Shi Jing, Wei Mingqing, Ni Jingnian, Sun Feng, Sun Li, Wang Junfu, Yu Tao, Wang Kai, Lv Peiyuan, Wang Yunfu, Zhang Yulian, Gao Xuguang, Gao Xuanzhao, Luo Benyan, Mao Shanping, Zhang Baorong, Ren Xiangyang, Yu Fengchun, Hu Wenli, Yin Ping, Wu Nanjin, Liu Xianfeng, Bi Qi, Wang Yongyan, Tian Jinzhou
Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China.
Zhongjing Wanxi Pharmaceutical Co., Ltd., Nanyang, 474550, Henan Province, China.
J Transl Med. 2020 Feb 13;18(1):76. doi: 10.1186/s12967-020-02232-z.
Tianzhi granule (TZ) is usually used for patients with vascular dementia (VaD) in China. The aim was to assess the effect of TZ by a randomized clinical trial (RCT).
A 24-week RCT was conducted in 16 centres. Participants were grouped into TZ, donepezil or placebo. The co-primary outcomes were the Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog) and Clinician's Interview-based Impression of Change-plus caregiver information (CIBIC-plus).
A total of 543 patients with mild to moderate VaD were enrolled, of whom 242 took TZ granules, 241 took donepezil, and 60 took placebo. The least-squares mean changes from baseline and 95% CI were 6.20 (5.31, 7.09) (TZ group), 6.53 (5.63, 7.42) (donepezil group) and 3.47 (1.76, 5.19) (placebo group), both TZ and donepezil showed small but significantly improvement compared with placebo group. The percent of improvement on the global impression which was measured by CIBIC-plus was 73.71% in TZ and 58.18% in placebo, there was significant different between TZ and placebo group (P = 0.004). No significant differences were observed between TZ and donepezil. No significant differences of adverse events were found.
TZ and donepezil could bring symptomatic benefit for mild to moderate VaD. Trial registration The protocol had retrospectively registered at clinical trial.gov, Unique identifier: NCT02453932, date of registration: May 27, 2015; https://www.clinicaltrials.gov/ct2/show/NCT02453932?term=NCT02453932&rank=1.
在中国，天智颗粒（TZ）常用于血管性痴呆（VaD）患者。本研究旨在通过一项随机临床试验（RCT）评估天智颗粒的疗效。
在16个中心进行了一项为期24周的RCT。参与者被分为天智颗粒组、多奈哌齐组或安慰剂组。共同主要结局指标为血管性痴呆评估量表认知子量表（VADAS-cog）和基于临床医生访谈的变化印象加照顾者信息（CIBIC-plus）。
共纳入543例轻度至中度VaD患者，其中242例服用天智颗粒，241例服用多奈哌齐，60例服用安慰剂。与基线相比的最小二乘均值变化及95%可信区间分别为：天智颗粒组6.20（5.31，7.09），多奈哌齐组6.53（5.63，7.42），安慰剂组3.47（1.76，5.19）。天智颗粒组和多奈哌齐组与安慰剂组相比均显示出虽小但显著的改善。CIBIC-plus评估的总体印象改善百分比在天智颗粒组为73.71%，在安慰剂组为58.18%，天智颗粒组与安慰剂组之间存在显著差异（P = 0.004）。天智颗粒组与多奈哌齐组之间未观察到显著差异。未发现不良事件的显著差异。
天智颗粒和多奈哌齐可为轻度至中度VaD带来症状改善。试验注册 该方案已在clinicaltrial.gov上进行回顾性注册，唯一标识符：NCT02453932，注册日期：2015年5月27日；https://www.clinicaltrials.gov/ct2/show/NCT02453932?term=NCT02453932&rank=1 。
