卡维地洛、普萘洛尔治疗肝硬化食管静脉曲张出血患者再出血的临床研究

Clinical trial of carvedilol and propranolol in the treatment of rebleeding in patients with cirrhosis and esophageal variceal bleeding

目的探讨卡维地洛、普萘洛尔对肝硬化食管静脉曲张出血(EVB)患者再出血的预防价值。方法将肝硬化EVB患者分为试验组和对照组。试验组给予卡维地洛分散片,起始剂量6.25mg,bid,口服;对照组给予盐酸普萘洛尔片,起始剂量20mg,bid,口服,2组疗程均为1年。比较2组患者的临床疗效,2组患者治疗6个月、治疗1年的再出血率、血流动力学,观察治疗期间安全性。结果试验组入组64例,对照组入组61例。治疗后,试验组和对照组的总有效率分别为93.75%(60例/64例)和91.80%(56例/61例),治疗6个月的再出血率分别为4.69%(3例/64例)和9.84%(6例/61例),在统计学上差异均无统计学意义(均P>0.05)。试验组和对照组治疗1年的再出血率分别为10.94%(7例/64例)和24.59%(15例/61例),在统计学上差异有统计学意义(P<0.05)。治疗6个月,试验组和对照组的门静脉内径(PVD)分别为(12.39±2.41)和(13.88±1.76)mm,脾静脉内径(SVD)分别为(7.56±1.52)和(8.35±1.69)mm,门静脉平均血流速度(Vp)分别为(35.26±7.04)和(38.12±7.60)cm·s^(-1),脾静脉平均血流速度(Vs)分别为(20.03±4.11)和(22.34±4.69)cm·s^(-1),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。治疗1年,试验组和对照组PVD分别为(11.87±2.52)和(13.15±2.04)mm,SVD分别为(7.33±1.48)和(8.22±1.55)mm,Vp分别为(33.96±6.75)和(37.46±6.83)cm·s^(-1),Vs分别为(19.26±4.33)和(21.55±4.47)cm·s^(-1),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应有心动过缓、低血压、头晕、恶心呕吐,对照组的药物不良反应有心动过缓、低血压、头晕、嗜睡、恶心呕吐、皮疹。试验组和对照组的总药物不良反应发生率分别为12.50%和27.87%,在统计学上差异有统计学意义(P<0.05)。结论卡维地洛相比普萘洛尔,预防再出血的效果更好,更能减轻食管静脉曲张。

Objective To investigate the value of carvedilol or propranolol in preventing rebleeding in patients with esophageal variceal bleeding(EVB)in liver cirrhosis.Methods Patients with EVB in liver cirrhosis were divided into the treatment group and the control group.The treatment group was treated with oral administration of carvedilol dispersible tablets,with an initial dose of 6.25 mg,bid.The control group was treated with oral administration of propranolol hydrochloride tablets,with an initial dose of 20 mg,bid.The treatment course of two groups was 1 year.The effects between two groups were compared.The rebleeding rate,and hemodynamics between two groups were compared treated after 6 months and 1 year of treatment.Safety that occurred during treatment were observed.Results The treatment group consisted of 64 patients,while the control group consisted of 61 patients.After treatment,the overall response rate in the treatment group was 93.75%(60 cases/64 cases),while the control group was 91.80%(56 cases/61 cases),without statistically significant difference between the groups(all P>0.05).After 6 months of treatment,rebleeding rates in the treatment group and the control group were 4.69%(3 cases/64 cases)and 9.84%(6 cases/61 cases),without statistically significant difference between the groups(P>0.05).After 1 year of treatment,rebleeding rates in the treatment group and the control group were 10.94%(7 cases/64 cases)and 24.59%(15 cases/61 cases),without statistically significant difference between the groups(P<0.05).After6 months of treatment,portal vein diameter(PVD)in the treatment group and the control group were(12.39±2.41)and(13.88±1.76)mm;splenic vein diameter(SVD)were(7.56±1.52)and(8.35±1.69)mm;mean blood flow velocity of portal vein(VP)were(35.26±7.04)and(38.12±7.60)cm·s^(-1);mean blood flow velocity of splenic vein(Vs)were(20.03±4.11)and(22.34±4.69)cm·s^(-1).Compared with control group,the above indexes of treatment group had statistical significance(all P<0.05).After 1 year of treatment,PVD in the treatment group and the control group were(11.87±2.52)and(13.15±2.04)mm;SVD were(7.33±1.48)and(8.22±1.55)mm;Vp were(33.96±6.75)and(37.46±6.83)cm·s^(-1);Vs were(19.26±4.33)and(21.55±4.47)cm·s^(-1).Compared with control group,the above indexes of treatment group had statistical significance(all P<0.05).Adverse drug reactions in the treatment group included bradycardia,hypotension,dizziness,nausea and vomiting,while adverse reactions in the control group included bradycardia,hypotension,dizziness,drowsiness,nausea and vomiting,and skin rash.The total incidence of adverse drug reactions in the treatment group was 12.50%,while the control group was 27.87%,the differences were statistically significant(P<0.05).Conclusion Compared to propranolol,carvedilol can better prevent rebleeding and relieve esophageal varices.