“水臌贴”敷脐联合西药治疗脾肾阳虚型肝硬化腹水随机安慰剂对照临床研究

Combination of ascites cataplasm and western medicine for ascites due to liver cirrhosis of spleen and kidney yang deficiency pattern: a randomized placebo-controlled trial

目的观察"水臌贴"敷脐联合西药治疗脾肾阳虚型肝硬化腹水的临床疗效。方法将108例脾肾阳虚型肝硬化腹水患者随机分为治疗组和对照组,每组54例。治疗组采用"水臌贴"敷脐加西医常规疗法,对照组采用"水臌贴"模拟安慰贴敷脐加西医常规疗法。两组疗程均为14天,观察临床疗效及不良反应发生率,比较中医证候积分及临床体征变化情况。结果 1疗程结束时,共有107例完成试验,其中治疗组54例,对照组53例。2治疗组、对照组总有效率分别为79.63%、66.04%;组间临床疗效比较,差异有统计学意义(P<0.05)。3治疗前后组内比较,两组中医证候积分差异有统计学意义(P<0.05);组间治疗后比较,中医证候积分差异有统计学意义,治疗组优于对照组(P<0.05)。4治疗前后组内比较,两组24 h尿量、腹围、体质量水平差异有统计学意义(P<0.05);组间治疗后比较,上述指标差异均有统计学意义,治疗组优于对照组(P<0.05)。5两组不良反应发生率差异无统计学意义(P>0.05)。结论 "水臌贴"敷脐联合西药治疗脾肾阳虚型肝硬化腹水疗效满意,可显著改善患者的临床症状及体征。

Objective To observe the clinical efficacy of ascites cataplasm and western medicine for the treatment of ascites due to liver cirrhosis of the spleen and kidney yang deficiency pattern. Methods One hundred and eight cases with ascites due to liver cirrhosis of the spleen and kidney yang deficiency pattern were randomized into treatment group and control group,with 54 cases in each group. Treatment group was treated with ascites cataplasm and western medicine,and control group was treated with placebo cataplasm and western medicine,with the course of 14 days. The clinical efficacy,occurrence rate of adverse reactions were observed in both groups,and the TCM symptom scores and changes of clinical signs were compared between the groups. Results 1 All the 107 cases were finished the trial,54 in the treatment group and 53 in the control group. 2 The total effective rate was 79. 63% in the treatment group and 66. 04% in the control group,with a difference between the two groups（ P〈0. 05）. 3 After treatment,there were significant difference in the TCM symptoms scores in each group（ P 〈0. 05）; with significant difference between the two groups,and treatment group was superior to the control group（ P〈 0. 05）. 4 In both groups,there were significant differences in the 24 h urine volume,abdominal circumference and body mass index between before and after treatment（ P〈 0. 05）; after treatment,there were significant differences in the above indexes between the two groups,and the treatment group was superior to the control group（ P〈 0. 05）. 5 Nosignificant difference was found in occurrence rate of adverse reactions in both groups（ P 〈0. 05）. Conclusion Combined ascites cataplasm and western medicine has positive effect on ascites due to liver cirrhosis of spleen and kidney yang deficiency pattern by improving its clinical symptoms and signs.