Abstract： Objective： To observe the clinical effect of Tongru Xiaoyong Prescription combined with Chinese medicine manipulation of lactation for acute mastitis in lactation period. Methods ： A total of 138 patients with acute mastitis in lactation period were divided into the Chinese medicine group， the lactation group，and the combination group according to the random number table method，with 46 cases in each group. The Chinese medicine group was treated with Tongru Xiaoyong Prescription， the lactation group was treated with Chinese medicine manipulation of lactation，and the combination group was treated with Tongru Xiaoyong Prescription combined with Chinese medicine manipulation of lactation. The three groups were treated for five days. The clinical symptom scores and levels of inflammatory indexes were compared before and after treatment among the three groups. The clinical effects，stimulation of lactation time， clinical symptom elimination time， temperature recovery normal time and incidence of adverse reactions were compared among the three groups. Results： The total effective rate was 97.83% in the combination group，higher than that of 82.61% in the Chinese medicine group and 86.96% in the lactation group (P＜0.05)； the stimulation of time， clinical symptom elimination time and temperature recovery normal time were shorter than those in the Chinese medicine group and the lactation group (P＜0.05)；there was no significant difference in the total effective rates，opening time，clinical symptom elimination time and temperature recovery normal time between the Chinese medicine group and the lactation group (P＞ 0.05). After treatment， the clinical symptom scores， and the levels of white blood cell count (WBC)， interleukin-6 (IL-6)， and C-reactive protein (CRP) in the three groups were decreased when compared with those before treatment (P＜0.05)，and the clinical symptom scores and various inflammatory indexes in the combination group were lower than those in the Chinese medicine group and the lactation group (P＜ 0.05)，and there was no significant difference in clinical symptom scores and various inflammatory indexes between the Chinese medicine group and the lactation group (P＞0.05). There was no significant difference in the incidence of adverse reactions among the three groups (P＞0.05). Conclusion： The combination of Tongru Xiaoyong Prescription combined with Chinese medicine manipulation of lactation has a good effect on acute mastitis in lactation period， which can alleviate clinical symptoms， lower levels of inflammatory factors，and is relatively safe.