ABSTRACT
ObjectiveTo explore the effectiveness and safety of Yiqi Huoxue Formula （益气活血方， YHF） in the adjuvant treatment of chronic pulmonary heart disease （CPHD） and heart failure （HF）with qi deficiency and blood stasis pattern. MethodsOne hundred and twenty patients with CPHD and HF with qi deficiency and blood stasis pattern were allocated randomly into treatment group and control group， with 60 case in each group. The control group was given conventional basic western medicine， while the treatment group was given oral administration of YHF granules in addition， one dose per day. The treatment course for both groups was 8 weeks. The TCM symptom scores， Minnesota Life Quality Scale （MLHF-Q） scores， echocardiographic indicators including right ventricular end-diastolic diameter （RVEDD）， left ventricular end-diastolic diameter （LVEDD）， left atrial end-diastolic diameter （LAEDD） and pulmonary artery mean pressure （PAMP）， six-minute walking distance （6MWD）， and plasma N-terminal pro-B-type natriuretic peptide （NT-ProBNP） level were compared between the groups. The effectiveness regarding cardiac function and TCM syndromes were compared between the two groups after treatment， and the occurrence of adverse events was observed. ResultsWith two drop-outs both in the treatment group and control group， and 58 cases in each group were included in the outcome analysis. The total effective rate regarding cardiac function and TCM syndromes in the treatment group were 91.38% （53/58） and 96.55% （56/58）， respectively， significantly higher than the corresponding 70.69% （41/58） and 48.27% （28/58） in the control group （P＜0.05）. After treatment， the TCM symptom scores and RVEDD level were significantly reduced in the treatment group， and MLHF-Q score， plasma NT-ProBNP level and PAMP level decreased significantly， while 6MWD increased in both groups （P＜0.01）. Compared to those in the control group， the TCM symptom scores， MLHF-Q score， plasma NT-ProBNP level and PAMP level significantly decreased， while 6MWD increased in the treatment group （P＜0.01）. There were no obvious abnormalities in the blood， urine， stool routine and liver and kidney function indicators in both groups. One adverse reaction each occurred in both groups， and there was no statistically significant difference in the incidence rates（P＞0.05）. ConclusionYHF combined with conventional western medicine can significantly improve the clinical efficacy， improve the clinical symptoms and cardiac function， increase the quality of life and exercise tolerance， and is relatively safe.