[Evaluation on tolerability and safety of long-term administration with shexiang baoxin pill in patients with coronary heart disease of stable angina pectoris].
OBJECTIVE
To evaluate the safety and tolerability of long-term (6 months) administration with Shexiang Baoxin Pill (SBP) in patients with coronary heart disease (CHD) of stable angina pectoris.


METHODS
Adopting randomized non-blinded and parallel controlled trial, 200 patients with CHD were randomly and equally assigned to the SBP group and the control group. Both received basic therapy for CHD, including anti-platelet, lipid regulating and anti-ischemia with additional SBP 2 pills, taken orally three times per day in the SBP group. They were followed up for 6 months. The drug tolerability and adverse drug reactions occurred in the observation period were recorded, and the laboratory indexes involving blood routine, liver function, renal function, blood glucose and blood lipids were detected before and after treatment.


RESULTS
The trial was completed in 92% of the patients, 5 patients withdrew in the SBP group and 11 patients in the control group; but none for the intolerable therapy. There were 1 case of adverse reaction related to SBP. No obvious change was found in blood glucose and blood lipids in the two groups before and after treatment. No serious adverse reaction and injury of liver and renal function or others happened.


CONCLUSIONS
Long-term administration of SBP has favorable clinical tolerability and safety for CHD patients.
Wang
Li-Jie
LJ
Department of Cardiology, Huashan Hospital of Fudan University, Shanghai.
Luo
Xin-Ping
XP
Wang
Yong
Y
D000787:Angina Pectoris / Q000188:drug therapy*; D003327:Coronary Disease / Q000188:drug therapy*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008516:Medicine, Chinese Traditional; D013607:Tablets
D004365:Drugs, Chinese Herbal; D013607:Tablets; C526712:shexiang baoxin