| ObjectiveTo analyze and evaluate the evidence of Shexiang Tongxin Dropping Pill in treating coronary atherosclerotic heart disease,form recommendations and consensus,provide a reference for the rational application and future research of Shexiang Tongxin Dropping Pill.Methods1 Constructing the clinical problemsThe clinical problems of Shexiang Tongxin Dropping Pills in treating coronary heart disease were collected by sorting out the instructions,literature pre-retrieval,expert interviews and clinical application research.An expert meeting was held,and experts were invited to screen and finally construct the clinical problems using Nominal Group Technique.2 Comprehensive analysis and evaluation of evidenceAccording to the clinical problems,the literature inclusion and exclusion criteria were determined,search the databases Embase,Cochrane Library,MEDLINE,CNKI,VIP,WANFANG DATA,Sino Med,screening randomized controlled trials(RCTs)/systematic reviews that met the criteria and extracting literature data.The quality of the RCT was assessed using the risk of bias tool in the Cochrane Collaboration and the quality of the systematic reviews was assessed using the methodological quality assessment tool for systematic reviews.Evidence analysis was performed using Review Manager 5.4.1,adverse events were listed.The quality of the evidence was systematically reviewed with the GRADE system.3 Survey on patient wishes and valuesThe willingness and main influencing factors of patients to choose Shexiang Tongxin Dropping Pills for coronary heart disease were investigated nationwide.4 Forming recommendations and consensusAn expert meeting was held,and the Nominal Group Technique was used to formulate recommendations(supported by evidence)and consensus(supported by no evidence)of Shexiang Tongxin Dropping Pills in treating coronary heart disease based on the GRADE system.Results1 Constructing the clinical questionA total of 36 clinical problems of Shexiang Tongxin Dropping Pills in treating coronary heart disease were constructed.According to the PICO model,it is sorted as follows(if the problems can’t be sorted according to the PICO model,it is listed as other clinical problems):(1)Stable angina pectorisResearch object(participants,P): patients with stable angina pectoris;Intervention measures(intervention,I): western medicine loading Shexiang Tongxin Dropping Pills;Control measures(control,C): western medicine treatment;Outcome indicators(outcome,O):angina symptoms,exercise tolerance,Seattle Angina Scale score,nitroglycerin dosage,efficacy of TCM syndromes and cardiovascular events.(2)Unstable angina pectorisP: patients with unstable angina pectoris;I: western medicine loading Shexiang Tongxin Dropping Pills;C: western medicine treatment;O: angina symptoms,the Seattle Angina Scale score,the dosage of nitroglycerin,the efficacy of TCM syndromes and cardiovascular events.(3)Coronary slow flowP: patients with coronary slow flow;I: western medicine loading Shexiang Tongxin Dropping Pills/Shexiang Tongxin Dropping Pills;C: western medicine/blank control;O:angina symptoms,Seattle Angina Scale score and the efficacy of TCM syndromes.(4)Microvascular angina pectorisP: patients with microvascular angina pectoris;I: western medicine loading Shexiang Tongxin Dropping Pills/Shexiang Tongxin Dropping Pills;C: western medicine treatment/blank control;O: angina symptoms,exercise tolerance,Seattle Angina Scale score and the efficacy of TCM syndromes.(5)Perioperative period of acute myocardial infarctionP: patients with acute myocardial infarction during peri-interventional operation;I:western medicine loading Shexiang Tongxin Dropping Pills;C: western medicine treatment;O: postoperative myocardial perfusion,surgery Posterior left ventricular ejection fraction,efficacy of TCM syndromes and cardiovascular events.(6)Coronary heart disease and heart failureP: patients with heart failure caused by coronary heart disease;I: western medicine loading Shexiang Tongxin Dropping Pills;C: western medicine treatment;O: left ventricular systolic function,quality of life,exercise tolerance,TCM syndrome efficacy and NT-pro BNP.(7)Other clinical problems(1)For patients with stable angina pectoris,unstable angina pectoris,slow coronary flow,microvascular angina pectoris and acute myocardial infarction during peri-interventional surgery,can Shexiang Tongxin Dropping Pills be taken for preventing angina occurs before physical activity known to cause angina pectoris?(2)When patients with coronary slow flow and microvascular angina attack angina pectoris,is it possible to take Shexiang Tongxin Dropping Pills to relieve the symptoms of angina pectoris?(3)For patients with slow coronary flow and microvascular angina pectoris,can Shexiang Tongxin Dropping Pill alone improve the symptoms of angina pectoris when the condition is stable?2 Comprehensive analysis and evaluation of evidence26 literatures were finally included,21 pieces of evidence of low quality(C)and 5 pieces of evidence of very low quality(D)were formed after evidence analysis and quality assessment:(1)Stable angina pectorisWestern medicine routine loading Shexiang Tongxin Dropping Pills in treating stable angina pectoris can further reduce the frequency of angina pectoris[MD=-1.19(-2.34,-0.05),P=0.04](D),prolong the treadmill exercise time [MD=2.43(1.56,3.30),P < 0.00001](C),reduce the maximum depression amplitude of the ST segment of the treadmill ECG[MD=-1.33(-1.88,-0.78),P < 0.00001](C),increase the metabolic equivalent of the treadmill exercise [MD=1.12(0.39,1.85),P=0.003](C),improve the Seattle Angina Scale score[MD=8.42(6.78,10.07),P<0.00001](C),improve the efficacy of TCM syndromes [RR= 1.57(1.13,2.18),P=0.007](C);in terms of reducing the occurrence of cardiovascular events(C)and shortening the duration of angina pectoris(C),there was no statistical difference between conventional western medicine loading Shexiang Tongxin Dropping Pills and western medicine conventional treatment.A total of 4 RCTs reported adverse events.The incidence of adverse events in the western medicine loading Shexiang Tongxin Dropping Pill group was 0.94%,including one case of mild gastrointestinal reactions;the incidence of adverse events in the western medicine treatment group was 1.47%,including two cases of diarrhea and one case of dizziness.(2)Unstable angina pectorisWestern medicine loading Shexiang Tongxin Dropping Pills in treating unstable angina pectoris can further reduce the frequency of angina pectoris[MD=-2.41(-2.89,-1.93),P<0.00001](C),shorten the duration of angina pectoris [MD=-0.84(-1.42,-0.26),P=0.005](C);in terms of reducing the occurrence of cardiovascular events(C),there was no statistical difference between western medicine loading Shexiang Tongxin Dropping Pills and western medicine conventional treatment.A total of 3 RCTs reported adverse events.The incidence of adverse events in the western medicine loading Shexiang Tongxin Dropping Pill group was 1.38%,including one case of headache and one case of nausea;the incidence of adverse events in the western medicine treatment group was 4.14%,including three cases of headache,one case of nausea and two cases of palpitations.(3)Coronary slow flowWestern medicine loading Shexiang Tongxin Dropping Pills in treating coronary slow flow can further reduce the CCS angina pectoris grade [MD=-1.19(-1.36,-1.02),P<0.00001](C),improve the Seattle Angina Scale score [MD=67.19(49.92,84.46),P<0.00001](D);There was no statistical difference between western medicine loading Shexiang Tongxin Dropping Pills and western medicine conventional treatment in reducing the frequency of angina pectoris(C).No adverse events were reported in the RCT.(4)Microvascular angina pectorisWestern medicine loading Shexiang Tongxin Dropping Pills in treating microvascular angina pectoris can further prolong the patient’s treadmill exercise time [MD=51.62(21.87,81.36),P=0.0007](C),reduce the maximum ST segment depression amplitude of treadmill ECG [MD=-0.37(-0.68,-0.06),P=0.02](C);in terms of reducing the number of angina pectoris attacks(C),there was no statistical difference between western medicine loading Shexiang Tongxin Dropping Pills and western medicine conventional treatment.One RCT reported adverse events,and the incidence of adverse events in the western medicine loading Shexiang Tongxin Dropping Pill group was 5.56%,including three cases of palpitations,headache,dizziness,body heat and facial flushing;the incidence of adverse events in the western medicine treatment group was 5.77%,including three cases of palpitations,headache,dizziness,body heat and facial flushing.(5)Perioperative period of acute myocardial infarctionWestern medicine loading Shexiang Tongxin Dropping Pills in treating acute myocardial infarction during peri-interventional operation can further improve the TIMI blood flow classification of patients at 6 months after operation [RR=2.76(1.58,4.84),P=0.0004](C)and the left ventricular ejection fraction [MD=6.21(2.21,10.20),P=0.002](D),reduce cardiovascular events [RR=0.11(0.04,0.32),P<0.0001](C).There was one RCT reporting adverse events,the incidence of adverse events in the western medicine loading Shexiang Tongxin Dropping Pill group was 7.69%,including five cases of gastrointestinal reactions;the incidence of adverse events in the western medicine treatment group was 18.46%,including twelve cases of gastrointestinal reactions.(6)Heart failure cause by coronary heart diseaseWestern medicine loading Shexiang Tongxin Dropping Pills in treating heart failure caused by coronary heart disease can further improve the left ventricular ejection fraction[MD=5.39(1.90,8.89),P=0.002](C),reduce the level of left ventricular end-diastolic diameter[MD=-3.11(-4.45,-1.77),P<0.00001](C),decrease Minnesota Heart Failure Quality of Life Survey Score [MD=-12.61(-15.30,-9.92),P <0.00001](C),prolonge6-minute walking distance [MD=40.28(15.76,64.81),P=0.001](D),improve the efficacy of TCM syndromes [MD=-4.28(-5.06,-3.50),P<0.00001](C),reduce NT-pro BNP level[MD=-342.55(-545.32,-139.77),P=0.0009](D).A total of 3 RCTs reported adverse events,and the incidence of adverse events in the western medicine loading Shexiang Tongxin Dropping Pill group was 3.09%,including three cases of nausea,one case of abnormal liver function,one case of dry cough and one case of dizziness;the incidence of adverse events in the western medicine treatment group was 4.10%,including three cases of nausea,two cases of abnormal liver function,two cases of dry cough and one case of dizziness.3 Survey on patient wishes and valuesA total of 270 patients were investigated,including 45 patients each who suffer from stable angina pectoris,unstable angina pectoris,slow coronary blood flow,microvascular angina pectoris,peri-interventional acute myocardial infarction and heart failure caused by coronary heart disease.More than 85% of the patients expressed their willingness to choose Shexiang Tongxin Dropping Pills.The primary factor influencing patients to choose Shexiang Tongxin Dropping Pills is effectiveness,followed by safety,and finally economy.4 Forming recommendations and consensusAfter comprehensively considering evidence-based evidence,the balance of pros and cons,safety and economy,the experts formed a total of 22 recommendations(18 strong recommendations and 4 weak recommendations)and a total of 17 consensus.(1)Stable angina pectorisWestern medicine loading Shexiang Tongxin Dropping Pills in treating stable angina pectoris,the curative effect is more satisfying than the western medicine treatment and safe.It is recommended to load Shexiang Tongxin Dropping Pills in western medicine to reduce the frequency of angina pectoris(strong recommendation),shorten the duration of angina pectoris(strong recommendation),improve exercise tolerance(strong recommendation),Seattle Angina Scale score(strong recommendation)and TCM syndrome efficacy(strong recommendation),reduce the occurrence of cardiovascular events(weak recommendation);It is suggested that western medicine load Shexiang Tongxin Dropping Pills to reduce the dosage of nitroglycerin in patients,and it is suggested that patients take Shexiang Tongxin Dropping Pills to relieve angina symptoms before physical activity that can cause angina pectoris.(2)Unstable angina pectorisWestern medicine loading Shexiang Tongxin Dropping Pills in treating unstable angina pectoris,the curative effect is more satisfying than the western medicine treatment and safe.It is recommended to load Shexiang Tongxin Dropping Pills in western medicine to reduce the frequency of angina pectoris(strong recommendation),shorten the duration of angina pectoris(strong recommendation)and reduce the occurrence of cardiovascular events(weak recommendation);It is suggested that western medicine load Shexiang Tongxin Dropping Pills to reduce nitroglycerin dosage in patients,improve the score of Seattle Angina Pectoris Scale and the efficacy of TCM syndromes.It is suggested that patients take Shexiang Tongxin Dropping Pills to relieve angina pectoris symptoms before physical activity that can cause angina pectoris.(3)Coronary slow flowWestern medicine routine loading Shexiang Tongxin Dropping Pills in treating coronary slow flow,the curative effect is more satisfying than the western medicine treatment and safe.It is recommended to load Shexiang Tongxin Dropping Pills in western medicine to reduce the frequency of angina attacks(strong recommendation),reduce the CCS angina pectoris classification(strong recommendation)and improve the Seattle Angina Scale score(strong recommendation).It is suggested that patients take Shexiang Tongxin Dropping Pills to relieve angina pectoris symptoms before physical activity that can cause angina pectoris,take Shexiang Tongxin Dropping Pills to relieve angina pectoris symptoms when angina pectoris occurs,and can use Shexiang Tongxin Dropping Pills alone to improve angina pectoris symptoms when the condition is stable.(4)Microvascular angina pectorisWestern medicine loading Shexiang Tongxin Dropping Pills in treating microvascular angina pectoris,the effect is more satisfying than the western medicine treatment and safe.It is recommended to load Shexiang Tongxin Dropping Pills in western medicine to reduce the frequency of angina attacks(strong recommendation)and improves exercise tolerance(strong recommendation).Patients can take Shexiang Tongxin Dropping Pills to relieve angina pectoris symptoms before physical activity that can cause angina pectoris,take Shexiang Tongxin Dropping Pills to relieve angina pectoris symptoms when angina pectoris occurs and can use Shexiang Tongxin Dropping Pills alone to improve angina pectoris symptoms when the condition is stable.(5)Perioperative period of acute myocardial infarctionWestern medicine loading Shexiang Tongxin Dropping Pills in treating acute myocardial infarction peri-interventional surgery,the effiect is more satisfying than western medicine treatment and safe.It is recommended that the loading of Shexiang Tongxin Dropping Pills in western medicine can improve postoperative myocardial blood perfusion(strong recommendation)and left ventricular ejection fraction(weak recommendation),reduce the occurrence of cardiovascular events(strong recommendation).It is suggested that western medicine load Shexiang Tongxin Dropping Pills to improve the efficacy of TCM syndromes,it is suggested that patients take Shexiang Tongxin Dropping Pills to relieve the symptoms of angina pectoris before physical activity that can cause angina pectoris.(6)Heart failure cause by coronary heart diseaseWestern medicine loading Shexiang Tongxin Dropping Pills in treating heart failure cause by coronary heart disease,the effect is more satisfying than the western medicine treatment and safe.It is recommended to load Shexiang Tongxin Dropping Pills in western medicine to improve left ventricular systolic function(strong recommendation),reduce Minnesota heart failure quality of life survey score(strong recommendation),improve exercise tolerance(strong recommendation)and TCM syndrome efficacy(strong recommendation),reduce NT-pro BNP levels(weak recommendation).Conclusion1 Based on the current evidence,it is recommended to load Shexiang Tongxin Dropping Pills to reduce the frequency of angina pectoris,shorten the duration of angina pectoris,improve quality of life,TCM syndromes and exercise tolerance in patients suffer from stable angina;reduce the frequency of angina pectoris and shorten the duration of angina pectoris in patients suffer from unstable angina;reduce the frequency of angina pectoris,decrease CCS angina grade,improve quality of life in patients suffer from coronary slow flow;reduce the frequency of angina pectoris and improve exercise tolerance in patients suffer from microvascular angina;improve postoperative myocardial blood perfusion and reduce cardiovascular events in patients who suffer from acute myocardial infarction during peri-interventional surgery;improve left ventricular systolic function,exercise tolerance,quality of life and TCM syndrome in patients who suffer from heart failure caused by coronary heart disease.2 Based on the clinical experience of experts,loading Shexiang Tongxin Dropping Pills can reduce the dosage of nitroglycerin in patients who suffer from stable angina pectoris and unstable angina pectoris,improve the quality of life of patients suffer from unstable angina pectoris and microvascular angina pectoris,and improve TCM syndromes in patients suffer from unstable angina pectoris,microvascular angina pectoris,coronary slow flow and acute myocardial infarction during peri-interventional surgery;Shexiang Tongxin Dropping Pill can be used alone to prevent exertional angina pectoris,relieve symptoms in patients with coronary slow flow and microvascular angina pectoris during angina attack and relieve angina symptoms when their condition is stable,but the above suggestions are lacked of evidence,looking forward to relevant clinical research evidence in the future to improve the evaluation system of Shexiang Tongxin Dropping Pills. |
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