CAJ | 학술논문

目的观察血管升压素受体拮抗剂托伐普坦对肝硬化失代偿期患者稀释性低钠血症的疗效和安全性.方法采用双盲法将96例失代偿性肝硬化稀释性低钠血症患者随机分为治疗组56例和对照组40例.治疗组给予常规治疗(保肝、降酶)加单次口服托伐普坦15 mg治疗;对照组给予常规治疗加口服安慰剂治疗.观察两组患者血Na+浓度、肝功能、腹水和下肢水肿情况.计量资料比较采用t检验,计数资料比较采用x2检验.结果治疗组第7天36例患者血清Na+浓度达到正常,占64.3％;对照组9例达到正常,占22.5％,两组比较差异有统计学意义(x2=5.241,P＜0.01).治疗组56例患者24 h总尿量均超过3500 mL,对照组仅3例24 h总尿量超过3500 mL;两组治疗7d期间24 h尿量比较,差异有统计学意义(t=20.899,P＜0.01).治疗组腹水减少39例,与对照组腹水减少15例相比,差异有统计学意义(x2=4.260,P=0.039);而下肢水肿的改善治疗组12例与对照组7例相比,差异无统计学意义(x2 =0.227,P=0.634).治疗组患者治疗前后ALT、TBil、血K+和Cr均有改善,但差异无统计学意义(t=1.509、0.783、1.107和1.237,均P＞0.05),与对照组相比,差异亦无统计学意义(t=1.712、1.635、1.121和0.873,均P＞0.05).结论单剂口服托伐普坦有较强的利尿作用,能够提高血清Na+浓度,对低钠血症患者有明显疗效.
목적 관찰혈관승압소수체길항제탁벌보탄대간경화실대상기환자희석성저납혈증적료효화안전성.방법 채용쌍맹법장96례실대상성간경화희석성저납혈증환자수궤분위치료조56례화대조조40례.치료조급여상규치료(보간、강매)가단차구복탁벌보탄15 mg치료;대조조급여상규치료가구복안위제치료.관찰량조환자혈Na+농도、간공능、복수화하지수종정황.계량자료비교채용t검험,계수자료비교채용x2검험.결과 치료조제7천36례환자혈청Na+농도체도정상,점64.3％;대조조9례체도정상,점22.5％,량조비교차이유통계학의의(x2=5.241,P＜0.01).치료조56례환자24 h총뇨량균초과3500 mL,대조조부3례24 h총뇨량초과3500 mL;량조치료7d기간24 h뇨량비교,차이유통계학의의(t=20.899,P＜0.01).치료조복수감소39례,여대조조복수감소15례상비,차이유통계학의의(x2=4.260,P=0.039);이하지수종적개선치료조12례여대조조7례상비,차이무통계학의의(x2 =0.227,P=0.634).치료조환자치료전후ALT、TBil、혈K+화Cr균유개선,단차이무통계학의의(t=1.509、0.783、1.107화1.237,균P＞0.05),여대조조상비,차이역무통계학의의(t=1.712、1.635、1.121화0.873,균P＞0.05).결론 단제구복탁벌보탄유교강적이뇨작용,능구제고혈청Na+농도,대저납혈증환자유명현료효.
Objective To investigate the efficacy and safety of vasopressin receptor antagonist tolvaptan for treating dilutional hyponatremia casused by decompensated liver cirrhosis.Methods Ninety-six subjects with decompensated liver cirrhosis complicated by dilutional hyponatremia were divided into test group (n =56) and control group (n =40) by double blind method.Test group were treated with a single dose of tolvaptan 15 mg orally in addition to routine therapy,while control group were treated with routine therapy plus placebo.The changes in serum sodium concentration,liver functions,ascites,and edema of lower extremities between the two groups were observed.Measurement data were compared by t test,and categorical data were compared by chisquare test.Results On day 7,36 (64.3％) patients in test group and 9 (22.5％) patients in control group reached normal serum sodium concentrations (x2 =5.241,P＜0.01).All the patients in test group and only 3 patients in control group had 24 hours' total urine volume above 3500 mL.Difference of 24 hours' total urine volume during 7-day treatment between the two groups was statistically significant (t=20.899,P＜0.01).Thirty-nine patients in test group and 15 patients in control group had reduced ascites (x2 =4.260,P=0.039),but improvement of edema in lower extremities of both groups was comparable (12 cases in test group and 7 cases in control group; x2 =0.227,P=0.634).Serum alanine aminotransferase (ALT),total bilirubin (TBil),potassium and creatinine levels of test group were improved after treatment,but were not significantly different from either baseline levels (t=1.509,0.783,1.107,1.237; both P＞0.05) or those of the control group (t=1.712,1.635,1.121,0.873; both P＞0.05).Conclusions Single dose of tolvaptan (15 mg) exerts a strong diuretic effect and is able to greatly increase serum sodium concentration,thus has distinct therapeutic effect for patients with decompensated liver cirrhosis complicated by dilutional hyponatremia.