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.     

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。     

Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study

Background: Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However, the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC. Objective: To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy. Methods: The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals at Beijing, Shanghai, Nanjing, and Guizhou, and assigned to three groups according to paitents'' wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy, (2) Chinese medicine (CM) group receiving only CM herbal treatment, and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS), quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, tumor control, and CM symptom score. Discussion: This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective, national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622)     

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.     

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、     

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。     

西妥昔单抗单药或与伊立替康联合治疗伊立替康耐药的转移性结直肠癌

1文献类型治疗。2证据水平1b。3文献来源Cunningham D,Humblet Y,Siena S,et al.Cetuximab monotherapy and Cetuximab plus Irino-tecan in Irinotecan-refractory metastatic colorectalcancer[J].N Engl J Med,2004,351:337-345.4背景目前转移性结直肠癌的二线化疗方案为伊立替康单用或与氟尿嘧啶/甲酰四氢叶酸联用,以及奥沙利铂与氟尿嘧啶/甲酰四氢叶酸联用,有效率为10%～15%,中位至进展时间4～6个月,中位生存时间8～11个月,长期预后仍比较差。对于伊立替康和奥沙利铂均耐药的转移性结直肠癌仍无有效的治疗手段。基础研究发现,表…     

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。     

中医与西医治疗晚期非小细胞肺癌病人远期生存率的临床研究

Objective： To investigate the prognostic influence on long-term overall survival （OS） from treatment with Chinese medicine （CM） and chemotherapy or targeted therapy in advanced non-small-cell lung cancer （NSCLC） patients. Methods： The clinical data of 206 advanced NSCLC patients who were treated with CM and Western medicine in Beijing Cancer Hospital from April 1999 to July 2013 were retrospectively analyzed. Long-term survivors were defined as OS ≥ 3 years after treatment with CM and chemotherapy. Twenty-eight patients had OS ≥ 3 years, 178 had OS 〈 3 years, and all clinical data were statistically analyzed with the Cox model. Variables were gender, age, smoking status, performance status （PS） score, pathological type, clinical stage, first-line chemotherapy, targeted therapy, and use of CM. Univariate survival analysis was performed using the Kaplan-Meier method and log-rank sequential inspection. Multivariate survival analysis was used to analyze the meaningful factors of univariate survival analysis with the Cox model. Results： The survival rate of patients with OS ≥ 3 years was 13.6% （28/206）. Cox multivariate regression analysis showed that PS score, clinical stage, disease control rate to first-line chemotherapy, and use of CM were independent factors of long- term OS （all P〈0.05）. However, gender, age, smoking, and use of epidermal growth factor receptor tyrosine- kinase inhibitor were not significant （P〉0.05）. Conclusion： PS score, clinical stage, disease control rate to first- line chemotherapy, and use of CM are probably independent prognostic factors for long-term OS in patients with advanced NSCLC.     

Clinical Study of Sudden Desfness Treated with Integrated Traditional Chinese and Western Medicine

Suddendeafnessissoundperceptionnervedeafnessthatoccurssuddenly,andbelongstothecategoryof"fulminantdeafness"intraditionalChinesemedicine(TCM).Thecauseofthediseasehasnuclearyet,andmayberelatedwithdisturbanceofbloodcirculation,auto--immuneandviralinfection.UPtonow,thereisnospecifictreatmenttocureit.TheauthorshavetreatedpatientsofsuddendeafnesswithintegratedtraditionalChineseandwesternmedicine(TCM--WM)andstudiedthemechanismofthedisease,thereportisasfollows.METHODSClinicalDataThe146patients…     

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。     

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)     

中西医结合治疗大肠癌的回顾性研究及对生存预后影响因素的分析

【目的】观察中西医结合治疗及西医治疗对大肠癌患者生存期的影响,探讨影响大肠癌患者生存期的相关因素,为大肠癌治疗方案的选择提供参考依据。【方法】对685例接受中西医结合治疗(中西医组)和510例接受西医治疗(西医组)的中晚期大肠癌患者进行回顾性研究,观察患者的中位生存期及影响生存预后相关因素。采用Kaplan-Meier法进行单因素生存分析,对有统计学差异的变量,再应用Cox比例风险模型筛选出对生存时间有影响的因素。【结果】中西医组中位总生存期64.97个月,西医组中位总生存期23.60个月;中西医组无病中位生存期51.87个月,西医组无病中位生存期29.27个月。经单因素分析显示:年龄、肿瘤部位、病理类型、分化程度、复发转移、西医治疗、中西医治疗等对大肠癌患者的生存预后有显著影响(P<0.05);再进入多因素Cox回归分析后提示:分化程度、复发转移、中西医治疗、西医治疗等均与大肠癌的无病生存期有显著相关性(P<0.05)。【结论】中西医组的中位总生存期、无病中位生存期较西医组显著延长,患者的远期生存率较西医组显著提高;分化程度、复发转移、中西医治疗、西医治疗等是影响大肠癌生存时间的独立预后因素。     

16例结直肠癌骨转移患者的循证治疗

目的查找循证医学证据,为16例结直肠癌骨转移患者制定合理的治疗方案。方法针对患者的临床问题,以metastatic colorectal cancer,RCT,human,systematic review,meta-analysis等为检索词,电子检索Cochrane图书馆（2010年第1期）、EMBASE（2005,1-2010,12）和Black Well electronic journals（2005,1-2010,12）查找相关的系统评价、随机对照试验等,并对所获得证据进行质量评价。结果从Cochrane临床试验中心登记库查到临床对照15篇,从EMBASE及Black Well electronic journals检索到Meta分析10篇,随机对照试验8篇,结果显示对转移性结直肠患者进行化疗可延缓病情的发展,提高患者的生存率,据此,结合医生经验及患者意愿,对该16例患者进行化疗及其他支持治疗,患者临床症状好转,生活质量提高。结论我们运用循证医学证据为16例结直肠癌骨转移患者选择了合理的治疗方案,但化疗的毒性、对患者生活质量的影响及病情症状的控制程度还需要进一步的高质量、大样本的随机对照试验研究。     

Current Situation and Reconsideration on Study of Integrated Chinese and Western Medicine Andrology

The development of Chinese medicine and Western medicine andrology is based on different social background and academic systems, either Chinese medicine or Western medicine andrology has their limitations, therefore, integration of Chinese and Western medicine (ICWM) andrology is in a great need. After more than 30 years of development, andrology has made great achievements in the construction of specialized academic association, holding academic conferences and publication of academic monographs, and the research progress on this field is mainly in the combination of disease and syndrome, microdifferentiation of symptoms and signs and basic research development. However, the comprehensive theoretic system of ICWM andrology has not yet established, and the related studies are still on the primary stage. In the future studies, great efforts still need to be made to expand the methods for the investigation of ICWM, and make innovations in the field of andrology.     

中西医结合治疗尖锐湿疣的临床观察

目的:比较单纯西医治疗及中西医结合治疗尖锐湿疣的疗效。方法:将80例尖锐湿疣患者随机分为,治疗组及对照组各40例,对照组采用微波或激光治疗,治疗组则同时配合中药内外法治疗。结果:对照组治愈率75％,复发率25％,治疗组治愈率92.5％,复发率7.5％,两组比较P<0.05,有显著性差异。结论:采用微波或激光同时配合中药内外法治疗尖锐湿疣疗效好于单纯采用微波或激光治疗,且降低复发率,值得临床推广。     

103例大肠癌中西医结合治疗疗效分析

目的比较大肠癌中西医结合治疗与单纯西医治疗的疗效。方法回顾性分析103例大肠癌患者生存期及生存率,其中中西医结合治疗50例,单纯西医治疗53例。单纯西医治疗组为手术、化疗或介入治疗,中西医结合治疗组在手术、化疗或介入治疗的基础上,再加复方苦参注射液或华蟾素注射液静脉滴注,或西黄解毒胶囊口服及中药辨证治疗。结果全组中位生存期21个月,平均生存期25.8个月,1、3、5年生存率分别为72.8%、22.3%、3.9%;中西医结合治疗组中位生存期27个月,平均生存期32.1个月,1、3、5年生存率分别为82%、32%、6%;单纯西医治疗组中位生存期16个月,平均生存期19.9个月,1、3、5年生存率分别为64.2%、13.2%、1.9%。两组比较,中位生存期和平均生存期差异有统计学意义(P0.05)。结论中医辨证论治加中成药结合手术和化疗治疗大肠癌的综合治疗模式,疗效肯定,值得进一步研究。     

中西医结合辨治精神焦虑症

精神焦虑症是以精神焦虑、心中烦躁、心悸不安、情绪易于波动为主要表现的一类疾病.采用口服西药舒乐安片加中药百合莲子甘草大枣方治疗该病,取得良好效果.     

Therapeutic Evaluation on Advanced Pancreatic Cancer Treated by Integrative Chinese and Western Medicine──Clinical Analysis of 56 Cases

Objective: In comparison with chemotherapy, to evaluate therapeutic effects on advanced pancreatic cancer treated by integrative Chinese and western medicine (ICWM) therapies. Methods: Based on the retrospective study of 56 patients with advanced pancreatic cancer, life table was applied to the analysis of patients' survival rate and Xz test to the comparison of therapeutic response between ICWM and chemotherapy groups. Results: The results showed that 1-year survival rate in the ICWM group was 55. 37%±3.24%; 2-year survival rate 34. 61%±16. 31%; 3-year survival rate 25. 96%±24. 64%; 5-year survival rate 25. 96%±24.64%; and median survival period 16. 3 months. However 1-year survival rate in the chemotherapy group was 21. 95%±27. 54% ; 2-year survival rate 7. 31%±27. 54% ; 3-year survival rate 0 % ; and median survival period 7. 5 months. The therapeutic effects between two groups were significantly different (P=0. 004). Further analysis suggested that the reduction of cancer mass in the ICWM grou