To observe the therapeutic effect of five-step oral and external use Chinese and western medicines on acute mastitis. Methods:After excluding breast abscess and other diseases, 86 early acute mastitis outpatients were taken Chinese and Western medicines orally and externally in five steps, 1 to 2 times per day, 1 to 5 days depending on the prognosis and outcome of disease. The curative rate and total effective rate were observed. Results:The total curative rate was 72.1%, and was 60% at Day 3, and the total effective rate was 93%. Conclusion:The integrated Chinese and Western medicine taken orally or externally in five steps showed good efficacy on acute mastitis within short period of treatment, and it does not interfere with breastfeeding and non- invasive. Therefore, it is recommendable for clinical use.