CN108938833A - 一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药 - Google Patents
一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药 Download PDFInfo
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Abstract
本发明涉及一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，由以下重量计的：黄芪30‑40g、刘寄奴20‑30g、山茱萸15‑25g、怀牛膝15‑25g和败酱草30‑40g制成；其中，将上述各原料药物混合在一起，加水浸泡，武火煎沸，改为文火煎煮，过滤，得第一次滤液；药渣再加水，武火煎沸，改为文火煎煮，过滤，得第二次滤液，合并两次滤液，浓缩；本发明采用纯天然的原料中草药物制成，各种药物之间有机配合，协同增效，配制合理，原料丰富易得，疗效佳，成本低，是治疗正虚瘀阻型良性前列腺增生症并膀胱逼尿肌功能障碍药物上的一大创新，经济和社会效益显著。
Description
技术领域
本发明涉及医药，特别是一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药。
背景技术
良性前列腺增生症(benign prostatic hyperplasia，BPH)是中老年男性常见病，50-60岁临床发病率为30-50％，60-70岁为60％，80岁高达83％，随着我国老龄人口的增加，该病发病率呈增高趋势。BPH临床主要表现为尿频、尿急、排尿困难、夜尿频数及尿潴留等下尿路症状，日久可能影响到肾脏的功能，造成肾功能不全，严重影响患者的生活质量甚至危及生命。
前列腺增生所导致的尿道梗阻是本病的初始原因，随之膀胱逼尿肌发生代偿性增强和肥厚，最终逼尿肌失代偿，收缩功能受损，排尿障碍。而完整的逼尿肌功能则是排空膀胱的基础。目前BPH治疗主要依靠α-受体阻断剂和手术，但药物和手术可以解除尿道梗阻，却无法恢复逼尿肌的收缩功能。对于逼尿肌收缩功能障碍所引起的排尿困难，无论手术还是药物治疗，效果都不理想；中医药在前列腺增生症的治疗中发挥了较好的作用，但是中医药治疗逼尿肌功能障碍仍处于临床试验阶段，既无成熟的理论，亦无效果满意的药物，因此，提供一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药势在必行。
发明内容
针对上述情况，为克服上述之缺陷，本发明根据“虚损生积”理论，指导BPH逼尿肌收缩功能障碍，提出“扶正化积”的治法和治则，创立“扶正化积癃闭汤”，据此，提供一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，可有效解决治疗正虚瘀阻型良性前列腺增生症并膀胱逼尿肌功能障碍效果不佳的问题。
本发明解决的技术方案是：本发明一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，由以下重量计的：黄芪30-40g、刘寄奴20-30g、山茱萸15-25g、怀牛膝15-25g和败酱草30-40g制成；其中，将上述各原料药物混合在一起，加水700-900ml浸泡30-60min，武火煎沸，改为文火煎煮20-30min，过滤，得第一次滤液；药渣再加水700-900ml，武火煎沸，改为文火煎煮20min，过滤，得第二次滤液，合并两次滤液，浓缩至200-400ml，即得。
本发明采用纯天然的原料中草药物制成，各种药物之间有机配合，协同增效，配制合理，原料丰富易得，方法简单，服用方便，疗效佳，成本低，是治疗正虚瘀阻型良性前列腺增生症并膀胱逼尿肌功能障碍药物上的一大创新，经济和社会效益显著。
具体实施方式
以下结合实施例对本发明的具体实施方式作进一步详细说明。
实施例1
本发明一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，由以下重量计的：黄芪25-35g、刘寄奴25-35g、山茱萸18-22g、怀牛膝18-22g和败酱草32-37g制成；其中，将上述各原料药物混合在一起，加水750-850ml浸泡35-55min，武火煎沸，改为文火煎煮22-28min，过滤，得第一次滤液；药渣再加水750-850ml，武火煎沸，改为文火煎煮20min，过滤，得第二次滤液，合并两次滤液，浓缩至200-400ml，即得。
实施例2
本发明一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，由以下重量计的：黄芪30g、刘寄奴20g、山茱萸15g、怀牛膝15g和败酱草30g制成；
制备方法同实施例1。
实施例3
本发明一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，由以下重量计的：黄芪35g、刘寄奴25g、山茱萸20g、怀牛膝20g和败酱草35g制成；
制备方法同实施例1。
实施例4
本发明一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，由以下重量计的：黄芪40g、刘寄奴30g、山茱萸25g、怀牛膝25g和败酱草40g制成；
制备方法同实施例1。
申请人要指出的是，本发明请求保护的技术核心是组方(中药复方)，凡是根据本组方中药制成的汤剂、丸剂、粉剂、胶囊剂、片剂，均属于本发明请求保护的范围。
在上述药物中，其中：
黄芪，系豆科植物蒙古黄芪或膜荚黄芪的根，主产于内蒙古、山西、黑龙江等地，春秋二季采挖，除去须根及根头，晒干，切片。本品甘温，归脾、肺经，具有补气健脾、益气固表、利尿消肿等功效。《本草汇言》：“补肺健脾，实卫敛汗，驱风运毒之药也。”主治脾气虚证、肺气虚证、气虚自汗、气血亏虚或疮疡难溃难腐等证。现代研究表明，本品含苷类、多糖、黄酮、氨基酸、微量元素等成分，具有促进机体代谢、抗疲劳、利尿、兴奋呼吸、增强和调节机体免疫功能、抗菌、抗衰老、抗缺氧、抗辐射、降血脂、保肝等多种作用。
刘寄奴，系菊科植物奇蒿的干燥地上部分，主要产于浙江、江苏、江西、湖南等地。本品味苦，性温，归心、肝、脾经，有散瘀止痛、疗伤止血、破血通经、消食化积等功效。《新修本草》：“破血下胀。多服令人下痢。”《日华子本草》：“治心腹痛，下气水胀、血气，通妇人癥结，止霍乱水泻。”主治跌打损伤，肿痛出血，血瘀经闭，产后瘀滞腹痛，食积腹痛，赤白痢疾等证。现代研究表明，本品主要含香豆精、异泽兰黄素、西米杜鹃醇、脱肠草素、奇蒿黄酮、奇蒿内脂醇等成分。药理研究表明，本品具有加速血液循环、解除平滑肌痉挛、促进血凝、抗缺氧、抑菌等多种作用。
山茱萸，系山茱萸科植物山茱萸的成熟果肉，主产于浙江、安徽、河南、陕西、山西等地。本品味酸、涩，性微温，主归肝、肾经，具有补益肝肾、收敛固涩等功效。《神农本草经》：“主心下邪气，寒热，温中，逐寒湿痹，去三虫。”《药性论》：“止月水不定，补肾气，兴阳道，添精髓，疗耳鸣，……止老人尿不节。”主治腰膝酸软、头晕耳鸣、阳痿、遗精滑精、遗尿尿频、崩漏、月经过多、大汗不止、体虚欲脱等证，还可与生地、天花粉等同用治疗消渴证。现代研究表明，本品含山茱萸苷、乌索酸、莫罗忍冬苷、7-O-甲基莫罗忍冬苷、獐牙菜苷、番木鳖苷、鞣质等。药理研究表明，本品煎剂在体外对痢疾杆菌、金黄色葡萄球菌及堇毛癣菌、流感病毒等有不同程度抑制作用；山茱萸注射液能强心、升压，并能抑制血小板聚集，抗血栓形成；山茱萸醇提取物有明显的降血糖作用；山茱萸流浸膏对麻醉犬有利尿作用；山茱萸对非特异性免疫功能有增强作用；体外试验能抑制腹水癌细胞；另外具有抗氧化、兴奋副交感神经、收敛等多种作用。本品多煎服，急救固脱可用20～30g。
牛膝，系苋科植物牛膝(怀牛膝)和川牛膝(甜牛膝)的根，主产于河南、四川、云南等地，以河南怀庆府所产者品质最佳，故称“怀牛膝”。本品味苦、甘、酸，性平，归肝、肾经，具有活血通经、补肝肾、强筋骨、利水通淋、引火(血)下行等功效。《神农本草经》：“主寒湿痿痹，四肢拘挛，膝痛不可曲伸，逐血气，伤热火烂，堕胎。”《本草纲目》：“治久疟寒热，五淋尿血，茎中痛，下痢，喉痹，口疮，齿痛，痈肿恶疮，伤折。”主治瘀血阻滞经闭、痛经、经行腹痛、跌打伤痛、腰膝酸痛、下肢痿软、淋证、水肿、小便不利、头痛、眩晕、齿痛、口舌生疮、吐血、衄血等证。现代研究表明，本品含三萜皂苷、蜕皮甾酮、牛膝甾酮、紫茎牛膝甾酮、多糖类、生物碱类、香豆素类等成分。药理研究表明，本品所含牛膝总皂苷对子宫平滑肌有明显的兴奋作用，怀牛膝苯提取物有明显抗生育、抗着床及抗早孕的作用；此外牛膝具有降压、利尿、降脂、抗凝、呼吸兴奋、抗炎、镇痛、提高机体免疫功能等作用。
败酱草，系败酱科植物黄花败酱、白花败酱的干燥全草，主产于四川、河北、河南、东北三省等地，夏、秋季采收，阴干或晒干。本品辛苦微寒，归胃、大肠、肝经，具有清热解毒、消痈排脓、祛瘀止痛等功效。《名医别录》：“除痈肿，浮肿，结热，风痹不足，产后腹痛。”《本草纲目》：“败酱，善排脓破血，故仲景治痈及古方妇人科皆用之。”主治肠痈肺痈、痈肿疮毒、产后瘀阻腹痛等。现代研究表明，本品含齐墩果酸、多种皂苷、挥发油、生物碱、鞣质等，具有抑菌、抗肝炎病毒、促进肝细胞再生，防止肝细胞变性，改善肝功能、抗肿瘤等作用。
前列腺增生症的逼尿肌收缩功能障碍病机为“虚损生积”，其病理基础为“正气虚损、肾失气化、瘀阻水道”，正气虚损、肾失气化为病之本，瘀阻水道为病之标。在此基础上，本发明提出了“扶正化积”的治疗原则，自拟扶正化积癃闭汤。方中黄芪性微温，味甘，归脾肺经，补气升阳，固表止汗，生津养血，利水消肿，托毒生肌，刘寄奴性温，味辛苦，归心、肝、脾经，破血通经，止血生肌，收湿敛疮，清肺化痰，二者同用，既可助肾与膀胱蒸腾气化以治本，又可利尿、破血、散瘀止痛以治标，共为君药；山茱萸性微温，味酸、涩，归肝肾经，补益肝肾，收涩固脱，怀牛膝性平，味辛、苦、甘，归肝、肾经，活血祛瘀，补肝肾强筋骨，利水通淋，引火下行，两者助君药补肾、利尿、活血祛瘀，共为臣药；败酱草性微寒，味辛、苦，归胃、大肠、肝经，清热解毒，消痈排脓，祛瘀止痛，既可祛瘀止痛，又可清瘀久所化之热毒，功兼佐使。纵观全方，药物配伍精炼严谨，使得证治相合，诸药合用，补肾以助气化，活血以助祛瘀，从而达到“扶正化积”之功效，标本兼顾，从而达到良好的治疗效果。本发明经临床应用，取得了良好的效果，有关资料如下：
临床试验：
1西医诊断标准
(1)前列腺增生症诊断标准BPH诊断标准参照《第五届国际良性前列腺增生症咨询委员会推荐意见》拟定①有下尿路症状(LUTS)；②>50岁男性；③国际前列腺症状评分(IPSS)>13；④生活质量评估(QoL)>3；⑤病理证实BPH。
(2)膀胱出口梗阻及逼尿肌功能障碍评定标准应用美国Medtronic公司DUET尿动力学仪进行压力-容积及压力-流率测定,按照国际规范化操作步骤进行。在测定过程中,记录最大尿流率、膀胱的感觉、容量、膀胱的顺应性、有无DI、DI的幅度、逼尿肌收缩力,压力-流率分析判断膀胱出口梗阻(BOO)。根据Schaefer列线图,将程度分为0-7个级别,将逼尿肌收缩力分为很弱、弱减、弱加、正常减、正常加和强烈6个级别。我们又将很弱、弱减、弱加定义为逼尿肌收缩力受损,正常减、正常加、强烈定义为逼尿肌收缩力好。所有尿动力学检查结果全部经两位以上本课题研究者进行判定,以排除假象。
2中医辨证标准
中医证候诊断标准参照《中药新药临床研究指导原则》(1997年发布)、《中华人民共和国中医药行业标准·中医病证诊断疗效标准》拟定标准:
(1)肾气虚弱:
主症:小便频数,夜间尤甚；小便不通或点滴不爽；排尿无力,射程缩短；小腹胀满,小便点滴而出或不出；尿失禁。
次症:腰膝酸软；尿液澄清；遗尿；阴囊湿冷；阳痿或遗精；面色无华；形寒肢冷。
舌脉:舌淡胖,苔白润,脉沉迟或细弱。
(2)瘀阻水道:
主症:小便点滴而下,或时断时续,或尿闭不通；尿细如线；尿线分叉。
次症:小腹胀痛；会阴胀痛；血尿；精出涩痛或血精。
舌脉:舌淡紫或紫暗或瘀点瘀斑或舌底络脉曲张,脉涩或细涩。
具备主症1项+次症2项+舌脉,或主症2项+次症1项+舌脉,即可诊断。
3纳入标准
①年龄在50～85岁之间；
②符合良性前列腺增生症的西医诊断标准；
③符合中医肾气虚弱及瘀阻水道证的辨证标准；
④尿动力学检查逼尿肌收缩力分级为极弱(VW)和弱减(W-)、弱加(W+)的患者
⑤签署知情同意书。
4排除标准
②动力学检查逼尿肌收缩力分级正常及增强的患者；
②彩超提示：前列腺体积明显增大者；
③对本药过敏或不耐受者；
④合并有难以控制的糖尿病和糖尿病性神经病变及病史或体检提示有神经系统疾病的患者；
⑤合并有严重心血管、肝脏和造血系统等严重原发性疾病及精神病患者；
⑥有前列腺癌、尿道狭窄、膀胱颈硬化、神经源性膀胱、间质性膀胱炎等疾病患者；
⑦有盆腔外科手术或外伤史的患者；
⑧需同时应用可能影响药品疗效和安全性评价药物者。
⑨研究中认为有任何不适宜入选的情况。
5脱落标准与剔除标准
5.1退出试验病例标准
①出现过敏反应或严重不良事件者，根据医生判断应该停止者。
②病程中病情恶化，根据医生判断应该停止者。
③患者在临床试验过程中依从性较差，不愿意继续进行治疗者。
5.2病例的脱落及处理
脱落的定义:纳入观察病例，进入随机分组者，无论何时何因退出，只要没有完成方案所规定的观察周期者，均称为脱落病例。未满1个疗程症状消失自行停药者，不作为脱落病例。当受试者脱落后，研究者受试者联系，询问理由、记录最后一次服药时间、完成所能完成的评估项目。因过敏反应、不良反应、治疗无效而退出试验病例，研究者应根据受试者实际情况，采取相应的治疗措施。凡是入选并已使用编号的病人，无论是否脱落，均应记录和保留病例观察表。脱落病人无需另补。所有脱落病例均应将病例观察表等资料汇总，统计分析。 5.3病例的剔除
未按医嘱应用药物治疗者；在随机化之后没有任何数据者给予剔除。
6分组及研究方法
120例筛选合格进入随机化试验的受试者按随机数字表法随机均分为2组，每组60例，治疗组采用本发明中药治疗，对照组采用翁立通胶囊治疗。本试验采用随机、平行、对照的临床试验方法。
7治疗方案
治疗组采用本发明中药治疗，每日2次，每次200ml，分早晚两次饭后温服。对照组采用翁立通胶囊，每日3次，每次3粒，口服。2组均4周为1个疗程，2个疗程结束后统计疗效。
8观察指标
8.1主要效应指标：国际前列腺症状评分(I-PSS)、生活质量评估(QOL)、膀胱出口梗阻(BOO)
程度、逼尿肌收缩强度。
①国际前列腺症状评分(I-PSS)：0-35分。见表1
病人可进行如下分类：
0-7分＝轻度症状；
8-19分＝中度症状；
20-35分＝重度症状。
②生活质量评估(QOL)：见表1.
表1国际前列腺症状评分及生活质量评估表
③膀胱出口梗阻(BOO)程度、逼尿肌收缩强度：应用美国Medtronic公司DUET尿动力学仪进行检测，严格按标准进行。
8.2次要效应指标：平均24h排尿次数、平均夜尿次数、前列腺体积、残余尿量、最大尿流率(Qmax)、症状体征及辅助检查分级计分标准。
①平均24h排尿次数＝连续3d排尿总次数/3
②平均夜尿次数＝连续3d夜尿总次数/3
③前列腺体积(V＝0.52×前后径×左右径×上下径)及残余尿量(ml)。由超声科专人负责，用彩超检测。
④最大尿流率(Qmax)：应用美国Medtronic公司DUET尿动力学仪进行检测，严格按标准进行。
⑤症状体征及辅助检查分级计分标准：见表2.
表2勃起功能IIEF-5国际评分表
8.3临床信息采集时点：治疗前、治疗4周结束分别进行上述指标采集。
8.4安全性评价指标：血压、脉搏、心电图、血、尿常规化验，肝、肾功能检查。
9疗效评定标准
9.1综合疗效评定标准
①显效:症状明显改善,前列腺指诊有改善或前列腺体积有所缩小,膀胱残余尿量减少 60％以上,膀胱逼尿肌收缩强度较前改善Ⅱ级以上或达到正常；
②有效:症状有改善,膀胱残余尿量减少范围在30％～59％,膀胱逼尿肌收缩强度改善Ⅰ级以上；
③无效:症状无改善,膀胱残余尿量减少<30％,膀胱逼尿肌收缩强度较前亦无改善或加重。
9.2症状改善程度评定标准
①明显改善:Ⅰ-PSS减少60％-99％；
②轻度改善:Ⅰ-PSS减少范围在30％-59％之间；
③无改善:Ⅰ-PSS减少<30％。
9.3膀胱残余尿量改善程度评定标准
①完全改善:膀胱残余尿量完全消失；
②明显改善:膀胱残余尿量减少60％-99％；
③轻度改善:膀胱残余尿量减少范围在30％-59％之间；
④无改善:膀胱残余尿量减少<30％或膀胱残余尿量增加。
9.4膀胱逼尿肌收缩力改善评定标准
①改善Ⅲ级:膀胱逼尿肌收缩力计分减少3分；
②改善Ⅱ级:膀胱逼尿肌收缩力计分减少2分；
③改善Ⅰ级:膀胱逼尿肌收缩力计分减少1分；
③改善:膀胱逼尿肌收缩力计分无减少或反而增加。
10统计学处理
①计量资料：先进行正态性检验，符合正态分布者进行t检验或方差分析，方差分析前进行方差齐性检验。两组间比较采用t检验，不符合正态性分布者则采用两组间秩和检验；组内治疗前后自身比较采用配对t检验(Paired-Samples T Test)，不符合正态性分布者则采用配对秩和检验。多组间两两比较符合正态性分布、方差齐者采用方差分析(one-way ANOVA)，两两组间比较用LSD法；不符合正态分布或方差不齐者用Wilcoxon秩和检验。
②计数资料：采用秩和检验，两两比较用Wilcoxon秩和检验；两个以上组间比较用Kruskal-Wallis检验。两个总体率(或构成比)之间比较，用χ2检验或确切概率法，多个样本率或构成比之间比较，采用列联表χ2检验。
③等级资料：采用Kruskal-Wallis H检验。
11结果
11.1两组患者总体疗效比较(见表3)
表3两组患者总体疗效比较(％)
| 组别 | n(例) | 显效 | 有效 | 无效 | 总有效率(％) |
| 治疗组 | 60 | 30 | 22 | 8 | 86.67* |
| 对照组 | 60 | 18 | 20 | 22 | 63.33 |
注：与对照组相比，*P＜0.05。
11.2两组患者治疗前后症状改善程度比较(见表4)
表4两组患者治疗前后症状改善程度比较
注：与对照组相比，*P＜0.05。
11.3两组患者治疗前后膀胱残余尿量的改善程度比较(见表5)
注：与对照组相比，*P＜0.05。
11.4两组患者治疗前后逼尿肌收缩力改善程度比较(见表6)
表6两组患者治疗前后逼尿肌收缩力改善程度比较
注：与对照组相比，*P＜0.05。
11.4安全性指标异常率情况
经统计学处理，治疗组和对照组各项安全性指标血压、脉搏、心电图、血、尿常规化验，肝、肾功能，治疗前后比较均无显著差异(P＞0.05)。
11.5不良反应
在服药的不同阶段，两组患者均无明显不良反应发生。血压、脉搏、心电图、血、尿常规化验，肝、肾功能未见明显异常。
六、结论
由上述表明，本发明已成功将“正虚生积”理论用于前列腺增生症的临床治疗中，将前列腺增生症的病机变化概括为“正气虚损、肾失气化、瘀阻水道”，指导辨证论治，据此创立了“扶正化积癃闭汤”，临床疗效显著。
本发明中药组方稳定可靠，治疗效果好，见效快，无毒副作用，在治疗正虚瘀阻型良性前列腺增生症并膀胱逼尿肌功能障碍上，能明显降低膀胱残余尿量，改善患者症状，提高膀胱收缩力，为正虚瘀阻型良性前列腺增生症并膀胱逼尿肌功能障碍提供了良好的治疗条件，有效率达到86.67％，是中医药学上的一大创造，有实际的临床意义，是治疗正虚瘀阻型良性前列腺增生症并膀胱逼尿肌功能障碍药物上的一大创新，有良好的社会和经济效益。
Claims (5)
1.一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，其特征是：由以下重量计的：黄芪30-40g、刘寄奴20-30g、山茱萸15-25g、怀牛膝15-25g和败酱草30-40g制成；其中，将上述各原料药物混合在一起，加水700-900ml浸泡30-60min，武火煎沸，改为文火煎煮20-30min，过滤，得第一次滤液；药渣再加水700-900ml，武火煎沸，改为文火煎煮20min，过滤，得第二次滤液，合并两次滤液，浓缩至200-400ml，即得。
2.根据权利要求1所述的治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，其特征是：由以下重量计的：黄芪25-35g、刘寄奴25-35g、山茱萸18-22g、怀牛膝18-22g和败酱草32-37g制成。
3.根据权利要求1所述的治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，其特征是：由以下重量计的：黄芪30g、刘寄奴20g、山茱萸15g、怀牛膝15g和败酱草30g制成。
4.根据权利要求1所述的治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，其特征是：由以下重量计的：黄芪35g、刘寄奴25g、山茱萸20g、怀牛膝20g和败酱草35g制成。
5.根据权利要求1所述的治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药，其特征是：由以下重量计的：黄芪40g、刘寄奴30g、山茱萸25g、怀牛膝25g和败酱草40g制成。
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