BACKGROUND We evaluated quality of life among subjects with upper- and lower-limb spasticity who received escalating doses of incobotulinumtoxinA (total body doses up to 800 U) in the prospective, single-arm, dose-titration TOWER study. METHODS In this exploratory trial, subjects (N = 155; 18-80 years of age) with upper- and lower-limb spasticity due to cerebral causes who were deemed to require total body doses of up to 800 U incobotulinumtoxinA received three consecutive injection cycles of incobotulinumtoxinA (400, 600, and up to 800 U), each with 12 to 16 weeks' follow-up. QoL was assessed using the EuroQol 5-dimensions questionnaire, three-level (EQ-5D), before and 4 weeks post-injection in each injection cycle and at the end of injection cycle 3. RESULTS The mean EQ-5D visual analog scale scores of 155 participants continuously improved from study baseline to 4 weeks post-injection in all injection cycles (mean [standard deviation] change 6.7 [14.1], 9.6 [16.3], and 8.6 [17.0] for injection cycles 1, 2, and 3, respectively; p < 0.0001 for all, paired sample t-test). In general, among those with a change in the EQ-5D rating of their condition, the proportion of subjects with 'improvement' was greater than that with 'worsening' for individual EQ-5D dimensions across all injection cycles. At the end of injection cycle 3, the proportion of subjects rating their condition as 'normal' increased from study baseline for all dimensions, and there was a ≥ 46% reduction in the proportion of subjects with a rating of 'severe impairment'. CONCLUSION These preliminary results suggest that escalating incobotulinumtoxinA doses up to 800 U are associated with improvement in quality of life ratings in subjects with multifocal upper- and lower-limb spasticity, and form a basis for future comparator studies. TRIAL REGISTRATION ClinicalTrials.gov, NCT01603459. Date of registration: May 22, 2012.

中文翻译：

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使用incobotulinumtoxinA治疗患有上肢和下肢痉挛的受试者的生活质量。

背景技术在前瞻性单臂剂量滴定TOWER研究中，我们评估了上肢和下肢痉挛的受试者的生活质量，这些受试者接受了递增剂量的incobotulinumxinA（总剂量高达800 U）。方法在该探索性试验中，被认为需要全身总剂量不超过800 U的因肉毒杆菌毒素A导致的上肢和下肢痉挛的受试者（N = 155； 18-80岁）接受了三个连续的注射周期的incobotulinumtoxinA（400、600和最大800 U），每组随访12至16周。在每个注射周期和注射周期结束后的注射前和注射后4周，使用EuroQol 5维问卷（三级（EQ-5D））评估QoL。结果在所有注射周期中，有155名参与者的平均EQ-5D视觉模拟量表评分从研究基线到注射后4周持续改善（平均[标准偏差]改变6.7 [14.1]，9.6 [16.3]和8.6 [17.0]）分别对应于进样周期1、2和3；对于所有配对样本t检验，p <0.0001）。通常，在所有情况下，在所有注射周期中，对个体EQ-5D尺寸进行“改善”的受试者比例中，“改善”的受试者的比例大于“恶化”的受试者的比例。在注射周期3结束时，所有条件下，其状况均被评定为“正常”的受试者比例从研究基准开始增加，并且评定为“严重损伤”的受试者比例降低了≥46％。结论这些初步结果表明，递增剂量的IncobotulinumtoxinA剂量高达800 U与多焦点上肢和下肢痉挛的受试者的生活质量改善有关，并为将来进行比较研究奠定了基础。试验注册ClinicalTrials.gov，NCT01603459。注册日期：2012年5月22日。