Adult ; Aged ; Benzamides ; therapeutic use ; Case-Control Studies ; Female ; Humans ; Imatinib Mesylate ; Immunoglobulins ; metabolism ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; drug therapy ; immunology ; Male ; Middle Aged ; Piperazines ; therapeutic use ; Pyrimidines ; therapeutic use ; T-Lymphocyte Subsets

Once uveal melanoma (UM) has distant metastasis, the median survival time of the patient is less than 12 months. There is currently a lack of standard treatment for metastatic UM. In recent years, immunotherapy is splendid in the field of oncology. Immune checkpoint therapy, cancer vaccine therapy and T cell adoptive therapy have been applied to UM therapy. However, most of the clinical effects are limited and the survival benefit is not high. The recent early research results of the new immunotherapeutic drug IMCgp100 are encouraging.

Some phytoestrogen-containing Chinese herbs have both estrogenic and antiestrogenic activity. With the development of phgtoestrogen study and the application of herbs in breast cancer, phytoestrogen-containing herbs become the hot researches, but consensus is hampered by conflicting data from various in vitro and in vivo experiments. This article will address the effects of some kinds of herbs on breast cancer cell proliferation, the mechanism and their biological activity. The review will focus on 3 popular botanical herb: Angelica sinensis (dong quai) , Salvia miltiorrhiza (dan-shen root) and ginseng.

[Objective]To investigate the relationship of baseline antimullerian hormone(AMH)and live birth rate of IVF/ICSI and further explore the prognostic effect of AMH on live birth rate.[Methods]All non-polycystic ovary patients who underwent their first embryo transfers in our unit and had basal serum AMH evaluated between 2010 and 2015 were evaluated in this retrospective study. Patients were grouped according to their AMH level,i.e. low AMH group with AMH less than 1.1 ng/mL(n = 485),middle AMH group with AMH between 1.1 ng/mL and 7.0 ng/mL (n = 1 989),and high AMH group with AMH higher than 7.0 ng/mL (n=468). For age subgroup analysis,patients were stratified as follow:group A(age≤29 years),group B(30~34 years),group C(35~39 years)and group D(over 40 years). We compared clinical outcomes between AMH groups in different age groups usingunivariate and multivariate analysis. ROC analysis was utilized to assess predictive value of AMH on live birth rate.[Results](1)In both fresh and frozen embryo transfers,baseline AMH was significantly related to clinical outcomes. The lower AMH was,the lower implantation rate,clinical pregnancy rate,and live birth rate. However,higher miscarriage rate was observed. All difference reached statistically significant.(2)In age subgroup analysis,we demonstrated AMH was related to live birth rate in patients in group A,B, and C,regardless of fresh or frozen embryo transferred. In those over 40 years,AMH was related to live birth rate in frozen cycles (P < 0.05)but not fresh cycles(P = 0.092). The further multivariate analysis confirmed the above results after controlling po?tential confounding variables.(3)The AUC of ROC analysis for AMH predicting live birth rate were 0.647,0.633 for fresh and fro?zen cycles respectively.[Conclusion]Baseline AMH as one of excellent ovarian reserve markers ,was significantly related to live birth rate in fresh or frozen cycles. Baseline AMH was an independent prognostic factor of live birth rate,but its predictive value on live birth rate was of limited clinical value.

Background Stickler syndrome is a genetic connective tissue disorder that affects the ocular,skeletal,orofacial and auditory systems.To determine the gene mutation loci can offer a basis for genetic diagnosis and management of Stickler syndrome.Objective The aim of this study was to research the clinical characteristics of a pedigree with Stickler syndrome and identify the disease-causing gene mutation.Methods This study was approved by Ethic Committee of Peking Union Medical College Hospital.The clinical study and pedigree analysis were performed in one family with Stickler syndrome type Ⅰ (STL Ⅰ).Nine family members were examined with informed consent.The entire coding regions of COL2A1 gene with flanking intronic regions were amplified by PCR and directly sequenced.The detected sequence change was confirmed to be mutationloci by examining whether they existed in normal control individuals.Mutant proteins were predicted with online software.Results There were 4 generations and 11 members in this family,and 2 members died,including 1 patient.Three patients were found in 9living families.Inheritance of this family complicd with an autosomal dominant inheritance mode.All affected individuals showed the consistent phenotypes with STL Ⅰ,including high myopia,membranous vitreous anomaly and surface central flat,short nose,palatoschisis,etc.Mutation screening of COL2A1 gene revealed that the first base of intron 12 was deleted(IVS12+1G del).Nucleotide sequence analysis showed that this mutation led to the functional abnormal of this gene by forming termination cordon in advance.This mutation occurred in all affected individuals,however,no mutation was observed in any unaffected member or 100 normal unrelated individuals.Conclusions This study identifies a novel splice-site mutation(IVS12+ 1G del)in COL2A1 gene in a Chinese STL Ⅰ pedigree.This is the first report on a mutation in a Chinese STL Ⅰ family.

Abstract: Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine (TCM), we elaborated the implementation process and demands of quality control measures of each level, including quality control, monitoring, auditing, and inspection. On the basis of joint inspection experience of 41 projects of the "Prevention and Treatment of Difficult and Complicated Diseases of TCM" plan of the "11th Five-year National Key Technology R&D Program", we analyzed the ensuring effect of 4-level quality control system and joint inspection model, and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model. Finally we investigated what should be revised in the quality control system and joint inspection model, thus providing the theoretical support for quality inspection improvement of TCM clinical research.

ABSTRACT: Data management has significant impact on the quality control of clinical studies. Every clinical study should have a data management plan to provide overall work instructions and ensure that all of these tasks are completed according to the Good Clinical Data Management Practice (GCDMP). Meanwhile, the data management plan (DMP) is an auditable document requested by regulatory inspectors and must be written in a manner that is realistic and of high quality. The significance of DMP, the minimum standards and the best practices provided by GCDMP, the main contents of DMP based on electronic data capture (EDC) and some key factors of DMP influencing the quality of clinical study were elaborated in this paper. Specifically, DMP generally consists of 15 parts, namely, the approval page, the protocol summary, role and training, timelines, database design, creation, maintenance and security, data entry, data validation, quality control and quality assurance, the management of external data, serious adverse event data reconciliation, coding, database lock, data management reports, the communication plan and the abbreviated terms. Among them, the following three parts are regarded as the key factors: designing a standardized database of the clinical study, entering data in time and cleansing data efficiently. In the last part of this article, the authors also analyzed the problems in clinical research of traditional Chinese medicine using the EDC system and put forward some suggestions for improvement.

ObjectiveTo investigate and analyze the current primary quality management situation in TCM clinical studies.Methods One sub-center unit from 39 projects of “Prevention and Treatment of Difficult and Complicated Disease of TCM” plan of the“11th Five-year National Key Technology R&D Program” was chosen. Executive condition of the primary quality control of each unit was under field investigation, and quality control quantitative evaluation indexes were used to conduct quantitative evaluation.Results Results were shown as the forms of statistical description and radar map. The average and median scores of primary quality management were 5.05 and 5.2, respectively. The best and preferable proportions of 39 units were 25.64% and 28.21%. Other 46.15% of these units performed poor. The problem mainly manifested on insufficient frequency and bad normalization of primary quality management, such as comprehensiveness and integrity of inspection contents, cases, problem recordings and problems timely feedback.ConclusionAlthough the primary quality management is widely conducted in TCM clinical studies, there are still some problems to be settled and improved.

Objective To explore the association between the genetic polymorphism of CYP3A4,CYP2D6 and response to methadone maintenance treatment(MMT)among heroin-dependent patients.Methods Patients undergoing MMT in 6 MMT clinics were randomly selected,information about general socia-demographic characteristics,drug abuse history,and MMT data of patients were collected,genotypes of peripheral blood CYP3A4 and CYP2D6 polymorphic loci were detected.Results A total of 820 patients were enrolled in the study,210 cases were with good response and 610 cases with poor response to MMT.Difference in age between different response groups was statistically significant(P<0.05).Distribution of genotype frequency and allele frequency of CYP3A4 rs2242480 and CYP2D6 rs16947 between good response and poor response groups was not significantly different(both P>0.05).Conclusion The association between CYP3A4 rs2242480,CYP2D6 rs16947 and response to MMT has not yet found in heroin-dependent patients.

TCM clinical research should attach importance on ethical issues,as it takes the human for the research subjects and the clinical research activities definitely involve the benefits and risks to the subjects.Ethics optimization on the basis of safety and scientificity is necessary.This study explores the optimization of some key links of ethics of TCM clinical research,i.e.optimization of ethics committee membership,optimization of ethical review of study protocol,optimization of informed consent process,and optimization of protection and compensation of the subject,thus providing the theoretical support for ethics improvement of TCM clinical research.