Objective,2,To observe the clinical effect of Sanjie Tongluo Granule combined with western medicine on the treatment of bone metastases （BMs） of malignant tumor.,Methods,2,Seventy patients with BMs of malignant tumor were randomly divided into treatment group （,n,=35） and control group （,n,=35）. The control group was administered with conventional western medicine， while the treatment group was administered with Sanjie Tongluo Granule besides the conventional treatment measures of the control group. The course of treatment in both groups was 6 months. We observed the clinical effect， progression-free survival （PFS） and medication safety， and compared the changes in scores of related indicators including numerical rating scale （NRS） for pain， serum calcium （Ca,2+,）， alkaline phosphatase （ALP）， serum tumor markers， immune function， TCM syndrome， and quality of life scale.,Results,2,①Finally， 33 cases in the treatment group and 33 cases in the control group completed the trial. ②According to the result of inter-group comparison， the treatment group showed significantly better treatment effect than the control group （,P,<,0.05）； The average and median PFS in the treatment group were significantly higher than those in the control group （,P,<,0.05）. ③The pain NRS score in the treatment group was significantly lower than that in the control group （,P,<,0.05）； The duration of pain relief was significantly longer and the dosage of oxycodone in 24 hours was significantly lower in the treatment group than those in the control group （,P,<,0.05）. ④After treatment， the ALP level in the treatment group was significantly lower than that in the control group （,P,<,0.05）. ⑤After treatment， the levels of CA15-3 and CEA in the treatment group were significantly lower than those in the control group （,P,<,0.05）. ⑥After treatment， the levels of CD,3+, and CD,4+, in the treatment group were significantly higher than those in the control group （,P,<,0.05）. ⑦After treatment， the TCM syndrome scores in the treatment group were significantly lower than those in the control group （,P,<,0.05）. ⑧After treatment， the scores of pain location， dysfunction and social psychological modules of the quality of life scale in the treatment group were significantly lower than those in the control group （,P,<,0.05）.,Conclusion,2,Sanjie Tongluo Granule combined with western medicine has achieved more satisfactory clinical effect than western medicine alone in treating bone metastases of malignant tumor.