Objective To observe the clinical effect and safety of Yifei Qinghua Soft Extract as an adjuvant therapy in the treatment of postoperative patients with non-small cell lung cancer. Methods A multicenter

large sample

randomized controlled clinical trial was designed. Three hundred and sixty cases of postoperative patients withⅠ

ⅢA stage of non-small cell lung cancer were randomly divided into treatment group with 184 cases and control group with 176 cases. Patients with ⅠB

ⅢA stage of disease in the both two groups were treated with Cisplatin or Carboplatin combined with Vinorelbine or Paclitaxel or Gemcitabine as the postoperative adjuvant chemotherapy for 4 episodes; while patients with stage Ⅲ A of disease or positive resection margin were accept postoperative adjuvant radiotherapy. The treatment group received additional oral administration of Yifei Qinghua Soft Extract

20 g each time

3 times a day. The course of treatment in both groups was 6 months

and the fellow-up was 2 years. The quality of life measurement scale of patients with lung cancer in the United States（ FACT-L V4. 0 Chinese version） was used to evaluate the quality of patients’ life

the changes of the Chinese medicine syndromes

Karnofsky score

body weight

and immune function were observed before and after treatment to determine the curative effect of Chinese medicine syndrome. Results For the treatment of Chinese medicine syndrome

among 117 cases in the treatment group

22 cases showed markedly effective

81 cases effective

and 14 cases ineffective; in the control group with 91 cases

8 cases showed markedly effective

53 cases effective

and 30 cases were ineffective. The curative effect in the treatment group was better than that in the control group（ P

<

0. 01）. In the treatment group

the physical condition score of the FACT-L V 4. 0 Chinese version began to decrease gradually after 3 months of treatment compared with that before treatment

and the scores of social family status

affective status

functional status

and additional attention were gradually decreased after 6 months of treatment compared with before treatment（ P

<

0. 05 or P

<

0. 01）. The scores in all aspects in the treatment group were better than those in the control group in a certain degree after treatment and during the follow-up

especially the scores in the physical condition

social family status and functional status（ P

<

0. 05 or P

<

0. 01）. In the treatment group

changes in the patients’ Karnofsky score

body weight

and immune function were better than those in the control group（ P

<

0. 05 or P

<

0. 01）. Conclusion Adjuvant therapy of Yifei Qinghua Soft Extract in the treatment of postoperative patients with non-small cell lung cancer can significantly improve the quality of life and regulate the immune function with no serious adverse reactions.