CN105944020A - 一种治疗卵巢功能下降的中药 - Google Patents
一种治疗卵巢功能下降的中药 Download PDFInfo
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Abstract
本发明公开了一种治疗卵巢功能下降的中药。它主要由下述原料药制成:菟丝子、女贞子、炙淫羊藿、桑椹子、金樱子、枸杞子、沙苑子、莲子、鹿角霜、山药、制香附、郁金、丹参、月季花、炒白芍、百合和炙甘草。本发明以纯中药组方,补肾调肝,养血活血,使肾中阴阳平秘,可以显著改善女性的月经,提高女性的生育能力。该中药治疗卵巢功能下降的有效率为91.25%。
Description
技术领域
本发明涉及一种治疗卵巢功能下降的中药,属于中药技术领域。
背景技术
卵巢功能下降(亦称卵巢功能减退),是指卵巢之卵泡池中卵子数量减少及质量降低,导致卵泡发育障碍,生育能力下降。现代医学对卵巢功能下降尚无明确的诊断标准,临床表现为:具有正常月经史及生育史的患者,40岁之前出现月经量减少、月经稀发甚至是闭经,不孕,或伴有潮热盗汗、性欲减退、失眠、烦躁易怒等围、绝经期症状。实验室指标:10IU/L<FSH<40IU/L,或同时伴有FSH/LH比值>3.0。本病的发生可能与心理、遗传、免疫疾病及感染、手术、生活环境等因素相关。
健康的卵巢与女性延缓衰老、推迟更年期、维持美丽息息相关,维持卵巢健康至关重要。卵巢功能下降不仅会降低女性的生育能力,还可对女性造成以下影响:(1)促使皮肤衰老:肌肤干燥、暗淡无光,皱纹滋生,各类斑点生成;(2)对女性健康埋下隐患:降低女性生理代谢、内分泌紊乱、更年期提前;形成痛经、月经不规则等疾患;(3)精神上也有所影响:出现失眠、烦躁焦虑等现象。因此,女性要对卵巢功能下降进行积极有效的治疗。
目前卵巢功能下降的治疗主要采取药物治疗。药物治疗一般是采用雌孕激素补充治疗,虽然可以不同程度的改善患者的临床症状,但这种治疗方式在临床治疗中有着一定的风险,长期使用激素会增加子宫内膜增生性疾病、生殖系统肿瘤、卒中等疾病的发病机率。因此中药治疗因其绿色、无副作用、治愈后不易复发等优点,受到越来越多的重视。
发明内容
本发明提供了一种治疗卵巢功能下降的中药,该中药以17味中药组方,补肾调肝,养血活血,可以显著改善女性的月经,提高女性的生育能力。
本发明的技术方案是:一种治疗卵巢功能下降的中药,其特征是,主要由下述重量份的原料药制成:菟丝子15~20份,女贞子10~20份,炙淫羊藿10~15份,桑椹子15~20份,金樱子10~20份,枸杞子15~20份,沙苑子10~20份,莲子10~15份,鹿角霜10~20份,山药20~30份,制香附10~20份,郁金10~20份,丹参20~30份,月季花10~20份,炒白芍10~20份,百合10~20份,炙甘草5~10份。
优选配比:菟丝子18份,女贞子15份,炙淫羊藿12份,桑椹子18份,金樱子15份,枸杞子18份,沙苑子15份,莲子12份,鹿角霜15份,山药24份,制香附15份,郁金15份,丹参24份,月季花15份,炒白芍15份,百合15份,炙甘草6份。
本发明可以在上述基础方的基础上,随证加入其它原料药。如加益母草15份、玫瑰花15份以活血调经,加夜交藤12份以养心安神。加仙灵脾9份,桂枝9份,从阴引阳,促进阴阳转化。咳嗽加桑叶12份,菊花15份,桔梗12份。还可以加入党参15份、茯苓12份、白术15份以健脾和胃调经。
配制及服用方法:水煎服,一日一剂,分两次温服,在月经周期第5天(闭经的患者在任意一天)开始服用,连续服用14天为一个疗程,连服3个月经周期。
上述原料药还可以进一步加入制备不同剂型时所需的各种常规辅料,如赋形剂、矫味剂、粘合剂等以常规的中药制剂方法制备成任何一种常用口服制剂,如颗粒剂、丸剂、胶囊剂、片剂、口服液等。优选为颗粒剂。
优选的,本发明颗粒剂的制备方法为:
(1)将菟丝子、桑椹子和枸杞子加入70%乙醇加热回流提取2次,每次0.5~1小时;合并提取液,备用;
(2)将女贞子、金樱子、丹参和炙淫羊藿加入90%乙醇加热回流提取2次,每次0.5~1小时,合并提取液,然后再合并步骤(1)的提取液,经200目筛网过滤后,加热除去乙醇,得到提取液;
(3)然后将剩余的中药(沙苑子、莲子、鹿角霜、山药、制香附、郁金、月季花、炒白芍、百合和炙甘草等)和步骤(1)、(2)的药渣合并,加水煎煮2次,每次煎煮0.5~1.5小时;合并煎煮液,经200目筛网过滤后,得到煎煮液;
(4)合并步骤(2)的提取液和步骤(3)的煎煮液,经加热浓缩至相对密度为1.20~1.30(60℃)的稠膏,然后加入1~3倍质量的蔗糖粉混合均匀,最后经制粒(制软材时适当加入少量70%乙醇)、干燥、筛分后,分装成袋。
卵巢功能下降属于中医“月经量少”、“月经后期”、“血枯”、“闭经”、“不孕”、“经断前后诸证”范畴。若先天肾气不足,或房劳多产损伤肾精,引起肾气肾精亏虚,冲任不充,血海空虚不能按时满溢,导致月经后期而至。若先天禀赋素弱或少年肾气未充,或多产(含多次人工流产、屡孕屡堕)房劳伤肾,以致肾气不足,精血不充,冲任血海空虚,经血化源不足以致经量减少;肾主藏精,精能生血,血能化精,是月经的重要物质来源,是孕、育的必要条件。肾精肾气亏虚,天癸缺少物质来源而不能成熟,导致卵巢功能下降。《格致余论·论秦桂丸》中说:“今妇人无子者,率由血少不足以摄精也……然欲得子者,必须调补阴血,使无亏欠,乃可推其有余以成胎孕”。故中医讲肾虚是卵巢功能下降的基本病机。肾精不足,血海亏虚,冲任失于濡养,血海不能按时满溢,则会出现月经后期、经量减少;肾精不足,生血无源,导致血海亏空,则出现经色淡,质稀;肾精亏虚,则血海空虚,气血不足,心失所养而出现心悸失眠;肾开窍于耳,脑为髓海,肾精不足,则髓海失充,故头晕耳鸣。肾阴虚,无以制阳,则潮热汗出,心烦易怒。故临床治疗上多采用补肾填精的方法进行治疗,补肾中药被认为具有提高卵巢储备的作用,以“补肾法”为主要治疗法则广泛应用于卵巢功能减退的临床治疗。但是本发明人认为该病治疗在补肾的同时应兼顾疏肝健脾,肝气畅达,经自调顺,健脾和胃,则化源充足。
本发明方解如下:
君药:菟丝子、女贞子。其中菟丝子补肝肾,益精髓,气味平和,既可补阳,以能益阴,温而不燥,补而不滞,与其他滋阴诸药之偏于腻滞者绝异。女贞子苦、甘,性平,入肝、肾经,补肝肾,强腰膝。二者配伍,肝肾同补。
臣药:桑葚子、沙苑子、枸杞子。桑葚子入肝肾之经,滋补肝肾之阴,与沙苑子相合直入肝肾之经以滋阴血。枸杞子甘平质润,体润滋阴,入肾补血;味甘助阳,入肾补所了,入肾能生精益髓而强盘骨,味重而纯,故能补阴,阴中有阳,故能补气。菟丝子其性微温,兼可助阳,上药与之相伍,正合张景岳“阳中求阴,阴中求阳”之说,使肾中阴阳平秘。
佐药:金樱子、莲子、制淫羊藿、鹿角霜、山药、香附、郁金、丹参、月季花、炒白芍、百合。金樱子、莲子、山药入肾经益肾固精,制淫羊藿、鹿角霜补肾助阳,五物相合可滋肾之阴阳,以助肾之阴阳平秘。香附疏肝理气,调经止痛,《本草纲目》谓:“得参术则补气,得归地则补血,乃气病之总司,女科之主帅也”。其药性偏温,专入气分,善舒肝行气,调经止痛。郁金药性偏寒,既入血分,又入气分,善活血止痛,行气解郁。丹参药性微寒,入血分以活血调经,祛瘀止痛;月季花入肝经活血调经、疏肝解郁,四物相合共奏活血调经、疏肝理气之效。白芍养血敛阴、柔肝止痛、平抑阴阳,百合养阴润燥,清心安神,两物相合养血敛阴,与上之四物相配以奏活血养血之效。
使药:炙甘草。甘草调和诸药,以之为使。
全方共奏补肾调肝、养血活血之效,尚可兼顾肾气,使肾中阴阳平秘,经候自调,则胎孕可成。
各原料及作用
菟丝子:辛、甘、微温,入肝、肾经。功可补肝肾,益精髓,气味平和,既可补阳,宜能益阴,温而不燥,补而不滞,《本经》称其“续绝伤,补不足益气力,肥健人”。《本草述钩元》谓:“菟丝子感于浮长之阳,而归降收之阴,故能益肾气,……固能助阳味以化阴而益气,……更能助阴味以化阳而精”。张山雷:“菟丝子为养阴通络之品。其味微辛,则阴中有阳,守而能走,与其他滋阴诸药之偏于腻滞者绝异”。
桑椹子:桑椹子为桑科落叶乔木桑树的成熟果实。全国各地均有出产。于果实红熟时采收,晒干生用,或加蜜熬膏用。性味:味甘,性寒。归经:归心、肝、肾经。功能:滋阴补血,生津,润肠。主治:久病体虚,肝肾阴亏,腰膝酸软,目暗耳鸣,关节不利,肠燥便秘,津亏血少,潮热遗精,糖尿病等。
淫羊藿:辛、甘,温。归经:归肝、肾经。功能主治:补肾阳,强筋骨,祛风湿。用于阳痿遗精,筋骨痿软,风湿痹痛,麻木拘挛;更年期高血压。炙淫羊藿:取羊脂油加热熔化,加入淫羊藿丝,用文火炒至均匀有光泽,取出,放凉。每100kg淫羊藿,用羊脂油(炼油)20kg。
金樱子:性味与归经:酸、甘、涩,平。归肾、膀胱、大肠经。功能与主治:固精缩尿,固崩止带,涩肠止泻。用于遗精滑精,遗尿尿频,崩漏带下,久泻久痢。
枸杞子:甘、平、质润,《药品化义》称其“体润滋阴,入肾补血;味甘助阳,入肾补所了”,入肾能生精益髓而强盘骨,《本草正》称其“味重而纯,故能补阴,阴中有阳,故能补气”。
女贞子:苦、甘,性平,入肝肾经,补肝肾,强腰膝,“养阴益肾,补气疏肝”(《本草再新》),《本草述》称其“固入血海益血,而和气以上荣……不独髭须为然也,即广嗣方中,多用之矣。
沙苑子:甘,温。归肝、肾经。功能主治:温补肝肾,固精,缩尿,明目。用于肾虚腰痛,遗精早泄,白浊带下,小便余沥,眩晕目昏。
莲子:甘、涩,平。归脾、肾、心经。功能与主治:补脾止泻,止带,益肾涩精,养心安神。用于脾虚泄泻,带下,遗精,心悸失眠。
鹿角霜:咸、涩,温。归肝、肾经。功能与主治:温肾助阳,收敛止血。用于脾肾阳虚,白带过多,遗尿尿频,崩漏下血,疮疡不敛。
山药:甘,平。归脾、肺、肾经。功能与主治:补脾养胃,生津益肺,补肾涩精。用于脾虚食少,久泻不止,肺虚喘咳,肾虚遗精,带下,尿频,虚热消渴。麸炒山药补脾健胃。用于脾虚食少,泄泻便溏,白带过多。
制香附:味辛、微苦、甘,性平。功效:疏肝理气,调经止痛。主治肝气郁滞,胸闷胁痛,胃病,腹痛;以及月经不调,痛经等病症。制香附:将碾碎之香附放入缸内,用黄酒及米醋拌匀。再用砂糖,加水适量炒烊,然后将香附倒入锅内,与砂糖水充分混合,炒干。(每香附粒100斤,用黄酒、米醋各20斤,砂糖6斤)。
郁金:辛、苦,寒。归肝、心、肺经。功能与主治:活血止痛,行气解郁,清心凉血,利胆退黄。用于胸胁刺痛,胸痹心痛,经闭痛经,乳房胀痛,热病神昏,癫痫发狂,血热吐衄,黄疸尿赤。
丹参:苦,微寒。归心、肝经。功能与主治:活血祛瘀,通经止痛,清心除烦,凉血消痈。用于胸痹心痛,脘腹胁痛,瘕瘕积聚,热痹疼痛,心烦不眠,月经不调,痛经经闭,疮疡肿痛。
月季花:甘,温。归肝经。功能与主治:活血调经,疏肝解郁。用于气滞血瘀,月经不调,痛经,闭经,胸胁胀痛。
炒白芍:苦、酸,微寒。归肝、脾经。功能主治:平肝止痛,养血调经,敛阴止汗。用于头痛眩晕,胁痛,腹痛,四肢挛痛,血虚萎黄,月经不调,自汗,盗汗。炒白芍:取净白芍片,锅内炒至微黄色。
百合:味甘、性平、微苦;归肺、心、肾经;和润滑利;具有养阴润肺,清心安神,止咳的功效。主治阴虚久咳,痰中带血,咽痛失音;热病后期,余热未清,或情志不遂,虚烦惊悸,失眠多梦,精神恍惚,痈肿。
炙甘草:甘,平。归心、肺、脾、胃经。功能主治:补脾和胃,益气复脉。用于脾胃虚弱,倦怠乏力,心动悸,脉结代,可解附子毒。炙甘草:取甘草片,照蜜炙法炒至黄色至深黄色,不粘手时取出,晾凉。
本发明的有益效果是:本发明以纯中药组方,补肾调肝,养血活血,使肾中阴阳平秘,可以显著改善女性的月经,提高女性的生育能力。该中药治疗卵巢功能下降的有效率为91.25%。
具体实施方式
实施例1
配比(单位:g):菟丝子18,炙淫羊藿12,桑椹子18,金樱子15,枸杞子18,女贞子15,沙苑子15,莲子12,鹿角霜15,山药24,制香附15,郁金15,丹参24,月季花15,炒白芍15,百合15,炙甘草6。
配制及服用方法:水煎服,一日一剂,分两次温服,在月经周期第5天(闭经的患者在任意一天)开始服用,连续服用14天为一个疗程,连服3个月经周期。
以下结合本发明中药治疗卵巢功能下降的临床资料和病例资料来说明其效果。
一、临床资料
1资料与方法
1.1一般资料
选择2013年1月-2015年2月于本院妇产科门诊就诊的163例卵巢功能下降的患者,年龄21~42岁,平均(28.3±3.6)岁;病程最短3个月,最长3年,平均(1.4±1.1)年。患者符合中医以及西医的诊断标准。随机分为观察组88例,年龄21~42岁,平均(31.4±2.3)岁;病程最短3个月,最长3年,平均(1.2±0.7)年。对照组75例,年龄21~42岁,病程3个月至3年,平均(1.6±0.8)年。
1.2诊断标准
1.2.1西医诊断标准
西医对卵巢功能下降尚无明确的诊断标准,本研究的诊断标准参照《妇产科学(第7版)》《实用妇科内分泌学(第2版)》和《妇产科疾病诊断与鉴别诊断(第2版)》拟定。
①月经紊乱:具有正常月经史及生育史的患者,在40岁之前出现月经量较以往明显减少,或月经周期延长7天以上,甚至数月来潮一次;
②实验室检查:10IU/L<FSH<40IU/L,或同时伴有FSH/LH比值>3.0。
1.2.2中医诊断标准
中医学对卵巢功能下降无明确病名记载,但是相似症状的描述可见于“月经量少”、“月经后期”、“血枯”、“闭经”、“不孕”、“经断前后诸证”等病证中。
1.2.2.1中医辨病诊断标准
参照中华人民共和国卫生部2002年制定《中药新药临床研究指导原则》和普通高等教材中医药规划教材《中医妇科学》月经不调的标准拟定:
①月经后期:连续两个或两个以上月经周期延后7天以上,月经量基本正常。
②月经过少:月经量较以往明显减少,经期不足两天,甚或点滴即净,月经周期基本正常。
1.2.2.2中医证候诊断标准
参照中华人民共和国卫生部2002年制定《中药新药临床研究指导原则》和普通高等教材中医药规划教材《中医妇科学》月经不调肾虚证的标准拟定:
主症:①月经后期,②月经过少,③经色淡,质清稀。
次症:④腰骶酸痛,⑤头晕耳鸣,⑥潮热,⑦失眠多梦,⑧性欲减退,⑨神疲乏力。
舌脉:舌黯淡,苔薄白,脉沉弱或沉迟。
具备主症①或②同时具备③,次症二项或二项以上,同时结合舌脉即可辨证为肾虚证。
1.3病例纳入标准
①年满21-40岁之间。
②符合本病西医及中医诊断标准者。
③三个月内未使用激素或其它药物治疗本病者。
④自愿参加本研究,能坚持完成临床观察者。
1.4病例排除标准
①年龄在21周岁以下或40周岁以上者。
②不符合中、西医诊断标准者。
③合并有乳腺或其他生殖器官器质性病变者。
④患有高泌乳素血症、甲状腺疾病、柯兴综合征、糖尿病等内分泌疾病。
⑤合并有心脑血管、消化或血液系统等严重原发性疾病、精神病等患者。
⑥3个月内使用性激素或其他药物治疗本病者。
⑦不能按规定用药等影响疗效判断者。
⑧其他原因引起的月经不调者。
⑨不配合本研究调查者。
2.方法
2.1治疗方法
对照组:口服补佳乐,每日1次,每次1.0mg,连服3个月。观察组口服本发明中药,每日一剂,分早晚两次服用,连服3个月。两组停药后继续观察3个月。
2.2.观察指标
2.2.1疗效性指标
①调经疗效:根据调经疗效判定标准,计算有效率。
②总体疗效:根据中医证候疗效判定标准,计算疗效指数,计算总体有效率。
③肾虚证候积分:根据中医症状分级量化表分别对治疗前后进行评分,计算症状总积分及单项症状积分,作为评价改善肾虚症状的观察指标。
④实验室指标:在月经周期第2-4天(闭经患者任意时间)抽血检测性激素,比较治疗前后血清FSH、FSH/LH水平。
⑤辅助检查:在月经周期第2-4天(闭经患者任意时间)行经阴道下B超监测基础窦卵泡数目,比较前后基础窦卵泡数目。
2.2.2疗效判定标准
2.2.3调经疗效判定标准
参照中华人民共和国卫生部2002年制定《中药新药临床研究指导原则》制定。
①痊愈:经治疗后月经周期、月经量、月经色质基本恢复至正常水平。
②显效:经治疗后月经周期较以前有所缩短或经量较前增加或经色质改善,一项以上积分值降低两个等级。
③有效:经治疗后月经周期较以前有所缩短或经量较前增加或经色质改善,一项以上积分值降低一个等级。
④无效:经治疗后月经周期、月经量、月经色质未见明显改善,积分值未见降低。
2.2.4中医证候疗效判定标准
参考《中药新药临床研究指导原则》的相关标准拟定。用尼莫地平法计算疗效指数:疗效指数(n)=(治疗前积分-治疗后积分)/治疗前积分×100%。
①治愈:临床症状基本消失,月经量、色质、周期恢复正常,维持3个月经周期以上。n≥95%。
②显效:临床症状得到明显改善,月经周期延迟<14天,经量较以往明显增加,色质明显改善,并持续3个月经周期以上。70%≤n<95%。
③有效:月经量有所增多,月经周期延迟<14天,临床症状均有好转,但未能持续3个月经周期。30%≤n<70%。
④无效:月经量、色质、周期未见明显改变,临床症状均无明显改善,甚或加重。n<30%。
2.2.5中医证候总积分及单项症状积分
参照新世纪教材《中医妇科学》和中华人民共和国卫生部2002年颁布的《中药新药临床研究指导原则》中月经不调中肾虚证的分级量化指标指导拟定。
表1肾虚证症状分级量化表
注:1.中医症状分级标准将临床症状分为:主症轻、中、重分别计2、4、6分;次症轻、中、重分别计1、2、3分;无症状计0分。各症状积分在治疗前和治疗后各记录1次。舌脉:具体描述,不计分。
2.3统计学方法
所有数据用SPSS17.0软件包进行统计学分析。
3结果
本研究选取了88例患者进行观察治疗,其中有8例患者在治疗过程中妊娠,故本研究仅对80例患者的结果进行分析。
3.1.1中医证候积分
表2结果显示:经本发明的中药治疗后各临床症状及总积分较治疗前明显下降,有显著性差异(P<0.05)。
表2中医证候积分(x±s)
治疗前 | 治疗后 | P值 | |
月经后期 | 4.00±1.695 | 1.60±1.495 | <0.05 |
月经量少 | 2.80±1.919 | 0.90±1.377 | <0.05 |
经色质 | 3.70±1.488 | 0.80±1.091 | <0.05 |
腰骶酸痛 | 1.87±1.097 | 0.85±0.636 | <0.05 |
头晕耳鸣 | 1.56±1.045 | 0.60±0.652 | <0.05 |
潮热 | 1.75±0.702 | 0.78±0.724 | <0.05 |
失眠多梦 | 1.63±0.925 | 0.70±0.748 | <0.05 |
神疲乏力 | 1.65±0.971 | 0.65±0.727 | <0.05 |
性欲减退 | 1.65±0.924 | 0.70±0.670 | <0.05 |
总积分 | 21.93±3.311 | 7.23±4.738 | <0.05 |
3.1.2两组治疗前后中医证候疗效比较
表3结果显示:对80例患者进行3个月经周期治疗后,结果显示:痊愈9例,显效22例,有效42例,无效7例,总体有效率为91.25%。
表3两组患者临床疗效比较[n(%)]
3.1.3调经疗效
表4结果显示:经发明的中药治疗后,12例患者月经基本恢复正常水平,6例患者月经情况无明显变化,调经总有效率达92.5%。
表4调经疗效
痊愈 | 显效 | 有效 | 无效 | |
治疗后 | 12 | 22 | 40 | 6 |
百分比% | 15 | 27.5 | 50 | 7.5 |
3.1.4激素水平
表5结果显示:经发明的中药治疗后,治疗后的FSH、LH水平及FSH/LH比值比治疗前明显下降,差异有统计学意义(P<0.05)。
表5激素水平
治疗前 | 治疗后 | P值 | |
FSH | 19.827±3.4183 | 8.504±2.154 | <0.05 |
LH | 7.046±1.287 | 5.721±1.424 | <0.05 |
FSH/LH | 2.526±0.573 | 1.455±0.421 | <0.05 |
3.1.5基础窦卵泡数目
表6结果显示:经发明的中药治疗后,治疗后的基础窦卵泡数目比治疗前有所上升,差异有统计学意义(P<0.05)。
表6基础窦卵泡数目
由此可以看出,本发明中药治疗卵巢功能下降疗效确切(总有效率91.25%),无副作用。
二、典型病例
1、王某,女,32岁。已婚,2013年5月28日初诊。
主诉:未避孕未孕2年半。
现病史:患者结婚3年,同居,性生活次数较少,工具避孕半年,后未避孕未孕至今。平素月经不规律,14岁初潮,7/35-45日,量少,色淡红,质清稀,伴腰骶酸痛、神疲乏力。面色少华,失眠多梦,大便稀溏,小便清长。舌黯淡,苔薄白,脉沉弱或沉迟。LMP:2013年5月22日(MC:7天)。
婚产史:G0。
既往史:2008年5月24日于当地医院行全麻腹腔镜崎胎瘤切除术。
妇科检查:无明显异常。
辅助检查:于2013年5月24日行经阴道B超,左侧卵巢可见1-2枚小卵泡,右侧卵巢可见3-4枚小卵泡。
实验室检查:患者于2013年5月24日在当地医院抽血查基础内分泌示:雌二醇(E2):72pg/mL,卵泡刺激素(FSH):18.62mIU/mL,泌乳素(PRL):21.58ng/mL,睾酮(T):0.16ng/mL,黄体生成素(LH):3.42mIU/mL,孕酮(P):0.11ng/mL,雄烯二酮(AND):4.27nmol/L,促甲状腺素(TSH):1.9132μIU/mL;
中医诊断:肾虚不孕症
西医诊断:卵巢储备功能下降
辨证分型:肾虚证
肾精不足,血海亏虚,冲任失于濡养,血海不能按时满溢,则会出现月经后期、经量减少;肾精不足,生血无源,导致血海亏空,则出现经色淡,质稀;肾精亏虚,则性欲低下;肾精不足,则血海空虚,气血不足,心失所养而出现心悸失眠;肾阳不足,无以温煦,故大便清稀,小便清长。舌黯淡,苔薄白,脉沉弱或沉迟,均为肾虚之象。治宜补肾填精,疏肝健脾。采用本发明实施例1的原料药为首方。共14剂,水煎服,日一剂。
二诊:2013年6月18日,LMP:2013年6月16日(MC:3天),上方药已服,今日复诊,月经量依然较少,色淡红,质清稀,腰骶酸痛、神疲乏力症状稍有好转。面色少华,失眠多梦,大便稀溏,小便清长。舌黯淡,苔薄白,脉沉弱或沉迟。患者现处于行经期,治宜活血化瘀调经,故加益母草15g、玫瑰花15g以活血调经,又患者夜失眠多梦,夜交藤12g以养心安神。共10剂,水煎服,日一剂,嘱咐患者于月经第五天时服用。
三诊:2013年6月28日,LMP:2013年6月16日(MC:15天),上方药已服,今日复诊,自述服药后腰骶酸痛、神疲乏力症状好转。失眠多梦症状好转,大便稀溏,小便清长。舌黯淡,苔薄白,脉沉弱或沉迟。现患者处于经间期,此期为重阴转化期,阴精充盛,由阴转阳,故在原方基础上加菟丝子15g,仙灵脾9g,桂枝9g,从阴引阳,促进阴阳转化。共7剂,水煎服,日一剂。
其后患者多次来诊,嘱其行经期服用二诊方,经间期服用三诊方,连服半年后,平素月经较以前规律,量色质明显好转大小便及失眠情况好转。
十六诊:2014年12月29日,LMP:2013年11月28日(停经31天),患者自述今日自测尿HCG(+),今日抽血查内分泌激素示:E2:413.0pg/ml,P:32.5ng/ml,β-HCG:1246.5U/L。患者自述见少量阴道流血3天,偶有腹部微胀、恶心,伴腰酸。余无明显不适。舌质淡,苔薄白,脉滑。中医诊断:胎动不安(肾虚)。遂行保胎治疗。监测β-HCG、E2、P水平,定期随诊,于2015年09月22日足月剖宫产一女婴,现体健。
按:本例患者性欲低下,月经量少,色淡红,质清稀,伴腰骶酸痛、神疲乏力。大便稀溏,小便清长。舌黯淡,苔薄白,脉沉弱或沉迟。此乃肾虚不孕证,故用温补肾阳之法,二诊之时正处于行经期,且肝郁化热之证显露,故加化瘀止血及疏肝解郁安神之剂,以通中兼收,顺势治疗;经间期,其治则重在从阴引阳,促进阴阳转化为主;后期乃遵前法之治,调理半年余,患者得以妊娠。
病例2:郑某,女,34岁,2014年5月12日初诊。
主诉:婚后未避孕未再孕3年,月经周期延长2年。
现病史:夫妇2008年结婚,婚后同居,性生活正常,于2009年5月顺产一女孩,现体健,产后工具避孕至2011年4月,后未避孕未再孕至今。患者平素月经规律14岁初潮,4-5/30-32日,量中,色淡红,质中。近两年月经周期延长,3-4/45-60日,量少,色淡红,质稀。自述经前乳房胀痛,烦躁易怒,夜间盗汗,失眠多梦,大小便正常。舌黯淡,苔薄白,脉沉细。LMP:2014年5月10日(MC:3天)。
婚产史:G1P1L1A0。
既往史:自述于2010年6月在当地医院行阑尾切除术。
妇科检查:无明显异常。
辅助检查:于今日行经阴道B超:子宫前位,大小:4.32×5.12×6.12厘米,内膜0.45厘米,左侧卵巢:2.27×3.21厘米,其内可探及3-4枚小卵泡,右侧卵巢:2.89×3.45厘米,其内可探及2-3枚小卵泡。
实验室检查:患者于2014年5月10日抽血查基础内分泌示:雌二醇(E2):80pg/mL,卵泡刺激素(FSH):12.8mIU/mL,黄体生成(LH):3.45mIU/mL,孕酮(P):0.11ng/mL,泌乳素(PRL):20.28ng/mL,睾酮(T):0.16ng/mL。
中医诊断:不孕症;月经后期
西医诊断:卵巢功能下降,继发性不孕症
辨证分型:肾阴虚型
肾主生殖,肾阴亏虚,或房劳多产损伤肾精,引起肾气肾精亏虚,冲任不充,血海空虚不能按时满溢,导致月经后期而至;若先天禀赋素弱或少年肾气未充,或多产(含多次人工流产、屡孕屡堕)房劳伤肾,以致肾气不足,精血不充,冲任血海空虚,经血化源不足以致经量减少;肾主藏精,精能生血,血能化精,是月经的重要物质来源,是孕、育的必要条件。肾精肾气亏虚,天癸缺少物质来源而不能成熟,导致卵巢功能下降。女性本多思多虑,或由工作家庭压力增大或因经久不孕继而肝气郁结,气行则血行,气滞则血瘀,气血不调,以致冲任失养,胞脉不通,胞宫不得摄精而受孕。治宜疏肝理气、活血化瘀为治则。采用本发明实施例1的中药治疗,共14剂,水煎服,日一剂。
二诊:2014年5月28日,患者自述服药后烦躁易怒,夜间盗汗,失眠多梦的症状有所好转,现诉近几日咳嗽、乏力,无痰,纳眠可。舌黯淡,苔薄白,脉浮。上方加桑叶12g,菊花15g,桔梗12g。共14剂,水煎服,日一剂。
三诊:2014年6月11日,患者诉咳嗽、乏力症状好转。今日行经阴道B超:子宫前位,大小:4.45×5.12×6.05厘米,左侧卵巢:2.35×3.45厘米,其内可探及3-4枚小卵泡,另探及1.5×1.8厘米无回声区,右侧卵巢:2.76×3.25厘米,其内可探及2-3枚小卵泡。已出现优势卵泡,治以温补肾气,促进阴阳转化,故于首诊方中加仙灵脾9g,桂枝9g。共14剂,水煎服,日一剂。
四诊:2014年6月25日,LMP:2014年6月23日,量较前稍多,色红,质稀。
今日抽血查基础内分泌示:雌二醇(E2):78pg/mL,卵泡刺激素(FSH):10.23mIU/mL,黄体生成(LH):4.25mIU/mL,孕酮(P):0.15ng/mL。今日行经阴道B超:子宫前位,大小:4.40×5.12×6.03厘米,左侧卵巢:2.35×3.45厘米,其内可探及5-6枚小卵泡,右侧卵巢:2.76×3.25厘米,其内可探及4-5枚小卵泡。患者月经较前好转,嘱咐患者继续服用首诊方中药。共14剂,水煎服,日一剂。
此后3个月,继续服用上方中药的加减。2014年09月21日复诊:诉末次月经2014年9月18日,自述经前乳房胀痛,烦躁易怒,夜间盗汗,失眠多梦症状明显好转,月经周期延长状况明显改善,4-5/32-40日,余无明显不适。嘱咐患者定期随诊。
按:若先天肾气不足,或房劳多产损伤肾精,肾虚引起肾气肾精亏虚,冲任不充,血海空虚不能按时满溢,导致月经后期而至;量少,色淡红,质稀为肾精亏虚的表现,经前期乳房胀痛、烦躁易怒为肝气瘀滞所导致,所以本患者应滋养肾阴、疏肝调经,则月经周期后延状况得以好转。
3、张某,女,28岁。已婚,2015年4月16日初诊。
主诉:未避孕未孕3年。
现病史:患者结婚3年,同居,性生活正常,未避孕未孕至今。平素月经稀发,14岁初潮,自述近几月服用补佳乐后,月经为3-4/46-59日,量少,色淡红,质清稀,伴腰骶酸软、神疲乏力。纳眠可,大小便正常。舌黯淡,苔薄白,脉沉弱或沉迟。LMP:2015年4月06日(MC:11天)。
婚产史:G0。
既往史:无明显异常。
妇科检查:无明显异常。
辅助检查:今日行B超示:子宫前位,大小:4.02×5.31×4.56厘米,左侧卵巢:2.21×3.12厘米,回声实,右侧卵巢:2.76×3.25厘米,其内可探及2-3枚小卵泡。
实验室检查:患者于2013年5月24日在当地医院抽血查基础内分泌示:雌二醇(E2):82pg/mL,卵泡刺激素(FSH):16.22mIU/mL,泌乳素(PRL):21.58ng/mL,睾酮(T):0.12ng/mL,黄体生成素(LH):4.22mIU/mL,孕酮(P):0.13ng/mL,雄烯二酮(AND):4.27nmol/L,促甲状腺素(TSH):1.91μIU/mL;
中医诊断:肾虚不孕症;
西医诊断:卵巢储备功能下降;
辨证分型:肾虚证;
肾精不足,血海亏虚,冲任失于濡养,血海不能按时满溢,则会出现月经后期、经量减少;肾精不足,生血无源,导致血海亏空,则出现经色淡,质稀。肾主生殖,研究发现补肾中药可促进卵泡的发育。舌黯淡,苔薄白,脉沉弱或沉迟,均为肾虚之象。治宜补肾填精,疏肝健脾。采用本发明的原料药,共14剂,水煎服,日一剂。
二诊:2015年4月30日,方药已服,今日复诊,自述近几日食欲低下,腹部不适。故在首方基础上加党参15g、茯苓12g、白术15g以健脾和胃调经。共10剂,水煎服,日一剂。
三诊:2015年5月10日,LMP:2015年5月7日(MC:4天),月经量中,色红,质中,无血块,痛经(-)。上方药已服,今日复诊,自述服药后食欲低下,腹部不适症状好转。食欲低下,腹部不适。今日行B超示:子宫前位,大小:4.21×5.21×4.67厘米,左侧卵巢:2.24×3.23厘米,其内可探及2-3枚小卵泡,右侧卵巢:2.82×3.31厘米,其内可探及4-5枚小卵泡。因患者基础窦卵泡发育有所改善,故嘱咐患者继续服用首方。共14剂,水煎服,日一剂,嘱咐患者于月经第5天开始服用。
其后患者多次来诊,连服半年后,平素月经规律,量色质明显好转,B超检测下窦卵泡发育改善明显。
按:本例患者卵巢储备功能下降,排卵及月经不规律,月经量少,色淡红,质清稀,伴腰骶酸软、神疲乏力为肾气虚的表现,故用填精益髓、温补肾气之法,因患者脾气虚弱,故期间加用健脾之药,可健脾益肾,增加精微物质的化源,有助于卵泡的发育,故经调理半年余,患者卵泡发育情况得以改善。
实施例2
配方(单位:g):菟丝子20,炙淫羊藿15,桑椹子20,金樱子18,枸杞子20,女贞子18,沙苑子18,莲子15,鹿角霜18,山药25,制香附18,郁金18,丹参28,月季花18,炒白芍18,百合18,炙甘草8。
配制及服用方法:水煎煮,每日1剂,分两次早晚服用。
实施例3
配方(单位:g):菟丝子15,炙淫羊藿10,桑椹子15,金樱子12,枸杞子15,女贞子12,沙苑子12,莲子10,鹿角霜12,山药22,制香附12,郁金12,丹参22,月季花12,炒白芍12,百合12,炙甘草5。
配制及服用方法:水煎煮,每日1剂,分两次早晚服用。
实施例4
配方(重量份):菟丝子18,炙淫羊藿12,桑椹子18,金樱子15,枸杞子17,女贞子15,沙苑子15,莲子12,鹿角霜15,山药23,制香附15,郁金15,丹参24,月季花15,炒白芍15,百合15,炙甘草6。
制备方法:
(1)将菟丝子、桑椹子和枸杞子加入70%乙醇加热回流提取2次,每次40分钟;合并提取液,备用;
(2)将女贞子、金樱子、丹参和炙淫羊藿加入90%乙醇加热回流提取2次,每次40分钟,合并提取液,然后再合并步骤(1)的提取液,经200目筛网过滤后,加热除去乙醇,得到提取液;
(3)然后将剩余的10味中药(沙苑子、莲子、鹿角霜、山药、制香附、郁金、月季花、炒白芍、百合和炙甘草)和步骤(1)的药渣合并,加水煎煮2次,每次煎煮30分钟;合并煎煮液,经200目筛网过滤后,得到煎煮液;
(4)合并步骤(1)的提取液和步骤(2)的煎煮液,经加热浓缩至相对密度为1.25(60℃)的稠膏,然后加入2倍质量的蔗糖粉混合均匀,然后加入少量70%乙醇制成软材,过14目尼龙筛制粒;湿颗粒干燥后,再过筛,保留14-50目的颗粒,然后分装成10g每袋。
服用方法:温水冲服,每日3次,一次1袋,饭后30~60分钟服用。1个月为1个疗程。
Claims (10)
1.一种治疗卵巢功能下降的中药,其特征是,主要由下述重量份的原料药制成:菟丝子15~20份,女贞子10~20份,炙淫羊藿10~15份,桑椹子15~20份,金樱子10~20份,枸杞子15~20份,沙苑子10~20份,莲子10~15份,鹿角霜10~20份,山药20~30份,制香附10~20份,郁金10~20份,丹参20~30份,月季花10~20份,炒白芍10~20份,百合10~20份,炙甘草5~10份。
2.如权利要求1所述的治疗卵巢功能下降的中药,其特征是,主要由下述重量份的原料药制成:菟丝子18份,女贞子15份,炙淫羊藿12份,桑椹子18份,金樱子15份,枸杞子18份,沙苑子15份,莲子12份,鹿角霜15份,山药24份,制香附15份,郁金15份,丹参24份,月季花15份,炒白芍15份,百合15份,炙甘草6份。
3.如权利要求2所述的治疗卵巢功能下降的中药,其特征是,由下述重量份的原料药制成:菟丝子18份,女贞子15份,炙淫羊藿12份,桑椹子18份,金樱子15份,枸杞子18份,沙苑子15份,莲子12份,鹿角霜15份,山药24份,制香附15份,郁金15份,丹参24份,月季花15份,炒白芍15份,百合15份,炙甘草6份,益母草15份,玫瑰花15份。
4.如权利要求2所述的治疗卵巢功能下降的中药,其特征是,由下述重量份的原料药制成:菟丝子18份,女贞子15份,炙淫羊藿12份,桑椹子18份,金樱子15份,枸杞子18份,沙苑子15份,莲子12份,鹿角霜15份,山药24份,制香附15份,郁金15份,丹参24份,月季花15份,炒白芍15份,百合15份,炙甘草6份,益母草15份,玫瑰花15份,夜交藤12份。
5.如权利要求2所述的治疗卵巢功能下降的中药,其特征是,由下述重量份的原料药制成:菟丝子18份,女贞子15份,炙淫羊藿12份,桑椹子18份,金樱子15份,枸杞子18份,沙苑子15份,莲子12份,鹿角霜15份,山药24份,制香附15份,郁金15份,丹参24份,月季花15份,炒白芍15份,百合15份,炙甘草6份,仙灵脾9份,桂枝9份。
6.如权利要求2所述的治疗卵巢功能下降的中药,其特征是,由下述重量份的原料药制成:菟丝子18份,女贞子15份,炙淫羊藿12份,桑椹子18份,金樱子15份,枸杞子18份,沙苑子15份,莲子12份,鹿角霜15份,山药24份,制香附15份,郁金15份,丹参24份,月季花15份,炒白芍15份,百合15份,炙甘草6份,桑叶12份,菊花15份,桔梗12份。
7.如权利要求2所述的治疗卵巢功能下降的中药,其特征是,由下述重量份的原料药制成:菟丝子18份,女贞子15份,炙淫羊藿12份,桑椹子18份,金樱子15份,枸杞子18份,沙苑子15份,莲子12份,鹿角霜15份,山药24份,制香附15份,郁金15份,丹参24份,月季花15份,炒白芍15份,百合15份,炙甘草6份,党参15份,茯苓12份,白术15份。
8.如权利要求1-7中任意一项所述的治疗卵巢功能下降的中药,其特征是,它为颗粒剂、丸剂、胶囊剂、片剂、口服液。
9.如权利要求8所述的治疗卵巢功能下降的中药,其特征是,它为颗粒剂。
10.权利要求9所述的治疗卵巢功能下降的中药的制备方法,其特征是,
(1)将菟丝子、桑椹子和枸杞子加入70%乙醇加热回流提取2次,每次0.5~1小时;合并提取液,备用;
(2)将女贞子、金樱子、丹参和炙淫羊藿加入90%乙醇加热回流提取2次,每次0.5~1小时,合并提取液,然后再合并步骤(1)的提取液,经200目筛网过滤后,加热除去乙醇,得到提取液;
(3)然后将剩余的中药和步骤(1)、(2)的药渣合并,加水煎煮2次,每次煎煮0.5~1.5小时;合并煎煮液,经200目筛网过滤后,得到煎煮液;
(4)合并步骤(2)的提取液和步骤(3)的煎煮液,经加热浓缩至60℃时相对密度为1.20~1.30的稠膏,然后加入1~3倍质量的蔗糖粉混合均匀,最后经制粒、干燥、筛分后,分装成袋。
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