癌症研究中安慰剂组的腹泻情况。
Diarrhea in Placebo Arms of Cancer Studies.
作者信息
Wolff Birte J, Wolff Johannes E
机构信息
Swedish Covenant Hospital Department of Gynecology, Chicago, IL, U.S.A.
AbbVie Inc, North Chicago, IL, U.S.A.
出版信息
Cancer Diagn Progn. 2021 Nov 3;1(5):379-385. doi: 10.21873/cdp.10050. eCollection 2021 Nov-Dec.
BACKGROUND/AIM: Diarrhea is among the most common adverse events in early oncology clinical trials, and drug causality may be difficult to determine.
MATERIALS AND METHODS
This is a systematic literature review of placebo arms of randomized cancer trials.
RESULTS
Anemia was reported in 95 of 127 placebo monotherapy cohorts. Publications involving healthy volunteers and cancer prevention studies reported lower frequencies than those with cancer patients. The average reported frequency of diarrhea grade 1 or higher among studies in cancer patients was 15%. The maximal reported frequencies for grades 1, 2, 3, 4, 5 were 56, 24, 6, 2, and 0%, respectively.
CONCLUSION
When higher diarrhea frequencies than those are observed in treatment arms of clinical trials, then drug causality is likely.
背景/目的：腹泻是肿瘤学早期临床试验中最常见的不良事件之一，药物因果关系可能难以确定。
材料与方法
这是一项对随机癌症试验安慰剂组的系统文献综述。
结果
127个安慰剂单药治疗队列中有95个报告了贫血。涉及健康志愿者和癌症预防研究的出版物报告的频率低于癌症患者的频率。癌症患者研究中报告的1级或更高等级腹泻的平均频率为15%。1、2、3、4、5级报告的最高频率分别为56%、24%、6%、2%和0%。
结论
当在临床试验治疗组中观察到比这些更高的腹泻频率时，则可能存在药物因果关系。
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