OBJECTIVETo observe the effect of Ningzhi Capsule (NZC) on blood lipid spectrum in type 2 diabetes mellitus patients complicated with hyperlipemia (DM-HL).

METHODSAdopting 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.

RESULTSAfter 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.

CONCLUSIONNZC could lower the blood lipid spectrum and improve the TCM symptoms in DM-HL patients without any adverse reaction.