Objective To observe the effect of TCM comprehensive treatment program on quality of life（ QOL） in patients with diabetic nephropathy（ DN） and its correlation with TCM patterns. Methods Totally 319 cases of DN were randomized into the experimental group and control group

with 159 and 160 in each. Both groups were given basic treatment. The experimental group was added with Zhixiao Tongmaining Granules

Zhixiao Wenshenning Granules and Zhixiao Baoshenning Granules based on pattern identification. The control group was added with Irbesartan Tablets and placebo. The treatment lasted for 3 months. The Diabetes-Specific Quality-of-Life Scale（ DQOL） and TCM Pattern Scale were used to analyze the QOL of patients and its correlation with TCM patterns in the experimental group. Results The physiological function score

psychological（ spiritual） score

therapeutic implication score and total score of DQOL in the experimental group were significantly improved after treatment（ P < 0. 05）. There was a significant difference between groups in the total score of DQOL after treatment（ P < 0. 05）. There were significant differences between groups in the physiological function score

psychological（ spiritual） score and total score of DQOL（ P < 0. 05）. There was a certain correlation between DQOL scores and TCM pattern scores in the experimental group before treatment（ P < 0. 05 or P < 0. 01）. There was a strong correlation between the total score of TCM patterns and DQOL after treatment（ r = 0. 266）. Conclusion TCM comprehensive treatment program can obviously increase the QOL of DN patients

and there is a certain correlation between QOL and TCM patterns.