Färber L, Stratz T, Brückle W, Späth M, Pongratz D, Lautenschläger J, Kötter I, Zöller B, Peter H H, Neeck G, Alten R, Müller W
Institut für Pharmakologie der Universität Regensburg, Germany.
Scand J Rheumatol Suppl. 2000;113:49-54. doi: 10.1080/030097400446643.
Based on a potential role for serotonin receptors in fibromyalgia, we investigated the efficacy and tolerability of treatment with tropisetron, a highly selective, competitive inhibitor of the 5-HT3 receptor.
In this prospective, multicenter, double-blind, parallel-group, dose-finding study, 418 patients suffering from primary fibromyalgia (ACR criteria) were randomly assigned to receive either placebo, 5 mg, 10 mg or 15 mg tropisetron once daily, respectively. The duration of treatment was 10 days. The clinical response was measured by changes in pain-score, visual analog scale (VAS), and the number of painful tender-points.
Treatment with 5 mg tropisetron resulted in a significantly higher response rate (39.2%) when compared with placebo (26.2%) (p=0.033). The absolute reduction in pain-score was -13.5% for 5 mg tropisetron, -13.0% for 10 mg tropisetron, and -6.3% for placebo (p<0.05). The effects of 15 mg tropisetron were similar to placebo, thus suggesting a bell-shaped dose-response curve. Compared with placebo, treatment with 5 mg tropisetron led to a significant improvement (p<0.05) in VAS, while a clear trend in terms of clinical benefit was seen with 10 mg tropisetron. The number of painful tender-points was also reduced significantly (p=0.002) in the 5 mg tropisetron group. Of interest, during the 12-month follow-up period, pain intensity of responders on 5 mg and 10 mg tropisetron was still markedly below baseline. The treatment was well tolerated, with gastro-intestinal complaints being the most frequently reported side effects, in keeping with the known safety profile for 5-HT3 receptor antagonists.
This study demonstrates the efficacy of short-term treatment with 5 mg tropisetron once daily in primary fibromyalgia. Treatment was well tolerated and prolonged clinical benefits were seen.
基于血清素受体在纤维肌痛中可能发挥的作用，我们研究了托烷司琼（一种5-HT3受体的高选择性竞争性抑制剂）治疗的疗效和耐受性。
在这项前瞻性、多中心、双盲、平行组、剂量探索研究中，418例原发性纤维肌痛患者（符合美国风湿病学会标准）被随机分配，分别每日一次接受安慰剂、5毫克、10毫克或15毫克托烷司琼治疗。治疗持续时间为10天。通过疼痛评分、视觉模拟量表（VAS）和疼痛压痛点数量的变化来衡量临床反应。
与安慰剂组（26.2%）相比，5毫克托烷司琼治疗组的反应率显著更高（39.2%）（p = 0.033）。5毫克托烷司琼组疼痛评分的绝对降低率为-13.5%，10毫克托烷司琼组为-13.0%，安慰剂组为-6.3%（p < 0.05）。15毫克托烷司琼的效果与安慰剂相似，因此提示呈钟形剂量反应曲线。与安慰剂相比，5毫克托烷司琼治疗使VAS显著改善（p < 0.05），而10毫克托烷司琼在临床获益方面有明显趋势。5毫克托烷司琼组疼痛压痛点数量也显著减少（p = 0.002）。有趣的是，在12个月的随访期内，5毫克和10毫克托烷司琼治疗的反应者的疼痛强度仍明显低于基线水平。该治疗耐受性良好，胃肠道不适是最常报告的副作用，这与5-HT3受体拮抗剂已知的安全性特征相符。
本研究证明了原发性纤维肌痛患者每日一次服用5毫克托烷司琼短期治疗的疗效。治疗耐受性良好且有持久的临床获益。
