Neurology department, The Affiliated Hospital of Putian University, Putian, Fujian, China.
Pak J Pharm Sci. 2022 May;35(3):741-745.
To evaluate the efficacy and safety of sodium oligomannate in the treatment of Alzheimer's disease. Patients with mild-to-moderate AD were randomly divided into three groups, the scores of ADAS-Cog, ADL, CIBIC-plus, NPI and CSDD were evaluated at the 0th, 12th, 24th, 36th and 48th weeks of medication. Comparing the mean scores of each scale in each cycle of each group. Using SPSS21.0 software for measurement data using t test, Chi-square test was used for counting data. A total of 72 patients with AD were included. The difference of CIBIC-plus score at week 12(P=0.007) and 24(P=0.005), ADAS-Cog scores (P=0.01) at week 24 in GV-971 group was statistically significant compared with that in the control group. The CIBIC-plus score at week 24(P=0.01) and week 48 (P=0.04), CSDD scores at week 48(P=0.02) of GV-971 group was statistically significant compared with that of donepezil group. There were 2 cases of adverse reaction of increased stool frequency in GV-971 (5.67%), and 2 cases of adverse reaction of nausea in donepezil group (8.33%), the difference was statistically significant. GV-971 is as effective as donepezil in the treatment of Alzheimer's disease, and may even be better. It has good safety.
评估低聚甘露糖钠治疗阿尔茨海默病的疗效和安全性。将轻度至中度 AD 患者随机分为三组,在用药第 0、12、24、36、48 周分别评估 ADAS-Cog、ADL、CIBIC-plus、NPI 和 CSDD 的评分,比较每组每个周期各量表的平均评分。采用 SPSS21.0 软件进行计量资料比较采用 t 检验,计数资料采用卡方检验。共纳入 72 例 AD 患者。GV-971 组在第 12 周(P=0.007)和第 24 周(P=0.005)的 CIBIC-plus 评分差异、第 24 周 ADAS-Cog 评分(P=0.01)与对照组比较差异有统计学意义。GV-971 组第 24 周(P=0.01)和第 48 周(P=0.04)的 CIBIC-plus 评分、第 48 周 CSDD 评分(P=0.02)与多奈哌齐组比较差异有统计学意义。GV-971 组有 2 例(5.67%)出现大便次数增多的不良反应,多奈哌齐组有 2 例(8.33%)出现恶心的不良反应,差异有统计学意义。GV-971 治疗阿尔茨海默病的疗效与多奈哌齐相当,甚至可能更好,且安全性良好。