CN111686115A - 一种治疗子宫腺肌病的药物及应用 - Google Patents
一种治疗子宫腺肌病的药物及应用 Download PDFInfo
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Abstract
本发明属于临床药物技术领域,公开了一种治疗子宫腺肌病的药物及应用,准备地诺孕素及左炔诺孕酮宫内缓释系统;采取HIFU消融联合地诺孕素及左炔诺孕酮宫内缓释系统综合治疗。本发明采取HIFU消融联合地诺孕素及左炔诺孕酮宫内缓释系统(LNG‑IUS)综合治疗子宫腺肌病。分析HIFU消融联合地诺孕素和LNG‑IUS治疗子宫腺肌病患者的有效率及复发率,并分析HIFU消融治疗子宫腺肌病症状的相关因素,旨在为临床上HIFU消融治疗子宫腺肌病提供参考。
Description
技术领域
本发明属于临床药物技术领域,尤其涉及一种治疗子宫腺肌病的药物及应用。
背景技术
目前,子宫腺肌病以子宫内膜腺体及间质侵入子宫肌层导致子宫局限性或弥漫性增大为特征;是常见的子宫良性疾病,痛经、异常阴道流血、不孕、慢性盆腔疼痛、压迫等是常见的临床症状。高强度聚焦超声(highintensityfocused ultrasound,HIFU)消融技术是一种新兴的无创外科技术,现常应用于子宫肌瘤等良性疾病的治疗,因此也为子宫腺肌病的无创保守性治疗提供了新的手段。但因异位内膜多呈弥漫性生长、子宫腺肌病病灶边界不清等特点,HIFU消融是子宫腺肌病保守性治疗的一种方法,虽研究证实疗效较好,但仍有较高的复发率。
作为一种慢性疾病,子宫腺肌病的治疗以药物治疗为主而非手术治疗为主,强调长期管理。其药物治疗包括促性腺激素释放激素激动剂(GnRH-a)、左炔诺孕酮宫内缓释系统(LNG-IUS)和口服孕激素等。高强度聚焦超声(HIFU)主要用于控制子宫腺肌病痛经这一症状。子宫腺肌病患者的长期管理应在HIFU治疗之后联合药物治疗,可以有效减少复发率。文献报道HIFU术后使用GnRH-a和LNG-IUS进行联合治疗。由于GnRH-a不可长期使用,指南中对其使用次数也有规定(3-6次),而子宫大者LNG-IUS又易脱落。地诺孕素是新引进治疗子宫腺肌病的药物,该药同时具有天然和合成孕激素的药理学优点,有很高的孕激素活性,仅与孕激素受体结合,故无雌激素、抗雌激素和雄激素活性,抗促性腺激素作用也很弱,但具有轻微抑制排卵和轻微降低雌激素水平的作用。此外,地诺孕素还具有抑制子宫内膜细胞增殖和降低神经生长因子和神经纤维密度的作用。近年研究表明,地诺孕素用于子宫内膜异位症疗效确切,但应用于子宫腺肌病的治疗尚处于初试阶段。与GnRH-a对比研究发现,地诺孕素对子宫腺肌病相关疼痛的缓解作用与GnRHa相近,地诺孕素长期应用可有效缓解子宫腺肌病相关疼痛症状,因此对于无生育要求且希望保留子宫或暂时不要求生育的子宫腺肌病患者,地诺孕素是一种较有效的药物治疗手段,相较于GnRH-a,地诺孕素可长期使用。此时先使用地诺孕素使子宫的体积缩小至妊娠2个月大小,再放置LNG-IUS便可达到较好的治疗效果。
通过上述分析,现有技术存在的问题及缺陷为:目前高强度聚焦超声消融方法有较高的复发率。
解决以上问题及缺陷的难度为:作为一种慢性疾病,子宫腺肌病的治疗以药物治疗为主而非手术治疗为主,强调长期管理。其药物治疗包括促性腺激素释放激素激动剂(GnRH-a)、左炔诺孕酮宫内缓释系统(LNG-IUS)和口服孕激素等。高强度聚焦超声(HIFU)主要用于控制子宫腺肌病痛经这一症状。子宫腺肌病患者的长期管理应在HIFU治疗之后联合药物治疗,可以有效减少复发率。文献报道HIFU术后使用GnRH-a和LNG-IUS进行联合治疗。由于GnRH-a不可长期使用,指南中对其使用次数也有规定(3-6次),而子宫大者LNG-IUS又易脱落。
解决以上问题及缺陷的意义为:地诺孕素是新引进治疗子宫腺肌病的药物,相较于GnRH-a,地诺孕素可长期使用。此时先使用地诺孕素使子宫的体积缩小至妊娠2个月大小,再放置LNG-IUS便可达到较好的治疗效果。
发明内容
针对现有技术存在的问题,本发明提供了一种治疗子宫腺肌病的药物及应用。
本发明是这样实现的,一种治疗子宫腺肌病的药物,所述治疗子宫腺肌病的药物为地诺孕素、左炔诺孕酮宫内缓释系统(LNG-IUS)。
本发明的另一目的在于提供一种所述治疗子宫腺肌病的药物的应用方法,所述治疗子宫腺肌病的药物的应用方法包括:
第一步,准备地诺孕素及左炔诺孕酮宫内缓释系统;
第二步,采取HIFU消融联合地诺孕素及左炔诺孕酮宫内缓释系统综合治疗子宫腺肌病。
本发明的另一目的在于提供一种所述治疗子宫腺肌病的药物在HIFU消融治疗子宫腺肌病药物中的应用。
结合上述的所有技术方案,本发明所具备的优点及积极效果为:本发明采取HIFU消融联合地诺孕素及左炔诺孕酮宫内缓释系统(LNG-IUS)综合治疗子宫腺肌病。分析HIFU消融联合地诺孕素和LNG-IUS治疗子宫腺肌病患者的有效率及复发率,并对分析HIFU消融治疗子宫腺肌病症状的相关因素,旨在为临床上HIFU消融治疗子宫腺肌病提供参考。
附图说明
为了更清楚地说明本申请实施例的技术方案,下面将对本申请实施例中所需要使用的附图做简单的介绍,显而易见地,下面所描述的附图仅仅是本申请的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下还可以根据这些附图获得其他的附图。
图1是本发明实施例提供的治疗子宫腺肌病的药物应用方法流程图。
图2是本发明实施例提供的统计分析原理图。
图3是本发明实施例提供的HIFU治疗子宫腺肌症前后超声造影图片术前图。
图4是本发明实施例提供的HIFU治疗子宫腺肌症前后超声造影图片术后图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。
针对现有技术存在的问题,本发明提供了一种治疗子宫腺肌病的药物及应用,下面结合附图对本发明作详细的描述。
如图1所示,本发明提供的治疗子宫腺肌病的药物的应用方法包括以下步骤:
S101:准备地诺孕素及左炔诺孕酮宫内缓释系统;
S102:采取HIFU消融联合地诺孕素及左炔诺孕酮宫内缓释系统(LNG-IUS)综合治疗子宫腺肌病。
下面结合具体实施例对本发明的技术方案作进一步的描述。
实施例1
1.1HIFU治疗
1.1.1治疗前准备
患者术前均完成了饮食、药物导泻和清洁灌肠的肠道准备。治疗前3天开始清淡少渣饮食,治疗前1天仅予以流质饮食且当日16:00-18:00用复方聚乙二醇电解质散冲水2000ml口服导泻;22:00以后绝对禁食禁饮。若肠道准备过程中出现头晕眼花、心慌冷汗、乏力等低血糖症状,可予以葡萄糖、电解质等静脉补液对症处理。治疗当天早上给予清洁灌肠(排泄物无渣为标准)。治疗开始前半小时需留置导尿管,导尿过程中注意防止气体进入膀胱及球囊,并对治疗区皮肤进行备皮、脱脂脱气处理。
1.1.2超声消融治疗
治疗过程中需患者保持相对静止俯卧于治疗床上,治疗区皮肤浸泡于脱气水中,水温由20℃逐渐降低,并维持于10℃左右,水囊水位保持48cm左右保证声通道内无空气,治疗头置于病灶正下方。治疗前根据术前定位、MRI结果及术中超声监控下向膀胱内灌注温生理盐水,以声通道基本安全又不将病灶推向后方为宜。予超声造影明确病灶范围及血供情况,造影剂使用六氟化硫微泡(声诺维)59mg,加5ml生理盐水溶解粉剂,1.5ml每次。治疗中需采用适当大小声窗适配球置于换能器于皮肤之间,推挤肠道至头侧声通道外。治疗过程监控超声实时显示患者矢状位图像,采用点扫描方式治疗,采用由深面到浅面、从足侧到头侧的治疗原则辐照,根据灰度、超声造影图像及最大耐受剂量等决定停止时间。治疗过程中通过缩宫素静脉滴注减少病灶血供。术后即刻排空膀胱,并向膀胱内灌注4-10℃冰生理盐水200-300ml2次,认真检查治疗区皮肤及双下肢运动感觉情况,行下腹部查体,观察是否有阴道流血流液情况。之后送患者回病房,监测生命体征1h,继续俯卧2h后逐渐恢复正常体位及进食。
1.2地诺孕素治疗:
HIFU消融治疗后第1次月经来潮的第1天口服地诺孕素,共3到6个月经周期。根据子宫体积、症状严重程度及患者要求决定地诺孕素用药疗程。
1.3 LNG-IUS植入
地诺孕素数疗程后于月经第七天,门诊行血常规、白带检查排除全身及阴道局部感染。患者排空膀胱后取膀胱截石位,消毒、铺巾后放入窥阴器暴露宫颈。宫颈钳夹宫颈前唇向外牵拉,用子宫探针测宫腔深度后,顺号扩张宫颈。将LNG-IUS经宫颈沿宫腔方送入宫腔,送入深度以与宫底相接触为止。术后即刻行经腹部超声检查确定LNG-IUS位于宫腔的位置。门诊休息、观察半小时,无特殊不适即可离院。
下面结合临床的应用对本发明的技术效果作详细的描述。
1 HIFU治疗
1.1治疗前准备
60例患者术前均完成了饮食、药物导泻和清洁灌肠的肠道准备。治疗前3天开始清淡少渣饮食,治疗前1天仅予以流质饮食且当日16:00-18:00用复方聚乙二醇电解质散冲水2000ml口服导泻;22:00以后绝对禁食禁饮。若肠道准备过程中出现头晕眼花、心慌冷汗、乏力等低血糖症状,可予以葡萄糖、电解质等静脉补液对症处理。治疗当天早上给予清洁灌肠(排泄物无渣为标准)。治疗开始前半小时需留置导尿管,导尿过程中注意防止气体进入膀胱及球囊,并对治疗区皮肤进行备皮、脱脂脱气处理。
1.2超声消融治疗
治疗过程中需患者保持相对静止俯卧于治疗床上,治疗区皮肤浸泡于脱气水中,水温由20℃逐渐降低,并维持于10℃左右,水囊水位保持48cm左右保证声通道内无空气,治疗头置于病灶正下方。治疗前根据术前定位、MRI结果及术中超声监控下向膀胱内灌注温生理盐水,以声通道基本安全又不将病灶推向后方为宜。予超声造影明确病灶范围及血供情况,造影剂使用六氟化硫微泡(声诺维)59mg,加5ml生理盐水溶解粉剂,1.5ml每次。治疗中需采用适当大小声窗适配球置于换能器于皮肤之间,推挤肠道至头侧声通道外。治疗过程监控超声实时显示患者矢状位图像,采用点扫描方式治疗,采用由深面到浅面、从足侧到头侧的治疗原则辐照,根据灰度、超声造影图像及最大耐受剂量等决定停止时间。治疗过程中通过缩宫素静脉滴注减少病灶血供。术后即刻排空膀胱,并向膀胱内灌注4-10℃冰生理盐水200-300ml2次,认真检查治疗区皮肤及双下肢运动感觉情况,行下腹部查体,观察是否有阴道流血流液情况。之后送患者回病房,监测生命体征1h,继续俯卧2h后逐渐恢复正常体位及进食。
1.3地诺孕素治疗:
HIFU消融治疗后第1-2次月经来潮的第1天口服地诺孕素,共3到6个月经周期。根据子宫体积、症状严重程度及患者要求决定地诺孕素用药疗程。
1.4 LNG-IUS植入
地诺孕素数疗程后于月经第七天,门诊行血常规、白带检查排除全身及阴道局部感染。患者排空膀胱后取膀胱截石位,消毒、铺巾后放入窥阴器暴露宫颈。宫颈钳夹宫颈前唇向外牵拉,用子宫探针测宫腔深度后,顺号扩张宫颈。将LNG-IUS经宫颈沿宫腔方送入宫腔,送入深度以与宫底相接触为止。术后即刻行经腹部超声检查确定LNG-IUS位于宫腔的位置。门诊休息、观察半小时,无特殊不适即可离院。
2评价和随访
2.1 HIFU、地诺孕素+LNG-IUS组及HIFU+地诺孕素+LNG-IUS组治疗并发症随访
观察HIFU、地诺孕素+LNG-IUS组及HIFU+地诺孕素+LNG-IUS组治疗术中及术后出现的并发症,其中出现的恶心呕吐、下腹胀痛、骶尾部胀痛、血尿、阴道流血、皮肤损伤、下肢疼痛等症状均视为治疗的副反应。认真分析并发症出现的原因并且予以对症处理。
2.2患者痛经症状随访
治疗前及治疗后1、3、6个月使用视觉模拟评分法(VAS),由患者在坐标轴上标定治疗前后痛经评分值来。“0”分代表无痛,“10”分表示最剧烈的疼痛,根据病人标出的位置为其评出分数。
2.3子宫体积大小随访
60例患者术前及术后1、3、6个月均由同一名医师使用同一台彩色超声仪器检查。依据妇科超声检查规范测量子宫大小。子宫体积=π×A×B×C/6cm3。
2.5统计分析
采用SPSS20.0统计软件进行分析,计数资料采用率表示,计量资料以x±s表示。两组比较用x2检验,两独立样本均数比较采用t检验,以P<0.05为差异有统计学意义。如图2。
HIFU治疗子宫腺肌症前后超声造影图片术前如图3。术后如图4。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,都应涵盖在本发明的保护范围之内。
Claims (3)
1.一种治疗子宫腺肌病的药物,其特征在于,所述治疗子宫腺肌病的药物为地诺孕素、左炔诺孕酮宫内缓释系统。
2.一种如权利要求1所述治疗子宫腺肌病的药物的应用方法,其特征在于,所述治疗子宫腺肌病的药物的应用方法包括:
第一步,准备地诺孕素及左炔诺孕酮宫内缓释系统;
第二步,采取HIFU消融联合地诺孕素及左炔诺孕酮宫内缓释系统综合治疗。
3.一种如权利要求1所述治疗子宫腺肌病的药物在HIFU消融治疗子宫腺肌病药物中的应用。
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