达格列净治疗合并2型糖尿病的难治性高血压的临床观察

Clinical observation of dapagliflozin in treatment of resistant hypertension complicated with type 2 diabetes mellitus

目的探讨达格列净对合并2型糖尿病的难治性高血压的临床效果。方法单中心前瞻性随机阳性药对照研究。入选2022年5~11月在新野县人民医院就诊的合并2型糖尿病、接受3种稳定的降压治疗≥12周的难治性高血压患者61例。按随机数字表法(1∶1)分为接受达格列净10 mg/d(31例)或安体舒通20 mg/d(30例)两组,持续12周。在基线、4周、8周和12周时测量诊室血压,在基线和12周时测量24 h动态血压和血生化指标等,并观察不良反应。结果在基线、4周、8周和12周时,达格列净组和安体舒通组的诊室血压(收缩压/舒张压)分别为(148.4±3.5/91.2±2.5)mmHg和(147.0±2.7/90.9±2.6)mmHg、(139.7±4.1/82.3±1.9)mmHg和(138.5±3.7/82.4±2.5)mmHg、(138.2±3.4/81.7±2.2)mmHg和(137.8±3.3/82.6±1.8)mmHg、(138.4±3.6/82.0±2.4)mmHg和(138.6±3.1/83.3±2.3)mmHg,在12周时达格列净组的诊室舒张压略低于安体舒通组(P=0.035)。在基线时,达格列净组和安体舒通组的动态血压(收缩压/舒张压)监测24 h平均血压分别为(139.3±2.2/83.5±1.7)mmHg和(138.8±3.0/84.6±2.0)mmHg、白天平均血压分别为(142.8±2.7/85.4±2.5)mmHg和(142.1±2.8/86.7±2.0)mmHg、夜间平均血压分别为(125.3±2.6/75.9±2.9)mmHg和(125.6±2.5/76.2±2.7)mmHg,达格列净组的24 h平均舒张压和白天平均舒张压均略低于安体舒通组(均为P<0.05);在12周时,两组24 h平均血压分别为(131.5±2.4/78.6±1.8)mmHg和(130.5±1.8/79.1±1.5)mmHg、白天平均血压分别为(133.3±2.9/80.3±2.0)mmHg和(132.1±2.2/81.1±2.4)mmHg、夜间平均血压分别为(124.3±1.7/71.8±2.6)mmHg和(124.1±2.0/71.1±2.8)mmHg。两组均无严重不良反应发生。结论对合并2型糖尿病的难治性高血压患者,达格列净具有与安体舒通一样的降压疗效,且无严重不良反应发生。

Objective To investigate the clinical efficacy of dapagliflozin in resistant hypertension patients complicated with type 2 diabetes mellitus.Methods This was a single-center,prospective,randomized,positive controlled study.Resistant hypertension patients with type 2 diabetes mellitus who were admitted to People’s Hospital of Xinye Country in May to November 2022 and received 3 stable antihypertensive treatments for≥12 weeks were selected.Eligible patients were randomized to receive dapagliflozin 10 mg QD(dapagliflozin group)or spironolactone 20 mg QD(spironolactone group)by the ratio of 1∶1 for 12 weeks.The office blood pressure(BP)was measured at baseline,4 weeks,8 weeks and 12 weeks,and the 24 h ambulatory BP,blood biochemical indexes and adverse events were recorded at baseline and 12 weeks.Results At baseline,4 weeks,8 weeks and 12 weeks,the office BP(systolic and diastolic BP)of the dapagliflozin group were 148.4±3.5/91.2±2.5 mmHg,139.7±4.1/82.3±1.9 mmHg,138.2±3.4/81.7±2.2 mmHg,138.4±3.6/82.0±2.4 mmHg respectively,while BP of the spironolactone group were 147.0±2.7/90.9±2.6 mmHg,138.5±3.7/82.4±2.5 mmHg,137.8±3.3/82.6±1.8 mmHg,138.6±3.1/83.3±2.3 mmHg respectively.The differences between two groups were not significant(all P>0.05)except diastolic BP at 12 weeks(P=0.035).At baseline,the 24 h average BP(systolic and diastolic BP)of the dapagliflozin group and the spironolactone group were 139.3±2.2/83.5±1.7 mmHg and 138.8±3.0/84.6±2.0 mmHg,the average daytime BP were 142.8±2.7/85.4±2.5 mmHg and 142.1±2.8/86.7±2.0 mmHg,and the nighttime average BP were 125.3±2.6/75.9±2.9 mmHg and 125.6±2.5/76.2±2.7 mmHg respectively;At 12 weeks,the 24 h average BP of the two groups were 131.5±2.4/78.6±1.8 mmHg and 130.5±1.8/79.1±1.5 mmHg,and the daytime average BP were 133.3±2.9/80.3±2.0 mmHg and 132.1±2.2/81.1±2.4 mmHg,the nighttime average BP were 124.3±1.7/71.8±2.6 mmHg and 124.1±2.0/71.1±2.8 mmHg respectively(all P>0.05).No serious adverse reactions occurred in the dapagliflozin group and the spironolactone group.Conclusions For patients with resistant hypertension complicated with type 2 diabetes mellitus,dapagliflozin has the same antihypertensive effect as spironolactone,and has no serious adverse reactions.