S S Xu, Z Y Cai, Z W Qu, R M Yang, Y L Cai, G Q Wang, X Q Su, X S Zhong, R Y Cheng, W A Xu, J X Li, B Feng
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引用次数: 0
摘要
目的:比较石杉碱- a (Hup)胶囊和片剂治疗阿尔茨海默病(AD)的疗效和安全性。方法:采用多中心、前瞻性、双盲、双模拟、平行、阳性对照和随机方法,将60例符合NINCDS-ARDRA标准的AD患者随机分为2组。胶囊组患者给予Hup胶囊4粒(每粒含50微克),安慰剂4片(内含乳糖和淀粉);片剂组给予Hup 4片(每片含50微克)和安慰剂4粒胶囊,p.o,每天2次,连用60 d。所有患者均进行了大量相关评分,并进行了生理和实验室检查。结果:两组患者在60 d治疗前后的各项心理评价均有显著差异(P < 0.01),但经组t检验,两组间差异无统计学意义(P > 0.05)。两组患者氧自由基变化均有明显改善。两组患者除中度至轻度恶心外均未见严重副作用。结论:Hup胶囊与片剂治疗AD患者的疗效和安全性相当,且可降低AD患者血浆和红细胞中氧自由基的病理改变。
Huperzine-A in capsules and tablets for treating patients with Alzheimer disease.
Aim: To compare the efficacy and safety between huperzine-A (Hup) in capsules and tablets for treating patients with Alzheimer disease (AD).
Methods: Using multicenter, prospective, double-blind, double-mimic, parallel, positive controlled and randomized methods, 60 patients meeting with the NINCDS-ARDRA criteria of AD were divided into 2 equal groups. Patients in the capsule group received 4 capsules of Hup (each contains 50 micrograms) and 4 tablets of placebo (lactose and starch inside); while the tablet group received 4 tablets of Hup (each contains 50 micrograms) and 4 capsules of placebo, p.o., twice a day for 60 d. All the patients were evaluated with a lot of related ranting scales, and physiological and laboratory examination.
Results: There were significant differences (P < 0.01) on all the psychological evaluations between 'before' and 'after' the 60-d trial of 2 groups, but there was no significant difference between 2 groups by group t test (P > 0.05). The changes of oxygen free radicals in 2 groups showed marked improvement. No severe side effect besides moderate to mild nausea was found in both groups.
Conclusion: There is equal efficacy and safety between Hup in capsule and tablet for treating patients with AD, and Hup can reduce the pathological changes of the oxygen free radicals in the plasma and erythrocytes of patients with AD.