CN109200229B - 一种治疗原发性肝癌综合微创术后正虚瘀结证的中药 - Google Patents
一种治疗原发性肝癌综合微创术后正虚瘀结证的中药 Download PDFInfo
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Abstract
本发明涉及治疗原发性肝癌综合微创术后正虚瘀结证的中药,可有效解决原发性肝癌综合微创术后正虚瘀结证的用药问题,其解决的技术方案是,该中药是由以下重量计的原料药物制成:黄芪25‑35g、菝葜25‑35g、党参12‑18g、白术12‑18g、白芍12‑18g、丹参25‑35g、鳖甲16‑24g、牡蛎25‑35g、猫人参25‑35g、陈皮10‑14g、柴胡8‑12g和甘草5‑7g,本发明配伍科学合理,原料丰富,服用方便,效果好,共奏扶正祛邪之效,有效用于治疗原发性肝癌综合微创术后正虚瘀结证患者,是治疗原发性肝癌综合微创术后正虚瘀结证药物上的创新。
Description
技术领域
本发明涉及医药领域,特别是一种治疗原发性肝癌综合微创术后正虚瘀结证的中药。
背景技术
原发性肝癌是我国常见的恶性肿瘤之一,发病率占恶性肿瘤第五位,占肿瘤致死病因的第三位,其五年自然病死率大于95%。肝癌患者往往合并不同程度肝硬化,肝功能较差,《原发性肝癌诊疗规范》把肝动脉导管化疗栓塞术(TACE)及局部消融术(综合微创)纳入肝癌治疗规范,多种治疗方法联合能提高肝癌患者的生存率和治疗效果,能够有效的降低肝癌患者的死亡率,然而综合微创术后许多出患者出现术后综合征,主要表现为发热、右上腹痛、食欲不振、恶心呕吐、乏力、肝功能损害,重者出现肾损伤等,严重影响患者生活质量,术后疾病控制率仍不理想,缺乏有效的防治措施。放化疗及靶向治疗虽一定程度上可延缓疾病进展,但不良反应加重,中医药通过整体调整和辨证论治能调整机体内环境稳定,增强患者机体抗病能力,缓解患者症状,提高生活质量,延长生存期,使机体的病态正常化,从而提高机体对微创治疗的耐受性,因此,发明一种治疗原发性肝癌综合微创术后综合征的中药势在必行。
发明内容
针对上述情况,为解决现有技术之缺陷,本发明之目的就是提供一种治疗原发性肝癌综合微创术后正虚瘀结证的中药,可有效解决原发性肝癌综合微创术后正虚瘀结证的用药问题。
本发明解决的技术方案是,该中药是由以下重量计的原料药物制成:黄芪25-35g、菝葜25-35g、党参12-18g、白术12-18g、白芍12-18g、丹参25-35g、鳖甲16-24g、牡蛎25-35g、猫人参25-35g、陈皮10-14g、柴胡8-12g和甘草5-7g,其中,将白术、陈皮粉碎,加白术、陈皮5倍量的质量浓度为70%的乙醇渗漉,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,将上述2味药材所得的药渣与黄芪、菝葜、党参、白芍、丹参、鳖甲、牡蛎、猫人参、柴胡、甘草10味药材合并在一起,加原料药物4-6倍量的水煎煮2次,每次2小时,合并2次所得煎液,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,合并2次制备得到的浸膏,干燥,粉碎成药粉,加入辅料,药粉与辅料配比为1:2,辅料组成为糊精-糖粉1:1,以质量浓度为80%的乙醇为润湿剂,均匀制成软材,过20目筛制粒,60℃进行干燥,14目筛过筛制粒,分装,即得颗粒剂。
本发明配伍科学合理,原料丰富,服用方便,效果好,共奏扶正祛邪之效,有效用于治疗原发性肝癌综合微创术后正虚瘀结证患者,是治疗原发性肝癌药物综合微创术后正虚瘀结证上的创新。
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
本发明在具体实施时,可由以下重量计的原料药物制成:黄芪26g、菝葜34g、党参13g、白术17g、白芍13g、丹参34g、鳖甲17g、牡蛎34g、猫人参26g、陈皮13g、柴胡9g和甘草7g,其中,将白术、陈皮粉碎,加白术、陈皮5倍量的质量浓度为70%的乙醇渗漉,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,将上述2味药材所得的药渣与黄芪、菝葜、党参、白芍、丹参、鳖甲、牡蛎、猫人参、柴胡、甘草10味药材合并在一起,加原料药物4倍量的水煎煮2次,每次2小时,合并2次所得煎液,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,合并2次制备得到的浸膏,干燥,粉碎成药粉,加入辅料,药粉与辅料配比为1:2,辅料组成为糊精-糖粉1:1,以质量浓度为80%的乙醇为润湿剂,均匀制成软材,过20目筛制粒,60℃进行干燥,14目筛过筛制粒,分装,即得颗粒剂。
实施例2
本发明在具体实施时,还可由以下重量计的原料药物制成:黄芪30g、菝葜30g、党参15g、白术15g、白芍15g、丹参30g、鳖甲20g、牡蛎30g、猫人参30g、陈皮12g、柴胡10g和甘草6g,其中,将白术、陈皮粉碎,加白术、陈皮5倍量的质量浓度为70%的乙醇渗漉,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,将上述2味药材所得的药渣与黄芪、菝葜、党参、白芍、丹参、鳖甲、牡蛎、猫人参、柴胡、甘草10味药材合并在一起,加原料药物5倍量的水煎煮2次,每次2小时,合并2次所得煎液,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,合并2次制备得到的浸膏,干燥,粉碎成药粉,加入辅料,药粉与辅料配比为1:2,辅料组成为糊精-糖粉1:1,以质量浓度为80%的乙醇为润湿剂,均匀制成软材,过20目筛制粒,60℃进行干燥,14目筛过筛制粒,分装,即得颗粒剂。
实施例3
本发明在具体实施时,还可由以下重量计的原料药物制成:黄芪34g、菝葜26g、党参17g、白术13g、白芍17g、丹参26g、鳖甲23g、牡蛎26g、猫人参34g、陈皮11g、柴胡11g和甘草5g,其中,将白术、陈皮粉碎,加白术、陈皮5倍量的质量浓度为70%的乙醇渗漉,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,将上述2味药材所得的药渣与黄芪、菝葜、党参、白芍、丹参、鳖甲、牡蛎、猫人参、柴胡、甘草10味药材合并在一起,加原料药物6倍量的水煎煮2次,每次2小时,合并2次所得煎液,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,合并2次制备得到的浸膏,干燥,粉碎成药粉,加入辅料,药粉与辅料配比为1:2,辅料组成为糊精-糖粉1:1,以质量浓度为80%的乙醇为润湿剂,均匀制成软材,过20目筛制粒,60℃进行干燥,14目筛过筛制粒,分装,即得颗粒剂。
中医认为“正虚瘀结”是肝癌发生的基本病机,“正气虚”、“毒邪盛”是疾病复发、转移的关键。本发明针对其正虚瘀结的病机特征,以益气扶正、解毒散结为治则。方中黄芪补气升阳,切中肝癌正虚为本之病机,为君药。党参补中益气可增强君药黄芪益气补虚之功;菝葜、鳖甲解毒破瘀散结,契合肝癌邪实为标的病机,与黄芪同用可扶正袪邪;三药辅助君药加强治疗主病、主症,是为臣药。白术培补脾胃,佐助君药黄芪、臣药党参加强健脾益气作用;猫人参清热解毒,牡蛎软坚散结,佐助臣药菝葜、鳖甲加强解毒散结祛邪作用;白芍养血敛阴、柔肝止痛,丹参活血祛瘀,可缓解胸肋疼痛等次要症状,辅助治疗症瘕结块;陈皮行气除胀、燥湿化痰、健脾和中,既能佐制补气药物太过而致气机壅滞,又能减弱解毒散结药物的寒凉碍胃之性。六药共为佐药。柴胡,疏肝理气,引诸药入肝经直达病所;甘草可缓和药性,减低或缓和药物烈性。二药共为使药。综合全方,配伍严谨,攻补兼施,共同发挥益气扶正、解毒散结的功效。并经试验和使用,取得了非常好的有益技术效果,有关试验资料如下:
1.选择病例的标准
临床诊断为原发性肝癌的患者;中医诊断为正虚瘀结证者。
诊断标准
依据2017年中华人民共和国卫生和计划生育委员会制定的《原发性肝癌诊疗规范》诊断及分期。肝功能Child-Pugh分级标准参考第七版人民卫生出版社出版的全国高等学校教材《内科学》诊断,生存质量评定标准采用国际通用的Karnofsy评分标准,由美国东部肿瘤协作组制定诊断。
排除标准
妊娠或哺乳期妇女;精神障碍疾病患者;有语言表达障碍,对自身症状缺乏判断能力者;过敏体质,或已知对本药成份过敏者;合并有心、肝、肺、肾和造血系统等严重原发性疾病者。
治疗方案
将160例诊断为原发性肝癌,综合微创术后的患者分治疗组和对照组,对照组西医常规基础治疗,治疗组在常规治疗基础上每日口服扶正消瘤颗粒,每日早晚各1次,每次1-2袋,每袋5g,每4周为一周期, 并根据病情给予常规对症处理,治疗时间为6个月,于治疗结束后进行全面复查评估治疗效果。
疗效评定标准
完全缓解(CR):所有目标病灶消失。
部分缓解(PR):基线病灶长径总和缩小30%。 病情稳定(SD):基线病灶长径总和有缩小,但未达到PR,或有增加,但未达到PD。
疾病进展(PD):基线病灶长径总和增加20%,或出现新病灶。
有效率(%) = (CR+PR+SD)/n×100%
6.统计学处理
经对160例入组的患者进行治疗,其中,男性患者105例,女性患者55例,年龄40-70岁,中位年龄56岁,按照原发性肝癌诊疗规范分期,I期患者41例,II期患者64例,III期患者55例,经随机分组,对照组中男性62例,女性18例,I期患者20例,II期32例,III期28例;治疗组中男性43例,女性37例,I期患者21例,II期32例,III期27例 。
采用计算机SPSS(19.0)统计分析软件,对实验数据进行统计分析,计数资料采用X2检验,计量资料以均数±标准差表示。
160例患者,经治疗后,客观疗效评价比较 表1(n,%)
组别 | 例数 | CR | PR | SD | PD | 有效率 |
对照组 | 80 | 0 | 16 | 30 | 34 | 57.50 |
治疗组 | 80 | 5 | 26 | 43 | 6 | 92.50 |
治疗前后临床症状改善情况 表2
组别 | 例数 | 右胁胀痛 | 倦怠乏力 | 脘腹胀满 | 纳呆食少 | 便溏 |
对照组 | 80 | 45/40 | 50/35 | 60/46 | 20/16 | 16/16 |
治疗组 | 80 | 50/21 | 48/13 | 63/21 | 26/12 | 11/8 |
在本试验中未发现有不良反应,表明本发明用药安全,疗效稳定可靠。
典型病例:
河南省南阳市李XX,男,68岁,右胁胀痛1年余,加重伴脘腹胀满7天,2017年10月2日至医院查CT示:肝内多发占位,门静脉癌栓。乙肝病史30年。于2017年10月10日、2017年11月16日,2018年1月2日分次行肝动脉介入栓塞术。
中医诊断:肝积(正虚瘀结型)
西医诊断:原发性肝癌 IIIa期
首诊患者自诉右胁部胀痛,腹胀,周身乏力,纳呆食少。治疗方案选择扶正消瘤颗粒。二诊时患者自诉周身乏力减轻,右胁部仍有胀痛,腹胀减轻,食欲差。继续原方案治疗,三诊时右胁部无明显胀痛,无周生乏力,无腹胀,纳食可。经CT复查示:肝内活性病灶较前减小。期间未见明显不适及其他不良反应。
结论
由以上情况表明,本发明配伍科学合理,原料丰富,服用方便,效果好,共奏扶正祛邪之效,有效率高达92.5%,有效用于治疗原发性肝癌综合微创术后正虚瘀结证患者,是治疗原发性肝癌综合微创术后正虚瘀结证药物上的创新,具有实际的临床意义。
Claims (4)
1.一种治疗原发性肝癌综合微创术后正虚瘀结证的中药,其特征在于,该中药是由以下重量计的原料药物制成:黄芪25-35g、菝葜25-35g、党参12-18g、白术12-18g、白芍12-18g、丹参25-35g、鳖甲16-24g、牡蛎25-35g、猫人参25-35g、陈皮10-14g、柴胡8-12g和甘草5-7g,其中,将白术、陈皮粉碎,加白术、陈皮5倍量的质量浓度为70%的乙醇渗漉,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,将上述2味药材所得的药渣与黄芪、菝葜、党参、白芍、丹参、鳖甲、牡蛎、猫人参、柴胡、甘草10味药材合并在一起,加原料药物4-6倍量的水煎煮2次,每次2小时,合并2次所得煎液,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,合并2次制备得到的浸膏,干燥,粉碎成药粉,加入辅料,药粉与辅料配比为1:2,辅料组成为糊精-糖粉1:1,以质量浓度为80%的乙醇为润湿剂,均匀制成软材,过20目筛制粒,60℃进行干燥,14目筛过筛制粒,分装,即得颗粒剂。
2.根据权利要求1所述的治疗原发性肝癌综合微创术后正虚瘀结证的中药,其特征在于,由以下重量计的原料药物制成:黄芪26g、菝葜34g、党参13g、白术17g、白芍13g、丹参34g、鳖甲17g、牡蛎34g、猫人参26g、陈皮13g、柴胡9g和甘草7g,其中,将白术、陈皮粉碎,加白术、陈皮5倍量的质量浓度为70%的乙醇渗漉,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,将上述2味药材所得的药渣与黄芪、菝葜、党参、白芍、丹参、鳖甲、牡蛎、猫人参、柴胡、甘草10味药材合并在一起,加原料药物4倍量的水煎煮2次,每次2小时,合并2次所得煎液,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,合并2次制备得到的浸膏,干燥,粉碎成药粉,加入辅料,药粉与辅料配比为1:2,辅料组成为糊精-糖粉1:1,以质量浓度为80%的乙醇为润湿剂,均匀制成软材,过20目筛制粒,60℃进行干燥,14目筛过筛制粒,分装,即得颗粒剂。
3.根据权利要求1所述的治疗原发性肝癌综合微创术后正虚瘀结证的中药,其特征在于,由以下重量计的原料药物制成:黄芪30g、菝葜30g、党参15g、白术15g、白芍15g、丹参30g、鳖甲20g、牡蛎30g、猫人参30g、陈皮12g、柴胡10g和甘草6g,其中,将白术、陈皮粉碎,加白术、陈皮5倍量的质量浓度为70%的乙醇渗漉,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,将上述2味药材所得的药渣与黄芪、菝葜、党参、白芍、丹参、鳖甲、牡蛎、猫人参、柴胡、甘草10味药材合并在一起,加原料药物5倍量的水煎煮2次,每次2小时,合并2次所得煎液,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,合并2次制备得到的浸膏,干燥,粉碎成药粉,加入辅料,药粉与辅料配比为1:2,辅料组成为糊精-糖粉1:1,以质量浓度为80%的乙醇为润湿剂,均匀制成软材,过20目筛制粒,60℃进行干燥,14目筛过筛制粒,分装,即得颗粒剂。
4.根据权利要求1所述的治疗原发性肝癌综合微创术后正虚瘀结证的中药,其特征在于,由以下重量计的原料药物制成:黄芪34g、菝葜26g、党参17g、白术13g、白芍17g、丹参26g、鳖甲23g、牡蛎26g、猫人参34g、陈皮11g、柴胡11g和甘草5g,其中,将白术、陈皮粉碎,加白术、陈皮5倍量的质量浓度为70%的乙醇渗漉,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,将上述2味药材所得的药渣与黄芪、菝葜、党参、白芍、丹参、鳖甲、牡蛎、猫人参、柴胡、甘草10味药材合并在一起,加原料药物6倍量的水煎煮2次,每次2小时,合并2次所得煎液,在50℃条件下,减压浓缩制备成相对密度为1.2的浸膏,合并2次制备得到的浸膏,干燥,粉碎成药粉,加入辅料,药粉与辅料配比为1:2,辅料组成为糊精-糖粉1:1,以质量浓度为80%的乙醇为润湿剂,均匀制成软材,过20目筛制粒,60℃进行干燥,14目筛过筛制粒,分装,即得颗粒剂。
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