Objective:To observe the efficacy and safety of compound danshen dripping pills(DDP)combined with intralesional tri-amcinolone acetonide(TA)injection in the treatment of oral submucous fibrosis(OSF).Methods:34 patients with clinically con-firmed OSF were randomly divided into 2 groups(n =17)and treated with DDP +TA and TA respectively,meanwhile the VAS of pain and mouth opening were recorded and compared.Results:Before treatment there was no statistical difference of the VAS scores and mouth opening between 2 groups(P >0.05),12 weeks after treatment,the difference was significant(P ＜0.05).The clinical condi-tion of treatment group were improved(χ2 =6.051,P ＜0.05),but there were no improvement in control group(χ2 =3.429,P >0.05).Conclusion:Compound danshen dripping pills combined with intralesional triamcinolone acetonide injection can significantly enhance the effects safely in the treatment of OSF.