Evidence Evaluation And Evidence-based Practice Study Of Antihypertensive Chinese Patent Medicine Combined With Western Medicine In Treating Hypertension

Hypertension is a kind of cardiovascular syndrome with high incidence worldwide,which is the primary risk factor for stroke,myocardial infarction and even cardiovascular and cerebrovascular death.It has become a global public health problem seriously endangering human health.Literature studies have found that the com-bination of Chinese patent medicine and Western medicine is a common method for the treatment of hypertension,which can significantly and stably improve the antihypertensive effect,effectively improve the quality of life of patients,reduce headache,vertigo,insomnia and other clinical symptoms,reduce the damage of target organs,and reduce complications.Although relevant industry organizations have issued guidance documents such as "Guidelines for the Clinical Diagnosis and Treatment of Hypertension in Traditional Chinese Medicine" and "Guidelines for the Clinical Application of Chinese Patent Medicine in the Treatment of Essential Hypertension",there is no guideline specification specifically for the treatment of hyperten-sion with Chinese patent medicine combined with Western medicine,and there is still a lack of evidence-based guidance for the clinical application of Chinese patent medicine combined with Western medicine in the treatment of hypertension.Therefore,this study intends to use the method of evidence-based medicine to comprehensively search clinical research literature,carry out literature quality evaluation,evidence synthesis and evidence classification,and on this basis,adopt the nominal group method to form recommendations,in order to provide guidance for the clinical use of Chinese patent medicine combined with Western medicine in the treatment of hypertension.PurposeTo clarify the medication situation of Chinese patent medicine combined with Western medicine in the treatment of hypertension,analyze the effectiveness and safety of Chinese patent medicine combined with Western medicine in the treatment of hypertension,form evidence-based recommendations of Chinese patent medicine combined with Western medicine in the treatment of hypertension,and provide support for the rational application of Chinese patent medicine combined with Western medicine in the treatment of hypertension.Methods1.Analysis of drug use of Chinese patent medicine combined with Western medicine in the treatment of hypertension based on literature:Search all literatures of Chinese patent medicine combined with Western medicine in the treatment of hypertension since the establishment of CNKI database,Wanfang Database,VIP database,PubMed and Embase database,establish screening criteria,extract literature title,publication time,PICOs,diagnosis,medication and other information.Standardized drug names,appropriate TCM syndromes were extracted according to Chinese patent medicine instructions,and the commonly used Chinese patent medicine combined with Western medicine,applicable population,dosage and course of treatment for hypertension were analyzed statistically.2.System assessment of evidence quality of antihypertensive Chinese patent medicine combined with Western medicine in the treatment of hypertension:more than 5 literatures were selected,and the program with the largest amount of literatures was used in combination of antihypertensive Chinese patent medicine and five first-line antihypertensive Western medicine.Systematic reviews or metaanalyses and RCTS were included to evaluate the methodological quality of the literature,and AMSTAR2 and ROB2 evaluation tools were used.Meta-analysis and quantitative synthesis were carried out for the included evidence with the same outcome indexes and data categories,while qualitative description was used for qualitative synthesis of the evidence that could not be quantitatively synthesized.3.Consensus on recommendation of Chinese patent medicine combined with Western medicine in the treatment of hypertension was formed based on nominal group method:GRADE pro software was used to grade the existing systematic evaluation and Meta results,form the evidence summary table and the results summary table,and preliminarily formulate recommendations,to form the TCM syndrome category,common dosage and efficacy advantage of the combination of Chinese patent medicine and Western medicine in the treatment of hypertension.Invite 15 experts in related fields,including clinicians of traditional Chinese medicine,clinicians of Western medicine,evidence-based medicine,standardization experts,etc.,to implement the nominal group method,comprehensively consider the evidence level,resource utilization,balance the advantages and disadvantages,patient preference and other factors,and put forward strong recommendation,weak recommendation,no clear recommendation,weak recommendation,strong recommendation.According to the GRADE grid counting rules,the recommendation strength was determined,and the final recom-mendation was made on the main points of application of Chinese patent medicine combined with Western medicine in the treatment of hypertension.Results1.Analysis of drug use of Chinese patent medicine combined with Western medicine in the treatment of hypertension based on literature:There were 725 literatures on the treatment of hypertension with Chinese patent medicine combined with Western medicine,involving 120 kinds of Chinese patent medicine.Through the analysis of literature on commonly used proprietary Chinese medicine which more than 10 articles,it was found that a total of 20 kinds of Chinese patent drugs were involved,including 12 kinds of Chinese patent drugs for reducing blood pressure,covering 286 literatures.The main syndroms included hyperactivity of liver Yang(117 articles,40.91%),hyperactivity of blood deficiency and liver(44 articles,15.38%),and syndrome of qi stagnation and blood stasis(36 articles,12.59%).The usual dosage is basically in accordance with the instructions.The western drugs used in combination with the above 12 antihypertensive Chinese patent drugs are mainly CCB and ARB antihypertensive drugs,and the most common combined application scheme is:Songling Xuemaikang Capsule combined with CCB antihypertensive drugs,Tianma Gouteng Granules combined with CCB antihypertensive drugs,Niuhuang antihypertensive drugs(capsules,tablets)combined with CCB antihypertensive drugs,Zhenju Jiangya tablets combined with CCB antihypertensive drugs,Xinmaitong tablets(capsules)combined with CCB antihypertensive drugs,Liuwei Dihuang Pills(Shui Pills,honeyed bolus,condensed pills)combined with CCB antihypertensive drugs,Qiju Dihuang Pills(Capsules and oral liquid)combined with CCB antihypertensive drugs,Yindan Xinnaotong soft capsule combined with CCB antihyperten-sive drugs,Qianglidingxuan(capsules and tablets)combined with CCB antihyper-tensive drugs,Xinkeshu tablet(capsules)combined with ARB Chinese patent medic-ine,Compound Xueshuantong capsule combined with ARB Chinese patent medicine,Yangxue Qingnao(granules and pills)combined with ACEI Chinese patent medicine.2.System assessment of evidence quality of antihypertensive Chinese patent medicine combined with Western medicine in the treatment of hypertension:A total of 56 literatures were included in 8 treatment regiments of Chinese patent medicine combined with Western medicine for hypertension,all of which were RCT literatures without systematic review or meta-analysis.Among the 56 literatures,11 were of low risk(19.6%),34 were of medium risk(60.7%),and 11 were of high risk(19.6%).The main outcome indicators of 8 kinds of Chinese patent medicine combined with Western medicine in the treatment of hypertension were qualitatively and quantitatively integrated.85 systematic evaluation results showed that Chinese patent medicine combined with Western medicine was superior to western medicine control group in reducing SBP and DBP,alleviating clinical symptoms such as headache and insomnia,regulating blood lipids,improving kidney function indicators BUN,SCr,UA,reducing IMT,improving left heart function index LVEF level and other aspects.3.Consensus on recommendation of Chinese patent medicine combined with Western medicine in the treatment of hypertension was formed based on nominal group method:GRADE classification results showed that the evidence of high quality accounted for 0%,the evidence of medium quality accounted for 29.51%,the evidence of low quali-ty accounted for 59.02%,and the evidence of very low quality accounted for 11.48%.According to the results of evidence evaluation,15 experts were invited to conduct two rounds of voting for the 26 recommendations to be agreed.Finally,all of them were recommended,including 2 strong recommendations and 24 weak recommendations.Songling Xuemaikang Capsule combined with CCB is suitable for hypertensive patients with hyperactivity of liver Yang.The dosage is 1.5g/3 capsules/time,3 times a day.It can reduce SBP and DBP(evidence level:B,highly recommended),improve the antihypertensive effective rate(evidence level:B,highly recommended),and regulate blood lipid level(evidence level:C,weakly recommendation),decreased the range of blood pressure variation,heart rate,the level of hypersensitive C-reactive protein hs-CRP(evidence level:C,weakly recommendation),and improved the levels of renal function indicators BUN,SCr,UA,MAU(evidence level:C,weakly recommendation).Gastroma uncaria Granule combined with CCB is suitable for patients with hyperactivity of liver Yang in hypertension with the dose of 5g per time,3 times a day.It has advantages in reducing SBP and DBP(evidence level:C,weakly recommended),reducing IMT(evidence level:C,weakly recommended),reducing blood pressure variability,and improving quality of life(evidence level:C,weakly recommended).Yangxue Qingnao Granules combined with ACEI are suitable for hypertension patients with blood deficiency and liver extra syndrome.The granule dose is 4g/1 bag/time,3 times a day,and the pill dose is 2.5g/time,3 times a day,which can reduce SBP and DBP(evidence level:B,weakly recommended),improve headache(evidence level:B,weakly recommended)and insomnia(evidence level:C,weakly recommendation),decreased CRP and increased β2-MG levels(evidence level:C,weakly recommendation);Xinkeshu capsule combined with ARB is suitable for patients with hypertension and blood stasis syndrome.The dose is 4 capsules/time,3 times a day.It can reduce SBP and DBP(evidence level:B,weakly recommended),improve LVEF(evidence level:B,weakly recommended),reduce LVDD,LVDPWT,LVMI,and increase SV(evidence level:C,weakly recommended)have advantages over others.Liuwei Dihuang Pill combined with CCB is suitable for hypertensive patients with kidney Yin deficit syndrome.The dosage is used according to the instruction manual.It has advantages in reducing SBP and SDP(evidence level:B,weakly recommended)and improving renal function index renal BUN,Cr and mAIb levels(evidence level:C,weakly recommended).Qiangli Dingxuan tablet combined with CCB is suitable for patients with hyperactive liver-yang syndrome in hypertension.The dose is 3-6 tablets/time,3 times a day.It can reduce SBP and DBP(evidence level:B,weakly recommended),improve antihypertensive efficacy(evidence level:B,weakly recommended),improve TCM syndrome(evidence level:C,weakly recommended),and reduce PWV and IMT values(evidence level:C)have advantages over others.Niuhuang Jiangya Wan capsule combined with CCB is suitable for patients with the syndrome of heart-liver fire and excessive phlegm heat in hypertension.The dose is 1 pill/time,once a day,which has advantages in improving the effective rate of antihypertensive(evidence level:C,weakly recommended)and regulating blood fat(evidence level:C,weakly recommended).Qiju Dihuang Pill combined with CCB is suitable for the syndrome of Yin deficiency and fire abundance in hypertension.The dosage is used according to the instruction manual.It has advantages in reducing SBP(evidence level:B,weakly recommended),reducing IMT and PWV,and increasing ABI level(evidence level:C,weakly recommended).Conclusion1.Compared with conventional western medicine treatment,antihypertensive Chinese patent medicine combined with Western medicine has advantages in improving antihypertensive effect,improving clinical symptoms and reducing damage to target organs.2.Antihypertensive Chinese patent medicine combined with CCB and ARB antihypertensive western medicine has certain safety in the treatment of hypertension.3.Most of the therapeutic advantages of antihypertensive Chinese patent medicine combined with Western medicine in the treatment of hypertension are weakly recommended,suggesting high-quality clinical research of Chinese patent medicine combined with Western medicine.