地诺孕素对卵巢子宫内膜异位囊肿的疗效及安全性研究

Efficacy and safety of dienogest on ovarian endometrioma

目的探讨地诺孕素对卵巢子宫内膜异位囊肿体积和临床症状的影响及安全性。方法回顾性分析2020年7月1日至2024年3月31日在南京医科大学第一附属医院进行地诺孕素(2 mg/d)治疗的75例卵巢子宫内膜异位囊肿患者的临床资料,比较治疗前后囊肿体积和子宫内膜异位症相关疼痛视觉模拟评分法(VAS)评分的变化,并观察血生物标志物、肝肾功能、凝血功能及乳腺的变化情况。结果地诺孕素治疗3、6和12个月卵巢子宫内膜异位囊肿患者的囊肿体积中位数分别为13.21 cm^(3)(体积下降率为36.00%)、8.33 cm^(3)(体积下降率为56.00%)和4.10 cm^(3)(体积下降率为77.62%),均较治疗前显著下降(P均<0.05)。地诺孕素治疗后3个月,所有患者的痛经症状均消失,VAS评分下降至0 mm,并持续至研究终点。血癌相关抗原125(CA125)及癌相关抗原19-9(CA19-9)水平在治疗期间均较治疗前显著下降(P均<0.05)。地诺孕素治疗期间患者的凝血功能、肝肾功能指标与治疗前比较,差异均无统计学意义(P均>0.05);随访期间有少数患者的乳腺结节有生长部位或病变分类的变化,但无乳腺癌或癌前病变发生。结论地诺孕素可明显减少卵巢子宫内膜异位囊肿体积,减轻子宫内膜异位症相关疼痛,不良反应少。

Objective To observe the effects and safety of dienogest on the volume and symptoms of ovarian endometrioma(OMA).Methods The clinical data of 75 patients with OMA who underwent treatment with dienogest(2 mg/day)at the First Affiliated Hospital of Nanjing Medical University from July 1st 2020 to March 31st 2024 were retrospectively analysed,mainly comparing the changes in the volume of OMA and the visual analogue scale(VAS)scores of endometriosis-related pain before and after the treatment,as well as observing the changes in the blood biological indicators,liver and kidney function,coagulation function and changes in breast.Results The median cyst volumes of the OMA patients at 3,6 and 12 months of dienogest treatment were 13.21 cm^(3)(volume reduction rate:36.00%),8.33 cm^(3)(volume reduction rate:56.00%)and 4.10 cm^(3)(volume reduction rate:77.62%),respectively,which were all significantly decreased from the pre-treatment period(all P<0.05).The VAS scores of pain of the OMA patients at 3,6 and 12 months of dienogest treatment all were 0 mm.Blood cancer antigen 125(CA 125)and cancer antigen 19-9(CA 19-9)levels decreased progressively during treatment(all P<0.05).There were no statistical differences in the coagulation indexes,liver and kidney function indexes of the patients during dienogest treatment compared with those before treatment(all P>0.05).During the follow-up period,there were a few patients with changes in the growth sites or lesion category of the breast nodules,but there were no occurrence of breast cancer or precancerous lesions.Conclusion Dienogest is effective in reducing OMA volume and alleviating endometriosis-related pain with few adverse effects.