Based On "The Real World" To Evaluate The Efficacy Of Qiliqiangxin Capsule In The Treatment Of Heart Failure

Background:In the effective and progressive prevention and control of cardiovascular disease (CVD), we are taking the exploration especially in the last step of cardiovascular continuum. Clinical mechanism is almost perfect, and drug therapy has made great progress, but, the morbidity and mortality of CVD is rising yearly worldwide.In recent years, with the development of evidence based medicine, people are paying more and more attention on Qiliqiangxin capsule, which is recommended in 2014 China heart failure diagnosis and treatment guidelines. In reality, the condition of heart failure is complicated. Many factors are related to it, including the severity, concomitant disease, drug combination, age, and so on. The further study is needed to confirm if the real effect of Qiliqiangxin capsule is related to the factors. To definite effect of Qiliqiangxin capsule in the treatment of chronic heart failure in reality and to provide the basis for clinical application, we carry out the research on the subject.ObjectiveComparing with the artical 《A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of the Effects of Qili Qiangxin Capsules in Patients With Chronic Heart Failure》 (RCT for short), which published in JACC of 2013, to observe and to evaluate the effect of Qiliqiangxin capsule in the treatment of heart failure in the real world, and to analyze the differences of the data and the possible influence factors. In brief, to provide the basis for the clinical application of Qiliqiangxin capsule.MethodsIt was a prospective observational study. The subjects were patients diagnosed with chronic heart failure in Guangdong Province Hospital of TCM, followed up and taking the medicine of Qiliqiangxin capsule for more than 3 months. In the study, we gathered evaluating cardiac function of the patients, LVEF before and after treatment, a specific quality of life (QOL) scale, adverse events, re-admissions, and general information, including the case number, age, sex, weight, syndrome types in TCM, basic vital signs, and related laboratory exams. Established a database, and used SPSS19.0 software for data analysis. The count data were analyzed with chi-square test or exact probabilities in fourfold table, while the measurement data was the mean standard deviation. Comparisons between each groups were analyzed by t test or the rank sum test. The analysis of the influence factors was linear correlation or logistic regression. A p-value less than 0.05 was considered statistically significant (P=0.05).Results1. There were 200 patients included corresponding to diagnosis standards of chronic heart failure.177 patients completed clinical trials, in the study, 23 cases shedding due to imperfect of data and death events.2. After 3 months of clinical observation, we found that NT-pro BNP level in the plasma of the patients were lower than the baseline level (p<0.05). That NT-pro BNP level in the plasma reduced by 30% was deemed valid, finally, the overall level of 177 cases reduced by 48.02%. Qiliqiangxin capsule played an important role in improving NYHA cardiac functional grading, LVEF, and quality of life. NT-pro BNP level in the plasma reduced sequentially in edema syndrome due to Yang deficiency, Heart Yang deficiency, phlegm-stasis in channels, and other syndrome types in TCM, and the level of EF gradually rised. NYHA cardiac functional grading, LVEF, and NT-pro BNP level in the plasma had significant difference before and after treatment in respective syndrome types in TCM (p<0.05). Compared among them, edema syndrome due to Yang deficiency, Heart Yang deficiency, and phlegm-stasis in channels were significantly different from other syndrome types in TCM (p<0.05). Edema syndrome due to Yang deficiency, Heart Yang deficiency, and phlegm-stasis in channels had no statistical difference.3. By observing clinical cases in reality, the progressive functional deterioration of chronic heart failure related to age, bad lifestyle habits, such as smoking and drinking, and laboratory exams, such as UA and glucose. However, there was a negative correlation between the indexes and the curative effect of Qiliqiangxin capsule.Conclusion1. In clinical studies, the "real world", Qiliqiangxin capsule in the treatment of heart failure a significant effect. Compared with published in JACC rigorous RCT test each observation indicators not showing a significant difference.2. In clinical studies, the "real world", Qiliqiangxin capsule broad scope of use, security is good, especially for the elderly elderly patients.3. The issue of blood glucose, liver function, uric acid level, age, body mass index, smoking, alcohol consumption, duration and other related indicators may affect the ultimate efficacy of the drug.