CN116549578A - 一种治疗肿瘤药物不良反应的中药组合物 - Google Patents
一种治疗肿瘤药物不良反应的中药组合物 Download PDFInfo
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Abstract
本发明涉及中药技术领域,尤其涉及的是一种治疗肿瘤药物不良反应的中药组合物,所述中药组合物由下列重量份配比的中药原料制备而成:水牛角15~30份、生地10~30份、丹皮10~20份、赤芍10~30份、当归10~20份、黄柏6~15份、砂仁6~15份、金银花10~30份、麦冬10~30份、茯苓10~30份、白术10~30份、党参10~30份、莲子10~30份、山药10~30份、扁豆10~30份、薏苡仁10~30份、乌梅10~30份、黄芪10~30份、白鲜皮10~30份、甘草6~15份。该药方通过清热凉血解毒、健脾化湿止泻来达到治疗肿瘤药物不良反应的目的,可以有效防治肿瘤药物出现的不良反应。
Description
技术领域
本发明涉及中药技术领域,尤其涉及一种治疗肿瘤药物不良反应的中药组合物。
背景技术
肿瘤治疗发展迅速,目前,已对肿瘤中检测到的特异分子研发出靶向性治疗药物。同时,肿瘤免疫治疗也逐渐展现其优势。这些靶向药物及免疫检查点抑制剂(ICI)较传统化疗药针对性更强、疗效更好、且相关不良反应减少。但随着这些药物在临床的广泛应用及患者对生活质量期望的不断提高,这些新型药物的不良反应越来越受到重视。
临床过程中我们发现,靶向药物和免疫检查点抑制剂最常见不良反应均表现为皮疹、腹泻、肝损害、口腔黏膜炎、甲沟炎、间质性肺炎、鼻腔出血等,以皮疹、黏膜炎最多见。如一代靶向药代表盐酸埃克替尼片(凯美纳)最常见的不良反应有:皮疹(40%)、腹泻(18.5%)、转氨酶升高(8%)和口腔溃疡(3.5%);三代靶向药代表甲磺酸奥西替尼片(泰瑞沙)最常见的不良反应有:腹泻(47%)、皮疹(45%)、甲沟炎(33%)、皮肤干燥(32%)和口腔黏膜炎(24%);免疫检查点抑制剂代表药物纳武利尤单抗注射液最常见的不良反应依次为:疲劳(30%)、皮疹(17%)、瘙痒(13%)、腹泻(13%)和口腔炎(常见)。这些不良反应会影响疗效和患者的生活质量,严重的可导致患者自行对药物进行减量或中止治疗。
中医药在防治靶向或免疫治疗不良反应的过程中取得了一定进展。但是目前的中医药研究大多是针对某一个不良反应,比如只针对皮疹,或者只针对腹泻,尚无针对多种不良反应的药物制剂研究,而临床实际中,治疗皮疹的药物多以清热解毒凉血药为主,该类药物容易加重腹泻;而治疗的腹泻的燥湿健脾药物,又可能加重皮疹,患者无从选择,这一现象已经成为了临床的一大困境。因此,研发一种可以同时将靶向药物多种不良反应综合治疗的中药制剂已经迫在眉睫。
肿瘤药物的不良反应表现多样,中医学将药物引起的皮肤不良反应归属于“药毒疹”、“药疹”范畴,早在《素问·生气通天论》中提到“诸痛痒疮,皆属于心(火)”,刘完素之“诸涩枯涸,干劲皴揭,皆属于燥”,《诸病源候论·疮诸病·头面身体诸疮候》认为“肺主气,候于皮毛;脾主肌肉。气虚则肤腠开,为风湿所乘;内热则脾气温,脾气温则肌肉生热也。湿热相搏,故头面身体皆生疮”,认为皮肤疮疹与火毒、湿热、津亏燥热等相关。
腹泻是最常见的靶向药物所致消化系统不良反应,临床表现为大便次数增多、大便性状改变(如水样便、稀便)等。该病属中医“泄泻”范畴。《景岳全书》云:“泄泻之本,无不由脾胃,脾弱者,因虚所以易泻,因泻所以愈虚,盖关门不固也”。《医宗必读》提到“无湿不成泄”,脾虚与湿邪为泄泻基本病机。
口腔黏膜炎是EGFR抑制剂常见不良反应,好发于口底、唇、舌等部位,临床多以疼痛为主要症状。中医认为,该病属“口疮”范畴,《口齿类要》认为口疮病机为“上焦实火,中焦虚寒,下焦阴火”,《脾胃论·饮食劳倦所伤始为热中论》“脾胃气衰,元气不足,而心火独盛”,总以虚火上炎为其基本病机。
临床上,全身不同部位的恶性肿瘤如肺癌、鼻咽癌、乳腺癌、结直肠癌、胃癌、肝癌、黑色素瘤、肾细胞癌、霍奇金淋巴瘤、各种肉瘤等,均可选择化疗、靶向治疗、免疫治疗等其中一种或多种联合。常用化疗药包括环磷酰胺、紫杉醇、长春新碱、多柔比星、铂类等;常用靶向药如吉非替尼、厄洛替尼、奥希替尼、克唑替尼、阿来替尼等;常用免疫检查点抑制剂如帕博利珠单抗、卡瑞利珠单抗、纳武利尤单抗、替雷利珠单抗等。但西药治疗过程中必然出现不同程度、不同形式的不良反应,且最终均会出现耐药。
综上,因肿瘤药物不良反应病机复杂,寒热交错、虚实夹杂,需要寒热同调、虚实兼顾。本方以犀角地黄汤、参苓白术散、封髓丹、乌梅丸、导赤散等中医经典方剂加减组合而成。
发明内容
本发明的目的在于克服现有技术的不足,提供了一种将多种不良反应综合考虑且疗效好、疗程短、毒副作用小的防治肿瘤药物不良反应的中药组合物。
第一方面,本发明提供一种治疗肿瘤药物不良反应的中药组合物,所述中药组合物由下列重量份配比的中药原料制备而成:水牛角15~30份、生地10~30份、丹皮10~20份、赤芍10~30份、当归10~20份、黄柏6~15份、砂仁6~15份、金银花10~30份、麦冬10~30份、茯苓10~30份、白术10~30份、党参10~30份、莲子10~30份、山药10~30份、扁豆10~30份、薏苡仁10~30份、乌梅10~30份、黄芪10~30份、白鲜皮10~30份、甘草6~15份。
优选的,所述中药组合物由下列重量份配比的中药原料制备而成,水牛角20~30份、生地15~30份、丹皮12~20份、赤芍12~30份、当归10~18份、黄柏6~12份、砂仁6~12份、金银花15~30份、麦冬12~30份、茯苓15~30份、白术12~30份、党参10~25份、莲子15~30份、山药15~30份、扁豆15~30份、薏苡仁15~30份、乌梅10~25份、黄芪10~25份、白鲜皮15~30份、甘草6~12份。
优选的,所述中药组合物由下列重量份配比的中药原料制备而成,水牛角25~30份、生地20~30份、丹皮14~20份、赤芍14~30份、当归10~15份、黄柏6~10份、砂仁6~10份、金银花15~20份、麦冬13~25份、茯苓20~30份、白术15~20份、党参10~20份、莲子20~25份、山药20~30份、扁豆20~30份、薏苡仁20~30份、乌梅10~20份、黄芪10~20份、白鲜皮20~30份、甘草6~10份。
优选的,所述中药组合物由下列重量配比的中药原料制备而成,水牛角30份、生地20份、丹皮15份、赤芍15份、当归12份、黄柏10份、砂仁10份、金银花20份、麦冬15份、茯苓20份、白术15份、党参15份、莲子30份、山药30份、扁豆30份、薏苡仁30份、乌梅15份、黄芪15份、白鲜皮15份、甘草10份。
第二方面,本发明提供一种治疗肿瘤药物不良反应的中药制剂,所述中药制剂包含可治疗肿瘤药物不良反应的中药组合物和药学上可接受的辅料,所述中药组合物由以下重量份配比的中药原料制备而成,水牛角15~30份、生地10~30份、丹皮10~20份、赤芍10~30份、当归10~20份、黄柏6~15份、砂仁6~15份、金银花10~30份、麦冬10~30份、茯苓10~30份、白术10~30份、党参10~30份、莲子10~30份、山药10~30份、扁豆10~30份、薏苡仁10~30份、乌梅10~30份、黄芪10~30份、白鲜皮10~30份、甘草6~15份。
优选的,所述中药组合物由下列重量份配比的中药原料制备而成,水牛角20~30份、生地15~30份、丹皮12~20份、赤芍12~30份、当归10~18份、黄柏6~12份、砂仁6~12份、金银花15~30份、麦冬12~30份、茯苓15~30份、白术12~30份、党参10~25份、莲子15~30份、山药15~30份、扁豆15~30份、薏苡仁15~30份、乌梅10~25份、黄芪10~25份、白鲜皮15~30份、甘草6~12份。
优选的,所述中药组合物由下列重量份配比的中药原料制备而成,水牛角25~30份、生地20~30份、丹皮14~20份、赤芍14~30份、当归10~15份、黄柏6~10份、砂仁6~10份、金银花15~20份、麦冬13~25份、茯苓20~30份、白术15~20份、党参10~20份、莲子20~25份、山药20~30份、扁豆20~30份、薏苡仁20~30份、乌梅10~20份、黄芪10~20份、白鲜皮20~30份、甘草6~10份。
优选的,所述中药组合物由下列重量份配比的中药原料制备而成,水牛角30份、生地20份、丹皮15份、赤芍15份、当归12份、黄柏10份、砂仁10份、金银花20份、麦冬15份、茯苓20份、白术15份、党参15份、莲子30份、山药30份、扁豆30份、薏苡仁30份、乌梅15份、黄芪15份、白鲜皮15份、甘草10份。
进一步的,所述的辅料是对主药具有增强疗效、降低毒性和/或减轻副作用的药用辅料。
进一步的,所述中药组合物的制剂可以为膏方、丸剂、丹剂、汤剂、颗粒剂、胶囊剂、散剂、片剂等。
进一步的,所述的肿瘤包括但不限于肺癌、鼻咽癌、乳腺癌、结直肠癌、胃癌、肝癌、黑色素瘤、肾细胞癌、霍奇金淋巴瘤、各种肉瘤。
进一步的,所述的肿瘤药物包括但不限于化疗药、靶向治疗药、免疫治疗药中的一种或多种。
更进一步的,所述的化疗药包括但不限于环磷酰胺、紫杉醇、长春新碱、多柔比星、铂类中的一种或多种。
更进一步的,靶向治疗药包括但不限于吉非替尼、厄洛替尼、奥希替尼、克唑替尼、阿来替尼中的一种或多种。
更进一步的,免疫治疗药物包括但不限于帕博利珠单抗、卡瑞利珠单抗、纳武利尤单抗、替雷利珠单抗中的一种或多种。
进一步的,所述的肿瘤药物不良反应包括但不限于各种皮疹、口腔黏膜炎、腹泻中的一种或多种。
本发明中各味中药原料的主要功效及药理作用为:
水牛角:味苦性寒,入心肝经,可清热凉血,解毒,定惊,功似犀牛角;治疗温病高热,神昏谵语,惊风,癫狂;血热妄行斑疹、吐衄;痈肿疮疡,咽喉肿痛。
水牛角主要化学成分含胆甾醇、肽类及多种氨基酸、多种微量元素。具有强心、降血压、增加血小板计数、缩短凝血时间、降低毛细血管通透性、抗炎、镇静等作用。以水牛角代替犀角为君药的犀角地黄汤具有凉血散瘀、清热解毒之功,临床治疗多种炎症性、变态反应性皮肤病、重症药物性皮炎等,均取得良好的疗效。
生地:味甘苦性寒,入心肝肾经,能清热凉血,养阴生津;治疗热入营血,舌绛烦渴,斑疹吐衄、阴虚内热,骨蒸痨热、津伤口渴,内热消渴,肠燥便秘。
生地黄中的主要化学成分为糖类、环烯和氨基酸等。药理学研究证实其具有抗氧化、抗衰老、免疫兴奋、降血糖、抗癌、抗脑缺血、保护神经中枢、促进造血、止血、强心、保肝及抑菌等作用。
牡丹皮:味苦辛性微寒,入心肝肾经,能清热凉血、活血化瘀、止血、清透伏热;治疗温毒发斑,血热吐衄、温病伤阴,阴虚发热,夜热早凉,无汗骨蒸、血滞经闭、痛经,跌打损伤、痈肿疮毒。
牡丹皮化学成分主要包括苯乙酮类、萜类及其苷类、有机酸类以及其他类成分,具有抗炎、调节免疫功能、保护心血管等作用。
赤芍:味苦性微寒,入肝经,能清热凉血,散瘀止痛,治疗温病发斑,血热吐衄/目赤肿痛,痈肿疮疡、肝郁胁痛,经闭痛经,癥瘕腹痛,跌打损伤。
赤芍含有丰富的苷类化合物,主要有芍药苷、芍药内酯苷、芍药新苷、芍药新甙、芍药醇、没食子酸乙酯、氧化芍药苷、芍药吉酮、芍药内酯A等成分。这些单萜苷被认为是赤芍的主要活性成分,故赤芍具有抗凝、抗血栓、消炎、抗肿瘤等功效。
当归:味甘辛性温,入肝心脾经,可补血调经,活血止痛,润肠通便,散寒止痛;治疗血虚诸证、血虚血瘀,月经不调,经闭,痛经、虚寒性腹痛,跌打损伤,痈疽疮疡,风寒痹痛、血虚肠燥便秘。
当归主要化学成分有挥发油、有机酸、多糖类、黄酮类等,对造血系统、心血管系统、免疫系统均有良好的药理作用,且当归还具有抗肿瘤、抗辐射、抗氧化以及消炎镇痛等多方面的作用。
黄柏:味苦性寒,入肾膀胱大肠,能清热燥湿、泻火解毒、除骨蒸,治疗湿热带下,热淋涩痛、湿热泻痢,黄疸、湿热脚气,痿证、骨蒸痨热,盗汗,遗精、疮疡肿毒,湿疹瘙痒。
黄柏主要化学成包括生物碱、内酯、酚酸、萜、苯丙素等多种类型成分,具有抗炎、抑菌、抗氧化、抗肿瘤、降糖、保护神经、止泻等多方面的理作用。
砂仁:味辛性温,入脾胃肾经,可化湿行气,温中止泻,安胎;治疗湿阻中焦及脾胃气滞、脾胃虚寒吐泻、气滞妊娠恶阻及胎动不安。
砂仁的化学成分包括以乙酸龙脑酯、樟脑、龙脑等为代表的挥发性成分和以多糖、黄酮苷类、无机成分以及有机酸类的非挥发性成分,具有抗溃疡作用、抑菌作用和调节菌群作用、降血糖作用、抗氧化作用。
金银花:味甘性寒,入肺心胃经,能清热解毒、疏散风热、凉血止痢,治疗痈肿疔疮、外感风热,温病初起、热毒血痢。
金银花化学成分主要含有黄酮类、有机酸类、挥发油类、磷脂化合物、环烯醚萜类等,具有抗炎、抗氧化、抗紫外线损伤、降血脂、降血糖、抗病毒等作用。常用于治疗发热、痢疾、丹毒、肺炎、咽喉肿疼、蜂窝状组织炎和热风邪等各种疾病。被称为“疮家圣药”。
麦冬:味甘微苦性微寒,入肺胃心经,能养阴润肺、益胃生津、清心除烦、润肠通便,治疗胃阴虚证、肺阴虚证、心阴虚证。
麦冬中有效化学成分为甾体皂苷、高异黄酮、糖类、挥发油和微量元素等,具有保护心血管、降糖降血脂、抗炎、抗氧化、抗肿瘤、抗衰老和免疫调节等药理学作用。
茯苓:味甘淡性平,入心脾肾经,能利水渗湿、健脾、宁心,治疗水肿、痰饮、脾虚泄泻、心悸失眠。
茯苓主要含多糖类、三萜类、甾醇类、挥发油类、蛋白质等,其主要活性成分有两种,一种是三萜类,另一种是多糖类化合物。其在泌尿系统、消化系统、中枢神经、免疫系统等都有疗效,具有利尿、保肝、镇静、提免疫力、抗炎、抗肿瘤以及降血脂等多种药理作用。
党参:味甘性平,入脾肺经,能补脾肺气、补血、生津、扶正祛邪,治疗脾肺气虚证、气血两虚、气津两伤。
党参主要含有生物碱、炔类、萜类、黄酮类、糖类等化学成分,对神经系统、内分泌系统、免疫系统、消化系统等具有药理作用。
白术:味甘苦性温,入脾胃经,可补气健脾,燥湿利水,止汗,安胎;治疗脾气虚、气虚自汗、脾虚胎动不安。
白术的化学成分主要为白术挥发油、白术内酯以及白术多糖。并具有保肝、调节胃肠运动、抗炎症、抗肿瘤、调节免疫系统、降血糖、调节免疫代谢等作用。
莲子:味甘涩性平,入脾肾心经,能益肾固精、补脾止泻、止带、养心安神、交通心肾,治疗遗精滑精、带下、脾虚泄泻、心悸失眠。
莲子主要含有生物碱、黄酮、糖苷、萜类、类固醇、脂肪酸、蛋白质、矿物质和维生素等化学成分,具有调脂减肥、抑菌、抗炎、抗氧化、止血等药理活性。
山药:味甘性平,入脾肺肾经,能益气养阴、补脾肺肾、固精止带,治疗脾虚、肺虚、肾虚、消渴气阴两虚证。
山药含有丰富的甾体皂苷类、多糖、尿囊素、黄酮类和酚苷类等活性成分,其化学成分的多样性使其拥有多种药理作用,如保肝、抗炎、免疫调节、降尿酸、抗肿瘤和在肾病方面的治疗作用等。
扁豆:味甘性微温,入脾胃经,能补脾和中、化湿,治疗脾气虚、暑湿吐泻。
扁豆含有蛋白质类(生物活性物质)、糖类、甾体及苷类、维生素和矿物质类等,具有抗菌、抗病毒、提高免疫功能、抗肿瘤、抗氧化活性、保护神经细胞等药理作用。
薏苡仁:味甘淡性凉,入脾胃肺经,能利水渗湿、健脾、除痹、清热排脓,治疗水肿、小便不利、脚气、脾虚泄泻、湿痹拘挛、肺痈,肠痈。
薏苡仁含有淀粉、脂肪酸及酯类、多糖、蛋白质,以及酚酸、甾醇、黄酮、内酰胺、三萜、生物碱、腺苷等各种营养物质。主要活性成分为酯类、不饱和脂肪酸、糖类及内酰胺类等;具有抗肿瘤、镇痛抗炎、调节糖脂代谢、增强免疫、降血压、抗氧化、抗衰老、美白等药理作用。
乌梅:味酸涩性平,入大肠肝脾肺经,能敛肺止咳、涩肠止泻、安蛔止痛、生津止渴,炒炭固冲止漏,外敷消疮毒、和胃止呕,治疗肺虚久咳、久泻久痢、蛔厥腹痛,及呕吐、虚热消渴、崩漏不止,便血、外敷胬肉外突、头疮。
乌梅的化学成分主要为有机酸、萜类、甾醇、挥发性成分、氨基类、糖类、脂类、黄酮类、生物碱等。具有抑菌、镇咳、镇静催眠及抗惊厥、抗病毒、抗变态反应、抗肿瘤、抗氧化、抗纤维化、降低血脂、抑制黑色素、抗生治疗结肠炎、降血糖、防治结石和止血等多种药理作用。
黄芪:味甘性微温,入脾肺经,能补气健脾、升阳举陷、益卫固表、利尿消肿、托毒生肌、补气生血,治疗脾气虚证、肺气虚、气虚自汗、气血亏虚,疮疡难溃难腐,或溃久难敛、痹证、中风后遗症等气虚血滞。
黄芪主要化学成分为多糖类、皂苷类、黄酮类、氨基酸类、生物碱类等,具有抗肿瘤、保护心脑血管、提高机体免疫功能、保护呼吸功能、保护代谢(肝、肾)组织、调节血压、抗衰老、防治骨质疏松症等作用。
白鲜皮:味苦性寒,入脾胃膀胱经,能清热燥湿、祛风解毒、通痹湿热,治疗疮毒,湿疹,疥癣、湿热黄疸,风湿热痹。
白鲜皮含有多种化学成分,包括生物碱、柠檬苦素、黄酮、倍半萜及其苷类、甾体等。白鲜皮具有广泛的药理作用,包括抗炎、抗真菌、抗动脉粥样硬化、止血、抗癌、神经保护以及抗氧化等。
甘草:味甘性平,入心肺脾胃经,能补脾益气、祛痰止咳、缓急止痛、清热解毒、调和诸药,治疗心气不足,脉结代,心动悸、脾气虚、咳喘、脘腹、四肢挛急疼痛、热病疮疡,咽喉肿痛,药食中毒、调和药性。
甘草化学成分多样,三萜皂苷类化合物、黄酮类化合物、香豆素类化合物以及多糖、脂肪等多种化学成分,具有广泛的抗肿瘤、抗炎、抗菌、抗病毒、神经保护、肝脏保护等药理作用。
犀角地黄汤清热凉血解毒,方用苦咸寒之犀角(现用水牛角代)为君,直入血分,凉血清心而解热毒,使热清毒解血宁。臣以甘苦寒之生地黄,清热凉血养阴,既助君药清热凉血,又复已失之阴血。君臣相伍,以清为主,兼以补固。芍药、丹皮为佐,清热凉血,活血散瘀,可收化斑之功。四药相配,共成清热解毒、凉血散瘀之剂。佐以当归养血润燥,白鲜皮清热燥湿、祛风解毒,主要针对皮疹反应。
封髓丹交通心肾、调和水火,能治一切虚火上冲。方用黄柏为君,以其味性苦寒,苦能坚肾,肾职得坚则阴水不虞其泛溢,寒能清肃,秋令一至,则龙火不至于奋阳,水火交摄,精有不安其位者乎;佐以甘草,以甘能缓急,泻诸火与肝火之内烦,且能使水土合为一家,以妙封藏之固;若缩砂者,以其味辛性温,善能入肾,肾之所恶在燥,而润之者惟辛,缩砂通三焦,达津液能纳五脏六腑之精,而归于肾,肾家之气纳,肾中之髓自藏矣。佐“疮家圣药”金银花清热解毒、麦冬滋阴清热,主要针对口腔黏膜炎。
参苓白术散补脾胃,益肺气。方中人参、白术、茯苓益气健脾渗湿,为君药。山药、莲子助人参益气健脾,兼能止泻;白扁豆、薏苡仁助白术、茯苓健脾渗湿,共为臣药。佐以砂仁醒脾和胃,桔梗宣肺利气,以通调水道,又载药上行,以益肺气。甘草健脾和中,调和诸药,为使药。诸药相合,共起补脾胃、渗湿浊、行气化滞之功。加黄芪增强补气健脾,乌梅生津止渴、收敛止泻,主要针对腹泻。
本发明的中药组合物的治则是通过清热凉血解毒、健脾化湿止泻来达到治疗肿瘤药物不良反应的目的,尤其是对于靶向、免疫等抗肿瘤药物引发的不良反应,最常见的如皮疹、腹泻、口腔黏膜炎等证属热入营血、脾虚湿盛的患者治疗效果最佳。纵观本中药方剂用药共20味,其药性平和,清热凉血解毒与健脾化湿止泻同行,寒热同调、虚实兼顾,可以有效防治肿瘤药物(靶向药物、免疫检查点抑制剂)出现的不良反应。
具体实施方式
下面对本发明的实施例作详细说明,以下实施例在以本发明技术方案为前提下进行实施,给出了详细的实施方式和具体的操作过程,但本发明的保护范围不限于下述的实施例。
实施例1
中药方剂重量配比如下:水牛角30份、生地30份、丹皮15份、赤芍15份、当归12份、黄柏10份、砂仁10份、金银花20份、麦冬20份、茯苓20份、白术15份、党参15份、莲子30份、山药30份、扁豆30份、薏苡仁30份、乌梅15份、黄芪15份、白鲜皮20份、甘草10份。
汤药煎煮方法:先用2500ml温开水将上述方剂药材(除砂仁外)浸泡半小时,然后用大火煮开8分钟,再换小火煎煮40分钟,砂仁在最后的10分钟时放入。
实施例2
中药方剂重量配比如下:水牛角15份、生地15份、丹皮12份、赤芍12份、当归12份、黄柏10份、砂仁10份、金银花15份、麦冬15份、茯苓30份、白术20份、党参15份、莲子30份、山药30份、扁豆30份、薏苡仁30份、乌梅30份、黄芪15份、白鲜皮15份、甘草10份。
汤药煎煮方法:先用2500ml温开水将上述方剂药材(除砂仁外)浸泡半小时,然后用大火煮开6分钟,再换小火煎煮40分钟,砂仁在最后的10分钟时放入。
实施例3
中药方剂重量配比如下:水牛角30份、生地20份、丹皮15份、赤芍15份、当归12份、黄柏10份、砂仁10份、金银花30份、麦冬15份、茯苓20份、白术15份、党参15份、莲子15份、山药20份、扁豆20份、薏苡仁20份、乌梅15份、黄芪15份、白鲜皮15份、甘草10份。
汤药煎煮方法:先用2500ml温开水将上述方剂药材(除砂仁外)浸泡半小时,然后用大火煮开10分钟,再换小火煎煮40分钟,砂仁在最后的10分钟时放入。
实施例4临床疗效观察
对2020.5-2023.4北京胸科医院中医科门诊及住院病房的肿瘤药物不良反应患者72例进行临床观察,随机分为两组,中药组与对照组各36例,所有受试者签署知情同意书并详细记录其临床病案信息。
中药组患者服用本发明实施例1所得方剂,每天一剂煎汤内服,早晚饭后半小时左右分两次温服,每次200ml,4周为一疗程,连续观察3个疗程(严重者需中西医结合治疗);对照组根据临床需要予以常规西医对症缓解治疗。
随访周期:12周;
随访频次:即基线、4周、8周、12周,共4次。
西医诊断标准:
肿瘤药物不良反应诊断标准参照美国国立癌症研究所通用毒性判定标准(NCI-CTCAE v5.0)制定,程度在2级到3级之间,即:
①各种皮疹(覆盖10-30%体表面积,伴或不伴症状;覆盖>30%体表面积,伴有中重度症状);
②口腔黏膜炎(中度疼痛/溃疡,不影响经口进食,需要调整饮食;重度疼痛,影响经口进食);
③腹泻(每天增加4-6次;造瘘口排出物中度增加;每天增加≥7次,造瘘口排出物重度增加,需要住院)。
①、②、③以不同程度的形式同时并存。
中医诊断辨证标准:
参考2002年《中药新药临床研究指导原则(试行)》中的证候辨证标准及《中医病证诊断疗效标准》中的热入营血、脾虚湿盛的辨证标准,即患者出现局部或全身皮疹,色红,高于皮面,皮面上伴或不伴水疱,甚至大疱、表皮坏死、松解,口腔溃疡,大便次数增多大于4次每日,舌淡红或红,苔薄或少,脉细数。
病例排除标准:
(1)非肿瘤药物所致者;(2)单纯皮肤反应,或者单纯口腔黏膜炎,或者单纯腹泻者;(3)确诊为肿瘤药物不良反应后3个月内接受过其他药物治疗者;(4)伴有严重其他系统疾病,如肾功能衰竭、心力衰竭等疾病;(5)对本次所用药物过敏者;(6)不能坚持服药或不能坚持随访者。
疗效标准:
根据2002年《中药新药临床研究指导原则(试行)》及《中医病证诊断疗效标准》进行疗效评估。治愈:皮疹完全消退,口腔黏膜炎完全消失,大便次数控制在1-2次每日;好转:皮疹消退超过50%,口腔黏膜炎偶尔发作,大便次数控制在3-4次每日;未愈::未达到好转标准。其临床总有效率=(治愈例数+好转例数)/总例数×100%(见表1和表2)。
表1药效统计
例数 | 治愈 | 好转 | 未愈 | 总有效率(%) | |
中药组 | 36 | 7 | 25 | 4 | 88.9% |
对照组 | 36 | 1 | 18 | 17 | 52.8% |
表2不同随访节点的肿瘤药物不良反应有效率
结果分析:
患者进行实施例1方剂治疗后总有效率为88.9%,且大部分患者在服药4周后不良反应即明显缓解,其中口腔溃疡缓解最快且有效率最高,服药4周后缓解率达69.4%,总有效率97.2%,皮疹缓解相对较慢且有效率较低。但目前市面上只有针对某一不良反应的治疗方案,只能单纯治疗皮疹,或者止泻,尚无针对肿瘤药物同时引发多种不良反应的综合治疗方案,因此本方对于填补这一临床空白是非常有意义的。
典型病例:
病例1:石某某,女,52岁。初诊日期:2020年8月20日。主诉:全身皮疹1月余。病史:2020年6月患者饮水后出现剧烈呛咳,伴胸闷、憋喘,当地医院行PET-CT提示左肺下叶背段占位病变,呈高代谢,周围型肺癌可能;左肺门及纵隔淋巴结代谢,转移可能;双肺多发结节,代谢高,肺内多发转移可能。2020年6月12日于北京胸科医院行CT引导下肺穿刺活检术,术后病理提示腺癌。基因检测结果EGFR20-Ins。予口服甲磺酸阿美替尼片(110mg,每天一次口服)行靶向治疗。2020年7月16日复查胸部CT提示病灶较前缩小,疗效评价SD。患者咳喘症状缓解,但出现皮疹、口腔溃疡、腹泻等药物不良反应。2020年8月20日就诊于中医科。刻下症:全身散在皮疹(覆盖>30%体表面积),头面部、胸背部明显,色红,瘙痒,部分结痂成块,脱屑,口腔溃疡,重度疼痛,影响进食,大便溏稀,每日4-6次,口干,心烦,乏力,稍干咳,舌暗红苔薄津少,脉细滑。西医诊断:1.左肺腺癌;2.药物性皮疹;3.口腔黏膜炎;4.腹泻。中医诊断:肺癌;药毒疹;口疮;泄泻。证型治法:证属热入营血、脾虚湿盛证,治以清热凉血解毒、健脾化湿止泻。服用本发明的实施例1中药配方汤剂4周后皮疹基本消退,口腔溃疡痊愈,大便次数减少为3-4次;8周后基本痊愈;后减量(两天服一剂)巩固至12周,未再出现皮疹、口腔炎、腹泻等不良反应,2020年12月10日复查胸部CT提示病灶明显缩小,疗效评价PR。
病例2:黄某某,男,68岁,2022年11月7日初诊。主诉:腹泻2月余。病史:患者2022年7月15日因出现咳嗽,痰中带血,于当地医院查胸部CT提示右肺上叶占位性病变(2.2×3.5cm)。2022年7月20日于北京胸科医院行手术切除,术后病理提示腺癌,基因检测提示E·1GFR 19-Del+。分期T2N1M0 b期。2022年8月15日予以甲磺酸奥西替尼片(80mg,每日一次口服)靶向治疗。服药2周后患者出现腹泻,每天大便次数≥7次,伴全身散在皮疹,口腔黏膜炎,心悸,遂将奥西替尼片减量(40mg,每日一次口服),但大便次数仍4-5次每日,服用整肠生、蒙脱石散等疗效不明显,2022年10月20复查胸部CT提示右肺癌术后改变,基本同前。2022年10月25日就诊于中医科。刻下症:腹泻,每天大便4-5次,伴全身散在皮疹(覆盖10-30%体表面积),色红,瘙痒,脱屑,口腔多发溃疡(影响经口进食),心悸,乏力,口干,舌淡红苔薄腻,脉细弦。西医诊断:1.右肺腺癌;2.腹泻;3.药物性皮疹;4.口腔黏膜炎。中医诊断:肺癌;泄泻;药毒疹;口疮。证型治法:证属热入营血、脾虚湿盛证,治以清热凉血解毒、健脾化湿止泻。服用本发明的实施例2中药配方汤剂4周后大便次数减少为2-3次,口腔溃疡痊愈,皮疹较前明显好转,又将奥希替尼片剂量增加至80mg每日;8周后大便次数控制在3-4次/每日,口腔溃疡未复发,皮疹基本消退;服药至12周时,大便次数控制在1-2次/每日,口腔溃疡、皮疹均未复发,2023年1月18日复查胸部CT提示右肺癌术后改变,基本同前。
病例3:艾某某,男,56岁,2021年9月30日初诊。主诉:皮疹1月余。患者2019年3月无明显诱因出现咳嗽,咳少量白痰,痰不易咳出,伴痰中带血,极少量,为粉红色,于当地医院查胸部CT提示左肺上叶前段实变影,患者遂就诊于北京胸科医院,入院后予患者完善气管镜检查(2021年4月14日):左舌叶顶区前支支气管新生物阻塞:支气管肺癌。患者左肺舌叶支气管黏膜活检及支气管镜刷检(2021年4月20日)均提示鳞状细胞癌,予患者完善NGS检测结果为阴性,完善免疫组化检测进一步明确肿瘤组织PD-L1表达情况为PD-L122C3(5%)。分期检查提示胸骨转移胸2椎体转移,头腹增强CT未见明显转移征象。患者IV期肺鳞癌诊断明确,2021年4月23日、5月14日、6月17日起予患者3周期化疗联合免疫治疗:白蛋白结合型紫杉醇400mgD1+顺铂60mgD1-2+替雷利珠单抗200mg,第一次化疗后患者出现食欲下降(CTCAE2级),粒缺性发热,第二、三次化疗后患者未出现明显不适症状,2021年7月21日起予患者第四周期化疗联合免疫治疗(方案同前),第四次治疗结束2周后患者双下肢出现散在红色皮疹,稍高于皮面,伴轻微瘙痒(CTCAE 1级),2021年8月25日起予患者第五周期化疗联合免疫治疗(方案同前),治疗后患者出现全身皮疹较前加重,部位增多(覆盖>30%体表面积),均为红色皮疹,高于皮面,部分皮面上可见水疱,考虑为免疫相关性,分级G3,伴轻微瘙痒,分级Gl,1周前(2021年9月22日)患者开始口服醋酸泼尼松片45mg qd治疗,患者服药后部分水疱结痴脱落,皮疹范围仍继续增大,遂请中医科会诊。刻下症:全身泛发性皮疹(覆盖>30%体表面积),色红,高于皮面,部分呈脓疱型,结痂,脱屑,大便溏稀,每日3-5次,口腔多发溃疡,伴疼痛,影响进食,睡眠可,舌淡红苔薄,脉滑数。西医诊断:1.左肺鳞癌晚期;2.药物性皮疹;3.口腔黏膜炎;4.腹泻。中医诊断:肺癌;药毒疹;口疮;泄泻。证型治法:证属热入营血、脾虚湿盛证,治以清热凉血解毒、健脾化湿止泻。服用本发明的实施例3中药配方汤剂2周后皮疹明显消退,口腔溃疡痊愈,大便次数减少为1-2次,将激素逐渐减量至停药;4周后基本痊愈;后减量(两天服一剂)巩固至12周,未再出现皮疹、口腔炎、腹泻等不良反应,2021年12月28日复查胸部CT提示病灶明显缩小,疗效评价PR。
以上所述仅是对本发明的较佳实施例而已,并非对本发明作任何形式上的限制,凡是依据本发明的技术实质对以上实施例所做的任何简单修改,等同变化与修饰,均属于本发明技术方案的保护范围内。
Claims (10)
1.一种治疗肿瘤药物不良反应的中药组合物,所述中药组合物由下列重量份配比的中药原料制备而成:水牛角15~30份、生地10~30份、丹皮10~20份、赤芍10~30份、当归10~20份、黄柏6~15份、砂仁6~15份、金银花10~30份、麦冬10~30份、茯苓10~30份、白术10~30份、党参10~30份、莲子10~30份、山药10~30份、扁豆10~30份、薏苡仁10~30份、乌梅10~30份、黄芪10~30份、白鲜皮10~30份、甘草6~15份。
2.如权利要求1所述的治疗肿瘤药物不良反应的中药组合物,其特征在于,所述中药组合物由下列重量份配比的中药原料制备而成,水牛角20~30份、生地15~30份、丹皮12~20份、赤芍12~30份、当归10~18份、黄柏6~12份、砂仁6~12份、金银花15~30份、麦冬12~30份、茯苓15~30份、白术12~30份、党参10~25份、莲子15~30份、山药15~30份、扁豆15~30份、薏苡仁15~30份、乌梅10~25份、黄芪10~25份、白鲜皮15~30份、甘草6~12份。
3.一种如权利要求1-2任一项所述的治疗肿瘤药物不良反应的中药组合物的制剂,所述中药组合物由以下重量份配比的中药原料制备而成,水牛角15~30份、生地10~30份、丹皮10~20份、赤芍10~30份、当归10~20份、黄柏6~15份、砂仁6~15份、金银花10~30份、麦冬10~30份、茯苓10~30份、白术10~30份、党参10~30份、莲子10~30份、山药10~30份、扁豆10~30份、薏苡仁10~30份、乌梅10~30份、黄芪10~30份、白鲜皮10~30份、甘草6~15份。
4.如权利要求3所述的治疗肿瘤药物不良反应的中药组合物的制剂,其特征在于,所述中药组合物的制剂包含可治疗肿瘤药物不良反应的组合物和药学上可接受的辅料。
5.如权利要求3所述的治疗肿瘤药物不良反应的中药组合物的制剂,其特征在于,所述的辅料是对主药具有增强疗效、降低毒性和/或减轻副作用的药用辅料。
6.如权利要求3所述的治疗肿瘤药物不良反应的中药组合物的制剂,其特征在于,所述中药组合物的制剂可以为膏方、丸剂、丹剂、汤剂、颗粒剂、胶囊剂、散剂、片剂。
7.一种制备治疗肿瘤药物不良反应的中药组合物药物中的应用,所述中药组合物由以下重量份配比的中药原料制备而成,水牛角15~30份、生地10~30份、丹皮10~20份、赤芍10~30份、当归10~20份、黄柏6~15份、砂仁6~15份、金银花10~30份、麦冬10~30份、茯苓10~30份、白术10~30份、党参10~30份、莲子10~30份、山药10~30份、扁豆10~30份、薏苡仁10~30份、乌梅10~30份、黄芪10~30份、白鲜皮10~30份、甘草6~15份。
8.如权利要求7所述的制备治疗肿瘤药物不良反应的中药组合物药物中的应用,其特征在于,所述的肿瘤选自肺癌、鼻咽癌、乳腺癌、结直肠癌、胃癌、肝癌、黑色素瘤、肾细胞癌、霍奇金淋巴瘤、各种肉瘤。
9.如权利要求7所述的制备治疗肿瘤药物不良反应的中药组合物药物中的应用,其特征在于,所述的肿瘤药物选自化疗药、靶向治疗药、免疫治疗药中的一种或多种。
10.如权利要求7所述的制备治疗肿瘤药物不良反应的中药组合物药物中的应用,其特征在于,所述的肿瘤药物不良反应选自各种皮疹、口腔黏膜炎、腹泻中的一种或多种。
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