赖诺普利氢氯噻嗪片治疗轻中度原发性高血压的疗效和安全性的多中心观察性临床研究
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摘要
目的评价真实世界中赖诺普利氢氯噻嗪片治疗轻中度原发性高血压的疗效和安全性。方法本研究为多中心回顾性调查。入选2015年6月至2016年8月期间就诊于国内16所二级或三级医院心内科门诊的1～2级原发性高血压、且已连续服用赖诺普利氢氯噻嗪片至少8周的患者,由经过统一培训的调查医生与患者进行面对面访谈完成调查问卷,并查阅病历收集资料,评估真实世界中赖诺普利氢氯噻嗪片治疗轻中度原发性高血压的疗效和安全性。结果共入选1 017例患者,男性509例(50.1%),女性508例(49.9%),年龄平均为(59.8±12.0)岁。(1)降压疗效评价:治疗4周,血压平均降幅为(25.3±10.9)/(13.1±6.5) mmHg,血压达标率为72.7%;治疗8周,血压平均降幅为(30.3±9.7)/(15.7±6.2) mmHg,血压达标率为96.7%。(2)安全性评价:最常见的不良反应为干咳(5.9%),其他依次为头晕(0.7%)、乏力(0.5%)、头痛(0.5%)、心悸(0.1%)和症状性低血压(0.1%)。结论赖诺普利氢氯噻嗪片治疗轻中度高血压疗效确切,且安全性良好。
Objective To evaluate the efficacy and safety of the fixed combination of lisinopril plus hydrochlorothiazide in the treatment of patients with mild to moderate essential hypertension in the real world. Methods This retrospective multicenter survey was conducted in departments of cardiology outpatient of 16 secondary or tertiary hospitals nationwide from June 2015 to August 2016 and included patients with grade 1 st or 2 nd essential hypertension who had received the fixed combination of lisinopril plus hydrochlorothiazide for at least 8 weeks. Patients were interviewed by a specially trained survey doctor and patients to complete the questionnaire and review electronic or paper medical records to assess the efficacy and safety of lisinopril hydrochlorothiazide tablets in the treatment of mild to moderate essential hypertension. Results A total of 1 017 patients were enrolled, including 509 males(50.1%) and 508 females(49.9%) with an average age of(59.8±12.0) years. The mean reductions in SBP and DBP after 4 and 8 weeks of treatment were(25.3±10.9)/(13.1±6.5) mmHg and(30.3±9.7)/(15.7±6.2) mmHg, respectively. The control rates were 72.7% and 96.7% after 4 and 8 weeks of treatment, respectively. The most frequently reported adverse reaction was dry cough(5.9%),followed by dizziness(0.7%), fatigue(0.5%), headache(0.5%), palpitation(0.1%), and symptomatic hypotension(0.1%). Conclusions The fixed combination of lisinopril plus hydrochlorothiazide is effective and safe in treatment of grade 1-2 essential hypertension.
Objective To evaluate the efficacy and safety of the fixed combination of lisinopril plus hydrochlorothiazide in the treatment of patients with mild to moderate essential hypertension in the real world. Methods This retrospective multicenter survey was conducted in departments of cardiology outpatient of 16 secondary or tertiary hospitals nationwide from June 2015 to August 2016 and included patients with grade 1 st or 2 nd essential hypertension who had received the fixed combination of lisinopril plus hydrochlorothiazide for at least 8 weeks. Patients were interviewed by a specially trained survey doctor and patients to complete the questionnaire and review electronic or paper medical records to assess the efficacy and safety of lisinopril hydrochlorothiazide tablets in the treatment of mild to moderate essential hypertension. Results A total of 1 017 patients were enrolled, including 509 males(50.1%) and 508 females(49.9%) with an average age of(59.8±12.0) years. The mean reductions in SBP and DBP after 4 and 8 weeks of treatment were(25.3±10.9)/(13.1±6.5) mmHg and(30.3±9.7)/(15.7±6.2) mmHg, respectively. The control rates were 72.7% and 96.7% after 4 and 8 weeks of treatment, respectively. The most frequently reported adverse reaction was dry cough(5.9%),followed by dizziness(0.7%), fatigue(0.5%), headache(0.5%), palpitation(0.1%), and symptomatic hypotension(0.1%). Conclusions The fixed combination of lisinopril plus hydrochlorothiazide is effective and safe in treatment of grade 1-2 essential hypertension.
引文
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[4] Brook RD, Weder AB. Initial hypertension treatment: one combination fits most?[J]. J Am Soc Hypertens, 2011, 5(2): 66-75. DOI: 10.1016/j.jash.2011.01.002.
[5] Wald DS, Law M, Morris JK, et al. Combination therapy vs. monotherapy in reducing blood pressure: meta-analysis on 11,000 participants from 42 trials [J]. Am J Med, 2009, 122(3): 290-300. DOI: 10.1016/j.amjmed.2008.09.038.
[6] 中国高血压防治指南修订委员会.中国高血压防治指南2010 [J].中华高血压杂志, 2011,19(8): 701-743. Writing Group of 2010 Chinese Guidelines for the Management of Hypertension. 2010 Chinese guidelines for the management of hypertension [J]. Chin J Hypertens, 2011,19(8): 701-743.
[7] Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA. Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines [J]. J Am Coll Cardiol, 2018, 71(19): E127-E248. DOI:10.1016/j.jacc.2017.11.006.
[8] Simpson K, Jarvis B. Lisinopril: a review of its use in congestive heart failure [J]. Drugs, 2000, 59(5): 1149-1167. DOI: 10.2165/00003495-200059050-00012.
[9] White CM. Pharmacologic, pharmacokinetic, and therapeutic differences among ACE inhibitors [J]. Pharmacotherapy, 1998,18(3): 588-599.
[2] 国家卫计生委疾病预防控制局. 中国居民营养与慢性病状况报告(2015)[M]. 北京: 人民卫生出版社, 2015, 33-35. National Health and Family Planning Commission, Disease Prevention and Control Bureau. Report on Nutrition and Chronic Disease of Chinese Residents (2015) [M]. Beijing: People’s Medical Publishing House, 2015, 33-35.
[3] Gu Q, Burt VL, Dillon CF, et al. Trends in antihypertensive medication use and blood pressure control among United States adults with hypertension: the National Health and Nutrition Examination Survey, 2001 to 2010 [J]. Circulation, 2012, 126(17): 2105-2114. DOI:10.1161/CIRCULATIONAHA. 112.096156.
[4] Brook RD, Weder AB. Initial hypertension treatment: one combination fits most?[J]. J Am Soc Hypertens, 2011, 5(2): 66-75. DOI: 10.1016/j.jash.2011.01.002.
[5] Wald DS, Law M, Morris JK, et al. Combination therapy vs. monotherapy in reducing blood pressure: meta-analysis on 11,000 participants from 42 trials [J]. Am J Med, 2009, 122(3): 290-300. DOI: 10.1016/j.amjmed.2008.09.038.
[6] 中国高血压防治指南修订委员会.中国高血压防治指南2010 [J].中华高血压杂志, 2011,19(8): 701-743. Writing Group of 2010 Chinese Guidelines for the Management of Hypertension. 2010 Chinese guidelines for the management of hypertension [J]. Chin J Hypertens, 2011,19(8): 701-743.
[7] Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA. Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines [J]. J Am Coll Cardiol, 2018, 71(19): E127-E248. DOI:10.1016/j.jacc.2017.11.006.
[8] Simpson K, Jarvis B. Lisinopril: a review of its use in congestive heart failure [J]. Drugs, 2000, 59(5): 1149-1167. DOI: 10.2165/00003495-200059050-00012.
[9] White CM. Pharmacologic, pharmacokinetic, and therapeutic differences among ACE inhibitors [J]. Pharmacotherapy, 1998,18(3): 588-599.