Objective:To systematically evaluate the efficacy and safety of Shaobei Injection in the treatment of mixed hemorrhoids and internal hemorrhoids. MethodsThe related databases at home and abroad were searched by computer, and literature on clinical randomized controlled trials of Shaobai Injection in the treatment of mixed hemorrhoids and internal hemorrhoids using Xiaozhiling Injection as control were collected. The search time limit was from establishment of the database to December 2018.Meta-analysis was performed using RevMan5.2.  Results:A total of 15 randomized controlled trials involving 4,8 patients were included. The meta-analysis results showed that compared with Xiaozhiling Injection, Shaobai Injection had better comprehensive effect on mixed hemorrhoids and internal hemorrhoids [RR=1.19,5% CI(1.12,1.25), Z=6.17, P<0.01], and could significantly reduce the overall incidence of postoperative adverse reactions [RR=0.04,5% CI(0.02,0.07), Z=9.56, P<0.01], the incidence of postoperative rectal induration [RR=0.01,5% CI(0.01,0.03), Z=10.14, P<0.01], the incidence of postoperative bleeding [RR=0.09,5% CI(0.02,0.30), Z=3.80, P<0.01], and the incidence of postoperative anorectal stenosis [RR=0.07,5% CI(0.02,0.21), Z=4.56, P<0.01].  Conclusion:Compared with Xiaozhiling Injection, Shaobai Injection has better overall efficacy in the treatment of mixed hemorrhoids and internal hemorrhoids, and can reduce the incidence of adverse reactions after operation. However, due to the low quality of literature, the above conclusion needs to be verified by follow-up study results.