Wörz R, Bolten W, Heller B, Krainick J U, Pergande G
Schmerzzentrum, Bad Schönborn.
Fortschr Med. 1996 Dec 20;114(35-36):500-4.
The analgesic and muscle-relaxing properties of flupirtine maleate, chlormezanone and placebo were compared in a total of 184 patients. Of these patients, 164 met the criteria of the treatment plan (intention to treat), and the data of 140 patients were finally evaluated in accordance with the test protocol. A positive response was defined as a reduction in pain intensity and muscle tension by 2 categories on the 5-category verbal scale "very severe/severe/moderate/mild/ none" on the seventh day of treatment.
In the per-protocol-analysis the responder rate was 60.9% for flupirtine, 47.8% for chlormezanone, and 43.8% for placebo, the difference between drugs and placebo not being significant. The overall assessment of the physicians involved was very good/ good in 47.8% and satisfactory in 37.0% of the flupirtine group, very good/good in 45.6% and satisfactory in 17.4% of the chlormezanone group, the corresponding figures for the placebo group being 33.4% and 20.6%, respectively. Flupirtine was thus superior to placebo (p = 0.007). The incidence of adverse drug reactions was 14.8% (8/54) for flupirtine, 19.3% (11/57) for chlormezanone, and 7.3% (4/55) for placebo.
对184例患者比较了马来酸氟吡汀、氯美扎酮和安慰剂的镇痛及肌肉松弛特性。其中，164例患者符合治疗方案标准（意向性治疗），最终根据试验方案对140例患者的数据进行了评估。阳性反应定义为治疗第7天疼痛强度和肌肉紧张度在“非常严重/严重/中度/轻度/无”五级语言量表上降低2个等级。
在符合方案分析中，氟吡汀的有效率为60.9%，氯美扎酮为47.8%，安慰剂为43.8%，药物与安慰剂之间的差异无统计学意义。氟吡汀组参与治疗的医生总体评价为非常好/好的占47.8%，满意的占37.0%；氯美扎酮组非常好/好的占45.6%，满意的占17.4%；安慰剂组相应的数据分别为33.4%和20.6%。因此，氟吡汀优于安慰剂（p = 0.007）。药物不良反应发生率氟吡汀为14.8%（8/54），氯美扎酮为19.3%（11/57），安慰剂为7.3%（4/55）。
