摘要
背景:已有实验表明益智胶囊可明显改善多发梗死性痴呆模型大鼠学习记忆能力,其对多发梗死性痴呆的疗效如何?对多发梗死性痴呆患者智力的改善是否有作用?目的:观察益智胶囊治疗多发梗死性痴呆患者的疗效及对智力的影响,并与吡拉西坦药物进行比较。设计:随机对照、双盲实验。单位:青岛大学医学院附属医院特需保健科,青岛大学医学院脑血管病研究所。对象:选择1999-10/2002-10青岛大学医学院附属医院特需保健科确诊为多发梗死性痴呆患者94例,男51例,女43例;年龄45～79岁。知情同意参加本实验。随机分为益智胶囊组47例和对照组47例。方法:益智胶囊组用药:益智胶囊成分为制何首乌14g,人参4g,石菖蒲8g,远志6g,水蛭10g,淫羊藿10g,知母6g,川芎12g,每粒胶囊含内容物0.228g,相当于生药10g。6粒/次,3次/d,口服。对照组用药:吡拉西坦,0.9g/次,3次/d,口服。两组均治疗3个月。参照卫生部1995年制定发布的中药新药治疗痴呆的临床研究指导原则中的疗效判定标准评估疗效(显效:症状、体征明显改善;证候积分减少≥70%;好转:症状、体征均有好转;证候积分减少≥30%;无效:症状、体征无明显改善,甚或加重;证候积分减少不足30%)。智力测验使用中国修订的韦氏成人智力量表:包括语言量表和操作量表两部分,共11个分测验。主要观察指标:①两组患者治疗效果。②两组患者治疗前后言语智商、操作智商、全智商。结果:参加实验94例,中途由于未按规定服药脱落12例,进入结果分析82例(益智胶囊组42例,对照组40例)。①治疗效果:益智胶囊组显效21例,有效14例,无效7例,总有效率达83%(35/42);对照组显效7例,有效15例,无效18例,总有效率55%(22/40)。益智胶囊组总有效率明显高于对照组(Z=3.549,P<0.001)。②两组患者治疗前后言语智商、操作智商、全智商数据比较:治疗前益智胶囊组和对照组基本一致(P>0.05)。治疗后益智胶囊组明显高于对照组[91.64±24.38,81.42±19.32;88.28±20.63,73.18±18.04;89.83±22.4,74.62±20.20,(t=5.198～6.958,P<0.001)]。结论:益智胶囊治疗多发梗死性痴呆有良好的疗效,在改善多发梗死性痴呆患者的智力方面优于吡拉西坦。
BACKGROUND： There have been researches showing that yizhi capsule can obviously improve the learning memory power of model rats with multiinfarct dementia. What is the effect of the yizhi capsule to multi-infarct dementia？ And whether it is effective to improvement of intelligence of patients with multi-infarct dementia. OBJECTIVE： To investigate the effect of yizhi capsule on patients with multi-infarct dementia and its influence to the intelligence, and to compare it with piracetam DESIGN： A randomized controlled and double blind trial. SETTING： Department of Special Health of the Affiliated Hospital, and Cerebrovascular Disease Institute of Medical College, Qingdao University. PARTICIPANTS： Totally 94 patients, 51 males and 43 females, aged 45-79 years, who were diagnosed to have multi-infarct dementia at Department of Special Health of the Affiliated Hospital of Medical College, Qingdao University from October 1999 to October 2002, were involved in the trial. Informed consent was ＇obtained from the patients. The patients were at random divided as yizhi capsule group （47 cases） and control group （47 cases） METHODS： Medicine for patients in the yizhi capsule group： Yizhi capsule, made from processed flowery knotweed 14 g, ginseng 4 g, acorns 8 g, polygala 6 g, leech 10 g, epimedium 10 g, anemarrhena 6 g, ligasticum 12 g, with each capsule contenting 0,228 g, which was consistent with 10 g raw drug, orally, 6 capsules, 3 time a day. Medicine for patients in the control group： Piracetam 0.9 g, three times a day, orally. The course for both groups was 3 months. The effect was estimated by effect judgment criteria in the guiding principles of clinical research on treatment of dementia with traditional Chinese new drugs issued in 1995 by the Ministry of Health, P.R. China （Markedly effective： The symptoms and signs were obviously improved; the reduction of syndrome integration ≥70%. Improved： The symptoms and signs were all improved, the reduction of syndrome integration ≥30%. lrresponsive： The symptoms and signs were not improved or even deteriorated, the reduction of syndrome integration 〈 30%）. Wechsler Adult Intelligence Scale-Revised in China （WAIS-RC） was used for assay of intelligence, including two parts of linguistic scale and operation scale, altogether 11 tests. MAIN OUTCOME MEASURES： ① The effects for patients of two groups. ② the linguistic intelligence quotient, operation intelligence quotient and total intelligence quotient of patients in the two groups RESULTS： Totally 94 patients were involved in the trial, there were 12 cases who dropped down because of not taking in the medicine properly during the trial, so 82 cases entered into the result analysis （42 cases in the yizhi capsule group and 40 in the control group）. ① Therapeutic result： In the yizhi capsule group 21 cases were markedly effective, 14 cases effective, 7 cases irresponsive, total effective rate was 83 % （35/42）; in the control group 7 cases were markedly effective, 15 cases effective, 18 cases irresponsive, total effective rate was 55 % （22/40）. The total effective rate in the yizhi capsule group was obviously higher than that in the control group （Z=3.549, P 〈 0. 001）. ② Comparison of data of the linguistic intelligence quotient, operation intelligence quotient and total intelligence quotient of patients in the two groups before and after treatment： Before treatment the data in the yizhi capsule group was basically the same as that in the control group （P 〉 0.05）. After treatment the data in the yizhi capsule group was obviously higher than that in the control group （91.64±24.38,81.42±19.32; 88.28±20.63, 73.18±18.04; 89.83±22.4, 74.62±20.20, t= 5.198 -6.958, P 〈 0.001）. CONCLUSION： Yizhi capsule had a good effect for treatment of multiinfarct dementia, it. was better than piraeetam in improving the intelligence of the patient with multi-infarct dementia.
出处
《中国临床康复》
CSCD
北大核心
2005年第36期155-157,共3页
Chinese Journal of Clinical Rehabilitation
