中药对照多奈哌齐治疗阿尔茨海默病的Meta分析

发布时间：2018-07-24 19:33

【摘要】：目的：评价中药及补肾活血类方剂对照多奈哌齐治疗阿尔茨海默病的疗效。方法：检索Pubmed、中国生物医学文献数据库(CBMdisc)、中国知网(CNKI)、万方数据库(WANFANG DATA)、维普数据库(VIP)等相关文献,根据cochrane Handbook关于Pubmed的检索策略进行检索,根据cochrane Handbook制定的中文相应的RCT检索策略对CBMdisc数据库进行检索,采用自由词对CNKI、VIP、WANFANG DATA等数据库进行检索,并且手工检索了《中国中西医结合杂志》、《中国老年学杂志》、《北京中医药大学学报》、《新中医》等杂志,检索时间从建库至2015年12月。未收集到未发表的文献。设定纳入排除标准,根据NINCDS-ADRDA、 DSM-IV和NIA-AA诊断标准确诊为阿尔茨海默病的患者；治疗组为中药或补肾活血类方剂,日二次或三次；对照组为多奈哌齐5mg日一次；以简易智能量表(MMSE)、日常生活能力评价量表(ADL)或ADL (Barthel指数)量表等作为主要评价指标；中医证候疗效、头颅核磁、血常规及生化为次要评价指标,筛选符合条件的研究。提取研究基本信息(作者、论文标题、发表时间、刊物名称、期卷页码、研究对象、干预措施、结局指标)。按照改良版Jadad量表进行研究质量评价,未叙述或描述不清楚的致电或当面询问。应用Revman 5.3软件进行统计分析。结果：研究一共搜集到中药对照多奈哌齐治疗阿尔茨海默病符合纳入标准的文献6篇,共纳入患者596名患者,根据改良版Jadad量表评分均为高质量研究。MMSE量表：MD:0.69,95%CI:[-0.17,1.56];调心方MMSE量表：MD:-1.50,95%CI:[-3.08,0.08];补肾方MMSE量表：MD:-1.92;95%CI:[-3.50,-0.33]; ADL量表：MD0.94,95%CI:[-1.54,3.43];24周轻中度ADL量表：MD:0.62,95% CI:[-2.99,4.23];24周重度ADL量表：MD:3.13,95%CI:[-6.92,13.18];48周轻中度ADL量表：MD:-0.73,95%CI:[-5.02,3-56]48周重度ADL量表：MD:4.23,95%CI:[-6.38,14.84]。研究二补肾活血类方剂对照多奈哌齐治疗阿尔茨海默病符合纳入标准的文献3篇,共纳入患者204例。根据改良版Jadad量表评分均为低质量研究。3项研究均采用了计算机生成的随机数字表,但均未采用盲法及随机化隐藏,三项研究均表示脱落病例较少,脱落病例未纳入统计。MMSE量表：Heterogeneity:P=0.04, I2=69%, Total (95%CI) MD 1.40[-0.04,2.85], Z=1.90 (P=0.06),试验组与对照组MMSE量表比较无明显差异性,试验无统计学意义；ADL量表：Heterogeneity:P=0.29, I2=12%, Total (95%CI) MD-3.01[-4.82,-1.19], Z=3.25 (P=0.001),试验组与对照组比较有差异性,试验有统计学意义。仅1篇文献应用ADL(Barthel指数)量表评分,研究结果显示试验组及对照组在治疗后评分升高,日常生活能力均有所改善,治疗前后比较P0.05,差异有统计学意义,组间比较P0.05,无显著差异。中医证候疗效指标：Heterogeneity:P:0.35,I2=0%,Total(95%CI)OR 1.63[0.82,3.26],Z=1.39(P=0.16),试验组与对照组比较无明显差异,试验无统计学意义。结论：1、患者认知功能改善和中医证候疗效试验组和对照组没有统计学差异：2、与多奈哌齐相比,补肾活血类方剂对患者日常生活能力有所改善；3、应用补肾活血类方剂治疗阿尔茨海默病未见明显不良反应。同时由于纳入研究质量低,应该谨慎看待本系统评价结论,希望有更多高质量的临床试验纳入Meta分析以提高证据级别,提供临床医生更多更好的治疗方法。
[Abstract]:Objective: To evaluate the therapeutic effect of traditional Chinese medicine and Bushen Huoxue Prescription on the treatment of Alzheimer's disease. Methods: retrieval of Pubmed, Chinese biomedical literature database (CBMdisc), Chinese knowledge network (CNKI), Wanfang database (WANFANG DATA), VP database (VIP) and other related documents, according to Cochrane Handbook on Pubmed retrieval strategy According to the corresponding Chinese RCT retrieval strategy developed by Cochrane Handbook, the CBMdisc database was retrieved, and the free words were used to retrieve the database of CNKI, VIP, WANFANG DATA and so on. And the Chinese Journal of Integrated Chinese and Western medicine, "Chinese Chronicles", < Beijing University of Chinese Medicine Journal >, < New TCM > and so on were retrieved manually. The retrieval time was from the library to December 2015. Unpublished literature was not collected. The patients were diagnosed as Alzheimer's disease according to NINCDS-ADRDA, DSM-IV and NIA-AA diagnostic criteria; the treatment group was Chinese medicine or kidney tonifying and activating blood type prescription, two or three times a day; the control group was donepezil 5mg once; with simple intelligence Scale (MMSE), daily living ability assessment scale (ADL) or ADL (Barthel index) scale as the main evaluation index; TCM syndrome effect, head NMR, blood routine and biochemistry as secondary evaluation index, screening suitable study. Extract research basic information (author, title, publication time, publication name, volume page number, research pair Image, intervention measures, outcome indicators). According to the revised version of the Jadad scale, the quality evaluation, not described or described unexplained call or face inquiry. Revman 5.3 software was used for statistical analysis. Results: a total of 6 articles were collected and included in the study of donepezil in the treatment of Alzheimer's disease. 596 patients, according to the modified Jadad scale, were all the high quality research.MMSE scale: MD:0.69,95%CI:[-0.17,1.56]; the MMSE scale of the centering formula: MD:-1.50,95%CI:[-3.08,0.08]; the kidney tonifying square MMSE scale: MD:-1.92; 95%CI:[-3.50, -0.33]; ADL: MD0.94,95%CI:[-1.54,3.43]; the 24 week mild and moderate scale .23]; 24 weeks severe ADL scale: MD:3.13,95%CI:[-6.92,13.18]; 48 weeks light and moderate scale ADL scale: MD:-0.73,95%CI:[-5.02,3-56]48 week severe ADL scale: MD:4.23,95%CI:[-6.38,14.84]. study two tonifying kidney and activating blood type prescriptions compared with donepezil in the treatment of Alzheimer's disease in accordance with the standard of the literature, including 204 cases. The scores of the Jadad scale were all low quality research in the study of.3, the random number table generated by computer was used, but the blind method and randomization were not used. The three studies all indicated that the shedding cases were less. The lost cases were not included in the statistical.MMSE scale: Heterogeneity:P=0.04, I2=69%, Total (95%CI) MD 1.40[-0.04,2.85], Z=1.90 (P=0.06). There was no significant difference between the test group and the control group MMSE scale. The ADL scale: Heterogeneity:P=0.29, I2=12%, Total (95%CI) MD-3.01[-4.82, -1.19], Z=3.25 (P=0.001), the test group was different from the control group, and the test had the significance. Only 1 literature used the ADL (Barthel index) scale. The results showed that the scores of the test group and the control group were increased after the treatment, and the daily living ability improved. The difference was statistically significant before and after the treatment. There was no significant difference between the group and the group P0.05. The therapeutic indexes of TCM syndrome were Heterogeneity:P:0.35, I2=0%, Total (95%CI) OR 1.63[0.82,3.26], Z=1.39 (P=0.16), the experimental group and the control group. There was no significant difference in the test. Conclusion: 1, there was no statistical difference between the patients' cognitive function improvement and the TCM syndrome efficacy test group and the control group: 2, compared with donepezil, the tonifying kidney and activating blood type prescription improved the patient's daily living ability; 3, the use of tonifying kidney and activating blood type prescription was not clear in the treatment of Alzheimer's disease. At the same time, due to the low quality of the study, we should look at the conclusion of the system carefully. We hope that more high quality clinical trials should be included in Meta analysis to improve the level of evidence and provide more and better treatment for clinicians.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R277.7

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