Hsiung G-Y R, Das S K, Ranawaya R, Lafontaine A-L, Suchowersky O
Movement Disorders Clinic, Department of Clinical Neurosciences at University of Calgary, Alberta, Canada.
Mov Disord. 2002 Nov;17(6):1288-93. doi: 10.1002/mds.10252.
Although botulinum toxin A (BTX) has been licensed in Canada for treatment of various movement disorders since 1990, few clinical studies regarding its long-term efficacy and side effects have been reported. We conducted a retrospective analysis of 235 patients who received BTX from our movement disorders clinic over a 10-year period (January 1990 to December 1999). A total of 2,616 treatment cycles (multiple injections) were administered to 235 patients with cervical dystonia (CD), hemifacial spasm (HS), blepharospasm (BP), and other movement disorders. Substantial benefit at 5 years was seen in most patients (90% in BP, 88% in HS, 63% in CD, 100% in jaw closing and lower limb dystonia, and 56% in writer's cramp). Benefit was maintained for up to 10 years in CD, HS, and BP data, with a 75.8% benefit reported. Twenty-eight percent of patients discontinued treatment during the follow-up period due to a variety of reasons. Of these, 9.1% of patients developed primary resistance, and 7.5% of patients secondary resistance. Adverse effects, mostly minor, developed in 27% of patients at any one time, occurring over 4.5% of treatment cycles. These were most frequently reported in blepharospasm (22 of 36 patients in 40 cycles), followed by hemifacial spasm (21 of 70 patients in 46 cycles), and cervical dystonia (17 of 106 in 28 cycles). Only 1.3% of patients discontinued therapy due intolerable adverse effects. The results show that BTX is a safe and effective treatment of various types of movement disorders, and most side effects are well tolerated. Discontinuation for any reason was also low after 5 years. Efficacy was maintained after long periods of treatment with high degree of patient satisfaction.
尽管自1990年以来肉毒杆菌毒素A(BTX)在加拿大已被批准用于治疗各种运动障碍,但关于其长期疗效和副作用的临床研究报道较少。我们对1990年1月至1999年12月这10年间在我们运动障碍诊所接受BTX治疗的235例患者进行了回顾性分析。共对235例患有颈部肌张力障碍(CD)、半面痉挛(HS)、眼睑痉挛(BP)和其他运动障碍的患者进行了2616个治疗周期(多次注射)。大多数患者在5年时获得了显著益处(BP患者中90%、HS患者中88%、CD患者中63%、下颌闭合和下肢肌张力障碍患者中100%、书写痉挛患者中56%)。在CD、HS和BP的数据中,益处持续了长达10年,报告的有益率为75.8%。28%的患者在随访期间因各种原因停止治疗。其中,9.1%的患者出现原发性耐药,7.5%的患者出现继发性耐药。在任何时候,27%的患者出现了不良反应,大多为轻微反应,占治疗周期的4.5%。这些不良反应在眼睑痉挛患者中最常报告(40个周期中的36例患者中有22例),其次是半面痉挛(46个周期中的70例患者中有21例)和颈部肌张力障碍(28个周期中的106例患者中有17例)。只有1.3%的患者因无法耐受的不良反应而停止治疗。结果表明,BTX是治疗各种类型运动障碍的安全有效方法,大多数副作用耐受性良好。5年后因任何原因停药的情况也较低。经过长期治疗,疗效得以维持,患者满意度较高。