ObjectiveTo evaluate the clinical effectiveness and safety of Lianling Formula （连苓方） in the treatment of adolescent atopic dermatitis （AD） exacerbation stage with heart fire and spleen deficiency syndrome. MethodsNinety-two patients were randomly divided into a treatment group and a control group， with 46 cases in each group. Patients in the control group took oral ebastine tablets， and patients in the treatment group took Lianling Formula orally， and both groups used 0.03% topical tacrolimus for 4 weeks. Before and after treatment， the improvement of scoring atopic dermatitis index by 50% （SCORAD50） and 75% （SCORAD75）， scoring atopic dermatitis index （SCORAD）， visual analog scale （VAS）， traditional Chinese medicine （TCM） symptom score， the children's dermatology life quality index （CDLQI）， Athens insomnia scale （AIS） score of both groups were evaluated， and the adverse reactions in both groups were recorded. ResultsFour cases in the treatment group and five cases in the control group were dropped， and intention-to-treat analysis was used. Finally 46 cases in each group were included in the statistics. The SCORAD scores after treatment were lower than those before treatment， and the scores in treatment group were lower than those of the control group （P＜0.01）； the attainment rates of SCORAD50 and SCORAD75 after treatment in the treatment group were 80.43% and 47.83%， which were significantly higher than those in the control group of 63.04% and 26.09%， respectively （P＜0.05）. VAS scores， TCM symptom scores， CDLQI scores， and AIS scores were lower than those before treatment （P＜0.01）， and VAS scores， TCM symptom scores， and CDLQI scores of the treatment group were lower than those of the control group after treatment （P＜0.05 or P＜0.01）， while AIS scores were higher than those of the control group （P＜0.05）. The erythema， papule/edema， oozing/crusting， epidermal peeling， and dryness in the SCORAD scores of the treatment group after treatment were lower than those before treatment （P＜0.05 or P＜0.01）， and the erythema， papule/edema， oozing/crusting， and dryness of children in the control group were lower than those before treatment （P＜0.05 or P＜0.01）. The scores of erythema， oozing/crusting， and epidermal peeling in the treatment group after treatment were all lower than those in the control group （P＜0.05）. The scores of vexation， itching， dry mouth， poor appetite and irregular bowel movements in terms of TCM symptoms in the treatment group after treatment were lower than those before treatment （P＜0.01）， and the scores of itching， vexation， dark urine in the control group were lower than those before treatment （P＜0.05 or P＜0.01）. The scores of itching， dry mouth， poor appetite， irregular bowel movements， and dark urine in the treatment group after treatment were all lower than that in the control group （P＜0.05 or P＜0.01）. No adverse reactions occurred in both groups of children during treatment. ConclusionLianling Formula combined with topical tacrolimus can effectively improve the clinical symptoms of adolescent AD exacerbation with heart fire and spleen deficiency syndrome， and the formula is effective and safe in improving the children's skin lesions， reducing itching， relieving the accompanied TCM symptoms， and improving the quality of life.