【作者】 王健；

【导师】 宋大庆；

【作者基本信息】 济宁医学院 ， 急诊医学（专业学位）， 2022， 硕士

【摘要】 研究目的:采用循证医学评估SGLT-2抑制剂在慢性心力衰竭中应用的疗效性及安全性,进一步探究SGLT-2抑制剂对心力衰竭在糖尿病分组及年龄分层上的疗效性,以期为慢性心力衰竭临床治疗提供参考。研究方法:全面收集并筛选国内外在2021年9月前发表的关于慢性心力衰竭及SGLT-2抑制剂的相关随机对照试验,其中包括CNKI、WANFANG、VIP、Pub Med、Embase、The Cochrane Library数据库,采用表格法提取相关数据,疗效性指标主要包括心血管死亡率、全因死亡率、心力衰竭住院/心血管死亡的复合事件及相关亚组的复合事件数,安全性指标主要包括容量衰竭事件、尿路感染、骨折及低血糖等不良反应事件发生情况,最后运用Rev Man5.4版本软件进行统计学分析。分析结果:本次筛选7篇文献,共计45358人纳入本次研究,全部为多中心、大型随机对照试验。分析显示实验组(口服SGLT-2抑制剂组)相较于对照组(安慰剂组),可明显降低心血管死亡率[RR 0.82,95%CI(0.68,0.98),P=0.03],降低全因死亡率[RR 0.87,95%CI(0.78,0.97),P=0.010]、降低心力衰竭住院/心血管死亡组成的复合事件[RR 0.78,95%CI(0.75,0.83),P<0.00001]的风险;通过分析其亚组发现,对患有糖尿病病史患者[RR 0.79,95%CI(0.72,0.86),P<0.00001]和无糖尿病病史患者[RR 0.78,95%CI(0.70,0.87),P<0.00001]复合事件发生率无统计学差异;对年龄≥65岁患者复合事件发生率[RR 0.79,95%CI(0.71,0.87),P<0.00001]有统计学差异,而年龄<65岁患者复合事件发生率[RR 0.82,95%CI(0.67,1.01),P=0.07]无统计学差异;安全性指标中,容量衰竭事件[RR 1.07,95%CI(0.97,1.18),P=0.20]、骨折事件[RR 1.03,95%CI(0.94,1.14),P=0.51]及低血糖事件[RR0.88,95%CI(0.69,1.11),P=0.28]的相对危险度统计学上无显著差异,尿路感染事件[RR 1.13,95%CI(1.01,1.27),P=0.03]与安慰剂出现明显差异性。结论:SGLT-2i对慢性心力衰竭(伴或不伴T2DM)患者具有保护作用,且不会增加容量衰竭、骨折、低血糖等不良反应的发生率,但使用过程中需要警惕尿路感染的发生。其次,SGLT-2i的应用可能对≥65岁以上老年心力衰竭群体更有优势,但该结论结构不稳健,解读需谨慎。更多还原

【Abstract】 Objective: Evidence based medicine was used to evaluate the efficacy and safety of SGLT-2 inhibitor in chronic heart failure.To further explore the efficacy of SGLT-2 inhibitor on heart failure in diabetes grouping and age stratification.In order to provide reference for the clinical treatment of chronic heart failure.Methods: We comprehensively collected and screened relevant randomized controlled trials of chronic heart failure and sglt-2 inhibitors published before September 2021 at home and abroad,including CNKI,WANFANG,VIP,Pub Med,Embase and The Cochrane Library databases.Table method was used to extract relevant data.Efficacy mainly includes cardiovascular mortality,all-cause mortality,composite events of heart failure hospitalization / cardiovascular death and composite event rates of related subgroups.Safety mainly includes the incidence of adverse events such as volume failure,urinary tract infection,fracture and hypoglycemia.Finally,Review Manage version 5.4 software was used for meta-analysis.Results: Seven literatures were selected and a total of 45358 people were included in this study.All of them were multicenter,large-scale randomized controlled trials.The analysis showed that the experimental group(oral SGLT-2 inhibitor group)significantly reduced cardiovascular mortality [RR 0.82,95% CI(0.68,0.98),P=0.03] and all-cause mortality[RR 0.87,95% CI(0.78,0.97),compared with the control group(placebo group).P = 0.010],heart failure hospitalization/cardiovascular death [RR0.78,95%CI(0.75,0.83),P < 0.00001];By analyzing its subgroups,There was no significant difference in the incidence of compound events(hospitalization for heart failure/cardiovascular death)between patients with diabetes history [RR 0.79,95%CI(0.72,0.86),P < 0.00001] and patients without diabetes history [RR 0.78,95%CI(0.70,0.87),P <0.00001].There was significant difference in the incidence of composite events [RR 0.79,95%CI(0.71,0.87),P<0.00001] in patients aged ≥ 65 years,but there was no significant difference in the incidence of composite events [RR 0.82,95%CI(0.67,1.01),P=0.07] in patients aged < 65 years;Among the security indicators,Volume failure events [RR 1.07,95%CI(0.97,1.18),P = 0.20],urinary tract infection events [RR 1.13,95%CI(1.01,1.27),P = 0.03],fracture events [RR 1.03,95%CI(0.94,1.14),P =0.51] and the relative risks of hypoglycemic events [RR 0.88,95%CI(0.69,1.11),P = 0.28] were not statistically significant.Conclusion: SGLT-2i has a protective effect on patients with chronic heart failure(with or without T2DM)and will not increase the incidence of adverse reactions such as volume failure,fracture and hypoglycemia.However,it is necessary to guard against the occurrence of urinary tract infection during use.Secondly,the application of SGLT-2i may have more advantages for the elderly with heart failure ≥ 65 years old,but the conclusion structure is not robust,and the interpretation should be cautious.更多还原