Objective To observe effects of Chinese medicine comprehensive treatment on quality of life of patients with human immunodeficiency virus / acquired immune deficiency syndrome（ HIV / AIDS）. Methods The researchers used cluster random sampling to sample patients from townships or villages in Henan Province participating in the Chinese medicine project in 2004. Patients with HIV / AIDS who participating in the Chinese medicine project were picked out into Chinese medicine treatment group

however who not participating in the project as non Chinese medicine treatment group. The non Chinese medicine treatment group was given highly active antiretroviral therapy（ HAART）. The Chinese medicine treatment group was given Yiaikang capsule（ 益艾康胶囊）

2. 5 g each time

three times a day. The Chinese medical project experts who composed of doctors from provincial or above medical institutions made a round of visits monthly to patients. If the patients had opportunistic infections

they would been given Chinese medical decoction according to syndrome differentiation till withdraw from the project. After that the patients also can participate in HAART. Then the researchers observed the general characteristics of patients in the two groups

using World Health Orgnization Quality of Life-HIV-BREF to investigate patient’s quality of life and using the multiple linear regression to analyze influence factors to quality of life. Results A total of 1112 cases were brought into the analysis including 569 cases in Chinese medicine treatment group and 543 cases in non Chinese medicine treatment group. In the Chinese medicine treatment group

scores in all fields of quality of life were higher than those in non Chinese medicine treatment group（ P

<

0. 05）; HARRT time was negatively correlated to each field except from spiritual field（ P

<

0. 01）; Age was negatively correlated to physiology field

psychology field and independence field（ P

<

0. 01）; High CD4

+

count of patients with HIV / AIDS got high scores in physiology field（ P

<

0. 05）.Conclusion Chinese medicine comprehensive treatment can improve quality of life of patients with HIV / AIDS.HARRT time

age and CD4

+

count can influence quality of life of patients with HIV / AIDS.