Cardiac Markers And Quality Of Life In Patients With Stage Ⅲ Rehabilitation After PCI

Objectives:1.To fully understand the post-PCI patients, especially the change of their life style, the management of the risk factors, their quality of life and to find the existing problems.2.To observe the effect of Ruanjian Tongmai Decoction on post-PCI patients participating in phase Ⅲ of home-based cardiac rehabilitation (CR), and try to explain the mechanism of Ruanjian Tongmai Decoction using inflammation and fibrosis theory.Methods:1. Using questionnaires, we get the informations of the outpatients and inpatients following PCI in our hospital during Jan 2015 to Jan 2016. The questions involve the life style, the cardivascuar risk factors and the China questionnaire of quality of life in patients with cardiovascular diseases (CQQC) was used to assess the quality of their life (QOL).2. The outpatients following PCI (phase III of CR) in our hospital during Jan 2015 to Jan 2016 were recruited to participate in the Randomized Controlled Trial (RCT). The patients were assigned into the control group or Ruanjian Tongmai Decoction group (RJTMD). Both groups received home-base CR and western medicines following the guideline; the RJTMD group also received Ruanjian Tongmai Decoction. The CQQC and the concentrations of high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and galectin-3 (GaL-3) were evaluated at the baseline and at 8 weeks.Results:1. The questionnaire part:(1) Participants included 132 cases of CR patients (27 in phase Ⅰ,17 in phase Ⅱ,88 in phaseⅢ),91 cases (68.9%) are men, with an average age of 61.02±8.89,41 cases (31.1%) are females, with an average age of 66.51±8.24, male age is much smaller than the female (t=3.353, P=3.353), the sex ratio is 2.2:1.(2) Low awareness of CR:88.6% of the patients had never heard of CR,9.8% of patients had heard of CR, but don’t know the specific meaning, only 2 patients have heard and know the content of the CR.(3) Drug use:The use of aspirin, beta blockers, ACEI/ARB and statins are 89.4%, 76.5%,58.3% and 76.5% respectively. Morisky questionnaire score 4 accounted for only 48.57% of the patients, more than half of the patients had problems with medication adherence.(4) Multiple risk factors control situation:(1) blood pressure:in accordance with the standards of 130/80 mmHg, the control rate was 52.1%, in accordance with the standards of 140/90 mmHg, the control rate is 61.0%; (2) blood glucose:the contral rate is 55.2%; (3) blood lipids (LDL-C):the high-risk groups (70/132,53.0%) had a control rate of 82.9%, extremely high-risk groups (62/132,47.0%) control rate is 38.7%; (4) Smoking:The patients with a history of smoking are younger than patients without history of smoking significantly (60.0±8.9 years vs 66.3±7.9 and 60.0, t= 4.2, P<0.001), quit smoking rate was 62.2% (46/74), in smokers still accounted for 21.2%(28/132); (5)0T0he overall contral rate of BMI was 23.5%(male 19.8%, female 31.7%); The overall contral rate of waist circumference was 50.0%(male 37.4%, female 78.0%); (6) Exercise:According to the exercise frequency survey of patients in CR (phase Ⅱ and Ⅲ),60.0% of patients exercised 3-5 times/week,9.5% of patients exercised 1-2 times/week,3.8%of the patients exercised<1 times/week, while 26.7% of patients didn’t movement; Nearly eighty percent of the patients’movement form is limited to walking, exercise time focused on 30-60 minutes.(5) Among post-PCI patients, the proportion of blood stasis, qi deficiency and phlegm syndrome were 89.4%,60.6% and 70.5%, respectively. The proportion of qi deficiency increased from phase Ⅰ to phase Ⅲ (phase Ⅰ 29.6%, phase Ⅱ 58.8%, phaseⅢ 70.5%).(6) QOL:(1) The average score of CQQC among post-PCI was 66.86±18.06 (male 70.16±18.34, female 59.51±15.19, Men’s QOL is significantly higher than women (t=3.249, P=3.249). (2) The scores of CQQC had significantly negative correlation with age (1=0.348,P<0.001).(7) The relationship between QOL and traditional Chinese medicine (TCM) syndrome: (1) The scores of CQQC negatively correlated with the scores of qi deficiency syndrome (Kendall correlation coefficient=0.317, P<0.001; Spearman correlation coefficient=0.001, P< 0.001); (2) The scores of CQQC also negatively correlated with the scores of phlegm syndrome (Kendall correlation coefficient=0.208, P=0.001; Spearman correlation coefficient=0.284, P=0.001); (3) The scores of CQQC among patients with Qi deficiency syndrome are significantly lower than the without qi deficiency syndrome (62.31±17.85 vs 73.85±16.18; t=3.762, P< 0.001).2. Randomized controlled trial part:(1) In total,62 outpatients following PCI (phase Ⅲ of CR) were enrolled. During the intervention period,3 were lost to follow-up,1 took prohibited TC M, and 2 take the initiative to quit. After 8 weeks,56 paticipants remained with 28 in the RJTMD group and 28 in the control group.(2) The total effective rate was 78.6% in the RJTMD group, significantly higher than 46.4% in the control group.(3) Inflammatory factors:(1) the hs-CRP levels declined both in the RJTMD group (P=0.004<0.004) and in control group (P=0.0160.05), but there was no statistically significant difference between two groups after treatment (P=0.805>0.05); (2) IL-6 levels also declined both in the RJTMD group (P=0.001<0.001) and in the control group (P=0.007<0.01), but there was no statistically significant difference between two groups after treatment (P=0.751>0.05) either; (3) The TNF-a levels in the two groups had no significant difference before and after treatment.(4) Heart failure indicator:After treatment the GaL-3 levels significantly declined from 3.93±0.29 ng/ml to 3.66±0.33 ng/ml (P=0.004<0.05) in the the RJTMD group, while the control group showed no significant change (P=0.403>0.05); Also there was no statistically significant difference between the two groups after the treatment (P= 0.479>0.05)(5) QOL:(1) Changes in scores of CQQC before and after the treatment show that both the RJTMD and the control can improve the patient’s QOL from the four dimensions of illness, medical condition, general life and social psychological status; (2) According to the changes in the scores of CQQC between the two groups, the improvement of the physical condition in the RJTMD group was superior to control group (P=0.006<0.01), and thus can more effectively improve the QOL of the patients (P=0.007<0.01); (3) Among the older patients (≥70 years old,11/56), although there was a trend in the improvement in QOL, the changes in scores of CQQC did not show statistical significance neither in the RJTMD group (P=0.217> 0.05) nor in the control grou p (P= 0.246> 0.05).Conclusions:1. The majority of post-PCI patients are lack of systemic and comprehensive health management and the awareness of CR is really low, and the contral rate of smoking cessation, blood pressure, LDL, blood glucose, BMI and waistline are not satisfying. The exacerbation of qi deficiency and phlegm syndrome cause the reduction of the QOL.2. After comprehensive CR, the patients’ symptoms,QOL and some of the inflammatory factors (hs-CRP, IL-6) were improved in both groups; compared with the control group, the RJTMD group had better QOL, suggesting that Chinese herbal Ruanjian Tongmai Decoction can help to increase the effect of CR in phase III.3. Chinese herbal Ruanjian Tongmai Decoction may slow the progression of heart failure at very early stage through inhibiting GaL-3 expression, but to prove this theory, more researches with larger sample size and long-term follow-up need to be carried out.