CN105726776A - 一种减轻紫杉醇类化疗引起的骨髓抑制反应用中药 - Google Patents
一种减轻紫杉醇类化疗引起的骨髓抑制反应用中药 Download PDFInfo
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Abstract
本发明公开了一种减轻紫杉醇类化疗引起的骨髓抑制反应用中药，是由原料药枸杞子20g，菟丝子20g，覆盆子15g，五味子9g，车前子15g，女贞子30g，生黄芪30g，枳实6g，白术6g，柴胡9g，白芍12g，茯苓30g，生甘草3g配制而成。本发明配方中重用枸杞子、菟丝子作为补肾益精的主药，辅以覆盆子、五味子固肾涩精，车前子泻肾经虚火，佐茯苓利水渗湿使水窍常开；配女贞子、炒白芍滋阴养血，用柴胡重振受化疗药抑遏的清阳之气，合枳实健脾消食、行气化湿以助化源；加黄芪益气托毒，借少量生甘草调和诸药。诸药合用，补中有泻、泻中寓补，共同发挥补肾填精、益气生血、促进骨髓再生的作用。
Description
技术领域
本发明涉及一种复方中药，尤其是涉及一种减轻紫杉醇类化疗引起的骨髓抑制反应用中药。
背景技术
近年来，肿瘤（癌症）患者越来越多，尤其是肺癌、乳腺癌、胃癌、淋巴瘤等，其死亡率逐年上升，严重影响着人类的生命和健康。目前在临床上，肿瘤的治疗方法主要有外科手术切除，放、化疗，生物疗法等。随着社会的发展，尽管新疗法如生物、基因治疗及分子靶向治疗等方法不断的涌现，但由于费用昂贵，使许多患者望而却步，且靶向药物只能用于部分人群。因此，化疗仍是当前医疗界治疗恶性肿瘤的主要手段。
以紫杉类化疗方案在非小细胞肺癌中的应用为例，TP方案(紫杉醇十卡铂)因其在有效率(晚期初治有效率为68%)及生存期(中位生存期为8.1个月)方面的显著优势，已经成为非小细胞肺癌姑息化疗最常用的一线方案,但化疗所用药物（如紫杉醇、卡铂等）所作用的细胞不具备选择特异性，可在治疗过程中引起大量副作用（如较高的消化道反应和骨髓抑制反应），其中，骨髓抑制是化疗后最常出现的不良反应之一。肿瘤患者放、化疗后出现骨髓抑制，主要临床表现是在其外周血单系和多系血细胞减少，以白细胞和中性粒细胞减少为主要表现，对于白细胞系统的抑制作用发生得最早也较为严重。放、化疗导致的骨髓抑制不仅会影响抗肿瘤治疗的疗效和进程，还可能引起发热、乏力等症状，造成患者不能按时按量完成化疗，甚至出现重度感染，危及患者生命。有研究表明，与Ⅳ度骨髓抑制的治疗相关死亡率可达4%~12%。
骨髓抑制是指骨髓中血细胞前体的活性下降。血流里的红细胞和白细胞都源于骨髓中的干细胞，血流里的血细胞寿命短，常常需要不断补充，为了达到及时补充的目的，作为血细胞前体的干细胞必须快速分裂。但目前化疗和放疗以及许多其它抗肿瘤的治疗方法针对的都是快速分裂的细胞（包括癌细胞和正常骨髓细胞），因而常常导致正常骨髓细胞受抑，使周围血细胞数减少。
目前临床上治疗由于肿瘤放、化疗而引起的骨髓抑制反应，主要采用粒细胞集落刺激因子(CSF)，促进骨髓造血干细胞(haemopoieticstemcells,HSCs)增殖分化。但有研究发现，在多种肿瘤细胞上，存在CSF及其受体的高表达，也发现了CSF具有可促进肿瘤生长的作用。另外，这些造血细胞因子的价格比较贵，且有反跳现象，可引起骨痛、发热等副作用。
针对西医治疗所带来的较大的副作用，近年来在临床上采用辅助化疗的中药制剂在治疗骨髓抑制反应方面也有了一定的经验。但由于所用药物成分单一（如参芪扶正注射液，主要成分仅为党参和黄芪），药效不足，部分患者服用后仍会出现轻量出血，恶心、呕吐，胸闷心慌等症状。
发明内容
本发明的目的在于提供一种减轻紫杉醇类化疗引起的骨髓抑制反应用中药，药物成本低且疗效显著。
为实现上述目的，本发明可采取下述技术方案：
本发明所述的减轻紫杉醇类化疗引起的骨髓抑制反应用中药，是由原料药枸杞子、菟丝子、覆盆子、五味子、车前子、女贞子、生黄芪、枳实、白术、柴胡、白芍、茯苓、生甘草按下述重量份配比和方法制备而成：
配比：枸杞子20g，菟丝子20g，覆盆子15g，五味子9g，车前子15g，女贞子30g，生黄芪30g，枳实6g，白术6g，柴胡9g，白芍12g，茯苓30g，生甘草3g；
制备方法：
第一步，首先取五味子，筛净灰屑，除去杂质，置蒸笼内蒸透后，晾干备用；将枸杞子、覆盆子、菟丝子、车前子、女贞子中杂质去除，备用；
第二步，将枳实、白术、白芍置于炒锅内小火炒至表面变黄，取出备用；
第三步，将剩余的原料药生黄芪、柴胡、茯苓、生甘草和第一、第二步处理后的所有原料一起置于非铁质容器内，再加入原料药总重量5~7倍量的水浸泡8~15分钟，大火加热至沸腾，转小火煎煮25~30分钟，关火后滤出药液备用；
第四步，在第三步剩余的药渣中再次加水煎煮25分钟，关火后滤出的药液与第三步滤出的药液混合即得汤剂；或将混合药液加热浓缩，加工制成丸剂、散剂或颗粒剂成药。
如采用工业化生产，所用原料药可按此比例扩大即可。
本发明中药汤剂一天服用两次，每次200ml，十五天为一疗程。
本发明的优点在于药物成本低，肿瘤患者按既定化疗方案进行治疗并同时服用本发明中药，可显著改善紫杉醇类化疗引起的患者骨髓抑制反应。
本发明配方中重用枸杞子、菟丝子作为补肾益精的主药，且菟丝子益阴兼能扶阳，温而不燥，补而不滞，辅以覆盆子、五味子固肾涩精，用车前子泻肾经虚火，佐茯苓利水渗湿使水窍常开，则小便利而湿热外泄，与补肾药相配，可使精窍常闭而无泄漏，精足则髓生；配女贞子、炒白芍滋阴养血，用柴胡重振受化疗药抑遏的清阳之气，合枳实健脾消食、行气化湿以助化源；加黄芪益气托毒，既能促进气化以助血生，又能托毒外出抑制肿瘤生长，借少量生甘草调和诸药。诸药合用，补中有泻、泻中寓补，共同发挥补肾填精、益气生血、促进骨髓再生的作用。
临床对45例年龄在23~72岁（其中男25例，女20例）行紫杉醇类化疗方案的恶性肿瘤患者（包括肺癌、乳腺癌、胃癌等主要类型）随机分为两组（23例为治疗组，22例为对照组）进行观察。
治疗组（男11例，女12例）按照既定化疗方案进行治疗并同时服用本发明中药汤剂（一天两次，一次200ml），十五天为一疗程，其血象观察结果如下：
白细胞显效17例，占73.9%；有效4例，占17.4%；
红细胞显效21例，占91.3%；有效2例，占8.7%；
血红蛋白显效19例，占82.6%；有效3例，占13.1%。
对照组（男10例，女12例）按既定化疗方案如期进行，定期检测患者血象，除3例重度骨髓抑制需对症即时给予粒细胞集落刺激因子治疗外，其余均作空白对照。血象观察七天结果如下：
白细胞有效4例，占18.2%；无效18例，占81.8%；
红细胞有效2例，占9.9%；无效20例，占90.1%；
血红蛋白有效1例，占4.6%；无效21例，占95.4%。
结果表明，本发明中药制剂对治疗恶性肿瘤患者化疗引起的骨髓抑制反应有显著疗效，具有推广价值。
注：上述选择病例的标准、治疗方案、疗效评定标准见说明书后附件。
具体实施方式
本发明所述的减轻紫杉醇类化疗引起的骨髓抑制反应用中药，是由原料药枸杞子、菟丝子、覆盆子、五味子、车前子、女贞子、生黄芪、枳实、白术、柴胡、白芍、茯苓、生甘草按下述重量份配比和方法制备而成：
配比：枸杞子20g，菟丝子20g，覆盆子15g，五味子9g，车前子15g，女贞子30g，生黄芪30g，枳实6g，白术6g，柴胡9g，白芍12g，茯苓30g，生甘草3g；若采用工业化生产，则各原料可按比例扩大。
其制备方法为：
第一步，首先取五味子，筛净灰屑，除去杂质，置蒸笼内蒸透后，晾干备用；将枸杞子、覆盆子、菟丝子、车前子、女贞子中杂质去除，备用；
第二步，将枳实、白术、白芍置于炒锅内小火炒至表面变黄，取出备用；
第三步，将剩余的原料药生黄芪、柴胡、茯苓、生甘草和第一、第二步处理后的所有原料一起置于非铁质容器（如砂锅）内，再加入原料药总重量5~7倍量（最佳量为6倍）的水浸泡8~15分钟，大火加热至沸腾，转小火煎煮25~30分钟，关火后滤出药液备用；
第四步，在第三步剩余的药渣中再次加水（水量同前）煎煮25分钟，关火后滤出的药液与第三步滤出的药液混合即得汤剂成药；
若将第四步得到的混合药液加热浓缩，喷雾干燥制成药粉后，加入液体辅料（如蜂蜜等），即可制成丸剂；
或将第四步得到的混合液压加热浓缩至稠膏，烘干后粉碎过筛，即可得到散剂；
或将第四步得到的混合药液加热浓缩，喷雾干燥制成药粉后，再加入辅料，制成软材，经挤压过筛网，制成颗粒，然后干燥、包装即可得到颗粒剂。
下面通过典型病例说明本发明中药的服用方法和其疗效。
1、李某，男，69岁，患者确诊非小细胞肺癌一周，排除化疗禁忌症后，行PP方案：紫杉醇（PTX）135~175mg/m2+顺铂(DDP)75~80mg/m2进行化疗，化疗后第一天，无明显诱因出现发热症状，体温38.7℃；中医四诊见症：神疲乏力、面色萎黄、食欲差、胫膝酸软、腰脊酸痛、自汗盗汗、头晕耳鸣。舌淡苔白，脉沉细。经检测血常规，WBC（白细胞）2.2×109/L，NEUT（中性粒细胞）0.85×109/L，HB（血红蛋白）88g/L，PLT（血小板）52×109/L，确诊为骨髓抑制II级。
2、袁某，男，52岁，经支气管镜穿刺活检，确诊为“小细胞肺癌”10天，8天后，排除化疗禁忌症，予TP方案：紫杉醇（PTX）135~150mg/m2+顺铂(DDP)30mg/m2化疗一周期（七天），同时口服本发明中药汤剂，每次200ml，早晚各一次。化疗第2、5天，分别检测血象，显示：WBC:5.25×109/L(5.16×109/L)；RBC:4.24×1012/L(5.11×1012/L)；HB:136g/L(152g/L)，无其他不良反应；化疗结束后第2、5天（自化疗起第9、13天），检测血常规，示：WBC:5.18×109/L(5.23×109/L)；RBC:4.23×1012/L(5.01×1012/L)；HB:132g/L(142g/L)。
3、朱某，男，51岁，经支气管镜穿刺活检，确诊为“小细胞肺癌（乳头状鳞状细胞癌）”一周，3天后，排除化疗禁忌症，予TP方案：紫杉醇（PTX）135~150mg/m2+顺铂(DDP)30mg/m2化疗一周期，同时口服本发明中药汤剂，每次200ml，早晚各一次。化疗第2、5天，分别检测血象，显示：WBC:6.15×109/L(5.11×109/L)；RBC:4.64×1012/L(5.21×1012/L)；HB:139g/L(152g/L)，无其他不良反应。化疗结束后第2、5天（自化疗起第9、13天），检测血常规，示：WBC:4.62×109/L(4.93×109/L)；RBC:4.52×1012/L(5.69×1012/L)；HB:147g/L(149g/L)。
4、乔某，女，46岁，经乳腺穿刺活检，确诊为“乳腺癌”，排除化疗禁忌症，予PA方案：紫杉醇（PTX）135~175mg/m2+表柔比星（EPI）50~60mg/m2化疗一周期，同时口服本发明中药汤剂，每次200ml，早晚各一次。化疗第2、5天，分别检测血象，显示：WBC:3.25×109/L(6.16×109/L)；RBC:3.26×1012/L(5.61×1012/L)；HB:146g/L(125g/L)，无其他不良反应。化疗结束后第2、5天（自化疗起第9、13天），检测血常规，示：WBC:4.12×109/L(4.23×109/L)；RBC:4.63×1012/L(5.41×1012/L)；HB:137g/L(146g/L)。
5、路某，女，42岁，经胃镜活检，确诊为“贲门癌”，排除化疗禁忌症，予TP方案：多西他赛（TXT）75mg/m2+顺铂(DDP)75mg/m2化疗一周期。中医症见：神疲纳呆、乏力懒言、面色苍白、偶尔胫膝酸软、腰脊酸痛。舌质淡，舌苔薄白，脉弱无力。化疗第2、5天，分别检测血象，显示：WBC:3.23×109/L(3.56×109/L)；RBC:3.76×1012/L(4.61×1012/L)；HB:126g/L(125g/L)，诊断为Ⅰ度骨髓抑制。化疗结束后第2、5天（自化疗起第9、13天），，检测血常规，示：WBC:3.62×109/L(4.03×109/L)；RBC:3.73×1012/L(3.41×1012/L)；HB:117g/L(126g/L)。
6、李某，男，56岁，经支气管镜穿刺活检，确诊为“肺腺癌”，排除化疗禁忌症，予PP方案：紫杉醇（PTX）135~175mg/m2+顺铂(DDP)75~80mg/m2化疗一周期，同时口服本发明中药汤剂，每次200ml，早晚各一次。化疗第2、5天，分别检测血象，显示：WBC:5.15×109/L(5.31×109/L)；RBC:4.04×1012/L(4.21×1012/L)；HB:132g/L(142g/L)，无其他不良反应。化疗结束后第2、5天（自化疗起第9、13天），检测血常规，示：WBC:4.52×109/L(4.73×109/L)；RBC:4.93×1012/L(5.21×1012/L)；HB:132g/L(156g/L)。
附件：
一．选择病例的标准：
选择45例年龄在23~72岁之间，行紫杉醇类化疗方案的恶性肿瘤（肺癌、乳腺癌、胃癌等主要类型）患者，随机分为对照组、治疗组。
病例收集标准，纳入标准：①凡经病理学确诊为恶性肿瘤，肺癌、乳腺癌、胃癌等符合NCCN(NationalComprehensiveCancerNetwork)恶性肿瘤临床实践指南；②按照国际抗癌联盟(UnionforInternationalCancerControl)简称UICC的TNM分期，临床分期为Ⅲa，Ⅲb，或Ⅳ期；③均为初治病例，未接受其他治疗，本次拟接受至少2个周期紫杉醇类方案化疗；④一般状况KPS评分在60分以上者；⑤心、肝、肾等主要脏器功能正常；⑥知情同意参加本次研究，签署知情同意书。
患者体力状况(Performaneestatus，PS)Karnofsky评分标准
中医辨证为肾精不足、气血两虚者。主症为面色萎黄，神疲纳差，气短乏力，恶心（和）或呕吐，头晕目眩，失眠，次症为自汗盗汗、或畏寒肢冷、舌淡、脉弱或沉细。
排除标准:①非首次化疗患者；②合并严重心、肝、肾、血液系统疾病患者；③感染患者及妊娠患者；④有药物及食物过敏史者。
二．治疗方案：
化疗方案根据病理分型不同，均对相应肿瘤有效，且有明显的骨髓抑制作用。乳腺癌，PA方案：紫杉醇（PTX）135~175mg/m2+表柔比星（EPI）50~60mg/m2；小细胞肺癌，TP方案：紫杉醇（PTX）135~150mg/m2+顺铂(DDP)30mg/m2；非小细胞肺癌，PP方案：紫杉醇（PTX）135~175mg/m2+顺铂(DDP)75~80mg/m2；胃癌，TP方案：多西他赛（TXT）75mg/m2+顺铂(DDP)75mg/m2。
治疗组在化疗的同时，给予本发明中药复方汤剂，对照组按常规化疗。在治疗期间监测血常规，2次/每周。
三．疗效评定标准：
根据国家卫生部制定的《药物临床研究指导原则》可分类如下：
（一）白细胞(WBC)
1、显效：WBC总数＞4×109/L，并在疗程中能维持疗效直至停药1周，临床症状显著减轻或消失；
2、有效：WBC总数＜4×109/L，但比治疗前上升(0.5～1.0×109/L)，并在疗程中能维持疗效直至停药1周，临床症状好转；
3、无效:WBC总数＜4×109/L,临床症状无好转。
（二）红细胞(RBC)及血红蛋白(HB)
1、显效：RBC总数＞4×1012/L，血红蛋白男性＞120g/L,并在疗程中能维持疗效直至停药1周，临床症状显著减轻或消失；
2、有效：RBC及HB低于正常水平的10%以内(成人一般RBC：男性＜4.0×1012/L，女性＜3.5×1012/L；血红蛋白：男性＜120g/L，女性＜105g/L)，但比治疗前上升(0.5～1.0×1012/L)，并在疗程中能维持疗效直至停药1周，临床症状好转；
3、无效：RBC及HB低于正常水平的10%以上,临床症状无好转。
Claims (1)
1.一种减轻紫杉醇类化疗引起的骨髓抑制反应用中药，其特征在于：是由原料药枸杞子、菟丝子、覆盆子、五味子、车前子、女贞子、生黄芪、枳实、白术、柴胡、白芍、茯苓、生甘草按下述重量份配比和方法制备而成：
配比：枸杞子20g，菟丝子20g，覆盆子15g，五味子9g，车前子15g，女贞子30g，生黄芪30g，枳实6g，白术6g，柴胡9g，白芍12g，茯苓30g，生甘草3g；
制备方法：
第一步，首先取五味子，筛净灰屑，除去杂质，置蒸笼内蒸透后，晾干备用；将枸杞子、覆盆子、菟丝子、车前子、女贞子中杂质去除，备用；
第二步，将枳实、白术、白芍置于炒锅内小火炒至表面变黄，取出备用；
第三步，将剩余的原料药生黄芪、柴胡、茯苓、生甘草和第一、第二步处理后的所有原料一起置于非铁质容器内，再加入原料药总重量5~7倍量的水浸泡8~15分钟，大火加热至沸腾，转小火煎煮25~30分钟，关火后滤出药液备用；
第四步，在第三步剩余的药渣中再次加水煎煮25分钟，关火后滤出的药液与第三步滤出的药液混合即得汤剂；或将混合药液加热浓缩，加工制成丸剂、散剂或颗粒剂成药。
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