醋酸戈舍瑞林缓释植入剂治疗术后复发卵巢内膜囊肿的临床观察

Clinical Observation of Acetic Acid Goserelin Sustained-release Implants in the Treatment of Ovary Endometrium Cyst Recurrence after Surgery

目的:探讨醋酸戈舍瑞林缓释植入剂(AGRI)治疗腹腔镜卵巢囊肿摘除术后复发卵巢内膜囊肿(OEC)的疗效及安全性。方法:选取张家港市第一人民医院2013年1月-2015年1月行腹腔镜卵巢囊肿摘除术后复发的OEC患者60例,采用随机数字表法分为对照组和观察组,各30例。两组患者均口服米非司酮片25 mg,qd。对照组患者口服孕三烯酮胶囊2.5 mg,2次/周;观察组患者给予AGRI 3.6 mg,皮下注射,1次/月,两组患者均持续治疗6个月。观察两组患者临床疗效,治疗前及治疗3、6个月血清促卵泡激素(FSH)、黄体生成素(LH)、雌二醇(E_2)水平和痛经、慢性盆腔痛视觉模拟评分法(VAS)评分,观察两组患者不良反应发生情况及随访12个月的预后情况。结果:观察组患者临床总有效率为86.67%,显著高于对照组的70.00%,差异有统计学意义(P<0.05)。治疗3个月,两组患者FSH、LH水平较治疗前显著降低,差异有统计学意义(P<0.05),但E_2水平无变化,且FSH、LH组间比较,差异均无统计学意义(P>0.05);治疗6个月,两组患者FSH、LH、E_2水平均显著降低,且观察组显著低于对照组,差异均有统计学意义(P<0.05)。治疗3、6个月,两组患者痛经、慢性盆腔痛VAS评分均显著降低,且观察组显著低于对照组,差异均有统计学意义(P<0.05)。观察组患者不良反应发生率40.00%,显著高于对照组的16.70%,差异有统计学意义(P<0.05)。两组患者复发率比较,差异无统计学意义(P>0.05),但观察组患者月经恢复正常率为86.67%、优势卵泡形成率为60.00%、妊娠率为53.33%,显著高于对照组的46.67%、46.67%、33.33%,差异均有统计学意义(P<0.05)。结论:AGRI治疗腹腔镜卵巢囊肿摘除术后复发OEC疗效显著,可有效缓解患者痛经和慢性盆腔痛,提高妊娠率;停药后仍有复发病例,且不良反应发生率较高,但症状轻微。

OBJECTIVE： To investigate therapeutic efficacy and safety of Acetic acid goserelin sustained-release implants （AGRI） in the treatment of ovary endometrium cyst （OEC） recurrence after laparoscopic enuleation of ovarian cyst. METHODS： Totally of 60 patients with OEC recurrence after laparoscopic enuleation of ovarian cyst in Zhangjiagang First People’s Hospital during Jan. 2013-Jan. 2015 were divided into control group and observation group according to random number table, with 30 cases in each group. Both groups were given Mifepristone tablets orally 25 mg, qd. Control group was given Gestrinone capsules orally 2.5 mg, twice a week. Observation group was given AGRI subcutaneously 3.6 mg, once a month. Both groups were treated for consecutive 6 months. Clinical efficacies of 2 groups were observed as well as the levels of serum follicle stimulating hormone （FSH）, luteinizing hormone （LH） and estradiol （E2）, VAS scores of dysmenorrheal and chronic pelvic pain before treatment, 3, 6 months after treatment. The occurrence of ADR and the prognosis of 12-month follow-up were observed in 2 groups. RESULTS： Total response rate of observation group was 86.67%, which was significantly higher than 70.00% of control group, with statistical significance （P〈0.05）. After 3 months of treatment, the levels of FSH and LH in 2 groups were decreased significantly compared to before treatment, with statistical significance （P〈0.05）; the level of E2 had no change; there was no statistical significance in the levels of FSH and LH between 2 groups （P〉0.05）; after 6 months of treatment, the levels of FSH, LH and E2 in 2 groups were decreased significantly, and the observation group was significantly lower than the control group, with statistical significance （P〈0.05）. After 3 and 6 months of treatment, VAS score of dysmenorrheal and chronic pelvic pain in 2 groups were decreased significantly, and the observation group was significantly lower than the control group, with statistical significance （P〈0.05）. The incidence of ADR in observation group was 40.00%, which was significantly higher than 16.70% of control group, with statistical significance （P〈0.05）. There was no statistical significance in recurrence rate between 2 groups （P〉0.05）. The recovery rate of menstruation in observation group was 86.67%, the rate of dominant follicle formation was 60.00% and pregnancy rate was 53.33%, which were significantly higher than 46.67%, 46.67% and 33.33% of control group, with statistical significance （P〈0.05）. CONCLUSIONS： AGRI shows significant therapeutic efficacy for OEC recurrence after laparoscopic enuleation of ovarian cyst, can effectively relieve dysmenorrhea and chronic pelvic pain, increase the rate of pregnancy. There is still recurrent cases after drug withdrawal. The incidence of ADR is high, but the symptoms are mild.