脆弱拟杆菌BF839治疗寻常型银屑病：一项单臂、开放初步临床试验

Treatment of psoriasis vulgaris using Bacteroides fragilis BF839: a single-arm, open preliminary clinical study

摘要:

银屑病被认为是一种T细胞主导的炎症性疾病，其发病与肠道菌群失调密切相关。脆弱拟杆菌 (Bacteroides fragilis，BF) 可通过调节T细胞的细胞因子表达起抗炎作用。目前尚无脆弱拟杆菌用于治疗银屑病的相关报道，文中率先探究脆弱拟杆菌BF839对银屑病的治疗效果。选择2019年4月至2019年10月广州医科大学附属第二医院就诊的27例银屑病患者，维持原治疗不变，口服脆弱拟杆菌BF839 12周，对比治疗前后银屑病皮损面积与严重程度指数 (Psoriasis area and severity index，PASI) 评分，统计治疗12周后药物减停率。结果表明，12周试验完成率为96.3% (26/27)，12周PASI30 (PASIN定义为治疗后PASI评分下降≥N%的患者比例) 为65.4%，PASI50为42.3%，PASI75为19.2%；治疗前PASI评分为9.1±5.9，治疗12周后PASI评分为5.8±4.9，具有显著统计学差异 (P<0.01)；治疗12周后皮肤瘙痒程度用视觉模拟量表 (Visual analog scale，VAS) 评分有效率为42.3%，治疗前VAS评分为2.9±2.2，治疗12周后VAS评分为2.3±2.1，无显著统计学差异 (P>0.05)。患者治疗12周内不良反应率为3.8% (1/26)，其中便秘1例，药物减停率为60.0%。以上结果提示脆弱拟杆菌BF839可能对银屑病治疗有一定疗效，可降低PASI评分及药物使用率，不良反应少，值得进一步研究。

Abstract:

Psoriasis is considered as an inflammatory disease driven by T cells, and its pathogenesis is closely related to the imbalance of intestinal bacteria flora. It has been reported that Bacteroides fragilis could play an anti-inflammatory role by regulating the expression of cytokines in T cells. To date, there is no report using B. fragilis to treat psoriasis. In this study, we explored the therapeutic effect of B. fragilis BF839 on psoriasis. We selected 27 psoriasis patients who were treated in the Second Affiliated Hospital of Guangzhou Medical University from April to October 2019. The patients were given B. fragilis BF839 orally for 12 weeks while maintaining the original treatment. The psoriasis area and severity index (PASI) score was evaluated before and after the treatment. The rate of drug withdrawal and reduction after 12 weeks of treatment were calculated. Our results showed that the rate of 12-week trial completion was 96.3% (26/27). We used PASIN to define the proportion of people whose PASI score decreased more than or equal to N% after treatment. At 12 weeks, PASI30, PASI50, and PASI75 were 65.4%, 42.3%, and 19.2%, respectively. The PASI score was 9.1±5.9 and 5.8±4.9 before and after 12 weeks of treatment respectively, and the difference was statistically significant (P<0.01). The effective rate of the visual analog scale (VAS) score was 42.3% at 12 weeks, and the VAS score was 2.9±2.2 and 2.3±2.1 before and after 12 weeks of treatment, respectively, which had no statistically significant difference (P>0.05). The adverse reaction rate of patients was 3.8% (1/26) within 12 weeks of treatment, including 1 case of constipation, and the rate of drug withdrawal and reduction was 60.0%. The above results suggest that B. fragilis BF839 may be functional on the treatment of psoriasis by reducing the PASI score and the drug usage rate with few side effect, which deserves further study.