Anderson K O, Bradley L A, Turner R A, Agudelo C A, Pisko E J
Arthritis Care Res. 1994 Jun;7(2):64-8. doi: 10.1002/art.1790070204.
This study examined the sensitivity of a behavioral observation method for the assessment of arthritis pain as an outcome measure in clinical drug trials.
The subjects were 33 rheumatoid arthritis patients who were receiving either an active experimental drug or a placebo. Disease activity measures, self-reports of pain, and pain behavior observations were completed for each subject prior to drug initiation, 6 weeks after drug initiation, and 12 weeks after drug initiation.
Significant reductions in measures of disease activity and self-report of pain were found for the subjects who received an active drug, relative to those who received the placebo. The pain behavior scores produced by both groups of subjects remained relatively stable during the study.
The lack of change in pain behavior suggests that arthritis pain behavior may lack sensitivity to short-term changes accompanying drug therapy.
本研究检验了一种行为观察方法在临床药物试验中作为评估关节炎疼痛结果指标的敏感性。
受试者为33名类风湿性关节炎患者，他们正在接受活性实验药物或安慰剂治疗。在药物开始前、药物开始后6周和药物开始后12周，对每个受试者完成疾病活动度测量、疼痛自我报告和疼痛行为观察。
与接受安慰剂的受试者相比，接受活性药物的受试者的疾病活动度测量值和疼痛自我报告有显著降低。两组受试者的疼痛行为评分在研究期间保持相对稳定。
疼痛行为缺乏变化表明，关节炎疼痛行为可能对药物治疗伴随的短期变化缺乏敏感性。
