Study On Hospital Registration Of Songling Xuemaikang Capsule In The Treatment Of Essential Hypertension Based On The Real World

ObjectiveTo observe the effects and safety of Songling xuemai kang capsule(SLXMK)on patients with essential hypertension(EH),also to access traditional Chinese medicine(TCM)syndrome effects,the reasons for doctor to use SLXMK,the satisfaction for patients with clinical efficacy,the combination therapy and safety in clinical practice of SLXMK.MethodReal-world study of the clinical research method is used.The patients with EH taking SLXMK are choosed in consecutive.The research can not pick out and miss the object in study,until the design of a good number cases completed.The object of study without prior grouping,or the queue divided in actual medical conditions.The drug is used according to the package insert or doctor's clinical experience.The patient's diagnosis,treatment,efficacy and safety situation are accurately recorded in real conditions.The patients are observed for eight weeks,once every two weeks follow-up,to record blood pressure(BP),clinical symptoms and concomitant medications during the study.After the data collection,depending on the different purpose,the data naturally divided into several groups to analysis.2974 cases had been selected,and1544 in traditional Chinese medicine group(TCM)and 1430 in Combine traditional Chinese and western medicine group(TCM+WM).BP effects:Using generalized boosted models(GBM),estimated the propensity score to compared BP changes before and after treatment between two groups.First,according to the actual situation of data,medical professional knowledge and propensity score conditions to define confounding factors between the TCM and TCM+WM;Second,using GBM for propensity score and to get the relative impact of confounding factors on two groups randomly assigned;according to K-S and P value to evaluate balancing effect before and after GBM.Third,by building multiple linear regression unweighted,propensity score weighted linear regression,and propensity score weighting combined covariate-adjusted linear regression three models to assess changes in BP before and after the treatment between two groups from different angles.The repeated measures data were analyzed by generalized estimating equation model(GEE)and conclusions weredrawn according tothe estimating of parameter and standard error.Whether to consider confounding factors to build two GEE models to compared the difference of BP efficacy among different time,treatment groups,and BP classification and discussed the BP efficacy of TCM and TCM+WM on SBP and DBP.BP target achievement:Non-parametric test used to compare the differences between two groups of BP target achievement at each treatment time point.Clinical symptoms:Non-parametric test used to compare the improvement of clinical symptoms before treatment and in eight weeks.Combination therapy:According to the study of combined medication recorded,classified the drugs' categories used.Summarized the types of western medicine antihypertensive drugs to find the most commonly used categories and combination therapy.Completion of clinical trial:After the study patients to continue taking medication were observed.We also focused on patients' medication during the study and patients' satisfaction with the efficacy of drugs,the reason of the researchers used drugs also be analyzed.Security:Adverse reactions to the study appearing were analyzed.ResultGBM model defined 42 confounding factors,according to the relative influence ranking between two groups of random assignment,ranked in the top ten were risk stratification,weight,waist circumference,blood pressure classification,duration,heart rate,TCM syndrome differentiation,dizziness,target organ damage(heart),and headache.After transforming categorical variable into dummy variables,97 collaborators variables were weighted by GBM,and K-S and P values were known to each confounding factors.No significant difference between two groups were observed(P>0.05).By building three multiple linear regression models to assess the efficacy of the two groups on BP.The results showed that,TCM+WM was superior to TCM at each treatment time point for SBP(P<0.001 or P<0.01).TCM was as effective as TCM+WM at each treatment time point for DBP(P>0.05).Using GEE model to compare the efficacy of SBP at different treatment time,group and BP classification,for the clinical efficacy of SBP,TCM was as effective as TCM+WM in lever 1 hypertension(P>0.05)and TCM+WM was superior to TCM in lever 2-3 hypertension(P<0.001)at each treatment time point.However,for the clinical efficacy of DBP,TCM was as effective as TCM+WM in lever 1-2 hypertension(P>0.05)and TCM+WM was superior to TCM in lever 3 hypertension(P<0.001)after 2 weeks,4 weeks and 6 weeks treatment.After 8 weeks of treatment,TCM+WM group was superior to TCM in leverl and 3 hypertension(P<0.001),and both groups showed similar efficacy in lever2 hypertension(P>0.05).BP target achievement of two groups gradually increased as the treatment time increased.After 8 weeks,TCM BP target achievement was 62.0%,and the TCM+WM 64.3%.The difference was not statistically significant in at each time point(P>0.05).After 8 weeks,clinical symptoms improved significantly compared with before(P<0.001),and the more obvious symptoms as dizziness,headache,insomnia,fatigue and palpitations.In the process of clinical trials,combined with western medicine antihypertensive 48.08%,antihyperlipidemic 12.27%,coronary heart disease drugs 9.68%,hypoglycemic agents 2.35%,cerebrovascular disease drugs 3.50%.The classes of antihypertensive drugs used in combination was calcium channel blocker(CCB),angiotensin receptor blocker(ARB),angiotensin-converting enzyme inhibitor(ACEI),?-blockers,thiazide diuretic,two components of compound preparation and ?-?-blockers,in which CCB was the most commonly used,followed by ARB and ACEI.And CCB + ARB or CCB + ACEI were the more common antihypertensive drugs used in combination.After the end of the study,89,4%of patients continued medication.During the study all 71.1%taking the drug,sometimes missed 27.4%,more than half and not taking all the drugs 1.5%.There are 42.6%patients who are very satisfied with the clinical efficacy and 54.7%satisfied.The reasons that researchers used SLXMK,which used alone to lower BP 28.8%,used in combination with western medicine 55.4%,and improved the clinical symptoms 14.7%.There are few adverse reactions in the clinical trial,such as epigastria fullness,nausea,diarrhea,palpitations,headache,low blood sugar,decreased sexual function,and decreased sexual function.However,these adverse effects do not affect the clinical research continues.ConclusionSLXMK capsule can lower blood pressure,especially for level 1 to 2 hypertension and DBP.SLXMK capsule can improve blood pressure target achievement and clinical symptom,which mainly used in combination with western medicine antihypertensive drugs to lower BP in clinical practice.