Objective: To develop a patient-reported traditional Chinese medicine kidney deficiency pattern (TCM-KDP) scale for colorectal cancer (CRC) patients and evaluate its reliability and validity. Methods: We administered the TCM-KDP questionnaire to postoperative patients with stage II and III CRC as part of a multicenter randomized controlled trial (RCT) conducted in China from December 2018 to September 2021. The TCM-KDP scale consists of eight items on patient-reported symptoms and is scored on a five-point Likert scale. The scale’s reliability was assessed using Cronbach’s α and test-retest reliability, while content validity was evaluated with the content validity index. We compared the differences in serum cytokine levels and other clinical factors between patients with higher and lower KDP scores. Results: Of the 378 patients analyzed in the original RCT, 352 (93.2%) completed the TCM-KDP questionnaire. The Cronbach’s α of the eight-item TCM-KDP scale was 0.734, and the test-retest reliability was 0.745. Our exploratory factor analysis yielded eight factors that explained the variance of 50.34%. The mean TCM-KDP score was 2.80 ± 0.92. Compared with patients with stage II CRC, those with stage III CRC had significantly higher TCM-KDP scores (2.25 vs. 2.50, P = .026). We categorized all patients into high- or low-KDP score groups (the cut-off score was 2.8). Patients with lower TCM-KDP scores had significantly higher serum interleukin-1β expression levels (P = .04). Conclusion: The patient-reported TCM-KDP scale demonstrated relatively good feasibility, internal consistency, and test-retest reliability among patients with CRC. Future studies could apply this scale to other cancer types and diseases.

PURPOSE:Many cancer patients express interest in using herbal medicine during chemotherapy, but little is known about its benefits and risks. This study aimed to evaluate the effects of the Chinese herbal medicine JianPi-BuShen formula (JPBS) on adjuvant chemotherapy completion in colon cancer patients. PATIENTS AND METHODS:This multi-center, phase III, randomized, placebo-controlled trial included patients with stage II (high risk for recurrence) and stage III colon cancer following surgery, planning to receive CAPOX (capecitabine and oxaliplatin) chemotherapy. Patients were randomized 1:1 to receive either JPBS or a placebo. The primary outcome was the completion rate of planned chemotherapy cycles. Secondary outcomes included relative dose intensity (RDI), chemotherapy-induced toxicities, quality of life (measured by the Edmonton Symptom Assessment System - ESAS), adverse events (AEs), and serious AEs (SAEs). Predefined subgroup analyses were performed by age (>65/≤65) and TNM stage (II/III). RESULTS:A total of 376 participants were analyzed, with a median age of 60.3 years; 56.9 % were male, and 67.6 % had stage III disease. Chemotherapy completion was significantly higher in the JPBS group than in the placebo group (63.0 % vs. 47.6 %, P = 0.003). Oxaliplatin RDI was also higher in the JPBS group (P = 0.049). Subgroup analyses showed JPBS significantly improved completion rates for stage II patients (73.0 % vs. 42.4 %, P = 0.001) and younger patients (66.9 % vs. 48.8 %, P = 0.004). JPBS reduced grade ≥ 2 vomiting (3.8 % vs. 6.4 %, P = 0.007) but increased grade ≥ 2 thrombocytopenia (16.2 % vs. 12.4 %, P = 0.012). Quality of life improved in stage II and younger patients. CONCLUSION:JPBS improved chemotherapy completion rates in stage II and younger colon cancer patients without compromising tolerability. Further research is needed to explore its mechanisms and long-term effects.

BackgroundCryoablation (cryo) is a local anti-tumor method and activation of immunity is one of its mechanisms, but it is affected by many factors. Numerous studies have proved that combination therapy based on cryo can activate immunity more effectively and synergistically. Cryo combined with chemotherapy(chemo) has been proven to improve the quality of life and prolong survival of tumor patients, but the immune effect is still unclear.MethodsC57B/L6 mouse lung cancer subcutaneous transplanted tumor model was established and sacrificed at two time points after intervention. We observed the effects of cryo + chemo on survival time, tumor growth, and dynamic changes of immune cells and cytokines.ResultsCryo + chemo could not only significantly prolong the survival period of mice, inhibit tumor growth and reduce the proliferation activity of tumor cells, but also promote immune response more effectively. Cryo + chemo could increase the number of CD4+ T cells both in spleen and tumor microenvironment, decrease the infiltration of Treg cells in the tumor microenvironment. Besides, cryo + chemo could increase the expression levels of IL-2 and IFN-gamma, and reduce the levels of TGF-beta. However, it is worth noting that the immune-promoting effect gradually decreases over time.ConclusionsCryo + chemo can effectively inhibit the growth of lung cancer, prolong the survival period and activate the immune response, providing a theoretical basis for the combined treatment. How to maintain the immune response for a long time is the next problem to be solved.

Objective To assess the effectiveness of Chinese herbal medicine (CHM) combined with adjuvant chemotherapy on myelosuppression for colorectal cancer (CRC) patients using network meta-analysis (NMA). Methods Literature searches in both international (PubMed, Embase, Web of Science, and Cochrane Library) and Chinese (China Science and Technology Journal Database, Wanfang Data, China National Knowledge Infrastructure) databases for relevant randomized controlled trials (RCTs) were conducted from inception until October 10, 2022. We included RCTs of patients who received CHM combined with chemotherapy, including FOLFOX, XELOX, FOLFIRI, and other relevant regimens in the CHM treatment group. The outcomes included the incidence of myelosuppression, leukopenia, hemoglobin reduction, and thrombocytopenia. Two reviewers independently screened the databases, extracted the data, and assessed the risk of bias and credibility of evidence. RevMan 5.4.1 software and STATA 14.0 were used to perform the NMA. Results A total of 31 RCTs were included, published from 2008 to 2021 in Chinese. Among these, 2,314 participants comparing the following 9 CHMs were identified: Shengbai Recipe (SBR), Bazhen Decoction (BZD), Jianpi Jiedu Recipe (JJR), Jianpi Recipe (JR), Compound Cantharis Capsule (CCC), Zaofan Pill (ZFP), Guilu Erxian Gel (GL), Buzhong Tiaogan Decoction (BZ), and Qiamagu Capsule (QM). The results of NMA found an indirect comparison. Based on the surface under the cumulative ranking curve (SUCRA), the ZFP+ chemotherapy group had the lowest incidence of myelosuppression, with an odds ratio (OR) of 0.08 [95% confidence interval (CI): 0.01, 0.76], whereas the GL+ chemotherapy group had the lowest incidence of leukopenia, hemoglobin reduction, and thrombocytopenia, with an OR of 5.25 (95% CI: 2.41, 11.43), 4.66 (95% CI: 2.23, 9.72), and 0.27 (95% CI: 0.13, 0.54), respectively. Moreover, BZD + chemotherapy could alleviate leukopenia, hemoglobin reduction, and thrombocytopenia ( P <0.01). Pairwise comparison showed that there was no difference in the efficacy among the 8 CHMs+ chemotherapy group. The comparison and adjustment funnel plot indicated that small-study effect had no impact on these outcomes. Conclusions This NMA provided evidence to support that patients with CRC benefit from receiving different combination of CHM chemotherapies. Among these, GL plus chemotherapy and BZD plus chemotherapy were the more effective for myelosuppression in patients; however, as the qualtiy of evidence is insufficient, further research is needed. (PROSPERO, No. CRD42022369025)

Objective: To investigate the role of Traditional Chinese Medicine (TCM) syndrome type, gut microbiome distribution, and host immunity function in predicting the early and advanced clinical stages of colorectal cancer (CRC). Methods: A cross-sectional case-control study was performed which included 48 early stage and 48 advanced patients with CRC enrolled from March 2018 to December 2020. 16S rRNA gene sequencing was performed to analyze the gut microbiomes of the patients, while T and B lymphocyte subsets in peripheral blood were assessed using flow cytometry. TCM syndrome type was measured using the spleen deficiency syndrome (SDS) scale. Results: The abundance levels of Prevotella, Escherichia-Shigella , and Faecalibacterium in the gut microbiota were significantly increased in the advanced group, while Bacteroides was significantly decreased. Phascolarctobacterium was detectable only in the early metaphase group, whereas Alistipes was detectable only in the advanced group. The lymphocyte ( P = .006), T helper cell (TH) ( P = .002), cytotoxic T cell (TC) ( P = .003), double positive T cell (DPT) ( P = .02), and total T counts ( P = .001) were significantly higher in the early metaphase group than in the advanced metaphase group. Compared with patients with early stage CRC, the advanced group had a higher SDS score. After adjusting for clinical stage, Spearman’s correlation analysis showed interactions among gut microbiome abundance, T cell level, and SDS score. Multivariate logistic analysis showed that after controlling for the SDS score, abundance of Alistipes and Faecalibacterium , and double negative T cell (DNT) level, DPT was significantly associated with a lower risk of advanced-stage disease (hazard ratio, 0.918; P = .022). Conclusion: Our study suggested associations between clinical stage, SDS, gut microbiota, and T lymphocytes, which provided insights for a potential prediction model for the disease progression of CRC.

BackgroundPatients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions, including nausea, vomiting, and diarrhea, which make it challenging for them to adhere to treatment. As an effective traditional Chinese medicine, the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.ObjectiveTo evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy. This statistical analysis plan (SAP) is intended to enhance the transparency and research quality of our randomized controlled trial.MethodsOur study is a multicenter, double-blind, randomized controlled clinical trial. This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula. To attenuate possible selection bias in the final report, we declared the overall trial design, outcome measures, subgroup analyses, and safety measures. Also, we described the data management and statistical analysis methods in detail.ConclusionThe SAP provides more detailed information than the trial protocol for data management and statistical analysis methods. Further post-hoc analyses can be performed by referring to the SAP, and possible selection bias can be attenuated.

Background: This study aimed to evaluate associations between lifestyle factors, survival outcomes and the gut microbiome among metastatic colorectal cancer (mCRC) patients.Methods: This was a secondary analysis of a randomized controlled clinical trial (RCT) conducted between April 2018 and March 2019 in Beijing, China, which randomly assigned 40 mCRC patients into a Quxie capsule group (a traditional Chinese herbal medicine compound) or a placebo group for one month of intervention. Thirty-four patients completed all interventions, and we followed up with them every three months for survival outcomes. The last follow-up was in January 2021. We collected patients’ stool samples at baseline and obtained lifestyle data, including diet, physical activity (PA) and other health behaviors, from the original RCT. Kaplan–Meier survival analyses and Cox regression models were used to evaluate the impact of different lifestyle factors on survival outcomes. A total of 16S rRNA sequencing approaches were utilized for the gut microbiome analysis.Results: Nineteen patients were still alive at the time of the last follow-up, and the estimated median overall survival (OS) after enrollment was 33.0±6.9 months. A Cox regression model showed that after controlling for the original tumor site, dietary habits, smoking behaviors, and treatment group, a high PA level was independently associated with a lower risk of death (hazard ratio 0.11, p=0.048). A gut microbiome community difference analysis showed that patients with high PA levels had a significantly higher alpha diversity, an increased abundance of Phascolarctobacterium and Ruminococcaceae and a decreased abundance of Megasphaera at the genus level.Conclusions: Among the lifestyle factors mentioned above, different PA levels were associated with regulation of the gut microbiome, which might influence the survival outcomes of mCRC patients.Funding Information: This study was funded by grants from the National Natural Science Foundation of China: General Program 2015 (No. 81573781) and the Young Scientists Program 2020 (No. 82004191).Conflict of Interests: The authors declare that they have no conflicts of interest in this work.Ethical Approval: The RCT study was approved by the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences (2016XLA122-1). All patients signed informed consent forms before enrollment.Trial Registration: Registration number: ChiCTR2000029599.

目的:基于中医脾虚量表分析结直肠癌脾气虚与非脾气虚患者在临床特征、肠道菌群及TB淋巴细胞亚群的差异性及相关性.方法:采用前瞻性临床观察研究方法对2018年3月至2020年12月期间在中国中医科学院西苑医院、北京大学肿瘤医院门诊及病房就诊的96例结直肠癌患者进行临床信息、肠道菌群及TB淋巴细胞亚群的相关分析.结果:脾气虚组与非脾气虚组在自然杀伤性T细胞绝对值的比较中差异有统计学意义(45.5,IQR 50.8 vs.28 IQR 52,U=208,P=0.049);肠道菌群物种组成差异分析结果显示,非脾气虚组中双歧杆菌属丰度显著低于脾气虚组且差异有统计学意义(P<0.05).结论:结直肠癌脾气虚与非脾气虚患者在肠道菌群组成及TB淋巴细胞亚群分布方面存在差异,可为探索结直肠癌脾气虚证的生物学特征提供客观依据.

Background:This study aimed to evaluate associations between physical activities, gut microbiome and survival outcomes among Chinese metastatic colorectal cancer (mCRC) patients.Methods:We conducted a secondary analysis nested in a randomized controlled clinical trial (RCT) of a traditional Chinese herbal medicine for mCRC patients (ChiCTR2000029599). After one-month intervention, we followed up patients every six months for survival outcomes and the last follow-up was in August 2022 (median follow-up time 28.6 months). We assessed patients' physical activity (PA) through short form of the International Physical Activity Questionnaire (IPAQ-SF) and collected patients' stool samples at baseline. Kaplan-Meier survival analyses and Cox regression models were used to evaluate the association between PA level and overall survival outcomes. 16S rRNA sequencing approaches were utilized for the gut microbiome analysis.Results:Among 40 mCRC patients enrolled in the original RCT, 15 patients were still alive at the time of the last follow-up. The mean IPAQ score was 2569.5 MET-min/week for all patients, indicating a moderate PA level. Specifically, there were 7 patients in high PA level group, 2 patients in low PA level group and the rest were in middle PA group. Gut microbiome community difference analysis showed that patients with high PA levels had a significantly higher alpha diversity than that of the middle PA group (131.53 vs. 98.12, p = 0.04), an increased abundance of Phascolarctobacterium and Ruminococcaceae and a decreased abundance of Megasphaera at the genus level. Cox regression model showed that after controlling for the original tumor site and TCM treatment, high PA level was independently associated with a lower risk of death (relative risk 0.13, p = 0.014).Conclusions:High PA level could be associated with survival benefits among Chinese mCRC patient through its potential role on modulating gut microbiome. Our results could be referred to patients' education and future clinical study design.

Objective: To evaluate the effectiveness of Chinese Herbal Medicine (CHM) on leukopenia/neutropenia induced by chemotherapy in adults with colorectal cancer (CRC). Methods: Eight electronic databases were searched from their inception to June 2020. Randomized controlled trials with clarified sequence generation were qualified. Two reviewers independently conducted the screening and data extraction. Methodological quality was assessed using the Risk of Bias tool. RevMan 5.4 was applied to the meta-analysis. Results: Twenty-seven studies involving 1867 participants were qualified, of which 26 were included in the quantitative synthesis. Meta-analysis showed that CHM significantly reduced the incidence of leukopenia induced by chemotherapy (RR = 0.69; 95% CI 0.59-0.82), as well as the grade 3/4 leukopenia (RR = 0.71; 95% CI 0.55-0.90). Meanwhile,CHM decreased the occurrence of neutropenia (RR = 0.52, 95% CI 0.35-0.77), especially for the grades 3/4 neutropenia (RR = 0.42, 95% CI 0.27-0.64). Twenty-six of the included studies focused on the adverse events related to CHM. Conclusion: CHM may relieve neutropenia/leukopenia induced by chemotherapy in adults with colorectal cancer.

目的 评价口服中药防治结直肠癌辅助化疗所致的骨髓抑制的疗效.方法 在8个电子数据库检索建库至2021年1月20日相关文献.两名研究者按照纳入、排除标准独立进行文献筛选和数据提取,运用RevMan 5.3对纳入的文献进行偏倚风险评估和数据合成.结果 研究共纳入37篇文献,全部为随机对照临床研究,共涉及受试者2705名.Meta分析结果显示,口服中药在降低结直肠癌辅助化疗所致的白细胞减少发生率、贫血发生率、血小板减少发生率、中性粒细胞减少发生率等方面具有疗效;在提高血小板计数、红细胞计数、白细胞计数、血红蛋白上没有显示出疗效.结论 口服中药可降低结直肠癌辅助化疗所致的白细胞减少、贫血、血小板减少、中性粒细胞减少的发生风险.临床实践中,可考虑推荐口服中药用于防治结直肠癌辅助化疗所致的骨髓抑制.

目的:分析转移性结直肠癌(mCRC)中医治疗优势人群肠道菌群及TB淋巴细胞亚群分布特征及相关性.方法:选取2018年3月至2019年3月期间中国中医科学院西苑医院肿瘤科门诊或病房收治的mCRC患者40例作为研究对象,采用随机双盲、安慰剂对照临床研究方法,随机分为观察组与安慰剂组,治疗给予常规中医治疗加用祛邪胶囊,对照组在与观察组相同治疗基础上服用安慰剂胶囊.收集基线时患者的粪便样本及外周血样本并进行检测.根据入组患者3年随访的生存结局以及mCRC中医治疗优势人群判定标准,将患者分为中医治疗优势人群及非优势人群,分析2组间肠道菌群及TB淋巴细胞亚群的差异性及相关性.结果:肠道菌群Alpha多样性分析显示,中医治疗非优势人群相比优势人群具有更高的sobs指数且差异有统计学意义(115.17±19.25 vs.81.96±36.79,P=0.005),中医治疗优势人群具有更高比例的拟杆菌属(30.6％vs.23.9％,P=0.33)和普雷沃氏菌属(5.7％vs.3.9％,P=0.69);TB淋巴细胞亚群分析结果发现,中医治疗优势人群组较非优势人群组具有更高的双阴T细胞绝对值(89.6±82.0 vs.37.1±16.5,P=0.01)以及非HLA依赖细胞毒性T细胞(83.0±43.6 vs.28.4±18.3,P=0.01);HLA依赖细胞毒性T细胞绝对值与粪厌氧棒状菌(Anaero-stipes)呈显著负相关(P=0.04).结论:mCRC中医治疗优势人群与非优势人群在肠道菌群分布以及TB淋巴细胞亚群特征方面存在显著差异且具有一定相关性,为进一步阐释中医优势人群特征及疗效机制提供了必要的科学依据.

目的 通过网络药理学方法探讨六君安胃方减少结肠癌化疗期间消化道不良反应的作用机制.方法 通过检索中药系统药理学分析平台(Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform,TCMSP)对六君安胃方中六味中药的化学成分、作用靶点进行筛选,并在GeneCards、在线人类孟德尔遗传数据库(Online Mendelian Inheritance in Man,OMIM)等相关数据库中筛选出"chemotherapy-induced nausea and vomiting(CINV)"、"chemotherapy-induced diarrhea(CID)"相关靶点.利用STRING和Cytoscape3.6.0构建PPI网络图并通过网络拓扑分析获得关键蛋白靶点;利用R软件ClusterProfiler进行GO及京都基因与基因组百科全书(Kyoto Encyclopedia of Genes and Genomes,KEGG)通路功能富集分析;利用AutoTools1.5.6进行有效化学成分与关键蛋白靶点的分子对接.结果 六君安胃方中的中药有效化学成分共103个,潜在作用靶点406个,CINV、CID疾病相关作用靶点851个,通过PPI网络拓扑分析得到关键蛋白靶点,前5个分别为AKT1、MAPK3、MAPK1、MAPK8、JUN;GO富集结果显示,氧化应激反应、凋亡信号通路调节、膜筏、膜微区域、泛素样蛋白连接酶结合、蛋白质丝氨酸/苏氨酸激活酶活性等排名靠前;KEGG富集通路结果显示,PI3K-AKt信号通路、MAPK信号通路、TNF信号通路等信号通路为主要作用通路;分子对接显示党参中的木犀草素与AKT1结合性最好.结论 六君安胃方可能通过调节AKT1、MAPK3、MAPK1等关键蛋白,干预PI3K-AKt等相关炎症信号通路来减少化疗期间消化道不良反应.

胃肠恶性肿瘤给我国人民的生命健康带来了严重的危害.中医学具有以人为本、整体调节的特点在我国胃肠肿瘤的防治体系中占据一席之地.当代中医形成了以健脾为核心的防治理念,但各医家对脾虚内涵的理解尚不统一,应用方药差异较大,制约中医药研究质量的提高和未来的发展.本团队多年来从脾虚论治结直肠癌的临床和科研工作取得了较好的成效,并与国内多家单位一起,围绕脾虚在胃肠肿瘤领域开展循证研究工作.现结合文献和团队多年来的实践,提出瘤之成因与治疗造就胃肠恶性肿瘤病机以脾虚为主,遵循以脾虚为本、邪实自内外而生、蕴化癌毒、病久及肾的病机演变规律,正虚、邪实、癌毒是中医认识其病机的3个层面,同时兼有胃癌易于阳化、肠癌易于寒化的特点.最后从证治规律、临床试验、生物机制3个方面列举当前已有的相关研究实践作为验证.对胃肠肿瘤脾虚理论的探索起到了抛砖引玉的作用,旨在促进中医肿瘤防治理论的创新,为更高质量的研究提供理论支撑.

Review question / Objective: P: Adult patients with colorectal cancer undergoing chemoradiotherapy, regardless gender or race.I: Oral herbal medicine (single herb, compound recipe or patent medicine).C: Addition of oral herbal medicine during c h e m o r a d i o t h e r a p y v e r s u s chemoradiotherapy alone or with placebo.O: Response Rate (RR), Kar nofsky performance scale score (KPS).S: Randomized or quasi-randomized trials regardless of blinding.Condition being studied: Due to the considerable changes in lifestyle and diet, colorectal cancer (CRC) ranks fourth in terms of incidence and fifth in terms of cancer-related mortality in China.It is INPLASY 1 International Platform of Registered Systematic Review and Meta-analysis Protocols INPLASY PROTOCOL Oral herbal medicine on chemoradiotherapy-induced gastrointestinal side effects in patients with colorectal cancer: a systematic review and meta-analysis

Background: The side effects of chemotherapy-induced nausea and vomiting (CINV) and myelosuppression reduce the cancer patients' adherence to chemotherapy. Many Chinese patients choose Chinese medicine (CM) during chemotherapy to reduce side effects; however, the evidence is lacking. The efficacy of a CM herbal treatment protocol, Jianpi Bushen Sequential Formula ((sic), JBSF) will be evaluated on chemotherapy completion rate among patients with colon cancer. Methods: A multi-center double-blind randomized controlled trial (RCT) will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine (CAPEOX). Patients will be randomized 1:1 to receive the JBSF or placebo formula. The primary outcome is the overall chemotherapy completion rate. The secondary outcomes include individual chemotherapy completion rate, 4-cycle completion rate of chemotherapy, time to treatment failure, relative dose intensity and treatment toxicity. Follow-up visits will be scheduled before every and after last chemotherapy. Discussion: This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer. (Trial registration: ClinicalTrials.gov, No. NCT03716518)

目的:观察六君安胃方对CIM小鼠小肠干细胞增殖及Wnt/β-catenin通路蛋白表达的影响.方法:60只雄性C57BL/6J小鼠,体质量分层随机分为正常对照组、模型组、蒙脱石散组(1.85 g/kg)、六君安胃高、中、低剂量组(15.66、7.83、3.92 g/kg),每组10只.腹腔注射5-FU注射液50 mg/kg连续7 d制备小鼠CIM模型.比较各组小鼠体质量、腹泻评分、小肠长度;HE染色观察空肠组织形态学;免疫组化检测空肠组织Lgr5+、BrdU+、Wnt、β-catenin蛋白表达.结果:与正常对照组相比,模型组小鼠体质量下降、腹泻明显、小肠缩短(P＜0.01);HE染色观察空肠黏膜绒毛高度缩短、萎缩(P＜0.01),绒毛间距变宽,上皮细胞变性、坏死及脱落,腺体减少,炎性细胞浸润,隐窝破坏变浅(P＜0.01);隐窝结构中Lgr5+、BrdU+细胞显著减少(P＜0.01),Wnt、β-catenin蛋白表达显著下降(P＜0.01).与模型组相比,六君安胃高、中、低组体质量减少轻(P＜0.05),腹泻评分少,小肠缩短程度显著减轻(P＜0.01);六君安胃组病黏膜病变较模型组轻,表现为绒毛高度高(P＜0.05),绒毛间距短,局部上皮细胞轻度变性,未见萎缩、坏死、脱落,腺体减少不明显,黏膜下层少量炎性细胞浸润,隐窝破坏较轻,隐窝深(P＜0.05),隐窝中Lgr5+、BrdU+细胞和Wnt、β-catenin蛋白表达增高(P＜0.05),其中高剂量组效果最为明显.结论:六君安胃方有效减轻5-FU所致小鼠小肠黏膜损伤,其可能机制是通过上调Wnt/β-catenin通路蛋白的表达,促进肠道干细胞增殖,修复肠上皮损伤.

辅助化疗有助于改善II(高危)/III期结直肠癌患者的生存.然而,辅助化疗的不良反应影响患者的生活质量,严重的不良反应甚至可能导致化疗的延期或终止,使得患者不能从辅助化疗中获益.中国中医科学院西苑医院杨宇飞教授根据多年临床经验,创新性提出辅助化疗期的"两阶段三部曲",即补肾健脾序贯疗法,第1阶段应用自拟六君安胃方健脾和胃,针对化疗导致的胃肠道反应;第2阶段运用芪菟二至方健脾益肾,针对化疗导致的骨髓抑制;以及辛凉解表感冒方,针对化疗期间的外感.临床应用取得了显著的疗效.文章详细阐述"两阶段三部曲"提出的背景及其主要内容.

目的 探讨临床试验受试者招募工作中存在的问题及对策.方法 基于一项中药辅助化疗治疗结肠癌的多中心临床试验,借鉴实施性研究方法思路,通过医院内招募和媒体招募两种措施,观察并记录受试者招募过程、分析影响招募效果的原因并提出改进建议.结果 2019年9-11月共筛选246例患者.其中通过医院内招募筛选合格患者23例,最后入组9例;通过媒体招募3个月来电咨询的患者分别为118、47、58例,每月筛选合格患者分别为4、6、10例,最后入组0、0、1例.认为影响招募效果的因素可能有:严格的合格性标准、招募人员难确定、试验筛选表记录不及时、招募信息不详细、招募信息发放频次少、招募实施资源需求大、患者对参与临床试验的认知偏差.结论 提高临床试验受试者招募效果应在医院内招募基础上结合媒体招募;招募信息应详略得当,对招募条件做出明确注释;要综合患者、医生、临床研究者的实际情况展开,丰富招募渠道.

目的 分析临床试验受试者依从性方法学中文研究特征,为后续临床试验依从性的研究提供参考.方法计算机检索CNKI、VIP、CBM和WanFang Data数据库,搜集临床试验中受试者依从性的方法学中文研究,检索时限为2000年1月至2018年12月.由2名研究者独立筛选文献、提取资料后,对文献特征进行定性分析.结果共纳入相关文献84篇,包括西医类68篇,中医类16篇.分析结果显示:自2003年以来,受试者依从性的方法学研究逐年增加,但中医类相关研究数量并未增加.所有纳入研究均总结了受试者依从性的对策,但缺少重要的质量评价信息.结论目前中国已发表的有关临床试验中如何提高受试者依从性以保证试验结果可靠的对策研究仍然非常缺乏.现有研究对受试者依从性影响因素的探讨不够系统全面,临床试验中的研究者对受试者依从性的重视程度不够,也缺乏完善的依从性方法学指导.