OBJECTIVE: To evaluate the efficacy of compound Kushen injection in prevention and treatment of oral mucositis induced by radiotherapy, so as to provide evidence-based reference for the clinical application. METHODS: CNKI, VIP, Wanfang Data and PubMed were retrieved to collect the randomized controlled trial of compound Kushen injection in the treatment oral mucositis induced by radiotherapy [the control measures were radiotherapy alone, or gargling solution (0. 9% sodium chloride injection + lidocaine + dexamethasone) before radiotherapy, or radiotherapy combined with cisplatin chemotherapy; the intervention measures were combined with compound Kushen injection on the basis of control measures] from Jan. 1st, 2011 to Jul. 1st, 2023. Meta-analysis was performed by using RevMan 5. 4 statistical software. RESULTS: After screening, 10 randomized controlled trials were enrolled, including 892 patients, who were divided into subgroup of radiotherapy alone (356 cases), subgroup of gargling before radiotherapy (260 cases), and subgroup of radiotherapy combined with cisplatin chemotherapy (276 cases) according to different control measures. Meta-analysis showed that the severity of oral mucositis decreased significantly after combined application of compound Kushen injection compared with radiotherapy alone, gargling before radiotherapy, and radiotherapy combined with chemotherapy. In the subgroup of radiotherapy alone, the incidence of severe radiation-induced oral mucositis in the compound Kushen injection group was 34. 27%(61 / 178), significantly lower than 61. 24%(109 / 178) in the radiotherapy alone group, the difference was statistically significant (OR = 3. 49, 95% CI = 2. 19-5. 55, Z = 5. 27, P < 0. 000 01). In the subgroup of gargling before radiotherapy, the incidence of severe radiation-induced oral mucicitis in the compound Kushen injection group was 18. 46%(24 / 130), significantly lower than 58. 46% (76 / 130 ) in the radiotherapy + gargle group, the difference was statistically significant (OR = 6. 90, 95%CI = 2. 92-16. 30, Z = 4. 41, P<0. 000 1). In the subgroup of radiotherapy combined with cisplatin chemotherapy, the incidence of severe radiation-induced oral mucositis in the compound Kushen injection group was 27. 01%(37 / 137), significantly lower than 56. 12%(78 / 139) in the radiotherapy combined with cisplatin chemotherapy group, the difference was statistically significant (OR = 3. 68, 95% CI = 2. 18-6. 19, Z = 4. 90, P <0. 000 01). CONCLUSIONS: For patients with oral mucositis induced by radiotherapy, compound Kushen injection can effectively reduce the occurrence of oral mucositis. [ABSTRACT FROM AUTHOR]