Salim A, Tan E, Ilchyshyn A, Berth-Jones J
Department of Dermatology, Walsgrave Hospital, University Hospitals Coventry and Warwickshire NHS Trust, Coventry CV2 2DX, U.K.
Br J Dermatol. 2006 Jun;154(6):1169-74. doi: 10.1111/j.1365-2133.2006.07289.x.
The value of folate supplementation in methotrexate (MTX)-treated patients remains controversial.
To determine the effect of folic acid (FA) on the efficacy of MTX and the frequency of side-effects associated with MTX therapy.
A 12-week double-blind clinical trial was conducted in patients with psoriasis stable on their long-term MTX doses but not receiving FA. They were randomized into two arms of either FA 5 mg or placebo daily. MTX doses were not changed throughout the study. Patients were monitored every 3 weeks by the same observer. Assessments included Psoriasis Area and Severity Index (PASI), a visual analogue scale (VAS) of patients' perception of their psoriasis severity and the Dermatology Life Quality Index (DLQI). Adverse events were systematically recorded. Haematological and biochemical monitoring was performed.
Twenty-two patients with psoriasis were recruited. Age, sex and weekly MTX doses were similar in both groups. All 22 patients completed the study. The mean PASI in the FA group increased from 6.4 at baseline to 10.8 at 12 weeks. In the placebo group the mean PASI fell from 9.8 at baseline to 9.2 at 12 weeks. The mean change from baseline in the FA group was 4.4 vs. -0.6 in the placebo group (P < 0.05). Similar trends were observed in the changes in VAS and in the DLQI and differences between the groups were significant for both these parameters (P < 0.05). Few adverse effects were reported.
This study suggests that supplementation with FA during long-term MTX treatment reduces the efficacy of MTX in the control of psoriasis. Due to the relatively small sample size and short duration of this study, no conclusions can be drawn regarding the possibility that FA may reduce the side-effects of MTX.
在接受甲氨蝶呤（MTX）治疗的患者中补充叶酸的价值仍存在争议。
确定叶酸（FA）对MTX疗效以及与MTX治疗相关的副作用发生频率的影响。
对长期服用MTX剂量稳定但未接受FA治疗的银屑病患者进行了一项为期12周的双盲临床试验。他们被随机分为两组，分别每日服用5mg FA或安慰剂。在整个研究过程中MTX剂量不变。由同一名观察者每3周对患者进行一次监测。评估包括银屑病面积和严重程度指数（PASI）、患者对自身银屑病严重程度的视觉模拟量表（VAS）以及皮肤病生活质量指数（DLQI）。系统记录不良事件。进行血液学和生化监测。
招募了22名银屑病患者。两组患者的年龄、性别和每周MTX剂量相似。所有22名患者均完成了研究。FA组的平均PASI从基线时的6.4增加到12周时的10.8。安慰剂组的平均PASI从基线时的9.8降至12周时的9.2。FA组相对于基线的平均变化为4.4，而安慰剂组为-0.6（P<0.05）。在VAS和DLQI的变化中观察到了类似趋势，并且两组在这两个参数上的差异均具有显著性（P<0.05）。报告的不良反应很少。
本研究表明，在长期MTX治疗期间补充FA会降低MTX控制银屑病的疗效。由于本研究样本量相对较小且持续时间较短，因此无法就FA是否可能降低MTX的副作用得出结论。
