芪蛭通络胶囊治疗缺血性脑卒中恢复期的临床研究

发布时间：2018-06-24 23:27

本文选题：芪蛭通络胶囊 + 步长脑心通胶囊　；参考：《大连医科大学》2016年硕士论文

【摘要】：目的:观察芪蛭通络胶囊治疗缺血性脑卒中(气虚血瘀证)恢复期的疗效与安全性。方法:本研究采用随机、双盲、阳性药和安慰剂平行对照的实验方法,选取2013年11月至2015年8月与我院住院期间符合急性缺血性脑卒中发病恢复期的36名患者,随机分为芪蛭通络胶囊组、脑心通组和安慰剂组,其中芪蛭通络胶囊组18例,脑心通组和安慰剂组各9例。疗效观察指标为简化Fugl-Meyer运动功能(上肢、下肢)、西方失语症成套测验(WAB)、BI评分、中医证候评分(气虚、血瘀)。安全性观察指标为:血常规、尿常规、便常规、肝肾功和不良反应。结果:芪蛭通络胶囊组、脑心通组和安慰剂组的一般资料组间比较差别均无统计学意义,两组基线资料均衡性良好。芪蛭组与脑心通组均较安慰剂组对下肢运动功能障碍改善有明显疗效,芪蛭组在发病前90天对下肢功能改善较脑心通组明显,虽无统计学差异,但趋势明显。芪蛭组及脑心通组对上肢运动功能障碍改善均较安慰剂组有效,芪蛭组改善更明显,虽无统计学差异,但趋势明显。芪蛭组与脑心通组对运动功能障碍的改善均较安慰剂组有效,芪蛭组比脑心通组改善更明显,虽无统计学差异,但趋势明显。芪蛭组与脑心通组较安慰剂组对AQ评分改善明显,芪蛭组在发病前90天对AQ评分改善较脑心通组明显,虽无统计学差异,但趋势明显。芪蛭组与脑心通组对血瘀症状改善均较安慰剂组明显有效,芪蛭组较脑心通组对血瘀症状改善更有效,组间比较虽无统计学差异,但趋势明显。芪蛭组比脑心通组和安慰剂组对气虚症状改善明显,虽无统计学差异,但趋势明显。芪蛭组的中医证候临床有效率在发病第90天和第12周较脑心通组和安慰剂组改善明显,(P=0.0041),有明显统计学差异。结论:1、下肢运动功能障碍的改善情况:芪蛭组与脑心通组对下肢运动功能障碍改善均较安慰剂组明显有效,芪蛭组在发病前90天对下肢功能改善较脑心通组明显,虽无统计学差异,但趋势明显。2、芪蛭组在对气虚血瘀证中医证候量化积分改善方面较脑心通组与安慰剂组明显有效,(P0.0041),有统计学意义。芪蛭组与脑心通组在对语言障碍的改善、日常生活能力的改善、上肢运动功能障碍改善、运动功能障碍的改善方面较安慰剂组明显有效,而芪蛭组在对语言障碍的改善、上肢运动功能障碍改善、运动功能障碍的改善方面较脑心通组略有效。
[Abstract]:Objective: to observe the efficacy and safety of Qizhi Tongluo capsule in the treatment of ischemic stroke (qi deficiency and blood stasis syndrome). Methods: a randomized, double-blind, positive-drug and placebo-controlled trial was conducted in 36 patients who met the convalescent stage of acute ischemic stroke from November 2013 to August 2015. Qizhitongluo capsule group, Naoxintong group and placebo group were randomly divided into Qizhitongluo capsule group (18 cases), Naoxintong group (9 cases) and placebo group (9 cases). The therapeutic effects were as follows: simplified Fugl-Meyer motor function (upper limb, lower limb), Western aphasia test (WAB) and BI score, TCM syndrome score (Qi deficiency, blood stasis). The safety indexes were blood routine, urine routine, stool routine, liver and kidney function and adverse reaction. Results: there was no significant difference between the two groups in general data of Qizhitongluo capsule group, Naoxintong group and placebo group. The baseline data of the two groups were well balanced. Compared with placebo group, Qizhi group and Naoxintong group had obvious effect on the improvement of lower limb motor dysfunction. The improvement of lower limb function in Qizhi group was more obvious than that in Naoxintong group 90 days before the onset of disease, although there was no statistical difference, but the trend was obvious. Qizhi group and Naoxintong group were more effective than placebo group in the improvement of upper limb motor dysfunction. The improvement of Qizhi group was more obvious, although there was no statistical difference, but the trend was obvious. The improvement of motor dysfunction in Qizhi group and Naoxintong group was more effective than that in placebo group. The improvement of Qizhi group was more obvious than that of Naoxintong group, although there was no statistical difference, but the trend was obvious. The AQ score of Qizhi group and Naoxintong group was significantly improved than that of placebo group, and the AQ score of Qizhi group was significantly improved than that of Naoxintong group 90 days before onset, although there was no statistical difference, but the trend was obvious. Both Qizhi group and Naoxintong group were more effective than placebo group in improving blood stasis symptoms, Qizhi group was more effective than Naoxintong group in improving blood stasis symptom, although there was no statistical difference between the two groups, the trend was obvious. Qi deficiency symptoms were improved significantly in Qizhi group compared with Naoxintong group and placebo group, although there was no statistical difference, but the trend was obvious. The effective rate of TCM syndromes in Qizhi group was significantly improved on the 90th and 12th week compared with the Naoxintong group and the placebo group (P0. 0041). Conclusion: the improvement of lower extremity motor dysfunction in Qizhi group and Naoxintong group is more effective than that in placebo group, and the improvement of lower limb function in Qizhi group is more obvious than that in Naoxintong group 90 days before onset. Although there was no statistical difference, the trend was obvious. The Qizhi group was more effective than the Naoxintong group and the placebo group in improving the quantitative integral of TCM syndromes of qi deficiency and blood stasis syndrome (P0.0041). Qizhi group and Naoxintong group were more effective than placebo group in improving speech disorder, daily living ability, upper limb motor dysfunction and motor dysfunction. The improvement of upper limb motor dysfunction was more effective than that of Naoxintong group.
【学位授予单位】：大连医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R277.7

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