肝豆灵片治疗肝豆状核变性痰瘀互结证的疗效观察

Treatment of Wilson's Disease with Intermin-gled Phlegm and Blood Stasis Syndrome by Gandouling Tablet

目的:观察肝豆灵片治疗肝豆状核变性痰瘀互结证的疗效,并探讨其作用机制。方法:将76例肝豆状核变性痰瘀互结证患者随机分为对照组和观察组,各38例,两组均给予西医基础治疗[二巯基丙磺酸钠(DMPS)和葡萄糖酸锌片],观察组加用肝豆灵片,治疗6个疗程后观察两者临床疗效。观察治疗前后两组中医证候积分,改良Goldstein分级,24 h尿铜(urine copper,u-Cu),游离铜(non-ceruloplasmin plasma copper,nCP-Cu)水平、肝功能和血常规等指标。结果:中医证候疗效总有效率对照组为60.53%,观察组为81.58%,观察组优于对照组(P<0.01)。临床疗效总有效率对照组为73.68%,观察组为84.21%,观察组优于对照组(P<0.05)。与治疗前比较,治疗后两组患者n CP-Cu水平明显降低(P<0.05),u-Cu水平显著升高(P<0.01);治疗后两组无统计学差异。与治疗前比较,两组患者血清总胆红素(total bilirubin,TBIL),天门冬氨酸氨基转移酶(aspartate aminotransferase,AST)和丙氨酸氨基转移酶(alanine amino-transferase,ALT)水平显著降低(P<0.01);治疗后与对照组比较,观察组TBIL,AST和ALT水平明显降低(P<0.05)。结论:肝豆灵片能显著改善肝豆状核变性痰瘀互结证患者中医证候,提高临床疗效,同时改善肝功能,且安全性高。

Objective：To observe the curative effect of Gandouling tablet in the treatment of Wilson’s disease（WD） with intermin-gled phlegm and blood stasis syndrome.Method：Totally 76 WD patients with intermin-gled phlegm and blood stasis syndrome were randomly divided into the control group（38 cases） and the observation group（38 cases）.The control group was given routine western medicine therapy,including dimercaptopropansulfonate sodium（DMPS） and zinc sulfate tablets.The observation group was given Gandouling tablet in addition to the therapy of control group.The curative effect was observed after 6 treatment courses.indexes such as traditional Chinese medicine（TCM） syndrome score,improved Goldstein classification,24-hour urine copper（u-Cu）,ceruloplasmin（CP） and plasma copper（p-Cu） were recorded,the level of nonceruloplasmin plasma copper（nCP-Cu） were calculated,and the blood cell counts,liver function and blood coagulation were detected before treatment and after treatment.Result：The TCM syndrome effective rates of control group and observation group were 60.53% and 81.58%,respectively,with a significant difference between two groups（P〈0.01）.The clinical effective rates of the control group and the observation group were 73.68% and84.21%,respectively,with a significant difference between two groups（P〈0.05）.The n CP-Cu decreased in both groups（P〈0.05）,while the u-Cu increased in both groups（P〈0.01）,but there was no significant difference between two groups.After treatment,total bilirubin（TBIL）,aspartate aminotransferase（AST） and alanine aminotransferase（ALT） decreased in both groups（P〈0.01）,particularly in observation group（P〈0.05）.Conclusion：Gandouling tablet can significantly regulate TCM syndrome,clinical efficacy and liver function in patients with WD with intermin-gled phlegm and blood stasis syndrome.