Clinical study on treatment of vascular cognitive impairment of qi deficiency and blood stasis syndrome with Qizhi Tongluo Capsule：a randomized， double⁃blind， and placebo⁃controlled trial

Weiping LI; Yanfang SHEN; Jumei DU; Jiang YAN; Tianhong DING

doi:10.16305/j.1007-1334.2022.2103085

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Clinical study on treatment of vascular cognitive impairment of qi deficiency and blood stasis syndrome with Qizhi Tongluo Capsule：a randomized， double⁃blind， and placebo⁃controlled trial

更新时间：2022-10-09

- Clinical study on treatment of vascular cognitive impairment of qi deficiency and blood stasis syndrome with Qizhi Tongluo Capsule：a randomized， double⁃blind， and placebo⁃controlled trial
- Shanghai Journal of Traditional Chinese Medicine Vol. 56, Issue 7, Pages: 59-63(2022)
- 作者机构：
  
  1.陕西中医药大学第二附属医院脑病科（陕西咸阳 712000）
  2.西北大学生命科学院（陕西西安 710000）
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2022.2103085
  CLC：
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李卫萍,申艳方,杜菊梅,等.芪蛭通络胶囊治疗气虚血瘀型血管性认知障碍的随机、双盲、安慰剂对照临床研究[J].上海中医药杂志,2022,56(7):59-63.

LI Weiping,SHEN Yanfang,DU Jumei,et al.Clinical study on treatment of vascular cognitive impairment of qi deficiency and blood stasis syndrome with Qizhi Tongluo Capsule：a randomized， double⁃blind， and placebo⁃controlled trial[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(7):59-63.
李卫萍,申艳方,杜菊梅,等.芪蛭通络胶囊治疗气虚血瘀型血管性认知障碍的随机、双盲、安慰剂对照临床研究[J].上海中医药杂志,2022,56(7):59-63. DOI： 10.16305/j.1007-1334.2022.2103085.

LI Weiping,SHEN Yanfang,DU Jumei,et al.Clinical study on treatment of vascular cognitive impairment of qi deficiency and blood stasis syndrome with Qizhi Tongluo Capsule：a randomized， double⁃blind， and placebo⁃controlled trial[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(7):59-63. DOI： 10.16305/j.1007-1334.2022.2103085.

摘要

目的,2,观察芪蛭通络胶囊治疗气虚血瘀型血管性认知障碍的临床疗效。,方法,2,将90例气虚血瘀型血管性认知障碍患者随机分为治疗组（60例）和对照组（30例）。两组均予基础治疗，治疗组加用芪蛭通络胶囊，对照组加用芪蛭通络胶囊安慰剂，疗程均为24周。观察临床疗效，比较中医证候积分及简易精神状态检查（MMSE）、画钟测验（CDT）、霍普金斯词语学习测验（HVLT）评分的变化情况，并进行安全性评价。,结果,2,①试验过程中，治疗组脱落3例，对照组脱落2例，最终完成试验者85例，其中治疗组57例、对照组28例。②治疗组临床总有效率为94.74%，对照组临床总有效率为53.57%；两组临床疗效比较，治疗组优于对照组（,P,<,0.01）。③治疗前后组内比较，两组气虚证候量表、血瘀证候量表积分减少（,P,<,0.01）；组间治疗后比较，治疗组气虚证候量表、血瘀证候量表积分少于对照组（,P,<,0.01）。④治疗前后组内比较，治疗组MMSE、CDT、HVLT评分升高（,P,<,0.05）；组间治疗后比较，MMSE、CDT、HVLT评分差异有统计学意义（,P,<,0.05）。⑤两组在试验期间均未出现严重的不良反应。,结论,2,芪蛭通络胶囊治疗气虚血瘀型血管性认知障碍疗效满意，能很好地改善患者的认知功能障碍及中医证候，且安全性良好。

Abstract

Objective,2,To observe the clinical efficacy of Qizhi Tongluo Capsule in treating vascular cognitive impairment （VCI） of qi deficiency and blood stasis syndrome.,Methods,2,Ninety patients with VCI of qi deficiency and blood stasis syndrome were randomly divided into a treatment group （,n,=60） and a control group （,n,=30）， and both groups were given basic treatment. The treatment group was additionally administered with Qizhi Tongluo Capsule and the control group was given Qizhi Tongluo Capsule mimics. The treatment course was 24 weeks. The clinical efficacy was observed， and the changes in the TCM syndrome scores as well as the scores of the Mini-mental State Examination （MMSE）， the Clock Drawing Test （CDT） and the Hopkins Word Learning Test （HVLT） were compared. The safety evaluation was performed.,Results,2,①During the trial， there were 3 drop-out cases in the treatment group and 2 drop-out cases in the control group， and 85 cases finally completed the trial， including 57 cases in the treatment group and 28 cases in the control group. ②The total clinical effective rate of the treatment group was 94.74%， and that of the control group was 53.57%； the clinical efficacy of the treatment group was better than that of the control group （,P,<,0.01）. ③The scores of qi deficiency syndrome scale and blood stasis syndrome scale decreased in both groups after treatment （,P,<,0.01）； the scores of qi deficiency syndrome scale and blood stasis syndrome scale in the treatment group were lower than those in the control group （,P,<,0.01）. ④The MMSE， CDT， and HVLT scores increased in the treatment group after treatment （,P,<,0.05）； the differences in MMSE， CDT， and HVLT scores between the two groups were statistically significant after treatment （,P,<,0.05）. ⑤No serious adverse reaction was observed in both groups during the trial.,Conclusion,2,Qizhi Tongluo Capsule has achieved satisfactory results in treating vascular cognitive impairment of qi deficiency and blood stasis syndrome， and it can significantly improve the cognitive dysfunction and TCM syndromes of patients with good safety.

关键词

血管性认知障碍痴呆气虚血瘀证芪蛭通络胶囊补阳还五汤临床试验

Keywords

vascular cognitive impairmentdementiaqi deficiency and blood stasis syndromeQizhi Tongluo CapsuleBuyang Huanwu Decoctionclinical trial

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