CN114887004A - 一种用于治疗胰腺癌的中药组合物及其应用 - Google Patents
一种用于治疗胰腺癌的中药组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种用于治疗胰腺癌的中药组合物及其应用,该中药组合物由以下原料组成:白花蛇舌草30‑40重量份、鸡内金15‑20重量份、制大黄6‑10重量份、薏苡仁20‑30重量份、山药20‑30重量份、蛇六谷15‑30重量份、白术10‑20重量份、甘草6‑10重量份、陈皮10‑20重量份,该中药组合物具有清热化湿、行气通腑等功效,临床试验显示其可明显改善胰腺癌患者的临床症状、KPS评分、不良反应方面优于单纯化疗,显著降低化疗副作用,提高患者体力评分,显著改善患者中医临床症状,在治疗胰腺癌方面具有较高的临床应用价值。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种用于治疗胰腺癌的中药组合物及其应用。
背景技术
胰腺癌是临床死亡率最高的消化道恶性肿瘤之一,胰腺癌发病率仍呈逐步增长趋势,死亡率居于全球恶性肿瘤第4位。胰腺癌发病隐匿,仅有15-20%胰腺癌患者可以接受根治性手术治疗,同时胰腺癌患者容易复发转移,确诊时超过90%患者存在转移灶或局部进展,5年生存率约9%。目前晚期胰腺癌主要的治疗方案以化疗为主,但因胰腺癌恶性程度高,尽管化疗能够显著延长患者的生存期,但因中晚期胰腺癌患者KPS评分较低,血液系统及肝肾储备功能有限,晚期胰腺癌患者标准化疗周期较长,易出现血液、肝肾功能不良反应,大约50%的患者需要延迟或减少化疗药物剂量,现有技术中尚缺乏有效的胰腺癌治疗方法。
发明内容
针对现有技术中的上述问题,本发明的主要目的是提供一种用于治疗胰腺癌的中药组合物,该中药组合物可明显改善胰腺癌患者的临床症状、KPS评分、不良反应方面优于单纯化疗,显著降低化疗副作用,提高患者体力评分,显著改善患者中医临床症状,在治疗胰腺癌方面具有较高的临床应用价值。
本发明的另一目的是提供上述用于治疗胰腺癌的中药组合物在药物制备中的应用。
为了达到上述目的,本发明提供如下技术方案:
本发明一方面提供一种用于治疗胰腺癌的中药组合物,按质量份数计包含由以下原料制备得到:白花蛇舌草30-40重量份、鸡内金15-20重量份、制大黄6-10重量份、薏苡仁20-30 重量份、山药20-30重量份、蛇六谷15-30重量份、白术10-20重量份、甘草6-10重量份和陈皮10-20重量份。
作为优选,所述中药组合物由以下原料制备得到:白花蛇舌草30重量份、鸡内金15重量份、制大黄6重量份、薏苡仁20重量份、山药20重量份、蛇六谷15重量份、白术10重量份、甘草6重量份和陈皮10重量份。
本发明所用各味药材的入经、功能、主治和作用原理如下:
白花蛇舌草:清热解毒,利尿消肿,活血止痛。具有清热散瘀,消痈解毒。治痈疽疮疡,瘰疬。又能清肺火,泻肺热。治肺热喘促、嗽逆胸闷。
鸡内金:健胃消食,涩精止遗。消积滞,健脾胃。具有治食积胀满,呕吐反胃,泻痢,疳积,消渴,遗溺,喉痹乳蛾,牙疳口疮。
制大黄:泻热通肠,凉血解毒,逐瘀通经。具有泻热毒,破积滞,行瘀血。具有下瘀血,血闭,寒热,破症瘕积聚,留饮宿食,荡涤肠胃,推陈致新,通利水谷,调中化食,安和五脏。
薏苡仁:健脾渗湿,除痹止泻,清热排浓。具有健脾,补肺,清热,利湿。治泄泻,湿痹,筋脉拘挛,屈伸不利,水肿,脚气,肺痿,肺痈,肠痈,淋浊,白带。
山药:补脾养胃,生津益肺,补肾涩精。具有健脾,补肺,固肾,益精。治脾虚泄泻,久痢,虚劳咳嗽,消渴,遗精、带下,小便频数。
蛇六谷:化痰散积,行瘀消肿。具有治痰嗽,积滞。疟疾,经闭,跌打损伤,痈肿,疔疮,丹毒,汤火伤。
白术:健脾益气,燥湿利水,具有补脾,益胃,燥湿,和中,安胎。治脾胃气弱,不思饮食,倦怠少气,虚胀,泄泻,痰饮,水肿,黄疸,湿痹,小便不利,头晕,自汗,胎气不安。
甘草:补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
陈皮:理气健脾,燥湿化痰。用于胸脘胀满,食少吐泻,咳嗽痰多。
本发明的上述用于治疗胰腺癌的中药组合物中,白花蛇舌草、鸡内金为君,清利湿热,健脾益气,湿去则脾运有权,脾健则湿邪得解;制大黄、蛇六谷、薏苡仁为臣,健脾化湿、破血祛瘀,君臣配伍,清利下焦湿热,使邪气有出路,癥瘕积聚得散。山药、白术、陈皮理气行滞,主取调畅中焦使补而不滞,又取血随气行而淤血自除之意,甘草为使药,有补脾和中,缓急止痛,调和诸药的作用。现代药理研究也证明,白花蛇舌草、大黄、蛇六谷、薏苡仁、白术具有抑制胰腺癌细胞生长,抑制胰腺癌细胞上皮间质转化、调节肿瘤微环境抑制肿瘤转移的作用。
本发明另一方面还提供上述用于治疗胰腺癌的中药组合物在制备治疗胰腺癌的药物中的应用。
作为优选,所述中药组合物的有效成分经过提取后的混合物制备为一种药学上可接受的药物制剂;所述药物制剂包含上述中药组合物的提取物和药学上可以接受的药物载体或赋形剂,所述药物制剂的剂型包括片剂、胶囊剂、软胶囊剂、颗粒剂、丸剂、粉剂、散剂、膏剂、混悬剂、口服液或注射剂。
作为优选,所述药物制剂为口服液,随化疗周期每日服用,每日1剂,分2次服用,每次100mL。
作为优选,所述口服液的制备方法包括如下步骤:
步骤一、将原料按照上述配方的量混合,加水浸过药面浸泡60分钟;
步骤二、向步骤一中浸泡好的配方原料中继续加水,没过药面3-4厘米,用大火煎煮至沸腾后,改为文火继续煎煮60分钟,至剩余药液浓缩至100mL,过滤,取滤液备用;
步骤三、向步骤二得到的剩余药物中继续加水,没过药面2-3厘米,用大火煎煮至沸腾后,改为文火煎煮60分钟,过滤,至剩余药液浓缩至100mL,取滤液后与步骤二中得到的滤液混合即可。
与现有技术相比,本发明提供的中药组合物用于制备治疗胰腺癌的药物,可明显改善胰腺癌患者的临床症状、KPS评分、不良反应方面优于单纯化疗,显著降低化疗副作用,提高患者体力评分,显著改善患者中医临床症状,在治疗胰腺癌方面具有较高的临床应用价值。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例,对本发明实施例的技术方案进行清楚、完整地描述。显然,所描述的实施例是本发明的一部分实施例,而不是全部的实施例。基于所描述的本发明的实施例,本领域普通技术人员在无需创造性劳动的前提下所获得的所有其它实施例,都属于本发明保护的范围。
实施例1
以下通过临床试验观察和验证本发明的中药组合物在治疗胰腺癌的临床疗效。
1、一般资料
收集217例治疗晚期进展期胰腺癌患者,所有患者治疗前均已了解中药及化疗可能出现的不良反应,并签署治疗知情同意书。
2、纳入标准
(1)均经病理组织学或细胞病理学确诊为胰腺癌;
(2)存在1个及以上可评估和测量的病灶;
(3)治疗前血常规、肝功能(胆红素,间接胆红素,直接胆红素,谷草转氨酶,谷丙转氨酶)、肾功能(肌酐、尿素氮、尿酸)、心电图在正常范围;
(4)年龄18-85岁;
(5)卡氏(Karnofsky)评分≥70分;
(6)符合湿热蕴结型胰腺癌诊断标准,诊断标准参考《恶性肿瘤中医诊疗指南》中胰腺癌湿热蕴结诊断标准:上腹部胀满不适或胀痛,发热缠绵,口渴而不喜饮,或见黄疸,小便黄赤,口苦口臭,便溏味重,心中懊侬,舌红苔黄或腻,脉数。
3、排除标准
(1)双原或多原发肿瘤及病理学不明确的患者;
(2)接受过其他中药及化疗方案治疗;
(3)治疗前已接受过手术、放疗或粒子照射等治疗;
(4)研究资料不全的患者。
最终纳入本试验的病人的化疗方案剂量及用法参考NCCN胰腺癌临床实践指南(2011),纳入本试验人群均重复疗程直至疾病变化、出现不可耐受不良反应或患者拒绝治疗。
4、治疗方案
本试验分为2组。A组化疗组:化疗方案包括指南推荐吉西他滨、奥沙利铂、顺铂、伊立替康为基础的化疗方案。B组中药组:治疗为化疗联合清热化湿方治疗,清热化湿方为本发明的中药组合物,其组成:白花蛇舌草30重量份、鸡内金15重量份、制大黄6重量份、薏苡仁20重量份、山药20重量份、蛇六谷15重量份、白术10重量份、甘草6重量份、陈皮10重量份,水煎服,每日1剂,分2次服用,每次100mL。
中药组在化疗基础上增加清热化湿方,每日1剂,分2次服用,服用至化疗周期结束或患者不能耐受或随访至终点。治疗前完善相关检查,行血常规、肝肾功能、电解质、心电图、心脏标志物检查,出现3/4级毒性者延迟化疗周期进行治疗,待患者各项指标符合化疗标准后进行下个疗程的化疗。
5、观察指标及随访
本试验主要观察指标为两组患者治疗后临床疗效评估。次要观察指标为生活质量评分、中医临床症状、不良反应。
5.1、临床疗效评估
结果参照RECIST 1.1标准分为完全缓解(CR)、部分缓解(PR)、疾病稳定(SD)及疾病进展(PD),CR+PR为客观有效率(ORR)。
5.2、不良反应
通过血常规及肝、肾功能等检查以及临床观察,参照PRO-CTCAE标准,记录治疗过程中出现的3/4级不良反应事件次数。结合住院病历、门诊病历及微信随访,对病人相关临床数据进行录入。记录患者疾病进展及死亡时间、治疗效果及3/4级不良反应事件发生情况。
5.3、卡氏(Karnofsky)评分
采用Karnofsky(KPS)评分治疗前和治疗疗程结束分别作为KPS评分定位点。
5.4、中医临床症状
中医临床症状根据中药新药临床研究指导原则(试用)观察记录中医症状,治疗前和治疗疗程结束分别作为观察定位点。
疗效指数(n)=[(疗前积分-疗后积分)÷疗前积分]×100%
临床痊愈:治疗前和治疗疗程结束后症状评分减少>90%;
显著改善:治疗前和治疗疗程结束后症状评分减少>70%;
有效:治疗前和治疗疗程结束后症状评分减少>30%;
无效:治疗前和治疗疗程结果后症状评分减少不足30%;
总有效率:[(临床痊愈+显效+有效)/人数]×100%。
6、统计学分析
采取SPSS 22.0统计软件包进行生存分析并绘制Kaplan-Meier曲线,计数资料采用率(%) 来表示,组间比较采用卡方检验、非参数检验。以P<0.05为差异具有统计学意义。
7、样本量计算
本试验基于生存期进行样本量计算,预计晚期转移性胰腺癌肿瘤患者中位生存期为6个月,化疗组的中位生存期为6个月,预计中药+化疗组的生存期为11个月,计划入组时间24 个月,随访时间为60个月,预计两组脱落率均为5%,中药组和化疗组的比例设置为1:1。设置检查水准为0.05,把握度为0.90,根据PASS 11软件计算样本量为189例。
8、结果
8.1、临床特征217例病人中,接受单纯化疗的病人110例,接受中药+化疗治疗的病人 107例。化疗组和中药组患者中位年龄分别为63岁(36-81岁)和62岁(34-84岁),化疗组患者男性77例(70%)和女性33例(30%);中药组患者男性63例(58.9%)和女性44 例(41.1%)。化疗组患者肿瘤部位位于胰头、胰体、胰尾的比例分别为43例(35.4%)、 31例(28.1%)和36例(32.7%),中药组患者肿瘤部位位于胰头、胰体、胰尾的比例分别为45例(42%)、30例(28%)和32例(30%)。化疗组患者KPS评分100、90、80及70 的人数分别为:16例(14.5%)、42(38.1%)、41(37.2%)、11(10%),中药组KPS评分100、90、80及70的人数分别为:24(22.4%)、41(38.3%)、37(34.5%)、5(4.6%)。根据AJCC(第8版)分期标准,其中化疗组局部进展期为35(31.8%)例,远处转移为75 (68.2%)例;中药组患者局部进展期为34(31.7%)例,远处转移为73(68.2%)例。各组患者主要转移的脏器为肝、肺、腹膜淋巴结及其他脏器。中位化疗周期中药组(12次)高于化疗组(9次)。化疗组CA-199水平在正常值、<60倍正常上限、≥60倍正常上限数量分别为:29、42、39;中药组CA-199水平在正常值、<60倍正常上限、≥60倍正常上限数量分别为:15、50、42;两组患者在基线数据比较,差异均无统计学意义(P均>0.05,见表1)。
表1:临床资料特征及基线数据
注:与化疗组比较,P值均>0.05;化疗周期数2为最小周期数,16、18为最大周期数
8.2、客观缓解率疗效两组比较差异无统计学意义(P=0.15,见表2)。化疗7例因后续治疗在外地完成,6例病情变化无法及时评估,记为无法评估;其余患者CR 0例,PR 28例,SD 33例,PD 36例。B组6例因化疗2个周期后不能耐受拒绝治疗,7例在外地治疗无法及时评估,记为无法评估;其余的患者CR 0例,PR 24例,SD 31例,PD 39例。两组治疗客观有效率分别为25.4%和22.4%(P=0.93,见表2)。中药组与化疗组相比客观缓解率无显著统计学差别。截止最后随访日期2020年09月30日。
表2:化疗组和中药组的进展期胰腺癌患者的客观缓解率比较
治疗反应 | 化疗组(n=110例) | 中药组(n=107) | P值 |
CR | 0 | 0 | - |
PR | 28 | 24 | - |
SD | 33 | 31 | - |
PD | 36 | 39 | - |
无法评估 | 13 | 13 | - |
ORR(%) | 25.4 | 22.4 | P=0.93 |
注:与化疗组比较,P>0.05;CR:完全缓解;PR:部分缓解;SD:疾病稳定;PD:疾病进展;ORR:客观有效率。
8.3、安全性化疗期间,化疗组中有53例发生3/4级不良反应事件(157次),其中最常见3/4级不良反应为中性粒细胞减少(31.8%)、周围神经毒性(24.5%)、纳差(19%)、感染性发热(14.5%)及血红蛋白减少(11.8%)。中药组有45例发生3/4级不良反应事件(115次),其中最常见3/4级不良反应为中性粒细胞减少(30.8%)、周围神经病变(15.9%)、感染性发热(11.2%)及血红蛋白减少(9.3%),患者治疗过程中出现≥3级不良反应事件,经对症支持治疗后均可耐受后续化疗。两组患者3/4级不良反应发生率比较,纳差发生率中药组显著低于化疗组,差异有显著统计学意义(P=0.03,见表3)。其余方面差别均无统计学意义(P>0.05,见表3)。在使用细胞刺激集落因子比例上,化疗组和中药组分别为42.7%和30.8%,两者无显著统计学差异(P=0.07,见表3)。
表3:两组进展期胰腺癌患者的不良反应和使用粒细胞集落刺激因子比较
3/4不良反应 | 化疗组(n=110) | 中药组(n=107) | P值 |
中性粒细胞减少 | 35(31.8) | 33(30.8) | P=0.87 |
血小板减少 | 11(10) | 8(7.5) | P=0.87 |
血红蛋白减少 | 13(11.8) | 10(9.3) | P=0.55 |
感染性发热 | 16(14.5) | 12(11.2) | P=0.46 |
周围神经毒性 | 27(24.5) | 17(15.9) | P=0.11 |
腹泻 | 7(6.3) | 10(9.3) | P=0.41 |
过敏反应 | 4(3.6) | 2(1.8) | P=0.68 |
恶心 | 5(4.5) | 4(3.7) | P=1 |
呕吐 | 4(3.6) | 2(1.9) | P=0.68 |
肝功能损害 | 6(5.5) | 7(6.5) | P=0.58 |
肾功能损害 | 6 | 6 | P=0.96 |
乏力 | 8(7.2) | 4(3.7) | P=0.25 |
纳差 | 21(19) | 6(5.6) | *P=0.03 |
使用粒细胞刺激集落因子的比例 | 47(42.7) | 33(30.8) | P=0.07 |
注:与化疗组比较,*P<0.05;其余P值>0.05;
8.4、KPS评分治疗前,中药组与化疗组的KPS评分无显著统计学差异(P>0.05)。治疗后,中药组及化疗组的KPS评分均有一定的升高,但中药组显著高于化疗组,中药组总改善率(79.4%)显著优于化疗组(50.9%)。具有统计学意义(P<0.001,见表4),总改善率=(显著改善+改善+稳定)/总人数。
表4:接受化疗组和接受中药组的进展期胰腺癌患者的体力评分改善比较
注:与化疗组比较,*P<0.05;其余P值>0.05;
8.5、中医临床症状改善化疗组在治疗前和治疗疗程结束后中医症状评分,临床痊愈0例,显著改善0例,有效38例,无效72例,总有效率为34.5%。中药组临床痊愈0例,显著改善1例,有效65例,无效41例,有效率为61.6%。中药组有效率显著高于化疗组,两者比较有显著统计学差异(P<0.001,见表5)。
表5:接受化疗组和接受中药组的进展期胰腺癌患者的中医临床症状改善比较(例)
注:与化疗组比较,*P<0.05;
下面结合典型病例具体地说明本发明的内容并对本发明作进一步阐述,但典型病例绝非对本发明有任何限制。
沈某,女性,75岁,因“发现胰腺恶性肿瘤9月余”入院治疗,住院号:13***23
患者2020年12月出现背部疼痛,2021-02月PET/CT提示:胰腺尾部占位侵犯毗邻血管和腹膜后淋巴结转移,第二胸椎骨转移;2021年2月行胰腺穿刺活检术,术后病理提示:胰腺导管腺癌。分期:cT4N1M1 IV期。ECOG评分1分。于2021年02月27日、2021年03 月13日、2021年03月27日、2021年04月10日、2021年05月08日、2021年5月22日行6周期AG方案化疗(白蛋白结合型紫杉醇150mg d1+吉西他滨1.3g d1 q2w),2021年5 月复查CT评估PR,2021年06月05日、2021年06月19日、2021年07月03日、2021年 07月17日、2021年07月31日、2021年8月14日继续行6周期AG方案化疗(白蛋白结合型紫杉醇150mg d1+吉西他滨1.3g d1q2w),2021年8月复查CT评估病情SD,患者化疗过程中出现手足麻木、活动受限,伴四肢乏力。
给予本发明的中药组合物方剂口服:按照该清热化湿方中药组合物配方加水浸过药面浸泡60分钟;中浸泡好的配方原料中继续加水,没过药面3-4厘米,用大火煎煮至沸腾后,改为文火继续煎煮60分钟,至剩余药液浓缩至100mL,过滤,取滤液备用;向剩余药物中继续加水,没过药面2-3厘米,用大火煎煮至沸腾后,改为文火煎煮60分钟,过滤,至剩余药液浓缩至100mL,每日口服2次,每次约100ml,随化疗药物周期用药约6月。
2021年9月11日患者再次住院,拟行AG方案化疗。诉口服清热化湿中药组合物后手手脚麻木伴疼痛症状有缓解,活动困难较前好转,根据美国国立癌症研究所通用不良事件标准(NCI-CTCAE)评分从3级降至1级,肿瘤患者神经毒性评估量表(FACT/GOG-Ntx)评分从3级降至2级。
徐某某,女性,71岁,因“确诊胰腺恶性肿瘤9月余”入院治疗,住院号:13***43
患者2021年01月无明显诱因出现间断性腹泻,不伴有腹胀腹痛等不适。2021年07月 06日PET/CT提示:胰腺钩突部形态饱满,周围脂肪间隙模糊,FDG代谢轻度增高。双肺及双侧胸膜下多发结节,2021年08月09日行超声内镜下细针穿刺活检术,考虑导管腺癌;分期:cTxNxM1 IV期。基因检测提示:K-ras基因第2、3、4外显子未检测到突变;ECOG评分1分,于2021年08月18日、2021年09月01日、2021年09月15日、2021年09月29 日、2021年10月13日、2021年10月27日行6周期AG联合靶向方案治疗(白蛋白结合型紫杉醇160mg d1+吉西他滨1.4g d1泰欣生400mg d1 q2w),2021年11月复查CT评估SD,患者化疗过程中出现持续性腹泻,手足麻木、乏力,进食困难。
给予本发明的中药组合物方剂口服:按照该清热化湿方中药组合物的配方加水浸过药面浸泡60分钟;中浸泡好的配方原料中继续加水,没过药面3-4厘米,用大火煎煮至沸腾后,改为文火继续煎煮60分钟,至剩余药液浓缩至100mL,过滤,取滤液备用;向剩余药物中继续加水,没过药面2-3厘米,用大火煎煮至沸腾后,改为文火煎煮60分钟,过滤,至剩余药液浓缩至100mL,每日口服2次,每次约100ml,随化疗药物周期用药约4月。
2021年12月12日患者再次住院,拟行AG方案化疗。诉口服清热化湿中药组合物后腹泻乏力较前好转,根据NCI-CTCAE化疗相关胃肠道反应评分从3级降至1级,中医临床症状评分较前明显改善。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应所述以权利要求的保护范围为准。
Claims (7)
1.一种用于治疗胰腺癌的中药组合物,其特征在于,所述中药组合物按质量份数计包含由以下原料制备得到:白花蛇舌草30-40重量份、鸡内金15-20重量份、制大黄6-10重量份、薏苡仁20-30重量份、山药20-30重量份、蛇六谷15-30重量份、白术10-20重量份、甘草6-10重量份和陈皮10-20重量份。
2.根据权利要求1所述的用于治疗胰腺癌的中药组合物,其特征在于,所述中药组合物由以下原料制备得到:白花蛇舌草30重量份、鸡内金15重量份、制大黄6重量份、薏苡仁20重量份、山药20重量份、蛇六谷15重量份、白术10重量份、甘草6重量份和陈皮10重量份。
3.权利要求1或2所述用于治疗胰腺癌的中药组合物在制备治疗胰腺癌的药物中的应用。
4.根据权利要求3所述的应用,其特征在于,所述中药组合物的有效成分经过提取后的混合物制备为一种药学上可接受的药物制剂。
5.根据权利要求4所述的应用,其特征在于,所述药物制剂包含上述中药组合物的提取物和药学上可以接受的药物载体或赋形剂,剂型包括片剂、胶囊剂、软胶囊剂、颗粒剂、丸剂、粉剂、散剂、膏剂、混悬剂、口服液或注射剂。
6.根据权利要求5所述的应用,其特征在于,所述药物制剂为口服液,随化疗周期每日服用,每日1剂,分2次服用,每次100mL。
7.根据权利要求6所述的应用,其特征在于,所述口服液的制备方法包括如下步骤:
步骤一、将权利要求1或2所述用于治疗胰腺癌的中药组合物原料按照配方的量混合,加水浸过药面浸泡60分钟;
步骤二、向步骤一中浸泡好的配方原料中继续加水,没过药面3-4厘米,用大火煎煮至沸腾后,改为文火继续煎煮60分钟,至剩余药液浓缩至100mL,过滤,取滤液备用;
步骤三、向步骤二得到的剩余药物中继续加水,没过药面2-3厘米,用大火煎煮至沸腾后,改为文火煎煮60分钟,过滤,至剩余药液浓缩至100mL,取滤液后与步骤二中得到的滤液混合即可。
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---|---|---|---|---|
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CN103071104A (zh) * | 2013-01-21 | 2013-05-01 | 戴玲玲 | 一种治疗中晚期胰腺癌的中药复方制剂 |
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CN103071104A (zh) * | 2013-01-21 | 2013-05-01 | 戴玲玲 | 一种治疗中晚期胰腺癌的中药复方制剂 |
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Title |
---|
杨兆硕,厉天瑜,鲍旭霞,范越,仇冬则: "清热化湿方联合化疗治疗湿热蕴脾型进展期胰腺癌 临床疗效观察", 中医药临床杂志 * |
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