Clinical Study Of Trimetazidine Combined With Coenzyme Q10 On Radiation-induced Myocardial Injury

ObjectiveThe purpose of this clinical trial is to investigate whether the use of trimetazidine combined with coenzyme Q10 can protect the radiation myocardial injury.And the two drugs were used in the early stage of chest radiotherapy to evaluate the protective effect,preventive effect and drug safety of radiation-induced myocardial injury.MethodsAccording to the selection criteria and exclusion criteria,177 patients with chest radiotherapy from November 2019 to December 2020 were collected from radiotherapy department of Gansu Provincial Hospital,Gansu Provincial Cancer Hospital and Lanzhou University Second Hospital.We divided the patients into the experimental group and the control group by the different treatment randomly.All patients were treated with chest radiation thearpy according to clinical condition after admission.The patients who were in the experimental group were treated with Trimetazidine Dihydrochloride Modified Release Tablets(20mg,tid)and Coenzyme Q10 Capsule(10mg/day,tid)for 30 days.The patients who were in the control group were given the conventional treatment.We would adjust the dosage of the drug according to the patient’s condition.The baseline data of the patients were obtained by asking the history diseases and recording the test data.We observed the clinical efficacy by the laboratory indexes[high sensitivity cardiac troponin T(hs-cTnT),N-terminal B-type natriuretic peptide(NT-pro-BNP),lactatedehydrogenase(LDH),creatine kinase-MB(CK-MB)],the electrocardiogram indexes[heart rate(HR),P-R interval,interval,abnormal electrocardiogram changes],the echocardiography indexes[longitudinal fraction shortening(LFS),early to late diastolic transmission the changes of flow velocity(E/A),left ventricular ejection fraction(LVEF)]and the main adverse cardiovascular events(acute myocardial infarction,heart failure,serious arrhythmia,etc.)in the different time of the two groups.The changes of the indexes in different time and the occurrence of adverse cardiovascular events in the experimental period were compared to analyze whether trimetazidine combined with coenzyme Q10 had protective and preventive effects on the radiation myocardial injury between the two groups.Results1.Comparison of clinical baseline data between the two groupsThere was no statistical significance between the two groups in baseline data,such as age,sex,height,BMI,number of smoking history,number of drinking history,number of hypertension history,number of diabetes history,cumulative irradiation dose,laboratory examination indexes,ECG indexes and echocardiography indexes(P>0.05).2.Comparison of laboratory indexes between two groupsThe trend of hs-cTnT in the experimental group and the control group was first increased and then decreased;the trend of CK-MB in the experimental group was not obvious and was first increased and then decreased in the control group,while the increase amplitude was higher than the experimental group at different time points;the trend of LDH in the control group was first increased and then decreased,but the LDH in the experimental group was not obvious;the trend of NT-proBNP was first decreased and then increased in the experimental group and the trend of increased continuously in the control group,the overall increase of the NT-proBNP in control group was always higher than it in the experimental group.When comparing the interaction between groups,time points and groups·time points,only hs-cTnT level had statistical significance(P<0.05);CK-MB level had statistical significance only between groups(P<0.05);LDH level had statistical significance only in different time points(P<0.05).In addition,other indicators had no statistical significance(P>0.05).3.Comparison of ECG indexes between two groupsThere were 5 cases with ECG abnormal(10.4%)in the experimental group,including 3cases with ST-T change(6.2%),1 case with sinus tachycardia(2.0%),1 case with sinus bradycardia(2.0%),and 54 cases(48.2%)in the control group,including 22 cases with ST-T change(19.6%),4 cases with first degree atrioventricular block(3.6%),10 cases with sinus tachycardia(8.9%),3 cases sinus with bradycardia(2.7%)and 8 cases with atrial premature(7.1%).The incidence of ST-T change(χ~2=2.063,P=0.033<0.05)and ECG abnormality(χ~2=1.741,P=0.000<0.05)in the two groups were statistically significant.The trend of P-R interval in the experimental group was first increased and then decreased slightly,while the control group was continuously increased.The P-R interval in control group was significantly higher than the experimental group in one month and three months after radiotherapy;the change of QTc interval in the experimental group was first increased and then decreased slightly,and the control group was increasing continuously;there were no obvious changes in heart rate between the experimental group and control group.When comparing the ECG indexes between the two groups,only the differences of QTc interval time between groups,time points,interaction between groups and time points were statistically significant(P<0.05);the differences of P-R interval time between groups were statistically significant(P<0.05);the differences of heart rate level were not statistically significant(P>0.05).4.Comparison of echocardiography indexes between two groupsThe LFS and LVEF between the experimental group and control group had no significant changes during the experimental peroid.The differences between the two groups in LVEF were statistically significant(P<0.05),and there were no significant differences between the other indexes(P>0.05).To the end of this clinical trial,there were 2 patients with E/A<1 in the experimental group(4.2%)and 5 patients with E/A<1 in the control group(4.6%).There was no statistical difference between the two groups(χ~2=2.032,P=0.154>0.05).5.Safety assessment of trimetazidine and coenzyme Q10During the clinical trial and the follow-up time,the subjects in the experimental group had stable vital signs.There were no common adverse reactions of two drugs and no serious cardiovascular events recorded.Conclusions1.The combined use of coenzyme Q10 and trimetazidine has protective effect on radiation-induced myocardial injury.2.The combination of two drugs has preventive effect on the radiation myocardial injury in the early stage of chest radiotherapy and the combination of the two drugs has higher drug safety.