Nicergoline in balance alterations in adult and elderly patients - A double-blind, placebo-controlled study
Nicergoline in balance alterations in adult and elderly patients - A double-blind, placebo-controlled study
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DOI：
10.2165/00044011-200222110-00002
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发表时间：
2002-01-01
影响因子：
3.2
通讯作者：
Pignataro, O
中科院分区：
文献类型：
--
作者：
Felisati, G;Battaglia, A;Pignataro, O
目的：评价尼麦角林治疗中枢性平衡障碍的有效性和安全性。设计和设置：前瞻性，双盲，安慰剂对照，平行组，随机试验，nicergoline 30mg，每日两次，安慰剂给予3个月。基线评估后，每月对患者进行疗效和安全性评估。这项研究在意大利五个中心的门诊病人中进行。患者：89例中枢性平衡障碍的成人和老年门诊患者（平均年龄67.1岁）。干预措施：在基线时，进行完整的临床和耳神经检查，并计算眩晕-头晕鉴别诊断评分。采用眩晕评定评定量表（DARS）、眩晕障碍量表（DHI）和静态体位法评价疗效。安全性评价包括监测不良事件、生命体征、血液学和血液化学。主要结局指标和结果：两种治疗均显著降低DARS总分；然而，从治疗的第一个月开始，与安慰剂组相比，尼麦角林组从基线开始的评分变化明显更大（p = 0.002）。在治疗后2个月至研究结束时，治疗间差异进一步增加（p < 0.001）。在所有时间点，无论是总分还是所有领域（功能、情绪和身体），尼麦角林组的DHI评分与基线相比变化也显著大于安慰剂组（p < 0.001）。从基线开始，DARS和DHI总分变化之间存在很强的相关性。静态姿势测量显示，尼麦角林组几乎所有考虑的变量都有改善，尽管与安慰剂组相比没有统计学上的显著差异；然而，仅在尼麦角林组观察到与基线相比的显著变化。在4.5%的尼麦角林组和4.4%的安慰剂组患者中观察到不良事件。结论：尼麦角林是治疗中枢性眩晕相关临床症状有效且耐受性良好的药物，可提高眩晕患者的生活质量。
Objective: To evaluate the efficacy and safety of nicergoline in the treatment of balance disorders of central origin in adult and elderly patients.Design and setting: Prospective, double-blind, placebo-controlled, parallel-group, randomised trial of nicergoline 30mg twice daily and placebo administered for 3 months. After baseline evaluation, patients were assessed monthly for efficacy and safety. The study was carried out in outpatients in five centres in Italy.Patients: Eighty-nine adult and elderly outpatients (mean age 67.1 years) with balance disorders of central origin.Interventions: At baseline, a complete clinical and instrumental otoneurological examination was carried out and the Vertigo-Dizziness Differential Diagnosis Score was calculated. Efficacy was assessed by the Dizziness Assessment Rating Scale (DARS), Dizziness Handicap Inventory (DHI) and static posturography. The safety evaluation included monitoring of adverse events, vital signs, haematology and blood chemistry.Main outcome measures and results: The DARS total score was significantly reduced by both treatments; however, score change from baseline was significantly greater in the nicergoline group compared with the placebo group from the first month of treatment (p = 0.002). The between-treatment difference further increased (p < 0.001) in the following 2 months of treatment up to the end of the study. The DHI score change from baseline was also significantly greater in the nicergoline group compared with placebo (p < 0.001) at all timepoints, both for the total score and for all domains (functional, emotional and physical). A strong correlation was observed between DARS and DHI total score change from baseline. Static posturography measurements indicated an improvement for almost all considered variables in the nicergoline group, although no statistically significant difference was observed compared with placebo; however, significant changes from baseline were observed only in the nicergoline group. Adverse events were observed in 4.5% of the nicergoline and 4.4% of the placebo patients.Conclusions: Nicergoline is an effective and well tolerated treatment for the clinical symptoms related to central vertigo and improves the quality of life of patients with dizziness.