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This study evaluated the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Wenxin Granules in the treatment of arrhythmia(ventricular premature beat and atrial premature beat) with deficiency of Qi and Yin. The multi-criteria decision analysis(MCDA) model was adopted, and the criterion layer and index layer were weighted by experts. CSC v2.0 was used for clinical comprehensive evaluation. This study embodies the clinical value of Wenxin Granules, promotes its safe, effective and rational use, and provides a basis for national medical decision-making. The multi-source evidence shows that the major adverse reaction of Wenxin Granules is gastrointestinal damage. According to the available studies, Wenxin Granules has controllable risk and thus is rated as grade B in terms of safety. The systematic evaluation of effectiveness shows that compared with antiarrhythmic western medicine, Wenxin Granules demonstrates improved clinical efficacy and electrocardiogram efficacy, which is supported by high-quality evidence, and thus the effectiveness of Wenxin Granules is evaluated as grade A. Economic research shows that Wenxin Granules is more economical than antiarrhythmic western medicine, which is supported by sufficient evidence and clear results, and thus the economy of this preparation is rated as grade B. The indications and contraindications of Wenxin Granules are clear and detailed to different types of arrhythmia, which, together with the precise positioning and prominent clinical innovation and industrial innovation, rates it as grade A in terms of innovation. The suitability of drug storage, prescription circulation, dosage form and course of treatment basically meet the clinical medication needs of doctors and patients, and thus the suitability of Wenxin Granules is evaluated as grade B. Because of the few restrictions and the sustainable resources of medicinal materials, the accessibility of Wenxin Granules is evaluated as grade A. The prescription compatibility focuses on the pathogenesis characteristics of deficiency of Qi and Yin, and there are more than 3 000 cases studied. Therefore, the characteristics of traditional Chinese medicine of Wenxin Granules are evaluated as grade B. Based on the evidence from all the above dimensions, Wenxin Granules has the clinical comprehensive value of class A and prominent characteristics of traditional Chinese medicine. It is suggested to include Wenxin Granules into the policy results related to basic clinical medication management according to the procedure.
Subject(s)
Humans , Anti-Arrhythmia Agents , Medicine, Chinese Traditional , Qi , Treatment Outcome , Ventricular Premature Complexes , Yin DeficiencyABSTRACT
This systematic review aims to evaluate the efficacy and safety of Wenxin Granules in the treatment of chronic heart failure with atrial fibrillation. Databases,such as CNKI,Wan Fang Date,VIP,PubMed,Cochrane Library,were electronically retrieved for relevant randomized controlled trials of Wenxin Granules in the treatment of chronic heart failure with atrial fibrillation. Two researchers independently screened out the literatures,extracted data according to the inclusion criteria,and conducted a quality assessment by the risk bias assessment tool in the Cochrane evaluation manual. Cochrane systematic evaluation software Rev Man 5. 3 was used for data analysis. Totally 11 randomized controlled trials,including 941 subjects. The intervention measures were the conventional treatment recommended by the guidelines combined with Wenxin Granules; and the control measures were the conventional treatment recommended by the guidelines alone. The results showed that compared with conventional treatment alone,Wenxin Granules combined with conventional treatment can better reduce the BNP level in patients with heart failure with atrial fibrillation( MD =-258. 18,95% CI[-464. 06,-52. 30],P= 0. 01) or NT-proBNP level,better improve left ventricular ejection fraction( MD = 6. 72,95%CI[4. 61,8. 84],P<0. 000 01),I~2= 65%,And the ventricular rate decreased more significantly( MD =-11. 66,95% CI[-15. 79,-7. 54],P<0. 000 01),and the cardiac function was improved more efficiently( RR = 1. 20,95%CI [1. 11,1. 31],P<0. 000 1),I~2= 23%.In conclusion,compared with the single administration of conventional Western medicine,the combined administration of Wenxin Granules has better effects in reducing the level of BNP or NT-proBNP,slowing down the ventricular rate,and improving the left ventricular ejection fraction,with fewer adverse reactions. However,due to the small sample size and the low quality of literatures included in this systematic review,it is shall be carefully applied in clinic. More rigorous randomized controlled trials shall be conducted to determine the efficacy of Wenxin Granules in improving cardiac function in the treatment of chronic heart failure with atrial fibrillation.
Subject(s)
Humans , Atrial Fibrillation/drug therapy , Drugs, Chinese Herbal/therapeutic use , Heart Failure/drug therapy , Randomized Controlled Trials as Topic , Stroke Volume , Ventricular Function, LeftABSTRACT
OBJECTIVE:To evaluate the effectiveness,safety and economy about Wenxin granules in the treatment of cardio-vascular diseases based on Meta-analysis. METHODS:Using“Wenxin granules”“Wenxinkeli”“Wenxin”as the search terms, searching PubMed,ProQuest,Springer,The Cochrane Library,CNKI,VIP and Wanfang data(Jan. 2000-Oct. 2015)through com-puter,relevant journals and conference papers by hand,randomized controlled trials about Wenxin granules in the treatment of car-diovascular diseases were screened and classified according to indications. Meta-analysis was performed by using RevMan 5.3 soft-ware,while cost-effectiveness analysis and minimum cost analysis were used for economic evaluation. RESULTS:Totally,38 liter-atures were involved,including 20 literatures of arhythmia,9 of premature ventricualr contraction,4 of coronary disease angina pectoris,3 of unstable angina pectoris,2 of pediatric viral myocarditis. Meta-analysis showed that compared with control drug, Wenxin granules showed better clinical efficacy for arrhythmia with less ADR;showed better clinical efficacy and ECG efficacy for premature ventricualr contraction with less ADR;showed better clinical efficacy for angina pectoris of coronary disease,unstable angina pectoris and pediatric viral myocarditis,with statistical significance (P<0.05). The incremental cost-effectiveness analysis showed that the additional cost of Wenxin granules in the treatment of above indications was worth it all,compared to control drug. Single factor sensitivity analysis supported the stability of results. CONCLUSIONS:Wenxin granules have a better effectiveness, safety and economy in the treatment of cardiovascular diseases,but still need high-quality evidence to support.
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To evaluate the efficacy and safety of Wenxin Granules (WG) in the treatment of arrhythmia using Meta-analysis. Cochrane library, PubMed database, Medline (Ovid) and MEDLINE In-Process & Other database, Embase (Ovid) Database, CNKI Database, VIP Database, and Wanfang Database were searched until June, 2013. The data of randomized controlled trials (RCT) of WG were chosen and extracted by two reviewers independently according to inclusion and exclusion criteria, and cross-checked and assessed in the quality and methodology. Meta analysis on all the data arecarriee out by using RevMan 5.0 software. There are totally 25 trials and 2 947 patients included. In the aspect of the effect of anti-arrhythmia: WG is better than Propafenone (OR=2.07; 95% CI: 1.52-2.83; P<0.00001), Metoprolol (OR=3.68; 95% CI: 2.11-6.41; P<0.00001), Mexiletine hydrochloride (OR=3.16; 95% CI: 1.75-5.72; P<0.0001), but is not significantly different with Amiodarone (OR=1.29, 95% CI: 0.90-1.85; P=0.16); In the improvement of ECG: WG is better than Propafenone (OR=2.39; 95% CI: 1.72-3.34; P<0.00001), but is not significantly different with Metoprolol (OR=1.80; 95% CI: 0.69-4.67; P=0.23); In the aspect of safety: the rate of gastric adverse reactions caused by WG is lower than that caused by Amiodarone (OR=0.54; 95% CI: 0.29-0.98; P=0.04); The rate of arrhythmia adverse reaction caused by WG is lower than that caused by amiodarone (OR=0.05; 95% CI: 0.02-0.16; P<0.00001). Conclusion: WG is effective and safe for arrhythmia, but more clinical study should be done to confirm the effective and safety.
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Objective To observe the treatment effect and relapse prevention of cardioversion of atrial fibrillation with Wenxin granules and amiodarone. Methods Sixty patients of chronic atrial fibrillation were divided randomly into treatment of Wenxin granules and amiodarone group (group A) and treatment of simple amiodarone gorup(group B),Thirty cases in each group. All cases were treated with amiodarone by intravenous drip along with oral amiodarone. Thirty cases in group A were treated with Wenxin granules (9 grams,per day) additionally for 4 weeks. Results Patients in group A resumed normal sinus rhythm significantly higher than that in group B. The increasing relapse tendency of atrial fibrillation was higher in group B within 6 months. Conclusion Drug combination with Wenxin granules and amiodarone has better effect than simple amiodarone in the relapse prevention of cardioversion of atrial fibrillation.
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OBJECTIVE: To observe the effect of Wenxin granules on heart function of patients with chronic congestive heart failure (CHF). METHODS: 82 CHF patients were randomly divided into treatment group and control group (n=41). Both groups were given routine treatment(alternative use digitalis,diuretic,vasodilator, ACEI, Beta-blockers according to patient’s condition). Treatment group were additionally administered with Wenxin granules for four weeks. The symptom and improvement of heart function of two groups were compared. RESULTS: The symptom and heart function of patients in both groups were improved remarkably. Treatment group was significantly superior to control group in curative effect (P
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OBJECTIVE:To evaluate the efficacy and safety of Wenxin granules for congestive heart failure (CHF).METHODS:Literatures about random controlled trails of Wenxin granules for CHF were retrieved from PubMed,EMbase,Cochrane,CBMdisc,CNKI while other relative research papers were searched by hands.Included studies were evaluated by methodological quality assessment and analyzed using RevMan5.0.0 software.RESULTS: Eight randomized controlled trials of Wenxin granules were included.The results of Meta-analysis showed the obvious effective rate and effective rate of improvement of heart function in patients with CHF or CHF complicated by ventricular arrhythmia (VA) in study group were better than in control group.The differences between study group and control group had no statistical significance.The obvious effective rate of improvement of VA and the levels of NSVT,PVBs and LVEF in patients with CHF complicated by VA in study group were superior to control group.The differences between study group and control group had statistical significance(P