Development of preliminary criteria for response to treatment in fibromyalgia syndrome.
Development of preliminary criteria for response to treatment in fibromyalgia syndrome.
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发表时间：
1991-10
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通讯作者：
R. Simms;D. Felson;D. Goldenberg
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作者：
R. Simms;D. Felson;D. Goldenberg
我们制定了一套初步的反应标准，用于未来的纤维肌痛综合征临床试验。我们确定的结果措施，从以前报道的临床试验，最好的区别与安慰剂或无效药物治疗的患者有效的药物治疗，使用逐步逻辑回归分析。结果测量的几种组合被确定并以受试者工作特征（ROC）曲线的形式绘制。具有最大ROC曲线下面积的变量组合包括（1）医生总体评估评分小于或等于4（0 =非常好，10 =非常差），（2）患者睡眠评分小于或等于6（0 =睡眠非常好，10 =睡眠非常差），以及（3）压痛点评分小于或等于14（最大可能压痛点评分等于20）。在一项未报道的环苯扎林治疗试验中，这些标准准确地区分了有效药物治疗组和安慰剂治疗组。该标准确定了阿米替林试验中14例患者中的11例和环苯扎林试验中6例患者中的4例，这些患者获得了独立测量的改善。用于定义这些初步标准的方法可用于完善标准，因为开发了额外的敏感性和临床相关结局。
We developed a set of preliminary response criteria for use in future clinical trials in fibromyalgia syndrome. We determined outcome measures from a previously reported clinical trial which best distinguished patients treated with effective medication from those treated with placebo or ineffective medication, using stepwise logistic regression analysis. Several combinations of outcome measures were identified and plotted in the form of receiver operating characteristic (ROC) curves. The combination of variables possessing the greatest area under the ROC curve included (1) physician global assessment score less than or equal to 4 (0 = extremely well, 10 = extremely poorly), (2) patient sleep score less than or equal to 6 (0 = sleeping extremely well, 10 = sleeping extremely poorly), and (3) tender point score less than or equal to 14 (maximum possible tender point score equalled 20). These criteria accurately distinguished those treated with effective drug from those treated with placebo when tested in an unreported therapeutic trial of cyclobenzaprine. The criteria identified 11 of 14 patients in the amitriptyline trial and 4 of 6 patients in the cyclobenzaprine trial who attained improvement measured independently. The methodology used to define these preliminary criteria may be applied to refine the criteria as additional sensitive and clinically relevant outcomes are developed.