还脑益聪胶囊治疗老年轻度认知损害的双盲随机对照研究

A randomized,controlled,double-blind trial of Huannao Yicong capsule in senile patients with mild cognitive impairment

目的:观察还脑益聪胶囊治疗老年轻度认知损害(mild cognitive impairment,MCI)的疗效并探讨其作用机制。方法:对各组试验药进行盲法要求包装,采用随机、双盲、阳性平行对照法共观察90例老年MCI患者,并选45例老年健康者进行治疗前对照分析相关指标。治疗组45例(剔除1例)用药为还脑益聪胶囊(每次3粒,3次/d),同时加服三乐喜模拟药(每次2粒,3次/d);对照组45例(剔除2例)用药为三乐喜胶囊(每次2粒,3次/d),同时加服还脑益聪胶囊模拟药(每次3粒,3次/d),温开水送服。两组疗程均为16周。于治疗前后进行临床记忆、中医症状、脑血流、自由基、炎性介质及脂代谢变化等情况的分析。结果:老年MCI患者临床记忆量表各项指标积分与老年健康对照组比较明显降低(P<0.01),血清乙酰胆碱酯酶(acetylcholinesterase,AchE)、白细胞介素-1α(interleukin-1α,IL-1α)和白细胞介素-6(interleukin-6,IL-6)含量较健康对照组明显增高(P<0.01,P<0.05),而超氧化物歧化酶(superoxide dismutase,SOD)的活性明显降低(P<0.05)。除指向记忆一项外,还脑益聪胶囊治疗组老年MCI患者治疗后的临床记忆量表积分值均较对照组明显提高(P<0.01),中医临床症状明显改善,与对照组比较差异有统计学意义(P<0.05);还脑益聪胶囊对患者大脑前、后动脉的平均血量参数均有明显提高作用(P<0.01,P<0.05),并且显著改善脑动脉的阻力指数(P<0.01);还脑益聪胶囊还能显著升高老年MCI患者血清SOD活性,同时降低AchE、IL-1α及IL-6的血清含量(P<0.01,P<0.05);还脑益聪胶囊对患者血脂的改善作用与三乐喜比较差异均有统计学意义(P<0.01,P<0.05)。结论:还脑益聪胶囊治疗老年轻度认知损害有较好疗效,效果优于阳性对照药三乐喜胶囊。

Objective：To observe the effect and explore the mechanism of Huannao Yicong capsule in treating senile patients with mild cognitive impairment （MCl）. Methods.The investigational drugs were packed by blind method. A randomized, double-blind and controlled trial was conducted on ninety senile patients with MCl. 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 HuannaoYicong 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 index scores of clinical memory scale and traditional Chinese medicine syndrome in patients of Huannao Yicong capsule-treated group were significantly improved as compared with those of the aniracetam-treated group （P〈0.05, P〈0.01）. The blood flow parameters of anterior cerebral artery, posterior cerebral artery and resistant index in patients of HuannaoYicong capsule-treated group were increased significantly （P〈0.01, P〈0.05）. Huannao Yicong capsule could significantly increase the activity of serum SOD and decrease the content of AchE, IL-1α and IL-6 （P〈0.01, P〈0.05）, better thananiracetam. Furthermore, Huannao Yicong capsule could significantly improve the blood lipid, such as the level of TG, LDL-C, HDL-C, ApoA-1 and ApoB-100 （P〈0.01, P〈0.05）, and better than aniracetam （P〈0.01, P〈0.05）. No significant changes were found after treatment in safety indexes, such as routine tests of blood and urine, hepatic and renal function tests and ECG. Conclusion： Huannao Yicong capsule has better therapeutic effect than aniracetam capsule in treating senile mild cognitive impairment.