邓老冠心胶囊治疗冠心病并发上消化道出血的临床观察
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摘要
研究目的：
随着生活水平的改善、人口寿命的延长以及社会竞争的日益剧烈，高血压病、糖尿病、高脂血症以及肥胖等患病人数呈逐年递增的趋势，由此导致冠心病的发病率增高。近年来，抗血小板药物对冠心病的防治作用也越来越受到重视，以阿司匹林为代表的抗血小板药已普遍用于冠心病的预防和治疗，但阿司匹林为NSAID，长期使用可导致胃肠黏膜损伤，故随着年龄的增长阿司匹林导致胃肠道黏膜损伤的可能性增加，老年人上消化道出血的危险性亦增加。上消化道出血是指屈氏韧带以上的消化道，包括食管、胃、十二指肠、上段空肠以及胰腺、胆道等部位的出血。其中，胃、十二指肠出血约占80％--90％，以呕血或(和)黑便为主要症状，重者常伴有急性周围循环衰竭以及重要器官功能不全等临床表现。近年来，一些效果较好的止血药物，价格却十分昂贵，内镜止血虽得到了广泛肯定，但由于目前老年(＞60岁)消化性溃疡合并上消化道出血较多(1／2—1／3)且严重，死亡率高，故多主张积极内科治疗。本试验将观察具有益气化痰、活血通络作用的邓铁涛教授经验方一一邓氏冠心胶囊治疗冠心病并发上消化道出血脾虚型的有效性和安全性。
方法：
选择随机单盲对照的试验方案进行研究。纳入符合冠心病并发上消化道出血脾虚型诊断标准的患者共41例，按照1∶1的比例随机分组成试验组(邓氏冠心胶囊加西药组)和对照组(西药组)，观察临床疗效，并通过电话访问追踪6个月，考察其上消化道出血复发频率。
研究结果：
所有统计数据均采用SPSS11.5统计软件包进行统计分析。试验组总显效率80.95％，总有效率95.23％，对照组总显效率50.00％，总有效率85.00％，二组均能改善上消化道出血，试验组总显效率优于对照组(P＜0.05)中对41例病人进行了追踪访问了其中成功回访38例，回访率92.68％。回访调查表明，试验组上消化道出血复发的频率低于对照组(P＜0.05)，二者有明显差异。说明邓老冠心胶囊加西药组治疗冠心病合并上消化道出血的疗效优于单纯西药组。临床试验组未发现明显的毒性和不良反应。血尿粪常规，肝肾功能等无明显影响。
结论：
通过以上研究，证实邓老冠心胶囊治疗冠心病并发上消化道出血脾虚型，疗效肯定，复发率低。是治疗冠心病并发上消化道出血脾虚型的有效药物，操作简单，方药服用方便，副作用小，价格低廉，值得推广应用。可以更加广泛的应用于临床。
Objective: The prevalence and morbidity of CHD gradually increases due to a high incidence of hypertension, diabetes, fat respectively in Chinese population. Recent years, aspirin has widely used in to the coronary disease treatment. But aspirin is NSAID which long-term use can injure the stomach mucous membrane and increase the dangerous of upper gastrointestinal hemorrhage. Upper gastrointestinal hemorrhage refers to the hemorrhage of alimentary tract above the ligament of Traitz, including that of the esophagus, stomach, duodenum, upper jejunum, pancreas and biliary tract, of which the hemorrhage of stomach and duodenum takes up 80-90%. Besides the major symptoms of hematemesis and melena, serious patients usually accompany with some clinical features of acute peripheral circulatory failure an dinsufficiency of some important organs, etc. In recent years, some haemostatic are effective but too expensive. Although hemostusia by endoscope has been widely confirmed, at present the death rate of old people (above 60) who suffer from both the acute and massive bleeding (1/3-1/2)peptic ulcer and upper gastrointestinal hemorrhage has reached high to be 8%-20%, so internal treatment is advocated in curing such diseases. To evaluate the efficacy and safety of Dr. Deng' s Coronary Heart Diseases (CHD) Capsules for the CHD and upper gastrointestinal hemorrhage in patients of the deficiency of spleen syndrome.
Methods: This is a single-blind, radomized, matched controlled trial. According to the the CHD and upper gastrointestinal hemorrhage in patients of the deficiency of spleen syndrome' s diagnosis criteria, a total of 41 patients were divided equally into a treatment group and a control group. The cases treated with the western medicine plus Dr. Deng's CHD capsules serve as treatment group, others with the western medicine as control group. Then we conducted a follow-up of 6 months by personal or telephone interview and recorded any upper gastrointestinal hemorrhage events during this period.
Results: All of the statistics were analyzed by Package for Encyclopedia Medical Statistics (PEMS). The overall efficiency and effective rates of the treatment group were 80.95% and 95.23%, while those of the control group were 50.00% and 85.00% respectively. The overall efficiency rates in the treatment group were higher than those in the control group(P＜0.05), which, indicated that the curative effect of Dr. Deng' s CHD capsules combined with western medicine on the treatment of CHD with upper gastrointestinal hemorrhage was superior to that of pure western medicine. There was a significant difference of recurrence of two group(P＜0.05). In 6 month, the treatment group' recurrence is 15%, and the recurrence of Western medicine control group is 44.4%. This study shows that TCM group is better than pure Western medicine control group(p＜0.05). During the courses of treatments, the treatment group showed no signs of poisonous or serious side effects, in the general blood tests (including significant differences resulted liver and kidney functional tests) or urine and fecal examinations.
Conclusion: This study proved Dr. Deng's CHD capsules has safe, cheap, convenient, definite curative effect, low recurrence rate, small side-effect. And it can treat the patients with CHD and upper gastrointestinal hemorrhage effectively. The effect of Dr. Deng' s CHD capsules is sure. It can be used widely in clinical to rise the effect.
随着生活水平的改善、人口寿命的延长以及社会竞争的日益剧烈，高血压病、糖尿病、高脂血症以及肥胖等患病人数呈逐年递增的趋势，由此导致冠心病的发病率增高。近年来，抗血小板药物对冠心病的防治作用也越来越受到重视，以阿司匹林为代表的抗血小板药已普遍用于冠心病的预防和治疗，但阿司匹林为NSAID，长期使用可导致胃肠黏膜损伤，故随着年龄的增长阿司匹林导致胃肠道黏膜损伤的可能性增加，老年人上消化道出血的危险性亦增加。上消化道出血是指屈氏韧带以上的消化道，包括食管、胃、十二指肠、上段空肠以及胰腺、胆道等部位的出血。其中，胃、十二指肠出血约占80％--90％，以呕血或(和)黑便为主要症状，重者常伴有急性周围循环衰竭以及重要器官功能不全等临床表现。近年来，一些效果较好的止血药物，价格却十分昂贵，内镜止血虽得到了广泛肯定，但由于目前老年(＞60岁)消化性溃疡合并上消化道出血较多(1／2—1／3)且严重，死亡率高，故多主张积极内科治疗。本试验将观察具有益气化痰、活血通络作用的邓铁涛教授经验方一一邓氏冠心胶囊治疗冠心病并发上消化道出血脾虚型的有效性和安全性。
方法：
选择随机单盲对照的试验方案进行研究。纳入符合冠心病并发上消化道出血脾虚型诊断标准的患者共41例，按照1∶1的比例随机分组成试验组(邓氏冠心胶囊加西药组)和对照组(西药组)，观察临床疗效，并通过电话访问追踪6个月，考察其上消化道出血复发频率。
研究结果：
所有统计数据均采用SPSS11.5统计软件包进行统计分析。试验组总显效率80.95％，总有效率95.23％，对照组总显效率50.00％，总有效率85.00％，二组均能改善上消化道出血，试验组总显效率优于对照组(P＜0.05)中对41例病人进行了追踪访问了其中成功回访38例，回访率92.68％。回访调查表明，试验组上消化道出血复发的频率低于对照组(P＜0.05)，二者有明显差异。说明邓老冠心胶囊加西药组治疗冠心病合并上消化道出血的疗效优于单纯西药组。临床试验组未发现明显的毒性和不良反应。血尿粪常规，肝肾功能等无明显影响。
结论：
通过以上研究，证实邓老冠心胶囊治疗冠心病并发上消化道出血脾虚型，疗效肯定，复发率低。是治疗冠心病并发上消化道出血脾虚型的有效药物，操作简单，方药服用方便，副作用小，价格低廉，值得推广应用。可以更加广泛的应用于临床。
Objective: The prevalence and morbidity of CHD gradually increases due to a high incidence of hypertension, diabetes, fat respectively in Chinese population. Recent years, aspirin has widely used in to the coronary disease treatment. But aspirin is NSAID which long-term use can injure the stomach mucous membrane and increase the dangerous of upper gastrointestinal hemorrhage. Upper gastrointestinal hemorrhage refers to the hemorrhage of alimentary tract above the ligament of Traitz, including that of the esophagus, stomach, duodenum, upper jejunum, pancreas and biliary tract, of which the hemorrhage of stomach and duodenum takes up 80-90%. Besides the major symptoms of hematemesis and melena, serious patients usually accompany with some clinical features of acute peripheral circulatory failure an dinsufficiency of some important organs, etc. In recent years, some haemostatic are effective but too expensive. Although hemostusia by endoscope has been widely confirmed, at present the death rate of old people (above 60) who suffer from both the acute and massive bleeding (1/3-1/2)peptic ulcer and upper gastrointestinal hemorrhage has reached high to be 8%-20%, so internal treatment is advocated in curing such diseases. To evaluate the efficacy and safety of Dr. Deng' s Coronary Heart Diseases (CHD) Capsules for the CHD and upper gastrointestinal hemorrhage in patients of the deficiency of spleen syndrome.
Methods: This is a single-blind, radomized, matched controlled trial. According to the the CHD and upper gastrointestinal hemorrhage in patients of the deficiency of spleen syndrome' s diagnosis criteria, a total of 41 patients were divided equally into a treatment group and a control group. The cases treated with the western medicine plus Dr. Deng's CHD capsules serve as treatment group, others with the western medicine as control group. Then we conducted a follow-up of 6 months by personal or telephone interview and recorded any upper gastrointestinal hemorrhage events during this period.
Results: All of the statistics were analyzed by Package for Encyclopedia Medical Statistics (PEMS). The overall efficiency and effective rates of the treatment group were 80.95% and 95.23%, while those of the control group were 50.00% and 85.00% respectively. The overall efficiency rates in the treatment group were higher than those in the control group(P＜0.05), which, indicated that the curative effect of Dr. Deng' s CHD capsules combined with western medicine on the treatment of CHD with upper gastrointestinal hemorrhage was superior to that of pure western medicine. There was a significant difference of recurrence of two group(P＜0.05). In 6 month, the treatment group' recurrence is 15%, and the recurrence of Western medicine control group is 44.4%. This study shows that TCM group is better than pure Western medicine control group(p＜0.05). During the courses of treatments, the treatment group showed no signs of poisonous or serious side effects, in the general blood tests (including significant differences resulted liver and kidney functional tests) or urine and fecal examinations.
Conclusion: This study proved Dr. Deng's CHD capsules has safe, cheap, convenient, definite curative effect, low recurrence rate, small side-effect. And it can treat the patients with CHD and upper gastrointestinal hemorrhage effectively. The effect of Dr. Deng' s CHD capsules is sure. It can be used widely in clinical to rise the effect.
引文
[1] Lanas A, Hirschowitz B I. Toxicity of NSAIDs in the stomach and duodenum[J]. Eur Gastroenterol Hepatol, 1999, 11(2): 375—381.
[2] Svanes C, Ovrebo K, Soreide O. Ulcer bleeding and perforation: nonsteroidal anti—inflammatory drugs or Helicobacter pylori[J]. Scand J Gastroenterol Suppl, 1996, 220(11): 128—131.
[3] Goldstcin Who need sprophylaxisofnonstcroidal an-ti. Inflammatory drug·Induce dulcers an dwhatisoptimalprophylaxis[J] Eur J Gastroenterol Hepatol, 2002, Suppl 1: SI1.
[4] 冠心病的五脏相关论治，湖北中医杂志，2005．8；邓铁涛治疗冠心病临床经验探析，辽宁中医学院学报，2005．4
[5] 明·薛己．薛氏医案[M]．北京：人民卫生出版社，1983．83．
[6] 明·武之望著，清·汪淇笺释，张黎临等校注．济阴纲目[M]．北京：中国中医药出版社，1998．1，2．
[7] 徐重明，聂天．脾虚证与血循环关系研究[J]．河北中医，1997，19(3)：2—3．
[8] 沈迪。沈霖．脾不统血证血小板聚集功能的研究[J]．中国中西医结合消化杂志。2001，9(1)：5—7．
[9] 马宗林，包力，刘翠霞，等．脾虚证外周微循环对比观察[J]．辽宁中医杂志，1995，22(10)：437．
[10] 杨建华，黄英俊．脾阴虚证与微观血瘀证的相关性研究[J]．中国中西医结合杂志，1996，16(2)：94．
[11] 瞿德，陈家旭．脾不统血证的现代研究概况[J]．河北中医，2001．23(8)：640．
[12] 黄星垣．中医内科急症证治[M]．北京：人民卫生出版社，1985．243—244．
[13] 陈修，陈维洲，曾贵云．心血管药理学[M]．第3版．北京：人民卫生出社，2002；743-761．
[14] Schus sheim AE, FusterV. The thrombosis anti thrombotic agentsand the anti thrombotic approach in cardiac disease [J]. ProgCardiovascDis, 1997, 40: 205-238.
[15] 余玲．小剂量阿司匹林诱发上消化道出血[J]．中原医刊．2002，29(4)．-40．
[16] Rostom A, Well G, Tugwell P, et al. The prevention ofchronic NSAIDs induced upper gasmfint~stinal toxicity: aCochrane collaboration meta-an alysis of randomized controlled trials[J]. JRhematol, 2000, 27: 2203.
[17] 黄海坤．血竭治疗上消化道出血23例观察．中国中西医结合杂志 1993；13(7)431
[18] 陈健．血宁冲剂治疗上消化道出血的临床观察．中国中医急症 1993；2(3)：1o
[19] 严玉莲，冯建滇，等．止血胶囊治疗急性上消化道出血临床观察．中国中西医脾胃杂志 1996；4(1)：57
[20] 袁叶，彭爱霞．大黄白及粉与凝血酶治疗上消化道出血疗效比较．中西医结合实用临床急救 1997；4(4)：167
[21] 陈无和．王宗和．消胃宁胶囊治疗上消化道出血30例疗效观察 中西医结合实用临床急救 1997；4(1)：3
[22] 李嘉福．陈浩．大黄白及粉治疗急性胃十二指肠出血的疗效观察 中西医结合实用临床急救 1996；3(6)：246
[23] 张宗铭，姜素贞，袁贵青．乌及汤加减治疗上消化道出血80例 中西医结合实用临床急救 1997；4(4)：154
[24] 李顺民．清胃止血汤治疗上消化道出血的疗效观察．中西医结合实用临床急救 1997；4(4)：149
[25] 刘丰．加昧泻心汤治疗轻中度上消化道出血38倒临床观察，新中医 1999；3(17)：37
[26] 甘草 《中药大辞典》 人民卫生出版社，1985，463
[27〕 王本祥 《人参的研究》 湖北科技出版社．1992．123
[28] Yoon. S. R: 《ibid refer》6. 186(008)1975
[2] Svanes C, Ovrebo K, Soreide O. Ulcer bleeding and perforation: nonsteroidal anti—inflammatory drugs or Helicobacter pylori[J]. Scand J Gastroenterol Suppl, 1996, 220(11): 128—131.
[3] Goldstcin Who need sprophylaxisofnonstcroidal an-ti. Inflammatory drug·Induce dulcers an dwhatisoptimalprophylaxis[J] Eur J Gastroenterol Hepatol, 2002, Suppl 1: SI1.
[4] 冠心病的五脏相关论治，湖北中医杂志，2005．8；邓铁涛治疗冠心病临床经验探析，辽宁中医学院学报，2005．4
[5] 明·薛己．薛氏医案[M]．北京：人民卫生出版社，1983．83．
[6] 明·武之望著，清·汪淇笺释，张黎临等校注．济阴纲目[M]．北京：中国中医药出版社，1998．1，2．
[7] 徐重明，聂天．脾虚证与血循环关系研究[J]．河北中医，1997，19(3)：2—3．
[8] 沈迪。沈霖．脾不统血证血小板聚集功能的研究[J]．中国中西医结合消化杂志。2001，9(1)：5—7．
[9] 马宗林，包力，刘翠霞，等．脾虚证外周微循环对比观察[J]．辽宁中医杂志，1995，22(10)：437．
[10] 杨建华，黄英俊．脾阴虚证与微观血瘀证的相关性研究[J]．中国中西医结合杂志，1996，16(2)：94．
[11] 瞿德，陈家旭．脾不统血证的现代研究概况[J]．河北中医，2001．23(8)：640．
[12] 黄星垣．中医内科急症证治[M]．北京：人民卫生出版社，1985．243—244．
[13] 陈修，陈维洲，曾贵云．心血管药理学[M]．第3版．北京：人民卫生出社，2002；743-761．
[14] Schus sheim AE, FusterV. The thrombosis anti thrombotic agentsand the anti thrombotic approach in cardiac disease [J]. ProgCardiovascDis, 1997, 40: 205-238.
[15] 余玲．小剂量阿司匹林诱发上消化道出血[J]．中原医刊．2002，29(4)．-40．
[16] Rostom A, Well G, Tugwell P, et al. The prevention ofchronic NSAIDs induced upper gasmfint~stinal toxicity: aCochrane collaboration meta-an alysis of randomized controlled trials[J]. JRhematol, 2000, 27: 2203.
[17] 黄海坤．血竭治疗上消化道出血23例观察．中国中西医结合杂志 1993；13(7)431
[18] 陈健．血宁冲剂治疗上消化道出血的临床观察．中国中医急症 1993；2(3)：1o
[19] 严玉莲，冯建滇，等．止血胶囊治疗急性上消化道出血临床观察．中国中西医脾胃杂志 1996；4(1)：57
[20] 袁叶，彭爱霞．大黄白及粉与凝血酶治疗上消化道出血疗效比较．中西医结合实用临床急救 1997；4(4)：167
[21] 陈无和．王宗和．消胃宁胶囊治疗上消化道出血30例疗效观察 中西医结合实用临床急救 1997；4(1)：3
[22] 李嘉福．陈浩．大黄白及粉治疗急性胃十二指肠出血的疗效观察 中西医结合实用临床急救 1996；3(6)：246
[23] 张宗铭，姜素贞，袁贵青．乌及汤加减治疗上消化道出血80例 中西医结合实用临床急救 1997；4(4)：154
[24] 李顺民．清胃止血汤治疗上消化道出血的疗效观察．中西医结合实用临床急救 1997；4(4)：149
[25] 刘丰．加昧泻心汤治疗轻中度上消化道出血38倒临床观察，新中医 1999；3(17)：37
[26] 甘草 《中药大辞典》 人民卫生出版社，1985，463
[27〕 王本祥 《人参的研究》 湖北科技出版社．1992．123
[28] Yoon. S. R: 《ibid refer》6. 186(008)1975