脑复康片治疗老年痴呆120例双盲研究

A DOUBLE BLIND CLINICAL STUDY ON THE PIRACETANUM TABLE IN TREATING ELDERLY WITH DEMENTIA.

目的 观察脑复康片治疗老年性痴呆的临床疗效。方法 治疗组６０例，对照组６０例。治疗组服脑复康片，对照组服淀粉片，每片０．４ｇ，每次２片，每日３次，一疗程为３个月，以ＭＭＳＥ，ＷＭＳ，ＨＤＳ评定疗效。结果（１）脑复康片与对照组治疗后ＭＭＳＥ增值分别为２．８９０±１．４００及１．７９０±１．３４６（Ｐ＜０．００１），治疗后总的有效率分别为６５．００％及６．７０％（Ｐ＜０．００１），均有显著差异；（２）ＨＤＳ增值分别为２．４０６±１．４５０及１．０７０±１．６２７（Ｐ＜０．００１），总的有效率分别为５３．４４％及８．３０％（Ｐ＜０．０５），亦均有显著差异；（３）脑复康片治疗前后ＭＱ分别为６８．２０±１２．７０及７２．３０±１４．３０（Ｐ＜０．００１），对照组治疗前后分别为６７．２０±１１．６０及６８.６０±１２．１０（Ｐ＜０．０１），脑复康片与对照组治疗后复查ＭＱ增值分别为４．１９１±３．４２１及１．５０１±３．９７６（ｔ＝３．７８，Ｐ＜０．００１）。二组总的有效率分别为４４．８４％及１０．１０％（Ｐ＜０．０５）。脑复康片对ＶＤ和ＡＤ均有一定的疗效，对ＶＤ效果优于ＡＤ。

Objective To study the efficacy of the piracetanum to treat dementia in the aged. Methods The double blind piracetanum trial was performed in 120 cases of dementia (Piracetanum 60, VD25, AD29, VD + AD6 ; placebo 60, VD28, AD24, VD + AD 8) in the age with MMSE≤ 24. The dosage of piracetanum (0 .4g/ tab) and starch for each case was 2 tables for 3 months. The effects were evaluted with MMSE、 MQ (WMS) and HDS. Results ①MMSE increment: Piracetanum 2.890 ± 1 .400, starch 1 .790 ± 1 .346(P < 0.01 ); total effective rate: Piracetanum 65.00%, starch 6.70% (P < 0.001 ). ②HDS increment: Piracetanum 2.406 ± 1 .450, starch: 1 .070 ± 1 .627 (P < 0.001 );Total effective rate: Piracetanum 53 .44%, starch 8 .30% (P < 0.05). ③ MQ increment: Piracetanum 4.191 ± 3 .421, starch 1 .501 ± 3 .976 (t = 3.78, P < 0.001 ); total effective rate: Piracetanum 44 .84%, starch 10. 10% (P < 0.05). ④Similar effects were observed in VD and AD with slightly better results in VD. No significant side effects were observed. ⑤The mechanism of Piracetanum to improve cognitive function in the demented may be related to its effects to enhance neuron growth, to increase acetylcholine and to decrease glutamine level in the brain as confirmed in cell and animal experiment, and to improve free radical metabolism and microcirculatory state as confirmed clinically. Conclusions Piracetanum is effective and safe to treat dementia (AD、VD) in the elderly.