Zachrisson Olof, Regland Björn, Jahreskog Marianne, Jonsson Michael, Kron Margareta, Gottfries Carl-Gerhard
Psychiatry Section, Institute of Clinical Neuroscience, Göteborg University, Göteborg, Sweden.
Eur J Pain. 2002;6(6):455-66. doi: 10.1016/s1090-3801(02)00044-7.
We have previously conducted a small treatment study on staphylococcus toxoid in fibromyalgia (FM) and chronic fatigue syndrome (CFS). The aim of the present study was to further assess the efficacy of the staphylococcus toxoid preparation Staphypan Berna (SB) during 6 months in FM/CFS patients. One hundred consecutively referred patients fulfilling the ACR criteria for FM and the 1994 CDC criteria for CFS were randomised to receive active drug or placebo. Treatment included weekly injections containing 0.1 ml, 0.2 ml, 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml, 0.9 ml, and 1.0 ml SB or coloured sterile water, followed by booster doses given 4-weekly until endpoint. Main outcome measures were the proportion of responders according to global ratings and the proportion of patients with a symptom reduction of > or =50% on a 15-item subscale derived from the comprehensive psychopathological rating scale (CPRS). The treatment was well tolerated. Intention-to-treat analysis showed 32/49 (65%) responders in the SB group compared to 9/49 (18%) in the placebo group (P<0.001). Sixteen patients (33%) in the SB group reduced their CPRS scores by at least 50% compared to five patients (10%) in the placebo group (P< 0.01). Mean change score on the CPRS (95% confidence interval) was 10.0 (6.7-13.3) in the SB group and 3.9 (1.1-6.6) in the placebo group (P<0.01). An increase in CPRS symptoms at withdrawal was noted in the SB group. In conclusion, treatment with staphylococcus toxoid injections over 6 months led to significant improvement in patients with FM and CFS. Maintenance treatment is required to prevent relapse.
我们之前针对纤维肌痛（FM）和慢性疲劳综合征（CFS）患者开展了一项关于葡萄球菌类毒素的小型治疗研究。本研究的目的是进一步评估葡萄球菌类毒素制剂“Staphypan Berna”（SB）在FM/CFS患者中6个月的疗效。100例连续转诊且符合美国风湿病学会（ACR）FM标准及1994年美国疾病控制与预防中心（CDC）CFS标准的患者被随机分组，分别接受活性药物或安慰剂治疗。治疗包括每周注射含0.1 ml、0.2 ml、0.3 ml、0.4 ml、0.6 ml、0.8 ml、0.9 ml和1.0 ml SB或有色无菌水，随后每4周给予加强剂量直至研究终点。主要结局指标是根据整体评分得出的反应者比例，以及在综合精神病理学评定量表（CPRS）的15项子量表上症状减轻≥50%的患者比例。该治疗耐受性良好。意向性分析显示，SB组49例中有32例（65%）为反应者，而安慰剂组49例中有9例（18%）为反应者（P<0.001）。SB组有16例患者（33%）CPRS评分至少降低50%，而安慰剂组有5例患者（10%）（P<0.01）。SB组CPRS的平均变化评分（95%置信区间）为10.0（6.7 - 13.3），安慰剂组为3.9（1.1 - 6.6）（P<0.01）。SB组在撤药时CPRS症状出现增加。总之，6个月的葡萄球菌类毒素注射治疗使FM和CFS患者有显著改善。需要维持治疗以防止复发。
