CN105343518A - 一种治疗慢性再生障碍性贫血的中药配方及其制备方法 - Google Patents

一种治疗慢性再生障碍性贫血的中药配方及其制备方法 Download PDF

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CN105343518A
CN105343518A CN201510807855.XA CN201510807855A CN105343518A CN 105343518 A CN105343518 A CN 105343518A CN 201510807855 A CN201510807855 A CN 201510807855A CN 105343518 A CN105343518 A CN 105343518A
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刘永华
方炳木
江锦红
章俏雷
曲志刚
马光丽
王笑秋
王晓丽
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Lishui City Peoples Hospital
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Abstract

本发明涉及一种治疗慢性再生障碍性贫血的中药配方及其制备方法。一种治疗慢性再生障碍性贫血的中草药组合物，组合物组成为黄芪45-50份，熟地黄12-15份，肉桂3-5份，补骨脂10-12份，淫羊藿8-10份，杜仲10-12份，山茱萸10-15份，淮山药15-22份，枸杞子10-15份，制首乌10-12份，黄精10-15份，当归10-12份，赤芍？8-10份，桃仁4-6份，鸡血藤10-12份。突破中医在该疾病的传统方法,以补肾、活血为治疗原则，自拟“活血补肾方”治疗慢性再生障碍性贫血的中草药，观察其疗效并探讨其潜在机制，效果非常明显。

Description

一种治疗慢性再生障碍性贫血的中药配方及其制备方法
技术领域
本发明涉及一种治疗慢性再生障碍性贫血的中药配方及其制备方法。
背景技术
再生障碍性贫血（简称再障）是较为常见的血液系统疾病之一，临床主要表现为贫血、感染及出血。其发病机制尚未得到完全阐明，一般认为与综合因素引起的骨髓造血微环境（土壤）破坏、造血干/祖细胞（种子）缺陷及免疫功能异常（虫子）有关，继而导致骨髓造血功能的衰竭，“血三系”显著下降。其中慢性再障的临床发病率较高，具有病程长，病情易反复缠绵的特点，较难得到完全根治，严重影响患者的生活质量。对其相关治疗，目前主要集中于对免疫调节剂（环孢霉素A）、雄激素等的使用。西药治疗慢性再障，因治疗时间长，患者经济负担重，副作用大（如肝肾功能损害，性激素紊乱，女性男性化，消化道不适等），影响和限制了疾病的治疗，同时增加了病人的心理负担。有效的长期中药治疗可以减少上述不足，提高患者的生活质量。
慢性再障中医治疗主要从“肾”论治已贯穿10余年，分为肾阴虚、肾阳虚、肾阴阳两虚3型，目前有关慢性再障的中药治疗，各地学者报道具有较高的有效率，在60％-90％不等，并具有副作用小，经济等优势。而慢性再障病程迁延，“久病必瘀”、“久病必虚”，瘀不化去，阻于髓骨，则阻碍造血生精，所谓“旧血不去，新血不生”；而一旦感触外界邪毒，病情易反复甚至可转为危重（重型再障Ⅱ型）。临床实践中我们常可发现，多数患者病情在补肾辨证论治的基础上能够得到显著改善，但其疗效有时会存在瓶颈现象，即部分患者血象难以再进一步提高，处于平台期。尽管此平台下患者的生活质量能得到一定保证，但仍存在着易感受外邪的高风险，如何更好地突破该局限，更大程度上提高补肾法的临床疗效，是我们现在和今后研究的重点所在。
任何治疗理念的根本目的在于尽量提高临床疗效，尽管慢性再障“从肾论治”的主轴已贯穿多年，但仍有可发展的空间，不应拘泥。“益肾生血、补肾活血”法是我们长期临床实践的经验总结，若在此基础上，结合经验方药的运用和验证，进行较为系统全面的多中心临床研究，将有利于拓展慢性再障的治疗思路，进一步促进中医药在该疾病中的研究应用，助于临床疗效的提高。
发明内容
针对现有技术存在的不足，本发明的一个目的是提供起到促进补肾活血的治疗慢性再生障碍性贫血的中药配方，其第二目的是煎煮适当，能最大发挥药效。
为了实现上述的第一个目的，本发明采用了以下的技术方案：一种治疗慢性再生障碍性贫血的中草药组合物，组合物组成为黄芪45-50份，熟地黄12-15份，肉桂3-5份，补骨脂10-12份，淫羊藿8-10份，杜仲10-12份，山茱萸10-15份，淮山药15-22份，枸杞子10-15份，制首乌10-12份，黄精10-15份，当归10-12份，赤芍8-10份，桃仁4-6份，鸡血藤10-12份。
作为优选方案，中草药组合物外还包括以下的组分：先煎半小时的淡附片4份。
为了实现上述的第二个目的，本发明采用了以下的技术方案：
治疗慢性再生障碍性贫血中草药的制备方法，该方法包括以下的步骤：
将以上中草药组合物包好用水浸泡1h后，倒入先煎半小时的淡附片4份，中火煎煮2次，第一次加8倍量水煎煮1.5h，第二次加6倍量水煎煮1h，合并两次煎煮液进行过滤，滤液加入单独煎煮的三七3份。
与现有技术相比较，本发明的有益效果是：本配方以补肾活血为原则，自拟“活血补肾方”中药复方联合西药治疗慢性再生障碍性贫血，研究发现该复方可明显提高该疾病的疗效，在改善中医症候及调节免疫方面效果显著；本研究在此西药治疗基础上，加用补肾活血中药复方，自拟“活血补肾方”。突破传统中医关于慢性再生障碍性贫血“滋阴补肾、温阳补肾”法则，通过随机、对照的前瞻性研究表明可显著提高该疾病疗效；通过系统的研究，课题组发现补肾活血复方中药可重塑患者机体免疫、改善造血组织微循环；本发明依托2011年国家中医行业专项“慢性再生障碍性贫血致重因素中医干预方案的研究”（201107001-14）、2009年浙江省重大疾病平台项目“益肾生血方联合西药治疗慢性再生障碍性贫血的临床研究”（2009ZDJB01-07）及2012年丽水市人民医院萌芽基金“‘补肾活血法’联合西药在慢性再生障碍性贫血中的治疗优势和机制研究”（2012MY13）等多个项目，突破中医在该疾病的传统方法,以补肾、活血为治疗原则，自拟“活血补肾方”治疗慢性再生障碍性贫血的中草药，观察其疗效并探讨其潜在机制，效果非常明显。
具体实施方式
下面对本发明的具体实施方式做一个详细的说明。
实施例1
一种治疗慢性再生障碍性贫血的中草药组合物，药物组成为黄芪50g，熟地黄15g，肉桂3g，补骨脂12g，淫羊藿8g，杜仲12g，山茱萸15g，淮山药15g，枸杞子15g，制首乌12份，黄精15g，当归10g，赤芍10g，桃仁6g，鸡血藤10g，汤内还包括以下的组分：先煎半小时的淡附片4g，将以上药物包好用水浸泡1h后，倒入淡附片，中火煎煮2次，第一次加8倍量水煎煮1.5h，第二次加6倍量水煎煮1h，合并两次煎煮液进行过滤，滤液加入单独煎煮的三七3g。得到200ml左右的药汤，分早晚2次餐前半小时口服，连续服用2个月为一个疗程，服用3个疗程共6个月，每2个疗程间断1周时间。
这样配制主要是针对有活动性出血患者，活血药如赤芍、桃仁、鸡血藤剂量适当减少以防止出血加重，同时加大黄芪、补骨脂、山茱萸、淮山药等益气补肾药物剂量以固本益气止血。
实施例2
一种治疗慢性再生障碍性贫血的中草药组合物，药物组成为黄芪45g，熟地黄13g，肉桂4g，补骨脂10g，淫羊藿9g，杜仲11g，山茱萸10g，淮山药22g，枸杞子13g，制首乌11g，黄精13g，当归11g，赤芍8g，桃仁4g，鸡血藤10g。将以上药物包好用水浸泡1h后，再倒入先煎半小时的淡附片4g，中火煎煮2次，第一次加8倍量水煎煮1.5h，第二次加6倍量水煎煮1h，合并两次煎煮液进行过滤，滤液加入单独煎煮的三七3g，得到200ml左右的药汤，分早晚2次餐前半小时口服，连续服用2个月为一个疗程，服用3个疗程共6个月，每2个疗程间断1周时间。
实施例3
一种治疗慢性再生障碍性贫血的中草药组合物，药物组成为黄芪47g，熟地黄15份，肉桂3g，补骨脂11g，淫羊藿9g，杜仲11g，山茱萸12g，淮山药18g，枸杞子14g，制首乌11份，黄精14g，当归11g，赤芍9g，桃仁5g，鸡血藤11g，汤内还包括以下的组分：先煎半小时的淡附片4g，将以上药物包好用水浸泡1h后，倒入淡附片，中火煎煮2次，第一次加8倍量水煎煮1.5h，第二次加6倍量水煎煮1h，合并两次煎煮液进行过滤，滤液加入单独煎煮的三七3g。得到200ml左右的药汤，分早晚2次餐前半小时口服，连续服用2个月为一个疗程，服用3个疗程共6个月，每2个疗程间断1周时间。
患者在使用本药方后，临床疗效观察：
（1）患者使用本配方6个月后外周血细胞数值明显上升，白细胞数值从2.40±1.24×109/L升高至4.05±1.62×109/L比，血红蛋白从68.57±26.59g/L升高至95.25±19.64g/L，血小板数值从40.23±20.01×109/L提升至72.65±37.76×109/L，三系细胞升高明显高于单纯西药治疗组；
（2）患者使用本配方治疗6个月后，患者外周血CD4+细胞较治疗前增多，CD8+细胞较治疗前减少，CD4+/CD8+比值较治疗前升高，显著高于西药对照及传统中药治疗组，提示其具有调节免疫的作用。
（3）患者使用本配方治疗后血清IFN-γ、TNF-α水平均治疗前明显下降，且以活血补肾方组和益气补肾组的下降较对照组更明显〔IFN-γ（ng/L）：21.62±9.46、25.43±10.16比30.46±12.62，TNF-α（ng/L）：15.48±12.50、17.43±9.86比20.43±11.83，均p＜0.05〕。
（4）使用本配方治疗慢性再障患者，其中医症候均较西药对照组明显改善，中医症候积分和同组治疗前比较，p值分别＜0.01。
（5）患者使用本配方治疗6个月后，总有效率较对照组明显提高（86.7%比66.7%，p＜0.01）。
从以上5点临床观察，可以比较直观的比较出服用本中药配方后，从心理机能上可以看出有明显效果。

Claims (3)

1.一种治疗慢性再生障碍性贫血的中草药组合物，其特征在于，组合物组成为黄芪45-50份，熟地黄12-15份，肉桂3-5份，补骨脂10-12份，淫羊藿8-10份，杜仲10-12份，山茱萸10-15份，淮山药15-22份，枸杞子10-15份，制首乌10-12份，黄精10-15份，当归10-12份，赤芍8-10份，桃仁4-6份，鸡血藤10-12份。
2.根据权利要求1所述的一种治疗慢性再生障碍性贫血的中草药组合物，其特征在于中草药组合物外还包括以下的组分：先煎半小时的淡附片4份。
3.一种权利要求1或2所述的治疗慢性再生障碍性贫血中草药的制备方法，其特征在于该方法包括以下的步骤：
将以上中草药组合物包好用水浸泡1h后，倒入先煎半小时的淡附片4份，中火煎煮2次，第一次加8倍量水煎煮1.5h，第二次加6倍量水煎煮1h，合并两次煎煮液进行过滤，滤液加入单独煎煮的三七3份。
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