复方海蛇胶囊治疗增龄相关记忆障碍进一步临床研究──117例双盲法对比分析

FURTHER REPORT OF THE EFFICACY OF REINIIARDT AND SEA CUCUMBER CAPSULE IN TREATING AGE-ASSOCIATED MEMORY IMPAIRMENT BY DOUBLE BLIND TRIAL

目的 进一步观察复方海蛇胶囊（Ｒ．Ｓ． Ｃ．）对增龄相关记忆障碍的疗效。方法 双盲法治疗１１７例增龄相关记忆障碍（ＡＡＭＩ）（ＭＱ＜９０），用药分别为Ｒ．Ｓ．Ｃ．组与空白对照组，均为每次４粒胶囊，每粒０．２８克，每日三次，疗程３个月。以ＷＭＳ评定疗效。结果 ５８例Ｒ．Ｓ．Ｃ．治疗前与治疗后ＭＱ分别为８０．１２±８．４８及８９．６７±１０．３９（Ｐ＜０．００１）。５９例对照组治疗前后分别为８２．１５±６．１５及８６．５３±７．２０（Ｐ＜０．００１）。Ｒ．Ｓ．Ｃ．与对照组治疗后复查ＭＱ增值分别为９．５７±７．５０及４．４１±５．７９（ｔ＝４．１７，Ｐ＜０．００１）。二组总有效率分别为６７．２４％及２８，８１％（Ｐ＜０．００１）。本组未见明显副作用。 结论 复方海蛇胶囊可显著提高增龄相关记忆障碍的记忆商，安全有效。

Objective To observe further the efficacy of Reinhardt and Sea Cucumber Capsule(RSC, Sea animal products) in treating Age - Associated Memory Impairment(AAMI) .Methods Double blind trial was perfermed in 117 cases of AAMI in the aged and preaged with MQ < 90(WMS) .The dosage of RSC and placebo were all 4 capsules(0.28g/cap)tid for 3 months. The effects were evaluated with MQ(WMS). Results The mean values of MQ(WMS) before and after treatment were 80. 12 ± 8 .48 and 89 .67 ± 10 .39(P < 0 .001) in 58 cases treated with R .S. C., and 82±15 ± 6. 15 and 86 .53 ± 7 .20 (P < 0 .001)in 59 cases in placebo group respectively. Significant difference of mean value of MQ increment between R. S. C. 9. 57 ± 7 .50 and placebo 4 .41 ± 5. 79 (t = 4. 17, P < 0.00l ) was observed. The total effective rate of the R. S. G . and Placebo were 67 .24% and 28 .81 % respectively (P < 0. 001 ). No sighficant side effects were observed. The mechanism of R. S. C. in improving memory function in the aged with AAMI may be related to its effects to enhance neuron giowth. to increase acetylcholine and to decrease glutamine level in the brain as confirmed in cell and animal experiments, and also to improve free radical metabolism and microcirculatory state as confirmed clinically. Conclusions RSC is effective and safe to improv memory and cognitive function in the elderly. [