摘要
目的评价重酒石酸卡巴拉汀治疗血管性痴呆(VD)的疗效和安全性。方法多中心、随机、开放、对照试验。5个城市7家医院共98例VD患者[简易精神状态检查(MMSE)10～26分],随机进入对照组(n=48)和卡巴拉汀治疗组(n=50),为期12周,受严重急性呼吸综合征(SARS)影响,13例脱落,最终对照组37例,治疗组48例。对照组应用改善血液循环的药物,治疗组在应用改善血液循环的药物的同时服用卡巴拉汀4.5～6.0mg/d。在患者入组时(基线期)和12周末进行疗效评价,采用MMSE、血管性痴呆评估量表认知分量表(VaDAScog)、日常生活能力量表(ADL)及阿尔茨海默病评估量表非认知分量表(ADASnoncog),评估患者在认知功能、日常生活能力及精神行为症状三方面的变化;以总体印象变化量表(ADCSCGIC)评估总体疗效。安全性检查包括每2～4周评估生命体征和在基线及研究终点进行实验室检查。结果治疗组在记忆力、定向力、注意力、结构运用能力等认知领域的测验分数有所改善,与对照组相比,治疗组的MMSE总分(12周末20.2±4.8,基线18.9±4.8,P=0.003)和数字倒背成绩(12周末3.5±1.5,基线4.2±1.8,P=0.01)提高;两组的日常生活能力较基线均无明显变化(P>0.05);治疗组妄想症状减轻(P=0.03),爱流泪现象减少(P=0.06)。总体印象评估治疗组65.1%的患者有改善,多于对照组(40.1%),两组差异接近统计学显著水平(P=0.06)。对照组和治疗组的总不良事件概率分别为8.1%～10.4%,两组差异无统计学意义。药物对患者生命体征及实验室指标无影响。结论卡巴拉汀可以改善VD患者的认知功能和行为症状,且安全性和耐受性良好,可作为VD治疗的候选药物。
Objective To evaluate the clinical efficacy and safety of rivastigmine in treatment of patients with vascular dementia （ VD ）. Methods All 98 VD patients （ MMSE score between 10 to 26 ） from 7 centers were randomized into two groups, the control group （ n = 48 ） took malntenane therapy for cerebral vascular disease （ CVD ） , the rivastigmine group （ n = 50 ） took rivastigmine 4. 5-6.0 mg/d, however 13 cases were dropped because of the interference of SARS, which resulted in a control group of 37 cases and a revastigmine group of 48 cases. The duration was 12 weeks. The scales of MMSE, VDAS-cog, ADL, and ADAS-noncog were used to assess the effects on cognitive function, ability of daily living, and behavior symptoms respectively at beth baseline and the end of 12 weeks; general change was rated with scales of ADCS-CGIC. Safety issues, including vital signs, lab assays, and ECG examinations, were measaured every 2 or 4 weeks. Results The subjects met the definition of ITT population. Patients of the rivastigmine group got statistically significant improvement in neuropsychological tests in memory, orientation, concentration, and visual-spatial functions. In rivastigmine group the total score of MMSE （12 weeks 20. 2 ±4.8, baseline 18.9 ±4. 8 ,P =0. 003 ） and digit span test （ 12 weeks 3.5 ± 1.5 , baseline 4. 2 ±1.8, P =0. 01 ） were improved than the baseline in comparison with the controlled group; no significant difference was found in ADL scale between 12 weeks and baseline in both groups （P 〈 0. 05 ） ; reduction of delusion（ P = 0. 03 ） and tearfulness （ P = 0. 06） appeared in patients of the rivastigmine group. There were 65.1% patients of the rivastigmine group declared clinical improvement, more than that of the control group （40. 1% ）. The difference of general efficacy between the two groups was nearly statistically significant （P = 0. 06）. One severe adverse event occurred in the control group during the trial. The incidence of the control group and the rivastigmine group adverse events was 8. 1% and 10. 4%, respectively, showing no significant differences between groups. Rivastigmine had little influence on vital signs and lab assays. Conclusion Rivastigmine might improve the clinical symptoms of VD patients, with acceptable safety and tolerance. It should be a candidate treatment for VD.
出处
《中华神经科杂志》
CAS
CSCD
北大核心
2005年第8期483-487,共5页
Chinese Journal of Neurology
