CN114366777A - 一种治疗肾虚型卵巢储备功能下降疾病的中药组合物及其应用 - Google Patents
一种治疗肾虚型卵巢储备功能下降疾病的中药组合物及其应用 Download PDFInfo
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Abstract
本发明涉及一种治疗肾虚型卵巢储备功能下降疾病的中药组合物,所述中药组合物由以下重量份的原料药制成:茯苓10‑14份、生地8‑12份、熟地8‑12份、女贞子8‑12份、仙茅8‑12份、仙灵脾8‑12份、巴戟天8‑12份、肉苁蓉8‑12份、鹿角霜8‑12份、紫石英28‑32份。本发明还提供了中药组合物的用途。本发明可有效改善DOR患者的内分泌激素水平,改善月经情况,缓解临床症状,具有良好的临床疗效,是治疗DOR的有效验方,为中医药治疗DOR提供了思路与循证医学证据,也值得后续更进一步明确本发明改善卵巢储备功能的作用机制。
Description
技术领域
本发明涉及中药技术领域,具体地说,是关于一种治疗肾虚型卵巢储备功能下降疾病的中药组合物及其应用。
背景技术
卵巢储备功能下降(DOR)的病因及发病机制复杂。随着女性社会压力增大、环境污染加剧、不良生活习惯等原因,DOR的发病率逐年升高且呈现低龄化趋势。目前西医在治疗上以激素替代为主。国内外学者均认为卵巢功能下降患者应用HRT可使HPOA得到暂时的休息,暂时控制病情。有研究显示,治疗3个月FSH可明显降低。然而芬吗通虽能降低FSH水平,但停药后可能出现FSH的反弹升高,其恢复卵巢功能的疗效不确切。此外,雌激素依赖性肿瘤、严重肝肾疾病、结缔组织病等是激素替代治疗的禁忌症,这使得HRT的应用局限。许多患者甚至医生对HRT的潜在风险和不良反应皆有顾虑,长期HRT对子宫内膜癌和乳腺癌的发生风险仍不确定。
中医根据DOR的临床表现将其归入“月经病”、“闭经”、“不孕病”的范畴。妇人经水以肾气为主导。肾为先天之本,是人体生长、发育和生殖的根本,肾虚是导致卵巢储备功能下降的主要因素。
中国专利文献CN104547418A公开了一种用于治疗卵巢功能减退的中药组合物,由以下重量配比的原料药组成:覆盆子100-300份,白术200-500份,菟丝子150-450份,女贞子200-500份,补骨脂150-450份,杜仲100-300份,山药100-300份。
中国专利文献CN104887832A公开了一种治疗肾虚血瘀型卵巢储备功能下降引起的中药。该中药由以下重量份的中药原料药制成:杜仲8-16份、续断8-16份、淫羊藿8-16份、紫河车2-4份、阿胶8-16份、枸杞子8-16份、女贞子8-16份、红花8-16份、桃仁8-16份、牛膝8-16份、鸡血藤8-16份、月季花4-8份、甘草4-8份。
而目前关于疗效显著,副作用小的,起效快的一种治疗肾虚型卵巢储备功能下降疾病中药组合物还未见报道。
发明内容
本发明的第一个目的是,针对现有技术中的不足,提供一种治疗肾虚型卵巢储备功能下降疾病的中药组合物。
本发明的第二个目的是,中药组合物的用途。
为实现上述第一个目的,本发明采取的技术方案是:一种治疗肾虚型卵巢储备功能下降疾病的中药组合物,所述中药组合物由以下重量份的原料药制成:茯苓10-14份、生地8-12份、熟地8-12份、女贞子8-12份、仙茅8-12份、仙灵脾8-12份、巴戟天8-12份、肉苁蓉8-12份、鹿角霜8-12份、紫石英28-32份。
作为一个优选例,所述中药组合物由以下重量份的原料药制成:茯苓11-13份、生地9-11份、熟地9-11份、女贞子9-11份、仙茅9-11份、仙灵脾9-11份、巴戟天9-11份、肉苁蓉9-11份、鹿角霜9-11份、紫石英29-31份。
作为一个优选例,所述中药组合物由以下重量份的原料药制成:茯苓12份、生地10份、熟地10份、女贞子10份、仙茅10份、仙灵脾10份、巴戟天10份、肉苁蓉10份、鹿角霜10份、紫石英30份。
为实现上述第二个目的,本发明采取的技术方案是:中药组合物在制备治疗肾虚型卵巢储备功能下降疾病药物中的应用。
本研究中使用本发明后发现,治疗后两组患者血清bFSH、bE2水平较治疗前均降低,AMH水平均升高,差异有统计学意义(P<0.05)。且治疗组患者血清bFSH水平与对照组比较显著降低,差异有统计学意义(P<0.05)。说明本发明与芬吗通均可有效提高患者性激素水平,且本发明在改善bFSH水平方面明显优于治疗组。治疗后,两组患者窦卵泡数较治疗前均升高,差异有统计学意义(P<0.05)。治疗组患者窦卵泡数与对照组比较有升高趋势,但差异无统计学意义(P>0.05)。说明本发明与芬吗通一样具有提高窦卵泡数的作用。治疗前,两组患者中医证候积分比较,差异无统计学意义(P>0.05)。治疗后,两组患者月经周期、经量、腰膝酸软、头晕耳鸣、潮热汗出的积分均有明显改善(P<0.05);且治疗组较对照组相比,差异有统计学意义(P<0.05)。说明本发明可有效改善患者的中医证候。
本发明优点在于:本发明可有效改善DOR患者的内分泌激素水平,改善月经情况,缓解临床症状,具有良好的临床疗效,是治疗DOR的有效验方,为中医药治疗DOR提供了思路与循证医学证据,也值得后续更进一步明确本发明改善卵巢储备功能的作用机制。
该方由云茯苓、生熟地、女贞子、仙茅、仙灵脾、巴戟天、肉苁蓉、鹿角霜、紫石英组成。方中茯苓健脾益气、入肾化气,推动卵巢发挥功能;生熟地、女贞子滋阴养血、丰盈血海,提供物质基础;仙茅、仙灵脾、巴戟天温肾助阳;紫石英温煦胞宫,配伍血肉有情之品,鹿角霜温肾填精。方中滋阴助阳兼顾,使“阴得阳生而泉源不竭,阳得阴助而生化无穷”。全方配合,共奏育肾培元、填精助阳、蓄精养血之效。
具体实施方式
下面结合具体实施方式,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1本发明中药组合物(一)
按重量份配比称取各原料药:茯苓12份、生地10份、熟地10份、女贞子10份、仙茅10份、仙灵脾10份、巴戟天10份、肉苁蓉10份、鹿角霜10份、紫石英30份。
实施例2本发明中药组合物(二)
按重量份配比称取各原料药:茯苓12份、生地8份、熟地12份、女贞子10份、仙茅8份、仙灵脾12份、巴戟天9份、肉苁蓉11份、鹿角霜12份、紫石英29份。
实施例3本发明中药组合物(三)
按重量份配比称取各原料药:茯苓10份、生地12份、熟地9份、女贞子8份、仙茅12份、仙灵脾9份、巴戟天11份、肉苁蓉10份、鹿角霜9份、紫石英31份。
实施例4本发明中药组合物(四)
按重量份配比称取各原料药:茯苓14份、生地9份、熟地11份、女贞子12份、仙茅9份、仙灵脾11份、巴戟天10份、肉苁蓉8份、鹿角霜11份、紫石英30份。
实施例5本发明中药组合物(五)
按重量份配比称取各原料药:茯苓11份、生地11份、熟地10份、女贞子9份、仙茅11份、仙灵脾10份、巴戟天8份、肉苁蓉12份、鹿角霜10份、紫石英8份。
实施例6本发明中药组合物(六)
按重量份配比称取各原料药:茯苓13份、生地10份、熟地8份、女贞子11份、仙茅10份、仙灵脾8份、巴戟天12份、肉苁蓉9份、鹿角霜8份、紫石英12份。
实施例7本发明中药组合物(七)
按重量份配比称取各原料药:茯苓10份、生地12份、熟地12份、女贞子8份、仙茅8份、仙灵脾12份、巴戟天9份、肉苁蓉11份、鹿角霜12份、紫石英29份。
实施例8本发明中药组合物(八)
按重量份配比称取各原料药:茯苓14份、生地9份、熟地9份、女贞子12份、仙茅12份、仙灵脾9份、巴戟天11份、肉苁蓉10份、鹿角霜9份、紫石英31份。
实施例9本发明中药组合物(九)
按重量份配比称取各原料药:茯苓11份、生地11份、熟地11份、女贞子9份、仙茅9份、仙灵脾11份、巴戟天10份、肉苁蓉8份、鹿角霜11份、紫石英30份。
实施例10本发明中药组合物(十)
按重量份配比称取各原料药:茯苓13份、生地10份、熟地10份、女贞子11份、仙茅11份、仙灵脾10份、巴戟天8份、肉苁蓉12份、鹿角霜10份、紫石英8份。
实施例11本发明中药组合物(十一)
按重量份配比称取各原料药:茯苓10份、生地8份、熟地8份、女贞子10份、仙茅10份、仙灵脾8份、巴戟天12份、肉苁蓉9份、鹿角霜8份、紫石英12份。
实施例12临床疗效实验
1.资料与方法
1.1病例选择
1.1.1诊断标准
西医诊断标准参考卵巢低反应博洛尼亚诊断标准及《妇产科学》拟定,符合以下三项中的任意一项:①抗缪勒氏管激素(Anti-Mullerian Hormone,AMH)<1ng/ml;②窦卵泡(AFC)<3~6个;③至少两次在月经周期第2~4天检测基础卵泡刺激素(follicle-stimulating hormone,FSH)为10~25IU/L,两次检测至少间隔4周以上。
中医肾虚证诊断标准参照新世纪教材《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》中月经病肾虚证。主症:月经先后不定期,量少,腰膝酸软。兼症:头晕耳鸣,潮热汗出,性欲减退。舌红或淡,苔薄,脉沉细无力。主症必备,兼症具备1项以上,结合舌脉即可辨证为肾虚证。
1.1.2纳入标准①符合上述西医诊断及中医证候诊断标准;②年龄在20~45岁之间;③知情同意、自愿参加本研究,签署知情同意书。
1.1.3排除标准①先天性生殖器官发育异常,子宫、单/双侧卵巢、输卵管切除,化疗等医源性因素导致卵巢功能下降;②多囊卵巢综合征、高泌乳素血症、高雄激素血症、慢性肾上腺皮质功能减退等内分泌疾病影响排卵者;③合并严重心脑血管、肝、肾、恶性肿瘤、造血系统及精神疾病者;④怀疑或确认妊娠者;⑤三个月内使用过任何激素类药物以及其他免疫抑制剂者。
1.1.4剔除及脱落标准①不符合纳入标准而误纳入者;②受试者依从性差,未按规定服药或未能定时随访;③受试者因个人原因自行退出、失访;④临床资料不全,无法判断疗效。
1.2一般资料纳入2017年9月至2019年9月期间就诊于本院蔡氏妇科专病门诊并符合诊断标准的患者84例,采用随机数字表法将纳入对象随机分为治疗组和对照组,每组各42例。治疗组平均年龄(36.23±4.19)岁,对照组平均年龄(36.45±4.77)岁。两组患者治疗前平均年龄、自然周期月经第3天基础内分泌水平(bFSH、bE2、AMH)、基础窦卵泡数等一般资料比较(表1),差异无统计学意义(P>0.05),具有可比性。
1.3治疗方法
1.3.1治疗组月经第5天至下次月经前服本发明(组成:茯苓12g、生地10g、熟地10g、女贞子10g、仙茅10g、仙灵脾10g、巴戟天10g、肉苁蓉10g、鹿角霜10g、紫石英30g),由四川新绿色药业科技发展有限公司提供的中药配方颗粒剂,每日一剂,温水200ml冲服,早晚分服。
1.3.2对照组于月经或撤退性出血第5天起服用芬吗通(雌二醇片含雌二醇1mg,雌二醇地屈孕酮片含雌二醇1mg和地屈孕酮10mg,Abbott Healthcare Products B.V,28片/盒),每天一片,按药物说明顺序连续服用28天。停药后注意观察月经,在次月月经第5天继续服用下一盒,如停药后月经未来潮,则于月经第7天继续服用下一盒。
1.3.3疗程两组均以3个月经周期为一疗程,治疗1个疗程后统计临床疗效。
1.4观察指标
1.4.1主要观察指标
血清性激素水平治疗前后月经第3天抽取患者肘静脉血。血清FSH、E2采用化学发光法测定。
AMH采用酶联免疫吸附法测定,试剂盒统一由苏州卡尔文生物科技有限公司生产。
1.4.2次要观察指标
AFC治疗前后月经第3天经阴道彩色多普勒检查双侧卵巢基础窦卵泡计数。采用GEVoluson E8彩色多普勒超声诊断仪,经阴道三维容积探头,频率5~9Mhz。
肾虚证候积分评分标准参照《中药新药临床研究指导原则》及《中医妇科学》。根据中医症状分级量化表分别对治疗前、后进行评分,计算单项症状积分,作为评改善肾虚症状的观察指标。
1.5统计学方法
采用SPSS 21.0软件进行数据分析,计量资料采用均数±标准差表示,组间比较采用独立样本t检验,组内比较采用配对t检验。计数资料采用卡方检验。所有统计检验采用双侧检验,P<0.05被认为差异有统计学意义。
2.结果
2.1两组患者血清性激素水平比较
治疗后,两组患者血清bFSH、bE2水平较治疗前均降低,AMH水平均升高,差异有统计学意义(P<0.05)。且治疗组患者血清bFSH水平与对照组比较显著降低,差异有统计学意义(P<0.05)。见表2
与本组治疗前比较,*P<0.05;与对照组治疗后比较,△P<0.05
2.2两组患者AFC比较。
治疗后,两组患者AFC较治疗前均升高,差异有统计学意义(P<0.05)。治疗组患者AFC与对照组比较有升高趋势,但差异无统计学意义(P>0.05)。见表3
与本组治疗前比较,*P<0.05;与对照组治疗后比较,△P<0.05
2.3两组患者肾虚证候积分比较
治疗前,两组患者中医证候积分比较,差异无统计学意义(P>0.05)。治疗后,两组患者月经周期、经量、腰膝酸软、头晕耳鸣、潮热汗出的积分均有明显改善(P<0.05);且治疗组较对照组相比,差异有统计学意义(P<0.05)。见表4
与本组治疗前比较,*P<0.05;与对照组治疗后比较,△P<0.05
实施例13动物实验
1方法:20只2~3月龄小鼠(SPF级)设为青年组,80只9月龄小鼠(SPF级)为自然衰老小鼠。80只9月龄小鼠随机分为中药一治疗组;中药二治疗组;对照中药一治疗组;对照中药二治疗组,每组20只。青年组:适应性喂养1个月后,给予0.2ml蒸馏水灌胃,灌胃3个月。中药一治疗组:适应性喂养1个月后给予实施例(3)中药2.6g/(kg·d)灌胃,灌胃3个月。中药二治疗组:适应性喂养1个月后给予实施例(5)中药2.6g/(kg·d)灌胃,灌胃3个月。对照中药一治疗组:适应性喂养1个月后给予对照中药一(按照以下方法制备:炒白术12g、生地10g、熟地10g、女贞子10g、仙茅10g、菟丝子10g、巴戟天10g、肉苁蓉10g、鹿角霜10g、蛇床子30g,粉碎,加10倍量水,煎煮2次,每次2小时。)2.6g/(kg·d)灌胃,灌胃3个月。对照中药二治疗组:适应性喂养1个月后给予对照中药二(按照以下方法制备:炒白术12g、生地10g、熟地10g、女贞子10g、仙茅12g、菟丝子10g、巴戟天11g、肉苁蓉10g、鹿角霜10g、蛇床子31g,粉碎,加10倍量水,煎煮2次,每次2小时。)2.6g/(kg·d)灌胃,灌胃3个月。卵子的获得:各组小鼠于灌胃3个月后,注射PMSG10IU,48h后注射HCG10IU,在注射HCG12~14h后脱臼处死小鼠,快速剖腹,剪下两侧输卵管,置于预温好的输卵管液中。在解剖镜下,用1ml的针头剖开输卵管壶腹部,用巴氏管将卵丘复合物移出,置于0.3mg/ml的透明质酸酶中吹打消化5min,将消化好的单个卵母细胞转移至干净的人输卵管液中洗净后,转入已经过4h以上平衡的胚胎培养液中,置于37℃、5%CO2的胚胎培养箱中培养,体式显微镜下观察获卵数、成熟卵子数。
2结果见表5。
注:与青年组比较,其余各组小鼠获卵数、成熟卵子数均显著下降,*P<0.01。与本发明中药一治疗组比较,对照中药一治疗组和对照中药二治疗组小鼠获卵数、成熟卵子数降低(P<0.05)。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。
Claims (4)
1.一种治疗肾虚型卵巢储备功能下降疾病的中药组合物,其特征在于,所述中药组合物由以下重量份的原料药制成:茯苓10-14份、生地8-12份、熟地8-12份、女贞子8-12份、仙茅8-12份、仙灵脾8-12份、巴戟天8-12份、肉苁蓉8-12份、鹿角霜8-12份、紫石英28-32份。
2.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物由以下重量份的原料药制成:茯苓11-13份、生地9-11份、熟地9-11份、女贞子9-11份、仙茅9-11份、仙灵脾9-11份、巴戟天9-11份、肉苁蓉9-11份、鹿角霜9-11份、紫石英29-31份。
3.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物由以下重量份的原料药制成:茯苓12份、生地10份、熟地10份、女贞子10份、仙茅10份、仙灵脾10份、巴戟天10份、肉苁蓉10份、鹿角霜10份、紫石英30份。
4.根据权利要求1-3任一所述的中药组合物在制备治疗肾虚型卵巢储备功能下降疾病药物中的应用。
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张利: "蔡氏周期疗法治疗月经后期32例疗效观察", 《山西中医》 * |
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