Cohort Study on the Effect of a Combined Treatment of Traditional Chinese Medicine and Western Medicine on the Relapse and Metastasis of 222 Patients with Stage Ⅱ and Ⅲ Colorectal Cancer after Radical Operation

Objective:To evaluate the effectiveness of a comprehensive therapy of traditional Chinese medicine(TCM)in reducing the relapse and metastasis of stageⅡandⅢcolorectal cancer based on conventional Western medicine(WM)therapy.Methods:Two hundred and twenty-two patients in total, diagnosed as stageⅡandⅢcolorectal cancer from February 2000 to March 2006,were recruited from Xiyuan Hospital,China Academy of Chinese Medical Sciences and the General Hospital of Beijing Military Area.They were followed-up once every 3-6 months.Twenty cases dropped out from the cohort.The remaining 202 patients were all treated with routine WM treatment [including R0 radical operation,or chemotherapy or/and radiotherapy according to national comprehensive cancer network(NCCN)clinical guidelines].These patients were assigned to two groups based on whether or not they were additionally treated with TCM comprehensive therapy(orally administered with a decoction according to syndrome differentiation,combined with a traditional patent drug over one year).Ninety-eight patients from Xiyuan Hospital were treated with WM and TCM(combined group),and 104 patients from the General Hospital of Beijing Military Area were treated with WM alone(WM group).The demographic data at baseline were comparable,including the operation times,age,sex,TNM staging,and pathological types.The patients were followed-up for one to five years.Up to now,there are 98,98,77,64,and 47 patients with 1,2,3, 4,and 5 years of follow-up in the combined group,respectively;and 104,104,97,81,and 55 patients in the WM group,respectively.The results of the 5-year follow-up of all the patients will be available in 2011. Results:The relapse/metastasis rate of 1-,2-,3-,4-,and 5-year were 0(0/98),2.04%(2/98),11.69% (9/77),14.06%(9/64),and 21.28%,(10/47)in the combined group,and were 4.80%(5/104),16.35% (17/104),21.65%(21/97),25.93%(21/81),and 38.18%(21/55)in the WM group,respectively.A significant difference was found in the second year between the two groups(χ~2=12.117,P = 0.000).Median relapse/ metastasis time was 26.5 months in the combined group and 16.0 months in the WM group.Conclusion: The combined therapy of TCM and WM may have great clinical value and a potential for decreasing the relapse or metastasis rate in stageⅡandⅢcolorectal cancer after conventional WM therapy.     

中药联合化疗治疗大肠癌临床进展

大肠癌是临床上常见的恶性肿瘤之一,大肠癌包括结肠癌和直肠癌,是我国第四大常见肿瘤,随着生活水平的提高和生活方式的改变,大肠癌的发病率和死亡率呈逐年上升趋势。大肠癌的治疗首选根治性手术切除,但对晚期不能手术和手术后出现复发转移的大肠癌患者,化疗是大肠癌的重要治疗手段[1],文章回顾近几年来临床有关中药联合化疗治疗大肠癌的相关报道,资料显示中医药对化疗具有减轻其毒副作用、增强疗效、提高缓解率、改善肿瘤患者的生存质量的作用,文章将临床有关中药联合化疗治疗大肠癌的报道,根据常用给药方式,分内服中药联合化疗和静脉中药制剂联合化疗两类,进行临床进展情况综述。     

Cohort Study on Prognosis of Patients with Metastatic Colorectal Cancer Treated with Integrated Chinese and Western Medicine

Objective: To investigate the efficacy of integrated Chinese and Western medicine(IM) in the treatment of metastatic colorectal cancer(m CRC) in a cohort study.Methods: The survival outcome of patients receiving IM was compared with that of patients receiving Western medicine alone.The study design was adopted with "continuous administration of Chinese medicine for 3 months" as the exposure factor.Patients who met this exposure factor were assigned to the IM cohort(Group A,110 patients).Patients who did not meet this exposure factor were assigned to the Western medicine cohort(Group B,225 patients).The overall survival(OS),progression-free survival(PFS),and 1 st year,2 nd year,and 3 rd year survival in the two cohorts were compared.Results: The median OS in Group A and B were 18 months [95% confidence interval(CI) 15–21] and 16 months(95% CI 14–18),respectively,and the median PFS in Group A and B were 6 months(95% CI 4–7) and 5 months(95% CI 4–6),respectively.No statistically significant differences were observed between the groups(P=0.186,P=0.223).Group A demonstrated significantly longer OS and PFS than Group B in the following subgroups: female patients,patients with lesions in the right half of the colon,and those who received first-line treatment(P0.05).In the subgroup of elderly patients(age65 years),the OS in Group A was longer than that in Group B(P0.05).Conclusion: IM could prolong the survival of patients with m CRC.(Registry No.Chi CTR-IOR-17010497)     

Comprehensive Treatment with Chinese Medicine in Patients with Advanced Non-Small Cell Lung Cancer: A Multicenter, Prospective, Cohort Study

Objective: To determine whether additional Chinese medicine(CM) could prolong survival and improve the quality of life(QOL) in patients with advanced non-small cell lung cancer(NSCLC) compared with Western medicine(WM) alone. Methods: This was a multicenter, prospective cohort study. A total of 474 hospitalized patients with stage Ⅲ–Ⅳ NSCLC were recruited and divided into 2 groups. Patients in the WM group received radiotherapy, chemotherapy, and optimal supportive therapy according to the National Comprehensive Cancer Network(NCCN) guidelines. In the integrative medicine(IM) group, individualized CM(Chinese patent medicines and injections) and WM were administered. The primary end point was overall survival, and the secondary end points were time to disease progression, adverse events, and QOL. Follow-up clinical examinations and chest radiography were performed every 2 months. Results: The median survival was 16.60 months in the IM group and 13.13 months in the WM group(P0.01). The incidences of loss of appetite, nausea, and vomiting in the IM group were significantly lower than those in the WM group(P0.05). The QOL based on Functional Assessment of Cancer Therapy-Lung in the IM group was markedly higher than that in the WM group at the fourth course(P0.05). Conclusions: Additional CM may prolong survival and improve the QOL patients with NSCLC. The adverse effects of radio-and chemotherapy may be attenuated as CM is used in combination with conventional treatments.     

中医药联合化疗治疗晚期结直肠癌近期疗效和生存质量的Meta分析

目的比较中医药联合化疗与单纯化疗治疗晚期结直肠癌在近期疗效和生存质量方面的差异。方法应用Meta分析方法的随机效应模型,对国内2000年1月-2012年6月为止单纯采用中医药联合化疗治疗晚期结直肠癌,并以单纯化疗作对照的研究文献进行定量合并分析。结果在肿瘤患者缓解率方面,中医药联合化疗组的418例患者中有159例取得了完全或部分缓解,化疗组363例患者中有107例取得了完全或部分缓解,2组比较,P0.01。中医药联合化疗组的147例患者中有89例生存时间超过1a,化疗组102例患者中有47例生存时间超过1a,2组比较,P0.01。在生存质量方面,中医药联合化疗组的267例患者中有155例卡氏评分提高,化疗组243例患者中有76例患者卡氏评分提高,2组比较,P0.01。结论中医药联合化疗方案在治疗晚期结直肠癌患者有效率和1年生存率上优于单纯化疗方案,而且中医药联合化疗在提高生存质量上有明显优势。     

中药汤剂联合化疗治疗乳腺癌临床疗效系统评价

目的:系统评价中药汤剂联合化疗治疗乳腺癌的临床疗效,得出相对可靠的目前中药汤剂联合化疗治疗乳腺癌疗效的循证医学证据。方法:计算机检索Cochrane Library、MEDLINE、EMBASE、CNKI、VIP、CBM。全面收集有关中药汤剂联合化疗治疗乳腺癌的随机对照试验,评价纳入研究的质量并提取资料,并用RevMan 5.0软件进行统计分析;运用频率分析法对中药进行归类统计。结果:共纳入21篇RCTs,分析结果显示:与单纯化疗方案相比,中药汤剂联合化疗方案可以提高乳腺癌患者的客观疗效有效率[OR=1.86,95%CI(1.38~2.50)]、体能状态评分有效率[OR=3.77,95%CI(2.47~5.74)],降低重度骨髓抑制发生率[OR=0.26,95%CI(0.16~0.40)]和重度消化道反应发生率[OR=0.22,95%CI(0.11~0.42)],差异均有统计学意义。结论:中药汤剂联合化疗可提高乳腺癌客观疗效有效率和体能状态评分有效率,降低重度骨髓抑制发生率和重度消化道反应发生率;配合化疗的中药汤剂多以益气养血与活血化瘀药物配伍使用。     

中医药联合化疗治疗大肠癌研究述评

中医药联合化疗是大肠癌综合治疗的一个重要的方面,也是大肠癌综合治疗研究的热点。近年来大量的相关研究发现,中医药与化疗联合治疗大肠癌可起到减毒、增效的作用,有效减少化疗所产生的多种不良反应,改善患者临床症状,降低耐药性,减少大肠癌的复发及转移,改善患者预后。本文将近年来论述侧重点不尽相同的研究进行总结,以期对后续研究的进一步开展以及相关临床应用有所启发。     

中医药治疗晚期大肠癌研究进展

从生存期、生存率的角度,回顾中医药治疗晚期大肠癌的研究进展,并对其研究现状作简要分析。     

化疗联合养正消积胶囊治疗中晚期大肠癌临床研究

目的:观察化疗联合养正消积胶囊治疗中晚期大肠癌的临床疗效。方法:将78例中晚期大肠癌患者随机分为观察组和对照组,对照组患者采用化疗治疗,观察组在化疗方案基础上加用养正消积胶囊口服,两组均治疗2个月。比较两组患者治疗后生存质量评分、临床疗效及临床症状改善情况。结果:观察组治疗后生存质量评分为(74.32±12.31)分,明显高于对照组的(67.24±11.98)分,两组比较,差异有统计学意义(P0.05);观察组治疗后有效率为89.74%,对照组有效率为61.54%,两组比较,差异有统计学意义(P0.01);观察组恶心、呕吐、食欲减退症状改善情况优于对照组,差异有统计学意义(P0.01);观察组不良反应明显低于对照组,差异有统计学意义(P0.01)。结论:化疗联合养正消积胶囊治疗中晚期大肠癌可明显提高患者生存质量,改善临床症状,减轻不良反应。     

中药治疗乳腺癌化疗致白细胞减少症的研究现状

近年来,中医药治疗乳腺癌化疗致白细胞减少症取得了一定的临床疗效,并开展了相关作用机制研究,其治则多从健脾补肾、益气养血着手,再辅以个体化辨证治疗。研究表明,中药抗白细胞减少症具有效果平稳持久、副作用小等优点,并通过影响骨髓细胞增殖周期、骨髓细胞凋亡、造血干/祖细胞增殖以及骨髓造血微环境方面发挥作用。     

结直肠癌术中区域化疗的安全性评价

目的评价结直肠癌术中区域化疗的安全性。方法治疗组术中经区域动脉灌注含5-Fu（15mg／kg）和羟基喜树碱（0．06mg／kg）化疗液100ml,对照组经区域动脉灌注生理盐水100ml,术后第1、3d检测肝肾功能、血常规和床旁心电图,观察胃肠道反应及3～7d有无吻合口漏。结果治疗组术后第1dAST明显增高（P〈0．01）,术后第3d即恢复正常（P〉0．05）;两组术后骨髓抑制、胃肠道反应、床旁心电图、肝功能的ALT、ALP、GGT、LDH及。肾功能无显著差异（P〉0．05）,两组均未出现吻合口漏。结论结直肠癌术中区域化疗是一种安全的化疗方式,但术前应选择肝功能正常的病人,并于术后适当保肝治疗。     

转移性结直肠癌治疗进展

奥沙利铂、伊立替康和氟尿嘧啶类药物仍是转移性结直肠癌化疗的三大类药物。卡培他滨作为氟尿嘧啶（Fluorouracil，FU）的前体口服制剂，在体内需经胸苷嘧啶磷酸化酶（thymidine phosphorylase，TP）活化方可转变为活性产物发挥抗肿瘤效应。与传统的FU／甲酰四氢叶酸（Leucovorin，LV）或LV5-FU2相比，有效率、疾病进展时间相当，除手足综合征外，无论血液学毒性还是非血液学毒性均明显下降。以这些药物为基础组成的化疗方案在一、     

Chinese Medicine for Outcomes in Colorectal Cancer Patients: A Retrospective Clinical Study

Objective: To investigate the effect of Chinese medicine(CM) on survival of patients with stage Ⅱ and Ⅲ colorectal cancer(CRC). Methods: A total of 295 patients who received chemotherapy were assigned to Group 1. The other 171 patients received the same chemotherapy treatment combined with the usage of CM Jianpi Jiedu Formula(健脾解毒方, JPJD) for more than 3 months(Group 2). Patients' survival time, relapse and metastasis, and cause of death were observed. Cox proportional hazard regression models were established for the analysis of the effect of independent factors on the survival prognosis of patients with CRC. Results: The survival rate of patients in Group 2 was higher than that of Group 1(P0.05). Compared with Group 1, the mean survival time was prolonged by 5.594 months and the median survival time was prolonged by 6 months in Group 2(P=0.004). Cox regression analysis indicated that CM combined with chemotherapy provided significant protective effect, as observed with the improvements in the survival rates of CRC patients(P0.01). Conclusion: CM can improve the survival rate in patients with stage Ⅱ and Ⅲ CRC.     

中西医结合治疗复发/转移性结直肠癌临床研究

目的:观察卡培他滨、伊立替康化疗联合生脉注射液治疗复发/转移性结直肠癌的疗效和安全性。方法:收集64例复发/转移性结直肠癌患者,给予伊立替康100 mg·m~(-2),第1天、第8天,静脉滴注;卡培他滨1 000 mg·m~(-2),第1天-第14天,每日两次口服;生脉注射液40 m L+(质量分数)5%葡萄糖溶液250 m L,每天静脉滴注1次。21 d为1个周期。评价临床疗效及不良反应。结果:64例中可进行疗效评价者60例,有效率为25.0%,疾病控制率为60.0%。64例患者均获随访,随访截止日为2014年5月30日,中位疾病进展时间为9.1个月(4~24个月),中位生存期为15.2个月(7~30个月);全组死亡36例,28例仍在随访中。其中消化道反应29例;粒细胞减少21例;血小板减少20例;乙酰胆碱综合征18例,Ⅰ~Ⅱ度,可耐受。最常见的Ⅲ~Ⅳ级不良反应为粒细胞减少(10/64,15.6%)及迟发性腹泻(8/64,12.5%)。全组无化疗死亡病例。结论:卡培他滨、伊立替康化疗联合生脉注射液治疗复发/转移性结直肠癌疗效较好,不良反应可以接受。     

针刺治疗对大肠癌化疗患者胃肠道毒副反应的疗效

目的:探讨针刺治疗对大肠癌化疗患者胃肠道毒副反应的临床疗效。方法:选择大肠癌(包括结肠癌和直肠癌)患者63例,随机分为对照组31例和治疗组32例。所有患者均给予一线大肠癌化疗方案治疗,对照组患者在化疗前30 min给予盐酸托烷司琼注射液静脉滴注,治疗组患者在化疗前30 min给予盐酸托烷司琼注射液静脉滴注,同时采用针刺穴位治疗。观察周期为5 d。观察两组患者化疗后的消化道毒副反应,比较两组患者的呕吐持续天数及追加止吐药剂量。结果:化疗第1天,两组患者的呕吐、恶心程度比较,差异无统计学意义(P0.05);化疗第2天至第5天,两组患者的呕吐、恶心程度比较,差异均有统计学意义(P0.01,P0.05),治疗组患者的呕吐、恶心程度较对照组明显减轻。两组患者的呕吐持续天数及追加止吐药剂量比较,差异均有统计学意义(P0.01,P0.05),治疗组患者的呕吐持续天数及追加止吐药剂量明显少于对照组。结论:针刺联合托烷司琼治疗能有效缓解大肠癌化疗患者的胃肠道毒副反应,从而提高患者对化疗的依从性及耐受性。     

Association between Chinese Medicine Therapy and Survival Outcomes in Postoperative Patients with NSCLC: A Multicenter, Prospective, Cohort Study

Objective: To evaluate the association between Chinese medicine(CM) therapy and disease-free survival(DFS) outcomes in postoperative patients with non-small cell lung cancer(NSCLC). Methods: This multiple-center prospective cohort study was conducted in 13 medical centers in China. Patients with stage Ⅰ,Ⅱ, or ⅢA NSCLC who had undergone radical resection and received conventional postoperative treatment according to the National Comprehensive Cancer Network(NCCN) guidelines were recruited. The recruited patients were divided into a CM treatment group and a control group according to their wishes. Patients in the CM treatment group received continuous CM therapy for more than 6 months or until disease progression. Patients in the control group received CM therapy for less than 1 month. Fol ow-up was conducted over 3 years. The primary outcome was DFS, with recurrence/metastasis rates as a secondary outcome. Results: Between May 2013 and August 2016, 503 patients were enrol ed into the cohort; 266 were classified in the CM treatment group and 237 in the control group. Adjusting for covariates, high exposure to CM was associated with better DFS [hazard ratio(HR) = 0.417, 95% confidential interval(CI): 0.307–0.567)]. A longer duration of CM therapy(6–12 months, 12–18 months, 24 months) was associated with lower recurrence and metastasis rates(HR = 0.225, 0.119 and 0.083, respectively). In a subgroup exploratory analysis, CM therapy was also a protective factor of cancer recurrence and metastasis in both stage Ⅱ–ⅢA(HR=0.50, 95% CI: 0.37–0.67) and stage ⅢA NSCLC postoperative patients(HR = 0.48, 95% CI: 0.33–0.71), DFS was even longer among CM treatment group patients.Conclusions: Longer duration of CM therapy could be considered a protective factor of cancer recurrence and metastasis. CM treatment is associated with improving survival outcomes of postoperative NSCLC patients in China.(Registration No. ChiC TR-OOC-14005398)     

乳腺癌化疗副作用中医药研究进展

中医药贯穿乳腺癌治疗的整个过程,是乳腺癌综合治疗的组成部分,而其在治疗乳腺癌化疗所致副作用方面则更是独树一帜。本文综述近年中医药治疗乳腺癌化疗所致副作用的研究文献,从中医对乳腺癌的基本认识,乳腺癌化疗后病因病机、经典名方对乳腺癌化疗所致副作用的治疗等几个方面,探寻乳腺癌化疗所致副作用的中医药治疗研究思路。     

216例辅助化学治疗期乳腺癌患者中医证候分布和演变规律研究

目的 探讨辅助化学治疗期乳腺癌患者的中医证候及其变化规律.方法 采集216例辅助化学治疗期乳腺癌患者的四诊信息,通过聚类分析结果结合专家经验归纳出中医证候的分布和演变规律.结果 化学治疗开始前患者多表现为脾虚与肝郁两证,第2周期化学治疗结束后患者表现为脾气虚证、肝郁化火证、心肝实热证,第4周期化学治疗结束后患者表现为肝、脾、胃三脏阴血不足为主的证候,第6周期化学治疗结束后患者出现心、肝、脾、胃等多脏腑不足的证候.结论 在辅助化学治疗期,患者中医证型总体以虚证为主;在化学治疗前期,主要为肝脾两脏的气病;随着化学治疗的延续,由阳病转为阴病;后期患者逐渐表现为类似五脏赢弱的证候.     

结直肠癌的中医治疗进展

本文综述1996年到2009年23篇有代表性文章,将中医在早中期结直肠癌抗转移复发的队列研究和随机研究、在晚期结直肠的随机研究或病例对照研究、在围手术期和放化疗期的随机对照或病例对照研究进行综述,一方面证实坚持中医治疗,对于结直肠癌根治术后的患者可能减少复发和转移;对晚期患者可能延长生存期,改善生活质量;对围手术期患者可能促进结直肠癌术后胃肠功能恢复,增强免疫力;对于放疗、化疗的患者可能预防或减轻放、化疗不良反应,值得深入探讨。另一方面提出目前在国内发表的文献多为小样本的临床研究或经验报道,大样本、多中心、随机双盲等高质量的临床研究不多,在循证医学中的证据水平不高,系统评价尚不能得出定量结论。     

Cohort Study on the Effect of a Combined Treatment of Traditional Chinese Medicine and Western Medicine on the Relapse and Metastasis of 222 Patients with Stage Ⅱ and Ⅲ Colorectal Cancer after Radical Operation

Objective： To evaluate the effectiveness of a comprehensive therapy of traditional Chinese medicine （TCM） in reducing the relapse and metastasis of stage Ⅱ and Ⅲ colorectal cancer based on conventional Western medicine （WM） therapy. Methods： Two hundred and twenty-two patients in total, diagnosed as stage Ⅱ and Ⅲ colorectal cancer from February 2000 to March 2006, were recruited from Xiyuan Hospital, China Academy of Chinese Medical Sciences and the General Hospital of Beijing Military Area. They were followed-up once every 3-6 months. Twenty cases dropped out from the cohort. The remaining 202 patients were all treated with routine WM treatment [including R0 radical operation, or chemotherapy or/and radiotherapy according to national comprehensive cancer network （NCCN） clinical guidelines]. These patients were assigned to two groups based on whether or not they were additionally treated with TCM comprehensive therapy （orally administered with a decoction according to syndrome differentiation, combined with a traditional patent drug over one year）. Ninety-eight patients from Xiyuan Hospital were treated with WM and TCM （combined group）, and 104 patients from the General Hospital of Beijing Military Area were treated with WM alone （WM group）. The demographic data at baseline were comparable, including the operation times, age, sex, TNM staging, and pathological types. The patients were followed-up for one to five years. Up to now, there are 98, 98, 77, 64, and 47 patients with 1, 2, 3, 4, and 5 years of follow-up in the combined group, respectively; and 104, 104, 97, 81, and 55 patients in the WM group, respectively. The results of the 5-year follow-up of all the patients will be available in 2011. Results： The relapse/metastasis rate of 1-, 2-, 3-, 4-, and 5-year were 0 （0/98）, 2.04% （2/98）, 11.69% （9/77）, 14.06% （9/64）, and 21.28% （10/47） in the combined group, and were 4.80%（5/104）, 16.35% （17/104）, 21.65% （21/97）, 25.93% （21/81）, and 38.