芍倍注射液与消痔灵治疗混合痔的临床研究

Clinical Study of Shaobei Injection with Xiaozhiling in the Treatment of Mixed Hemorrhoids

目的:比较分析芍倍注射液与消痔灵对静脉曲张型混合痔的治疗效果及安全性,为临床治疗提供指导意义。方法:患者为笔者2年余门诊或住院诊断静脉曲张型混合痔患者125例,按随机数字表法分为观察组和对照组,对照组57例采用消痔灵注射液治疗,观察组68例采用芍倍注射液治疗,治疗后比较2组间临床疗效,注射前、术后3 d及7 d采用肛镜观察痔核黏膜变化情况,术后随访并观测不良反应状况。结果:对照组(80.70%)显著低于观察组有效率(95.59%),差异有统计学意义;在痔核黏膜变化上,2组间术前比较差异无统计学意义,对照组术前与术后3 d、术后7 d均存在显著变化,观察组术前与术后3 d、术后7 d均存在显著变化,2组间在术后3 d、术后7 d比较差异有统计学意义;在疼痛变化上2组间术前比较差异无统计学意义,对照组术前与术后24 h比较差异无统计学意义,观察组术前与术后24 h存在显著变化,2组间术后24 h存在差异;对照组随访(6.45±2.37)个月,观察组随访(6.51±2.44)个月,差异无统计学意义,2组间在硬结发生率上存在显著差异,在直肠狭窄、坏死出血及肛门疼痛上比较差异无统计学意义。结论:芍倍注射液对静脉曲张型混合痔效果及安全性远高于消痔灵,值得临床推广。

Objective： To compare and analyze the therapeutic effect and safety of Shaobei injection with Xiaozhiling injection in patients with varicose mixed hemorrhoids and to provide guiding significance to clinical treatment. Methods： This cohort study included 125 patients who writer had diagnosed with varicose mixed hemorrhoids in outpatient service or inpatient department during more than 2 years,we separated it into treatment group and control group using random number table. The cohort included patients who underwent either Shaobei injection treatment（ the treatment group,68 cases） or Xiaozhiling injection treatment（ the control group,57 cases）. All patients were followed up after remedy,the observing indices between two groups included clinical treatment effect,the change condition of hemorrhoids mucous through anoscope before injection and after operation in 3 days and 7days,follow-up and observation of adverse effect condition after operation. Results： The efficacy rate was 80. 70% in the control group,significantly lower than the treatment group（ 95. 59%）,indicating significant difference; associated with the change of hemorrhoids mucous,there had no difference between two groups before operation,there existed significant change in the control group when before operation and after operation in 3 days and 7 days,the treatment group was same as the control group above,but there existed significant difference between two groups after 3 days operation and 7 days operation; at the level of pain change,there had no difference between two groups before operation,there had no change in control group before and after operation during 24 hours,but there had significant change in treatment group,there existed difference between two groups after operation during 24 hours; the control group was followed up for 6. 45 ± 2. 37 mouths,the treatment group was followed up for 6. 51 ±2. 44 mouths,no difference between them,there had significant difference between two groups in incidence rate of callosity,had no difference in anorectal stricture,hemorrhagic necrosis and anal pain. Conclusion： The treatment with Shaobei injection to the varicose mixed hemorrhoids demonstrated superior clinical effect and safety to Xiaozhiling injection,therefore,it is worth to be spreaded.