Abstract: Objective: To observe the clinical effect of Buzhong Yiqi pills combined with 5- aminolevulinic acid photodynamic therapy(ALA-PDT) for condyloma acuminatum(CA). Methods:A total of 82 cases of CA patients were selected and divided into the study group and the control group according to the random number table method,41 cases in each group. Both groups suspended sexual life, and were given routine western medicine; the control group was additionally treated with ALA- PDT, and the study group was additionally given the oral administration of Buzhong Yiqi pills based on the treatment of the control group.The clinical effect was compared between the two groups. Contents of Th1/Th2 cytokines in serum [interferon- γ(IFN- γ), interleukin- 10(IL- 10), and interleukin- 2(IL- 2)], lymphotactin(LTN), and transforming growth factor- β1(TGF-β1),as well as score of Quality of Life Evaluation of condylomaacuminatum(CECA10) were detected before and after treatment.In the follow-up three months,six months,and nine months after treatment,recurrence rate of the disease was recorded. Results:The total effective rate was 92.68% in the study group,higher than that of 75.61% in the control group,the difference being significant(P<0.05). Before treatment,when compared levels of IFN-γ,IL-10,and IL-2 in serum between the two groups,there was no significance being found in the difference(P>0.05). After treatment, levels of IFN-γ,IL-2,and IL-10 in the two groups were improved when compared with those before treatment(P<0.05); levels of IFN-γ and IL-2 in the study group were higher than those in the control group,and the level of IL- 10 was lower than that in the control group(P<0.05). Before treatment,when compared levels of LTN and TGF-β1 in serum between the two groups,there was no significance being found in the difference(P>0.05).After treatment,levels of LTN and TGF-β1 in serum in the two groups were increased when compared with those before treatment,and the two levels in the study group were higher than those in the control group(P<0.05).Before treatment,when compared score of CECA10 Scale between the two groups,there was no significance being found in the difference(P>0.05).After treatment,scores of CECA10 Scale in the two groups were increased when compared with those before treatment,and the score in the study group was higher than that in the control group(P<0.05).Nine months after treatment,the recurrence rate was 11.11% in the study group, lower than that of 36.67% in the control group(P<0.05). Conclusion: The therapy of Buzhong Yiqi pills combined with ALA- PDT has defined curative effect in the treatment of CA patients, which can increase levels of LTN and TGF- β1 in serum,enhance immune function of body,improve quality of life,and reduce recurrence rate of the disease.