柴芩温胆汤治疗慢性乙型病毒性肝炎睡眠障碍的随机单盲对照试验研究  

Randomized Single Blind Controlled Research on Caiqin Wendan Decoction in Treating Sleep Disorders with Chronic Hepatitis B

作　　者：周坚 潘陈为[1] 郑园园[1] 林士毅[1] 毛丹丹[1] 蔡进章[1] 刘时觉[1] 

机构地区：[1]温州医科大学附属第二医院,浙江温州325027

出　　处：《中华中医药学刊》2017年第12期3214-3216,共3页Chinese Archives of Traditional Chinese Medicine

基　　金：温州市科技计划项目(Y20120255)

摘　　要：目的:观察柴芩温胆汤治疗慢性乙肝患者睡眠障碍的临床疗效。方法:选择ICD-10诊断标准诊断为失眠症,中医辨证为肝郁脾虚、痰热内扰证的慢性乙肝患者60例,随机分为柴芩温胆汤治疗组30例和安慰剂对照组30例,两组均给予常规保肝降酶药物,治疗前和治疗28 d后观察匹兹堡睡眠质量指数(PSQI)量表和中医证候量表评分变化情况,以减分率评定疗效,并对治疗组和对照组进行治疗前后血常规、尿常规、肝功能、肾功能、心电图、乙肝病毒学分析。结果:治疗28 d后,两组总有效率差异有统计学意义(P<0.01);治疗组治疗前后中医证候积分有明显改善(均P<0.01),治疗后组间比较有差异有统计学意义(P<0.05,P<0.01);两组治疗后谷丙转氨酶(ALT)、谷草转氨酶(AST)、谷氨酰转肽酶(GGT)、总胆红素(TBIL)与治疗前比较差异有统计学意义(P<0.05);治疗后组间比较差异有统计学意义(P<0.05);两组治疗后乙肝表面抗原(HBs Ag),乙肝e抗原(HBe Ag),乙肝e抗体(HBe Ab),乙肝病毒脱氧核糖核酸(HBV-DNA)检测与治疗前比较差异无统计学意义(P>0.05);治疗后组间比较差异无统计学意义(P>0.05)。结论:柴芩温胆汤可保护肝细胞,改善肝功能,且安全性较高,是治疗肝郁脾虚、痰热内扰型慢性乙肝患者睡眠障碍的有效方剂。Objective：To observe the therapeutic effect of Chaiqin Wendan Decoction on sleep disorders in patients with chronic hepatitis B. Methods ： Sixty patients with chronic hepatitis B were selected by ICD - 10 diagnostic criteria of insomnia and TCM syndrome of the liver depression and spleen deficiency and phlegm - heat disturbance. They were ran- domly divided into two groups： Chaiqin Wendan Decoction group （30 patients） and placebo control group （30 patients）. The two groups were given conventional liver protect drugs, before treatment and 28 days after treatment we observed Pittsburgh Sleep Quality Index （PSQI） scales and TCM syndrome score changes. The efficacy was evaluated by the rate of reduction. The blood routine, urine routine, liver function, renal function, electrocardiogram and hepatitis B virus were analyzed before and after treatment in the treatment group and the control group. Results ： After treatment for 28 days, the total effective rate of the two groups was statistically significant （P 〈 0. 01 ）. Treatment group~ TCM syndrome scores before and after treatment were significantly improved （P 〈 0. 01 ） and the difference between groups after treatment was statistically significant （P 〈 0. 05 ,P 〈 0.01 ）. The levels of alanine aminotransferase （ ALT）, aspartate aminotransferase （AST）, glutamyl transpeptidase （GGT） and total bilirubin （TBIL） after treatment were statistically different from those before treatment （P 〈 0. 05） and there was significant difference between the two groups after treatment （P 〈 0. 05 ）. Af- ter treatment, the levels of hepatitis B virus surface antigen （HBsAg） and hepatitis B virus e antigen （ HBeAg）, hepatitis B virus e antibody （HBeAb） and hepatitis B virus deoxyribonucleic acid （HBV -DNA） were not significantly different from those before treatment （ P 〉 0. 05 ） and there was no significant difference between the two groups after treatment （ P 〉 0. 05 ）. Conclusion ： Chaiqin

关 键 词：乙型病毒性肝炎 睡眠障碍 中医药疗法 柴芩温胆汤 随机对照试验 

分 类 号：R512.62[医药卫生—内科学]