Mondrup K, Pedersen E
Acta Neurol Scand. 1984 Apr;69(4):200-6. doi: 10.1111/j.1600-0404.1984.tb07802.x.
In a double-blind cross-over trial of two 2-week periods, the clinical effect of progabide was compared to placebo. 16 patients with spasticity in a stationary phase completed the trial. 14 had multiple sclerosis, 2 hereditary spastic paraplegia. 5 were female and 11 male. The median age was 45.5 years (range 30-62 years). The median daily dosage of progabide was 24.3 mg/kg (range 14.3-32.7 mg/kg). During progabide treatment, there was a reduction in spastic hypertonia (P less than 0.01), a suppression of tendon reflexes (patellar) (P less than 0.01), and a reduction in the frequency of flexor spasms (P less than 0.05). No significant changes in voluntary power were registered. The global clinical impression revealed a therapeutic effect in 87% of the patients (95% confidence limits 61-98%). The improvement was judged as medium or important in 50% of the patients (95% confidence limits 23-77%). No side-effects or laboratory abnormalities were seen.
在一项为期两个两周阶段的双盲交叉试验中，将丙戊酰胺的临床效果与安慰剂进行了比较。16例处于病情稳定期的痉挛患者完成了试验。其中14例患有多发性硬化症，2例患有遗传性痉挛性截瘫。5例为女性，11例为男性。年龄中位数为45.5岁（范围30 - 62岁）。丙戊酰胺的每日剂量中位数为24.3毫克/千克（范围14.3 - 32.7毫克/千克）。在丙戊酰胺治疗期间，痉挛性张力亢进有所减轻（P < 0.01），髌腱反射受到抑制（P < 0.01），屈肌痉挛频率降低（P < 0.05）。未发现随意肌力有显著变化。整体临床印象显示87%的患者有治疗效果（95%置信区间61 - 98%）。50%的患者改善程度被判定为中等或显著（95%置信区间23 - 77%）。未观察到副作用或实验室检查异常。
