Radix Sodium Chloride Injection In The Treatment Of Angina Pectoris (qdbs) Clinical Observation

ObjectivesTo evaluate through clinical trial the safety and efficacy of Astragalus Membranaceus Total Saponins Sodium Chloride(AMTSSC)Injection on Coronary Heart Disease Angina Pectoris with TCM syndromes of Qi deficiency and blood stagnation.And discuss its mechanisms.The AMTSSC Injection of this study is undergone PhaseⅡclinical trial,for providing theoretical basis for clinical application and promotion.Methods1 Clinical Data:The Guiding Principles for Clinical Research on New Drugs (Traditional Chinese Medicine)for Coronary Heart Disease Angina Pectoris(2002 Edition)was accorded for selecting cases with the diagnosed TCM syndrome of Qi deficiency and blood stagnation(of Coronary Heart Disease Angina Pectoris)for observation.All of the involved cases were divided into 2 groups(Treatment Group, n=27;Control Group,n=27;totally 54 cases)through random,double-blind and positive medicine parallel controlled method.The 2 groups were comparable due to the statistical P value greater than 0.1 in comparisons in general data,TCM symptoms and laboratory examinations,which indicated no significant difference.2 Drug Administration:100ml per bottle AMTSSC Injection was given to Treatment Group intravenously for one time each day,along with Buxinqi oral liquid stimulant for 10ml per time for 3 times a day.The Control Group was given 100ml per bottle tetramethylpyrazine hydrochloride in sodium chloride injection intravenously for one time per day,along with Buxinqi oral liquid stimulant for 10ml per time for 3 times a day.Both groups received 2 weeks' treatment.Medicines for Coronary Heart Disease Angina Pectoris except nitroglycerin were prohibited during the trial.3 Observation Indexes:All patients received examinations of blood,urine,feces, liver function(AST,ALT)and kidney function(Cre,BUN);Symptoms of angina pectoris such as times for painful onset,severity of pain,duration and intake dose of nitroglycerin were recorded once a week,along with relevant symptoms and signs such as TCM syndromes,tongue,pulse,heart rate,heartbeat rhythm,blood pressure, and electrocardiogram etc.4 Statistical Analysis:DAS for Clinical Trial 2.0 software was used.For measurement data,t -test,paired t -test,rank sum test,Wilcoxon rank sum test and median test were applied;and for enumeration data,Chi-square test,Fisher's Exact Test;and the rank data were analyzed with Ridit analysis,CMH method.Results1 Therapeutic effect for angina pectoris:for symptoms of AP in Treatment Group, obvious effective rate was 29.6%,total improvement rate was 66.7%;for Control Group,respectively 25.9%and 74.1%;and the two groups were statistically no difference(P＞0.05).Both groups can lower AP score and reduce the AP onset,and obvious differences were demonstrated when comparisons were made before and after treatment for each group(P＜0.01),whereas no significant differences between the 2 groups(P＞0.05),which indicated an equivalent effectiveness between the 2 groups on treating AP,lowering AP score and reducing AP onset frequency.2 Efficacy on ECG:In Treatment Group,the obvious effective rate was 14.8%,total improvement rate was 48.1%;for Control Group,respectively 22.2%and 48.1%;and no differences were statistically observed between the two groups(P＞0.05).Both groups can decrease the total reduction of ST segment in every leads,and obvious differences were demonstrated when comparisons were made before and after treatment for each group(P＜0.01),whereas no significant differences between the 2 groups(P＞0.05),which indicated an equivalent effectiveness between the 2 groups on improving ECG.3 Efficiency on TCM syndromes:In Treatment Group,the total obvious effective rate was 29.6%,total improvement rate was 85.2%;for Control Group,respectively 37% and 92.6%;no significant differences were observed between the two groups(P＞0.05). Both groups can decrease the total score of TCM syndromes,and obvious differences were demonstrated when comparisons were made before and after treatment for each group(P＜0.01),whereas no significant differences between the 2 groups(P＞0.05), which indicated an equivalent effectiveness between the 2 groups on improving TCM syndromes and lowering total score of TCM syndromes.4 Analysis on Safety:No untoward reactions and abnormalities were observed both in clinical observations and laboratory examinations.ConclusionsAstragalus Membranaceus Total Saponins Sodium Chloride Injection has been proved efficient through intravenous application in treating Coronary Heart Disease Angina Pectoris with TCM syndromes of Qi deficiency and blood stagnation,along with no statistical differences observed in comparisons on main indexes with that of Control Group(Buxinqi oral liquid stimulant plus tetramethylpyrazine hydrochloride in sodium chloride injection combined therapy).Indexes of safety manifested no abnormality.