Balagon M V, Walsh D S, Tan P L, Cellona R V, Abalos R M, Tan E V, Fajardo T T, Watson J D, Walsh G P
Leonard Wood Memorial Center for Leprosy Research (American Leprosy Foundation), Cebu City, Philippines.
Int J Dermatol. 2000 Jan;39(1):51-8. doi: 10.1046/j.1365-4362.2000.00862.x.
New treatments for psoriasis are being developed, but many are associated with limited efficacy, side-effects, or rapid recurrence after discontinuation. Thus, the aim of new agents is to induce longer term remissions with fewer side-effects. Preliminary studies have shown that Mycobacterium vaccae, a nonpathogenic organism prepared as a heat-killed suspension, may induce periods of remission in some psoriasis patients when administered intradermally.
To further assess the efficacy and tolerability of M. vaccae in patients with moderate to severe psoriasis (psoriasis area and severity index (PASI) of 12-35), we conducted an open label study whereby 24 patients received two intradermal inoculations of M. vaccae in lesion-free deltoid skin, separated by a period of 3 weeks.
Twelve weeks after starting treatment, 14 of 24 patients (58%) showed marked improvement in the PASI score (greater than 50% reduction), two had moderate improvement (25-50% reduction), six were unchanged (< 25% reduction), and two had worsened (> 5% increase). By 24 weeks, 11 of 22 patients continued to show greater than 50% improvement. Five patients had complete clearance of skin lesions that lasted for at least 6 months.
Intradermal administration of heat-killed M. vaccae suspension was well tolerated and induced clinically significant improvement in a majority of psoriasis patients in this cohort. Placebo-controlled testing to further define the efficacy of this treatment is warranted.
银屑病的新疗法正在不断研发，但许多疗法疗效有限、伴有副作用或停药后迅速复发。因此，新型药物的目标是诱导更长期的缓解且副作用更少。初步研究表明，母牛分枝杆菌，一种制备成热灭活悬液的非致病性生物体，皮内注射时可使部分银屑病患者出现缓解期。
为进一步评估母牛分枝杆菌对中度至重度银屑病患者（银屑病面积和严重程度指数（PASI）为12 - 35）的疗效和耐受性，我们开展了一项开放标签研究，24例患者在无皮损的三角肌皮肤处接受两次皮内注射母牛分枝杆菌，间隔3周。
开始治疗12周后，24例患者中有14例（58%）的PASI评分显著改善（降低超过50%），2例中度改善（降低25% - 50%），6例无变化（降低<25%），2例病情恶化（增加>5%）。到24周时，22例患者中有11例持续显示改善超过50%。5例患者皮损完全清除，持续至少6个月。
皮内注射热灭活的母牛分枝杆菌悬液耐受性良好，使该队列中的大多数银屑病患者出现了具有临床意义的改善。有必要进行安慰剂对照试验以进一步明确该治疗方法的疗效。
