Sechi GianPietro, Agnetti Virgilio, Sulas Franca M I, Sau GianFranco, Corda Davide, Pitzolu Maria G, Rosati Giulio
Neurological Clinic, University of Sassari, Viale San Pietro 10, 07100 Sassari, Italy.
Prog Neuropsychopharmacol Biol Psychiatry. 2003 Sep;27(6):1023-7. doi: 10.1016/S0278-5846(03)00170-2.
To evaluate the safety and potential beneficial effect of topiramate (TPM) as monotherapy or adjunctive therapy to carbamazepine (CBZ) in patients with cerebellar tremor.
Nine patients with cerebellar tremor participated a 4-week, open-label, prospective-controlled trial. TPM was given as monotherapy (n=7 cases), or in combination with CBZ (n=2 cases), at dosages ranging from 25 mg twice daily to 100 mg twice daily. The severity of tremor was assessed clinically on a 0-4 scale, by tremograms, by the Patients Global Impressions Scale, and by a "free writing" task at baseline and after 4 weeks.
TPM was discontinued in four patients due to adverse effects (sedation=2; cognitive impairment=2; increased aggressiveness=2; asthenia=1). During TPM, all patients improved. The mean tremor amplitude, compared with the baseline period, was reduced from 20% to 75%. After TPM, mean clinical scores of postural tremor and kinetic tremor decreased from 2.1+/-0.8 to 0.9+/-0.9 and from 2.1+/-1 to 1.4+/-1 (P<.05), respectively. All patients with head tremor improved. Writing, eating, and drawing were improved with TPM. Four patients chose to keep taking the drug.
Our study indicates that TPM may be useful for the management of cerebellar tremors. A prospective placebo-controlled trial of TPM in this kind of tremor is warranted. TPM dosages should be titrated slowly to avoid the potential side effects of the drug. The range and the frequency of adverse events might limit the clinical usefulness of TPM.
评估托吡酯（TPM）作为单药治疗或卡马西平（CBZ）辅助治疗对小脑性震颤患者的安全性和潜在益处。
9例小脑性震颤患者参与了一项为期4周的开放标签前瞻性对照试验。TPM作为单药治疗（n = 7例）或与CBZ联合使用（n = 2例），剂量范围为每日两次，每次25毫克至每日两次，每次100毫克。在基线和4周后，通过临床0 - 4级评估震颤严重程度、震颤图、患者整体印象量表以及“自由书写”任务进行评估。
4例患者因不良反应停用TPM（镇静作用2例；认知障碍2例；攻击性增加2例；乏力1例）。在服用TPM期间，所有患者均有改善。与基线期相比，平均震颤幅度从20%降至75%。服用TPM后，姿势性震颤和运动性震颤的平均临床评分分别从2.1±0.8降至0.9±0.9以及从2.1±1降至1.4±1（P <.05）。所有头部震颤患者均有改善。TPM使书写、进食和绘图能力得到改善。4例患者选择继续服用该药物。
我们的研究表明，TPM可能对小脑性震颤的治疗有用。有必要对TPM在这类震颤中进行前瞻性安慰剂对照试验。TPM剂量应缓慢滴定以避免药物的潜在副作用。不良事件的范围和频率可能会限制TPM的临床应用价值。
