复方番石榴合剂对超重肥胖型2型糖尿病患者炎症因子的作用研究

Effects of Compound Fanshiliu Mixture on Inflammatory Factors in Overweight and Obese Patients with Type 2 Diabetes Mellitus

【目的】观察复方番石榴合剂(由番石榴叶、五指毛桃、黄连、鬼箭羽等中药组成)治疗超重肥胖型2型糖尿病患者的临床疗效及对血清炎症因子的影响,探讨其降糖及改善胰岛素抵抗的作用机制。【方法】将64例超重肥胖型2型糖尿病湿热困脾证患者随机分为观察组33例和对照组31例。对照组给予二甲双胍+胰岛素降糖治疗,观察组在对照组的基础上加用复方番石榴合剂治疗,疗程为12周。观察2组患者治疗前后中医证候积分、空腹血糖(FBG)、餐后2 h血糖(2hPG)、糖化血红蛋白(HbA1c)、胰岛素抵抗指数(HOMA-IR)、血清白细胞介素6(IL-6)、肿瘤坏死因子α(TNF-α)、细胞间黏附分子1(ICAM-1)和单核细胞趋化蛋白1(MCP-1)的变化情况,并评价2组患者的中医证候疗效和安全性。【结果】(1)治疗12周后,观察组的总有效率为93.94%(31/33),对照组为74.19%(23/31),组间比较,观察组的中医证候疗效明显优于对照组(P<0.05)。(2)治疗后,2组患者的中医证候积分均较治疗前明显下降(P<0.05),且观察组对中医证候积分的下降作用明显优于对照组(P<0.05)。(3)治疗后,2组患者的FBG、2hPG、HbA1c、HOMA-IR水平均较治疗前明显下降(P<0.05),且观察组对FBG、2hPG、HbA1c、HOMA-IR水平的下降作用均明显优于对照组(P<0.05)。(4)治疗后,2组患者的血清IL-6、TNF-α、MCP-1、ICAM-1水平均较治疗前明显下降(P<0.05),且观察组对血清IL-6、TNF-α、MCP-1、ICAM-1水平的下降作用均明显优于对照组(P<0.05)。(5)治疗过程中,除观察组有2例患者出现轻度的胃部不适感、可自行缓解外,2组患者均未表现明显的不良反应;同时,2组患者的血、尿、大便常规和肝功能、肾功能等安全性指标均无明显异常变化。【结论】复方番石榴合剂可显著提高超重肥胖型2型糖尿病湿热困脾证患者的临床疗效,其作用机制可能与抑制炎症反应、改善胰岛素抵抗有关。

Objective To investigate the clinical efficacy of Compound Fanshiliu Mixture(abbreviated as CFM,mainly composed of Folium Psidii Guajavae,Radix Fici Hirtae,Rhizoma Coptidis and Ramulus Euonymi Alati)for the treatment of overweight and obese patients with type 2 diabetes mellitus(T2DM)and to observe its effect on serum inflammatory factors,so as to explore the its mechanism in decreasing blood glucose and improving insulin resistance.Methods Sixty-four overweight and obese patients with T2DM differentiated as damp-heat trapping spleen syndrome were randomly divided into 33 cases in the observation group and 31 cases in the control group.The control group was given glucose-lowering treatment with metformin and insulin,while the observation group was treated with CFM based on the treatment for the control group.Both groups were treated for a course of 12 weeks.The changes in the scores of traditional Chinese medicine(TCM)syndrome and levels of fasting blood glucose(FBG),2-hour postprandial glucose(2hPG),glycosylated hemoglobin(HbA1c),insulin resistance index(HOMA-IR),and serum interleukin 6(IL-6),tumor necrosis factorα(TNF-α),intercellular adhesion molecule 1(ICAM-1)and monocyte chemotaxis protein 1(MCP-1)of patients in the two groups before and after treatment were observed.Meanwhile,the TCM syndrome efficacy and clinical safety of the two groups were also evaluated.Results(1)After 12 weeks of treatment,the overall effective rate of the observation group was 93.94%(31/33),while the control group was 74.19%(23/31);the intergroup comparison showed that the TCM syndrome efficacy in the observation group was significantly superior to that in the control group(P<0.05).(2)After treatment,the TCM syndrome scores of patients in both groups were significantly decreased compared with those before treatment(P<0.05),and the effect on lowering the TCM syndrome scores of the observation group was significantly superior to that of the control group(P<0.05).(3)After treatment,the FBG,2hPG,HbA1c and HOMA-IR levels of the two groups were all significantly lower than those before treatment(P<0.05),and the effect on lowering the FBG,2hPG,HbA1c and HOMA-IR levels of the observation group was significantly superior to that of the control group(P<0.05).(4)After treatment,the serum levels of IL-6,TNF-α,MCP-1and ICAM-1 in both groups were significantly decreased compared with those before treatment(P<0.05),and the effects on lowering the serum levels of IL-6,TNF-α,MCP-1 and ICAM-1 of the observation group were significantly superior to those of the control group(P<0.05).(5)During the treatment,except for 2 patients in the observation group experiencing mild gastric discomfort which could be relieved spontaneously,there were no significant adverse reactions occurring in the two groups.Meanwhile,there were no significant abnormal changes in the safety indexes of blood,urine,stool routine test and the examination of liver function and kidney function in the two groups.Conclusion CFM exerts significant effect on enhancing the clinical efficacy of overweight and obese patients with T2DM differentiated as damp-heat trapping spleen syndrome,and the mechanism may be related to the inhibition of inflammatory response and the improvement of insulin resistance.