我国示范乡镇卫生院基本药物循证评价与遴选之十二:抗高血压药物

Evidence-Based Evaluation and Selection of Essential Medicine for Township Health Centre in China: 12.Antihypertensive Medicine

目的基于疾病负担循证评价与遴选中国东中西部乡镇卫生院治疗高血压的基本药物。方法应用本系列研究之二制定的循证评价与遴选标准、方法和流程,循证评价并推荐基本药物。结果①共纳入5个高血压临床指南,含2个循证指南。②各国指南共涉及抗高血压药物9类70种。③硝苯地平、维拉帕米、氢氯噻嗪和依那普利均被WHO EML(2011)、NEML(2009)、CNF(2010)推荐,在各指南中证据较多,证据质量较高;螺内酯、普萘洛尔、美托洛尔也均被3个目录推荐,但指南证据质量相对较低;吲达帕胺和氨氯地平未全被3个目录推荐,但其指南证据较多,质量较高;噻米和噻吗洛尔在指南中证据较少,不作推荐。④9个推荐药物国内均有相应剂型和规格上市,美托洛尔、氨氯地平和依那普利价格相对较高(每日费用美托洛尔3.80～7.60元,氨氯地平2.16～4.32元,依那普利0.86～6.88元),但总体药物价格均可负担。⑤国内研究表明:硝苯地平、维拉帕米、依那普利3种强推荐药物安全有效,经济性和适用性均较高。结论①抗高血压药物强推荐硝苯地平、维拉帕米、依那普利,弱推荐氢氯噻嗪、吲达帕胺、螺内酯、普萘洛尔、美托洛尔、氨氯地平;弱不推荐噻米和噻吗洛尔。②国内抗高血压药物高质量证据较少,尤其缺少基于当地人群长期安全性研究和药物经济学研究证据。③建议对6个弱推荐药物开展安全性、有效性和经济性研究,生产高质量的本地化证据。

Objective To evaluate and select essential antihypertensive medicine using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were ana- lyzed by Review Manager （RevMan） 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results （1） Five clinical guidelines on hypertension were included, two of which were evidence-based. （2） Totally there were nine classes and 70 antihypertensive medicines listed in the guidelines. （3） According to WHOEML （2011）, NEML （2009）, CNF （2010）, other guidelines, and the quantity and quality of evidence, we offered a strong recommendation for nifedipine, verapamil and enalapril and a weak recommendation for hydrochlorothiazide, indapamide, spironolactone, propranolol, rnetoprolol and amlodipine. We made a recommendation against furosemide and timolol due to the lack of evidence from guidelines. （4） Nine recommended medicines have been marketed with the dosage forms and specifications corresponding to guidelines in China. 3he prices of metoprolol, amlodipine and enalapril were higher than those of other six （daily cost： metoprolol 3.80 to 7.60 yuan, amlodipine 2.16 to 4.32 yuan, and enalapril 0.86 to 6.88 yuan）. As a whole, the prices of recommended anti- hypertensive medicine were affordable. （5） Results of domestic studies indicated that three strongly-recommended medicines （including nifedipine, verapamil and enalapril） were safe, effective, economical and applicable. Conclusion （1） We offer a strong recommendation for nifedipine, verapamil and enalapril as antihypertensive medicine and a weak rec- ommendation for hydrochlorothiazide, indapamide, spironolactone, propranolol, metoprolol and amlodipine. （2） There is lack of high-quality evidence from relevant domestic studies, especially on long-term safety and pharmacoeconomic evidence. （3） We propose that more studies should be carried ou.t on the safety, efficacy and pharmacoeconomics of six medicines for which we make a weak recommendation to produce high-quality local evidence.