| Purpose: malignant pleural effusion (MPE) was the common complication of carcinoma. Pulmonary carcinoma was the most common carcinoma complicated by pleural effusion, especially adenocarcinoma,which complication rate was 37%. Pleural effusion indicated the disease had diffused locally or widely. So,treating the pleural effusion actively was the effective method to prolong the survival time and improve the quality of life.XiaoshuiⅡ was exterior compound according to the principle of " treating the inner diseases by exterior medicine" of TCM. And there had been some animal experiments and clinical trials studying to its effect. Basing on those studies,the effect and mechanism of XiaoshuiⅡ were researched in this study.Methods: clinical trial: forty lung cancer patients with pleural effusion were divided into two groups,XiaoshuiⅡ group and Cisplatin (DDP) group. The patients of XiaoshuiⅡ group were given XiaoshuiⅡ external used on the thoracic wall for 4 weeks, changed every 2 days. Cisplatin,40mg solved in 40ml saline,was injected into the thoracic cavities of the patients in Cisplatin group every week for 4 weeks. The quality of life (QoL) and survival time were evaluated. In addition,ELISA was used to examine the CD44v6, MMP-2,MMP-9,IL-2,IFN-γ,sIL-2R,activity of NK and T subset in pleural effusion respectively before and after treatment. The effect of survival rate related with the change of MMP-9,MMP-2,CD44v6, remission rate, QoL and CD4/CD8 was analysed by COX analysis.Animal experiment: at first,the pleura metastasis model of human pulmonary adenocarcinoma A549 in nude mouse was established. Thirty nude mice were divided into control group,Cisplatin group and XiaoshuiⅡ group. The body weight, food intake, survival time and infiltration of tumor cells in pleural cavity were observed. And the expression of CD44v6,MMP-2,MMP-9,TIMP-1,TIMP-2 in tumor tissue were examined using the method of immunohistochemistry. Results: In Cisplatin group, there were CR 9 case, PR 6 case and NC 5 case and the remission rate was 75%. While in XiaoshuiⅡ group they were 7,7,6 and 70% respectively. XiaoshuiⅡ and Cisplatin could improve patient's QoL level. In Cisplatin group it was 5 mark but in XiaoshuiⅡ group it was 17 (p<0.05). The mean survival time in Cisplatin group was 139 days and the median time was 134 whereas those in XiaoshuiⅡ group were 171,170 respectively. There was remarkable difference between two groups (p<0.05). The result of survival rate by multiple factor analysis showed that MMP-9,MMP-2,CD44,remission rate and QoL had effects on the survival time and the relative risk were therapeutic method,MMP-2,MMP-9,QoL and CD44v6. by uniwariate analysis After treating,CD44v6,IL-2,IFN-γand the activity of NK cell and T cell subset increased while MMP-2,MMP-9 and SIL-2R decreased in XiaoshuiⅡ group. But in the Cisplatin group CD44v6,IL-2,IFN-γ,MMP-9,SIL-2R and the activity of NK cell and T cell subset decreased after treating.In the animal experiment,the median time in XiaoshuiⅡ groups, which was 43 days,was obviously longer than 36 days in the Cisplatin group. The infiltration of tumor cells in pleural cavity reduced in XiaoshuiⅡ group and there was remarkable difference to the control group. The expression of CD44v6,MMP-9,MMP-2 reduced and TIMP-1, TIMP-2 increased after XiaoshuiⅡ treating.Conclusion: XiaoshuiⅡ used externally is effective to treat malignant pleural effusion. It can improve the patient's QoL and prolong the survival time. The mechanisms of XiaoshuiⅡ treating malignant pleural effusion partly are: (1) activating immune system to promote pleural adhesions and reduce the development of pleural effusion, (2) suppressing the expression of tumor Adhesiveness molecul CD44v6 and keeping the balance between TIMPs and MMPs to decrease the metastasis of tumor.
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