CN108210839B - 一种辅助治疗中晚期肝癌腹水的中药 - Google Patents

一种辅助治疗中晚期肝癌腹水的中药 Download PDF

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CN108210839B
CN108210839B CN201611193962.9A CN201611193962A CN108210839B CN 108210839 B CN108210839 B CN 108210839B CN 201611193962 A CN201611193962 A CN 201611193962A CN 108210839 B CN108210839 B CN 108210839B
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rhizoma
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chinese medicine
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CN108210839A (zh
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韩涛
李京
郑振东
刘璐
祁兴顺
杨晓丹
谷佳
付洋
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LIAONING XINGHAI PHARMACEUTICAL CO Ltd
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Abstract

本发明涉及中药领域，更具体地说，是涉及一种治疗中晚期肝癌腹水的中药。按重量份数计，其组成及重量配比为：柴胡5～50份，厚朴5～50份，枳实5～50份，乌药5～50份，木香5～50份，砂仁5～50份，苍术5～50份，鸡内金5～50份，陈皮5～50份，青皮5～50份，姜半夏5～50份，三棱5～50份，莪术5～50份，茯苓5～50份，猪苓5～50份，泽泻5～50份，大腹皮5～50份，泽兰5～50份，鳖甲5～50份，生牡蛎5～50份，酒军5～50份，商陆5～50份，决明子5～50份，猕猴桃根5～50份，黄连5～50份，生甘草5～50份，党参5～50份，黄芪5～50份，白术5～50份，山药5～50份，当归5～50份，枸杞子5～50份，白芍5～50份。

Description

一种辅助治疗中晚期肝癌腹水的中药
技术领域：
本发明涉及中药领域，更具体地说，是涉及一种治疗中晚期肝癌腹水的中药。
背景技术：
原发性肝癌是我国最为常见的恶性肿瘤之一，其死亡率很高，位于我国城市和农村恶性肿瘤的第2位，我国肝癌发病率可占全球的45％。晚期顽固性腹水即为晚期肝癌主要的并发症，如不能对其进行有效地治疗和控制，将严重影响患者的生存质量，病情凶险，预后极差。控制快速大量增长的晚期肝癌腹水，西医主要采取利尿、限盐、腹腔穿刺抽液、抽腹水后腹腔内注入化疗药物及生物反应调节剂等方法，但治疗后疗效并不理想。
近年来医学界普遍认识到，对于肿瘤的治疗，最理想的治疗方法即为带瘤生存，提高生活质量和延长生存期，现已成为肿瘤治疗的主流方向，而中医药在此方面具有明显优势。肝癌腹水可归属于中医学“臌胀”、“癥瘕”、“积聚”、“水蛊等范畴。其病情复杂，具有本虚标实、虚实夹杂、气血水合而为病的特点。肝癌腹水的主要病变在于肝、脾、肾三脏，以肝脾肾俱虚、气血亏虚为本，邪气积聚、气滞血瘀、湿浊内生、水饮内停为标。
由于晚期肝癌腹水的发生缠绵难愈，给目前的防治工作带来很大困难，如何选择有效治疗晚期肝癌腹水的中药方剂，减轻临床症状，提高生活质量，延长生存期，已成为目前中医临床工作亟待解决的问题。
发明内容：
本发明就是针对上述问题，提供了一种治疗中晚期肝癌腹水的中药，解决现有技术中晚期肝癌腹水防治困难等问题。
为了实现本发明的上述目的，本发明采用如下技术方案，
一种治疗中晚期肝癌腹水的中药，按重量份数计，其组成及重量配比为：柴胡5～50份，厚朴5～50份，枳实5～50份，乌药5～50份，木香5～50份，砂仁5～50份，苍术5～50份，鸡内金5～50份，陈皮5～50份，青皮5～50份，姜半夏5～50份，三棱5～50份，莪术5～50份，茯苓5～50份，猪苓5～50份，泽泻5～50份，大腹皮5～50份，泽兰5～50份，鳖甲5～50份，生牡蛎5～50 份，酒军5～50份，商陆5～50份，决明子5～50份，猕猴桃根5～50份，黄连 5～50份，生甘草5～50份，党参5～50份，黄芪5～50份，白术5～50份，山药5～50份，当归5～50份，枸杞子5～50份，白芍5～50份。
所述的治疗中晚期肝癌腹水的中药，按重量份数计，其组成及重量配比优选为：柴胡5～30份，厚朴5～30份，枳实5～30份，乌药5～30份，木香5～30 份，砂仁5～30份，苍术5～30份，鸡内金5～30份，陈皮5～30份，青皮5～ 30份，姜半夏5～30份，三棱5～30份，莪术5～30份，茯苓5～30份，猪苓5～ 30份，泽泻5～30份，大腹皮5～30份，泽兰5～30份，鳖甲5～30份，生牡蛎 5～30份，酒军5～30份，商陆5～30份，决明子5～30份，猕猴桃根5～30份，黄连5～30份，生甘草5～30份，党参5～30份，黄芪5～30份，白术5～30份，山药5～30份，当归5～30份，枸杞子5～30份，白芍5～30份。
本发明的优点及有益效果是：
本发明首次提出了“肝病调脾”的理论，《金匮翼·积聚统论》曰“凡忧思郁怒，久不得解者，多成此疾。”肝癌其病位在肝，七情过度，情志不畅，抑郁日久，或恼怒伤肝，可导致肝郁气滞，脏腑功能失调，肝郁伤脾，湿浊内生，气机阻滞则血运不畅，久则肝体受损，脉络受伤，痰瘀胶着，进而导致气滞湿租，瘀结水留，日积月累发为臌胀。因此，在肝癌中晚期腹水的治疗中，应同时采用了“消、清、补”相结合的方法。消法是通过消导和散结，使气、血、痰、水、食等聚之实邪渐消缓散的治法。疏肝理气、活血化瘀、燥湿化痰、利水渗湿、软坚散结、泻下通腹等治法均可归属于消法，本发明中运用柴胡、厚朴、枳实疏肝理气，乌药温中理气散结，调畅气机；肝癌腹水多为脾虚湿困，《金匮要略》中有云：“见肝之病，知当传脾，当先实脾”，依据“肝病调脾”的理论，应用木香、砂仁、苍术、鸡内金健脾行气，调中化湿，顾护脾胃；陈皮、青皮、姜半夏燥湿化痰；三棱、莪术具有破血行气、消积止痛之功效，现代药理学研究表明其具有抗氧化、抗凝血、抗肿瘤和保肝等活性成份，正如《金匮要略·水气》中有云：“血不利则为水”，活血散瘀之品具有消积散结之功效，可以改善肝脏微循环和解除循环障碍；茯苓、猪苓、泽泻、大腹皮利水渗湿消肿，猪苓中含有猪苓多糖，具有明显的抗癌作用，其抗肿瘤机制除直接抑制肿瘤细胞DNA合成和核苷转运外，尚能增强机体免疫功能从而抑制肿瘤细胞生长，有研究表明其可抑制多种动物移植性肿瘤生长；泽兰味苦、辛，性微温，归肝、脾经，具有活血行水之功效，《本草纲目》中有：“泽兰气香而温，味辛而散，阴中之阳，足太阴厥阴经药也。脾喜芳香，肝宜辛散。脾气舒，则三焦通利而正气和。泽兰走血分，故能治水肿，涂痈毒，散瘀血，消痈痛，而为妇人要药。”泽兰即可解除癌肿之瘀滞，又可行水消肿；鳖甲、生牡蛎柔肝软坚散结，具有提高血浆蛋白水平，增强免疫力，抑制结缔组织增生及抗肿瘤作用。酒军、决明子具有活血泻下通腑之功效，商陆味苦，性寒，有毒，归肺、脾、肾、大肠经，可攻逐水饮，给邪气以出路，对二便不利、腹胀水肿等症有确切疗效。现代药理研究发现，商陆具有较强的抗病毒、降脂、补钾、保肝、利尿和抗肿瘤等多重作用，可有效降低转氨酶，促进胃肠道消化吸收，增强免疫力，对降低肝癌患者门静脉压及提高食欲等具有良好的临床效果。对顽固性腹水患者，与泽泻、泽兰、大腹皮合用可明显增强利水的临床效果。另一方面肿瘤患者由于体内湿热壅结不解，血瘀不畅，导致羁留体内的癌毒，弛张活跃，缠绵难愈。因此，清法贯穿于疾病治疗之始终，这也是临床各家之共识。清法又称清热法，是一种通过运用寒凉性质的药物以达到泻火、解毒、凉血等功效的治疗方法。肝癌应用清热解毒之品，可以挫其锐气，抑其弛张，起到清除癌毒，化解湿热的目的。猕猴桃根、黄连、生甘草均有清热解毒之功，现代药理学研究显示，猕猴桃根提取物在体外治疗胃癌、肝癌以及食道癌等肿瘤细胞株具有显著的效果。从现代医学研究角度来分析，清热解毒中药可有效阻止病毒对肝细胞的破坏，也有利于肝组织的恢复，间接也起到治本的作用。补法以扶正祛邪原则，通过中药调节人体的阴阳平衡，激活机体免疫活性细胞，以达到祛除病邪的目的。“脾胃为气血生化之源”，方中运用党参、黄芪、白术、山药益气健脾，可扶助正气，提高机体的免疫功能，使抗邪有力；当归、枸杞子、白芍补血养肝，养阴调营，使气血充盛，利水而不伤正。诸药合用，全方共奏健脾化湿、理气活血、攻逐水饮之功，且无伤阴耗气之虞。
结果显示，服用本发明的患者腹水改善情况总有效率为77.55％。明显高于对照组的53.06％，差异有显著性意义(P＜0.05)。服用本发明的患者治疗前后抽取腹水时间间隔平均为(18.25±5.36)天，对照组为(11.27±4.67)天，两组比较差异有显著性(P＜0.05)。服用本发明的患者腹痛、腹胀、疲劳乏力、恶心呕吐、食少纳呆等中医症状积分较对照组降低更为明显，差异有统计学意义(P＜0.05)。服用本发明的患者Karnofsky评分较治疗前提高，对照组较治疗前降低，两组治疗前后差值比较均有显著性差异(P＜0.05)；服用本发明的患者生活质量改善情况优于对照组，两组结果差异有统计学意义(P＜0.05)。服用本发明的患者随访3个月后的腹水复发情况为16.33％(8/49)，对照组为63.27％(31/49)，两组比较有显著性差异(P＜0.05)。服用本发明的患者治疗后1年的生存率为34.69％(17/49)，对照组 14.29％(7/49)，两组比较有显著性差异(P＜0.05)。从而表明，本发明基于“肝病调脾”的理论，采用“消、清、补”相结合，祛邪扶正，运用健脾化湿、理气活血、攻逐水饮的治疗方法，调节人体的阴阳平衡，增强免疫功能，抑制肿瘤细胞生长，降低门静脉压，可明显消除腹水，降低腹水复发率，改善临床症状，提高生存质量，延长生存期。
具体实施方式：
下面，通过实施例和临床试验对本发明进一步详细阐述。
实施例1
本实施例中，治疗中晚期肝癌腹水的中药，其组成及重量配比为：
柴胡15g，厚朴15g，枳实15g，乌药15g，木香10g，砂仁10g，苍术15g，鸡内金15g，陈皮10g，青皮10g，姜半夏15g，三棱15g，莪术15g，茯苓15g，猪苓15g，泽泻30g，大腹皮30g，泽兰30g，鳖甲30g，生牡蛎30g，酒军9g，商陆9g，决明子15g，猕猴桃根30g，黄连9g，生甘草10g，党参15g，黄芪30g，白术15g，山药30g，当归15g，枸杞子30g，白芍30g。所述的中药为颗粒状，制备时，将原料药粉碎后按比例混合即可。
实施例2
本实施例中，治疗中晚期肝癌腹水的中药，其组成及重量配比为：
柴胡15g，厚朴10g，枳实10g，乌药15g，木香7g，砂仁7g，苍术15g，鸡内金15g，陈皮10g，青皮10g，姜半夏10g，三棱10g，莪术10g，茯苓15g，猪苓15g，泽泻20g，大腹皮30g，泽兰30g，鳖甲30g，生牡蛎30g，酒军5g，商陆6g，决明子10g，猕猴桃根15g，黄连5g，生甘草10g，党参15g，黄芪30g，白术15g，山药20g，当归15g，枸杞子15g，白芍20g。所述的中药为颗粒状，制备时，将原料药粉碎后按比例混合即可。
实施例3
本实施例中，治疗中晚期肝癌腹水的中药，其组成及重量配比为：
柴胡15g，厚朴15g，枳实15g，乌药15g，木香10g，砂仁10g，苍术15g，鸡内金15g，陈皮10g，青皮10g，姜半夏15g，三棱10g，莪术10g，茯苓15g，猪苓15g，泽泻30g，大腹皮30g，泽兰30g，鳖甲30g，生牡蛎30g，酒军6g，商陆6g，决明子10g，猕猴桃根30g，黄连6g，生甘草10g，党参15g，黄芪30g，白术15g，山药30g，当归15g，枸杞子30g，白芍30g。所述的中药为颗粒状，制备时，将原料药粉碎后按比例混合即可。
临床试验
选取确诊为晚期肝癌腹水的患者98例，所有患者均符合《内科肿瘤学》所制定的西医诊断标准，经超声、CT或MRI影像学检查明确有肝内实质性占位病变；持续4周以上AFP＞400μg/L；生活质量评分在40分以上，预计生存期在1 个月以上；排除继发性肝癌。按超声检查评估腹水量：小于500ml为轻度腹水， 500～2000ml为中度腹水，大于2000ml为重度腹水。中医诊断标准参照《中药新药临床研究指导原则》制定，并采用随机数字法抽取患者分为实验组与对照组，实验组49例(男性36例，女性13例)，男女比例为2.78：1，年龄35～75岁，平均(57.5±7.87)岁，腹水程度：轻度25例，中度20例，重度4例。对照组49 例(男性34例，女性15例)，男女比例为2.27：1，年龄25～95岁，平均(58.3±7.87) 岁，腹水程度：轻度27例，中度19例，重度3例；两组患者性别、年龄、病程、腹水量、原发肿瘤的部位、病理类型、转移部位的分布、转移灶的数目、体力状况KPS评分，中医症候积分、初、复治情况上基本均衡，差异无统计学意义(P ＞0.05)，具有可比性。
对照组患者予以呋塞米40mg/d，螺内酯100mg/d，药量根据腹水消退情况进行增减。低蛋白血症者(低于25g/L)予以人血白蛋白纠正低蛋白血症以利尿。实验组患者在对照组的基础上取实施例1的药方服用，每剂2煎，每煎加水500ml，文火煎至300mL，早、中、晚饭后温服，每天三次，每次100ml。1个月为一个疗程，治疗3个疗程。治疗结束后，观察治疗前后腹水变化情况、腹围、24h尿量、TBili、ALT、生活质量及中医症状积分变化情况。治疗后每1个月随访一次，进行腹部超声检查，以腹水复发为终点事件，计算实验组和对照组腹水复发率。对患者生存期进行随访，观察在治疗后3个月、6个月、1年以上的生存期(指从治疗日开始至死亡或末次随访日期为止)。
疗效标准：(1)腹水疗效判定标准按WHO制定的标准。完全缓解(CR)：经1个疗程治疗后症状缓解，腹水完全消失，并且维持4周以上。部分缓解(PR)：经1个疗程治疗后症状缓解，腹水消失或减少≥50％；稳定(NC)：经1个疗程治疗后腹水减少小于50％。无效或进展(PD)：腹水无减少或进一步增加，引起腹胀或呼吸困难加重，缓解症状需再次抽取腹水者。(2)中医临床证候疗效判定标准参照《中药新药临床研究指导原则》制定，首先将各个症状进行分级量化，共分成无、轻、中、重4个级别，分别记为0、1、2、3分，统计并比较治疗前后总积分，疗效根据尼莫地平法进行判断，显效：积分减少≥70％，有效：积分减少≥30％，无效：积分减少＜30％。总有效率＝[(治疗前积分-治疗后积分)÷治疗前积分]×100％。(3)生活质量评分标准参照《内科肿瘤学》拟定，根据治疗前后体力状况按体力状况，采用卡式评分标准(Karnofsky评分)。提高：较治疗前 Karnofsky评分上升≥10分；稳定：较治疗前Karnofsky评分上升或下降不足10 分；下降：较治疗前Karnofsky评分下降≥10分。
结果：(1)腹水改善情况比较。实验组完全缓解2例，显效12例，有效24 例，无效11例，总有效率为77.55％。对照组显效8例，有效18例，无效23例，总有效率为53.06％。实验组腹水改善情况明显优于对照组，两组结果有显著性差异(P＜0.05)。两组治疗后抽取腹水时间间隔均有所延长，其中，实验组治疗前后抽取腹水时间间隔平均为(18.25±5.36)天，对照组为(11.27±4.67)天，两组比较差异有显著性(P＜0.05)。(2)中医症状积分比较。治疗后两组患者临床症状均有所好转，但实验组患者腹痛、腹胀、疲劳乏力、恶心呕吐、食少纳呆等中医症状积分较对照组降低更为明显，差异有统计学意义(P＜0.05)。(3)生活质量比较。服用本发明的患者Karnofsky评分较治疗前提高，对照组较治疗前降低，两组治疗前后差值比较均有显著性差异(P＜0.05)；实验组生活质量提高者12例，稳定者14 例，下降者4例；对照组生活质量提高者3例，稳定者14例，下降者13例；两组生活质量改善情况差异有统计学意义(P＜0.05)。(4)腹水复发情况比较。随访1个月复发：实验组16.33％(8/49)，对照组38.78％(19/49)，虽然实验组较对照组腹水复发率低，但无显著性差异(P＞0.05)。随访3个月复发：实验组 16.33％(8/49)，对照组63.27％(31/49)，两组比较有显著性差异(P＜0.05)。(5) 生存期比较。治疗后3个月的生存率：实验组91.84％(45/49)，对照组87.76％(43/49)，两组比较无显著性差异(P＞0.05)。治疗后6个月的生存率：实验组62.22％(28/45)，对照组41.86％(18/43)，虽然实验组较对照组生存率有提高，但无显著性差异(P＞0.05)。治疗后1年的生存率：实验组34.69％(17/49)，对照组14.29％(7/49)，两组比较有显著性差异(P＜0.05)。
实施例结果表明，采用本发明可有效治疗中晚期肝癌腹水的中药方剂，减轻临床症状，提高生活质量，延长生存期。

Claims (3)

1.一种辅助治疗中晚期肝癌腹水的中药，其特征在于，按重量份数计，其组成及重量配比为：柴胡15份，厚朴15份，枳实15份，乌药15份，木香10份，砂仁10份，苍术15份，鸡内金15份，陈皮10份，青皮10份，姜半夏15份，三棱15份，莪术15份，茯苓15份，猪苓15份，泽泻30份，大腹皮30份，泽兰30份，鳖甲30份，生牡蛎30份，酒军9份，商陆9份，决明子15份，猕猴桃根30份，黄连9份，生甘草10份，党参15份，黄芪30份，白术15份，山药30份，当归15份，枸杞子30份，白芍30份。
2.一种辅助治疗中晚期肝癌腹水的中药，其特征在于，按重量份数计，其组成及重量配比为：柴胡15份，厚朴10份，枳实10份，乌药15份，木香7份，砂仁7份，苍术15份，鸡内金15份，陈皮10份，青皮10份，姜半夏10份，三棱10份，莪术10份，茯苓15份，猪苓15份，泽泻20份，大腹皮30份，泽兰30份，鳖甲30份，生牡蛎30份，酒军5份，商陆6份，决明子10份，猕猴桃根15份，黄连5份，生甘草10份，党参15份，黄芪30份，白术15份，山药20份，当归15份，枸杞子15份，白芍20份。
3.一种辅助治疗中晚期肝癌腹水的中药，其特征在于，按重量份数计，其组成及重量配比为：柴胡15份，厚朴15份，枳实15份，乌药15份，木香10份，砂仁10份，苍术15份，鸡内金15份，陈皮10份，青皮10份，姜半夏15份，三棱10份，莪术10份，茯苓15份，猪苓15份，泽泻30份，大腹皮30份，泽兰30份，鳖甲30份，生牡蛎30份，酒军6份，商陆6份，决明子10份，猕猴桃根30份，黄连6份，生甘草10份，党参15份，黄芪30份，白术15份，山药30份，当归15份，枸杞子30份，白芍30份。
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CN102274464A (zh) * 2011-08-10 2011-12-14 马彦秀 一种治疗慢性肝炎、脾大及肝硬化的中药组合物

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CN102274464A (zh) * 2011-08-10 2011-12-14 马彦秀 一种治疗慢性肝炎、脾大及肝硬化的中药组合物

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