van Beusekom H J, van de Laar M A, Franssen M J, van Valburg J A, Gijzel W P, Couvée J E
Clin Rheumatol. 1997 Sep;16(5):471-6. doi: 10.1007/BF02238940.
Incidences of diarrhoea and loose stools are reported up to 50% in patients starting treatment with auranofin. Moreover, +/-4% of patients discontinue treatment because of severe diarrhoea. We investigated whether a water binding agent would diminish the incidence of loose stools and diarrhoea. Endpoints were the patient's general impression of the quality of stools and a daily assessment of stool's frequency/consistency and adverse events. Secondly, some disease activity parameters were used to evaluate whether the bulkforming agent influences the efficacy of auranofin. In this study 269 patients suffering from Rheumatoid Arthritis (RA) were treated with auranofin 6 mgr daily for a period of six months. Simultaneously the patients were randomly treated with either a bulkforming agent (Volcolon: psyllium fibres) or placebo. Results show a 15% incidence of loose stools and diarrhoea during treatment with auranofin. During the treatment period the patients' general impression of defecation consistency showed a shift to softer types. The changes in defecation consistency was not significantly different between groups (Intention-to-treat analysis: C2=4.01; p=0.13). Also, the percentage of patients experiencing episodes of diarrhoea (reported as an adverse experience) was not different (14% of the patients treated with bulkformer versus 15% with placebo). During the first month 7% (n=5) of placebo treated patients reported short episodes of watery stools versus none in the bulkformer treated group. The percentage of days with loose or watery stools, reported on the diary cards, was consistently lower in bulkformer treated patients. Both groups improved equally with respect to disease activity parameters. Sixty-eight percent of patients continued auranofin treatment after the study period. In conclusion, these data do not support adjuvant therapy with a bulkforming agent on initiation of auranofin therapy. The overall low incidence of loose stools and diarrhoea suggests that a dose increase to 9 mgr daily is an option to enhance the efficacy of auranofin treatment.
据报道，开始使用金诺芬治疗的患者中，腹泻和稀便的发生率高达50%。此外，约4%的患者因严重腹泻而停止治疗。我们研究了一种水结合剂是否会降低稀便和腹泻的发生率。观察指标包括患者对粪便质量的总体印象以及对粪便频率/稠度和不良事件的每日评估。其次，使用一些疾病活动参数来评估容积形成剂是否会影响金诺芬的疗效。在本研究中，269例类风湿关节炎（RA）患者每天服用6毫克金诺芬，为期6个月。同时，患者被随机给予容积形成剂（聚卡波非钙：车前草纤维）或安慰剂治疗。结果显示，使用金诺芬治疗期间，稀便和腹泻的发生率为15%。在治疗期间，患者对排便稠度的总体印象显示向更软的类型转变。两组之间排便稠度的变化无显著差异（意向性分析：C2 = 4.01；p = 0.13）。同样，经历腹泻发作（报告为不良经历）的患者百分比也无差异（接受容积形成剂治疗的患者为14%，接受安慰剂治疗的患者为15%）。在第一个月，7%（n = 5）接受安慰剂治疗的患者报告有短暂的水样便发作，而接受容积形成剂治疗的组中无此情况。在日记卡上报告的稀便或水样便天数百分比，接受容积形成剂治疗的患者一直较低。两组在疾病活动参数方面改善程度相同。研究期结束后，68%的患者继续使用金诺芬治疗。总之，这些数据不支持在开始金诺芬治疗时使用容积形成剂进行辅助治疗。稀便和腹泻的总体低发生率表明，将剂量增加至每日9毫克是增强金诺芬治疗疗效的一种选择。
