长期服用降压宝系列中成药对高血压患者结局影响的队列研究
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摘要
背景高血压与心血管疾病发病和死亡风险间存在密切的因果关系,降压宝系列中成药对于治疗原发性高血压病有较好的疗效。目的评价长期服用降压宝系列中成药对高血压患者结局的影响。方法采用队列研究,选取2001—2003年于河南省高血压中西医结合诊疗中心就诊的1 364例原发性高血压病患者为研究对象。均进行高血压的标准二级预防措施并服用降压宝系列中成药,利用受试者脱离服药自然形成的队列差,以服药总月数42个月为标准分为短期服药组236例和长期服药组1 128例。收集年龄、高血压早发家族史、病程、血压级别、抗高血压西药使用情况、吸烟史、饮酒史、文化水平、运动量、睡眠状况等资料,连续追踪调查42个月,记录不良结局(心脑血管死亡、心肌梗死、脑梗死、脑出血等)的发生情况。采用Cox比例风险回归模型分析长期服用降压宝系列中成药对高血压患者结局的影响。结果入组患者不良结局发生率为15.90%(217/1 364),2001、2002、2003年入组患者的不良反应发生率分别为22.22%(80/360)、13.06%(64/490)、14.20%(73/514)。至试验结束,长期服药组不良结局发生率低于短期服药组,差异有统计学意义[10.17%(24/236)比17.11%(193/1 128),χ~2=7.03,P=0.008]。Cox比例风险回归分析结果显示,在不同回归模型中,短期服药组不良结局发生率均高于长期服药组(HR均>1.00,P均<0.05)。结论长期服用降压宝系列中成药能明显降低高血压患者不良结局的发生率。
Background There is a close causal relationship between hypertension and the risk of cardiovascular disease morbidity and mortality. Jiangyabao series of Chinese patent medicines(a sort of hypotensors) have good effects on essential hypertension. Objective To evaluate the effect of long-term administration of Jiangyabao series of Chinese patent medicines on the outcome of patients with hypertension. Methods This study was carried out from 2001 to 2003 based on a cohort design. The 1 364 participants with essential hypertension were recruited from Henan Hypertension Management Center of Integrated Traditional Chinese and Western Medicine. All of them received standardized secondary prevention interventions for hypertension and oral administration of Jiangyabao series of Chinese patent medicines. In accordance with the duration of voluntary administration,they were assigned to short-term medication group(n=236, ≤ 42 months),long-term medication group(n=1 128,>42 months),respectively. Data of age,family history of early onset of hypertension,duration of hypertension,stage of hypertension,use of western antihypertensive drugs,smoking history,drinking history,education level,amount of exercise and sleeping status were collected. All of them were followed up for 42 months,during which the incidence of adverse outcomes(death caused by cardiovascular and cerebrovascular diseases,myocardial infarction,cerebral infarction,cerebral hemorrhage) was recorded. Cox proportional hazards regression analysis was used to analyze the effect of long-term administration of Jiangyabao series of Chinese patent medicines on the outcome. Results The incidence of adverse outcomes in new included participants during the whole study period was 15.90%(217/1 364),and 22.22%(80/360),13.06%(64/490) and 14.20%(73/514)in 2001,2002 and 2003. By the end of the experiment,the incidence of adverse outcomes in the long-term medication group was lower than that in the short-term medication group [10.17%(24/236)vs 17.11%(193/1 128),χ~2=7.03,P=0.008].Analyses with different Cox proportional risk regression models showed that the incidence of adverse outcomes in short-term medication group was higher than that of the long-term medication group(HR>1.00,P<0.05).Conclusion Long-term administration of Jiangyabao series of Chinese patent medicines can significantly reduce the incidence of adverse outcomes in patients with hypertension.
Background There is a close causal relationship between hypertension and the risk of cardiovascular disease morbidity and mortality. Jiangyabao series of Chinese patent medicines(a sort of hypotensors) have good effects on essential hypertension. Objective To evaluate the effect of long-term administration of Jiangyabao series of Chinese patent medicines on the outcome of patients with hypertension. Methods This study was carried out from 2001 to 2003 based on a cohort design. The 1 364 participants with essential hypertension were recruited from Henan Hypertension Management Center of Integrated Traditional Chinese and Western Medicine. All of them received standardized secondary prevention interventions for hypertension and oral administration of Jiangyabao series of Chinese patent medicines. In accordance with the duration of voluntary administration,they were assigned to short-term medication group(n=236, ≤ 42 months),long-term medication group(n=1 128,>42 months),respectively. Data of age,family history of early onset of hypertension,duration of hypertension,stage of hypertension,use of western antihypertensive drugs,smoking history,drinking history,education level,amount of exercise and sleeping status were collected. All of them were followed up for 42 months,during which the incidence of adverse outcomes(death caused by cardiovascular and cerebrovascular diseases,myocardial infarction,cerebral infarction,cerebral hemorrhage) was recorded. Cox proportional hazards regression analysis was used to analyze the effect of long-term administration of Jiangyabao series of Chinese patent medicines on the outcome. Results The incidence of adverse outcomes in new included participants during the whole study period was 15.90%(217/1 364),and 22.22%(80/360),13.06%(64/490) and 14.20%(73/514)in 2001,2002 and 2003. By the end of the experiment,the incidence of adverse outcomes in the long-term medication group was lower than that in the short-term medication group [10.17%(24/236)vs 17.11%(193/1 128),χ~2=7.03,P=0.008].Analyses with different Cox proportional risk regression models showed that the incidence of adverse outcomes in short-term medication group was higher than that of the long-term medication group(HR>1.00,P<0.05).Conclusion Long-term administration of Jiangyabao series of Chinese patent medicines can significantly reduce the incidence of adverse outcomes in patients with hypertension.
引文
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[4]刘玉堂.中药治疗高血压病的临床观察[J].中西医结合心血管病杂志,2014,2(14):51,53.LIU Y T.Clinical observation on the treatment of hypertension with traditional Chinese medicine[J].Cardiovascular Disease Journal of intagrated traditional Chinese and Western Medicine,2014,2(14):51,53.
[5]崔伟锋,王秉权,范军铭,等.降压宝系列中成药治疗原发性高血压的meta分析[J].中医药临床杂志,2015,27(6):849-850.CUI W F,WANG B Q,FAN J M,et al.Meta-analysis of Jiangyabao series of Chinese patent medicines in the treatment of essential hypertension[J].Clinical Journal of Traditional Chinese Medicine,2015,27(6):849-850.
[6]中国高血压防治指南起草委员会.中国高血压防治指南[J].高血压杂志,2000,8(2):103-112.Drafting Committee of Guidelines for the Prevention and Treatment of Hypertension in China.Chinese guidelines for the management of hypertension[J].Chinese Journal of Hypertension,2000,8(2):103-112.
[7]延秀敏.高血压病的中医药研究进展[J].光明中医,2015,30(7):1585-1588.DOI:10.3969/j.issn.1003-8914.2015.07.119.YAN X M.Advances in traditional Chinese medicine for hypertension[J].Guangming Journal of Chinese Medicine,2015,30(7):1585-1588.DOI:10.3969/j.issn.1003-8914.2015.07.119.
[8]秦金霞.高血压病的中医研究概况[J].新中医,2010,42(4):107-108.QIN J X.Overview of TCM research on hypertension[J].Journal of New Chinese Medicine,2010,42(4):107-108.
[9]袁志俊,李小刚,何晓英,等.天舒片治疗后循环缺血合并高血压患者的临床疗效及其对内皮细胞膜微粒表达的影响[J].实用心脑肺血管病杂志,2018,26(2):84-87.DOI:10.3969/j.issn.1008-5971.2018.02.021.YUAN Z J,LI X G,HE X Y,et al.Clinical effect of Tianshu Tablets in treating posterior circulation ischemia patients merged with hypertension and the impact on expression of endothelial microparticles[J].Practical Journal of Cardiac Cerebral Pneumal and Vascular Disease,2018,26(2):84-87.DOI:10.3969/j.issn.1008-5971.2018.02.021.
[10]葛汝青,张继东.中医药治疗高血压病作用机制研究概况[J].辽宁中医杂志,2011,38(5):1019-1021.GE R Q,ZHANG J D.Research outline of mechanism in tcm treatment on hypertension[J].Liaoning Journal of Traditional Chinese Medicine,2011,38(5):1019-1021.
[11]刘建平.循证医学与中医疗效评价[J].中医杂志,2007,48(1):26-28.DOI:10.3321/j.issn:1001-1668.2007.01.012.LIU J P.Evidence-based medicine and effectiveness evaluation of traditional Chinese medicine[J].Journal of Traditional Chinese Medicine,2007,48(1):26-28.DOI:10.3321/j.issn:1001-1668.2007.01.012.
[12]张惠敏,陈薇,刘建平.队列研究应用于评价中医临床疗效中暴露的定义和测量方法[J].循证医学,2011,11(4):249-252.DOI:10.3969/j.issn.1671-5144.2011.04.009.ZHANG H M,CHEN W,LIU J P.Definition and measurement of exposure in cohort study applying in clinical effect evaluation of TCMby cohort study[J].The Journal of Evidence-Based Medicine,2011,11(4):249-252.DOI:10.3969/j.issn.1671-5144.2011.04.009.
[13]李丛煌,花宝金,林洪生,等.队列研究在肺癌临床研究中的应用[J].中华中医药学刊,2011,29(1):45-47.LI C H,HUA B J,LIN H S,et al.Application of cohort study in clinical research of lung cancer[J].Chinese Archives of Traditional Chinese Medicine,2011,29(1):45-47.
[14]范军铭.中医药临床疗效评价的新思路:CPOE模式[J].中医研究,2012,25(4):1-4.FAN J M.CPOE model:a new idea for evaluating the clinical efficacy of traditional Chinese medicine[J].Traditional Chinese Medicinal Research,2012,25(4):1-4.
[15]柯阳,钟鉴宏,郭哲,等.倾向性评分匹配法对巴塞罗那B期肝细胞癌两种治疗方法的再评价[J].中华医学杂志,2014,94(10):747-750.DOI:10.3760/cma.j.issn.0376-2491.2014.10.007.KE Y,ZHONG J H,GUO Z,et al.Comparison liver resection with transarterial chemoembolization for Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma patients on long-term survival after SPSS propensity score matching[J].National Medical Journal of China,2014,94(10):747-750.DOI:10.3760/cma.j.issn.0376-2491.2014.10.007.
[16]叶晓勤,杨伟,谢雁鸣,等.基于倾向性评分的中医复杂干顶临床疗效评价[J].中国中医基础医学杂志,2012,18(2):218.YE X Q,YANG W,XIE Y M,et al.Clinical evaluation of complex dry roof of traditional Chinese medicine based on tendency score[J].Chinese Journal of Basic Medicine of Traditional Chinese Medicine,2012,18(2):218.
[17]ROSENBAUM P R,RUBIN D B.The central role of the propensity score in observational studies for causal effects[J].Biometrika,1983,70:41-55.
[18]姜俊杰,李霖,谢雁鸣,等.真实世界中疏血通注射液治疗脑梗死疗效分析[J].中国中药杂志,2013,38(18):3180-3186.DOI:10.4268/cjcmm20131845.JIANG J J,LI L,XIE Y M,et al.Based on propensity score methods analysis of outcomes of parenterally administered Shuxuetong in treatment of cerebral infarction[J].China Journal of Chinese Materia Medica,2013,38(18):3180-3186.DOI:10.4268/cjcmm20131845.
[19]范军铭,乔珊,刘鹏,等.倾向评分法评价针灸治疗脑梗死疗效回顾性分析[J].中国针灸,2015,35(1):72-76.DOI:10.13703/j.0255-2930.2015.01.022.FAN J M,QIAO S,LIU P,et al.Retrospective analysis on acupuncture in treatment of cerebral infarction evaluated with propensity score[J].Chinese Acupuncture&Moxibustion,2 0 1 5,3 5(1):7 2-7 6.D O I:1 0.1 3 7 0 3/j.0 2 5 5-2930.2015.01.022.
[2]中国高血压防治指南修订委员会.中国高血压防治指南2010[J].中华高血压杂志,2011,39(7):701-743.DOI:10.3760/cma.j.issn.0253-3758.2011.07.002.Revision Committee of the Guidelines for the Prevention and Treatment of Hypertension in China.2010 Chinese guidelines for the management of hypertension[J].Chinese Journal of Cardiology,2011,39(7):701-743.DOI:10.3760/cma.j.issn.0253-3758.2011.07.002.
[3]刘明波,李镒冲,刘世炜,等.2010年中国人群高血压疾病负担[J].中华流行病学杂志,2014,35(6):680-683.DOI:10.3760/cma.j.issn.0254-6450.2014.06.014.LIU M B,LI Y C,LIU S W,et al.Burden on blood-pressurerelated diseases among the Chinese population in 2010[J].Chinese Journal of Epidemiology,2014,35(6):680-683.DOI:10.3760/cma.j.issn.0254-6450.2014.06.014.
[4]刘玉堂.中药治疗高血压病的临床观察[J].中西医结合心血管病杂志,2014,2(14):51,53.LIU Y T.Clinical observation on the treatment of hypertension with traditional Chinese medicine[J].Cardiovascular Disease Journal of intagrated traditional Chinese and Western Medicine,2014,2(14):51,53.
[5]崔伟锋,王秉权,范军铭,等.降压宝系列中成药治疗原发性高血压的meta分析[J].中医药临床杂志,2015,27(6):849-850.CUI W F,WANG B Q,FAN J M,et al.Meta-analysis of Jiangyabao series of Chinese patent medicines in the treatment of essential hypertension[J].Clinical Journal of Traditional Chinese Medicine,2015,27(6):849-850.
[6]中国高血压防治指南起草委员会.中国高血压防治指南[J].高血压杂志,2000,8(2):103-112.Drafting Committee of Guidelines for the Prevention and Treatment of Hypertension in China.Chinese guidelines for the management of hypertension[J].Chinese Journal of Hypertension,2000,8(2):103-112.
[7]延秀敏.高血压病的中医药研究进展[J].光明中医,2015,30(7):1585-1588.DOI:10.3969/j.issn.1003-8914.2015.07.119.YAN X M.Advances in traditional Chinese medicine for hypertension[J].Guangming Journal of Chinese Medicine,2015,30(7):1585-1588.DOI:10.3969/j.issn.1003-8914.2015.07.119.
[8]秦金霞.高血压病的中医研究概况[J].新中医,2010,42(4):107-108.QIN J X.Overview of TCM research on hypertension[J].Journal of New Chinese Medicine,2010,42(4):107-108.
[9]袁志俊,李小刚,何晓英,等.天舒片治疗后循环缺血合并高血压患者的临床疗效及其对内皮细胞膜微粒表达的影响[J].实用心脑肺血管病杂志,2018,26(2):84-87.DOI:10.3969/j.issn.1008-5971.2018.02.021.YUAN Z J,LI X G,HE X Y,et al.Clinical effect of Tianshu Tablets in treating posterior circulation ischemia patients merged with hypertension and the impact on expression of endothelial microparticles[J].Practical Journal of Cardiac Cerebral Pneumal and Vascular Disease,2018,26(2):84-87.DOI:10.3969/j.issn.1008-5971.2018.02.021.
[10]葛汝青,张继东.中医药治疗高血压病作用机制研究概况[J].辽宁中医杂志,2011,38(5):1019-1021.GE R Q,ZHANG J D.Research outline of mechanism in tcm treatment on hypertension[J].Liaoning Journal of Traditional Chinese Medicine,2011,38(5):1019-1021.
[11]刘建平.循证医学与中医疗效评价[J].中医杂志,2007,48(1):26-28.DOI:10.3321/j.issn:1001-1668.2007.01.012.LIU J P.Evidence-based medicine and effectiveness evaluation of traditional Chinese medicine[J].Journal of Traditional Chinese Medicine,2007,48(1):26-28.DOI:10.3321/j.issn:1001-1668.2007.01.012.
[12]张惠敏,陈薇,刘建平.队列研究应用于评价中医临床疗效中暴露的定义和测量方法[J].循证医学,2011,11(4):249-252.DOI:10.3969/j.issn.1671-5144.2011.04.009.ZHANG H M,CHEN W,LIU J P.Definition and measurement of exposure in cohort study applying in clinical effect evaluation of TCMby cohort study[J].The Journal of Evidence-Based Medicine,2011,11(4):249-252.DOI:10.3969/j.issn.1671-5144.2011.04.009.
[13]李丛煌,花宝金,林洪生,等.队列研究在肺癌临床研究中的应用[J].中华中医药学刊,2011,29(1):45-47.LI C H,HUA B J,LIN H S,et al.Application of cohort study in clinical research of lung cancer[J].Chinese Archives of Traditional Chinese Medicine,2011,29(1):45-47.
[14]范军铭.中医药临床疗效评价的新思路:CPOE模式[J].中医研究,2012,25(4):1-4.FAN J M.CPOE model:a new idea for evaluating the clinical efficacy of traditional Chinese medicine[J].Traditional Chinese Medicinal Research,2012,25(4):1-4.
[15]柯阳,钟鉴宏,郭哲,等.倾向性评分匹配法对巴塞罗那B期肝细胞癌两种治疗方法的再评价[J].中华医学杂志,2014,94(10):747-750.DOI:10.3760/cma.j.issn.0376-2491.2014.10.007.KE Y,ZHONG J H,GUO Z,et al.Comparison liver resection with transarterial chemoembolization for Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma patients on long-term survival after SPSS propensity score matching[J].National Medical Journal of China,2014,94(10):747-750.DOI:10.3760/cma.j.issn.0376-2491.2014.10.007.
[16]叶晓勤,杨伟,谢雁鸣,等.基于倾向性评分的中医复杂干顶临床疗效评价[J].中国中医基础医学杂志,2012,18(2):218.YE X Q,YANG W,XIE Y M,et al.Clinical evaluation of complex dry roof of traditional Chinese medicine based on tendency score[J].Chinese Journal of Basic Medicine of Traditional Chinese Medicine,2012,18(2):218.
[17]ROSENBAUM P R,RUBIN D B.The central role of the propensity score in observational studies for causal effects[J].Biometrika,1983,70:41-55.
[18]姜俊杰,李霖,谢雁鸣,等.真实世界中疏血通注射液治疗脑梗死疗效分析[J].中国中药杂志,2013,38(18):3180-3186.DOI:10.4268/cjcmm20131845.JIANG J J,LI L,XIE Y M,et al.Based on propensity score methods analysis of outcomes of parenterally administered Shuxuetong in treatment of cerebral infarction[J].China Journal of Chinese Materia Medica,2013,38(18):3180-3186.DOI:10.4268/cjcmm20131845.
[19]范军铭,乔珊,刘鹏,等.倾向评分法评价针灸治疗脑梗死疗效回顾性分析[J].中国针灸,2015,35(1):72-76.DOI:10.13703/j.0255-2930.2015.01.022.FAN J M,QIAO S,LIU P,et al.Retrospective analysis on acupuncture in treatment of cerebral infarction evaluated with propensity score[J].Chinese Acupuncture&Moxibustion,2 0 1 5,3 5(1):7 2-7 6.D O I:1 0.1 3 7 0 3/j.0 2 5 5-2930.2015.01.022.