加味四逆散治疗2型糖尿病非酒精性脂肪性肝病(肝郁气滞)随机平行对照研究
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摘要
[目的]观察加味四逆散治疗2型糖尿病非酒精性脂肪性肝病(肝郁气滞)疗效。[方法]使用随机平行对照方法,将90例住院患者按病案号抽签,随机分为两组。对照组45例血脂康,2粒/次,2次/d,餐后口服。治疗组45例加味四逆散(柴胡、白芍、枳实、甘草、丹参、赤芍各10g,黄芪15g,白术10g,葛根15g),150mL/袋,1袋/d,饭后口服。连续治疗16周为1疗程。观测临床表现、甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋(LDL-C)、高密度脂蛋白(HDL-C)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、谷氨酰转肽酶(γ-GT)、空腹血糖、餐后2h血糖、胰岛素敏感指数(ISI)、胰岛素抵抗指数(HOMA-IR)、谷胱甘肽过氧化物酶(GSH-Px)、过氧化氢酶(CAT)、超氧化物歧化酶(SOD)、不良反应。治疗1疗程(16周),判定疗效。[结果]治疗组显效33例,有效10例,好转2例,总有效率95.56%;对照组显效20例,好转18例,无效9例,总有效率80.00%;治疗组疗效优于对照组(P<0.05)。TG、TC、LDL-C、HDL-C、ALT、AST、γ-GT两组均有改善(P<0.05,P<0.01),治疗组改善优于对照组(P<0.05,P<0.01)。FBG、2hPBG、ISI、HOMA-IR、CAT、SOD、两组均有改善(P<0.05,P<0.01),治疗组改善优于对照组(P<0.05,P<0.01),GSH-Px治疗前后两组均无显著变化(P>0.05)。[结论]加味四逆散治疗2型糖尿病非酒精性脂肪性肝病(肝郁气滞),疗效满意,无严重不良反应,值得推广。
[Objective] To observe the therapeutic effect of Jiawei Sini San on type 2 diabetes mellitus with non-alcoholic fatty liver disease(Ganyu Qizhi). [Method] 90 inpatients were randomly divided into two groups by drawing lots according to the disease sign using a randomized parallel control method. The control group consisted of 45 cases of Xuezhikang, 2 capsules per time, 2 times per day, orally after meals. In the treatment group, 45 cases of Jiawei Sini San(Chaihu, Baishao, Zhishi,Gancao, Danshen, Chishao each 10 g, Huangqi15 g, Baizhu 10 g, Gegen 15 g), 150 mL/bag, 1 bag/day, oral after meals). Continuous treatment for 16 weeks is a course of treatment. Clinical manifestations, triglyceride(TG), total cholesterol(TC), low density lipoprotein(LDL-C), high density lipoprotein(HDL-C), alanine aminotransferase(ALT), glutathione transaminase(AST),glutamyltransferase(γ-GT), fasting blood glucose, 2 h postprandial blood glucose, insulin sensitivity index(ISI), insulin resistance index(HOMA-IR), glutathione peroxidase(GSH-Px), catalase(CAT), and hyper were observed. Oxide dismutase(SOD), adverse reactions. One course of treatment(16 weeks) was used to determine the curative effect. [Result] 33 cases were markedly effective in the treatment group, 10 cases were effective, 2 cases were improved, the total effective rate was 95.56%; 20 cases were markedly effective in the control group, 18 cases were improved, 9 cases were ineffective, the total effective rate was 80.00%; the curative effect of the treatment group was better than that of the control group(P<0.05). TG, TC, LDL-C,HDL-C, ALT, AST and gamma-GT were improved in both groups(P<0.05, P<0.01). The improvement in treatment group was better than that in control group(P<0.05, P<0.01). FBG, 2 hPBG, ISI, HOMA-IR,CAT, SOD and two groups were all improved(P<0.05, P<0.01). The improvement of treatment group was better than that of control group(P<0.05, P<0.01). There was no significant difference between the two groups before and after GSH-Px treatment(P>0.05). [Conclusion] Jiawei Sini San is effective in treating type 2 diabetes mellitus with non-alcoholic fatty liver disease(liver depression and Qi stagnation). It has no serious adverse reactions and is worth popularizing.
[Objective] To observe the therapeutic effect of Jiawei Sini San on type 2 diabetes mellitus with non-alcoholic fatty liver disease(Ganyu Qizhi). [Method] 90 inpatients were randomly divided into two groups by drawing lots according to the disease sign using a randomized parallel control method. The control group consisted of 45 cases of Xuezhikang, 2 capsules per time, 2 times per day, orally after meals. In the treatment group, 45 cases of Jiawei Sini San(Chaihu, Baishao, Zhishi,Gancao, Danshen, Chishao each 10 g, Huangqi15 g, Baizhu 10 g, Gegen 15 g), 150 mL/bag, 1 bag/day, oral after meals). Continuous treatment for 16 weeks is a course of treatment. Clinical manifestations, triglyceride(TG), total cholesterol(TC), low density lipoprotein(LDL-C), high density lipoprotein(HDL-C), alanine aminotransferase(ALT), glutathione transaminase(AST),glutamyltransferase(γ-GT), fasting blood glucose, 2 h postprandial blood glucose, insulin sensitivity index(ISI), insulin resistance index(HOMA-IR), glutathione peroxidase(GSH-Px), catalase(CAT), and hyper were observed. Oxide dismutase(SOD), adverse reactions. One course of treatment(16 weeks) was used to determine the curative effect. [Result] 33 cases were markedly effective in the treatment group, 10 cases were effective, 2 cases were improved, the total effective rate was 95.56%; 20 cases were markedly effective in the control group, 18 cases were improved, 9 cases were ineffective, the total effective rate was 80.00%; the curative effect of the treatment group was better than that of the control group(P<0.05). TG, TC, LDL-C,HDL-C, ALT, AST and gamma-GT were improved in both groups(P<0.05, P<0.01). The improvement in treatment group was better than that in control group(P<0.05, P<0.01). FBG, 2 hPBG, ISI, HOMA-IR,CAT, SOD and two groups were all improved(P<0.05, P<0.01). The improvement of treatment group was better than that of control group(P<0.05, P<0.01). There was no significant difference between the two groups before and after GSH-Px treatment(P>0.05). [Conclusion] Jiawei Sini San is effective in treating type 2 diabetes mellitus with non-alcoholic fatty liver disease(liver depression and Qi stagnation). It has no serious adverse reactions and is worth popularizing.
引文
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[17]杨硕,娄金丽,王谦,等葛根素治疗2型糖尿病KKAy小鼠肝脏损伤的实验研究[J].中国中西医结合杂志2009,29(8):707-710.
[18]贺琴,李芳,谭华炳.绞股蓝皂苷对2型糖尿病并发非酒精性脂肪性肝病大鼠脂质过氧化的影响[J].导报,2014,12(33):1549-1553.
[19]李忻,顾立刚,赵婷婷,等.福辛普利对2型糖尿病大鼠肝脏氧化应激的影响及肝损伤的保护作用[J].中日友好医院学报,2015,29(3):173-176.
[20]刘爽,崔卫正.芹菜素对链脲佐菌素诱导糖尿病大鼠肝损伤的影响[J].国际中医中药杂志,2015,4(37):335-338.
[21]牟忠卿,李晓博,陈丽.糖尿病大鼠肝脏组织中氧化应激标志物的表达变化及意义[J].山东医药,2015,55(7):26-28.
[22]孙治华.新诊断2型糖尿病合并非酒精性脂肪肝胰岛素抵抗和胰岛β细胞功能特点分析[J].新医学,2014,45(6):412-414.
[23]黄晶,高建立.SOD、GSH-PX、CAT系列氧化清除酶活性监测对肝组织损伤诊断的临床意义[J].临床肝胆病杂志,1998,14(3)181-183.
[24]夏金荣,林春生.肝星状细胞在肝纤维化中的作用[J].临床荟萃2006,21(12):907-908.
[25]刘琦,曹燕,宋阳,等.RBP-4及网膜素与NAFLD患者胰岛素抵抗的关系研究[J].中国医药指南,2015,13(16):208.
[26]董晶晶.球型脂联素对糖尿病大鼠胰岛素分泌和IR、IRS-1表达的影响[D].福州:福建医科大学,2013.
[27]汪燕燕.2型糖尿病合并非酒精性脂肪肝相关危险因素及中医证素分析[J].河北中医,2012,34(12):1789-1791.
[28]灵枢经[M].北京:人民卫生出版社,2012:71.
[29]黄帝内经素问[M].北京:人民卫生出版社,2012:176.
[30]关崧,赵翠芳.化湿降浊活血法治疗2型糖尿病并发非酒精性脂肪肝疗效观察[J].陕西中医,2013,4(34):412-413.
[31]钱秋海,钱卫斌,蔡欣蕊,等.健脾益气调肝解毒活血法治疗糖尿病脂肪肝经验[J]河北中医,2013,4(35):527-528.
[32]肖星月,李鸣鑜,倪青,等.林兰教授辨治糖尿病性肝损伤经验[J]国际中医中药杂志,2007,2(29):113-114.
[33]张仲景.伤寒论[M].钱超尘,郝万山,整理.北京:人民卫生出版社2008:91.
[34]高学敏.中药学[M].北京:中国中医药出版社,2007.
[35]周春祥,徐强,曹劲松,等.四逆散改善细胞免疫性肝损伤作用机理研究[J].中国中医基础医学杂志,2002,8(5):48-49.
[36]王付,尚立芝,苗小玲,等.四逆散加味对肝纤维化大鼠肝功能、肝纤维化指标及病理变化的影响[J].中国实验方剂学杂志,201218(5):177-180.
[37]王剑锋,王付,苗小玲,等.四逆散加味对肝纤维化大鼠RhoamRNA和蛋白表达影响的研究[J].时珍国医国药,2013,24(9):2116-2117.
[38]刘亚军,王佳,王春生.加味四逆散治疗2型糖尿病脂肪肝肝损害临床观察[J],北京中医药,2009,28(7):530-531.
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[2]中华医学会糖尿病分会.中国2型糖尿病防治指南(2010年版)[J]中国实用乡村医生杂志2012,19(6):1-9.
[3]Keyhani-Nejad F,Innler M,Isken F,et a1.Nutritional strategy to prevent fatty Iiver and insuIin resistance independent of obesity by reducing glucose-dependent insulinotropic olypeptide responses in mice[J].Diabetologia,2015,58(2):374-383.
[4]郭敏,郗光霞,杨娜,等.2型糖尿病合并非酒精性脂肪性肝病的代谢相关危险因素分析[J].中华肝脏病杂志,2014,22(8):631-635.
[5]中华人民共和国卫生部.涉及人的生物医学研究伦理审查办法(试行)[S].(2007-03-26)[2018-07-01].http://www.moh.gov.cn/qjjys/s3581/200804/b9f1bfee4ab344ec892e68097296e2a8.shtml.
[6]中华医学会肝病学分会脂肪肝和酒精性肝病学组.非酒精性脂肪性肝病诊疗指南[J].中华内科杂志,2007,19(1):1-3.
[7]周仲瑛.中医内科学[M].北京:中国中医药出版社,2004:273.
[8]陆伦根,曾民德.肥胖症肝病理学表现[J].肝脏,2005,10(2):116-117.
[9]赵玲,杜娟,徐勉,等.2型糖尿病合并非酒精性脂肪性肝病与胰岛素抵抗及血脂代谢紊乱的关系[J].中华内分泌代谢杂志,2012,28(1):16-20.
[10]范慧,张鹏睿,徐援.2型糖尿病合并非酒精性脂肪肝与胰岛素抵抗及心血管病变发生的关系研究[J].中国全科医学,2011,14(2):147-150.
[11]谈力欣,刘焱,张秀云,等.2型糖尿病合并非酒精性脂肪肝患者炎性因子、氧化应激、硫氧还蛋白互作蛋白水平研究及相关性分析[J].河北医药,2018,40(9):1285-1289.
[12]Albano E,Mottaran E,Vidali M,et al,Immune response towards lipid eroxidation products as a Predictor of progression of non-alcoholic fatty liver disease to advaned fibrosis.J.Cut,2005,54(7):987-993.
[13]毕小云,黄琳,黄维嘉.2型糖尿病中游离脂肪酸与胰岛素抵抗的关系[J].现代医药卫生,2004,20(12):1115-1116.
[14]段云,吴兆丰,刘秉文.中老年男性血糖与血清脂质及载脂蛋白的关系[J].四川大学学报(医学版),2001,32(3):382-384.
[15]刘东慧,颜勇,刘美晓,等.2型糖尿病与非酒精性脂肪性肝病[J].承德医学院学报,2017,34(1):61-63.
[16]丁娟娟,李强.非酒精性脂肪性肝病与代谢综合征相关2型糖尿病的相关性研究[J].中国医药导报,2014,11(11):51-53.
[17]杨硕,娄金丽,王谦,等葛根素治疗2型糖尿病KKAy小鼠肝脏损伤的实验研究[J].中国中西医结合杂志2009,29(8):707-710.
[18]贺琴,李芳,谭华炳.绞股蓝皂苷对2型糖尿病并发非酒精性脂肪性肝病大鼠脂质过氧化的影响[J].导报,2014,12(33):1549-1553.
[19]李忻,顾立刚,赵婷婷,等.福辛普利对2型糖尿病大鼠肝脏氧化应激的影响及肝损伤的保护作用[J].中日友好医院学报,2015,29(3):173-176.
[20]刘爽,崔卫正.芹菜素对链脲佐菌素诱导糖尿病大鼠肝损伤的影响[J].国际中医中药杂志,2015,4(37):335-338.
[21]牟忠卿,李晓博,陈丽.糖尿病大鼠肝脏组织中氧化应激标志物的表达变化及意义[J].山东医药,2015,55(7):26-28.
[22]孙治华.新诊断2型糖尿病合并非酒精性脂肪肝胰岛素抵抗和胰岛β细胞功能特点分析[J].新医学,2014,45(6):412-414.
[23]黄晶,高建立.SOD、GSH-PX、CAT系列氧化清除酶活性监测对肝组织损伤诊断的临床意义[J].临床肝胆病杂志,1998,14(3)181-183.
[24]夏金荣,林春生.肝星状细胞在肝纤维化中的作用[J].临床荟萃2006,21(12):907-908.
[25]刘琦,曹燕,宋阳,等.RBP-4及网膜素与NAFLD患者胰岛素抵抗的关系研究[J].中国医药指南,2015,13(16):208.
[26]董晶晶.球型脂联素对糖尿病大鼠胰岛素分泌和IR、IRS-1表达的影响[D].福州:福建医科大学,2013.
[27]汪燕燕.2型糖尿病合并非酒精性脂肪肝相关危险因素及中医证素分析[J].河北中医,2012,34(12):1789-1791.
[28]灵枢经[M].北京:人民卫生出版社,2012:71.
[29]黄帝内经素问[M].北京:人民卫生出版社,2012:176.
[30]关崧,赵翠芳.化湿降浊活血法治疗2型糖尿病并发非酒精性脂肪肝疗效观察[J].陕西中医,2013,4(34):412-413.
[31]钱秋海,钱卫斌,蔡欣蕊,等.健脾益气调肝解毒活血法治疗糖尿病脂肪肝经验[J]河北中医,2013,4(35):527-528.
[32]肖星月,李鸣鑜,倪青,等.林兰教授辨治糖尿病性肝损伤经验[J]国际中医中药杂志,2007,2(29):113-114.
[33]张仲景.伤寒论[M].钱超尘,郝万山,整理.北京:人民卫生出版社2008:91.
[34]高学敏.中药学[M].北京:中国中医药出版社,2007.
[35]周春祥,徐强,曹劲松,等.四逆散改善细胞免疫性肝损伤作用机理研究[J].中国中医基础医学杂志,2002,8(5):48-49.
[36]王付,尚立芝,苗小玲,等.四逆散加味对肝纤维化大鼠肝功能、肝纤维化指标及病理变化的影响[J].中国实验方剂学杂志,201218(5):177-180.
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