益气通脉口服液治疗冠心病心绞痛的临床观察
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摘要
目的：
观察益气通脉口服液对48例(观察组24例、治疗组24例)冠心病稳定型心绞痛患者，中医辨证属气虚血瘀型胸痹心痛患者的疗效和不良反应，客观评价益气通脉口服液治疗稳定型心绞痛的有效性及安全性。
方法：
通过随机双盲对照实验法，将合格受试者以1：1的比例分配至治疗组24例与对照组24例，药物按随机双盲、阳性药平行对照的原则，把原药(治疗及对照药)和模拟剂进行随机编盲编号，患者将随机分为实验及对照组，依患者就诊时间顺序按编号发药，每次提供同一编号、可服用4周的药物。治疗药为益气通脉口服液，每次1支，每日3次，四周为一疗程。对照药为舒心口服液，每次1支，每日2次。两种药不一致的地方，用安慰剂来调节。治疗共一个疗程用药四周。停药后在1周内复查。根据观察指标进行疗效评价：1．疗效性观测：(1)症状、体征积分；(2)心电图ST-T改变；(3)血脂、血液流变学检查；(4)治疗前后硝酸甘油消耗量变化。2．安全性检测，包括三大常规、肝肾功能，对不良反应进行监测。实验结束后进行数据的录入、揭盲及处理。最后进行实验数据的统据分析，所有的统计检验均采用单侧检验，p值小于0.05将被认为所检验的差别有统计意义。
结果：
疗程结束后，两组均能显著改善患者的症状(p＜0.01)，降低血脂(TG、TC)水平(p＜0.05)，改善血液流变学和心电图心肌缺血程度(p＜0.05)。治疗组和对照组在改善心电图心肌缺血程度方面无显著性差异(P＞0.05)，两组总体疗效无显著性差异(P＞0.05)。但治疗组在降低患者症状积分、降低血脂、改善血液流变学与对照组比较有显著性差异(P＜0.05)。
结论：
经过四周的疗程治疗及观察，益气通脉口服液治疗稳定型心绞痛的临床疗效略优于舒心口服液，益气通脉口服液在降低患者症状积分、降低血脂、改善血液流变学指标优于舒心口服液。临床证实益气通脉口服液适用于稳定型心绞痛，证属气虚血瘀型的患者，是一种安全、有效的中药制剂。
To observe the clinical effect and blight of YiQi TongMai(YQTM) oral Liquid to patients with stable angina, which belong to Qi deficiency and Blood stasis by TCM Bianzheng. To evluate objectively the validity and security of YQTM oral liquid in treating.
Methods:
The qualified test-acceptors were randmoly divided into treated group and control group in propotion to 1:1. They were given the drugs on time order. The remedial drug and simulant drug were numbered at random and double-blind. YQTM oral liquid and ShuXin(SX) oral liquid were used to remedial drug and contrust drug. The administration of YQTM oral liquid was one piece a time,three times a day,the other one was one piece a time,two times a day,both four weeks. Placebo was used in the difference.According to the observed results,evaluated the
treatment effectiveness:1 .The indicatrixes of treatment effectiveness. (1) Accumulated score of sympotum and sign;(2)Electrocardiograph (ECG) changing of
ST-T.(3) Blood lipid and Hemorrheologic tests.(4)The changes of nitroglycerin comsumption.2.Security tests include the three frequent exams.liver and kidney
function.At last,analysed the statistic data with one side test.When p < 0.05,it was
considered as statistic meanings.
Result:
After four weeks treatment,both groups can improve significantly the clinic sympotums(P <0.01)reduce blood lipid(TGTC) ( P < 0.05)lighten the degree of ischemic changes in ECG and hemorrheologic(P< 0.05).There is no significant difference between the two groups hi reducing blood lipid and improving the degree of ischemic changes inECG ( P > 005 ) The total treatment effect is similar ( P > 005 ) But the treated group is significantly better than the control one in improving symptom and hemorrheologic andreducing blood lipid(P < 005 ) .
Conclusion:
By four weeks treatment,the clinic effect of YQTM is a little superior to SX,but in improving symptom and hemorrheologic,and reducing blood lipid, YQTM is much better than SX.Therefore, YQTM is adapt to patients with stable angina,which belong to Qi deficiency and Blood stasis by TCM Bianzheng. It was considered as statistic meanings.lt has been certified a safe and effective prescription of Chinese herbal meadicine by clinic experiment.
观察益气通脉口服液对48例(观察组24例、治疗组24例)冠心病稳定型心绞痛患者，中医辨证属气虚血瘀型胸痹心痛患者的疗效和不良反应，客观评价益气通脉口服液治疗稳定型心绞痛的有效性及安全性。
方法：
通过随机双盲对照实验法，将合格受试者以1：1的比例分配至治疗组24例与对照组24例，药物按随机双盲、阳性药平行对照的原则，把原药(治疗及对照药)和模拟剂进行随机编盲编号，患者将随机分为实验及对照组，依患者就诊时间顺序按编号发药，每次提供同一编号、可服用4周的药物。治疗药为益气通脉口服液，每次1支，每日3次，四周为一疗程。对照药为舒心口服液，每次1支，每日2次。两种药不一致的地方，用安慰剂来调节。治疗共一个疗程用药四周。停药后在1周内复查。根据观察指标进行疗效评价：1．疗效性观测：(1)症状、体征积分；(2)心电图ST-T改变；(3)血脂、血液流变学检查；(4)治疗前后硝酸甘油消耗量变化。2．安全性检测，包括三大常规、肝肾功能，对不良反应进行监测。实验结束后进行数据的录入、揭盲及处理。最后进行实验数据的统据分析，所有的统计检验均采用单侧检验，p值小于0.05将被认为所检验的差别有统计意义。
结果：
疗程结束后，两组均能显著改善患者的症状(p＜0.01)，降低血脂(TG、TC)水平(p＜0.05)，改善血液流变学和心电图心肌缺血程度(p＜0.05)。治疗组和对照组在改善心电图心肌缺血程度方面无显著性差异(P＞0.05)，两组总体疗效无显著性差异(P＞0.05)。但治疗组在降低患者症状积分、降低血脂、改善血液流变学与对照组比较有显著性差异(P＜0.05)。
结论：
经过四周的疗程治疗及观察，益气通脉口服液治疗稳定型心绞痛的临床疗效略优于舒心口服液，益气通脉口服液在降低患者症状积分、降低血脂、改善血液流变学指标优于舒心口服液。临床证实益气通脉口服液适用于稳定型心绞痛，证属气虚血瘀型的患者，是一种安全、有效的中药制剂。
To observe the clinical effect and blight of YiQi TongMai(YQTM) oral Liquid to patients with stable angina, which belong to Qi deficiency and Blood stasis by TCM Bianzheng. To evluate objectively the validity and security of YQTM oral liquid in treating.
Methods:
The qualified test-acceptors were randmoly divided into treated group and control group in propotion to 1:1. They were given the drugs on time order. The remedial drug and simulant drug were numbered at random and double-blind. YQTM oral liquid and ShuXin(SX) oral liquid were used to remedial drug and contrust drug. The administration of YQTM oral liquid was one piece a time,three times a day,the other one was one piece a time,two times a day,both four weeks. Placebo was used in the difference.According to the observed results,evaluated the
treatment effectiveness:1 .The indicatrixes of treatment effectiveness. (1) Accumulated score of sympotum and sign;(2)Electrocardiograph (ECG) changing of
ST-T.(3) Blood lipid and Hemorrheologic tests.(4)The changes of nitroglycerin comsumption.2.Security tests include the three frequent exams.liver and kidney
function.At last,analysed the statistic data with one side test.When p < 0.05,it was
considered as statistic meanings.
Result:
After four weeks treatment,both groups can improve significantly the clinic sympotums(P <0.01)reduce blood lipid(TGTC) ( P < 0.05)lighten the degree of ischemic changes in ECG and hemorrheologic(P< 0.05).There is no significant difference between the two groups hi reducing blood lipid and improving the degree of ischemic changes inECG ( P > 005 ) The total treatment effect is similar ( P > 005 ) But the treated group is significantly better than the control one in improving symptom and hemorrheologic andreducing blood lipid(P < 005 ) .
Conclusion:
By four weeks treatment,the clinic effect of YQTM is a little superior to SX,but in improving symptom and hemorrheologic,and reducing blood lipid, YQTM is much better than SX.Therefore, YQTM is adapt to patients with stable angina,which belong to Qi deficiency and Blood stasis by TCM Bianzheng. It was considered as statistic meanings.lt has been certified a safe and effective prescription of Chinese herbal meadicine by clinic experiment.
引文
[1]朱继先、朱云河．预防冠心病与预防冠心病加重．人民军医出版社．2002．2：129．
[2]中国中西医结合学会心血管学会．冠心病中医辨证标准．中西医结合杂志．1991，11(5)：257
[3]葛健．舒心口服液治疗冠心病心绞痛的疗效观察[J]．湖北中医杂志．2000．22(5)：11-12．
[4]李玉英．灯盏细辛注射液治疗稳定型心绞痛72例临床观察[J]．中国全科医学．2002．(5)．6：495．
[5]胡大一、黄元铸．急性冠脉综合征．人民卫生出版社．2001．5：109．
[6]雷载权．中华临床中药学．人民卫生出版社．1998．4：161 3．
[7]陆曙，章寄南．黄芪的心血管药理作用研究进展[J]．中草药，1 998，29(1)：59．
[8]黎玉，万福生，万义福．川芎嗪对大鼠心肌缺血损伤的拮抗作用．中成药．2003．25(8)：646-648．
[9]唐刚华，姜国辉．川芎哚及其类似物对凝血功能和血液流变学的影响[J]．中国药理学通报．2002．18(2)：238-239．
[10]雷载权．中华临床中药学．人民卫生出版社．1998．4：1157．
[11]丁安伟．现代中药临床手册．江苏科技出版社．2000．8：239．
[12]张淑英，陈辉，邵小松．丹参注射液对兔缺血再灌注心肌损伤中细胞凋亡的影响[J]．江苏医药．2003．29(8)：585-586．
[13]董昆山，王秀琴。现代临床中药学．中国中药学出版社．1998．10．208-210．
[14]严晓红，欧阳静萍．当归对氧化低密度脂蛋白所致血管内皮细胞损伤的保护作用[J]．湖北医科大学学报．1999．20(3)：181-183．
[15]王芳，李东．当归的化学及药理研究进展[J]．中国药房．2003．14(10)：630．
[16]赵荣莱．临床中药学研究进展．北京出版社．2000．4：485．
[17]雷载权．中华临床中药学．人民卫生出版社．1998．4：979．
[18]陈嘉钰、李胜涛．益气通脉口服液对麻醉犬心脏血流动力学的影响[J]．华西药学杂志．1999，14(1)：19～21
[2]中国中西医结合学会心血管学会．冠心病中医辨证标准．中西医结合杂志．1991，11(5)：257
[3]葛健．舒心口服液治疗冠心病心绞痛的疗效观察[J]．湖北中医杂志．2000．22(5)：11-12．
[4]李玉英．灯盏细辛注射液治疗稳定型心绞痛72例临床观察[J]．中国全科医学．2002．(5)．6：495．
[5]胡大一、黄元铸．急性冠脉综合征．人民卫生出版社．2001．5：109．
[6]雷载权．中华临床中药学．人民卫生出版社．1998．4：161 3．
[7]陆曙，章寄南．黄芪的心血管药理作用研究进展[J]．中草药，1 998，29(1)：59．
[8]黎玉，万福生，万义福．川芎嗪对大鼠心肌缺血损伤的拮抗作用．中成药．2003．25(8)：646-648．
[9]唐刚华，姜国辉．川芎哚及其类似物对凝血功能和血液流变学的影响[J]．中国药理学通报．2002．18(2)：238-239．
[10]雷载权．中华临床中药学．人民卫生出版社．1998．4：1157．
[11]丁安伟．现代中药临床手册．江苏科技出版社．2000．8：239．
[12]张淑英，陈辉，邵小松．丹参注射液对兔缺血再灌注心肌损伤中细胞凋亡的影响[J]．江苏医药．2003．29(8)：585-586．
[13]董昆山，王秀琴。现代临床中药学．中国中药学出版社．1998．10．208-210．
[14]严晓红，欧阳静萍．当归对氧化低密度脂蛋白所致血管内皮细胞损伤的保护作用[J]．湖北医科大学学报．1999．20(3)：181-183．
[15]王芳，李东．当归的化学及药理研究进展[J]．中国药房．2003．14(10)：630．
[16]赵荣莱．临床中药学研究进展．北京出版社．2000．4：485．
[17]雷载权．中华临床中药学．人民卫生出版社．1998．4：979．
[18]陈嘉钰、李胜涛．益气通脉口服液对麻醉犬心脏血流动力学的影响[J]．华西药学杂志．1999，14(1)：19～21