通心络胶囊治疗血管性痴呆临床疗效及安全性的Meta分析
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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。
[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.
[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.
引文
[1]韩飞,荆志伟,于亚南,等.中药有效成分治疗血管性痴呆的研究进展[J].中国实验方剂学杂志,2012,18(7):273-276.
[2] Smith E E. Clinical presentations and epidemiology of vascular dementia[J]. Clinical Science,2017,131(11):1059-1068.
[3]吴永贵.谭子虎教授血管性痴呆辨治经验[J].浙江中医药大学学报,2015,39(10):747-749.
[4]刘双秀,郭和宗,冯书凤,等.通心络胶囊治疗血管性痴呆的临床疗效观察[J].疑难病杂志,2014,13(4):336-338.
[5]江敬伟.通心络胶囊治疗血管性痴呆的临床效果及对生活质量的影响[J].临床合理用药杂志,2016,27(9):108-110.
[6]李爱平.通心络治疗血管性痴呆临床研究探析[J].中外医疗, 2010, 29(15):136-136.
[7]王玲琳,应培珍,王孝妹.通心络胶囊治疗血管性痴呆患者的临床疗效观察[J].疑难病杂志,2005,4(5):260-262.
[8]郝伟平,叶锋华,李丽珠.通心络胶囊治疗血管性痴呆患者临床观察[J].临床心身疾病杂志,2006,12(6):424-425.
[9]陈春雷,邱智辉,苏世鑫,等.通心络治疗血管性痴呆的疗效观察[J].疑难病杂志, 2009, 8(5):272-274.
[10]杨文文,杨慧艳,陈东晖,等.理气化痰祛瘀法治疗血管性痴呆临床观察[J].辽宁中医药大学学报,2012,14(2):146-148.
[11]袁莲芳,刘楠,李毓新,等.通心络胶囊对脑卒中后不同程度血管性认知功能障碍并偏瘫患者功能结局的影响[J].疑难病杂志,2011,10(2):83-86.
[12]李红兵,谭子虎.加减薯蓣丸对血管性痴呆大鼠海马突触再生和可塑性影响的研究[J].浙江中医药大学学报,2018,42(6):473-478.
[13]刘春援.通心络胶囊临床应用拓展举隅[J].江西中医药,2016,47(6):21-24.
[2] Smith E E. Clinical presentations and epidemiology of vascular dementia[J]. Clinical Science,2017,131(11):1059-1068.
[3]吴永贵.谭子虎教授血管性痴呆辨治经验[J].浙江中医药大学学报,2015,39(10):747-749.
[4]刘双秀,郭和宗,冯书凤,等.通心络胶囊治疗血管性痴呆的临床疗效观察[J].疑难病杂志,2014,13(4):336-338.
[5]江敬伟.通心络胶囊治疗血管性痴呆的临床效果及对生活质量的影响[J].临床合理用药杂志,2016,27(9):108-110.
[6]李爱平.通心络治疗血管性痴呆临床研究探析[J].中外医疗, 2010, 29(15):136-136.
[7]王玲琳,应培珍,王孝妹.通心络胶囊治疗血管性痴呆患者的临床疗效观察[J].疑难病杂志,2005,4(5):260-262.
[8]郝伟平,叶锋华,李丽珠.通心络胶囊治疗血管性痴呆患者临床观察[J].临床心身疾病杂志,2006,12(6):424-425.
[9]陈春雷,邱智辉,苏世鑫,等.通心络治疗血管性痴呆的疗效观察[J].疑难病杂志, 2009, 8(5):272-274.
[10]杨文文,杨慧艳,陈东晖,等.理气化痰祛瘀法治疗血管性痴呆临床观察[J].辽宁中医药大学学报,2012,14(2):146-148.
[11]袁莲芳,刘楠,李毓新,等.通心络胶囊对脑卒中后不同程度血管性认知功能障碍并偏瘫患者功能结局的影响[J].疑难病杂志,2011,10(2):83-86.
[12]李红兵,谭子虎.加减薯蓣丸对血管性痴呆大鼠海马突触再生和可塑性影响的研究[J].浙江中医药大学学报,2018,42(6):473-478.
[13]刘春援.通心络胶囊临床应用拓展举隅[J].江西中医药,2016,47(6):21-24.