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一项开放性随机研究,比较标准达那唑与改良曲普瑞林方案对中重度子宫内膜异位症术后疾病管理的疗效。

An open and randomized study comparing the efficacy of standard danazol and modified triptorelin regimens for postoperative disease management of moderate to severe endometriosis.

作者信息

Wong Alice Yuen Kwan, Tang Lawrence

机构信息

Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Hong Kong SAR, People's Republic of China.

出版信息

Fertil Steril. 2004 Jun;81(6):1522-7. doi: 10.1016/j.fertnstert.2003.12.020.

Abstract

OBJECTIVE

To compare the efficacy of danazol and triptorelin (Decapeptyl CR, Ferring, Kiel, Germany) in the management of moderate and severe endometriosis in terms of symptom control and revised American Fertility Society (AFS) score reduction, and to evaluate the hormonal profile of patients treated with triptorelin every 6 weeks.

DESIGN

Open and randomized trial.

SETTING

Kwong Wah Hospital, a large public hospital in an urban location (Hong Kong).

PATIENT(S): Forty patients after their first conservative operation for endometriosis, with surgical confirmation of revised AFS stage III or IV endometriosis.

INTERVENTION(S): Postoperative 6 months' therapy of danazol or triptorelin every 6 weeks, postmedical therapy second-look laparoscopy.

MAIN OUTCOME MEASURE(S): Symptom control and patients' tolerance during medical therapy, posttherapy revised AFS score, hormonal profile during triptorelin therapy.

RESULT(S): Pain control was similar between danazol and triptorelin therapy. There was less breakthrough bleeding with triptorelin. More patients failed to complete the whole course of danazol because of its side effects. The revised AFS score at second-look laparoscopy did not show a significant difference between the two medications. Adequate pituitary suppression was observed with injection of triptorelin every 6 weeks.

CONCLUSION(S): Lengthening of triptorelin administration intervals from 4 weeks to 6 weeks is effective in maintaining a hypoestrogenic state. Patients were more compliant with triptorelin than danazol. Thus, triptorelin injection every 6 weeks is more cost-effective than conventional regimens.

摘要

目的

比较达那唑与曲普瑞林(德国基尔辉凌公司的Decapeptyl CR)在控制中重度子宫内膜异位症症状及降低美国生育协会(AFS)修正评分方面的疗效,并评估每6周接受曲普瑞林治疗的患者的激素水平。

设计

开放性随机试验。

地点

位于市区的大型公立医院广华医院(香港)。

患者

40例因子宫内膜异位症首次接受保守手术的患者,手术证实为AFS修正分期III期或IV期子宫内膜异位症。

干预措施

术后6个月使用达那唑或每6周使用曲普瑞林进行治疗,药物治疗后进行二次腹腔镜检查。

主要观察指标

药物治疗期间的症状控制和患者耐受性、治疗后AFS修正评分、曲普瑞林治疗期间的激素水平。

结果

达那唑和曲普瑞林治疗在疼痛控制方面相似。曲普瑞林的突破性出血较少。更多患者因达那唑的副作用而未能完成整个疗程。二次腹腔镜检查时,两种药物的AFS修正评分无显著差异。每6周注射曲普瑞林可观察到充分的垂体抑制。

结论

将曲普瑞林的给药间隔从4周延长至6周可有效维持低雌激素状态。患者对曲普瑞林的依从性高于达那唑。因此,每6周注射曲普瑞林比传统方案更具成本效益。

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