降压胶囊治疗老年单纯收缩期高血压的疗效评价与作用机制研究
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摘要
目的评价中药降压胶囊对老年单纯收缩期高血压(EISH)的疗效与作用机制。同时,探讨病证结合治疗模式的临床效应与作用途径。
方法(1)检索古代相关文献、近十年来老年高血压及老年单纯收缩期高血压的文献资料,整理分析西医、中医及中西医结合领域对老年高血压及老年单纯收缩期高血压的研究现状。(2)采用多中心、随机、双盲、对照的研究设计方法,将符合纳入病例标准的270例EISH患者分为三组,即中药降压胶囊组(简称中药组),降压胶囊联合尼莫地平组(简称联合组)和西药尼莫地平组(简称西药组)各90例。共241例患者完成试验,29例脱落,脱落率为10.7%,其中中药组脱落10人,联合组脱落14人,西药组脱落5人。试验疗程为4周,分析评价各组对患者临床症状、降低血压及改善生活质量的作用;观察各组治疗前后尿免疫球蛋白(IgG)、尿微量白蛋白(mALB)、β_2微球蛋白(β_2-MG)、转铁蛋白(TRF)和尿N-乙酰-β-D-氨基葡萄糖苷酶(NAG)五项联检指标的变化情况,分析各组对早期肾损害的防治作用。观察各组治疗前后血清一氧化氮(NO),血浆内皮素-1(ET-1)、血栓素B_2(TXB_2)、6-酮-前列腺素F_(1α)(6-Keto-PGF_(1α))以及血清超敏C反应蛋白(hs-CRP)含量变化,探讨药物治疗作用的可能机制与途径。(3)以自发性高血压大鼠(SHR)模型为研究对象,将SHR66只,随机分为6组(每组11只):模型组(给予等量纯净水)、降压胶囊小剂量组(2g生药/kg,简称中药小剂量组)、降压胶囊大剂量(4g生药/kg,简称中药大剂量组)组、降压胶囊小剂量(2g生药/kg)+尼莫地平(5mg/kg)组(简称联合小剂量组)、降压胶囊大剂量(4g生药/kg)+尼莫地平(5mg/kg)组(简称联合大剂量组)、尼莫地平(5mg/kg)组(简称西药常量组)。连续灌胃8周。观察血压、左室重量指数(LVMI)、内皮素-1(ET-1)、降钙素基因相关肽(CGRP)、血管紧张素Ⅱ(AngⅡ)、心肌血管紧张素1型(AT1)受体蛋白及mRNA的表达情况。
结果(1)老年单纯收缩期高血压属老年高血压的一个常见类型,具有随年龄增长收缩压逐渐升高、波动不稳、易发生心血管事件并严重影响生活质量的特点。中医药对老年高血压有较好的降压作用,尤其在改善症状、提高生活质量等方面有突出优势,但中西医结合的治疗模式,能明显取得优势互补临床效应。目前尚缺乏大样本符合循证医学原则治疗EISH的中医或中西医结合研究证据。
(2)降压胶囊治疗后能明显降低EISH收缩压,联合尼莫地平治疗有明显协同降压效应(P＜0.05),且联合用药降低收缩压作用明显优于单纯中药或单纯的西药治疗(P＜0.05)。降压胶囊对阴虚阳证候患者的降压效应明显优于非阴虚阳亢证候患者(P＜0.05):中西联合用药对阴虚阳亢证候患者的降压作用,又明显优于单纯中药或西药两组阴虚阳亢证候患者(P＜0.05)。降压胶囊及其联合尼莫地平两组对EISH患者24h收缩压及白天收缩压均较治疗前明显降低(P＜0.05):而联合用药对患者夜间收缩压也有明显降低(P＜0.05),同时,对白天收缩压的降低作用既明显优于单纯中药和单纯的西药组(P＜0.05)。降压胶囊及其联合尼莫地平两组均能明显改善患者的临床症状积分值(P＜0.05),且对阴虚阳亢证候患者的症状积分改善也均优于西药尼莫地平组。降压胶囊治疗后能改善EISH患者SF-36生活质量量表七个维度的积分值(P＜0.05),且对其中的五个维度积分值的改善优于尼莫地平(P＜0.05),但其联合尼莫地平治疗对八个维度的积分均能明显改善(P＜0.05),并且均优于尼莫地平(P＜0.05)。降压胶囊及其联合尼莫地平治疗后均能明显降低患者尿微量白蛋白及β_2微球蛋白的水平(P＜0.05);联合用药后降低患者尿微量白蛋白作用又明显优于单纯中药或西药组。降压胶囊及其联合尼地平两组均能改善EISH患者血浆(清)NO、ET-1、TXB_2、6-Keto-PGF_(1α)、hs-CRP水平,均优于治疗前(P＜0.05,P＜0.01);联合治疗降低血浆TXB_2水平作用又优于单纯中药或单纯西药组(P＜0.05)。
(3)降压胶囊及其联合尼莫地平治疗8周后,均能明显降低SHR模型收缩期血压值(P＜0.05,P＜0.01),而治疗4周后,仅降压胶囊大剂量联合尼莫地平有明显的降压效应(P＜0.05)。降压胶囊(大剂量组)及其联合尼莫地平治疗后,能明显降低SHR左室重量及其左室重量指数(P＜0.05);同时,能明显降低SHR血浆ET、AngⅡ水平,且升高SHR血浆CGRP水平(P＜0.05),尤其降低ET及升高CGRP水平作用均优于西药尼莫地平(P＜0.05)。降压胶囊及其联合尼莫地平各剂量组均能够使SHR心肌AT1受体蛋白及mRNA表达显著降低(P＜0.05,P＜0.01);但降压胶囊联合尼莫地平治疗后,这种表达的降低更为显著,既优于单纯中药组又优于单纯西药组(P＜0.05,P＜0.01)。
结论降压胶囊对EISH有较好的临床疗效,改善细胞内皮功能、抗炎及降低心肌AT1受体蛋白及mRNA表达等可能是其部分作用机制。降压胶囊联合尼莫地平的病证结合治疗模式,对EISH的治疗有明显的协同效应,值得推广应用。
Objective:To evaluate the therapeutic effect and mechanism of Jiangya Capsule on elderly isolated systolic hypertension(EISH),and study the effect of therapeutic mode of integration of disease and syndromes.
Methods:(1) To review pertinent literature about EISH of ancient times and recent ten years,arrange and analyze current situation of ISH and EISH in west medicine,TCM and integrated traditional Chinese and west medicine domain.(2) Multi-centre,randomized, double-blind and controlled experiment design was applied.270 cases of EISH patients were divided into 3 groups,Jiangya capsule combined with Nimodipine group(combination group),Jiangya capsule group(Chinese medicine group) and Nimodipine group(west medicine group),and there were 90 cases in each group.241 cases finished the trail and 29 case were lost,and the rate was 10.7%(10 cases in Chinese medicine group,14 cases in combination group,5 cases in west medicine group).The course of treatment was 4 weeks.To observe and evaluate the changes of clinical symptom integral,blood pressure and quality of life before and after the treatment.To observe changes of IgG,mALB,β_2-MG,TRF and NAG in urine before and after the treatment,and analyze the preventive and therapeutic effect on early kidney injury.To detect NO,ET-1, TXB_2,6-Keto-PGF_(1α) and hs-CRP level in blood plasma before and after the treatment,and explore its mechanism.(3) 66 spontaneous hypertensive rats were randomized into 6 groups:model group,Nimodipine(5mg/kg) and Jiangya capsule low dose group(2g crude drug/kg),Nimodipine(5mg/kg)and Jiangya capsule large dose group(4g crude drug/kg), Jiangya capsule low dose group(2g crude drug/kg),Jiangya capsule large dose group(4g crude drug/kg),Nimodipine group(5mg/kg).The course of intragastric administration was 8 weeks.To detect blood pressure before and after treatment,detect LVMI,ET,CGRP, AngⅡ,expression of protein and mRNA of AT1 receptor after the treatment.
Results:(1) EISH is a common type of ESH,characterized by systolic pressure rising with age,fluctuation,prone to cardio-cerebral events,and influencing quality of life seriously. There were some progresses in TCM area,and therapeutic mode of integrated Chinese and west medicine had its clinical dominance,but lack of evidence based on large sample clinical study.(2) Jiangya capsule could decrease systolic blood pressure after the treatment,and Jiangya capsule combined with Nimodipine had the same effect on systolic blood pressur(P＜0.05),and the effect of combination group was superior to Chinese medicine group or west medicine group.Jiangya capsule had better effect in decreasing systolic pressure of yin deficiency with yang hyperactivity patients than non- yin deficiency with yang hyperactivity patients(P＜0.05).And the effect on blood pressure of yin deficiency with yang hyperactivity patients in combination group had better effect than yin deficiency with yang hyperactivity patients in Chinese medicine group or west medicine group(P＜0.05).Jiangya capsule or combined with Nimodipine could decrease 24h and daily systolic blood pressure(P＜0.05),and the combination group could also decrease night systolic blood pressure(P＜0.05).Jiangya capsule or combined with Nimodipine could improve clinical symptom integral,and the effect on yin deficiency with yang hyperactivity patients was superior to that of west medicine group.Jiangya capsule could improve integral of 7 dimensions of SF-36 measuring scale on quality of life(P＜0.05),and was superior to west medicine group in 5 dimensions(P＜0.05).Combination group could improve integral of 8 dimensions,and was superior to west medicine group in all dimensions(P＜0.05).Jiangya capsule or combined with Nimodipine could reduce mALB andβ_2-MG in urine(P＜0.05),and the combination group was superior to Chinese medicine group or west medicine group in reducing mALB.Jiangya capsule or combined with Nimodipine could improve NO、ET-1、TXB2、6-Keto-PGF_(1α)、hs-CRP levels in plasma(serum),and combination group was superior to Chinese medicine group or west medicine group in decreasing TXB_2(P＜0.05).(3) After 8 weeks of treatment,Jiangya capsule or combined with Nimodipine could decrease systolic pressure in SHR model(P＜0.05,P＜0.01),only Jiangya capsule of high dose combined with Nimodipine group could decrease systolic pressure in SHR model after 4 weeks of treatment.Jiangya capsule of high dose or combined with Nimodipine group could reduce the weight of left ventricular and its index(P＜0.05);at the same time,ET-1,AngⅡreduced and CGRP elevated in the 2 groups,and was superior to that of Nimodipine group(P＜0.05).In addition,Jiangya capsule or also inhibit protein and mRNA expression of AT1 receptor in myocardium(P＜0.05,P＜0.01);and the effect of Jiangya capsule combined with Nimodipine was superior to west medicine group or TCM group(P＜0.05).
Conclusion:Jiangya capsule has good effect on EISH patients,and its mechanism might relate to improving endothelial function,anti-inflammation,and inhibiting protein and mRNA expression of AT1 receptor.Jiangya capsule combined with Nimodipine which belongs to integration of disease and syndromes therapeutic mode has synergistic effect in treating EISH patients,deserves to be popularized and applied.
方法(1)检索古代相关文献、近十年来老年高血压及老年单纯收缩期高血压的文献资料,整理分析西医、中医及中西医结合领域对老年高血压及老年单纯收缩期高血压的研究现状。(2)采用多中心、随机、双盲、对照的研究设计方法,将符合纳入病例标准的270例EISH患者分为三组,即中药降压胶囊组(简称中药组),降压胶囊联合尼莫地平组(简称联合组)和西药尼莫地平组(简称西药组)各90例。共241例患者完成试验,29例脱落,脱落率为10.7%,其中中药组脱落10人,联合组脱落14人,西药组脱落5人。试验疗程为4周,分析评价各组对患者临床症状、降低血压及改善生活质量的作用;观察各组治疗前后尿免疫球蛋白(IgG)、尿微量白蛋白(mALB)、β_2微球蛋白(β_2-MG)、转铁蛋白(TRF)和尿N-乙酰-β-D-氨基葡萄糖苷酶(NAG)五项联检指标的变化情况,分析各组对早期肾损害的防治作用。观察各组治疗前后血清一氧化氮(NO),血浆内皮素-1(ET-1)、血栓素B_2(TXB_2)、6-酮-前列腺素F_(1α)(6-Keto-PGF_(1α))以及血清超敏C反应蛋白(hs-CRP)含量变化,探讨药物治疗作用的可能机制与途径。(3)以自发性高血压大鼠(SHR)模型为研究对象,将SHR66只,随机分为6组(每组11只):模型组(给予等量纯净水)、降压胶囊小剂量组(2g生药/kg,简称中药小剂量组)、降压胶囊大剂量(4g生药/kg,简称中药大剂量组)组、降压胶囊小剂量(2g生药/kg)+尼莫地平(5mg/kg)组(简称联合小剂量组)、降压胶囊大剂量(4g生药/kg)+尼莫地平(5mg/kg)组(简称联合大剂量组)、尼莫地平(5mg/kg)组(简称西药常量组)。连续灌胃8周。观察血压、左室重量指数(LVMI)、内皮素-1(ET-1)、降钙素基因相关肽(CGRP)、血管紧张素Ⅱ(AngⅡ)、心肌血管紧张素1型(AT1)受体蛋白及mRNA的表达情况。
结果(1)老年单纯收缩期高血压属老年高血压的一个常见类型,具有随年龄增长收缩压逐渐升高、波动不稳、易发生心血管事件并严重影响生活质量的特点。中医药对老年高血压有较好的降压作用,尤其在改善症状、提高生活质量等方面有突出优势,但中西医结合的治疗模式,能明显取得优势互补临床效应。目前尚缺乏大样本符合循证医学原则治疗EISH的中医或中西医结合研究证据。
(2)降压胶囊治疗后能明显降低EISH收缩压,联合尼莫地平治疗有明显协同降压效应(P＜0.05),且联合用药降低收缩压作用明显优于单纯中药或单纯的西药治疗(P＜0.05)。降压胶囊对阴虚阳证候患者的降压效应明显优于非阴虚阳亢证候患者(P＜0.05):中西联合用药对阴虚阳亢证候患者的降压作用,又明显优于单纯中药或西药两组阴虚阳亢证候患者(P＜0.05)。降压胶囊及其联合尼莫地平两组对EISH患者24h收缩压及白天收缩压均较治疗前明显降低(P＜0.05):而联合用药对患者夜间收缩压也有明显降低(P＜0.05),同时,对白天收缩压的降低作用既明显优于单纯中药和单纯的西药组(P＜0.05)。降压胶囊及其联合尼莫地平两组均能明显改善患者的临床症状积分值(P＜0.05),且对阴虚阳亢证候患者的症状积分改善也均优于西药尼莫地平组。降压胶囊治疗后能改善EISH患者SF-36生活质量量表七个维度的积分值(P＜0.05),且对其中的五个维度积分值的改善优于尼莫地平(P＜0.05),但其联合尼莫地平治疗对八个维度的积分均能明显改善(P＜0.05),并且均优于尼莫地平(P＜0.05)。降压胶囊及其联合尼莫地平治疗后均能明显降低患者尿微量白蛋白及β_2微球蛋白的水平(P＜0.05);联合用药后降低患者尿微量白蛋白作用又明显优于单纯中药或西药组。降压胶囊及其联合尼地平两组均能改善EISH患者血浆(清)NO、ET-1、TXB_2、6-Keto-PGF_(1α)、hs-CRP水平,均优于治疗前(P＜0.05,P＜0.01);联合治疗降低血浆TXB_2水平作用又优于单纯中药或单纯西药组(P＜0.05)。
(3)降压胶囊及其联合尼莫地平治疗8周后,均能明显降低SHR模型收缩期血压值(P＜0.05,P＜0.01),而治疗4周后,仅降压胶囊大剂量联合尼莫地平有明显的降压效应(P＜0.05)。降压胶囊(大剂量组)及其联合尼莫地平治疗后,能明显降低SHR左室重量及其左室重量指数(P＜0.05);同时,能明显降低SHR血浆ET、AngⅡ水平,且升高SHR血浆CGRP水平(P＜0.05),尤其降低ET及升高CGRP水平作用均优于西药尼莫地平(P＜0.05)。降压胶囊及其联合尼莫地平各剂量组均能够使SHR心肌AT1受体蛋白及mRNA表达显著降低(P＜0.05,P＜0.01);但降压胶囊联合尼莫地平治疗后,这种表达的降低更为显著,既优于单纯中药组又优于单纯西药组(P＜0.05,P＜0.01)。
结论降压胶囊对EISH有较好的临床疗效,改善细胞内皮功能、抗炎及降低心肌AT1受体蛋白及mRNA表达等可能是其部分作用机制。降压胶囊联合尼莫地平的病证结合治疗模式,对EISH的治疗有明显的协同效应,值得推广应用。
Objective:To evaluate the therapeutic effect and mechanism of Jiangya Capsule on elderly isolated systolic hypertension(EISH),and study the effect of therapeutic mode of integration of disease and syndromes.
Methods:(1) To review pertinent literature about EISH of ancient times and recent ten years,arrange and analyze current situation of ISH and EISH in west medicine,TCM and integrated traditional Chinese and west medicine domain.(2) Multi-centre,randomized, double-blind and controlled experiment design was applied.270 cases of EISH patients were divided into 3 groups,Jiangya capsule combined with Nimodipine group(combination group),Jiangya capsule group(Chinese medicine group) and Nimodipine group(west medicine group),and there were 90 cases in each group.241 cases finished the trail and 29 case were lost,and the rate was 10.7%(10 cases in Chinese medicine group,14 cases in combination group,5 cases in west medicine group).The course of treatment was 4 weeks.To observe and evaluate the changes of clinical symptom integral,blood pressure and quality of life before and after the treatment.To observe changes of IgG,mALB,β_2-MG,TRF and NAG in urine before and after the treatment,and analyze the preventive and therapeutic effect on early kidney injury.To detect NO,ET-1, TXB_2,6-Keto-PGF_(1α) and hs-CRP level in blood plasma before and after the treatment,and explore its mechanism.(3) 66 spontaneous hypertensive rats were randomized into 6 groups:model group,Nimodipine(5mg/kg) and Jiangya capsule low dose group(2g crude drug/kg),Nimodipine(5mg/kg)and Jiangya capsule large dose group(4g crude drug/kg), Jiangya capsule low dose group(2g crude drug/kg),Jiangya capsule large dose group(4g crude drug/kg),Nimodipine group(5mg/kg).The course of intragastric administration was 8 weeks.To detect blood pressure before and after treatment,detect LVMI,ET,CGRP, AngⅡ,expression of protein and mRNA of AT1 receptor after the treatment.
Results:(1) EISH is a common type of ESH,characterized by systolic pressure rising with age,fluctuation,prone to cardio-cerebral events,and influencing quality of life seriously. There were some progresses in TCM area,and therapeutic mode of integrated Chinese and west medicine had its clinical dominance,but lack of evidence based on large sample clinical study.(2) Jiangya capsule could decrease systolic blood pressure after the treatment,and Jiangya capsule combined with Nimodipine had the same effect on systolic blood pressur(P＜0.05),and the effect of combination group was superior to Chinese medicine group or west medicine group.Jiangya capsule had better effect in decreasing systolic pressure of yin deficiency with yang hyperactivity patients than non- yin deficiency with yang hyperactivity patients(P＜0.05).And the effect on blood pressure of yin deficiency with yang hyperactivity patients in combination group had better effect than yin deficiency with yang hyperactivity patients in Chinese medicine group or west medicine group(P＜0.05).Jiangya capsule or combined with Nimodipine could decrease 24h and daily systolic blood pressure(P＜0.05),and the combination group could also decrease night systolic blood pressure(P＜0.05).Jiangya capsule or combined with Nimodipine could improve clinical symptom integral,and the effect on yin deficiency with yang hyperactivity patients was superior to that of west medicine group.Jiangya capsule could improve integral of 7 dimensions of SF-36 measuring scale on quality of life(P＜0.05),and was superior to west medicine group in 5 dimensions(P＜0.05).Combination group could improve integral of 8 dimensions,and was superior to west medicine group in all dimensions(P＜0.05).Jiangya capsule or combined with Nimodipine could reduce mALB andβ_2-MG in urine(P＜0.05),and the combination group was superior to Chinese medicine group or west medicine group in reducing mALB.Jiangya capsule or combined with Nimodipine could improve NO、ET-1、TXB2、6-Keto-PGF_(1α)、hs-CRP levels in plasma(serum),and combination group was superior to Chinese medicine group or west medicine group in decreasing TXB_2(P＜0.05).(3) After 8 weeks of treatment,Jiangya capsule or combined with Nimodipine could decrease systolic pressure in SHR model(P＜0.05,P＜0.01),only Jiangya capsule of high dose combined with Nimodipine group could decrease systolic pressure in SHR model after 4 weeks of treatment.Jiangya capsule of high dose or combined with Nimodipine group could reduce the weight of left ventricular and its index(P＜0.05);at the same time,ET-1,AngⅡreduced and CGRP elevated in the 2 groups,and was superior to that of Nimodipine group(P＜0.05).In addition,Jiangya capsule or also inhibit protein and mRNA expression of AT1 receptor in myocardium(P＜0.05,P＜0.01);and the effect of Jiangya capsule combined with Nimodipine was superior to west medicine group or TCM group(P＜0.05).
Conclusion:Jiangya capsule has good effect on EISH patients,and its mechanism might relate to improving endothelial function,anti-inflammation,and inhibiting protein and mRNA expression of AT1 receptor.Jiangya capsule combined with Nimodipine which belongs to integration of disease and syndromes therapeutic mode has synergistic effect in treating EISH patients,deserves to be popularized and applied.
引文
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