| 陈阳昊,孔丽娅,毛盈颖,等.通心络胶囊治疗血管性痴呆临床疗效及安全性的Meta分析[J].浙江中医药大学学报,2019,43(5):504-511. |
| 通心络胶囊治疗血管性痴呆临床疗效及安全性的Meta分析 |
| Meta Analysis of the Clinical Efficacy and Safety of Tongxinluo Capsule in Treating Vascular Dementia |
| DOI：10.16466/j.issn1005-5509.2019.05.025 |
| 中文关键词: 通心络胶囊 血管性痴呆 系统评价 Meta分析 |
| 英文关键词: Tongxinluo capsule vascular dementia systematic evaluation Meta analysis |
| 基金项目:浙江省大学生科技创新活动计划(新苗人才计划)项目(2018R410039) |
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| 中文摘要: |
| [目的]评价通心络胶囊治疗血管性痴呆的疗效及安全性，为临床合理用药提供可靠的循证依据。[方法]通过检索中国知网(China National Knowledge Infrastructure,CNKI)、万方、维普、中国生物医学文献数据库(China Biology Medicine, CBM)、PubMed、Cochrane Library等国内外数据库，获取通心络治疗血管性痴呆的所有相关文献。两名独立的研究者根据Cochrane系统评价法对所获取的文献进行筛选及质量评价，采用Revman5.3软件对最终纳入文献进行Meta分析。[结果]最终共纳入8篇随机对照试验文献，共计667名例患者，其中试验组334例，对照组333例。Meta分析结果显示单用通心络胶囊组总有效率优于西药对照组，相较于西药对照组可以改善总体精神状态，然而在提高日常生活能力方面无明显统计学意义；通心络胶囊联合西药组总有效率优于西药对照组，相较于西药对照组可以改善总体精神状态，提高日常生活能力，加快智能恢复情况。安全性分析结果显示通心络胶囊治疗血管性痴呆相较于西药常规治疗安全性更高，减少不良反应的发生率。[结论]通心络胶囊单用或与西药联合治疗，相较于西药对照组均能明显提高总体疗效，安全性高。但由于纳入文献样本量较小且有一定潜在偏倚风险，故需要更多大样本高质量临床随机对照试验加以验证。 |
| 英文摘要: |
| [Objective] To evaluate the efficacy and safety of Tongxinluo capsule in the treatment of vascular dementia, and to provide reliable evidence basis for rational clinical medication. [Methods] All relevant literatures on the treatment of vascular dementia by Tongxinluo were obtained by searching domestic and foreign databases including CNKI, Wanfang, Weipu, CMB, PubMed and Cochrane Library. Two independent researchers conducted the screening and quality evaluation of the obtained literature according to the Cochrane systematic evaluation method, and adopted the Revman5.3 software for Meta analysis of the final included literature.[Results]A total of 8 randomized controlled trials were eventually included, including 667 patients, 334 patients in the experimental group and 333 patients in the control group. Meta analysis showed that the total efficiency of Tongxinluo capsule alone was better than that of western drug control group. Compared with western drug control group, the overall mental state could be improved, but there was no significant statistical significance in improving daily life ability. The total efficiency of Tongxinluo capsule combined with western medicine group was better than that of western medicine control group. Compared with western medicine control group, it could improve the overall mental state, improve the ability of daily life, and accelerate the intelligence recovery. The results of safety analysis showed that Tongxinluo capsule was safer than western medicine in treating vascular dementia and reduced the incidence of adverse reactions. [Conclusion] Tongxinluo capsule alone or combined with western medicine can significantly improve overall efficacy and safety compared with western medicine control group. However, due to the small sample size of the included literature and the risk of potential bias, more large samples of high-quality clinical randomized controlled trials are needed to be verified. |
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