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疏肝健脾方治疗2型糖尿病合并非酒精性脂肪肝肝郁脾虚证的临床研究
A Clinical Research on Prescription of Soothing Liver and Invigorating Spleen to Interfere in the Syndrome of Liver Qi Depression and Spleen Dificiency in Type2Diabetes Mellitus and Non-alcoholic Fatty Liver Disease
【作者】 金晓雯；
【导师】 王旭；
【作者基本信息】 南京中医药大学 ， 中医内科学， 2012， 硕士
【摘要】 目的：探讨中医学对2型糖尿病合并非酒精性脂肪肝的认识,采用疏肝健脾方治疗2型糖尿病合并非酒精性脂肪肝,客观评价疏肝健脾方治疗2型糖尿病合并非酒精性脂肪肝的疗效及安全性,探讨其防治本病的机理。方法：采用随机平行对照的研究方法,将符合2型糖尿病合并非酒精性脂肪肝肝郁脾虚证的患者,随机分为治疗组(30例)和对照组(30例)。在一般治疗和西药降糖、调脂、降酶的基础上,治疗组再予中药疏肝健脾方水煎剂每日1剂,分为早晚两次服用,疗程12周。治疗前后分别评价两组临床症状、体征的变化,及血糖(FBG、P2hBG)、糖化血红蛋白(HbA1c)、血脂(TC、TG、HDL-C、LDL-C)、肝脏生化(AST、ALT)、空腹胰岛素(FINS)、胰岛素抵抗指数(HOMA-IR)和肝脏B超等指标的变化。全部数据以SPSS17.0统计软件进行统计学分析。结果：确认并纳入的2型糖尿病合并非酒精性脂肪肝肝郁脾虚证患者共60例(治疗组和对照组各30例)。治疗前两组患者的年龄、性别、病程等基线数据经统计学处理无显著性差异,两组数据具有可比性(P>0.05)。疗效指标比较结果：①对体征、症状的改善：治疗组治疗后症状明显改善,总有效率达86.67%,对照组总有效率为60.00%。治疗组体征、症状的改善情况优于对照组(P<0.01)。②血糖指标：治疗组与对照组患者空腹血糖、餐后2小时血糖、糖化血红蛋白均明显降低,与治疗前比较均有显着性差异(P<0.01),且治疗组空腹血糖及餐后血糖降低优于对照组(P<0.05),治疗组糖化血红蛋白降低明显优于对照组(P<0.01)。③血脂指标：治疗组和对照组患者甘油三酯、总胆固醇、低密度脂蛋白与治疗前比较均明显下降(P<0.01),高密度脂蛋白明显升高(P<0.01),且治疗组调脂疗效明显优于对照组(P<0.01)。④肝功能指标：治疗组和对照组患者的谷丙、谷草转氨酶治疗后均在正常范围,且治疗组转氨酶降低程度明显优于对照组(P<0.01)。⑤空腹血清胰岛素和胰岛素抵抗指数指标：两组患者治疗后空腹血清胰岛素及胰岛素抵抗指数明显降低,与治疗前比有显著性差异(P<0.01)；治疗组空腹血清胰岛素降低较对照组有显著差异(P<0.01),胰岛素抵抗指数较对照组有差异(P<0.05)。⑥肝脏B超：治疗组患者B超下肝脏脂肪分度改善,与治疗前比较有显著性差异(P<0.05),而对照组治疗前后无明显差异(P>0.05)。⑦安全性指标：治疗组患者安全性指标均在正常范围。结论：从初步临床研究来看,中西医结合治疗2型糖尿病合并非酒精性脂肪肝效果明显优于单纯西药治疗,中药治疗既可改善2型糖尿病合并非酒精性脂肪肝患者的临床症状,改善胰岛素抵抗、降低血糖、调节血脂、降低谷丙谷草转氨酶等,且安全、有效,具有广泛的应用前景,值得进一步深入研究。
【Abstract】 Purpose:To discuss the understanding of traditional Chinese medicine about type2diabetes mellitus and non-alcoholic fatty liverdisease by using prescription of soothing liver and invigorating spleen. To observe the therapeutic efficacy of this method in treating the syndrome of liver qi depression and spleen dificiency in type2diabetes mellitus and non-alcoholic fatty liverdisease.Methods:A randomized, controlled trial was conducted.60patients with the syndrome of liver qi depression and spleen deficiency in type2diabetes mellitus and non-alcoholic fatty liverdisease were randomly classified into two proups. Besides the basic of regular treatment and modern medicine,the patients of treated group (n=30) were treated by Chinese medicine while the patients of controlled groups (n=30) were not. Twelve weeks was a course of treatment. The observed indexes included both curative effect indexes, such as clinical symptoms, FBG, P2HBG, HbAlc, AST, ALT, TC, TG, HDL-C, LDL-C, HOMA-IR, liver type-B ultrasonic, and safety indexes, such as routine blood, urine and stool test,, the function of liver and kidney and harmful reaction. All data were analyzed by the SPSS17.0statistics software.Results:Prior treatment, no differences were found in the gender, age, course of disease between the two groups.①The total effective rate of treated group’s patients was86.7%, while the controlled group was60%. The treated group gained an advantage over the controlled group (P<0.01).②he fasting blood glucose, postprandial blood glucose of two groups were lowered(.P<0.01). And the treated group had an advantage than the controlled group(P<0.05). The HbAlc of two groups were lowered(P<0.01). And the treated group had an advantage than the controlled group(P<0.01).③ompared with pre-treatment, in two group patients’TG、TC、 LDL-C had a lowering(P<0.01), and HDL-C had marked increased(P<0.01). And the treated group had an advantage than the controlled group(P<0.01). That showes that the combination of western medicine and chinese medicine has the function of adjusting fat and it does much better than using western medicine effected in TG, TC, LDL-C and HDL-C.④he AST and ALT of two groups were lowered(P<0.01).And the treated group had an advantage than the controlled group(P<0.01).⑤ll of patients after treatment of FINS and HOMA-IR decreased significantly compared with before treatment, there were significant differences(P<0.01). And the treated grouppatients’FINS had an advantage than the controlled group(P<0.01),while HOMA-IR had an advantage than the controlled group(P<0.05).⑥The treatment group patients’liver B-mode ultrasonography had improved(p<0.05), while the control group showed no significant difference before and after treatment (P>0.05).⑦t the same time, Group therapy for patients with renal function tests were within the normal range.Conclusion:Chinese medicine of method in soothing liver and invigorating spleen has a sure curative effected in treating type2diabetes mellitus and non-alcoholic fatty liver disease. It is worth studying deeply and developing further.