Rijk M C, van Hogezand R A, van Lier H J, van Tongeren J H
University Hospital Nijmegen, The Netherlands.
Ann Intern Med. 1991 Mar 15;114(6):445-50. doi: 10.7326/0003-4819-114-6-445.
To determine whether sulphasalazine plus prednisone is more effective than sulphasalazine alone in treating active Crohn disease.
Randomized, double-blind, placebo-controlled trial.
Multicenter trial in one university hospital and nine general hospitals.
Patients with active Crohn disease and a Van Hees Activity Index of 140 or more. Of 71 patients who were randomly assigned, 60 completed treatment and were analyzed.
For 16 weeks, 30 patients received sulphasalazine, 6 g/d (or 4 g/d if adverse effects occurred) and prednisone, 30 mg/d initially. Prednisone therapy was tapered in increments of 5 mg/2 wk to 10 mg/d after 8 weeks. Thirty other patients received sulphasalazine and a placebo.
In the first 6 weeks of treatment, the Van Hees Activity Index decreased to a median of 70% (interquartile range, 57% to 81%) of the initial value in patients treated with sulphasalazine and prednisone and to a median of 87% (interquartile range, 70% to 94%) in patients treated with sulphasalazine alone (P = 0.001). In the last 4 weeks of treatment, the corresponding figures were 63% (interquartile range, 40% to 75%) and 70% (interquartile range, 54% to 90%) (P = 0.10). The Crohn's Disease Activity Index decreased in the first 6 weeks to a median of 65% (interquartile range, 57% to 86%) in patients receiving sulphasalazine and prednisone and to a median of 75% (interquartile range, 58% to 101%) in patients receiving sulphasalazine alone (P = 0.13). In the last 4 weeks of treatment, the corresponding figures were 65% (interquartile range, 42% to 90%) and 76% (interquartile range, 49% to 110%) (P = 0.19).
The use of prednisone in addition to sulphasalazine in patients with active Crohn disease results in a significantly faster initial improvement, but not in a significantly better result after 16 weeks of treatment, when disease activity is measured by the Van Hees Activity Index.
确定柳氮磺胺吡啶联合泼尼松治疗活动期克罗恩病是否比单用柳氮磺胺吡啶更有效。
随机、双盲、安慰剂对照试验。
在一家大学医院和九家综合医院进行的多中心试验。
活动期克罗恩病且范赫斯活动指数为140或更高的患者。在71例随机分组的患者中，60例完成治疗并进行分析。
为期16周，30例患者接受柳氮磺胺吡啶，6 g/天（若出现不良反应则为4 g/天），初始时联合泼尼松30 mg/天。8周后泼尼松治疗以每2周减少5 mg的幅度逐渐减量至10 mg/天。另外30例患者接受柳氮磺胺吡啶和安慰剂治疗。
在治疗的前6周，接受柳氮磺胺吡啶联合泼尼松治疗的患者范赫斯活动指数降至初始值的中位数为70%（四分位间距，57%至81%），而单用柳氮磺胺吡啶治疗的患者降至中位数为87%（四分位间距，70%至94%）（P = 0.001）。在治疗的最后4周，相应数字分别为63%（四分位间距，40%至75%）和70%（四分位间距，54%至90%）（P = 0.10）。接受柳氮磺胺吡啶联合泼尼松治疗的患者克罗恩病活动指数在前6周降至中位数为65%（四分位间距，57%至86%），单用柳氮磺胺吡啶治疗的患者降至中位数为75%（四分位间距，58%至101%）（P = 0.13）。在治疗的最后4周，相应数字分别为65%（四分位间距，42%至90%）和76%（四分位间距，49%至110%）（P = 0.19）。
对于活动期克罗恩病患者，在柳氮磺胺吡啶基础上加用泼尼松可使病情在初始时显著更快改善，但在以范赫斯活动指数衡量疾病活动度时，治疗16周后效果并无显著更好。
