软坚通脉汤对PCI术后Ⅲ期康复患者心脏标志物及生活质量研究

发布时间：2018-01-11 01:31

本文关键词：软坚通脉汤对PCI术后Ⅲ期康复患者心脏标志物及生活质量研究　出处：《北京中医药大学》2016年博士论文　论文类型：学位论文

【摘要】：目的：1.对目前冠心病PCI术后患者的整体情况进行摸底,结合《冠心病康复与二级预防中国专家共识》,重点调查PCI术后患者的生活方式、危险因素控制及生活质量情况,找出目前存在的问题。2.初步观察软坚通脉汤对冠心病PCI术后Ⅲ期心脏康复患者的疗效,并从炎症及纤维化角度对其作用机制进行初步探讨；探索在现有条件下,采取家庭为基础的心脏康复配合中药处方作为PCI术后心脏康复形式的可行性。方法：1.采用问卷调查的方法,对2015年1月至2016年1月期间在我院心血管内科门诊、住院的PCI术后患者进行调查,采集患者的基本信息、生活方式、危险因素控制等情况,采用《中国心血管病人生活质量问卷(CQQC问卷)》对患者生活质量进行评价。2.采用随机对照试验的方法,纳入2015年1月至2016年1月在我院心血管内科门诊PCI术后Ⅲ期心脏康复患者,随机分为对照组和治疗组,对照组给予有充分循证证据的冠心病二级预防用药,治疗组在对照组的基础上加用软坚通脉汤,两组均给予家庭康复,疗程8周。观察软坚通脉汤对PCI术后Ⅲ期心脏康复患者中医症状、生活质量的改善；对炎症指标IL-6、NF-α、hs-CRP,心衰标志物Gal-3的影响。结果：1.问卷调查部分：(1)共纳入患者132例(Ⅰ期27例,Ⅱ期17例,Ⅲ期88例),其中男性91例(68.9%),平均年龄61.02±8.89岁,女性41例(31.1%),平均年龄66.51+8.24岁,男性年龄明显小于女性(t=-3.353,P=0.001),男女比例2.2：1。(2)心脏康复的知晓率极低：88.6%的患者表示从未听说过心脏康复,9.8%的患者听说过心脏康复,但不知道具体的涵义,132名患者中只有2名听过并且知道心脏康复的内容。(3)药物使用：阿司匹林、p受体阻滞剂、ACEI/ARB.他汀类药物的使用率分别为89.4%、76.5%、58.3%和94.7%。用药依从性Morisky问卷得分4分的患者仅占48.57%,一半以上的患者或多或少的存在着不能规律服药的问题。(4)多重危险因素控制情况：①血压：按照130/80mmHg的标准,达标率为52.1%,按照140/90mmHg的标准,达标率为61.0%；②血糖：达标率为55.2%；③血脂(LDL-C)：高危人群(70/132,53.0%)的达标率为82.9%,极高危人群(62/132,47.0%)的达标率为38.7%；④吸烟：有吸烟史的患者年龄非常显著的小于无吸烟史的患者(60.0±8.9岁vs66.3+7.9岁；t=-4.2,P0.001),戒烟率62.2%(46/74),仍在吸烟者占比21.2%(28/132)；⑤体质量：BMI的总达标率为23.5%,男性达标率19.8%,女性达标率31.7%；腰围的总达标率为50.0%,男性达标率37.4%,女性达标率为78.0%；⑥运动：Ⅱ、Ⅲ期康复患者的运动频率调查显示,60.0%的患者3-5次／周,9.5%的患者1-2次／周,3.8%的患者1次/周,26.7%的患者没有运动,近八成的患者运动形式局限于散步,运动的时间多集中在30～60分钟。(5)中医证候的调查结果发现,PCI术后患者中血瘀证、气虚证和痰浊证的比例分别为89.4%、60.6%、70.5%,其中气虚证患者在Ⅰ期(29.6%)、Ⅱ期(58.8%)、Ⅲ期(70.5%)患者中的比例逐渐升高。(6)生活质量：①PCI术后患者CQQC问卷得分为66.86+18.06分,其中男性平均得分70.16+18.34分,女性平均得分59.51+15.19,男性生活质量显著高于女性(t=3.249,P=0.001).②CQQC问卷得分与年龄呈显著的负相关(r=-0.348,P0.001)。(7)生活质量与中医证候关系：①CQQC问卷得分与气虚证积分呈负相关(Kendall相关系数=-0.317,P0.001；Spearman相关系数=-0.425,P0.001)；②CQQC问卷得分与痰浊证积分也呈负相关(Kendall相关系数=-0.208,P=0.001；Spearman相关系数=-0.284,P=0.001)；③气虚证患者CQQC问卷得分明显低于非气虚证患者(62.31±17.85vs73.85±16.18:t=.3.762,P0.001).2.随机对照试验：(1)试验共纳入患者62例,失访3例,随访期间服用其他中药患者1例,主动退出试验2例,最后纳入分析56例,治疗组和对照组各28例。(2)中医证候改善有效率：治疗组的总有效率为78.6%,明显高于对照组的总有效率46.4%。(3)炎症因子：①组内比较,治疗后hs-CRP水平无论在治疗组(P=0.0040.01)还是对照组(P=0.0160.05)均较治疗前出现了降低,但治疗后两组之间差异无统计学意义(P=0.8050.05)；②与hs-CRP结果一致,组内比较,治疗后IL-6水平无论在治疗组(P=0.0010.01)还是对照组(P=0.0070.01)都较治疗前出现了降低,但治疗后两组之间差异无统计学意义(P=0.7510.05);③TNF-α水平在两组治疗前后均没有出现显著差异。(4)心衰指标：治疗组在治疗后出现了GaL-3水平显著的下降,由3.93±0.29ng/ml下降到3.66±0.33ng/ml (P=0.0040.01),而对照组则治疗前后无明显变化(P=0.2030.05)；治疗后两组间差异无统计学意义(P=0.3300.05)。(5)生活质量：①治疗前后CQQC问卷得分比较,治疗组和对照组均可以从病情、医疗状况、一般生活和社会心理状况四个维度上提高患者的生活质量；②治疗前后CQQC问卷得分差值比较,治疗组对于患者体力状况的改善优于对照组(P=0.0060.01),因而更能有效提高患者的生活质量(P=0.0070.01)；③经过治疗,70岁以上的高龄患者(11/56)生活质量虽然有改善趋势,但无论治疗组(P=0.2170.05)还是对照组(P=0.2460.05)治疗前后CQQC问卷得分并未呈现出统计学意义。结论：1.PCI术后患者普遍缺乏系统和全面的健康管理,对于心脏康复的知晓度极低,在用药规范性和依从性方面有待提高,在戒烟、血压、血脂、血糖、体质量的达标率等方面亦不令人满意,气虚证和痰浊证的程度的加重显著降低了患者的生活质量。2.经过康复教育、规范的循证用药及生活方式调整等强化管理措施后,PCI术后Ⅲ期康复患者在中医症状、生活质量、部分炎性因子(hs-CRP、IL-6)等方面均得到改善；与单纯西医治疗比较,加用中药软坚通脉汤后,患者的症状和生活质量改善更为明显,提示在PCI术后Ⅲ期康复方案中加用中药软坚通脉汤可以提高康复疗效。3. 软坚通脉汤可能通过下调GaL-3的表达而在早期延缓心衰的进展,值得扩大样本量、延长随访时间,进行进一步研究。
[Abstract]:Objective: 1. to the present situation of patients with coronary heart disease after PCI thoroughly, combined with the "two grade prevention rehabilitation of coronary heart disease and Chinese expert consensus >, focused on the investigation of patients after PCI lifestyle risk factors control and quality of life, to find out the current problems of the.2. preliminary observation of Ruanjian Tongmai Decoction on the curative effect of the patients phase III cardiac rehabilitation after PCI with coronary heart disease, and to explore its mechanism from the perspective of inflammation and fibrosis; explore under the existing conditions, take home based cardiac rehabilitation combined with traditional Chinese medicine prescription for PCI postoperative cardiac rehabilitation. Methods: 1. forms of the feasibility of using the method of questionnaire survey from January 2015 to January 2016 during the cardiovascular clinic of our hospital, the hospital after PCI patients were investigated, the basic information collection, the lifestyle of the patients, the risk factors of control, using the < Chinese effort Pipe the quality of life of patients (CQQC questionnaire) questionnaire > evaluation method of.2. with randomized controlled trial of patients' quality of life, in January 2015 to January 2016 in our hospital cardiology clinic after PCI III cardiac rehabilitation patients were randomly divided into control group and treatment group, the control group was given sufficient evidence of coronary heart disease two preventive medication, the treatment group in the control group plus Tongmai Decoction with soft Kennedy, two groups were given family rehabilitation, treatment for 8 weeks. Observe Ruanjian Tongmai Decoction on PCI postoperative stage of cardiac rehabilitation in patients with clinical symptoms, improve the quality of life; on the inflammatory indexes of IL-6, NF- alpha, hs-CRP, mark effect of Gal-3 heart failure. Results: a questionnaire survey of 1. parts: (1) a total of 132 patients were included (27 patients in stage I, 17 cases of stage II, III in 88 cases), including 91 cases of male (68.9%), mean age 61.02 + 8.89 years old, female 41 cases (31.1%), the average age of 66.51+8.24 years old, Male age was less than that of female (t=-3.353, P=0.001), 2.2:1. (2) and the proportion of cardiac rehabilitation awareness rate is extremely low: 88.6% of the patients had never heard of cardiac rehabilitation, 9.8% patients heard of cardiac rehabilitation, but do not know the specific meaning of the 132 patients, only 2 had heard and that of cardiac rehabilitation. (3) drug use: aspirin, P receptor blockers, statins use ACEI/ARB. rates were 89.4%, 76.5%, 58.3% and 94.7%. Morisky compliance questionnaire score of 4 patients accounted for 48.57%, more than half of the patients there are not regular medication (4) control problem. Multiple risk factors: blood pressure: according to 130/80mmHg standard, the standard rate of 52.1%, according to the 140/90mmHg standards, compliance rate was 61%; the blood sugar compliance rate was 55.2%; the blood lipid (LDL-C): the high-risk population (70/132,53.0%) The compliance rate was 82.9%, extremely high risk (62/132,47.0%) of the compliance rate was 38.7%; the smoking: smoking history in patients younger than significant smoking patients (60 + 8.9 vs66.3+7.9 years old; t=-4.2, P0.001), smoking rate was 62.2% (46/74), smokers accounted for 21.2% (28/132 the body mass:); the overall compliance rate of BMI is 23.5%, the male female compliance rate of 19.8%, compliance rate of 31.7%; the total compliance rate of 50% male waistline, compliance rate of 37.4%, the standard rate of 78% for women; the movement: II, survey frequency of exercise rehabilitation of patients with stage III, 60% patients / 3-5 times week, 9.5% of the patients 1-2 times per week, 3.8% of the patients 1 times per week, 26.7% of the patients did not exercise, nearly 80% of patients with movement is limited to walking, exercise time and more concentrated in 30~60 minutes. (5) the investigation of TCM syndromes were found after PCI in patients with blood stasis syndrome, Qi deficiency syndrome and Phlegm respectively 89.4%, 60.6%, 70.5%, the Qi deficiency in patients with stage I (29.6%), II (58.8%), III (70.5%) patients increased. (6) the quality of life of patients after PCI CQQC score 66.86+18.06 points, the average male score 70.16+18.34, female average score of 59.51+15.19, the quality of life is significantly higher in men than women (t=3.249, P=0.001). A significant negative correlation of CQQC questionnaire scores and age (r=-0.348, P0.001). (7) the relationship between quality of life and traditional Chinese medicine syndrome: the CQQC score was negatively correlated with Qi deficiency syndrome score (Kendall correlation coefficient =-0.317, P0.001; Spearman correlation coefficient =-0.425, P0.001); the CQQC score was negatively correlated with phlegm syndrome score (Kendall correlation coefficient =-0.208, P=0.001; Spearman correlation coefficient =-0.284, P=0.001); the patients with Qi deficiency syndrome CQQC score was significantly lower than that of qi deficiency Patients (62.31 + 17.85vs73.85 + 16.18:t=.3.762, P0.001).2. (1): a randomized controlled trial enrolled 62 patients, 3 cases were lost, 1 cases of other Chinese patients during the follow-up period, take the initiative to withdraw from the test in 2 cases, and 56 cases were included in the analysis, the treatment group and the control group of 28 cases (2). To improve the efficiency of TCM syndrome: the treatment group the total effective rate was 78.6%, significantly higher than the control group in the total efficiency of 46.4%. (3): comparison of inflammatory factors within the group, the levels of hs-CRP after treatment in treatment group (P=0.0040.01) and control group (P=0.0160.05) than before treatment decreased, but no significant the significance of differences between the two groups after treatment (P=0.8050.05); the results were consistent with hs-CRP, the comparison group, the levels of IL-6 after treatment in treatment group (P=0.0010.01) and control group (P=0.0070.01) than before treatment decreased, but there was no significant difference between the two groups after treatment ( P=0.7510.05); the levels of TNF- in two groups before and after treatment were not significantly different. (4) heart failure index: the treatment group after treatment appeared GaL-3 level was significantly decreased, decreased from 3.93 + 0.29ng/ml to 3.66 + 0.33ng/ml (P=0.0040.01), while the control group had no obvious change before and after treatment (P=0.2030.05); no statistically significant differences between the two groups after treatment (P=0.3300.05). (5) the quality of life: a comparison of CQQC scores of before and after treatment, the treatment group and control group were from illness, medical condition, general life and social psychology in four dimensions on improving the quality of life of patients; comparison of CQQC score difference before and after therapy, the treatment group were better than those for the physical condition of patients in control group (P=0.0060.01), so it can effectively improve the patient's quality of life (P=0.0070.01); the after treatment, elderly patients over the age of 70 (11/56) quality of life Although the improvement trend, but in both the treatment group (P=0.2170.05) and control group (P=0.2460.05) before and after treatment, CQQC scores showed no statistical significance. Conclusion: 1.PCI patients generally lack of systematic and comprehensive health management, for cardiac rehabilitation awareness is very low, needs to be improved, in the drug regulatory and compliance aspects in the smoking, blood pressure, blood lipid, blood glucose, body quality compliance rate is not satisfactory, aggravation of qi deficiency and phlegm turbid syndrome had significantly lower levels of the quality of life of patients after.2. rehabilitation education, standardized evidence-based medication and lifestyle adjustment measures to strengthen management, rehabilitation of postoperative patients with PCI III in the period of TCM symptoms, quality of life, some inflammatory factors (hs-CRP, IL-6) and other aspects were improved; compared with the pure western medicine treatment, the use of traditional Chinese medicine Ruanjian Tongmai Decoction after the symptoms and improve the quality of life More significantly, suggesting that PCI in postoperative rehabilitation programs in phase III combined with traditional Chinese medicine Ruanjian Tongmai Decoction can improve the curative effect of rehabilitation on.3. Ruanjian Tongmai Decoction could downregulate the expression of GaL-3 in the early and delayed heart failure, is worthy of a larger sample with increasing duration of follow-up for further research.

【学位授予单位】：北京中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R259

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