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还脑益聪胶囊治疗老年轻度认知损害双盲随机对照探究
还脑益聪胶囊治疗老年轻度认知损害双盲随机对照探究
作者:李浩, 姚明江, 赵文明, 官杰, 蔡琳琳, 崔玲
【关键词】 中草药制剂; 轻度认知损害; 随机对照试验; 双盲法; 中医
Objective:To observe the effect and explore the mechanism of Huannao Yicong capsule in treating senile patients with mild cognitive impairment (MCI).
Methods:The investigational drugs were packed by blind method. A randomized, double-blind and controlled trial was conducted on ninety senile patients with MCI. Other forty-five senile healthy persons were recruited to the healthy control group. The ninety senile patients were randomly divided into the Huannao Yicong capsule-treated group (45 patients administered with three Huannao Yicong capsules and two aniracetam capsule analogues) and aniracetam-treated group (45 patients treated with two aniracetam capsules and three Huannao Yicong capsule analogues). Patients in the two groups were treated three times daily for 16 weeks. Memory, traditional Chinese medicine syndrome, cerebral blood flow, free radicals and inflammatory mediators, such as superoxide dismutase (SOD), malondialdehyde (MDA), acetylcholinesterase (AchE), interleukin-1α (IL-1α) and interleukin-6 (IL-6) were determined before and after the treatment. Blood lipids, including triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), apolipoprotein A-1 (ApoA-1) and apolipoprotein B-100 (ApoB-100), were detected before and after the treatment. The safety indexes, such as routine tests of blood and urine, hepatic and renal function tests and electrocardiogram (ECG) were taken before and after the treatment.
Results:Index score of clinical memory scale in senile healthy people was significantly higher than that in MCI patients before treatment (P<0.01), and the content of AchE, IL-1α and IL-6 was obviously lower (P<0.01, P<0.05), the activity of SOD was higher (P<0.05). No significant difference was found in direction memory of clinical memory scale between the two treatment groups. Other i
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