OBJECTIVETo evaluate the efficacy and safety of Fulu Baoxinping (FLBXP) oral liquid in the treatment of coronary heart disease patients with premature ventricular beat (PVB), differentiated as qi-yin deficiency with phlegm-stasis syndrome type.

METHODSAdopting randomized, double-blinded, double-simulated, positive drug parallel controlled and multi-centered clinical research method, 240 patients enrolled were randomly assigned equally to the treatment group treated with FLBXP 10 mL (containing 13.33 g of crude drug) thrice a day and the control group treated with Wenxin Granule 9 g thrice a day. Meanwhile, simulator of the test or positive control drug was given to them all correspondingly. The therapeutic course for them all was 28 days. Efficacy on PVB and TCM syndrome was observed.

RESULTSThe markedly effective rate and total effective rate on PVB were 55.0% and 78.4% in the treatment group, and 37.2% and 53.1% in the control group, significant difference between groups was shown in comparison of both indexes (P < 0.05). Dynamic ECG showed the total number of PVB decreased for 3460.59 +/- 6516.56 beats/24 h in the treatment group, and for 2148.36 +/- 5129.47 beats/24 h in the control group, difference between them showed no statistical significance (P > 0.05). The TCM syndrome score in both groups was markedly decreased after treatment when compared with before treatment (P < 0.01); the differences of the treated and the control groups were -9.34 +/- 4.21 and -8.08 +/- 4.33 respectively, showing sigificant difference (P < 0.05).

CONCLUSIONFLBXP oral liquid has certain effect on PVB in CHD patients of qi-yin deficiency with phlegm-stasis syndrome type, no obvious adverse reaction was found in the clinical trial.