To analyze the disease burden, temporal trends, and attributable risk factors of early-onset female breast cancer (EOBC) in China and globally from 1990 to 2021.

Intestinal flora can mediate intestinal inflammation to the joint site through the"gut-joint axis",activate local or systemic immune response,and cause joint inflammation and injury.Traditional Chinese medicine(TCM)has unique advantages in the treatment of autoimmune diseases.Recent studies have shown that the interaction between TCM and intestinal flora in the mucosal immune system is closely related to the occurrence and development of autoimmune diseases.Therefore,the possible therapeutic mechanism of the interaction of TCM and intestinal flora in autoimmune arthritis is discussed in this paper,with the view of"gut-joint axis",in order to bring new ideas for clinical prevention and treatment.

Objective:To evaluate the efficacy and safety of hippocampal avoidance whole-brain irradiation with simultaneous integrated boost in the treatment of brain metastases of lung cancer.Methods:Forty lung cancer patients with brain metastases who received whole-brain radiotherapy with simultaneous integrated boost and hippocampal avoidance in Cancer Hospital, Chinese Academy of Medical Sciences from 2014 to 2020 were enrolled in this study. Brain MRI, survival follow-up and evaluation of side effects were performed before radiotherapy and at 1, 3, 6 and 12 months after radiotherapy, respectively. Overall survival (OS), progression-free survival (PFS) and changes in cognitive function were analyzed. Continuous data were described as Mean ± SD. Categorical data were described by frequency and composition ratio or percentage. Survival analysis was conducted by Kaplan-Meier method. Influencing factors of survival were identified by univariate and multivariate Cox's regression analyses.Results:A total of 40 patients were enrolled in the study. The median follow-up time was 14.2 months and the median OS, PFS and intracranial PFS of all patients were 14.8 months, 6.7 months and 14.8 months, respectively. Multivariate analysis showed that male gender and newly diagnosed stage Ⅳ disease were associated with worse OS and PFS, respectively. The Hopkins verbal learning test-revised (HVLT-R) scores at baseline and 1, 3 and 6 months after radiotherapy were 21.94±2.99, 20.88±3.12, 20.03±3.14, and 19.78±2.98, respectively. The HVLT-R score at 6 months after radiotherapy was decreased by approximately 9.8% compared with the baseline. No grade 3 or above toxic and side effect occurred in the entire cohort.Conclusion:Hippocampal avoidance whole-brain irradiation with simultaneous integrated boost is a safe and effective treatment for brain metastases of lung cancer, which is expected to reduce the impact of radiotherapy on cognitive function.

Objective To investigate the effect of improving immunity in the treatment of chronic brucellosis,and to analyze and evaluate its clinical curative effect.Methods A patient with chronic brucellosis was treated with Mongolian medicine combined with chemical drugs to enhance immunity.The clinical symptoms,serological antibodies,Brucella DNA and immune function were compared before and after treatment.The specific antibody against Brucella in serum was detected by tube agglutination test (SAT) and tiger red plate agglutination test (RBPT).Brucella DNA in serum and blood cells was detected by PCR,and the peripheral blood lymphocyte subsets were detected by flow cytometry.Immuno-luminescence technique was used to detect serum immunoglobulin and complement components.Results After treatment,the clinical symptoms such as cold back,fatigue,and joint pain disappeared completely,and the results of serum specific antibodies against Brucella were SAT 1 ∶ 50 (++)and RBPT (+) with no changes before and after treatment,and the results of cells and serum were both negative after treatment though the results of DNA detection of Brucella were cell positive and seronegative before treatment.The results of immunological function test showed that γδT cells decreased to 9.50％ after treatment compared to 14.00％ before treatment,and the percentage of monocytes and Treg cells were 5.59％ and 7.33％ after treatment,which were higher than 3.35％ and 4.72％ of before treatment,and the level of complement C3 was 0.79 g/L before treatment and 0.91 g/L after treatment that was returned to normal reference range (0.88 ～ 2.01 g/L).Conclusion The patients with chronic brucellosis can improve their clinical treatment by improving immunity.

Objective To evaluate the reporting item quality of randomized controlled trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer. Methods The terms including Chinese medicine, Chinese herbal medicine, randomized controlled trials, and non-small cell lung cancer were searched in Chinese and English databases by computer systems to collect relevant literatures. Based on the CONSORT 2010 (consolidated standards of reporting trials 2010), the reporting item quality of the abstracts and main text in eligible papers was evaluated. Results Ninety-five eligible studies were identified from 692 potential eligible articles. None reported all of abstract and main text items in CONSORT 2010. Only 4.12％could be identified as the randomized trial in the title. More than 40％of reports showed the scientific background or rationale in the abstract but not in the main text. Three (3.16％) eligible reports defined the primary or secondary outcome measures. None reported complete information of subjects throughout the clinical trial process. Results A total of 95 eligible papers were collected, of which 0 papers reported complete abstracts and text entries according to the CONSORT. The titles of 4.12％papers were identified as randomized trials. More than 40％of the papers only reported the study purpose or hypothesis in the abstract. 3.16％of the papers reported primary and secondary efficacy index entries, and 0 papers reported complete information of subjects from enrollment to included data analysis sets. Conclusion There is a serious problem of items shortage in the literatures of randomized controlled clinical trials on Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer. The randomized controlled clinical trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer should be reported based on the CONSORT to improve the quality of trials.

Safety hospital centralized monitoring is one of the important methods for evaluating the medication safety of TCM injections in clinic.It is critical to warrant research quality by reasonable statistical analysis.However,universally accepted standards and guidelines for the statistical analysis of hospital centralized monitoring of TCM injections have not been issued so far,which would probably reduce the research quality of safety hospital centralized monitoring of TCM injections since the unreasonable use of statistical analysis methods.Combined with previous practical experience and understanding,we put forward the problems of statistical analysis of hospital centralized monitoring of TCM injections with the provision of some advice in this paper based on the analysis of the preceding studies,laying a foundation for the same kind of researches.

The safety of TCM injection triggered attentions and hotspots in recent years in China.The centralized monitoring of TCM injection provided important evidence for analyzing the safety risk of TCM injections,recognizing adverse reactions and contraindications and perfecting the instructions.This study aimed at exploring the ethical problems on centralized monitoring.In this paper,we retrieved and screened the ethical issues of TCM injections over hospital centralized monitoring in China National Knowledge Infrastructure (CNKI,1979-Ju1.,2016).Issues over it were put forward and addressed.It is found that the current ethical issues related to hospital centralized monitoring lacks sufficient attentions,corresponding norms and requirements.Based on the ethical issues reflected from the literatures,suggestions should be pressed ahead with the ethical review of centralized surveillance,signing of informed consents,registration of research programs,data statistics and reporting stages,for the better protection of the rights and interests of subjects and improvement of research quality.

The launch of the clinical trial registry is a milestone event in the field of clinical research in the 21st century that has played an important role in safeguarding the openness,transparency,ethics,data sharing and process control of clinical research.The current clinical research registry is mainly aimed at clinical trial research with lack of professional registration system for security and other real events of observational study.In order to improve the level of clinical safety research,promote transparency and process quality control,we proactively proposed and established a registration platform for clinical safety research of traditional Chinese medicine.This paper made a brief introduction hereof.

According to the related requirements of safety reevaluation of TCM injections,hospital centralized monitoring of the safety of TCM injection was consecutively pressed ahead.Centralized security monitoring was a large-scale real world research involving numerous data acquisition,transmission,verification and analysis.The quality of data acquisition and data verification directly affected the authenticity and reliability of research data and results.Therefore,data management played a significant role in the safety monitoring of TCM injections.Based on the analysis of previous researches,this paper discussed the implementation content,links and the frequent problems and corresponding solutions of data management during the safety monitoring of TCM injections,combining with the experience in the implementation of projects.

Safety is a critical link restricting the development of TCM injections.Hospital centralized monitoring is of importance in the safety evaluation of TCM injections.However,the results of centralized monitoring studies usually deviated from the actual situation because of problems in design and process quality.Our research team have completed several projects over centralized monitoring in recent years.Based on the previous research experience,this paper mainly discussed the current statuation,the significance and methods for standard process of hospital centralized monitoring in regard to TCM injections,in order to improve the quality of centralized monitoring studies and provide technique support for recognizing the safety of TCM injections.