Clinical Evaluation Study Of Chinese Patent Medicine For Essential Hypertension Based On Meta-analysis And Data Mining

OBJECTIVE:1.To provide theoretical basis and reference for the research direction and clinical decision of traditional Chinese medicine for essential hypertension prevention and treatment by analysis of the rules of antihypertensive Chinese patent medicine use.2.To provide a reliable evidence-based medicine basis for objective evaluation of the efficacy of antihypertensive Chinese patent medicines,based on comprehensive and systematic qualitative evaluation and quantitative analysis of eligible studies.To provide reference for Chinese patent medicine use based on systematic reviews of antihypertensive Chinese patent medicines of Pinggan Qianyang.METHODS:1.Data mining"Hypertension" or "blood pressure" as the key words were used to search for Chinese patent medicines clearly labeled with function or indication of hypertension in the "National Essential Drugs List"(2018 edition),"National Basic Medical Insurance Work Injury Insurance and Maternity Insurance Drugs List"(2017 edition),"Basic Medical Insurance Work Injury Insurance and Maternity Insurance Drugs List in every province,autonomous region and municipality under the central government" and the Chinese Pharmacopoeia(2015 edition).Excel datasets and software data mining models were created.Frequency analysis,principal component analysis and association rule analysis of the compatibility of Chinese patent medicines were done based on Apriori algorithm in SPSS Clementine 12.0.High frequency drugs and their combinations were analyzed to summarize the medication rules to provide reference for clinical medication.2.Meta analysis"Hypertension" or "blood pressure" as the key words were used to search for Chinese patent medicines clearly labeled with function or indication of hypertension in the "National Essential Drugs List"(2018 edition)."National Basic Medical Insurance Work Injury Insurance and Maternity Insurance Drugs List"(2017 edition),"Basic Medical Insurance Work Injury Insurance and Maternity Insurance Drugs List in every province,autonomous region and municipality under the central government" and the Chinese Pharmacopoeia(2015 edition)."Name of Chinese patent medicines" and "hypertensior" were taken as key words to cross search in MEDLINE,PubMed,EMBase,Cochrane library,NGC,CNKI,Wanfang and VIP databases for the randomized controlled trials(RCTs)of the antihypertensive Chinese patent medicines.RevMan 5.3 software was used to evaluate the risk of bias and conduct meta analysis,and provide the forest maps and funnel charts to present outcome indicators and publication bias separately.RESULTS:1.Data mining resultsA total of 73 antihypertensive Chinese patent medicines were selected,involving a total of 230 traditional Chinese medicines.The total frequency of traditional Chinese medicines used was 624.of which 21 were traditional Chinese medicines with frequency>8 times,222 times in total and accounting for 35.58%of the total frequency.According to the correlation analysis,there were 15 eligible drug association rules.11 rules were generated by 3 traditional Chinese medicines combined which number was the largest,and 4 rules were generated by the combination of 2.Scutellaria baicalensis had the highest frequency of all the traditional Chinese medicines involved in all the rules,which had 13 association rules.These drug pairs and groups were mainly different combinations of traditional Chinese medicines of Qingre,Huoxue Huayu,Kaiqiao and Anshen.2.Meta analysis results2.1 Meta analysis results of 16 antihypertensive Chinese patent medicines(1)Songlingxuemaikang capsule:A total of 49 RCTs were included according to the inclusion and exclusion criteria.There were 14 RCT studies on treating hypertension by Songlingxuemaikang capsule alone.The results of meta analysis showed that there was no statistical difference between the group of Songlingxuemaikang capsule alone and the control group in reducing blood pressure,reducing SBP and DBP(P>0.05).There were 35 RCT studies on treating hypertension by Songlingxuemaikang capsule and antihypertensive western medicine.The meta analysis showed that there was significant statistical difference between the combination group and the control group in the effective rate of blood pressure reduction and reducing SBP,DBP(P<0.05).(2)Tianmagouteng granule:A total of 6 RCTs were included according to the inclusion and exclusion criteria.There were 2 RCT studies on treating hypertension by Tianmagouteng granule alone.The results of meta analysis showed that there was no statistical difference between the group of Tianmagouteng granule alone and the control group in reducing SBP and DBP(P>0.05).There were 4 RCT studies on treating hypertension by Tianmagouteng granule and antihypertensive western medicine.Two studies reported the effective rate of blood pressure reduction.The meta analysis showed that there was no significant difference between the antihypertensive effect of antihypertensive western medicine combined with Tianmagouteng granule and the treatment of simple antihypertensive western medicine(P>0.05).Three studies reported the blood pressure before and after treatment.The results showed that there was significant statistical difference between the combination group and the control group in reducing SBP(P<0.05),but no statistical difference in reducing DBP(P>0.05).(3)Niuhuangjiangya tablet(pill,capsule):A total of 13 RCTs were included according to the inclusion and exclusion criteria.There were 4 RCTs on Niuhuangjiangya tablet(pill,capsule)alone for the hypertension treatment reporting the effective rate of blood pressure reduction.The meta analysis showed that there was no statistical difference between the group of Niuhuangjiangya tablet(pill,capsule)alone and the control group in the efficiency of blood pressure reduction(P>0.05).Four studies reported SBP and DBP.The meta analysis showed that there was no statistical difference between the group of Niuhuangjiangya tablet(pill,capsule)alone and the control group in reducing SBP and DBP(P>0.05).There were 6 RCTs on Niuhuangjiangya tablet(pill,capsule)combined with antihypertensive western medicine for the treatment of hypertension reporting the effective rate of blood pressure reduction.The results showed that there was significant statistical difference between the combination group and the control group in reducing the effective rate of blood pressure(P<0.05).Two RCTs reported the blood pressure before and after treatment.The results showed that there was significant statistical difference between the combination group and the control group in reducing SBP(P<0.05),but no statistical difference in reducing DBP(P>0.05).(4)Angongjiangya pill:A total of 9 RCTs were included according to the inclusion and exclusion criteria.All of the studies reported the effective rate of blood pressure reduction.The meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing the effective rate of blood pressure(?<0.05).Five studies were reported on 24h SBP and 24h DBP.The meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing 24h SBP and 24h DBP(P<0.05).(5)Qingganjiangya capsule:A total of 10 RCTs were included according to the inclusion and exclusion criteria.There were 6 studies reporting the effective rate of blood pressure reduction.Meta analysis showed that there was significant statistical difference between the group of Qingganjiangya capsule combined with western medicine and the control group in reducing the effective rate of blood pressure(P<0.05).There were 8 studies reporting SBP and DBP.The meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).(6)Qianglidingxuan tablet(capsule):A total of 7 RCTs were included according to the inclusion and exclusion criteria.There were 6 studies reporting the effective rate of blood pressure reduction.The meta analysis showed that there was significant statistical difference between the group of Qianglidingxuan tablet(capsule)combined with western medicine and the control group in reducing the effective rate of blood pressure(P<0.05).Six studies of SBP and DBP were reported.The meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).(7)Xinkeshu tablet(capsule):A total of 9 RCTs were included according to the inclusion and exclusion criteria.There were 3 studies reporting the effective rate of blood pressure reduction.The meta analysis results showed that there was no statistical difference between the group of Xinkeshu tablet(capsule)combined with western medicine and the control group in reducing the effective rate of blood pressure(P>0.05).There were 9 studies reporting SBP and DBP.Meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).(8)Qingnaojiangya tablet(capsule):A total of 7 RCTs were included according to the inclusion and exclusion criteria.There were 4 RCTs reporting the effective rate of blood pressure reduction.The meta analysis showed that there was significant statistical difference between the group of Qingnaojiangya tablet(capsule)combined with western medicine and the control group in reducing the effective rate of blood pressure(P<0.05).There were 7 RCTs reporting SBP and DBP.The meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).There were 4 studies reporting the incidence of adverse reactions.Meta analysis showed that there was significant statistical difference between the combination group and the control group in the incidence of adverse reactions(P<0.05).(9)Annao pill:A total of 7 RCTs were included according to the inclusion and exclusion criteria.There were 5 studies reporting the effective rate of blood pressure reduction.The meta analysis showed that there was significant statistical difference between the group of Annao pill combined with western medicine and the control group in reducing the effective rate of blood pressure(P<0.05).There were 7 studies reporting SBP and DBP.Meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).(10)Maijun'an tablet:A total of 3 RCTs were included according to the inclusion and exclusion criteria.One of the studies conducted a stratified study on target population,and two studies reported the effective rate of blood pressure reduction.The results of meta analysis showed that there was no statistical difference between the group of Maijun'an tablet combined with western medicine and the control group in reducing the effective rate of blood pressure(P>0.05)(11)Zhenjujiangya tablet:A total of 25 RCTs were included according to the inclusion and exclusion criteria.There were 23 studies reporting the effective rate of blood pressure reduction.Meta analysis results showed that there was no statistical difference between the group of Zhenjujiangya tablet combined and the control group in reducing the effective rate of blood pressure(P>0.05).There were 18 studies reporting SBP and DBP.Meta analysis results showed that there was no statistical difference between the group of Zhenjujiangya tablet combined and the control group in reducing SBP and DBP(P>0.05).There were 10 RCTs on Zhenjujiangya tablet combined with antihypertensive western medicine for the treatment of hypertension.5 studies reported the effective rate of blood pressure reduction.The meta analysis showed that there was significant statistical difference between the group of Zhenjujiangya tablet combined with western medicine and the control group in reducing the effective rate of blood pressure(P<0.05).All the 10 studies reported the blood pressure before and after treatment.Meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).(12)Xinmaitong tablet(capsule):A total of 9 RCTs were included according to the inclusion and exclusion criteria.There were 8 studies reporting the effective rate of blood pressure reduction.The meta analysis showed that there was significant statistical difference between the group of Xinmaitong tablets(capsule)combined with western medicine and the control group in reducing the effective rate of blood pressure(P<0.05).8 studies reported the blood pressure before and after treatment.There was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).(13)Shanlucha antihypertensive tablet(capsules):A total of 4 RCTs were included according to the inclusion and exclusion criteria.All of the 4 studies reported the effective rate of blood pressure reduction.The meta analysis results showed that there was significant statistical difference between the group of Shanlucha antihypertensive tablet(capsules)and the control group in reducing the effective rate of blood pressure(P<0.05).There were 2 studies on SBP and DBP.The meta analysis showed that there was significant statistical difference between the Shanlucha group and the control group in reducing SBP(P<0.05),but no statistical difference in reducing DBP(P>0.05).(14)Compound luobuma tablet:A total of 10 RCTs were included according to the inclusion and exclusion criteria.There were 8 studies reporting the effective rate of blood pressure reduction.The results of meta analysis showed that there was significant statistical difference between the group of Compound luobuma tablet combined with western medicine and the control group in reducing the effective rate of blood pressure(P<0.05).Seven studies of SBP and DBP were reported.The meta analysis results showed that there was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).(15)Xinxuening tablet(capsule):A total of 3 RCTs were included according to the inclusion and exclusion criteria.All of the 3 studies reported the effective rate of blood pressure reduction.The results of meta analysis showed that there was statistical difference between the group of Xinxuening tablet(capsule)combined with western medicine and the control group in reducing the effective rate of blood pressure(P=0.05).Two studies of SBP and DBP were reported.The results of meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).(16)Tianshu capsule(tablet):A total of 4 RCTs were included according to the inclusion and exclusion criteria.There were 2 studies reporting the effective rate of blood pressure reduction.The meta analysis showed that there was statistical difference between the group of Tianshu capsule(tablet)and the control group in reducing the effective rate of blood pressure(P<0.05).There were 2 RCTs on Tianshu capsule(tablet)combined with antihypertensive western medicine for the treatment of hypertension.Both of the studies reported the effective rate of blood pressure reduction.The results of meta analysis showed that there was no statistical difference between the group of Tianshu capsule(tablet)combined with western medicine and the control group in reducing the effective rate of blood pressure(P>0.05).2.2 Meta analysis results of antihypertensive Chinese patent medicines of Pinggan Qianyang(1)In the case of using Pinggan Qianyang antihypertensive Chinese patent medicine only to treat hypertension,there were 15 RCTs reporting the effectiveness of blood pressure reduction.The results of meta analysis showed that there was no statistical difference between the group of Pinggan Qianyang Decoction alone and the control group in reducing the effective rate of blood pressure(P>0.05).19 RCTs reported SBP and DBP.The results of meta analysis showed that there was no significant statistical difference between the group of Pinggan Qianyang Decoction alone and the control group in reducing SBP and DBP(P>0.05).(2)In the case of using western medicine combined with Pinggan Qianyang antihypertensive Chinese patent medicine to treat hypertension,there were 40 RCTs reporting the effectiveness of blood pressure reduction.The meta analysis showed that there was significant statistical difference between the group of Pinggan Qianyang Decoction combined with western medicine and the control group in reducing the effective rate of blood pressure(P<0.05).37 RCTs reported SBP and DBP.The meta analysis showed that there was significant statistical difference between the combination group and the control group in reducing SBP and DBP(P<0.05).CONCLUSION:1.Through the analyses of the prescriptions and collocation rules of antihypertensive Chinese patent medicines,we found that the treatment principles of hypertension by Chinese patent medicines were Pinggan Qianyang,Huoxue Huayu.Bushen Pinggan,Tongmai Huoxue in sequence,of which Pinggan Qianyang was the main rule.The kinds of traditional Chinese medicine were mainly Qingre,Pinggan Xifeng,Huoxue Huayu.2.Based on the existing literature,antihypertensive Chinese patent medicine had certain antihypertensive effect.The blood pressure could be further reduced by the combination of antihypertensive western medicine and antihypertensive Chinese patent medicine.However,due to the low overall score and high heterogeneity of the study,no definite conclusion has been reached.