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目的观察二氯醋酸二异丙胺(DIPA)对2型糖尿病(T2DM)患者脂代谢紊乱等的影响及安全性。方法对辽宁地区8个中心的TG≥4.0 mmol/L的T2DM患者240例进行随机阳性药物平行对照研究,DIPA组、非诺贝特组各120例。结果 (1)两组治疗10 d、30 d后TG均显著下降(P<0.01);静脉滴注10 d后DIPA组TG下降4.53 mmol/L,非诺贝特组下降3.37 mmol/L,两组差异有统计学意义(P=0.036);继续口服20 d后两组分别下降5.45、4.33 mmol/L,两组差异无统计学意义(P=0.132)。(2)两组HDL-C在治疗前后及组间比较均无统计学差异(P>0.05)。(3)两组TC及LDL-C治疗后均下降(P<0.01),但组间差异无统计学意义(P>0.05)。(4)治疗30 d后DIPA组ALT明显下降(P<0.01),非诺贝特组无明显下降(P>0.05)。结论 DIPA可明显改善糖尿病患者的TG、TC、LDL-C,疗效与非诺贝特相当,从ALT复常率的变化来看,DIPA不损害肝细胞功能。
Objective To observe the effect and safety of DIPA on lipid metabolism disturbance in type 2 diabetes mellitus (T2DM). Methods A total of 240 patients with T2DM of TG≥4.0 mmol / L in 8 centers in Liaoning Province were randomly divided into two groups: 120 cases in DIPA group and fenofibrate group. Results (1) After 10 days and 30 days of treatment, TG decreased significantly in both groups (P <0.01); TG decreased 4.53 mmol / L in DIPA group and 3.37 mmol / L in fenofibrate group (P = 0.036). There was no significant difference between the two groups (P = 0.132) after continuing oral administration for 20 days and decreasing by 5.45 and 4.33 mmol / L respectively. (2) There was no significant difference in HDL-C between the two groups before and after treatment (P> 0.05). (3) Both TC and LDL-C decreased after treatment (P <0.01), but there was no significant difference between the two groups (P> 0.05). (4) After 30 days of treatment, the ALT in DIPA group decreased significantly (P <0.01), but not in fenofibrate group (P> 0.05). Conclusion DIPA can significantly improve the TG, TC, LDL-C in diabetic patients, and the efficacy is similar to fenofibrate. From the change of ALT normalization rate, DIPA does not damage the function of hepatocytes.