OBJECTIVETo evaluate the effect of long-term Shexiang Baoxin Pill (SXBXP) administration on cardiovascular events in patients with stable angina pectoris (SAP).

METHODSA prospective randomized non-blind parallel controlled study was conducted in the early stage (the first 6 months) of the trial, then a cohort study was succeeded in the later stage. Two hundred patients with SAP, who visited the hospital between May 2005 and June 2006, were selected and randomly assigned to the trial group and the control group, 100 patients in each group. Both were treated with conventional therapy, including treatment for anti-platelet, blood lipid regulating, anti-ischemia, etc, and to patients in the trial group, SXBXP was administered additionally for 2 pills, three times a day by oral intake. The therapeutic course lasted for at least 6 months. All patients were followed up until January 2008, the clinical events and conditions of treatment were recorded. The composite terminal of various cardiovascular events was regarded as the primary endpoint.

RESULTSThe median follow-up time of the study was 2.25 years (ranging from 0.5 to 2.75 years). In the trial group, the occurrence (cases) was 23 for all-clinical event, 20 for primary-clinical event and 9 for angina pectoris event, which were lesser than those in the control group, 33, 29 and 19 cases respectively, showing a significant difference between groups (P < 0.05). The dosage of nitrates used in the trial was decreased more than that before treatment. Besides, all the incidences (cases), in terms of all-cause death (2 vs 5), cardiovascular death (1 vs 2), congestive heart failure (3 vs 4), stroke (2 vs 4), and other clinical (5 vs 6) events, as well as in the need for percutaneous coronary intervention or coronary artery bypass graft (2 vs 4), showed somewhat lowering in the trial group as compared with the corresponding items in the control group, but statistical analysis showed an insignificant difference between them (P > 0.05).

CONCLUSIONLong-term SXBXP administration could reduce the occurrence of angina pectoris events and some other clinical events, and cut down the dosage of nitrates used in patients with SAP.