗效显著且耐受性良好,可能是治疗成人和青少年上下呼吸道感染的首选抗生素。