宁脂胶囊对2型糖尿病高脂血症患者血脂谱的影响

目的 观察宁脂胶囊对2型糖尿病高脂血症患者血脂谱的影响。方法 采用随机平行对照研究。共纳入符合2型糖尿病气阴两虚、痰瘀互阻型高脂血症患者70例，分为两组。中药组给予宁脂胶囊5粒，每天3次口服；对照组根据血脂成分的不同分别给予贝特类和他汀类的药物治疗；原用的降糖降压药物维持不变。治疗过程中因药物不良反应退出2例，失访8例（中药组4例，西药组4例）。疗程6个月，疗程结束时资料完整60例。结果 中药组治疗后，患者胆固醇、甘油三酯、低密度脂蛋白载脂蛋白B及脂蛋白（a）的水平降低、高密度脂蛋白及载脂蛋白A的水平提高，与治疗前比较，差异均有统计学意义（P＜0.05，P＜0.01）；与西药组（除高密度脂蛋白外）治疗后比较，差异均无统计学意义（P＞005）。中药组治疗后中医症状积分亦明显下降（P＜0.01）；血、尿常规，肝肾功能无明显变化。结论 宁脂胶囊具有改善糖尿病高脂血症患者的血脂谱及中医症状的作用。

Effect of Ningzhi Capsule on Blood Lipid Spectrum in Type 2 Diabetes Mellitus Patients Complicated with Hyperlipidemia

OBJECTIVE: To observe the effect of Ningzhi Capsule (NZC) on blood lipid spectrum in type 2 diabetes mellitus patients complicated with hyperlipemia (DM-HL). METHODS: Adopting randomized, parallel and controlled trail method, a total of 70 DM-HL patients of qi-yin deficiency and phlegm-blood stagnant syndrome type were randomized into two groups. The original medication for lowering blood sugar and blood pressure was unchanged, the trial group received oral administration of NZC 5 tablets, 3 times a day, while the control group received Lipanthgl or Simvastatin depending on their different constituents of blood lipids. After 6 months of treatment, sixty subjects completed the trail while two patients dropped out due to side effect and 8 patients lost follow-up (4 in each group). Levels of blood lipids, blood routine, liver and kidney function and symptoms in patients were detected and compared. RESULTS: After treatment, levels of total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL-C), apoprotein B, and lipoprotein a (LPa) lowered, while levels of high-density lipoprotein (HDL-C) and apoprotein A raised in the trial group as compared with those before treatment (P < 0.05, P < 0.01), but showed no difference between the two groups after treatment except HDL level (P > 0.05). Scores of symptoms were also lowered significantly in the trial group (P < 0.01). In the observation period, no abnormal findings in blood and urine routine examination as well as in liver and renal function were found. CONCLUSION: NZC could lower the blood lipid spectrum and improve the TCM symptoms in DM-HL patients without any adverse reaction.