目的挖掘噁拉戈利钠的不良反应信号,为子宫内膜异位症患者临床安全合理用药提供参考。方法提取美国食品药品监督管理局(Food and Drug Administration,FDA)不良事件报告系统数据库(Adverse Event Reporting System,FAERS)中2018年7月23...目的挖掘噁拉戈利钠的不良反应信号,为子宫内膜异位症患者临床安全合理用药提供参考。方法提取美国食品药品监督管理局(Food and Drug Administration,FDA)不良事件报告系统数据库(Adverse Event Reporting System,FAERS)中2018年7月23日至2024年9月30日噁拉戈利钠所有药品不良事件(ADE)数据,获取以噁拉戈利钠列为“首要怀疑”(PS)的报告,用报告比值比法(ROR)、成比例报告比值比法(PRR)、贝叶斯置信区间神经网络传播法(BCPNN)、多重伽马-泊松收缩估计法(MGPS)进行数据分析。结果本研究共识别10005份与噁拉戈利钠相关的ADE报告,涉及3775名患者。累及27个系统-器官分类(SOC)和145个阳性首选语(PT)。其中同时满足4种算法的阳性SOC是各种手术及医疗操作,生殖系统及乳腺疾病,精神病类,血管与淋巴管类疾病。发生频次最高的PT是潮热、疼痛、恶心、头痛等,与说明书对比还发现了新的ADE,如脱发、贪食、脐出血等。结论临床上使用噁拉戈利钠治疗子宫内膜异位症患者时,应结合药物ADE特点,密切监测患者不良事件,尽早发现用药风险,保证临床合理用药。展开更多
Endometriosis is an inflammatory oestrogen dependent disease defined by the presence of endometrial glands and stroma at extrauterine sites. The modern advance in treatment of endometriosis management is tackling the ...Endometriosis is an inflammatory oestrogen dependent disease defined by the presence of endometrial glands and stroma at extrauterine sites. The modern advance in treatment of endometriosis management is tackling the debilitating pain it causes, besides the infertility in patients desiring fertility in reproductive age group. This can be achieved by surgical or medical means, although in most cases a combination of both treatments is required. Usually, long term treatment is required in most cases. Unfortunately in most cases, pain symptoms recur between 6months and 12 months once treatment is stopped. A lot of research has gone in understanding the pathogenesis and further medical management of endometriosis besides surgery to be useful in relieving pain and use in patients desiring fertility besides hormonal treatments used earlier like hormonal contraceptives (oral, transdermal or vaginal administration), progestogens, danazol, Gonadotrophic releasing hormone agonist (GnRH), aromatase inhibitors. Newer agents like antiangiogenic drugs, phytochemical agents like resveratrol, TNF-α inhibitors, GnRH antagonists like egalogolix, statins, antiinflammatory agents like COX2 Inhibitors and PPARγ inhibitors like pioglitazone etc., with recent work of combined efficacy of telmesartan of both PPARγ partial agonism along with angiotensin 1 receptor agonism having more efficacy, role of immunomodulators like rapamycin, lipoxin 4 and pentoxyphylline, GnRH antagonists like egalogolix are still under study undergoing phase III trials although preliminary results show promising results with fewer side effects as compared to similar duration of GnRH agonist and much less BMD side effects. Increasing number of trials show the safety of SPRM’s, along with efficacy although disadvantage is suppression of fertility so cannot be used for women desiring fertility. Currently, only mifepristone and ulipristal have received FDA approval for indication in fibroid treatment, MTP and not for endometriosis as yet. The advantages and disadvantages of all the recent advances are discussed in an update in the pathophysiology as well medical treatment of endometriosis.展开更多
文摘目的挖掘噁拉戈利钠的不良反应信号,为子宫内膜异位症患者临床安全合理用药提供参考。方法提取美国食品药品监督管理局(Food and Drug Administration,FDA)不良事件报告系统数据库(Adverse Event Reporting System,FAERS)中2018年7月23日至2024年9月30日噁拉戈利钠所有药品不良事件(ADE)数据,获取以噁拉戈利钠列为“首要怀疑”(PS)的报告,用报告比值比法(ROR)、成比例报告比值比法(PRR)、贝叶斯置信区间神经网络传播法(BCPNN)、多重伽马-泊松收缩估计法(MGPS)进行数据分析。结果本研究共识别10005份与噁拉戈利钠相关的ADE报告,涉及3775名患者。累及27个系统-器官分类(SOC)和145个阳性首选语(PT)。其中同时满足4种算法的阳性SOC是各种手术及医疗操作,生殖系统及乳腺疾病,精神病类,血管与淋巴管类疾病。发生频次最高的PT是潮热、疼痛、恶心、头痛等,与说明书对比还发现了新的ADE,如脱发、贪食、脐出血等。结论临床上使用噁拉戈利钠治疗子宫内膜异位症患者时,应结合药物ADE特点,密切监测患者不良事件,尽早发现用药风险,保证临床合理用药。
文摘Endometriosis is an inflammatory oestrogen dependent disease defined by the presence of endometrial glands and stroma at extrauterine sites. The modern advance in treatment of endometriosis management is tackling the debilitating pain it causes, besides the infertility in patients desiring fertility in reproductive age group. This can be achieved by surgical or medical means, although in most cases a combination of both treatments is required. Usually, long term treatment is required in most cases. Unfortunately in most cases, pain symptoms recur between 6months and 12 months once treatment is stopped. A lot of research has gone in understanding the pathogenesis and further medical management of endometriosis besides surgery to be useful in relieving pain and use in patients desiring fertility besides hormonal treatments used earlier like hormonal contraceptives (oral, transdermal or vaginal administration), progestogens, danazol, Gonadotrophic releasing hormone agonist (GnRH), aromatase inhibitors. Newer agents like antiangiogenic drugs, phytochemical agents like resveratrol, TNF-α inhibitors, GnRH antagonists like egalogolix, statins, antiinflammatory agents like COX2 Inhibitors and PPARγ inhibitors like pioglitazone etc., with recent work of combined efficacy of telmesartan of both PPARγ partial agonism along with angiotensin 1 receptor agonism having more efficacy, role of immunomodulators like rapamycin, lipoxin 4 and pentoxyphylline, GnRH antagonists like egalogolix are still under study undergoing phase III trials although preliminary results show promising results with fewer side effects as compared to similar duration of GnRH agonist and much less BMD side effects. Increasing number of trials show the safety of SPRM’s, along with efficacy although disadvantage is suppression of fertility so cannot be used for women desiring fertility. Currently, only mifepristone and ulipristal have received FDA approval for indication in fibroid treatment, MTP and not for endometriosis as yet. The advantages and disadvantages of all the recent advances are discussed in an update in the pathophysiology as well medical treatment of endometriosis.
