首页> 中文期刊> 《中国医药》 >托伐普坦治疗心力衰竭的有效性及安全性观察

托伐普坦治疗心力衰竭的有效性及安全性观察

摘要

Objective To investigate the efficacy and safety of tolvaptan in treating heart failure.Methods Totally 54 patients with decompensated heart failure from August 2013 to October 2015 were randomly divided into control group and tolvaptan group (27 cases in each group).Both groups were given basic treatment,tolvaptan group was additionally given tolvaptan (15 mg,1 time/d,for 7 days).The degrees of dyspnea,pulmonary rale,edema of lower extremity,the 24 h urine volume,the body mass index (BMI),the serum sodium,the plasma osmotic pressure,the levels of alanine transaminase,aspartate transaminase,plasma creatinine,uric acid,plasma B-type natriuretic peptide,the left ventricular end diastolic diameter,the left ventricular ejection fraction were compared between groups after 7 days of treatment;the adverse reactions were also observed.Results One case in tolvaptan group withdrew from the study because of hypernatremia 4 d after treatment,and 26 cases were finally enrolled.The congestive symptoms including dyspnea,lung rale and lower extremity edema were significantly improved in tolvaptan group compared with that in control group (P < 0.05).After 7 days,the daily urine volume,serum sodium,the plasma osmotic pressure were significantly higher than those before treatment and those in control group [(1 982±249) mlvs (1 260±400),(1 594 ±311) ml,(138 ±5) mmol/Lvs (134 ±5),(135 ± 5) mmol/L,(291 ± 10) mOsm/L vs (277 ± 11),(279 ± 10) mOsm/L] (P < 0.05);in tolvaptan group BMI decreased to (24.2 ± 2.6) kg/m2 from (24.4 ± 2.5) kg/m2 after treatment (P < 0.01);the other monitoring indexes were not significantly different between groups (P > 0.05).In tolvaptan group,the adverse reactions included dry mouth (9 cases),frequent micturition (2 cases),elevated serum sodium (1 case);in control group,the adverse reactions included dry mouth (8 cases) and kaliopenia (2 cases).Conclusions Tolvaptan can improve the signs and symptoms of heart failure in a short time,but it can increase the serum sodium level,therefore serum sodium should be closely monitored for preventing the hypernatremia.%目的 探讨托伐普坦治疗心力衰竭的有效性及安全性.方法 选取2013年8月至2015年10月因心力衰竭失代偿于北京市宣武中医医院住院治疗的患者54例,完全随机分为对照组和托伐普坦组,各27例.对照组给予心力衰竭基础治疗,托伐普坦组在对照组基础上口服托伐普坦15 mg,1次/d,连续7d.治疗7d后比较2组患者呼吸困难、肺部啰音、下肢水肿程度和24 h尿量、体重指数、血钠、血浆渗透压、丙氨酸转氨酶、天冬氨酸转氨酶、血肌酐、血尿酸、氨基末端B型脑钠肽前体、左心室舒张末期内径、左心室射血分数,同时观察不良反应.结果 托伐普坦组l例服用托伐普坦第4天因高钠血症撤出观察,最终入选26例.与用药前比较,托伐普坦组用药后呼吸困难症状和肺部啰音、下肢水肿程度均明显改善,且呼吸困难症状和下肢水肿程度明显轻于对照组,差异均有统计学意义(均P<0.05).用药后,托伐普坦组24 h尿量、血钠、血浆渗透压明显高于用药前及对照组同时点[(1 982±249) ml比(1 260±400)、(1 594±311) ml,(138±5) mmol/L比(134±5)、(135±5)mmol/L,(291±10)mOsm/L比(277±11)、(279±10) mOsm/L],体重指数明显低于用药前[(24.2±2.6)kg/m2比(24.4±2.5) kg/m2],差异均有统计学意义(均P<0.01).2组其余监测指标比较,差异均无统计学意义(均P>0.05).托伐普坦组26例患者中出现口干9例,尿频2例,血钠升高1例.对照组口干8例,低钾血症2例.结论 口服托伐普坦可短期内改善心力衰竭的症状体征,提高血钠水平,同时需密切监测血钠,预防高钠血症发生.

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