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芪蛭通絡(luò)膠囊治療缺血性腦卒中恢復(fù)期的臨床研究

發(fā)布時(shí)間:2018-06-24 23:27

  本文選題:芪蛭通絡(luò)膠囊 + 步長(zhǎng)腦心通膠囊。 參考:《大連醫(yī)科大學(xué)》2016年碩士論文


【摘要】:目的:觀察芪蛭通絡(luò)膠囊治療缺血性腦卒中(氣虛血瘀證)恢復(fù)期的療效與安全性。方法:本研究采用隨機(jī)、雙盲、陽(yáng)性藥和安慰劑平行對(duì)照的實(shí)驗(yàn)方法,選取2013年11月至2015年8月與我院住院期間符合急性缺血性腦卒中發(fā)病恢復(fù)期的36名患者,隨機(jī)分為芪蛭通絡(luò)膠囊組、腦心通組和安慰劑組,其中芪蛭通絡(luò)膠囊組18例,腦心通組和安慰劑組各9例。療效觀察指標(biāo)為簡(jiǎn)化Fugl-Meyer運(yùn)動(dòng)功能(上肢、下肢)、西方失語(yǔ)癥成套測(cè)驗(yàn)(WAB)、BI評(píng)分、中醫(yī)證候評(píng)分(氣虛、血瘀)。安全性觀察指標(biāo)為:血常規(guī)、尿常規(guī)、便常規(guī)、肝腎功和不良反應(yīng)。結(jié)果:芪蛭通絡(luò)膠囊組、腦心通組和安慰劑組的一般資料組間比較差別均無(wú)統(tǒng)計(jì)學(xué)意義,兩組基線資料均衡性良好。芪蛭組與腦心通組均較安慰劑組對(duì)下肢運(yùn)動(dòng)功能障礙改善有明顯療效,芪蛭組在發(fā)病前90天對(duì)下肢功能改善較腦心通組明顯,雖無(wú)統(tǒng)計(jì)學(xué)差異,但趨勢(shì)明顯。芪蛭組及腦心通組對(duì)上肢運(yùn)動(dòng)功能障礙改善均較安慰劑組有效,芪蛭組改善更明顯,雖無(wú)統(tǒng)計(jì)學(xué)差異,但趨勢(shì)明顯。芪蛭組與腦心通組對(duì)運(yùn)動(dòng)功能障礙的改善均較安慰劑組有效,芪蛭組比腦心通組改善更明顯,雖無(wú)統(tǒng)計(jì)學(xué)差異,但趨勢(shì)明顯。芪蛭組與腦心通組較安慰劑組對(duì)AQ評(píng)分改善明顯,芪蛭組在發(fā)病前90天對(duì)AQ評(píng)分改善較腦心通組明顯,雖無(wú)統(tǒng)計(jì)學(xué)差異,但趨勢(shì)明顯。芪蛭組與腦心通組對(duì)血瘀癥狀改善均較安慰劑組明顯有效,芪蛭組較腦心通組對(duì)血瘀癥狀改善更有效,組間比較雖無(wú)統(tǒng)計(jì)學(xué)差異,但趨勢(shì)明顯。芪蛭組比腦心通組和安慰劑組對(duì)氣虛癥狀改善明顯,雖無(wú)統(tǒng)計(jì)學(xué)差異,但趨勢(shì)明顯。芪蛭組的中醫(yī)證候臨床有效率在發(fā)病第90天和第12周較腦心通組和安慰劑組改善明顯,(P=0.0041),有明顯統(tǒng)計(jì)學(xué)差異。結(jié)論:1、下肢運(yùn)動(dòng)功能障礙的改善情況:芪蛭組與腦心通組對(duì)下肢運(yùn)動(dòng)功能障礙改善均較安慰劑組明顯有效,芪蛭組在發(fā)病前90天對(duì)下肢功能改善較腦心通組明顯,雖無(wú)統(tǒng)計(jì)學(xué)差異,但趨勢(shì)明顯。2、芪蛭組在對(duì)氣虛血瘀證中醫(yī)證候量化積分改善方面較腦心通組與安慰劑組明顯有效,(P0.0041),有統(tǒng)計(jì)學(xué)意義。芪蛭組與腦心通組在對(duì)語(yǔ)言障礙的改善、日常生活能力的改善、上肢運(yùn)動(dòng)功能障礙改善、運(yùn)動(dòng)功能障礙的改善方面較安慰劑組明顯有效,而芪蛭組在對(duì)語(yǔ)言障礙的改善、上肢運(yùn)動(dòng)功能障礙改善、運(yùn)動(dòng)功能障礙的改善方面較腦心通組略有效。
[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.
【學(xué)位授予單位】:大連醫(yī)科大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2016
【分類號(hào)】:R277.7

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