Norrby S R
Dept. of Infectious Diseases, Lund University Hospital, Sweden.
Infection. 1992;20 Suppl 3:S181-8; discussion S189-92. doi: 10.1007/BF01704370.
This overview deals with the optimization of the design of clinical trials in patients with urinary tract infections (UTIs). Despite the fact that UTI is one of the most common types of infection and that the main end-point (elimination or persistence of bacteriuria) is objective and easy to register, the quality of studies performed and published has generally been less than optimal. Problems that should always be addressed in the study protocol are definitions of terms used, for example bacteriuria, level of the infection (cystitis or pyelonephritis), and uncomplicated and complicated infections; dimension of the patient's sample to allow adequate testing of a null hypothesis; procedures before, during and after treatment; methods for analysis of the results.
本综述探讨了尿路感染（UTIs）患者临床试验设计的优化。尽管UTI是最常见的感染类型之一，且主要终点（菌尿的消除或持续存在）客观且易于记录，但已开展并发表的研究质量总体上并不理想。研究方案中应始终解决的问题包括所用术语的定义，例如菌尿、感染程度（膀胱炎或肾盂肾炎）以及单纯性和复杂性感染；患者样本量的大小，以便对无效假设进行充分检验；治疗前、治疗期间和治疗后的程序；结果分析方法。
