蒂诺安与唯散宁治疗卵巢子宫内膜异位囊肿疗效比较分析

Comparative analysis of the therapeutic effects of Dinuoan and Visanne in the treatment of ovarian endometriotic cysts

目的 比较蒂诺安与唯散宁治疗卵巢子宫内膜异位囊肿的疗效及副反应差异。方法 选取2022年4月至2023年6月在浙江大学医学院附属妇产科医院经超声诊断为卵巢子宫内膜异位囊肿的患者157例,其中服用蒂诺安49例(研究组),服用唯散宁108例(对照组)。观察两组治疗前后的囊肿最大径、囊肿体积与疼痛视觉模拟评分法(VAS)分数改变及异常子宫出血情况。采用非劣效性检验比较两组疗效及副反应。结果 用药6个月后研究组在缩小囊肿最大径及降低VAS评分的疗效方面不劣于对照组,但对于缩小囊肿体积疗效的非劣效性具有不确定性。组内比较,用药3、6个月后两组囊肿与治疗前比较均显著缩小(P=0.001),疼痛评分均显著下降(P=0.001);用药3个月后囊肿体积缩小程度在两组中差异无统计学意义(P=0.306),用药6个月后囊肿体积相对用药3个月后缩小程度在两组中组内差异无统计学意义(P=0.479)。两组用药6个月后异常子宫出血发生率差异无统计学意义(P=0.146)。随访期间两组子宫体积与子宫肌瘤大小均无显著改变(P>0.05)。结论 在缩小卵巢子宫内膜异位囊肿最大径和缓解痛经方面蒂诺安药效不劣于唯散宁,副反应相似,但对缩小囊肿体积的疗效具有不确定性。

Objective Comparative analysis of the clinical efficacy and side effects of Dinuoan and Visanne in the treatment of ovarian endometriotic cysts.Methods A total of 157 patients diagnosed with ovarian endometriotic cysts by ultrasound were recruited at Women's Hospital school of medicine Zhejiang University from April 2022 to June 2023.Among them,49 patients were treated with Dinuoan(study group),and 108 patients were treated with Visanne(control group).The size of ovarian endometriotic cysts(cyst maximum diameter and volume),pain VAS scores,and abnormal uterine bleeding were observed before and after treatment in both groups.The non-inferiority tests were used to analyze the differences in efficacy and side effects between two groups.Results After 6 months of treatment,Dinuoan was as effective as Visanne in reducing the maximum diameter of endometrioma.The effect of Dinuoan about reducing VAS score was also not inferior to Visanne.However,the therapeutic effect in reducing the volume of ovarian cysts was uncertain.After 3 or 6 months of treatment,the maximum diameter,volume of cyst and the VAS score of both groups significantly decreased compared to the initial value(P=0.001).Furthermore,the difference in cyst volume reduction after 3 months treatment did not reach statistical significance between the two groups(P=0.306).The difference in cyst volume reduction after further 3 months treatment did not reach statistical significance between the two groups(P=0.479).There was no significant difference in the incidence of abnormal uterine bleeding after 6 months of treatment between the two groups(P=0.146).In addition,there was no change in uterine volume and uterine fibroid size after 6 months treatment for both groups of patients(P>0.05).Conclusions Dinuoan demonstrates equivalent efficacy to Visanne in reducing the endometriotic cyst maximum diameter,relieving the dys-menorrhea and has similar side effects.But the effect on cyst volume is uncertain.