van Everdingen Amalia A, Siewertsz van Reesema Dirk R, Jacobs Johannes W G, Bijlsma Johannes W J
University Medical Center, Utrecht, The Netherlands.
Arthritis Rheum. 2004 Apr 15;51(2):233-8. doi: 10.1002/art.20251.
Our previous analysis of patients with early active rheumatoid arthritis (RA) treated with prednisone or placebo revealed the following discrepancy: although a significant retardation of joint damage was observed in the prednisone group compared with the placebo group, no differences in clinical variables between the 2 groups were observed, due to greater use of additional therapy in the placebo group. We sought to investigate whether this discrepancy would extend to variables of well-being.
We conducted a double-blind, randomized, placebo-controlled clinical trial of prednisone (10 mg) in patients with RA; the duration of the study was 2 years. Following the placebo-controlled trial, a 1-year open-label followup study was conducted in 81 patients with early (</=1 year) active, previously untreated RA. Forty-one patients were allocated to receive oral prednisone, 10 mg/day, and 40 patients were assigned to the placebo group. Analgesics, nonsteroidal antiinflammatory drugs (NSAIDs), local injections of a glucocorticoid (only when absolutely necessary), and use of physiotherapy were allowed in both groups. After 6 months, sulfasalazine (2 gm/day) could be prescribed as rescue therapy in both groups. At the beginning of the study and every 6 months thereafter, 2 questionnaires (the VDF [Dutch version of the Health Assessment Questionnaire] and the IRGL [Dutch version of the Arthritis Impact Measurement Scales]) were administered. A visual analog scale (VAS) for morning pain was administered every 3 months. Disease activity and radiologic scores were assessed.
VDF scores in the 2 groups were not statistically significantly different. No statistically significant differences between groups were observed in almost all parameters of the IRGL. In the prednisone group (and only at 6 months), the VAS scores for morning pain and general well-being showed improvement comparable with the transient improvement in some of the disease activity variables. In the prednisone group, use of NSAIDs, analgesics, local injections of glucocorticoids, and physiotherapy sessions was approximately 50% that in the placebo group.
Although significant retardation of joint damage in the prednisone group indicates better disease control, no differences between the groups for variables of well-being were found. This discrepancy may be attributed to greater use of additional therapy in the placebo group. In future clinical trials, the use of additional therapies should be taken into account when analyzing the differences in effect between drugs.
我们之前对接受泼尼松或安慰剂治疗的早期活动性类风湿关节炎（RA）患者进行的分析发现了以下差异：尽管与安慰剂组相比，泼尼松组关节损伤明显延缓，但由于安慰剂组更多地使用了额外治疗，两组临床变量未见差异。我们试图研究这种差异是否会扩展到健康状况变量。
我们对RA患者进行了一项泼尼松（10毫克）的双盲、随机、安慰剂对照临床试验；研究持续时间为2年。在安慰剂对照试验之后，对81例早期（≤1年）活动性、既往未治疗的RA患者进行了为期1年的开放标签随访研究。41例患者被分配接受口服泼尼松，每日10毫克，40例患者被分配到安慰剂组。两组均允许使用镇痛药、非甾体抗炎药（NSAIDs）、局部注射糖皮质激素（仅在绝对必要时）以及进行物理治疗。6个月后，两组均可将柳氮磺胺吡啶（每日2克）作为挽救治疗药物开具。在研究开始时及此后每6个月，发放2份问卷（VDF[健康评估问卷荷兰版]和IRGL[关节炎影响测量量表荷兰版]）。每3个月进行一次晨痛视觉模拟量表（VAS）评分。评估疾病活动度和放射学评分。
两组的VDF评分无统计学显著差异。在IRGL的几乎所有参数中，两组间均未观察到统计学显著差异。在泼尼松组（且仅在6个月时），晨痛和总体健康状况的VAS评分显示出改善，与某些疾病活动变量的短暂改善相当。在泼尼松组，NSAIDs、镇痛药、局部注射糖皮质激素的使用以及物理治疗疗程约为安慰剂组的50%。
尽管泼尼松组关节损伤明显延缓表明疾病控制更好，但在健康状况变量方面两组未发现差异。这种差异可能归因于安慰剂组更多地使用了额外治疗。在未来的临床试验中，分析药物疗效差异时应考虑额外治疗的使用情况。
