Blechman W, Willkens R, Boncaldo G L, Hoffmeister R T, Lockie L M, Multz C
Ann Rheum Dis. 1978 Feb;37(1):80-4. doi: 10.1136/ard.37.1.80.
In this double-blind crossover trial, naproxen (750 mg/day) was compared to placebo for the treatment of osteoarthrosis of the hip and knee. Patients were randomly assigned to treatment with either naproxen or placebo for 4 weeks and then to treatment with the alternate agent for a second 4-week period. 8 out of 9 objective and subjective measurements of drug efficacy clearly differentiated naproxen from placebo at highly significant levels (P = 0.0001 to 0.0004). Patient daily check lists of osteoarthrotic symptoms also showed a statistically significant difference between naproxen and placebo therapy. Both physicians and patients, when asked to give a 'final drug preference', showed a significant preference for naproxen over placebo. In general, the incidence of side effects was low and approximately the same for both naproxen and placebo. Laboratory assessments showed little difference between groups. The trial showed naproxen to be an effective and well tolerated drug for the treatment of osteoarthrosis of the hip and knee.
在这项双盲交叉试验中,将萘普生(750毫克/天)与安慰剂进行比较,用于治疗髋部和膝部骨关节炎。患者被随机分配接受萘普生或安慰剂治疗4周,然后在第二个4周期间改用另一种药物治疗。9项药物疗效的客观和主观测量指标中有8项在高度显著水平(P = 0.0001至0.0004)上明确区分了萘普生和安慰剂。骨关节炎症状的患者每日检查表也显示萘普生和安慰剂治疗之间存在统计学上的显著差异。当被要求给出“最终药物偏好”时,医生和患者都表现出对萘普生的显著偏好超过安慰剂。总体而言,副作用发生率较低,萘普生和安慰剂的副作用发生率大致相同。实验室评估显示两组之间差异不大。该试验表明萘普生是一种治疗髋部和膝部骨关节炎的有效且耐受性良好的药物。