To explore the curative effect of Modified Gegen Qinlian Decoction（加味葛根芩连汤）and its influences on immune function in patients with recurrentoral ulceration（ROU）.

According to simple randomization method，they were divided into observation group and control group，56 cases in each group. The control group was treated with Kangfuxin Solution，while the observation group was treated with Modified Gegen Qinlian Decoction for 8 weeks. The curative effect and the number of oralulceration in the two groups were recorded. The ulceration pain［Visual analogue scale（VAS）］，the scores of TCM syndromes，the levels of inflammatory cytokines［Interleukin（IL）-1β，IL-17，IL-10，tumor necrosis factor-α（TNF-α）］in peripheral blood，cellular immune function（CD3⁺，CD4⁺，CD8⁺），quality of life［World health organization quality of life scale（WHOQOL-100）］and adverse reactions in the two groups were evaluated. All were followed up for 8 weeks after treatment to evaluate recurrence rates.

The total response rate of the observation group was higher than that of the control group（P<0.05）. After treatment，the scores of TCM syndromes and the number of ulceration in the observation group were lower than those in the control group（P<0.05）. After 4 and 8 weeks of treatment，the levels of serum IL-1β，IL-17，IL-10 and TNF-α were decreased in both groups，which were lower in the observation group than those in the control group，and the above serum indexes were the lowest in the observation group after 8 weeks of treatment（P<0.05）. After 4 and 8 weeks of treatment，the levels of CD3⁺and CD4⁺were increased，while CD8⁺levelwas decreased in both groups. The levels of CD3⁺and CD4⁺in the observation group were higher than those in the controlgroup，while CD8⁺level was lower than that in the control group. After8 weeks of treatment，the levels of CD3⁺ and CD4⁺ were the highest，while CD8⁺ level was the lowest in the observation group（P<0.05）. As the treatment time changed，VAS score was gradually decreased，and WHOQOL-100 score was gradually increased in both groups. After 2，4，6 and 8 weeks of treatment，VAS scores in the observation group were lower than those in the control group，and WHOQOL-100 scores were higher than those in the control group（P<0.05）. There was no significant difference in the incidence of adverse reactions between the two groups（P>0.05）. The recurrence rate in the observation group was lower than that in the control group（P<0.05）.

Modified Gegen Qinlian Decoction can not only improve the clinical curative effect，relieve inflammatory response and pain，butalso improve the immune function and quality of life，and reduce the recurrence rate in ROU patients，with high safety.