Objective:

2

To investigate the effect and safety of Guanxinning Tablet (冠心宁片

GXN) for the treatment of stable angina pectoris patients with Xin (Heart)-blood stagnation syndrome (XBSS).

Methods:

2

One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN (80 cases) or placebo (80 cases

Guanxinning simulation tablets

mainly composed of lactose)

4 tablets (0.38 g/tablet)

thrice daily for 12 weeks. After treatment

an exercise stress test (treadmill protocol)

Chinese medicine (CM) syndrome score

electrocardiogram (ECG)

and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile

adverse events (AEs) were evaluated during the whole clinical trial.

Results:

2

Compared with the control group

the time extension of exercise duration in the GXN group increased 29.28±17.67 s after treatment (

P

>

0.05); moreover

the change of exercise duration in the GXN group increased 63.10±96.96 s in subgroup analysis (

P

<

0.05). The effective rates of angina pectoris

CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%

90.67%

45.76%

and 70.73%

respectively in the GXN group

which were all significantly higher than those in the control group (40.58%

75.36%

26.92%

28.21%

respectively

P

<

0.05).

Conclusion:

2

GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets

thrice daily.