尼麦角林治疗血管性认知功能障碍的前瞻性、多中心临床研究

Nicergoline in treatment of vascular cognitive disorder:a prospective, multicenter clinical trial.

目的 验证尼麦角林 (乐喜林 )治疗血管性认知功能障碍的有效性和安全性。 方法 前瞻性、分层随机、阳性药物 (脑通 )对照的多中心临床试验。选择 15 0例认知功能障碍的患者 ,主要评价指标为精神认知能力 (CCSE)和社会活动功能 (FAQ)以及CCI指数 (CCSE +FAQ) ,次要评价指标为血液流变学指标和疗效指数。 结果 CCSE评分由治疗前的 (16 85± 5 2 3)分提高到治疗后的(2 0 6 1± 5 2 6 )分 ,FAQ评分由治疗前的 (14 77± 5 93)分提高到治疗后的 (18 74± 6 12 )分 ,差异均有显著性 (P <0 0 1) ,CCI指数由治疗前 31 6 2± 10 96提高到治疗后 39 35± 11 13(P <0 0 1) ;全血低切黏度由 7 0 7± 2 6 5下降到 6 0 8± 3 2 2、红细胞压积由 (4 3 4 7± 4 30 )下降到 (4 0 82± 3 93) %、血浆比黏度由 1 91± 0 38下降到 1 78± 0 30 ,差异均有显著性 (P <0 0 1) ;通过阳性药物 (脑通 )对照 ,结果表明国产尼麦角林和进口尼麦角林对血液流变学和认知功能方面具有相同的功效 ,对认知功能障碍的总有效率分别为 76 %和 70 %。 结论 乐喜林是治疗血管性认知功能障碍的高效、安全的药物 ,与进口尼麦角林具有相同的品质。

Objective To study the efficacy and safety of nicergoline in treatment of vascular cognitive disorder. Methods A multicenter, randomized, laminatel, efficient drug controlled clinical trial was carried out. 150 patients were enrolled with the diagnosis of cerebral cognitive disorder. We used CCSE and FAQ and index of CCI as main assessing items, and the index of hemodynamics and curative importance index as secondary assessing items. Results All patinets were assessed. The scores of CCSE and FAQ were raised in both groups after the treatment. The score of CCSE was raised from16.85±5.23 to 20.61±5.26, the score of FAQ was raised from 14.77± 5.93 to 18.74±6.12 (P<0.05). The index of CCI was raised from 31.62±10.96 to 39.35±11.13 after the treatment (P<0.01). The platelet aggregation, plasma viscosity and erythrocyte deformability were improved. The effective rate of local and import nicergoline for treating cognitive disorder was 76% & 70% separately. Local nicergoline had the same quality as import nicergoline. Conclusions Nicetgoline is an effective and safe drug in treatment of vascular cognitive disorder.