Palombini B C, André-Alves M R, Dagrosa E E
Misericordian Hospital, Catholic University, Porto Alegre, Brazil.
Arzneimittelforschung. 1997 Mar;47(3):299-302.
The safety and efficacy of two dose regimens of cefodizime (CAS 69739-16-8, HR 221) in hospitalized patients with lower respiratory tract infections were assessed in two consecutive studies. Sputum bacteriology, chest X-ray and a safety laboratory check were performed at baseline and after therapy. In order to compensate for the lack of a double-blind design the evaluation was conducted as a clinical intention-to-treat analysis. 32 patients (16 males, 16 females, mean age: 64 years) were admitted to study A and 42 subjects (30 males, 12 females, mean age: 66 years) to study B. The dosage regimens of cefodizime were 1 g b.i.d. (median 7 days) in study A and 2 g once daily (median 6 days) in study B. Parenchymal involvement was confirmed by chest X-ray in 56% of the patients in study A and 64% in study B, the remainder patients had acute exacerbations of chronic bronchitis with reasonable evidence of bacterial infection. The most frequent pathogens were Streptococcus pneumoniae and Haemophilus spp. The clinical cure rate was 97% in study A and 88% in study B. Eradication rates were 100% and 94%, respectively. No superinfection occurred. No adverse reactions were observed. In conclusion, a single daily injection of cefodizime 2 g achieved similar clinical and bacteriological cure rates to the standard dose regimen of 1 g b.i.d.
在两项连续的研究中，评估了两种剂量方案的头孢地嗪（CAS 69739-16-8，HR 221）对住院下呼吸道感染患者的安全性和有效性。在基线和治疗后进行痰细菌学、胸部X光检查和安全实验室检查。为弥补缺乏双盲设计的不足，评估采用临床意向性治疗分析。32例患者（16例男性，16例女性，平均年龄：64岁）纳入研究A，42例受试者（30例男性，12例女性，平均年龄：66岁）纳入研究B。头孢地嗪的剂量方案在研究A中为1g，每日两次（中位7天），在研究B中为2g，每日一次（中位6天）。研究A中56%的患者和研究B中64%的患者经胸部X光检查证实有实质受累，其余患者为慢性支气管炎急性加重且有合理的细菌感染证据。最常见的病原体是肺炎链球菌和嗜血杆菌属。研究A中的临床治愈率为97%，研究B中的为88%。根除率分别为100%和94%。未发生二重感染。未观察到不良反应。总之，每日单次注射2g头孢地嗪与标准剂量方案1g每日两次的临床和细菌学治愈率相似。
