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肝豆灵片治疗痰瘀互结型肝豆状核变性脂代谢异常的随机对照试验及相关性分析

Randomized Controlled Trial and Correlation Analysis of Gandouling Tablet in Treatment of Abnormal Lipid Metabolism of Wilson's Disease with Turbid Phlegm and Blood Stasis
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摘要 目的:探讨肝豆灵(GDL)对肝豆状核变性(WD)脂代谢异常的临床疗效及肝脂肪变性预测模型与WD脂代谢相关指标的相关性。方法:选取86例WD脂代谢异常患者,统计治疗前患者24 h尿铜、丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、血清甘油三酯(TG)、总胆固醇(TC)、载脂蛋白B(ApoB)、低密度脂蛋白胆固醇(LDL-C)、胆汁酸(BA)、γ-谷氨酰转移酶(GGT)、肝脂肪变性预测模型[肝脂肪变性指数(HSI)、浙江大学指数(ZJU指数)]、超声衰减系数成像(ATT)及中医证候积分,采用Pearson相关性检验分析探讨TG、TC、LDL-C、ApoB、ALT、AST、ALT/AST、BA、GGT、中医证候积分及ATT与HSI及ZJU指数的相关性。采用随机数字表法将患者分为观察组和对照组,每组各43例,观察组给予肝豆灵联合二巯丙磺钠(DMPS)治疗,对照组仅给予DMPS作为对照。经6个疗程的治疗后,观察比较治疗前后两组患者24 h尿铜、TC、TG、LDL-C、ApoB、HSI、ZJU指数、ATT、中医证候积分及临床有效率,并分析HSI、ZJU指数与血清TC、TG、LDL-C、ApoB、ALT、AST、ALT/AST、BA、GGT水平及中医证候积分、ATT的相关性。结果:Pearson相关性分析显示,WD脂代谢异常患者血清TC(r=0.811)、TG(r=0.826)、LDL-C(r=0.802)、ApoB(r=0.820)、ALT(r=0.497)、ALT/AST(r=0.826)、中医证候积分(r=0.716)、ATT(r=0.736)与HSI呈正相关(P<0.01),AST、BA、GGT与HSI无明显相关性。TC(r=0.718)、TG(r=0.765)、LDL-C(r=0.667)、ApoB(r=0.699)、ALT/AST(r=0.403)、中医证候积分(r=0.666)、ATT(r=0.684)与ZJU指数呈正相关(P<0.01),ALT、AST、BA、GGT与ZJU指数无明显相关性。观察组总有效率为86.05%(37/43),对照组总有效率为72.09%(31/43),观察组总有效率高于对照组(Z=-2.301,P<0.05)。与本组治疗前比较,两组患者24 h尿铜显著增加,TC、TG、LDL-C、ApoB水平显著下降,HSI、ZJU指数、ATT显著下降(P<0.01)。与对照组治疗后比较,观察组患者上述指标改善更优(P<0.05,P<0.01)。 Objective:To investigate the clinical efficacy of Gandouling tablet(GDL)on abnormal lipid metabolism in Wilson's disease(WD)and the correlation between the prediction model of hepatic steatosis and the related indexes of lipid metabolism in WD.Method:A total of 86 patients with abnormal lipid metabolism in WD were selected.The 24-hour urine copper,alanine aminotransferase(ALT),aspartate aminotransferase(AST),serum triglyceride(TG),total cholesterol(TC),apolipoprotein B(ApoB),low density lipoprotein cholesterol(LDL-C),bile acid(BA),γ-glutamyl transferase(GGT),prediction model of hepatic steatosis[hepatic steatosis index(HSI)and Zhejiang University index(ZJU index)],ultrasonic attenuation coefficient imaging(ATT),and traditional Chinese medicine(TCM)syndrome score were statistically analyzed before treatment.Pearson correlation test was used to analyze the correlation between TG,TC,LDL-C,ApoB,ALT,AST,ALT/AST,BA,GGT,TCM syndrome score,ATT,and HIS and ZJU.The patients were divided into an observation group and a control group by random number table method,with 43 cases in each group.The observation group was treated with GDL combined with sodium dimercaptopropane sulfonate(DMPS),while the control group was only treated with DMPS as a control.After six courses of treatment,24-hour urine copper,TC,TG,LDL-C,ApoB,HSI,ZJU,ATT,TCM syndrome score,and clinical efficiency before and after treatment were observed and compared between the two groups.The correlation between HSI and ZJU and serum TC,TG,LDL-C,ApoB,ALT,AST,ALT/AST,BA,GGT,TCM syndrome scores,and ATT was analyzed.Result:Pearson correlation analysis showed that serum TC(r=0.811),TG(r=0.826),LDL-C(r=0.802),ApoB(r=0.820),ALT(r=0.497),ALT/AST(r=0.826),TCM syndrome score(r=0.716),and ATT(r=0.736)were positively correlated with HSI(P<0.01),while AST,BA,and GGT had no significant correlation with HSI.TC(r=0.718),TG(r=0.765),LDL-C(r=0.667),ApoB(r=0.699),ALT/AST(r=0.403),TCM syndrome score(r=0.666),and ATT(r=0.684)were positively correlated with ZJU(P<0.01).ALT,AST,BA,and GG
作者 梁丰 董婷 田丽伟 赵晨玲 郭瑞雪 王琼 张宇琦 LIANG Feng;DONG Ting;TIAN Liwei;ZHAO Chenling;GUO Ruixue;WANG Qiong;ZHANG Yuqi(The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230031,China)
出处 《中国实验方剂学杂志》 CAS CSCD 北大核心 2024年第12期121-128,共8页 Chinese Journal of Experimental Traditional Medical Formulae
基金 安徽省自然科学基金面上项目(208085MH270) 第二批全国西医学习中医优秀人才研修项目(国中医药人教函[2023]214号) 国家中医药管理局中医药循证能力建设项目(2019XZZX-NB001) 国家自然科学基金区域创新发展联合基金项目(U22A20366)。
关键词 肝豆状核变性 脂代谢异常 肝豆灵片 预测模型 超声衰减系数成像 Wilson's disease abnormal lipid metabolism Gandouling tablet prediction model ultrasound attenuation coefficient imaging
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