| BackgroundChronic Heart Failure(CHF),which is also called Chronic Congestion Heart Failure,is the termination and the main fatal reason of most heart diseases.According to WHO,the morbidity of CHF in common people came to 1.3%～5.6%,which increase continuously with aging.Approximately 5 million patients in the USA have HF.Each year over 550,000 patients are diagnosed with HF for the first time and nearly 300,000 patients died of HF.The European Society of Cardiology represents countries with a population of＞900 million,and there are at least 15 million patients with HF in those 51 countries.Overall 50%of patients are dead at 4 years and 40%of patients admitted to hospital with HF are dead within 1 year.In our country, according to a random sampling investigation of 15518 inhabidents among 35 to 74 years old in 2002,the morbidity of HF is 0.9%,which adds up to 4 million.The number of the HF patients inceases gradually because of aging,and it is estimated that at present there are over 6 million patients.Consequently,heart failure is a major and growing pubilic health prlblem not only in our country but all over the world.During the past ten years,we knew more about the nature and pathomechanism of CHF with the further research on the CHF mechanism.It has been known that the excess activation of the Renin - angiotensin - aldosterone system(RAAS) and the Sympathetic nervous system(SNS),especially the former,plays an important part in the process of starting cardiac remodling and the change from remodling to HF.The effect of the drugs that resist the remodling,including Angiotensin-converting enzyme inhibitor(ACEI) and AngiotensinⅡreceptor antagonist(ARB) have been confirmed by a a great many EBM studies and recommended by the guidelines. However,the admission rate and mortality are still high though we have used ACEI and ARB,even durg combination.Therefore,it is necessary for us to make further study of CHF drugs.Traditional Chinese Medicine,which has a long history,has been improved rapidly with the development of the modern technology in the late 20 century.The old TCM prescription Shengmai San has become one of the most improtant ways of curing heart diseases after being changed into injection.According to pharmacology studies,Shengmai injection has the advantages of asepsis,safeness and effect,which is used wildly in qi and yin deficiency of acute myocardial infarction,cardiogenic shock,toxic shock,hemorrhagic shock,coronary heart disease,chronic heart failure and so on.Lots of studies reported that Shengmai injection has a good and safe effect on curing CHF,which not only resist the adverse effect of the western medicine,but also coordinate with the western medicine,so it is an useful drug for CHF.We may conclude that it is worthwhile to investigate the combination of the conventional therapy and Chinese drugs pharmaceutics in CHF therapy.Nevertheless,although there are many clincal reports about Shengmai injection,the problems such as lack of empirical researches,small scale,low quality,dim indications,different dose and duration still exisit,so how to use Shengmai injection mainly depends on experiences. Consequently,the systematic,strict reviews and analysises for the clinical trials of CHF therapy with Shengmai injection are very necessary and urg.Systematic reviews are different from troditional description reviews.According to the epidemiological principles and methods which can reduce bias and random errors,they collect the pubished and unpublished clinical trials on a concrete clinical problem all over the world from which they select the literatures meeting the criterion, make qualitative and quantitative analysises,then make a reliable conclution eventually.And quntitative analysis,also called Meta-analysis can reflect the results more precisely by mathematics,which combine reviews and statistics together.So Mata-analysis was used more widly. ObjectiveTo systematicall evaluate the therapeutic efficacy of Shengmai Injection(SMI) on the effective rate of the patients with chronic heart failure(CHF).Methods1.Set out inclusion and exclusion critera and for analysis according to the requests of systematic review,including the characteristics of the subjects,interventions and measure indexes.2.Literature associated with randomized controlled trials(RCT) or quasi-RCT of SMI in treating patients with CHF were retrieved by computerized searching from Cochrane Central Register of Controlled Trials,PudMed,EMBASE,OVID,Chinese Biological Medicine Database,CNKI,VIP and those in Chinese Conference Treatises in cardiovascular diseases were hand searched.3.Assess the quality of eligible trials independently using a predefined quality assessment tool including a rating of allocation sequence and concealment,blinding and completeness of primary outcome reporting with the method recommended in Cochrane Reviewer's Handbook 4.2.6.4.Use the Review Manager(RevMan) version 4.2 to perform the meta-analysis. Dichotomous and continuous data were calculated as relative risk(RR) and weighted mean differences(WMD) respectively.If no heterogeneity was detected between included trials,a fixed-effect model was used to perform meta-analysis.Results1.Description of studiesA total of 19 studies were included into the review.They reported that patients with CHF were randomly allocated into shengmai plus usual treatment group or usual treatment group.All the trials included a total of 1440 patients.Of these,754 were in shengmai group who were treated with shengmai Injection plus usual treatment,while 686 were in the ccntrol group which were treated as usual.There is no statistical significant differences on the base line comparability between the two groups in all the trials(P＞0.05).There were variations in dosage of shengmai from 20 to 200 mL per day.The duration of treatment varied from 10 to 30 days. 2.Results of meta-analysis2.1 NYHA classification of clinical statusAs no heterogeneity was detected between included trials,a fixed-effect model was used to perform meta-analysis.It was shown that on the change of NYHA class shengmai group had more benefit(RR 1.28,95%CI 1.21,1.36) compared with the control group(P＜0.00001).2.2 Data of Doppler echocardiography(1) Left ventricular ejection fraction(LVEF)Seven trials provided data for LVEF.A random-effect model was used and shengmai group showed a significant increase on LVEF(WMD 7.42,95%CI 4.79, 10.05) compared with the control group(P＜0.00001).(2) Stroke volume(SV)Three trials compared the change of SV.A fixed-effect model was used and there was statistically significant difference in improving SV(WMD 4.78,95%CI 3.17, 6.40) by combining with shengmai(P＜0.0001).(3) Cardiac output(CO)Four trials provided data for CO.Shengrnai group showed a significant increase on CO(WMD 0.48,95%CI 0.16,0.81) compared with the control group(P=0.004).(4) Cardiac index(CI)Four trials provided data for CI.Shengmai group showed a significant increase on CI(WMD 0.74,95%CI 0.50,0.99) compared with the control group(P＜0.00001).(5) Left ventricular minor axis shortened rate(FS)Three trials provided data for FS.No significant difference in FS(WMD -0.05, 95%CI -0.01,0.12) between the two groups(P=0.10).(6) E/A ratioTwo trials compared E/A ratio between the two groups.It showed that shengmai group showed a significant increase on E/A ratio(WMD 0.11,95%CI 0.05, 0.16)compared with the control group(P=0.001).2.3 Other indexes (1) Heart rate(HR)Five trials provided data for HR.A random-effect model was used to perform the meta-analysis.No significant difference in heart rate(WMD -5.99,95%CI -16.03, 4.05) between the groups(P=0.24).(2) Cardiothoracic ratio(CTR)Two trials provided data for CTR.A fixed-effect model was used to perform the meta-analysis.No significant difference in CTR(WMD -0.03,95%CI -0.07,0.01) between the groups(P=0.15).2.4 Adverse effectsTen trials obsvered the adverse effects of Shengmai Injection.Of these,six reported that no adverse effects were found at the end of treatment,while four recorded the number of the patients who had side effects after using Shengmai Injection and described their symptoms.However,nine trials did not mentioned any information about adverse effects.ConclusionsThis review found 19 possibly controlled clinical trials of the use of Shengmai Injection in addition to usual conbentional Western drugs in the treatment of CHF. Benefits of shengmai were reported,in comparison with usual treatment alone,on clinical outcomes including effective rate,LVEF,CO,CI,SV and so on.No severe adverse effects were reported.However,the evidence for any benefit of is very weak, as the original trials were all of low quality.The effect of shengmai injection in the treatment of heart failure must be determined in a properly controlled clinical trial. On the other hand,life quality of CHF patients should also be considered in outcome selection in the future.
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