Objective: To standardize the reporting system on hepatitis B in order to improve the quality of monitoring program in Henan province. Methods: A total of 6 sites of Hepatitis B pilot surveillance were selected in Xinzheng of Zhengzhou city, Linzhou of Anyang city, Shanyang district of Jiaozuo city, Shaoling district of Luohe city, Yongcheng of Shangqiu city, Pingqiao district of Xinyang city in Henan province. Subjects under study were those reported hepatitis B cases, from 2012 to 2016. Cases diagnosed in 2011 were chosen as controls. Data on classification of hepatitis B, time that HBsAg became positive and ALT value of the cases were analyzed annually. 5 ml venous blood was collected and anti-HBc IgM confirmed test was made for those suspected acute cases on hepatitis B. Based on the 2016 data from the monitoring system, the incidence of acute hepatitis B in Henan province was estimated. Results: The number of reported hepatitis B cases had declined in 6 sites of Hepatitis B pilot surveillance substantially. A total of 17 436 hepatitis B reported in 2011 but only 2 632 cases were reported in 2016, with a reduction of 84.90%(14 804/17 436) in these six monitoring sites. The number of unclassified hepatitis B cases also dropped sharply. In 2011, 36.87% of the cases were unclassified, but the figure reduced to 0.08% in 2016, from the six sites. The rate on ALT detection also gradually improved. The rate of misdiagnosis on HBV carrier from hepatitis B almost disappeared. From 2013 to 2016, 777 blood samples were collected from six pilot sites. 29.34% (228/777) of the blood samples were tested positive for anti-HBc IgM after confirmed by the hepatitis laboratory of the China Center for Disease Control and Prevention. Conclusions: Since the development of the pilot surveillance program, the quality of reporting system on hepatitis B had been improved, as well as the accuracy of diagnosis. Rate on the accuracy of reporting on hepatitis B and the methods of testing should be improved at the monitoring sites.
China/epidemiology* ; Cities ; Disease Notification/statistics & numerical data* ; Hepatitis A/epidemiology* ; Hepatitis B/epidemiology* ; Hepatitis B Antibodies/blood* ; Hepatitis B Surface Antigens/blood* ; Humans ; Incidence ; Pilot Projects ; Population Surveillance ; Sentinel Surveillance

Objective: To explore the effect of vaginal micro-environment alterations and HPV16 infection and their interaction in the progression of cervical intraepithelial neoplasia. Methods: The participants of this study came from the cervical lesions study cohort in Shanxi province, including 623 women with normal cervical (NC), 303 patients with pathogenically diagnosed low-grade cervical intraepithelial neoplasia (CINⅠ) and 93 patients with pathogenically diagnosed high-grade cervical intraepithelial neoplasia (CINⅡ/Ⅲ). The data of the demographic characteristics of the study subjects and factors related to cervical intraepithelial neoplasia were collected, and HPV16 infection were detected by using flow-through hybridization technology and H(2)O(2), β-glucuronidase, clotting enzyme, neuraminidase and leucocyte esterase in vaginal secretions were detected by using the combined detection kit of aerobic vaginitis and bacterial vaginosis. pH value and vaginal cleanliness were also detected at the same time. The database was established and analyzed by SPSS statistical software (version 22.0). Results: The HPV16 infection rate (trend χ(2)=55.45, P<0.001) and the abnormal rates of H(2)O(2) (trend χ(2)=26.19, P<0.001), pH (trend χ(2)=5.06, P=0.024), vaginal cleanliness (trend χ(2)=19.55, P<0.001), β-glucuronidase (trend χ(2)=17.52, P<0.001) and neuraminidase (trend χ(2)=14.90, P<0.001) increased gradually along with the severity of cervical intraepithelial neoplasia, but the abnormal rates of clotting enzyme and leucocyte esterase showed no same trend. The results of GMDR model analysis showed that there was interaction between HPV16 infection and abnormalities of H(2)O(2), β-glucuronidase, clotting enzyme and neuraminidase in CINⅠ group, and the interaction between HPV16 infection and the abnormalities of vaginal cleanliness, H(2)O(2), β-glucuronidase and neuraminidase in CIN Ⅱ/Ⅲ group. Conclusion: Our findings indicated that the vaginal micro-environment alterations and HPV16 infection could increase the risk of cervical intraepithelial neoplasia, and they might have an important synergistic effect in the progression of cervical intraepithelial neoplasia.
Female ; Human papillomavirus 16/isolation & purification* ; Humans ; Hydrogen Peroxide ; Papillomavirus Infections/virology* ; Uterine Cervical Neoplasms/virology* ; Uterine Cervical Dysplasia/virology*

OBJECTIVE：To establish a method for the determination of pyrrotinib concentration in plasma ，and apply it in clinic. METHODS ：After precipitated with methanol ，the plasma sample was determined by LC-MS/MS using imatinib as internal standard. The determination was performed on Ultimate AQ-C 18 column with mobile phase consisted of methanol （containing 0.1％ formic acid ）and water （containing 0.1％ formic acid ）（gradient elution ）at the flow rate of 0.4 mL/min. The column temperature was 40 ℃，and the sample size was 5 µL. The ion source was electrospray ionization source ，and the positive ion scanning was carried out in multiple reaction mode. The ion pairs for quantitative analysis were m/z 583.4→138.3（pyrrotinib）and m/z 494.5→ 393.4（internal standard ），respectively. Thirty breast cancer patients taking pyrrotinib were collected from the Affiliated Hospital of Qingdao University during Jun.-Nov. 2020 to determine their steady-state trough concentrations of pyrrotinib after a week of treatment. RESULTS ：The linear range of pyrrotinib were 5-300 ng/mL（r＝0.999 3）. The lower limit of quantification was 5 ng/mL. RSDs of intra-day and inter-day were not higher than 9.30％，and relative errors （REs）ranged －6.70％-5.04％. REs of stability tests were in the range of －1.92％-5.42％. The extraction method ，matrix effect and residual effect did not affect the quantitative analysis of the substance to be tested. The steady-state trough concentrations of pyrrotinib were 32.6-82.8 ng/mL，with an average plasma concentration of 53.8 ng/mL；there was about 2.54 fold individual difference. CONCLUSIONS ：Established LC-MS/MS method is simple ，sensitive and accurate ，and can be used for the plasma concentration monitoring of pyrrotinib in breast cancer patient.

Humans ; Erdheim-Chester Disease/diagnostic imaging* ; Histiocytosis, Langerhans-Cell/surgery* ; Tomography, X-Ray Computed

Objective: To evaluate the effects of polycyclic aromatic hydrocarbons (PAHs) and high risk human papillomavirus (HR-HPV) infection and their interaction on the progression of cervical intraepithelial neoplasia. Methods: A total of 486 patients, including 208 women with normal cervix (NC), 154 patients with low-grade cervical intraepithelial neoplasm (CINⅠ), 124 patients with high-grade cervical intraepithelial neoplasm (CINⅡ/Ⅲ), were selected from the cervical lesions cohort from June to December, 2014. HR-HPV was detected by using flow-through hybridization technology and the urine concentration of 1-hydroxypyrene (1-OHP) was detected with high performance liquid chromatography. By using software SPSS 22.0, the χ(2) test, trend χ(2) test, Kruskal-Wallis H test, Nemenyi rank test and Spearman rank correlation analysis were performed. And the interaction effects were evaluated by additive model. Results: The HR-HPV infection rates in NC, CINⅠ and CINⅡ/Ⅲ groups were 27.9%, 37.0% and 58.9%, respectively. The urine concentrations of 1-OHP (μmol/molCr) were 0.07±0.09, 0.11±0.10 and 0.17±0.15, respectively. With increasing severity of the cervical lesions, the HR-HPV infection rate gradually increased (trend χ(2)=29.89, P<0.001) and the high exposure rate of PAHs gradually increased (trend χ(2)=27.94, P<0.001). HR-HPV infection was positively correlated with 1-OHP exposure (r=0.680, P<0.001). There was a positive additive interaction between HPV infection and PAHs exposure in CIN Ⅱ/Ⅲ group, but it was not found in CIN Ⅰ group. Conclusion: Both HR-HPV infection and high exposure of PAHs might increase the risk of cervical intraepithelial neoplasm, and might have a synergistic effect on the progression of high-grade cervical intraepithelial neoplasia.
Case-Control Studies ; Cohort Studies ; Disease Progression ; Female ; Humans ; Papillomaviridae/isolation & purification* ; Papillomavirus Infections/virology* ; Polycyclic Aromatic Hydrocarbons/pharmacology* ; Pyrenes/urine* ; Severity of Illness Index ; Uterine Cervical Dysplasia/virology* ; Uterine Cervical Neoplasms/virology*

Objective: To investigate the association between the distribution of tumor infiltrating lymphocytes (TIL) in EBV associated lymphoepitheliomatoid carcinoma (LELC) and the pathological subtypes of LELC, as well as the clinical significance of TIL distribution. Methods: The LELC patients with sufficient tumor tissues, complete clinical data and positive EBER, who visited Zhejiang Cancer Hospital, Hangzhou, China from January 2006 to October 2018, were selected. Various immunohistochemical markers (CD20, CD138, CD4, CD8, CD56 and FOXP3) were examined for TIL typing. Two pathologists reviewed the hematoxylin and eosin (HE) staining sections and interpreted the immunohistochemical results. Correlation analysis was used to evaluate the relationship between the distribution of TIL subgroups and LELC's pathological characteristics. Survival analyses were conducted to study the prognostic values of TIL subgrouping. Results: A total of 102 patients with EBV related LELC were included. 46 of them were classic LELC (c-LELC) with rich interstitial TIL, and 56 were non-classic LELC (n-LELC) with relatively fewer interstitial TIL. The results of TIL analysis showed that all subtypes of c-LELC were rich in TIL, with B lymphocytes as the dominant subgroup. The number of TIL in n-LELC was fewer than that in c-LELC, with T lymphocytes as the dominant subgroup. There was no significant difference in the distribution of plasma cells between the two groups. Survival analysis showed that the total number of TIL, and the infiltrations of CD20⁺B cells, CD4⁺T cells, and FOXP3⁺Treg cells were associated with better overall survivals (P=0.004, 0.003, 0.008 and 0.025, respectively) and disease-free survivals (P=0.011, 0.003, 0.038 and 0.041, respectively) in patients with LELC. Conclusions: The morphologic subtypes of EBV-related LELC have different tumor immune characteristics. The total number of TIL in the stroma of c-LELC is significantly higher than that of n-LELC. Interestingly, B lymphocytes are the dominant TIL in c-LELC, while T lymphocytes are the dominant TIL in n-LELC. The infiltration of TIL, CD20⁺B cells, CD4⁺T cells and FOXP3⁺Treg cells in LELC may suggest a better prognosis.
Humans ; Lymphocytes, Tumor-Infiltrating ; Herpesvirus 4, Human ; Clinical Relevance ; Prognosis ; Carcinoma, Squamous Cell/pathology* ; Forkhead Transcription Factors

Precision medicine became the key strategy in development priority of science and technology in China. The large population-based cohorts become valuable resources in preventing and treating major diseases in the population, which can contribute scientific evidence for personalized treatment and precise prevention. The fundamental question of the achievements above, therefore, is how to construct a large population-based cohort in a standardized way. The Chinese Preventive Medicine Association co-ordinated experienced researchers from Peking University and other well-known institutes to write up two group standards Technical specification of data processing for large population-based cohort study (T/CPMA 001-2018) and Technical specification of data security for large population-based cohort study (T/CPMA 002-2018), on data management. The standards are drafted with principles of emphasizing their scientific, normative, feasible, and generalizable nature. In these two standards, the key principles are proposed, and technical specifications are recommended in data standardization, cleansing, quality control, data integration, data privacy protection, and database security and stability management in large cohort studies. The standards aim to guide the large population-based cohorts that have been or intended to be established in China, including national cohorts, regional population cohorts, and special population cohorts, hence, to improve domestic scientific research level and the international influence, and to support decision-making and practice of disease prevention and control.
China ; Cohort Studies ; Delivery of Health Care ; Humans ; Population Surveillance ; Quality Control ; Reference Standards

This paper introduced the Revised Cochrane Risk of Bias Tool RoB2.0 for cluster-randomized control trials (CRCT) and compared RoB2.0 of CRCT with individually randomized, parallel group trials, and illustrated the application of RoB2.0 for CRCT in a published CRCT. Special signal questions were designed for CRCT according to its specialty that different from individually randomized, parallel group trials in RoB2.0 and also providing information on risk of bias about CRCT in systematic reviews for the synthesis of evidence.
Bias ; Humans ; Randomized Controlled Trials as Topic ; Risk ; Risk Assessment/methods*

In clinical follow-up studies, hazard ratio (HR) is routinely used to quantify the differences between-groups, however, it is being estimated by the Cox procedure. HR, the ratio of two hazard functions has abstract meaning only and is in lack of the context to give an intuitive explanation of the survival of patients and the assumption of proportional hazards (PH) must be satisfied. Under this context, the restricted mean survival time (RMST) can be used as a relatively effective measure or index of statistics. This paper introduces the RMST-based statistical analysis methods, including estimation of RMST and its difference, hypothesis testing and regression analysis. The application of RMST in data analysis is also introduced. All the evidence demonstrates that RMST can be used as an effective analytical tool with straightforward interpretation. RMST is also more effective than HR in comparing differences between groups, when non-PH is observed. Therefore, RMST is suggested to be stated along with HR in the process of disease efficacy evaluation and prognosis analysis. Cooperation and complement of the two, a precise reflection on the characteristics of data can be expected.
Clinical Trials as Topic ; Endpoint Determination/methods* ; Follow-Up Studies ; Humans ; Kaplan-Meier Estimate ; Prognosis ; Proportional Hazards Models ; Regression Analysis ; Survival Rate/trends* ; Treatment Outcome

Objective: To study the characteristics of social relations and relative factors among MSM in Guangzhou. Methods: Data was collected through a cross-sectional study in Guangzhou from November 2016 to May 2017. Sample size was estimated and participants were recruited from the voluntary counseling and testing services (VCT) which were set for MSM population, by nongovernmental organizations (NGOs) and the Centers for Disease Control and Prevention (CDC). Social ties and demographic characteristics of the respondents and their sexual partners were analyzed through both Chi square test and generalized estimating equations (GEE). Results: A total of 1 073 MSM, together with their nominated 4 301 partners were successfully recruited and involved in this study. Age (OR=1.2, P=0.01) and non-internet based intercourse (OR=1.65, P<0.01) were easy to form close relation with strong ties. Compared with MSM traditional venues (chess and cards room, tea room bathhouse, club), general public venue (bars, KTV, parks, shopping malls, schools, restaurants) (OR=1.46-3.12, P<0.01) showed close relation with strong ties. Our finding showed that MSM at the age of 18-25 preferred to build weak ties with the older MSM, while the 26-30-year-olds and 31-40-year-olds prefer to establish weak ties with younger partners but the 41-50-year-olds preferred to develop weak ties with one that were ten years younger. Conclusions: Clusters were noticed in the MSM populations when grouping and making friends with ones at different age. Characteristics regarding the relationship between sexual partners in choosing venues and ways of dating were different. Targeted intervention programs need to be explored innovatively.
Coitus ; Cross-Sectional Studies ; Homosexuality, Male/psychology* ; Humans ; Interpersonal Relations ; Male ; Middle Aged ; Recreation ; Risk-Taking ; Schools ; Sexual Behavior ; Sexual Partners ; Social Behavior ; Surveys and Questionnaires