基于GRADE系统的两种钙通道阻滞剂联合治疗高血压的循证实践
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摘要
目的:采用GRADE系统评价方法评估临床实践中两种钙通道阻滞剂(calcium channel blocker,CCB)联合治疗高血压的循证证据,以期建立一种可行的寻找药物治疗方案循证证据的工作方法,促进临床合理用药。方法:将两种CCB联合治疗高血压这一临床问题根据PICO原则转换后,检索相关数据库,按设定标准对结果进行筛选和证据质量评级,再对每一个结局指标做综合性评价,最终判断药物治疗方案的合理性。结果:两种CCB联合治疗高血压有循证证据,但证据质量低。具体联合方案为二氢吡啶类(dihydropyridine,DHP)联合非二氢吡啶类(nondihydropyridine,NDHP)。与单用DHP相比,DHP与NDHP联合治疗可使血压下降、心率减慢;与单用NDHP相比,联合治疗可使血压下降、心率加快;与单用DHP或NDHP相比,联合治疗不良反应发生率降低。结论:GRADE是一种可行的评估药物治疗方案循证证据的有效方法,结果表明,DHP与NDHP联合治疗高血压疗效增加,不良反应发生率降低,但证据质量低,需开展大样本、多中心的高质量RCT进一步验证联合用药方案的有效性及安全性。
Objective: Applying GRADE system to evidence-based evaluate the rationality of dual calcium channel blockers( CCB) treating hypertension,we try to establish a feasible method of evidence-based evaluation of pharmacotherapeutic schemes,and promote the rational use of medicines. Methods: The two kinds of CCB combined treatment of the clinical problem of hypertension according to the principle of PICO conversion,retrieval related database,according to the set standards for screening and evidence of quality rating results. Then,the evidence quality of original research was rated and each outcome index was comprehensively evaluated. Finally,the rationality of the medicine treatment scheme was evaluated. Results: Dual CCB,namely dihydropyridine( DHP) and nondihydropyridine( NDHP),in the treatment of hypertension was graded as evidence-based medicine,but the evidence quality was relatively low. Compared with DHP,dual CCB reduced both blood pressure and the heart rate. Compared with NDHP,dual CCB reduced blood pressure and increased the heart rate. Dual CCB had lower incidence of adverse drug reaction in comparison with monotherapy. Conclusion: The GRADE system is an effective method of evidence-based evaluation of pharmacotherapeutic schemes. This result shows that combination therapy of DHP and NDHP increased the therapeutic effects and decreased the adverse drug reactions. However,since the evidence quality is relatively low,more large-sample,multicenter,and high-quality RCTs are required to further proof the efficiency and safety of this combined therapy.
Objective: Applying GRADE system to evidence-based evaluate the rationality of dual calcium channel blockers( CCB) treating hypertension,we try to establish a feasible method of evidence-based evaluation of pharmacotherapeutic schemes,and promote the rational use of medicines. Methods: The two kinds of CCB combined treatment of the clinical problem of hypertension according to the principle of PICO conversion,retrieval related database,according to the set standards for screening and evidence of quality rating results. Then,the evidence quality of original research was rated and each outcome index was comprehensively evaluated. Finally,the rationality of the medicine treatment scheme was evaluated. Results: Dual CCB,namely dihydropyridine( DHP) and nondihydropyridine( NDHP),in the treatment of hypertension was graded as evidence-based medicine,but the evidence quality was relatively low. Compared with DHP,dual CCB reduced both blood pressure and the heart rate. Compared with NDHP,dual CCB reduced blood pressure and increased the heart rate. Dual CCB had lower incidence of adverse drug reaction in comparison with monotherapy. Conclusion: The GRADE system is an effective method of evidence-based evaluation of pharmacotherapeutic schemes. This result shows that combination therapy of DHP and NDHP increased the therapeutic effects and decreased the adverse drug reactions. However,since the evidence quality is relatively low,more large-sample,multicenter,and high-quality RCTs are required to further proof the efficiency and safety of this combined therapy.
引文
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[23]Spedding M,Fraser S,Clarke B,et al.Factors modifying the tissue selectivity of calcium-antagonists[J].J Neural Transm Suppl,1990,31(31):5-16.
[2]Petrak O,Zelinka T,Strauch B,et al.Combination antihypertensive therapy in clinical practice.The analysis of 1254 consecutive patients with uncontrolled hypertension[J].Journal of Human Hypertension,2016,30(1):35-39.
[3]Calhoun DA,Jones D,Textor S,et al.Resistant hypertension:diagnosis,evaluation,and treatment.A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research[J].Hypertension,2008,51(6):1403-1419.
[4]孙宁玲,霍勇,王继光,等.难治性高血压诊断治疗中国专家共识[J].中国介入心脏病学杂志,2013,5(2):69-74.
[5]Kaesemeyer WH,Carr AA,Bottini PB,et al.Verapamil and Nifedipine in Combination for the Treatment of Hypertension[J].Journal of Pharmacology,1994,34(1):48-51.
[6]Nalbantgil I,Onder R,Kiliccioglu B,et al.Combination therapy with verapamil and nitrendipine in patients with hypertension[J].Journal of Human Hypertension,1993,7(3):305-308.
[7]Kiowski W,Erne P,Linder L,et al.Arterial vasodilator effects of the dihydropyridine calcium antagonist amlodipine alone and in combination with verapamil in systemic hypertension[J].American Journal of Cardiology,1990,66(20):1469-1472.
[8]Alviar CL,Devarapally S,Nadkarni GN,et al.Efficacy and safety of dual calcium channel blockade for the treatment of hypertension:a meta-analysis[J].American Journal of Hypertension,2013,26(2):287-297.
[9]Pucci PD,Pollavini G,Zerauscheck M,et al.Acute effects on exercise tolerance of felodipine and diltiazem,alone and in combination,in stable effortangina[J].European Heart Journal,1991,12(1):55-59.
[10]Andreyev N,Bichkov I,Skutelis A,et al.Comparison of diltiazem,nitrendipine,and their combination for systemic hypertension and stable angina pectoris[J].Journal of Cardiovascular Pharmacology,1991,18(6):S73-76.
[11]Frishman W,Charlap S,Kimmel B,et al.Diltiazem,nifedipine,and their combination in patients with stable angina pectoris:effects on angina,exercise tolerance,and the ambulatory electrocardiographic ST segment[J].Circulation,1988,77(4):774-786.
[12]Comerio G,Cuspidi C,Bocciolone M,et al.Antihypertensive and humoral effects of verapamil and lacidipine in combination in hypertensive patients[J].Journal of Hypertension Supplement Official Journal of the International Society of Hypertension,1993,11(5):S336-337.
[13]Saseen JJ,Carter BL,Brown TE,et al.Comparison of nifedipine alone and with diltiazem or verapamil in hypertension[J].Hypertension,1996,28(1):109-114.
[14]Sica DA.Combination Calcium Channel Blocker Therapy in the Treatment of Hypertension[J].Journal of Clinical Hypertension,2001,3(5):322-327.
[15]Kiowski W,Erne P,Linder L,et al.Arterial vasodilator effects of the dihydropyridine calcium antagonist amlodipine alone and in combination with verapamil in systemic hypertension[J].American Journal of Cardiology,1990,66(20):1469-1472.
[16]Saseen JJ,Carter BL.Dual calcium-channel blocker therapy in the treatment of hypertension[J].Annals of Pharmacotherapy,1996,30(7-8):802-810.
[17]Jacob LP,Malhotra D,Chan L,et al.Absence of a dose-response of cyclosporine levels to clinically used doses of diltiazem and verapamil[J].American Journal of Kidney Diseases,1999,33(2):301-303.
[18]OHASHI K,Sudo T,Sakamoto K,et al.The Influence of Pretreatment Periods with Diltiazem on Nifedipine Kinetics[J].Journal of Clinical Pharmacology,1993,33(3):222-225.
[19]Ehlert FJ,Roeske WR,Itoga E,et al.The binding of[3H]nitrendipine to receptors for calcium channel antagonists in the heart,cerebral cortex,and ileum of rats[J].Life Sciences,1982,30(25):2191-2202.
[20]Tamargo J,Ruilope LM.Investigational calcium channel blockers for the treatment of hypertension[J].Expert opinion on investigational drugs,2016,25(11):1295-1309.
[21]Godfraind T,Salomone S,Dessy C,et al.Selectivity scale of calcium antagonists in the human cardiovascular system based on in vitro studies[J].Journal of cardiovascular pharmacology,1992,20(6):S34-41.
[22]国家卫生计生委合理用药专家委员会,中国医师协会高血.高血压合理用药指南[J].中国医学前沿杂志(电子版),2015(6):22-64.
[23]Spedding M,Fraser S,Clarke B,et al.Factors modifying the tissue selectivity of calcium-antagonists[J].J Neural Transm Suppl,1990,31(31):5-16.