Singh Satyendra Kumar, Rai Tulika
Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
Indian J Dermatol Venereol Leprol. 2015 Mar-Apr;81(2):144-7. doi: 10.4103/0378-6323.152175.
Background : Systemic therapy with methotrexate is a very useful modality in psoriasis, but relapses can occur soon after stopping it. Aim : To compare the relapse rates in psoriasis with two different tapering regimens of methotrexate after control is achieved. Methods : This was a randomized open-label controlled study, and patients of chronic plaque psoriasis with psoriasis area and severity index (PASI) >10 were included. Methotrexate 0.3 mg/kg weekly was given and the PASI calculated every 2 weeks. After achieving a 75% reduction in the PASI (PASI-75), patients were assigned randomly in to one of three groups. In the half-dose group, the dose of methotrexate was reduced to half and given weekly; in the 2-weekly group, the same dose was given at 2-week intervals; in the control group, methotrexate was stopped. Patients were followed up for 12 weeks. Results : Out of 141 registered patients, 81 were included: 27 in the half-dose group, 28 in the 2-weekly group, and 26 in the control group. After further exclusions due to adverse effects and loss to follow-up, the results were analysed for 16, 17 and 19 patients respectively in the 3 groups. There was statistically a highly significant difference in relapse rates between the half-dose and control groups (P < 0.001), and a significant difference between the 2-weekly and control groups (P = 0.001). Relapse rates in the half-dose and 2-weekly groups did not show a significant difference (P = 0.680).
Many (35.8%) patients were excluded and only 52 (64.2%) completed the study.
There appears to be no significant difference in the frequency of relapse in psoriasis whether methotrexate is tapered by halving the weekly dose or by doubling the interval between two doses, and both methods led to fewer relapses than abrupt cessation of the drug.
背景：甲氨蝶呤全身治疗是银屑病治疗中一种非常有用的方法，但停药后很快就可能复发。目的：比较银屑病在病情得到控制后采用两种不同甲氨蝶呤减量方案的复发率。方法：这是一项随机开放标签对照研究，纳入银屑病面积和严重程度指数（PASI）>10的慢性斑块状银屑病患者。每周给予甲氨蝶呤0.3mg/kg，并每2周计算一次PASI。在PASI降低75%（PASI-75）后，将患者随机分为三组之一。在半量组中，甲氨蝶呤剂量减至一半并每周给药；在两周一次组中，以两周的间隔给予相同剂量；在对照组中，停用甲氨蝶呤。对患者进行12周的随访。结果：在141名登记患者中，81名被纳入：半量组2次，两周一次组28名，对照组26名。由于不良反应和失访而进一步排除后，分别对三组中的16名、17名和19名患者的结果进行了分析。半量组和对照组之间的复发率在统计学上有高度显著差异（P<0.001），两周一次组和对照组之间有显著差异（P=0.001）。半量组和两周一次组的复发率没有显著差异（P=0.680）。
许多（35.8%）患者被排除，只有52名（64.2%）完成了研究。
无论是将甲氨蝶呤每周剂量减半还是将两次给药间隔加倍来逐渐减量，银屑病的复发频率似乎没有显著差异，并且这两种方法导致的复发都比突然停药少。
