Abstract：Objective：To observe the clinical effect of the therapy of Injury No.1 Prescription combined with Diclofenac Sodium Sustained- Release Tablets on acute soft tissue injury. Methods ： A total of 100 patients with acute soft tissue injury were randomly divided into the observation group and the control group according to the random number table method，with 50 cases in each group. The two groups were treated with Diclofenac Sodium Sustained- Release Tablets， and the observation group was additionally treated with Chinese medicine Injury No.1 Prescription based on the treatment of the control group. Both groups were treated for 2 weeks. The clinical effects were compared between the two groups， and the traditional Chinese medicine (TCM) syndrome scores， hemorheology indexes and serum inflammatory factors were compared in the two groups before and after treatment. Results：The total effective rate was 96.00% in the observation group， higher than that of 84.00% in the control group (P＜0.05). After treatment， the TCM syndrome scores such as pain， swelling， limited limb movement， ecchymosis， insomnia， dry mouth and constipation were all decreased in the two groups (P＜0.05)， and the above scores in the observation group were lower than those in the control group (P＜0.05). After treatment， plasma viscosity，low-shear whole blood viscosity，high-shear whole blood viscosity and fibrinogen in the two groups were decreased on average (P＜0.05)，and the above indexes in the observation group were lower than those in the control group (P＜0.05). After treatment，serum levels of interleukin- 1β (IL- 1β)， interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) in the two groups were decreased (P＜0.05)，and the above levels in the observation group were lower than those in the control group (P＜0.05). Conclusion： The therapy of Injury No.1 Prescription combined with Diclofenac Sodium Sustained-Release Tablets has a significant therapeutic effect on patients with acute soft tissue injury，which can effectively relieve clinical symptoms，improve hemorheology indexes and reduce inflammation.