Haus U, Varga B, Stratz T, Späth M, Müller W
Novartis Pharma GmbH, Department of Clinical Research, Nürnberg, Germany.
Scand J Rheumatol Suppl. 2000;113:55-8. doi: 10.1080/030097400446652.
The 5-HT3 receptor antagonists are a novel therapy for patients suffering from fibromyalgia, although the optimal duration of treatment is still unclear. The objective of this phase II study was to evaluate whether prolonging treatment with tropisetron to 4 weeks is tolerable and correlated with an improved clinical benefit. Thirty female patients with fibromyalgia received oral tropisetron (5 mg) daily for 28 days in an open-label fashion. Treatment resulted in significantly decreased pain as measured by visual analog scale (VAS), with a mean reduction of 59.7% and an absolute median change of -25.0 from baseline to day 28 (p<0.0001). A similar, significant reduction of 55.7% and absolute median change of -31.0 was observed in the painscore (p<0.0001). The response rate with patients showing a > or = 35% reduction in individual pain scores was 72.4% at day 28. The pressure tolerance of tender-points was slightly increased at the end of the treatment period. In addition, significant improvements were observed in the State-Trait-Anxiety-Inventory (STAI), scales of von Zerssen (Bf-S) and Beck Depression Index (BDI). Functional symptoms were compared with the results from a 10-day, randomized, double-blind phase III study of tropisetron in 418 fibromyalgia patients. In both studies several functional symptoms such as sleep disturbances and dizziness improved significantly (p<0.05). In the 28 days study, the number and extent of improvement in functional symptoms was increased compared with the shorter trial. Tolerability and safety of tropisetron was good, and typically for 5-HT3-receptor antagonists, gastrointestinal symptoms and headache were the most frequently reported events. In conclusion, 28 days treatment of fibromyalgia patients with 5 mg tropisetron resulted in significant pain reduction, which was most pronounced after 10 days with a further reduction up to day 28. Psychometric tests showed significant improvements in depression and anxiety state scores, while functional symptoms improved with extended tropisetron treatment.
5-羟色胺3（5-HT3）受体拮抗剂是治疗纤维肌痛患者的一种新疗法，尽管最佳治疗时长仍不明确。这项II期研究的目的是评估将托烷司琼治疗时间延长至4周是否可耐受，以及是否与临床疗效改善相关。30名女性纤维肌痛患者以开放标签方式每日口服托烷司琼（5毫克），持续28天。治疗后，视觉模拟量表（VAS）测量的疼痛显著减轻，从基线到第28天平均减轻59.7%，绝对中位数变化为-25.0（p<0.0001）。疼痛评分也有类似的显著降低，降幅为55.7%，绝对中位数变化为-31.0（p<0.0001）。在第28天，个体疼痛评分降低≥35%的患者的缓解率为72.4%。治疗期末，压痛点的压痛耐受性略有增加。此外，状态-特质焦虑量表（STAI）、冯·泽尔森量表（Bf-S）和贝克抑郁量表（BDI）均有显著改善。将功能症状与418名纤维肌痛患者参加的为期10天的托烷司琼随机双盲III期研究结果进行了比较。在两项研究中，睡眠障碍和头晕等几种功能症状均有显著改善（p<0.05）。在为期28天的研究中，与较短的试验相比，功能症状改善的数量和程度有所增加。托烷司琼的耐受性和安全性良好，与5-HT3受体拮抗剂的情况一致，胃肠道症状和头痛是最常报告的事件。总之，用5毫克托烷司琼治疗纤维肌痛患者28天可显著减轻疼痛，在10天后最为明显，直至第28天进一步减轻。心理测试显示抑郁和焦虑状态评分有显著改善，而功能症状随着托烷司琼治疗时间延长而改善。
