CN105664016A - 一种治疗鼻咽癌的中药制剂 - Google Patents
一种治疗鼻咽癌的中药制剂 Download PDFInfo
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Abstract
本发明公开了一种治疗鼻咽癌的中药制剂,属于中药技术领域。该中药制剂由山豆根、五灵脂、麦冬、地鳖虫、赤芍、半枝莲、乳香、夏枯草、板蓝根、白花蛇舌草、玄参、生地黄、杏仁、丹参、玉竹、石上柏、当归、血竭、莪术、山慈菇、壁虎、甘草加工而成。该中药制剂对鼻咽癌具有治疗效果好、无毒副作用、调治结合等技术优势;并且该制剂的药效稳定,制剂原材料易得,制剂工艺简便易行,适合工业化规模生产,易于推广应用。
Description
技术领域
本发明属于中药技术领域,涉及一种治疗鼻咽癌的中药制剂。
背景技术
鼻咽癌是指发生于鼻咽腔顶部和侧壁的恶性肿瘤。是我国高发恶性肿瘤之一,发病率为耳鼻咽喉恶性肿瘤之首。常见临床症状为鼻塞、涕中带血、耳闷堵感、听力下降、复视及头痛等。鼻咽癌大多对放射治疗具有中度敏感性,放射治疗是鼻咽癌的首选治疗方法。但是对较高分化癌,病程较晚以及放疗后复发的病例,手术切除和化学药物治疗亦属于不可缺少的手段。
中医辨证论治鼻咽癌。中医治疗疾病用的是辨证的方法,事实证明很多癌症采用中医辅助治疗是有明显效果的。中医对鼻咽癌的辨证论治主要从以下几个方面入手:
1、火毒困结
主证:头痛,鼻塞,涕中带血,口腔溃烂疼痛,口干,尿黄便结。舌质红或紫红,苔薄黄或黄腻,脉弦数或数。本证多见于火热体质鼻咽癌患者,临床表现为火毒困结症状。治法:泻火解毒,消肿散结。
2、肝肺郁热
主证:鼻塞,涕中带血,微咳痰黄,口干,头痛,饮食正常,尿黄便结。舌质红,舌苔薄黄,脉数。本证多见于鼻咽癌早期,肿块局限于鼻咽腔,无颈淋巴结转移及全身远处转移,现代临床分期多为鼻咽癌Ⅰ期及Ⅱ期。治法:疏肝清肺,泻热解毒。
3、痰浊结聚
主证:咳嗽痰黄,头昏头重,颈部淋巴结肿大,肤色不红,或伴有胸闷体倦。舌质偏胖,舌苔腻,脉滑。病机分析:痰浊内生,郁火凝痰,致咳嗽痰黄,头昏头重,或见胸闷体倦;痰浊聚结鼻咽则成癌,结于颈项则见颈项包块,舌苔腻,脉滑均为痰湿之证。本证多见于鼻咽癌颈淋巴结转移,但不伴有火热症者。治法:化痰散结,解毒消肿。
4、脾胃失调
主证:放化疗后,面色白或萎黄,神疲乏力,形体消瘦,胃纳欠佳,恶心呕吐,呃逆心烦,便溏,舌淡白,苔薄白,脉细弱。治法:健脾益气,和胃止呕。
发明内容
本发明要解决的技术问题是提供一种对鼻咽癌有较好疗效的中药制剂及其制备方法。为了实现发明目的,发明人的技术方案为:一种治疗鼻咽癌的中药制剂,其中药组方是由如下重量份的中药材组成的:
山豆根10-32份、五灵脂5-19份、麦冬6-23份、地鳖虫3-12份、赤芍7-28份、半枝莲7-23份、乳香3-12份、夏枯草11-35份、板蓝根8-29份、白花蛇舌草15-40份、玄参8-28份、生地黄6-27份、杏仁6-23份、丹参7-24份、玉竹5-21份、石上柏14-45份、当归6-22份、血竭10-31份、莪术5-22份、山慈菇10-32份、壁虎4-12份、甘草8-16份。
具有优异疗效的两个组方配比分别以重量份表示为:
配比1:山豆根21份、五灵脂12份、麦冬14份、地鳖虫7份、赤芍17份、半枝莲15份、乳香8份、夏枯草23份、板蓝根18份、白花蛇舌草25份、玄参18份、生地黄16份、杏仁14份、丹参15份、玉竹13份、石上柏28份、当归14份、血竭20份、莪术13份、山慈菇21份、壁虎8份、甘草12份。
配比2:山豆根24份、五灵脂13份、麦冬14份、地鳖虫8份、赤芍16份、半枝莲17份、乳香8份、夏枯草25份、板蓝根16份、白花蛇舌草23份、玄参16份、生地黄15份、杏仁15份、丹参17份、玉竹14份、石上柏27份、当归13份、血竭21份、莪术14份、山慈菇23份、壁虎7份、甘草13份。
一种治疗鼻咽癌的中药制剂的制备方法为以下步骤:
(1)、按本发明中药组方分别称取山豆根、五灵脂、麦冬、地鳖虫、赤芍、半枝莲、乳香、夏枯草、板蓝根、白花蛇舌草、玄参、生地黄、杏仁、丹参、玉竹、石上柏、当归、血竭、莪术、山慈菇、壁虎、甘草各味中药材;
(2)、将五灵脂、乳香、甘草分别粉碎,炒制磨细,过80-130目筛,混合得细粉,备用;
(3)、将山豆根、麦冬、地鳖虫、赤芍、半枝莲、夏枯草、板蓝根、白花蛇舌草、玄参、生地黄、杏仁、丹参、玉竹、石上柏、当归、血竭、莪术、山慈菇、壁虎分别粉碎混合,加入初始药材4-17倍重量的纯化水,浸泡4-24小时,回流煎煮1-6小时,过滤,再加入初始重量3-12倍重量的纯化水,回流煎煮1-5小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.24-1.28的浓缩液备用;
(4)、将步骤(3)的滤渣加5-15倍重量的浓度65-85%的乙醇,回流提取2次,每次1-6小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.24-1.28的浓缩液备用;
(5)、将步骤(3)和(4)所得的浓缩液合并,加入步骤(2)所制得的混合细粉,混合均匀,继续浓缩至55℃相对密度为1.42-1.46的中药稠膏,即为中药有效成分原膏,备用;
(6)、将中药有效成分原膏添加适当的辅料,利用现代通用的中药制剂技术,制成临床需要的中药成品制剂,如汤剂、丸剂(含水丸、蜜丸)、胶囊剂(含软胶囊)、颗粒剂、片剂、酊剂、散剂、糖浆剂等剂型。
本发明中药制剂所用原材料的来源及性质特点如下:
山豆根:药材来源为防己科植物四川千金藤的根。味苦,性寒;归肺、心、大肠经;清热解毒,止痛,杀虫。主咽喉肿痛,牙痛,腹痛,痔疮肿痛,蛇虫咬伤,蛲虫病。
五灵脂:为鼯鼠科动物橙足鼯鼠或飞鼠科动物小飞鼠的干燥粪便。味苦,甘,性温;归肝;脾经;活血止痛;化瘀止血;消积解毒。
麦冬:本品为百合科植物麦冬(沿阶草)的干燥块根。味甘,微苦,性微寒;归心、肺、胃经;养阴生津,润肺清心。
地鳖虫:本品为鳖蠊科昆虫地鳖或冀地鳖的雌虫干燥体。捕捉后,置沸水中烫死,晒干或烘干。味咸,性寒;归肝经;破瘀血,续筋骨。
赤芍:本品为毛茛科植物芍药或川赤芍的干燥根。味苦,性微寒;归肝经;清热凉血,散瘀止痛。
半枝莲:本品为唇形科植物半枝莲的干燥全草。味辛、苦,性寒;归肺、肝、肾经;清热解毒,化瘀利尿。
乳香:橄榄科乳香树属植物乳香树、药胶香树及野乳香树等,以其树干皮部伤口渗出的油胶树脂入药。味辛苦,性温;入心、肝、脾经;调气活血,定痛,追毒。
夏枯草:本品为唇形科植物夏枯草的干燥果穗。味辛、苦,性寒;归肝、胆经;清火,明目,散结,消肿。
板蓝根:本品为十字花科植物菘蓝的干燥根。味苦,性寒;归心、胃经;清热解毒,凉血利咽。
白花蛇舌草:本品为茜草科耳草属植物白花蛇舌草的全草。味甘、淡,性凉;入胃、大肠、小肠经;清热解毒,利尿消肿,活血止痛。
玄参:本品为玄参科植物玄参的干燥根。味甘、苦、咸,性微寒;归肺、胃、肾经;凉血滋阴,泻火解毒。
生地黄:本品为玄参科植物地黄的新鲜或干燥块根。味甘,性寒;归心、肝、肾经;清热凉血,养阴,生津。
杏仁:为蔷薇科植物杏或山杏等味苦的干燥种子。味苦,性温;入肺、大肠经;祛痰止咳,平喘,润肠。
丹参:本品为唇形科植物丹参的干燥根及根茎。味苦,性微寒;归心、肝经;祛瘀止痛,活血通经,清心除烦。
玉竹:本品为百合科植物玉竹的干燥根茎。味甘,性微寒;归肺、胃经;养阴润燥,生津止渴。
石上柏:为卷柏科卷柏属植物深绿卷柏,以全草入药。味甘,微苦,涩,性凉,淡,温;清热解毒;祛风除湿。
当归:本品为伞形科植物当归的干燥根。味甘、辛,性温;归肝、心、脾经;补血活血,调经止痛,润肠通便。
血竭:本品为棕榈科植物麒麟竭果实渗出的树脂经加工制成。味甘、咸,性平;归心、肝经;祛瘀定痛,止血生肌。
莪术:本品为姜科植物蓬莪术、广西莪术或温郁金的干燥根茎。味辛、苦,性温;归肝、脾经;行气破血,消积止痛。
山慈菇:为兰科植物杜鹃兰、独蒜兰等的假球茎。味甘微辛,性寒;入肝、脾经;消肿,散结,化痰,解毒。
壁虎:守宫科动物无疣壁虎以干燥全体入药。味咸;性寒;小毒;归肝经;祛风定惊;解毒散结。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明中药组方的方解:
本发明中药组方是以白花蛇舌草、夏枯草、石上柏、山豆根、山慈菇、血竭为君药,活血止痛、散结消肿、清热解毒、止痛杀虫、化痰解毒、祛瘀定痛;以赤芍、板蓝根、玄参、生地黄、半枝莲、丹参为臣药,清热凉血、凉血利咽、泻火解毒、化瘀利尿、活血通经;以五灵脂、麦冬、地鳖虫、壁虎、乳香为佐药,消积解毒、养阴生津、破血续骨、解毒散结、定痛追毒;以杏仁、玉竹、当归、莪术为使药,祛痰止咳、养阴润燥、补血活血、消积止痛;以甘草调和诸药性,使君臣佐使诸药配合,互为表里,阴阳相谐,共同达到活血止痛、散结消肿、清热解毒、止痛杀虫、化痰解毒、祛瘀定痛、凉血利咽、泻火解毒、化瘀利尿、破血续骨、祛痰止咳、养阴润燥、补血活血等功效,对鼻咽癌有十分显著的治疗效果。
与现有技术相比,本发明中药制剂具有以下技术优势:
1、治疗效果好,特别是对晚期鼻咽癌,五年生存率明显提高;
2、无毒副作用,可以长期服用,调理患者身体,增强抗病能力;
3、制剂的药效稳定,制剂原材料易得,制剂工艺简便易行,适合工业化规模生产,易于推广应用。
因此,本发明还要求保护上述中药制剂在制备治疗鼻咽癌药物中的应用。
具体实施方式
为了进一步验证本发明生产工艺和组方的可行性,并为后续的相关实验提供受试样品,发明人选取组方范围内的一组任意值和两个优选配比进行丸剂的生产。本发明所保护的范围包括但不仅限于如下实施例的范畴。
实施例1
(1)、按本发明中药组方分别称取山豆根3200g、五灵脂600g、麦冬2200g、地鳖虫300g、赤芍2000g、半枝莲800g、乳香300g、夏枯草3500g、板蓝根900g、白花蛇舌草3900g、玄参800g、生地黄2700g、杏仁1500g、丹参1800g、玉竹500g、石上柏4400g、当归700g、血竭3100g、莪术500g、山慈菇3200g、壁虎500g、甘草1500g;
(2)、将五灵脂、乳香、甘草分别粉碎,炒制磨细,过100目筛,混合得细粉,备用;
(3)、将山豆根、麦冬、地鳖虫、赤芍、半枝莲、夏枯草、板蓝根、白花蛇舌草、玄参、生地黄、杏仁、丹参、玉竹、石上柏、当归、血竭、莪术、山慈菇、壁虎分别粉碎混合,加入初始药材13倍重量的纯化水,浸泡12小时,回流煎煮2小时,过滤,再加入初始重量8倍重量的纯化水,回流煎煮2小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.24-1.28的浓缩液备用;
(4)、将步骤(3)的滤渣加11倍重量的浓度70%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.24-1.28的浓缩液备用;
(5)、将步骤(3)和(4)所得的浓缩液合并,加入步骤(2)所制得的混合细粉,混合均匀,继续浓缩至55℃相对密度为1.42-1.46的中药稠膏,即为中药有效成分原膏,备用;
(6)、将中药有效成分原膏添加适当的辅料,利用现代通用的中药制剂技术,制成丸剂,规格为0.88g生药/g丸剂。
实施例2
(1)、按本发明中药组方分别称取山豆根2100g、五灵脂1200g、麦冬1400g、地鳖虫700g、赤芍1700g、半枝莲1500g、乳香800g、夏枯草2300g、板蓝根1800g、白花蛇舌草2500g、玄参1800g、生地黄1600g、杏仁1400g、丹参1500g、玉竹1300g、石上柏2800g、当归1400g、血竭2000g、莪术1300g、山慈菇2100g、壁虎800g、甘草1200g;
(2)、将五灵脂、乳香、甘草分别粉碎,炒制磨细,过100目筛,混合得细粉,备用;
(3)、将山豆根、麦冬、地鳖虫、赤芍、半枝莲、夏枯草、板蓝根、白花蛇舌草、玄参、生地黄、杏仁、丹参、玉竹、石上柏、当归、血竭、莪术、山慈菇、壁虎分别粉碎混合,加入初始药材13倍重量的纯化水,浸泡12小时,回流煎煮2小时,过滤,再加入初始重量8倍重量的纯化水,回流煎煮2小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.24-1.28的浓缩液备用;
(4)、将步骤(3)的滤渣加11倍重量的浓度70%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.24-1.28的浓缩液备用;
(5)、将步骤(3)和(4)所得的浓缩液合并,加入步骤(2)所制得的混合细粉,混合均匀,继续浓缩至55℃相对密度为1.42-1.46的中药稠膏,即为中药有效成分原膏,备用;
(6)、将中药有效成分原膏添加适当的辅料,利用现代通用的中药制剂技术,制成丸剂,规格为0.88g生药/g丸剂。
实施例3
(1)、按本发明中药组方分别称取山豆根2400g、五灵脂1300g、麦冬1400g、地鳖虫800g、赤芍1600g、半枝莲1700g、乳香800g、夏枯草2500g、板蓝根1600g、白花蛇舌草2300g、玄参1600g、生地黄1500g、杏仁1500g、丹参1700g、玉竹1400g、石上柏2700g、当归1300g、血竭2100g、莪术1400g、山慈菇2300g、壁虎700g、甘草1300g;
(2)、将五灵脂、乳香、甘草分别粉碎,炒制磨细,过100目筛,混合得细粉,备用;
(3)、将山豆根、麦冬、地鳖虫、赤芍、半枝莲、夏枯草、板蓝根、白花蛇舌草、玄参、生地黄、杏仁、丹参、玉竹、石上柏、当归、血竭、莪术、山慈菇、壁虎分别粉碎混合,加入初始药材13倍重量的纯化水,浸泡12小时,回流煎煮2小时,过滤,再加入初始重量8倍重量的纯化水,回流煎煮2小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.24-1.28的浓缩液备用;
(4)、将步骤(3)的滤渣加11倍重量的浓度70%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.24-1.28的浓缩液备用;
(5)、将步骤(3)和(4)所得的浓缩液合并,加入步骤(2)所制得的混合细粉,混合均匀,继续浓缩至55℃相对密度为1.42-1.46的中药稠膏,即为中药有效成分原膏,备用;
(6)、将中药有效成分原膏添加适当的辅料,利用现代通用的中药制剂技术,制成丸剂,规格为0.88g生药/g丸剂。
实施例4
本发明中药制剂的安全性试验:
1、试验药品:本发明实施例1-3所制得中药丸剂(规格为0.88g生药/g丸剂),加纯化水调制成所需浓度的稀糊。
试验所用动物:普通级NIH小鼠,体重24g±4g,雌雄各半,雌性小鼠均无孕;普通级SD大鼠,初始体重227±13g,雌雄各半,雌性大鼠均无孕。试验动物由武汉大学动物实验中心购买。
2、急性毒性试验
应用小鼠进行急性毒性实验表明:小鼠灌胃本发明的中药丸剂,在747.5g生药/kg剂量下,给药后小鼠出现轻微活动减少,1.5小时左右恢复正常,给药后连续观察7天,无一小鼠死亡,且全身状况、饮食、摄水、小便和体重增长均正常。实验结果表明:小鼠灌胃本发明的中药丸剂的最大给药量为747.5g生药/kg/d(LD50>747.5g生药/kg)。本发明的中药制剂每日临床用药总量为0.44g生药/kg/d;按体重计,小鼠灌胃本发明中药制剂的耐受量为临床病人的1698.9倍。提示该药急性毒性极低,临床用药安全。
3、长期毒性试验
选用SD大鼠,给予三种剂量的本发明中药丸剂:79.2g生药/kg、26.4g生药/kg、8.8g生药/kg(单位体重给药量按临床用药量的20倍计算,临床用药量依据《中华人民共和国药典》2015年版一部)。每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化;给药后90天和停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、Glu、BUN、Crea、TP、T.BIL、ALB、CHOL)、尿液生化、脏器系数、病理组织学等指标检查。
试验结果表明:本发明的中药制剂在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的180、60、20倍,根据试验结果:本发明中药制剂在高、中、低三个剂量(79.2g生药/kg、26.4g生药/kg、8.8g生药/kg)连续90天给药对大鼠(除体重增加外)无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,提示本发明的中药制剂临床应用的剂量安全性很高。
实施例5本发明中药制剂的临床试验
1、一般资料
此次临床试验研究共纳入患者417例。所有受试者均来自某省肿瘤医院,为该院自2011年2月至2015年1月收治的鼻咽癌患者,年龄28-68岁,平均年龄51.3岁,男200例,女217例。将病例根据年龄、性别、病情平均分成试验A组、试验B组和对照组三个组,使这三个组具备统计学意义上的可比性。
2、治疗方法
三组病例均采用热塑面膜固定,并在CT或X线模拟机下定位,6MV-X射线照射,颈切线野均采用60Co-r射线照射。
(1)、二维挡铅技术:患者仰卧标准位,张口含塞,在数字化X线模拟定位机(核通公司)摄取定位片,并勾画面颈联合野及面耳前小野,完成后制做挡铅模具,根据CT分别确定设野边界,下颈切线野根据定位片及计算半影确定上界。放疗剂量分次采用超分割方法,120cGy/次,BID/天,鼻咽总剂量为72-76.8Gy/60-64次,面颈联合野鼻咽部剂量达43.2Gy/36次/24天后定位片上缩野。全颈切线预防剂量达50Gy/25次/5周,颈部阳性区域采用电子线根据淋巴结大小补量16-26Gy,常规分次,200cGy/次。
(2)、调强适形放疗技术(IMRT):患者采用头颈摆位固定装置,仰卧体位,在CT下获取治疗计划设计图像,部份患者采用MRI图像融合,GTV:72-78Gy,2.2-2.4Gy/次;CTV1:66-68Gy,2.1-2.2Gy/次;CTV2:56-62Gy,2Gy/次;GTVN:66-78Gy,2.2-2.4Gy/次;CTVN:52-55Gy,1.6-1.8Gy/次;所有患者均以PTV计算,95%为描述剂量。部分患者采用剂量动态IMRT(2-3次CT/MRI)。
三组均同步化疗,化疗采用DF方案:氯氨铂(CDDP)为80mg/m2,d1,5-氟尿嘧啶(5-FU)为500mg/m2,d1-3。每3周重复化疗1次,总计2个周期。
对照组只进行基础的癌放疗、化疗;
试验A组癌放疗、化疗的基础上配合本发明实施例2制造的中药丸剂(规格为0.88g生药/g丸剂),每日3次,每次10g,直到放化疗总计划结束;
试验B组癌放疗、化疗的基础上配合本发明实施例3制造的中药丸剂(规格为0.88g生药/g丸剂),每日3次,每次10g,直到放化疗总计划结束。
3、观察指标和方法
(1)、治疗中每周检验1次全血常规。每2周检查1次肝、肾功能及心电图。观察标准:RTOG(放射肿瘤治疗协作组)、WHO制定的毒副反应分级标准。黏膜反应:0级,正常;I级,红斑,有轻微疼痛,不需止痛药;II级,斑点状黏膜炎,伴浆液性渗出,中等度疼痛;III级,成片状纤维素黏膜炎,疼痛剧烈,需止痛药;IV级,出血、溃疡、坏死。
(2)、近期疗效:据WHO治疗恶性肿瘤评定标准评定疗效:
完全缓解(CR):所有可见的病变完全消失至少4周;
部分缓解(PR):肿瘤大小估计缩小≥50%至少4周;
无变化(NC):无明显变化至少4周,包括病变稳定,肿瘤大小估计扩大不足25%,缩小不足50%;
病变扩展(PD):新病灶出现或原有病变估计扩大>25%。
4个等级评定鼻咽部原发灶及颈淋巴结转移灶肿瘤体积变化。
4、统计方法
用统计软件包SPSS16.0Wileoxon符合秩和检验、配对t检验及独立样本t检验。
5、试验结果
(1)、三组急性反应比较,结果见表1,试验组对口腔黏膜及胃肠道反应的减轻明显优于对照组,统计学上具有显著性差异(P<0.05)。
表1三组急性反应比较表
注:三组间两个指标比较,p<0.05。
(2)、三组血液系统副反应比较
试验组血液系统反应中白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)下降较对照组明显减轻,统计学上具显著性差异(P<0.05)。见表2。
表2三组血液系统副反应比较表
(3)、三组治疗前后肝肾功能的比较
试验组放化疗后丙氨酸转氨酶(ALT)、尿素氮(UN)、血液肌酐(CR)、γ-谷氨酰转移酶(GGT)值显著降低,具统计学意义(P<0.05);而对照组ALT、UN、CR值较放化疗前无显著变化(P>0.05),如表3所示。
表3肝肾功能治疗前后比较(±SD)
注:与对照组相比△P>0.05,*P<0.05。
(4)、三组的近期疗效比较
为期一年的放化疗之后,对三组的试验结果进行统计分析,如表4所示。
表4疗效统计分析表
6、试验结论
通过以上试验结果,可以清晰地看出,本发明中药制剂在辅助放化疗治疗鼻咽癌时起到了十分显著的治疗作用,显著降低了患者的副反应,改善了患者的生存状况;特别是本发明实施例3药物对试验B组患者的治疗显著,使总有效率提高了36个百分点,并且CR患者更是对照组的2.5倍。这些数据充分说明了,本发明中药制剂对鼻咽癌有十分显著的疗效,在该领域获得了巨大的技术进步和科研成果,其巨大的经济价值和社会效益应当被知识产权所保护。
Claims (3)
1.一种治疗鼻咽癌的中药制剂,其特征在于,所述中药制剂的组方由如下重量份的中药材组成:山豆根10-32份、五灵脂5-19份、麦冬6-23份、地鳖虫3-12份、赤芍7-28份、半枝莲7-23份、乳香3-12份、夏枯草11-35份、板蓝根8-29份、白花蛇舌草15-40份、玄参8-28份、生地黄6-27份、杏仁6-23份、丹参7-24份、玉竹5-21份、石上柏14-45份、当归6-22份、血竭10-31份、莪术5-22份、山慈菇10-32份、壁虎4-12份、甘草8-16份。
2.根据权利要求1所述的一种治疗鼻咽癌的中药制剂,其特征在于,所述中药制剂的组方由如下重量份的中药材组成:山豆根24份、五灵脂13份、麦冬14份、地鳖虫8份、赤芍16份、半枝莲17份、乳香8份、夏枯草25份、板蓝根16份、白花蛇舌草23份、玄参16份、生地黄15份、杏仁15份、丹参17份、玉竹14份、石上柏27份、当归13份、血竭21份、莪术14份、山慈菇23份、壁虎7份、甘草13份。
3.根据权利要求1或2所述的一种治疗鼻咽癌的中药制剂,其特征在于:所述中药制剂的剂型为汤剂、丸剂、胶囊剂、颗粒剂、片剂、酊剂、散剂或糖浆剂。
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