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曲普瑞林与安慰剂对子宫内膜异位症症状的影响。

Effects of triptorelin versus placebo on the symptoms of endometriosis.

作者信息

Bergqvist A, Bergh T, Hogström L, Mattsson S, Nordenskjöld F, Rasmussen C

机构信息

Department of Obstetrics and Gynecology, Malmö University Hospital, Sweden.

出版信息

Fertil Steril. 1998 Apr;69(4):702-8. doi: 10.1016/s0015-0282(98)00019-3.

DOI:10.1016/s0015-0282(98)00019-3
PMID:9548161
Abstract

OBJECTIVE

To compare the effect of a GnRH-agonist, triptorelin, versus placebo on the symptoms of endometriosis.

DESIGN

A prospective, randomized, double-blind study of 6 months of treatment followed by 12 months of follow-up.

SETTING

Departments of Obstetrics and Gynecology at two universities and one general hospital.

PATIENT(S): Forty-nine women with symptoms of laparoscopically verified endometriosis.

INTERVENTION(S): Triptorelin depot or placebo was given every 4 weeks. Clinical evaluation, including the Duration Intensity Behavior Scale and Visual Analogue Scale for pain, was performed before the injections and up to 12 months after treatment. A control laparoscopy was performed 4-6 weeks after the last injection.

MAIN OUTCOME MEASURE(S): Quantitation of pain.

RESULT(S): Twenty-four patients had active treatment and 25 received placebo. Pain symptoms according to both scales were significantly more reduced after 2 months of triptorelin treatment compared to placebo. The extent of endometriotic lesions was reduced 50% during triptorelin treatment and increased 17% during placebo. The average area of endometriotic lesions was reduced 45% during triptorelin treatment but was unchanged during placebo. Side effects, mainly hot flushes, were experienced by 80% of the actively treated group but also by 33% of patients in the placebo group. Because of recurrent symptoms, only five patients could be observed for 12 months after completion of treatment.

CONCLUSION(S): Triptorelin reduces endometriotic lesions and pain to a significantly higher degree than placebo.

摘要

目的

比较促性腺激素释放激素激动剂曲普瑞林与安慰剂对子宫内膜异位症症状的影响。

设计

一项前瞻性、随机、双盲研究,治疗6个月,随后随访12个月。

地点

两所大学的妇产科和一家综合医院。

患者

49名经腹腔镜检查确诊为子宫内膜异位症且有症状的女性。

干预措施

每4周注射一次曲普瑞林长效制剂或安慰剂。在注射前及治疗后长达12个月进行临床评估,包括持续时间强度行为量表和疼痛视觉模拟量表。在最后一次注射后4 - 6周进行对照腹腔镜检查。

主要观察指标

疼痛定量。

结果

24名患者接受积极治疗,25名接受安慰剂治疗。与安慰剂相比,曲普瑞林治疗2个月后,两种量表所评估的疼痛症状均显著减轻。曲普瑞林治疗期间,子宫内膜异位症病变范围减少50%,而安慰剂治疗期间增加17%。曲普瑞林治疗期间,子宫内膜异位症病变的平均面积减少45%,而安慰剂治疗期间无变化。积极治疗组80%的患者出现副作用,主要为潮热,安慰剂组也有33%的患者出现。由于症状复发,治疗结束后仅5名患者能够被观察12个月。

结论

曲普瑞林比安慰剂能更显著地减少子宫内膜异位症病变和疼痛。

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