Department of Clinical Infectious Diseases, Aichi Medical University Hospital, Aichi, Japan; Department of Infection Control and Prevention, Aichi Medical University Hospital, Japan.
Department of Infection Control and Prevention, Aichi Medical University Hospital, Japan.
J Microbiol Immunol Infect. 2022 Feb;55(1):147-153. doi: 10.1016/j.jmii.2020.11.003. Epub 2020 Dec 2.
Evidenced based medicine (EBM) is necessary to standardize or treatment for infection since EBM is established based on the results of clinical trials. Entry criteria for clinical trials are very strict, and many patients have difficulties in being enrolled in any clinical trials regarding candidemia. It is questionable if the results of clinical trials reflect the real world of general medicine in this case.
For the purpose of examining how many patients could join any randomized clinical trials for the treatment of candidemia, we reviewed all the candidemia patients in our institute during 2014-2018. The patients were divided into two groups: patients who were eligible for clinical trials (participation possible group), and those who were not (participation impossible group). Exclusion criteria for clinical trials were set based on previous clinical trials.
A total of 70 patients was enrolled in this study. The median age was 73 years (range 36-93 years). Of these, 41 patients (59%) were male. As for site of infections, catheter related blood stream infection was most frequently seen in 37 (53%). Seventeen patients (24%) were classified as participation possible group and 53 patients (76%) were participation impossible group. Comparing the two groups, participation possible group patients have much better performance status, have less comorbidities and have longer overall survival times than participation impossible group patients.
Only 24% of candidemia patients were eligible for the clinical trials. Thus, we can see that clinical trials might not correctly reflect the real world among candidemia patients.
循证医学（EBM）对于感染的治疗标准化是必要的，因为 EBM 是基于临床试验的结果建立的。临床试验的纳入标准非常严格，许多患者在参加念珠菌血症的任何临床试验方面都存在困难。在这种情况下，临床试验的结果是否能反映一般医学的真实情况是值得怀疑的。
为了检验有多少患者可以参加任何治疗念珠菌血症的随机临床试验，我们回顾了 2014 年至 2018 年期间我院所有的念珠菌血症患者。这些患者被分为两组：符合临床试验条件（有参与可能的组）和不符合临床试验条件（无参与可能的组）。临床试验的排除标准是基于以前的临床试验设定的。
本研究共纳入 70 例患者。中位年龄为 73 岁（范围 36-93 岁）。其中，41 例（59%）为男性。就感染部位而言，导管相关血流感染最为常见，有 37 例（53%）。17 例（24%）患者被归类为有参与可能的组，53 例（76%）患者为无参与可能的组。比较两组患者，有参与可能的组患者的表现状态更好，合并症更少，总生存时间更长。
只有 24%的念珠菌血症患者符合临床试验的条件。因此，我们可以看到临床试验可能不能正确反映念珠菌血症患者的真实情况。
