| Objectives To evaluate the anti-anginal efficacy and the safety of ranolazine in combination with conventional treatment in patients with stable angina pectoris and observe the effects of ranolazine on Visfatin and high-sensitivity C-reactive protein.Methods A completely randomized controlled study was performed on a total of40Patients (including23males and17females) with stable angina pectoris. The patients with basic treatment were randomly assigned to a test group basic (ranolazine,500mg bid, n=20) or a contrast group basic (placebo,500mg bid, n=20). Treadmill exercise testing was adopted and the following indexes were measured at baseline and after8weeks:(1) numbers of angina episodes per week, numbers of nitroglycerin consumption per week, the Seattle Angina Questionnaire (SAQ) score;(2) exercise duration, time to lmm ST-segment depression, the maximum ST segment depression, hemodynamic parameters at rest and during maximum exercise. The serum Visfatin levels were determined by ELISA. Adverse effects of drugs were monitored during the following-up.Results1. After8weeks of treatment, all parameters remained unchanged in the placebo group. But numbers of angina episodes decreased from (7.5±3.5) to (2.5±2.6)(-66.7%, P<0.01), numbers of nitroglycerin consumption decreased from (4.5±3.6) tablets to (1.2±2.0) tablets (-73.3%, P<0.01), the physical limitation score increased from(41.4±11.5) to (55.4±10.1)(33.8%, P<0.01), the anginal stability score increased from(47.5±7.7) to (72.5±11.2)(52.6%, P<0.01), the angina frequency score increased from(31.0±13.3) to (59.0±21.0)(90.3%, P<0.01), the treatment satisfaction score increased from(45.0±7.9) to (58.5±10.4)(30%, P<0.01), the disease perception score increased from(44.2±12.8) to (53.3±11.6)(20.6%, P<0.01) in the treatment group.2. After8weeks, the exercise duration increased from (791.6±133.5) s to (843.7±115.5) s (52.1s, P=0.038), the time to1mm ST-segment depression increased from (670.7±158.5) s to (753.1±109.5) s (82.4s, P=0.008), the maximum ST segment depression decreased from (1.80±0.63) mm to (1.55±0.57) mm (-0.25mm, P=0.005) in the treatment group. However, there were no significant changes before and after treatment in the control group (P>0.05). Besides, the hemodynamic parameters at rest and during maximum exercise did not change significantly in the two groups (P>0.05).3. The difference of serum Visfatin and hsCRP was not significant between the two groups at baseline. After8weeks, the levels of Visfatin were reduced from (17.99±1.91) μg/L to (15.89±1.28) μg/L (p<0.01), the levels of hsCRP declined from (3.45±2.10) mg/L to (1.95±1.51) mg/L (p<0.01) in the treatment group. In the control group, there were no significant changes before and after treatment (P>0.05).4. Person related analysis showed that the serum levels of Visfatin, hsCRP had a positive correlation(r=0.661, p<0.01).5. During the observation, there were no adverse events including allergic reaction, myocardial infarction, sudden cardiac death and other serious incidents in two groups before and after treatment in patients with stable angina pectoris. Meanwhile, the blood sugar, creatine kinase isoenzyme, liver and kidney function were not significantly different before and after treatment between two groups (P>0.05). The corrected QT interval prolonged from (414.5±26.7) ms to (421.7±26.2) ms (7.2ms, P<0.05), without any arrhythmia.Conclusion1. Ranolazine can reduce numbers of angina episodes per week, numbers of nitroglycerin consumption per week, and improve the quality of life in patients with stable angina pectoris.2. Ranolazine can increase exercise tolerance in patients with stable angma pectoris.3. Ranolazine can decrease the serum level of Visfatin, hsCRP in stable angina pectoris, suggesting its possible anti-inflammatory effect.4. Ranolazine is a safe agent for stable angina pectoris without obvious adverse reactions. |
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