Objective To study the bioequivalence of generic and original dapoxetine hydrochloride tablets in Chinese healthy subjects after single dose under fasting and fed conditions.Methods A single-center,random,open,single-dose,two-preparations,double-period,crossover study was adopted.Fasting and fed tests were performed on 36 subjects each.Single oral dose 60 mg of test and reference pre parations were taken under fasting and fed conditions,respectively.Plasma concentration of dapoxetine was determined by liquid chromatography tandem mass spectrometry.The main pharmacokinetic(PK)parameters were calculated by Phoenix WinNonlin 8.0 software.Results The main PK parameters of the test and reference preparations of dapoxetine tablets in the fasting group were as follows:Cmax were(449.36±203.01)and(432.85±199.75)ng·mL-1;AUC0-t were(2 400.96±1 392.58)and(2 251.82±1 225.84)ng·mL-1·h;AUC0-∞ were(2 529.94±1 498.05)and(2 371.06±1 305.22)ng·mL-1·h.The main PK parameters of the test and reference preparations of dapoxetine tablets in the fed group were as follows:Cmax were(651.29±179.38)and(672.83±249.42)ng·mL-1;AUC0-t were(3 391.27±1 358.73)and(3 314.56±1 360.39)ng·mL-1·h;AUC0-∞ were(3 630.79±1 605.89)and(3 549.22±1 526.61)ng·mL-1·h.Under the fasting and fed conditions,the 90％confidence intervals of the main PK parameters of the test and reference preparations of dapoxetine tablets are 80.00％-125.00％.Conclusion Under the fasting and fed conditions,a single oral dose of generic and original dapoxetine hydrochloride tablets in Chinese healthy adult volunteers showed bioequivalence.

Objective To study the bioequivalence of generic and original dapoxetine hydrochloride tablets in Chinese healthy subjects after single dose under fasting and fed conditions.Methods A single-center,random,open,single-dose,two-preparations,double-period,crossover study was adopted.Fasting and fed tests were performed on 36 subjects each.Single oral dose 60 mg of test and reference pre parations were taken under fasting and fed conditions,respectively.Plasma concentration of dapoxetine was determined by liquid chromatography tandem mass spectrometry.The main pharmacokinetic(PK)parameters were calculated by Phoenix WinNonlin 8.0 software.Results The main PK parameters of the test and reference preparations of dapoxetine tablets in the fasting group were as follows:Cmax were(449.36±203.01)and(432.85±199.75)ng·mL-1;AUC0-t were(2 400.96±1 392.58)and(2 251.82±1 225.84)ng·mL-1·h;AUC0-∞ were(2 529.94±1 498.05)and(2 371.06±1 305.22)ng·mL-1·h.The main PK parameters of the test and reference preparations of dapoxetine tablets in the fed group were as follows:Cmax were(651.29±179.38)and(672.83±249.42)ng·mL-1;AUC0-t were(3 391.27±1 358.73)and(3 314.56±1 360.39)ng·mL-1·h;AUC0-∞ were(3 630.79±1 605.89)and(3 549.22±1 526.61)ng·mL-1·h.Under the fasting and fed conditions,the 90％confidence intervals of the main PK parameters of the test and reference preparations of dapoxetine tablets are 80.00％-125.00％.Conclusion Under the fasting and fed conditions,a single oral dose of generic and original dapoxetine hydrochloride tablets in Chinese healthy adult volunteers showed bioequivalence.

Intervention mapping (IM) is a framework for formulating theory-and evidence-based health education projects with participatory approaches from ecological perspectives.The intervention program designed via IM plays a role in reducing the exposure of cancer risk factors,increasing cancer prevention behaviors,and promoting early cancer screening and rehabilitation of cancer patients.This study summarizes the characteristics,implementation steps,and application status of IM in tertiary prevention of cancer,aiming to provide reference for the application of IM in the health education projects for cancer in China.
Humans ; Tertiary Prevention ; Neoplasms/prevention & control* ; China ; Risk Factors

China has a high incidence of esophageal cancer，more than 90% of which are esophageal squamous cell carcinoma （ESCC）. Abnormal proliferation，migration and new microvessels of intraepithelial neoplasia cells are the important pathogenic links in the transformation from esophageal intraepithelial neoplasia （EIN） to ESCC. Studies on the progression of esophageal precancerous lesions into esophageal cancer mostly focus on environment and genetic susceptibility，such as inflammatory factors，abnormal vascular endothelial growth factor （VEGF） signaling pathway transduction，p53 gene mutation，and DNA methylation. Some pharmacology studies have confirmed that traditional Chinese medicine （TCM） can inhibit inflammatory factors，regulate abnormal signaling pathways and improve the microenvironment. A large number of patients with esophageal cancer have been found to be in advanced stage，and the 5-year survival rate is low even after active treatment. The quality of life of patients in advanced stage is worrying due to esophageal obstruction and lung infection，and therefore， early prevention is important. Early intervention in patients with esophageal precancerous lesions is in line with clinical needs and embodies the TCM theory of “treating disease before its onset.” The mechanism of action and clinical efficacy of TCM has been gradually confirmed and promoted， with certain clinical significance. To explore simple，economical and effective TCM intervention measures conforms to the clinical diagnosis and treatment standards and the modernization of TCM.

Through a retrospective analysis of the projects supported by the National Natural Science Foundation of China in the past ten years in the field of Chinese medicine for the treatment of malignant tumors, this article systematically summarized the main research contents and hotspots of Chinese medicine in efficacy enhancement and toxicity reduction. The efficacy enhancement of Chinese medicine mainly included the mitigation of molecule-targeted drug resistance, multidrug resistance, and chemotherapy resistance, synergistic efficacy enhancement, and radiotherapy sensitization. The toxicity reduction is mainly reflected in the alleviation of the side effects of radiotherapy and chemotherapy. In addition, Chinese medicine has advantages in reducing serious adverse reactions of malignant tumors, providing more options for the adjuvant treatment of tumors.
China ; Foundations ; Humans ; Medicine, Chinese Traditional ; Natural Science Disciplines ; Neoplasms/drug therapy* ; Retrospective Studies

Objective:To investigate the effects of external application of modified Xiangsha Liujunzi Tang in improving gastrointestinal reaction，immune function， and quality of life in patients with gastrointestinal tumors after moderately/highly emetogenic chemotherapy. Method:A total of 140 inpatients （from January 2018 to May 2021） with gastrointestinal malignancies diagnosed by the Oncology Department of Integrated Traditional Chinese and Western Medicine of China-Japan Friendship Hospital and treated with moderately/highly emetogenic chemotherapy were randomly divided into an experimental group （n=70） and a control group （n=70） according to the Good Clinical Practice （GCP）. Participants were given routine antiemetic treatment once 20 minutes before chemotherapy （tropisetron 5 mg + dexamethasone 5 mg or methylprednisolone 40 mg）. On this basis， the patients in the experimental group were treated with external application of modified Xiangsha Liujunzi Tang for 1 week on the second day after chemotherapy （the selected points were Zhongwan， Neiguan and Zusanli， 6 hours a day， and the application was changed every day）， and the patients in the control group were applied with comfort patch at the same time. The gastrointestinal reaction grade， subset concentration of lymphocytes， and Karnofsky score in two groups before and one week after chemotherapy were recorded， and all data were analyzed by SPSS 19.0 statistical software. Result:The grades of chemotherapy-related gastrointestinal reaction in two groups after treatment decreased as compared with that before treatment （P<0.05）. The experimental group was superior to the control group after treatment in terms of grade decrease （P<0.05）. The total response rate of the experimental group was 81.43% （57/70）， higher than 62.86% （44/70） in the control group （χ²=9.73， P<0.05）. Stratified analysis was performed on the experimental group. Compared with the conditions before treatment， the grade of gastrointestinal reaction in patients with esophageal cancer and colorectal cancer of the experimental group decreased after treatment （P<0.05）， and that in patients of different genders decreased after treatment （P<0.05）. The results of immune function showed that there was no significant difference in the concentrations of CD3⁺， CD4⁺， CD8⁺， and NK cell subsets of the control group before and after treatment， while the concentrations of CD3⁺， CD4⁺， and NK cell subsets of the experimental group were higher than those before treatment and even superior to those in the control group （P<0.05）. The Karnofsky score of quality of life in the experimental group was higher than that in the control group， with quality of life improved （P<0.05）. Conclusion:External application of modified Xiangsha Liujunzi can improve the gastrointestinal reaction，immune function， and quality of life of patients with gastrointestinal tumors after moderately/highly emetogenic chemotherapy.

Purpose: Systemic inflammatory response is a critical factor that promotes the initiation and metastasis of malignancies including pancreatic cancer (PC). This study was designed to determine and compare the prognostic value of neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), and fibrinogen-to-albumin ratio (FAR) in resectable PC and locally advanced or metastatic PC. Materials and Methods: Three hundred fifty-three patients with resectable PC and 807 patients with locally advan-ced or metastatic PC were recruited in this study. These patients were classified into a training set (n=758) and a validation set (n=402). Kaplan-Meier survival plots and Cox proportional hazards regression models were used to analyze prognosis. Results: Overall survival (OS) was significantly better for patients with resectable PC with low preoperative PLR (p=0.048) and MLR (p=0.027). Low FAR, MLR, NLR (p < 0.001), and PLR (p=0.003) were significantly associated with decreased risk of death for locally advanced or metastatic PC patients. FAR (hazard ratio [HR], 1.522; 95% confidential interval [CI], 1.261 to 1.837; p < 0.001) and MLR (HR, 1.248; 95% CI, 1.017 to 1.532; p=0.034) were independent prognostic factors for locally advanced or metastatic PC. Conclusion The prognostic roles of FAR, MLR, NLR, and PLR in resectable PC and locally advanced or metastatic PC were different. FAR showed the most prognostic power in locally advanced or metastatic PC. Low FAR was positively correlated with OS in locally advanced or metastatic PC, which could be used to predict the prognosis.

Adaptive intervention(AI)is a methodology which dynamically evaluates adaptive variables at decision points and timely adjusts and develops tailored strategies to meet individual needs.The study reviewed the origin and development and elaborated the core elements(including intervention outcomes,intervention options,decision points,tailoring variables,and decision rules)and the classification of AI.Based on the literature,the key points of the design and implementation of AI were prospected,which can provide evidence for the research and development of health behavior intervention.

Objective:To explore the behavior and influencing factors of mobile health (m-Health) information searching among patients with cancer, aiming to provide evidence for the provision of medical health information.Methods:A cross-sectional survey was conducted.A total of 535 patients with cancer were recruited from a cancer hospital in Zhejiang Province from September to December 2017.Measurement tools included the demographic information questionnaire, mobile health information search behavior questionnaire, mobile health information search environment questionnaire, cancer needs questionnaires-short form and ehealth literacy scale.SPSS 26.0 was used for descriptive statistical analysis, one-way analysis of variance, Pearson correlation analysis and multiple linear regression analysis.Results:The total score of mobile health information search behavior of cancer patients was (60.84±9.60), and 66.5% of participants reported that they "never" or "occasionally" searched health information via mobile.The total score of information needs was (80.99±27.86), electronic health literacy was (26.54±7.85), mobile health information search environment was (8.00±2.86). m-Health information search behavior was positively correlated with information needs ( r=0.251, P<0.01), ehealth literacy ( r=0.538, P<0.01), and m-Health information search environment ( r=0.267, P<0.01). The stepwise regression analysis revealed that the place of residence, working status, income level, ehealth literacy, mobile health information search environment and information needs were statistically significant associated with the m-Health information searching behavior among cancer patients, which accounted for 39.3% of the total variance ( F=12.151, P<0.01). Compared with patients living in the central cities, those living in the small and medium-sized cities( β=0.092, P=0.031) had higher score in m-Health information behavior.Compared with patients working on normal schedule, those took sick days ( β=0.156, P=0.017) and working fewer hours ( β=0.138, P=0.002) had higher score m-Health information behavior.Compared with patients with monthly income of 1 000-3 000 yuan ( β=-0.194, P=0.002), those with monthly income less than 1 000 yuan had higher score in m-Health information behavior.The ehealth literacy ( β=0.425, P=0.000), mobile health information search environment ( β=0.179, P=0.000) and information needs ( β=0.091, P=0.027) were positive influencing factors of m-Health information search behavior. Conclusion:Patients with cancer did not report high m-Health information search behavior.Place of residence, working status, income level, ehealth literacy, m-Health information search environment and information demand were the influencing factors of m-Health information search behavior among patients with cancer.

Background:The increasing prevalence of colorectal cancer (CRC) in China and the paucity of information about relevant expenditure highlight the necessity of better understanding the financial burden and effect of CRC diagnosis and treatment.We performed a survey to quantify the direct medical and non-medical expenditure as well as the resulting financial burden of CRC patients in China.Methods:We conducted a multicenter,cross-sectional survey in 37 tertiary hospitals in 13 provinces across China between 2012 and 2014.Each enrolled patient was interviewed using a structured questionnaire.All expenditure data were inflated to the 2014 Chinese Yuan (CNY;1 CNY =0.163 USD).We quantified the overall expenditure and financial burden and by subgroup (hospital type,age at diagnosis,sex,education,occupation,insurance type,household income,clinical stage,pathologic type,and therapeutic regimen).We then performed generalized linear modeling to determine the factors associated with overall expenditure.Results:A total of 2356 patients with a mean age of 57.4 years were included,57.1％ of whom were men;13.9％ of patients had stage Ⅰ cancer;and the average previous-year household income was 54,525 CNY.The overall average direct expenditure per patient was estimated to be 67,408 CNY,and the expenditures for stage Ⅰ,Ⅱ,Ⅲll,and Ⅳ disease were 56,099 CNY,59,952 CNY,67,292 CNY,and 82,729 CNY,respectively.Non-medical expenditure accounted for 8.3％ of the overall expenditure.The 1-year out-of-pocket expenditure of a newly diagnosed patient was 32,649 CNY,which accounted for 59.9％ of their previous-year household income and caused 75.0％ of families to suffer an unmanageable financial burden.Univariate analysis showed that financial burden and overall expenditure differed in almost all subgroups (P ＜ 0.05),except for sex.Multivariate analysis showed that patients who were treated in specialized hospitals and those who were diagnosed with adenocarcinoma or diagnosed at a later stage were likely to spend more,whereas those with a lower household income and those who underwent surgery spent less (all P ＜ 0.05).Conclusions:For patients in China,direct expenditure for the diagnosis and treatment of CRC seemed catastrophic,and non-medical expenditure was non-ignorable.The financial burden varied among subgroups,especially among patients with different clinical stages of disease,which suggests that,in China,CRC screening might be cost-effective.