Abstract: AIM: To evaluate the efficacy, safety and effects on changes of T-lymphocyte subsets of mycobacterium phlei and cisplatin in treatment of patients with malignant pleural effusion (MPE).METHODS: 62 patients of MPE were randomly assigned to two groups.The test group was treated once aweek lasting for 1-3 weeks with NS 20 ml +mycobacterium phlei 8.6 μg +cisplatin 40 mg, while the control one with NS 20 ml +cisplatin 40mg only.The efficacy and changes of T-lymphocyte subsets before and after therapy were analyzed separately.RESULTS: The overall response rate in the test group was 87.5 %, which meant significantly higher than that in the control group (P<0.01), and the side effects were mild.After the treatment, the levels of CD⁺₃ and CD⁺₄ cells and the ratio of CD⁺₄ CD⁺₈ increased greatly (P<0.05 or 0.01), while the level of CD⁺₈ dropped sharply(P<0.01).CONCLUSION: The therapy of mycobacterium phlei combined with cisplatin is effective in controlling the MPE with low side-effect, and can greatly improve the inhibition of T-lymphocyte subsets in patients with MPE.

Key words: mycobacterium phlei, cisplatin, malignant pleural effusions, T-lymphocyte subsets, cellular immunity, immunotherapy, synergisitic effect