Comparing the Effect of An's Shaobei Injection(安氏芍倍注射液) with Xiaozhiling Injection(消痔灵注射液) in Patients with Internal Hemorrhoids of GradeI-III:A Prospective Cohort Study

Objective:To compare the effect of An's Shaobei Injection(安氏勺倍注射液) with Xiaozhiling Injection(消痔灵注射液) in patients with internal hemorrhoids of grade Ⅰ-Ⅲ.Methods:This cohort study included 1,520 internal hemorrhoids patients with grade Ⅰ-Ⅲ who were scheduled for liquid injection treatment from July 2003 to July 2009.The cohort included patients who underwent either An's Shaobei Injection treatment(the treatment group,760 cases) or Xiaozhiling Injection treatment(the control group,760 cases).All patients were followed up regularly for 3 years;the observing indices included anal function recovery and clinical response after operation.Results:Among the 1,520 patients,1,508(99.2%) completed the 3-year follow-up.The efficacy rate was 97.5%in the treatment group,significantly higher than the control group(91.8%,P0.01).The recurrence rate in the treatment group was 0.5%,significantly lower than that of the control group(1.3%,P0.01).In addition,perianal callosity occurred in 8 cases(1.1%) and anorectal stricture in 26 cases(3.5%)after operation in the control group.There was no perianal callosity and anorectal stricture in the treatment group.Conclusion:The treatment with An's Shaobei Injection demonstrated superior clinical effect to Xiaozhiling Injection with fewer adverse effects.