Cargando…
The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China
Triptorelin is one of the most commonly used gonadotropin-releasing hormone agonists and has been used in the treatment of deep infiltrating endometriosis (DIE). This study aimed to evaluate the efficacy and safety of up to 24 weeks of triptorelin treatment after conservative surgery for DIE. This p...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8812645/ https://www.ncbi.nlm.nih.gov/pubmed/35119037 http://dx.doi.org/10.1097/MD.0000000000028766 |
_version_ | 1784644698108854272 |
---|---|
author | Zhu, Libo Guan, Zheng Huang, Yan Hua, Keqin Ma, Liguo Zhang, Jian Yang, Dazhen Perrot, Valerie Li, Hongbo Zhang, Xinmei |
author_facet | Zhu, Libo Guan, Zheng Huang, Yan Hua, Keqin Ma, Liguo Zhang, Jian Yang, Dazhen Perrot, Valerie Li, Hongbo Zhang, Xinmei |
author_sort | Zhu, Libo |
collection | PubMed |
description | Triptorelin is one of the most commonly used gonadotropin-releasing hormone agonists and has been used in the treatment of deep infiltrating endometriosis (DIE). This study aimed to evaluate the efficacy and safety of up to 24 weeks of triptorelin treatment after conservative surgery for DIE. This prospective, non-interventional study was performed in 18 tertiary hospitals in China. Premenopausal women aged ≥18 years treated with triptorelin 3.75 mg once every 28 days for up to 24 weeks after conservative surgery for DIE were included. Endometriosis symptoms were assessed, using a visual analogue scale (0–10 cm) or numerical range (0–10), at baseline (pre-surgery) and routine visits 3, 6, 9, 12, 18, and 24 months after surgery. Changes in symptom intensity over time were primary outcome measures. A total of 384 women (mean [standard deviation] age, 33.4 [6.2] years) were analyzed. Scores for all symptoms (pelvic pain, dysmenorrhea, ovulation pain, dyspareunia, menorrhagia, metrorrhagia, and gastrointestinal and urinary symptoms) assessed decreased from baseline over 24 months. Cumulative improvement rates in pelvic pain, dysmenorrhoa, ovulation pain, and dyspareunia were 74.4%, 83.6%, 55.1%, and 66.9%, respectively. The 24-month cumulative recurrence rate (≥1 symptom) was 22.2%. The risk of symptom recurrence was higher in patients with ≥2 versus 1 lesion (odds ratio [OR] 2.539; 95% CI: 1.458–4.423; P = .001) and patients with moderate (OR 5.733; 95% CI: 1.623–20.248; P = .007) or severe (OR 8.259; 95% CI: 2.449–27.851; P = .001) pain versus none/mild pain. Triptorelin was well tolerated without serious adverse events. Triptorelin after conservative surgery for DIE improved symptoms over 24 months of follow up. The recurrence rate of symptoms was low and triptorelin was generally well tolerated. Trial registration number: ClinicalTrials.gov, NCT01942369. |
format | Online Article Text |
id | pubmed-8812645 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-88126452022-02-18 The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China Zhu, Libo Guan, Zheng Huang, Yan Hua, Keqin Ma, Liguo Zhang, Jian Yang, Dazhen Perrot, Valerie Li, Hongbo Zhang, Xinmei Medicine (Baltimore) 7400 Triptorelin is one of the most commonly used gonadotropin-releasing hormone agonists and has been used in the treatment of deep infiltrating endometriosis (DIE). This study aimed to evaluate the efficacy and safety of up to 24 weeks of triptorelin treatment after conservative surgery for DIE. This prospective, non-interventional study was performed in 18 tertiary hospitals in China. Premenopausal women aged ≥18 years treated with triptorelin 3.75 mg once every 28 days for up to 24 weeks after conservative surgery for DIE were included. Endometriosis symptoms were assessed, using a visual analogue scale (0–10 cm) or numerical range (0–10), at baseline (pre-surgery) and routine visits 3, 6, 9, 12, 18, and 24 months after surgery. Changes in symptom intensity over time were primary outcome measures. A total of 384 women (mean [standard deviation] age, 33.4 [6.2] years) were analyzed. Scores for all symptoms (pelvic pain, dysmenorrhea, ovulation pain, dyspareunia, menorrhagia, metrorrhagia, and gastrointestinal and urinary symptoms) assessed decreased from baseline over 24 months. Cumulative improvement rates in pelvic pain, dysmenorrhoa, ovulation pain, and dyspareunia were 74.4%, 83.6%, 55.1%, and 66.9%, respectively. The 24-month cumulative recurrence rate (≥1 symptom) was 22.2%. The risk of symptom recurrence was higher in patients with ≥2 versus 1 lesion (odds ratio [OR] 2.539; 95% CI: 1.458–4.423; P = .001) and patients with moderate (OR 5.733; 95% CI: 1.623–20.248; P = .007) or severe (OR 8.259; 95% CI: 2.449–27.851; P = .001) pain versus none/mild pain. Triptorelin was well tolerated without serious adverse events. Triptorelin after conservative surgery for DIE improved symptoms over 24 months of follow up. The recurrence rate of symptoms was low and triptorelin was generally well tolerated. Trial registration number: ClinicalTrials.gov, NCT01942369. Lippincott Williams & Wilkins 2022-02-04 /pmc/articles/PMC8812645/ /pubmed/35119037 http://dx.doi.org/10.1097/MD.0000000000028766 Text en Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) |
spellingShingle | 7400 Zhu, Libo Guan, Zheng Huang, Yan Hua, Keqin Ma, Liguo Zhang, Jian Yang, Dazhen Perrot, Valerie Li, Hongbo Zhang, Xinmei The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China |
title | The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China |
title_full | The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China |
title_fullStr | The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China |
title_full_unstemmed | The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China |
title_short | The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China |
title_sort | efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: a multicenter, prospective, non-interventional study in china |
topic | 7400 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8812645/ https://www.ncbi.nlm.nih.gov/pubmed/35119037 http://dx.doi.org/10.1097/MD.0000000000028766 |
work_keys_str_mv | AT zhulibo theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT guanzheng theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT huangyan theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT huakeqin theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT maliguo theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT zhangjian theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT yangdazhen theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT perrotvalerie theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT lihongbo theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT zhangxinmei theefficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT zhulibo efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT guanzheng efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT huangyan efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT huakeqin efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT maliguo efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT zhangjian efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT yangdazhen efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT perrotvalerie efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT lihongbo efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina AT zhangxinmei efficacyandsafetyoftriptorelintherapyfollowingconservativesurgeryfordeepinfiltratingendometriosisamulticenterprospectivenoninterventionalstudyinchina |