盘点:子宫肌瘤相关研究进展一览

2016-11-16 MedSci MedSci原创

子宫肌瘤是女性最常见的良性肿瘤,可单发或多发,小到几毫米,大到30厘米甚至更多。50岁之前几乎70%白人女性和超过80%的黑人女性都至少有一个子宫肌瘤。有症状的子宫肌瘤通常采用手术,但会带来相应的医疗负担。关于子宫肌瘤相关研究进展,梅斯医学编辑为您盘点。【1】醋酸乌利司他治疗子宫肌瘤,III期临床获得成功近日公布了有关避孕药醋酸乌利司他(ulipristal acetate)治疗女性子宫肌瘤(

子宫肌瘤是女性最常见的良性肿瘤,可单发或多发,小到几毫米,大到30厘米甚至更多。50岁之前几乎70%白人女性和超过80%的黑人女性都至少有一个子宫肌瘤。有症状的子宫肌瘤通常采用手术,但会带来相应的医疗负担。关于子宫肌瘤相关研究进展,梅斯医学编辑为您盘点。

【1】醋酸乌利司他治疗子宫肌瘤,III期临床获得成功

近日公布了有关避孕药醋酸乌利司他(ulipristal acetate)治疗女性子宫肌瘤(uterine fibroids)的2个关键III期研究的其中一个研究Venus I的积极数据。在美国,子宫肌瘤是导致子宫切除的首要原因,Venus I研究的数据显示,醋酸乌利司他有望为罹患子宫肌瘤的女性群体提供首个也是唯一一个非侵入性的长期治疗选择

Venus I研究是一项随机、多中心、双盲、安慰剂对照III期研究,纳入了157例18-50周岁的绝经前女性子宫肌瘤患者,这些患者在过去6个月经周期中周期性(22-35天)异常子宫出血次数≥4次,月经失血量≥80mL,任何大小及位置的离散子宫肌瘤≥1个,卵泡刺激素≤20mIU/mL。研究中,101例患者随机分配至5mg和10mg剂量醋酸乌利司他,56例分配至安慰剂。研究的共同主要疗效终点是无子宫出血的患者比例以及实现无子宫出血的时间。数据显示,该研究达到了全部共同主要终点和次要终点,与安慰剂组相比,2种剂量乌利司他治疗组均有显著更多的患者实现无子宫出血(10mg剂量组:58.3%;5mg剂量组:47.2%;安慰剂组:1.8%),数据具有统计学显著差异(均为p<0.0001)。

该研究的次要疗效终点是从治疗的第11天至治疗结束实现无子宫出血的患者比例,以及治疗结束时UFS-QOL修订活动量表从基线的变化。数据显示,与安慰剂组相比,10mg剂量乌利司他和5mg乌利司他治疗组均有显著更多的患者从第11天至治疗结束实现无子宫出血(10mg剂量组:58.3%;5mg剂量组:43.4%;安慰剂组:0%),数据具有统计学显著差异(均为p<0.0001)。UFS-QOL修订活动量表从基线的改善幅度,乌利司他10mg剂量组(59.0;p<0.0001)和5mg剂量组(52.1;p<0.0001)均显著大于安慰剂组(21.2)。UFS-QOL是一种疾病特异性症状和健康相关生活质量问卷,这是一种成熟的工具,用于评估疾病对罹患子宫肌瘤女性患者幸福感的影响。(文章详见--醋酸乌利司他治疗子宫肌瘤,III期临床获得成功

【2】JCEM:雄性激素增加了女性患子宫肌瘤的风险

根据发表在Journal of Clinical Endocrinology & Metabolism的一项研究,有高水平的睾丸激素和雌激素的中年女性比激素水平较低的女性的面临对更大的子宫疾病风险,即子宫肌瘤。

斯坦福大学医学院Sc.D,该研究的作者之一, Jason Y.Y. Wong说,四分之三的女性到50岁时会发展为子宫肌瘤。非裔美国女性或超重的女性发展为子宫肌瘤的风险更大。子宫肌瘤可以导致不规则出血,不孕,盆腔疼痛,复发性流产和其他生殖并发症。第一线治疗是接受子宫切除术,并且目前可用的一些其他的治疗选择较少。

这项13年的纵向研究检测了参加全国女性健康研究(SWAN)中的女性激素水平和子宫肌瘤的的发病率之间的关系。在研究开始时共有3240名女性参加,43.6%的参与者完成了后续的访问。在近一年的访问中,参加者进行了血液测试检查雌激素和雄激素水平。此外,这些女性还被问及她们是否曾被诊断患有或接受过子宫肌瘤治疗。

在参与者中,512名女性报告只有一次子宫肌瘤的发病,另有478名女性有复发状况。在血液中有较高水平的睾酮的参与者更容易患子宫肌瘤,是睾丸激素水平低的女性的1.33倍。有高水平的睾丸激素和雌激素女性面临更大的风险。虽然这两种激素水平很高的女性更可能患单发性子宫肌瘤,但她们也不太可能比低激素水平的女性有较高的复发率。(文章详见--JCEM:雄性激素增加了女性患子宫肌瘤的风险

【3】BMJ:子宫肌瘤你治对了吗?

子宫肌瘤是女性最常见的良性肿瘤,可单发或多发,小到几毫米,大到30厘米甚至更多。50岁之前几乎70%白人女性和超过80%的黑人女性都至少有一个子宫肌瘤。有症状的子宫肌瘤通常采用手术,但会带来相应的医疗负担。

原味作者运用文献检索,以MeSH、文字,“纤维瘤”、“平滑肌瘤”为关键词,在Medline、Embase、Cochrane Reviews、个人参考资料中进行了关于子宫肌瘤的检索。检索资料为英文妇科方向刊物,同时也参考了可信度高的比如国家卫生健康部门颁布的指南。

得到的基础知识有:

1.子宫肌瘤无症状,超声或MRI确诊后一般不需要治疗。

2.女性应该了解可行的治疗方法,比如药物、放射或手术,以及治疗是否有必要。

3.药物治疗对于由子宫肌瘤引起月经出血量大的女性可能有效,但尚没有足够证据证明。

4.女性还应知道治疗建议很多时候并没有足够证据,特别是子宫肌瘤剔除术这类的治疗。

5.子宫切除术的确有效,但应结合个人具体情况决定是否采用,或采用别的方法比如保守治疗或放射治疗。

6.粘膜下或肌壁内肌瘤会减低怀孕几率,但没有确定性的证据表明任何方式剔除子宫肌瘤可以提高怀孕几率。(文章详见--BMJ:子宫肌瘤你治对了吗?

【4】Eur J Obstet Gynecol Reprod Biol:不要吝啬在腹腔镜子宫肌瘤剔除术中的打洞数

为了评估单端口腹腔镜辅助下经脐腹腔镜子宫肌瘤剔除术(SPLA - TUM )具有比单端口腹腔镜子宫肌瘤剔除术( SP- LM)更短的操作时间,并且没有负面影响,如术后疼痛和美容效果。

我们在一所大学的教学医院进行了一项随机对照试验。共有92例绝经前妇女有症状,将浅表肌壁间或浆膜下肌瘤随机分配到SPLA – TUM组与SP- LM组,分别接受SPLA - TUM或SP- LM 。测量的主要结果是手术时间。之后测量的数据包括术后疼痛与美容效果,由视觉模拟评分( VAS )评估术后2 、 6 、 12 、 24以及48小时的疼痛数据;由温哥华疤痕量表( VSS )和患者疤痕满意度测量,比较两中手术在美容效果上的区别,在术后3个月后再使用VAS。

结果:这两组病人的人口统计学差异与切除的肌瘤的临床特征上没有显著差异性。结果显示,血红蛋白的变化、肠道活动的恢复、住院天数,与并发症发生率均无显著性差异。平均手术时间SPLA - TUM组比SP- LM组短( 87.0 ± 32.7min对比102.3 ± 32.9min ,P = 0.026) 。每组患者的术后疼痛水平、VSS分数与疤痕满意没有差异性,但SPLA - TUM组与SP -LM组相比有一个较长的脐伤口。2例( 4.3 %)SPLA - TUM组的患者最后接受SP- LM术 。1例( 2.2 % )SP- LM组的患者和2例( 4.3 %)SPLA - TUM组的患者被转换成两个或三个端口腹腔镜下子宫肌瘤剔除术。

结论:由于方便缝合和打结,SPLA - TUM比SP –LM所需更短的操作时间,这两个程序在术后疼痛水平和美容效果上具有可比性。然而,需要进一步的研究来评估SPLA-TUM术长期预后结果。(文章详见--Eur J Obstet Gynecol Reprod Biol:不要吝啬在腹腔镜子宫肌瘤剔除术中的打洞数

【5】JAMA Oncol:子宫肌瘤切除术后潜在的癌症

子宫肌瘤是子宫中的良性平滑肌瘤。这些肌瘤是很常见的,据估计20%-50%女性有子宫肌瘤。尽管子宫肌瘤通过是无症状的,但能造成疼痛、月经不调以及生育能力降低。子宫肌瘤切除术现在常常通过微创手术得以实现。电动分碎术,或者使用机械装置切除子宫肌瘤有可能被用于促进子宫肌瘤的切除。为了分析潜在的癌症和癌症前期变化的患病率,研究人员使用了美国国家数据库进行回顾性分析。数据是在2006年1月至2012年12月间,496所医院中有子宫肌瘤女性所提供的。在当时,电动分碎术已经被研究了。对子宫癌、不确定性恶性肿瘤和子宫内膜增生的患病率进行估计。建立多变量的混合影响回归模型以检验电动分碎术使用的影响因素和与不良病理结果相关的因素。

本次试验共有样本数41777例,其中3220人(7.7%)接受电动分碎术切除子宫肌瘤。在不使用电动分碎术切除子宫肌瘤的患者中,有73人(0.19%,95%CI 0.15%-0.23%)罹患子宫癌;使用电动分碎术切除子宫肌瘤的患者中,有3人(0.09%,95%CI 0.02%-0.27%)罹患子宫癌。不确定性恶性肿瘤和子宫内膜增生相应的比例分别为0.67%(257人)和0.43%(14人)。子宫癌最严重的风险因素是高龄。

总言之,无论是否使用电动分碎术切除子宫肌瘤,癌症的患病率和癌症前期的子宫异常比例都是较低的。但是,研究表明随着年龄增加,风险相应地增大。因此,对高龄子宫肌妇女使用电动分碎术应当更为审慎。(文章详见--JAMA Oncol:子宫肌瘤切除术后潜在的癌症

【6】FDA安全通告: 子宫和子宫肌瘤切除术中腹腔镜组织粉碎术的应用

腹腔镜组织粉碎器是用于不同类型腹腔镜手术(微创)的医疗设备。包括治疗某些子宫肌瘤的手术,例如子宫切除术或子宫肌瘤切除术。粉碎术指的是将切除的组织划分成小块或碎片,常被用于腹腔镜手术,以便从小的切口取出的手术。

子宫肌瘤是从子宫肌层组织发展来的良性肿瘤。大多数女性在一生的某个阶段将罹患子宫肌瘤(也称为平滑肌瘤),该病多数无任何症状。然而,在某些情况下,肌瘤也会出现症状,包括大量或长期阴道出血,盆腔压迫或疼痛,和/或尿频等症状,需要药物或外科手术治疗。许多女性选择接受经腹腔镜子宫或子宫肌瘤切除术,因为相对经腹部子宫切除术和子宫肌瘤切除术,这样可缩短术后恢复时间,降低感染风险。许多腹腔镜手术过程中需要使用组织粉碎器。

对于症状性子宫肌瘤的女性,其他的一些治疗方案是有效的。包括传统的子宫切除术和子宫肌瘤切除术(经阴道或经腹部);没有粉碎器的腹腔镜子宫和子宫肌瘤切除术;使用较小切口的剖腹手术(显微剖腹术);深思熟虑的子宫动脉栓塞术(以导管为基础的治疗子宫肌瘤的栓塞技术);高强度聚焦超声和药物治疗。证据表明,在可行的情况下,经阴道子宫切除术比腹腔镜或腹式子宫切除术具有更好的结局和更少的并发症。

重要的是,基于FDA对当前可用数据的分析显示:因子宫肌瘤接受子宫切除术或肌瘤切除术的,每350位妇女中就有一位可能潜在未知的子宫肉瘤——一种包括平滑肌肉瘤的子宫癌,如果腹腔镜组织粉碎术应用于这些未知的子宫肉瘤的女性,有可能将癌组织播散到腹部和盆腔内,显著缩短患者的有效生存期。因为没有可靠的方法来预测患有子宫肌瘤的女性是否为子宫肉瘤,FDA不鼓励子宫肌瘤患者在子宫切除术或肌瘤切除术使用腹腔组织粉碎术。(文章详见--FDA安全通告: 子宫和子宫肌瘤切除术中腹腔镜组织粉碎术的应用

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    2016-11-19 虈亣靌

    讲的好学习一下

    0

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    2016-11-19 cqykthl

    学习新知识。

    0

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channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160718/IMG578C993D395567540.jpg, createdBy=59b81918946, createdName=flysky120, createdTime=Thu Nov 17 09:16:21 CST 2016, time=2016-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=156229, encodeId=dc1915622920, content=学习新知识谢谢。, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Thu Nov 17 05:01:11 CST 2016, time=2016-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=156212, encodeId=1f3d15621233, content=学习了,子宫肌瘤确实高发, beContent=null, objectType=article, 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    2016-11-17 虈亣靌

    讲得好学习了

    0

  6. 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    2016-11-17 doctorJiangchao

    继续学习

    0

  7. 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channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160718/IMG578C993D395567540.jpg, createdBy=59b81918946, createdName=flysky120, createdTime=Thu Nov 17 09:16:21 CST 2016, time=2016-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=156229, encodeId=dc1915622920, content=学习新知识谢谢。, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Thu Nov 17 05:01:11 CST 2016, time=2016-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=156212, encodeId=1f3d15621233, content=学习了,子宫肌瘤确实高发, beContent=null, objectType=article, 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    2016-11-17 doctorJiangchao

    继续关注

    0

  8. 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    2016-11-17 flysky120

    希望药物治疗能更好

    0

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channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160718/IMG578C993D395567540.jpg, createdBy=59b81918946, createdName=flysky120, createdTime=Thu Nov 17 09:16:21 CST 2016, time=2016-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=156229, encodeId=dc1915622920, content=学习新知识谢谢。, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Thu Nov 17 05:01:11 CST 2016, time=2016-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=156212, encodeId=1f3d15621233, content=学习了,子宫肌瘤确实高发, beContent=null, objectType=article, 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    2016-11-17 刘煜

    学习新知识谢谢。

    0

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    2016-11-17 明崖

    学习了,子宫肌瘤确实高发

    0

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