血脂康胶囊治疗绝经后女性2型糖尿病合并非酒精性脂肪肝的临床观察

Clinical Observation of Xuezhikang Capsule in the Treatment of Post-menopause Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

目的：观察血脂康胶囊治疗绝经后女性2型糖尿病（T2DM）合并非酒精性脂肪肝患者（NAFLD）的疗效、安全性及对相关指标的影响。方法：100例绝经后女性T2DM合并NAFLD患者随机分为对照组（50例）和观察组（50例）。两组患者给予常规生活方式干预,包括饮食干预、控制体质量和适当运动等。在此基础上,对照组患者给予盐酸二甲双胍肠溶胶囊起始剂量0.5 g,口服,每日2次,后逐渐增加剂量至0.5 g,口服,每日3次＋辛伐他汀片起始剂量10-20 mg,口服,每日1次,后逐渐增加剂量至40 mg,口服,每日1次。观察组患者在对照组治疗的基础上给予血脂康胶囊0.6 g,早晚饭后服用。两组疗程均为12周。两组患者治疗期间禁用其他影响血糖血脂代谢、肝肾功能的药物（如糖皮质激素等）。观察两组患者的临床疗效、治疗前后血糖血脂水平[血浆总胆固醇（TC）、三酰甘油（TG）、低密度脂蛋白胆固醇（LDL-C）和高密度脂蛋白胆固醇（HDL-C）、空腹血糖（FPG）、糖化血红蛋白（Hb A1c）、空腹胰岛素（FINS）、胰岛素抵抗指数（HOMA-IR）]、肝肾功能指标[丙氨酸转氨酶（ALT）、天冬氨酸转氨酶（AST）、谷氨酰胺转肽酶（GGT）、总胆红素（TBIL）、血肌酐（Scr）、血尿素氮（BUN）]、超氧化物歧化酶（SOD）、丙二醛（MDA）、C反应蛋白（CRP）、白细胞介素（IL）-6及不良反应发生情况。结果：观察组患者总有效率显著高于对照组,差异有统计学意义（P〈0.05）。治疗后,两组患者FPG、Hb A1c、FINS、HOMA-IR、TC、TG、LDL-C、ALT、AST、GGT、TBIL、MDA、CRP、IL-6均显著低于同组治疗前,且观察组低于对照组,HDL-C、SOD均显著高于同组治疗前,且观察组高于对照组,差异均有统计学意义（P〈0.05）。两组患者不良反应发生率比较差异无统计学意义（P〉0.05）。结论：在常规治疗的基础上,血脂康胶囊治疗绝经后女性T2DM合并NAFLD的疗效显著,可改善胰岛素抵抗状态,且安全性较好。

OBJECTIVE： To observe the clinical efficacy and safety of Xuezhikang capsule in the treatment of post-menopanse patients with type 2 diabetes and nonalcoholic fatty liver disease and its effect on related indicators. METHODS： 100 patients were randomly divided into observation group （50 cases） and control group （50 cases）. All patients received conventional lifestyle inter- vention, including diet intervention, controlling body mass and appropriate exercise, etc. Based on it, control group was given Metformin hydrochloride enteric-coated capsule with initial dose of 0.5 g, orally, twice a day, gradually increased to 0.5 g, orally, 3 times a day＋Simvastatin tablet with initial dose of 0.5 g, orally, once a day, gradually increased to 40 mg, orally, once a day. Observation group was additionally given Xuezhikang capsule, twice a day, taking after breakfast and dinner. The treatment course was 12 weeks. Other drugs affected blood glucose and lipid metabolism, hepatic and renal functions （such as glucocorticoids） were forbidden. Clinical efficacy, blood glucose and lipid metabolism indicators （TC, TG, LDL-C, HDL-C, FPG, HbAtc, FINS, HOMA-IR）, hepatic and renal function indicators （ALT, AST, GGT, TBIL, Scr,BUN）, SOD, MDA, CRP, IL-6 before and af- ter treatment and the incidence of adverse reactions in 2 groups were observed. RESULTS： The total effective rate in observation group was significantly higher than control group, with statistic significance （P〈0.05）. After treatment, FPG, HbAlc, FINS, HOMA-IR, TC, TG, LDL-C, ALT, AST, GGT, TBIL, MDA, CRP and IL-6 in 2 groups were significantly lower than before, and observation group was lower than control group, HDL-C and SOD were significantly higher than before, and observation group was higher than control group, with statistic significances （P〈0.05）. And there was no significant difference in the inci- dence of adverse reactions （P〉0.05）. CONCLUSIONS： Based on conventional treatment, Xuezhikang capsule shows superior effi- cacy in the treatment of post-menopause patients with type 2 diabetes and nonalcoholic fatty liver disease, it can improve insulin re- sistance, with good safety.