OBJECTIVE： To observe the occurrence of paclitaxel（PTX）-induced muscle soreness and therapeutic efficacy and safety of diclofenac sodium. METHODS： Among 84 patients with malignant tumor receiving PTX chemotherapy， 56 patients suffered from PTX-induced muscle soreness， among which 22 female patients suffered from medium and severe muscle soreness and then were randomly divided into group A and B， with 11 cases in each group. Group A was given Diclofenac sodium sustained-release tablet 75 mg orally， once a day； group B was given Paracetamol and tramadol hydrochloride tablets one tablet orally， once a day， and then given Promethazine hydrochloride injection 100 mg subcutaneously， 2-3 times a day when muscle soreness could not be born. Treatment course of both groups lasted for 5 d. The distribution of muscle soreness were observed. The onset time and duration of muscle soreness were also observed as well as pain relief and the occurrence of ADR in group A and B. RESULTS： Among 84 cases， the incidence of muscle soreness was 66.67％， among which mild pain accounted for 23.81％， moderate pain accounted for 13.10％， and severe pain accounted for 29.76％. Among 56 patients with muscle soreness， earliest muscle soreness occurred on the day of medication， and most of muscle soreness occurred on 1-3 days after medication， mainly manifesting as sore， activity limitation when severe， associated with fatigue. The pain relief rate of group A and B were 100％， but the incidence of adverse reactions in group A was significantly lower than group B， with statistical significances （P＜0.05）.CONCLUSIONS： Diclofenac sodium is similar to paracetamol and tramadol hydrochloride in the treatment of PTX-induced muscle soreness，but it is better than paracetamol and tramadol hydrochloride in safety.