天智颗粒治疗轻中度血管性痴呆肝阳上亢证的疗效与安全性观察

目的：观察天智颗粒治疗轻中度血管性痴呆肝阳上亢证的疗效与安全性。方法：纳入全国28个中心诊断的轻中度血管性痴呆肝阳上亢证患者965例，给予天智颗粒5 g/次，3次/天，治疗前、治疗后4周、12周、24周进行简易状态量表（MMSE）、肝阳上亢证量表（GYSK）、临床医师访谈时对病情变化的印象补充量表（CIBIC-plus）评估。结果：治疗后轻度和中度血管性痴呆组MMSE评分均增高，GYSK评分均降低，与治疗前比较有显著性差异（P<0.01）。CIBIC-plus显示符合方案集（per protocol set，PPS）轻度血管性痴呆组有总有效率为81.71%，中度血管性痴呆组总有效率为84.99%。不良反应主要以腹泻、恶心、呕吐、失眠等轻微症状为主。结论：天智颗粒能明显改善轻中度血管性痴呆患者的认知功能和中医证候，不良反应少，安全性高。

Clinical efficacy and safety of Tianzhi granules for mild-to-moderate vascular dementia (hyperactivity of liver-yang syndrome)

OBJECTIVE To explore the efficacy and safety of Tianzhi granules in the treatment of mild-to-moderate vascular dementia(hyperactivity of liver-yang syndrome).METHODS A total of 965 patients with vascular dementia(hyperactivity of liver-yang syndrome) were recruited from 28 domestic centers. Tianzhi granules was orally taken at a dose of 5 g each time thrice daily for 6 months. Before treatment and at Week 4/12/24 post-treatment, the assessments of MMSE, GYSK and CIBIC-plus were conducted.RESULTS After treatment, there were a marked increase of MMSE and an obvious decrease of GYSK. And the differences at pre-treatment and post-treatment were statistically significant(P<0.01). As evaluated by CIBIC-plus, the efficacy rate was 81.74% in mild vascular dementia group and 81.74% in moderate vascular dementia group. The side effects included diarrhea, insomnia, nausea and vomiting.CONCLUSION Capable of significantly improving cognitive functions and TCM syndromes, Tianzhi granules has few adverse reactions with a high safety.