A network meta-analysis to evaluate the efficacy and safety of different dosages of new drugs in the treatment of psoriatic arthritis / 中华风湿病学杂志

Objective:To compare the efficacy and safety of different dosages of new drugs in the treatment of PsA by using network meta-analysis.Methods:Three medical databases (PubMed, Web of Science, Cochrane Library) were searched for the studies that compared the efficacy and safety of 4 new drugs (secukinumab, ixekizumab, apremilast, tofacitinib) with different dosages in the treatment of PsA. Data from included studies were analyzed by Stata 15.0.Results:A total of 16 RCTs were included. The results of the network meta-analysis showed that: (1) Among the overall patients, in terms of ACR20 response rate, the larger the surface under the cumulative ranking (SUCRA), the more effective it is. Secukinumab 300 mg Q4W(96.1%) had the best efficacy, followed by ixekizumab 80 mg Q4W(79.0%), ixekizumab 80 mg Q2W(75.1%), secukinumab 150 mg Q4W(73.2%), apremilast 30 mg BID(50.6%), apremilast 20 mg BID(38.6%), tofacitinib 5 mg BID(18.1%), tofacitinib 10 mg BID(17.7%) and placebo(2.0%). (2) In terms of PASI75 response rate, the larger the area under the SUCRA curve, the more effective it is. Ixekizumab 80 mg Q4W(96.1%) had the best efficacy, followed by ixekizumab 80 mg Q2W(88.7%), secukinumab 300 mg Q4W(75.6%), secukinumab 150 mg Q4W(63.3%), apremilast 30 mg BID(44.5%), apremilast 20 mg BID(38.4%), tofacitinib 10 mg BID(30.0%), tofacitinib 5 mg BID(12.5%) and placebo(1.0%). (3) Among the overall patients, in terms of safety, the smaller the area under the SUCRA curve, the higher the safety it is. Secukinumab 300 mg Q4W (17.3%) has the best safety. (4) The results of subgroup analysis showed that in terms of ACR20 response rate, ixekizumab 80 mg Q2W(85.3%) had the best efficacy in bDMARDs-na?ve patients, while in bDMARDs-IR patients, secukinumab 300 mg Q4W(83.9%) had the best efficacy.Conclusion:Among all patients, secukinumab 300 mg Q4W is the best in terms of ACR20 response rate and safety, but ixekizumab 80 mg Q4W is more effective in improving PsA lesions comparing yo other drugs.

Mechanism of action of oxidative stress in severe traumatic brain injury and its complications: recent progress / 中华创伤杂志

Severe traumatic brain injury (sTBI) is characterized by critical condition, high lethality and poor prognosis. Its development and progression will lead to the damage and death of a large number of nerve cells, eventually causing a series of serious complications. The current treatments of sTBI and its complications are not optimistic due to problems such as unclear mechanism of action, challenges in treatment, and lack of effective prevention strategies. In recent years, more research evidences have shown that oxidative stress plays an important role in the development and progression of sTBI and its related complications. Therefore, it is of great significance to clarify the relationship of oxidative stress with sTBI and its complications and to understand the way of oxidative stress participating in the development and progression of sTBI. However, relevant researches are scattered and there lacks comprehensive and systematic summaries of oxidative stress participating in sTBI and its related complications. To this end, the authors reviewed the progress of the mechanism by which oxidative stress involves in sTBI and its complications, hoping to provide references for the research, treatment and prevention of sTBI.

Accuracy of three-dimensional periodontal ligament models generated using cone-beam computed tomography at different resolutions for the assessment of periodontal bone loss / 대한치과교정학회지

Objective@#To develop a method for generating three-dimensional (3D) digital models of the periodontal ligament (PDL) using 3D cone-beam computed tomography (CBCT) reconstruction and to evaluate the accuracy and agreement of the 3D PDL models in the measurement of periodontal bone loss. @*Methods@#CBCT data collected from four patients with skeletal Class III malocclusion prior to periodontal surgery were reconstructed at three voxel sizes (0.2 mm, 0.25 mm, and 0.3 mm), and 3D tooth and alveolar bone models were generated to obtain digital PDL models for the maxillary and mandibular anterior teeth. Linear measurements of the alveolar bone crest obtained during periodontal surgery were compared with the digital measurements for assessment of the accuracy of the digital models. The agreement and reliability of the digital PDL models were analyzed using intra- and interexaminer correlation coefficients and Bland–Altman plots. @*Results@#Digital models of the maxillary and mandibular anterior teeth, PDL, and alveolar bone of the four patients were successfully established. Relative to the intraoperative measurements, linear measurements obtained from the 3D digital models were accurate, and there were no significant differences among different voxel sizes at different sites. High diagnostic coincidence rates were found for the maxillary anterior teeth. The digital models showed high intra- and interexaminer agreement. @*Conclusions@#Digital PDL models generated by 3D CBCT reconstruction can provide accurate and useful information regarding the alveolar crest morphology and facilitate reproducible measurements. This could assist clinicians in the evaluation of periodontal prognosis and establishment of an appropriate orthodontic treatment plan.

Epidemiological and etiological characteristics of active surveillance of foodborne illness / 公共卫生与预防医学

Objective To realize the epidemiological and pathogenic characteristics of foodborne illness in Shiyan in 2019 and provide targeted measures for the prevention and control work of the foodborne illness． Methods The active surveillance data of foodborne illness in shiyan in 2019 were collected and analyzed. The Salmonella strains isolated from the patients with foodborne illness were tested with serotyping，PFGE molecular classification and drug sensitivity test respectively according to《National foodborne illness surveillance workbook 2019》. Result A total of 3 191 cases of foodborne illness were analyzed. The pre-school children were the highest-risk group of foodborne diseases. Grain and grain product was the main suspicious contaminated food．The main location of eating place was family. A total of 330 samples were tested. The positive detection rate of foodborne illness was 20.30%（73/330）.The main pathogen were Rotavirus and Salmonella,and the detection rates were 11.21%(37/330) and 4.85%(16/330) respectively. The pre-school children were the group with the highest detection rate, which was 57.27% (63/110). The dominant serotype of the 14 Salmonella strains isolated from patients were Salmonella typhimurium and Salmonella enteritis. 14 different genotypes were obtained through PFGE classification and clustering. 64.29% (9/14) of Salmonella strains were multidrug-resistant strains. The drug resistance rates of ampicillin and tetracycline were the highest, which were 71.43%（11/14）and 64.29%（10/14）respectively. Conclusions The publicity and education of food safety should be strengthened and the surveillance network system of food-borne disease should be further improved according to the epidemiological and pathogenic characteristics of foodborne illness in Shiyan in 2019, and the use of clinical antibiotics should be controlled reasonably as well.

Analysis and enlightenment of the current situation of medical psychology undergraduate education in China and foreign countries / 西安交通大学学报(医学版)

With the economic development of China and transformation of medical model, people pay more attention to their spiritual world and psychological health, and medical psychology has become a major in urgent need of construction. Foreign medical/clinical psychology education was established earlier and has become relatively mature, thus making its experience valuable for reference. This paper compares and analyzes the current situation of undergraduate medical psychology education, and puts forward optimization strategies from the aspects of college planning, curriculum training scheme and teachers’ teaching philosophy, hoping to provide some ideas for the construction of undergraduate medical psychology education in China.

Correlation between expression of centromere protein K and epithelial-mesenchymal transition in triple-negative breast cancer and its clinical significance / 肿瘤研究与临床

Objective:To investigate the correlation of centromere protein K (CENPK) expression in triple-negative breast cancer (TNBC) with epithelial-mesenchymal transformation (EMT) and its clinical significance.Methods:Immunohisochemical SABC method was used to detect the expressions of CENPK and EMT-related proteins (E-cadherin, Vimentin and N-cadherin) in 69 specimens of TNBC and cancer-adjacent tissues collected from patients in Binzhou People's Hospital Affiliated to Shandong First Medical University from January 2015 to December 2018. The correlations of CENPK expression with clinicopathological characteristics of patients and expressions of EMT-related proteins were analyzed.Results:The positive expression rates of CENPK in TNBC and cancer-adjacent tissues were 72.46% (50/69) and 14.49% (10/69), respectively, and the difference was statistically significant ( χ2 = 47.18, P<0.001). The CENPK expression in TNBC was related to pathological grade, clinical stage and lymphatic metastasis (all P<0.05). The CENPK expression in TNBC was negatively correlated with E-cadherin expression ( r = -0.447, P<0.01), but positively correlated with Vimentin and N-cadherin expressions ( r values were 0.503 and 0.415, both P<0.01). The median overall survival time of CENPK high-expression group was 24 months (95% CI 10-39 months), while that of CENPK low-expression group was 42 months (95% CI 19-50 months). The difference in overall survival between the two groups was statistically significant ( χ2 = 7.36, P = 0.016). Conclusions:CENPK may be involved in the occurrence and development of TNBC through EMT, and the expression of CENPK may be related to the prognosis of patients.

The relationship between career resilience and voice behavior in organ transplantation specialist nurses: the mediating role of thriving at work / 中国实用护理杂志

Objective:To investigate the status quo of thriving at work, career resilience and voice behavior in organ transplantation nurses, and mediation effects of thriving at work between the latter two.Methods:From June to August 2018,180 nurses with organ transplant qualification departments in two Grade A hospitals in Fuzhou, Fujian Province were investigated by the general situation survey form, Thriving At Work Scale, Career Resilience Scale and Voice Behavior Scale.Results:The scores of thriving at work, career resilience and voice behavior were 3.68 ± 0.65, 3.56 ± 0.61 and 3.42 ± 0.62. There was a pairwise positive correlation among the three: thriving at work, career resilience and voice behavior( r values were 0.270-0.664, all P<0.05). Thriving at work played a partial mediating role between career resilience and voice behavior ( B values were 0.138-0.611, all P<0.05). Conclusions:Ii is necessary to improve thriving at work, career resilience and voice behavior in organ transplantation nurses. Thriving at work is the intermediary factor between the latter two. The improvement of thriving at work and career resilience will help to promote organ transplant specialist nurses to make positive voice behavior.

Investigation of high-incidence skin diseases in the army and its application in the curriculum integration of skin diseases / 中华医学教育探索杂志

Taking the curriculum integration of skin diseases as an example, this paper summarizes the skin diseases with high incidence in the army such as acne, tinea pedis, warts, folliculitis, corns and calluses, sunburns, etc. The results have been applied to the integration of the skin disease curriculum in Air Force Medical University. During the course integration process, we integrated the courses of dermatology, plastic surgery and burn surgery together, and simplified the teaching content according to the "organ-system" orientation and features of military medical university. In the teaching process, the PBL teaching method was used to guide the students to discuss with the problems. At the end of the course, the students were assessed by tests, and the satisfaction evaluation were carried out. The results showed that the application of high incidence of skin diseases in the army in curriculum integration can help improve the teaching effect and the satisfaction of students, which will provide a certain reference for the curriculum integration reform of military medical universities.

In situ Metabolomics of Metabolic Reprogramming Involved in a Mouse Model of Type 2 Diabetic Kidney Disease.

The in situ metabolic profiling of the kidney is crucial to investigate the complex metabolic reprogramming underlying diabetic kidney disease (DKD) and to allow exploration of potential metabolic targets to improve kidney function. However, as the kidney is a highly heterogeneous organ, traditional metabolomic methods based on bulk analysis that produce an averaged measurement are inadequate. Herein, we employed an in situ metabolomics approach to discover alternations of DKD-associated metabolites and metabolic pathways. A series of histology-specific metabolic disturbances were discovered in situ using airflow-assisted desorption electrospray ionization mass spectrometry imaging (AFADESI-MSI). In combination with integrated metabolomics analysis, five dysfunctional metabolic pathways were identified and located in the kidneys of type-2 DKD mice simultaneously for the first time, including taurine metabolism, arginine and proline metabolism, histidine metabolism, biosynthesis of unsaturated fatty acids, and fatty acid degradation pathways. As crucial nodes of metabolic pathways, five dysregulated rate-limiting enzymes related to altered metabolic pathways were further identified. These findings reveal alternations from metabolites to enzymes at the molecular level in the progression of DKD and provide insights into DKD-associated metabolic reprogramming.

Single-cell transcriptomic atlas of individuals receiving inactivated COVID-19 vaccines reveals distinct immunological responses between vaccine and natural SARS-CoV-2 infection

To control the ongoing COVID-19 pandemic, CoronaVac (Sinovac), an inactivated vaccine, has been granted emergency use authorization by many countries. However, the underlying mechanisms of the inactivated COVID-19 vaccine-induced immune response remain unclear, and little is known about its features compared to SARS-CoV-2 infection. Here, we implemented single-cell RNA sequencing (scRNA-seq) to profile longitudinally collected PBMCs (peripheral blood mononuclear cells) in six individuals immunized with CoronaVac and compared these to the profiles of COVID-19 infected patients from a Single Cell Consortium. Both inactivated vaccines and SARS-CoV-2 infection drove changes in immune cell type proportions, caused B cell activation and differentiation, and induced the expression of genes associated with antibody production in the plasma. The inactivated vaccine and SARS-COV-2 infection also caused alterations in peripheral immune activity such as interferon response, inflammatory cytokine expression, innate immune cell apoptosis and migration, effector T cell exhaustion and cytotoxicity, however, the magnitude of change was greater in COVID-19 patients, especially those with severe disease, than in immunized individuals. Further analyses revealed a distinct peripheral immune cell phenotype associated with CoronaVac immunization (HLA class II upregulation and IL21R upregulation in naive B cells) versus SARS-CoV-2 infection (HLA class II downregulation and IL21R downregulation in naive B cells severe disease). There were also differences in the expression of important genes associated with proinflammatory cytokines and thrombosis. In conclusion, this study provides a single-cell atlas of the systemic immune response to CoronaVac immunization and reveals distinct immune responses between inactivated vaccines and SARS-CoV-2 infection.

Proteomic and metabolomic signatures associated with the immune response in healthy individuals immunized with an inactivated SARS-CoV-2 vaccine

SummeryCoronaVac (Sinovac), an inactivated vaccine for SARS-CoV-2, has been widely used for immunization. However, analysis of the underlying molecular mechanisms driving CoronaVac-induced immunity is still limited. Here, we applied a systems biology approach to understand the mechanisms behind the adaptive immune response to CoronaVac in a cohort of 50 volunteers immunized with 2 doses of CoronaVac. Vaccination with CoronaVac led to an integrated immune response that included several effector arms of the adaptive immune system including specific IgM/IgG, humoral response and other immune response, as well as the innate immune system as shown by complement activation. Metabolites associated with immunity were also identified implicating the role of metabolites in the humoral response, complement activation and other immune response. Networks associated with the TCA cycle and amino acids metabolic pathways, such as phenylalanine metabolism, phenylalanine, tyrosine and tryptophan biosynthesis, and glycine, serine and threonine metabolism were tightly coupled with immunity. Critically, we constructed a multifactorial response network (MRN) to analyze the underlying interactions and compared the signatures affected by CoronaVac immunization and SARS-CoV-2 infection to further identify immune signatures and related metabolic pathways altered by CoronaVac immunization. These results suggest that protective immunity against SARS-CoV-2 can be achieved via multiple mechanisms and highlights the utility of a systems biology approach in defining molecular correlates of protection to vaccination.

The study on the relationship among negative physical self,fear of negative evaluation, physical appearance perfectionism and social appearance anxiety in female patients with psoriasis / 中国实用护理杂志

Objective:To analyze the relationship between physical appearance perfectionism, negative body self, fear of negative evaluation and social appearance anxiety in female patients with psoriasis.Methods:A total of 251 female patients with psoriasis in Xinhua Hospital Affiliated to Medical College of Shanghai Jiaotong University from June 2019 to June 2020 were selected as the subjects. Physical Appearance Perfectionism Scale (PPAS), Social Appearance Anxiety Scale (SAAS), Brief Fear of Negative Evaluation Scale (BFNES) and Negetive Physical Self Scale (Npss) were used in the survey. The correlation of negative body self and negative evaluation fear between the appearance perfectionism and social appearance anxiety of female psoriasis patients was analyzed.Results:The score of physical appearance perfectionism was 49.42±5.32, the score of social appearance anxiety was 58.72±6.24, the score of fear of negative evaluation was 30.59±7.21 and the score of negative physical self was 29.21±6.24. Pearson correlation analysis showed that there was a significant positive correlation among physical appearance perfectionism, social appearance anxiety, fear of negative evaluation and negative physical self ( r value was 0.402-0.488, P<0.01). The mediating effect of negative physical self between physical appearance perfectionism and social appearance anxiety was 0.164 (95% CI 0.082-0.227), the mediating effect of negative body self between physical appearance perfectionism and social appearance anxiety was 0.152 (95% CI 0.079-0.214) and the chain mediating effect of fear of negative evaluation and negative physical self was 0.067 (95% CI 0.025-0.108). Conclusions:Female patients with psoriasis have a high level of physical appearance perfectionism, which can directly affect their social anxiety, while fear of negative evaluation and negative physical self indirectly affect the correlation between appearance perfectionism and social appearance anxiety. Psychological intervention measures should be taken to reduce their psychological burden on their own appearance defects and carry out social anxiety and fear.

Subjective and Objective Assessment of Monoenergetic and Polyenergetic Images Acquired by Dual-Energy CT in Breast Cancer

Objective@#To objectively and subjectively assess and compare the characteristics of monoenergetic images [MEI (+)] and polyenergetic images (PEI) acquired by dual-energy CT (DECT) of patients with breast cancer. @*Materials and Methods@#This retrospective study evaluated the images and data of 42 patients with breast cancer who had undergone dual-phase contrast-enhanced DECT from June to September 2019. One standard PEI, five MEI (+) in 10-kiloelectron volt (keV) intervals (range, 40–80 keV), iodine density (ID) maps, iodine overlay images, and Z effective (Z eff) maps were reconstructed. The contrast-to-noise ratio (CNR) and the signal-to-noise ratio (SNR) were calculated. Multiple quantitative parameters of the malignant breast lesions were compared between the arterial and the venous phase images. Two readers independently assessed lesion conspicuity and performed a morphology analysis. @*Results@#Low keV MEI (+) at 40–50 keV showed increased CNR and SNR breast lesion compared with PEI, especially in the venous phase ([CNR: 40 keV, 20.10; 50 keV, 14.45; vs. PEI, 7.27; p < 0.001], [SNR breast lesion: 40 keV, 21.01; 50 keV, 16.28; vs.PEI, 10.77; p< 0.001]). Multiple quantitative DECT parameters of malignant breast lesions were higher in the venous phase images than in the arterial phase images (p < 0.001). MEI (+) at 40 keV, ID, and Z eff reconstructions yielded the highest Likert scores for lesion conspicuity. The conspicuity of the mass margin and the visual enhancement were significantly better in 40-keV MEI (+) than in the PEI (p = 0.022, p = 0.033, respectively). @*Conclusion@#Compared with PEI, MEI (+) reconstructions at low keV in the venous phase acquired by DECT improved the objective and subjective assessment of lesion conspicuity in patients with malignant breast lesions. MEI (+) reconstruction acquired by DECT may be helpful for the preoperative evaluation of breast cancer.

Incidence and trend of severe postpartum hemorrhage between 2016 and 2019 in China / 中华妇产科杂志

Objective:To investigate the incidence and trend of severe postpartum hemorrhage (sPPH) in China, and to provide basic data for the development and evaluation of sPPH prevention and control strategy.Methods:Obstetric data was extracted from annual national representative sampling surveys based on the National Clinical Improvement System. From 2016 to 2019, 2 978, 3 400, 4 576 and 4 594 maternity hospitals with sPPH cases were included for statistics. The annual incidence of sPPH was calculated according to province and type of medical institutions and generalized linear model was emplyed to identify the determinants affecting sPPH incidence.Results:In China, sPPH incidence increased from 0.62% in 2016 to 0.93% in 2018, and was 0.92% in 2019. Eighteen provinces had an inverted U-shaped trend of sPPH over time and most of them had the highest incidence in 2018; ten provinces had an upward trend of sPPH and 3 provinces had a U-shaped trend. In 2019, the top five provinces with the highest sPPH incidence were Yunnan (1.88%), Beijing (1.45%), Jiangsu (1.31%), Guizhou (1.26%), and Ningxia Hui Autonomous Region (1.22%); the top five provinces with the lowest incidence were Henan (0.55%), Jiangxi (0.60%), Inner Mongolia Autonomous Region (0.64%), Liaoning (0.64%) and Gansu (0.69%). In 2019, the sPPH incidence in different types of medical institutions were as follows: tertiary public general hospital (1.15%), tertiary public specialized hospital (1.02%), secondary public general hospital (0.81%), private hospital (0.61%) and secondary public specialized hospital (0.58%). sPPH incidence was positively associated with proportion of twin pregnancies, macrosomia, primipara, and puerpera aged ≥35 years in maternity hospitals ( P<0.05). Conclusions:sPPH incidence generally showes an increasing trend from 2016 and is stable at a high level in recent two years in China. It is warranted to further strengthen the monitoring of postpartum hemorrhage, and improve the capability of hierarchical management and treatment in maternity institutions and regions, in order to reduce sPPH incidence and maternal mortality.

Subjective and Objective Assessment of Monoenergetic and Polyenergetic Images Acquired by Dual-Energy CT in Breast Cancer

Objective@#To objectively and subjectively assess and compare the characteristics of monoenergetic images [MEI (+)] and polyenergetic images (PEI) acquired by dual-energy CT (DECT) of patients with breast cancer. @*Materials and Methods@#This retrospective study evaluated the images and data of 42 patients with breast cancer who had undergone dual-phase contrast-enhanced DECT from June to September 2019. One standard PEI, five MEI (+) in 10-kiloelectron volt (keV) intervals (range, 40–80 keV), iodine density (ID) maps, iodine overlay images, and Z effective (Z eff) maps were reconstructed. The contrast-to-noise ratio (CNR) and the signal-to-noise ratio (SNR) were calculated. Multiple quantitative parameters of the malignant breast lesions were compared between the arterial and the venous phase images. Two readers independently assessed lesion conspicuity and performed a morphology analysis. @*Results@#Low keV MEI (+) at 40–50 keV showed increased CNR and SNR breast lesion compared with PEI, especially in the venous phase ([CNR: 40 keV, 20.10; 50 keV, 14.45; vs. PEI, 7.27; p < 0.001], [SNR breast lesion: 40 keV, 21.01; 50 keV, 16.28; vs.PEI, 10.77; p< 0.001]). Multiple quantitative DECT parameters of malignant breast lesions were higher in the venous phase images than in the arterial phase images (p < 0.001). MEI (+) at 40 keV, ID, and Z eff reconstructions yielded the highest Likert scores for lesion conspicuity. The conspicuity of the mass margin and the visual enhancement were significantly better in 40-keV MEI (+) than in the PEI (p = 0.022, p = 0.033, respectively). @*Conclusion@#Compared with PEI, MEI (+) reconstructions at low keV in the venous phase acquired by DECT improved the objective and subjective assessment of lesion conspicuity in patients with malignant breast lesions. MEI (+) reconstruction acquired by DECT may be helpful for the preoperative evaluation of breast cancer.

Reverse transcription loop-mediated isothermal amplification combined with nanoparticles-based biosensor for diagnosis of COVID-19

Given the scale and rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, known as 2019-nCov) infection (COVID-19), the ongoing global SARS-CoV-2 outbreak has become a huge public health issue. Rapid and precise diagnostic methods are thus immediately needed for diagnosing COVID-19, providing timely treatment and facilitating infection control. A one-step reverse transcription loop-mediated isothermal amplification (RT-LAMP) coupled with nanoparticles-based biosensor (NBS) assay (RT-LAMP-NBS) was successfully established for rapidly and accurately diagnosing COVID-19. A simple equipment (such as heating block) was required for maintaining a constant temperature (63{degrees}C) for only 40 min. Using two designed LAMP primer sets, F1ab (opening reading frame 1a/b) and np (nucleoprotein) genes of SARS-CoV-2 were simultaneously amplified and detected in a one-step and single-tube reaction, and the detection results were easily interpreted by NBS. The sensitivity of SARS-CoV-2 RT-LAMP-NBS was 12 copies (each of detection target) per reaction, and no cross-reactivity was generated from non-SARS-CoV-2 templates. Among clinically diagnosed COVID-19 patients, the analytical sensitivity of SARS-CoV-2 was 100% (33/33) in the oropharynx swab samples, and the assays specificity was also 100% (96/96) when analyzed the clinical samples collected from non-COVID-19 patients. The total diagnosis test from sample collection to result interpretation only takes approximately 1 h. In sum, the RT-LAMP-NBS is a promising tool for diagnosing the current SARS-CoV-2 infection in first line field, public health and clinical laboratories, especially for resource-challenged regions.

Application analysis of career planning combined with layered training mode for clinical research nurses / 中华医院管理杂志

Objective:To explore the application of career planning combined with layered training mode in management of clinical research nurses(CRN)and its effect evaluation.Methods:100 CRNs from 8 tertiary hospitals in Shanxi province were randomly enrolled and divided into an intervention group and a control group. Both groups participated in training and meetings organized by drug research institutions. On this basis, the intervention group was added with a management method combining career planning guidance and layered training for 10 months. Before and after the intervention, career status questionnaire was used to evaluate the career status of the two groups of CRNs.Results:Before the intervention, the total scores of CRN career evaluation in the two groups were(66.64 ± 12.71)and(66.68 ± 12.88), respectively, and the difference was not statistically significant( P>0.05). The score of career evaluation in the intervention group was(79.94 ± 12.26)points after intervention, which was significantly higher than that before intervention(66.64 ± 12.71)points; the score of career evaluation in the intervention group was also higher than that in the control group after the intervention; the differences were statistically significant( P<0.05). After the intervention, the CRN career evaluation scores of the junior and senior seniority were higher than those of the middle seniority( P<0.05). Conclusions:Career planning combined with layered training mode can play a positive role in CRN management. Especially, it has a more significant impact on the career status of CRNs of junior and senior seniority.

Analysis of drug clinical trials for rheumatic diseases in China / 中华风湿病学杂志

Objective:To analyze and summarize the drug registration clinical trial for rheumatic diseases in China from January 2013 to November 2019.Methods:The website of CDE was searched to obtain the data and statistical analysis was conducted.Results:①The number of drug clinical trials for rheumatic diseases in China increased year by year and the total was 525. The registered indications mainly included diffuse connective tissue disease, spondylo arthritis, metabolic diseases and degenerative diseases, including rheumatoid arthritis (RA) (189), gout (122), osteoarthritis (OA) (89), ankylosing spondylitis (AS) (60) and systemic lupus erythematosus (SLE) (39). ② The phaseⅡ-Ⅲ clinical trials were mainly for biological disease-modifying antirheumatic drugs (bDMARDs). Most of the bioequivalence test (BE) were chemical drugs.③ The domestically developed chemicals and biological included BLyS/APRIL, CD22, JAK1, S1P1 and BTK. ④ Adalimumab and tocilizumab accounted for the largest proportion of biosimilar drugs. The indications were mainly RA. ⑤ The number of international multi-center clinical trials increased year by year, with the indications mainly for RA and SLE.Conclusion:① The overall number of drugs trials for rheumatic diseases in China has been increasing rapidly in recent years. ② The research and development of chemicals and biologics is the trend. ③ Significant achievements have been made in the research and development of biosimilars in China and it is expected to benefit more patients by broaden the indications.

Experience in quality control of clinical trials of DMARDs / 中国临床药理学与治疗学

In recent years, many new DMARDs have been emerging, mainly in bDMARDs and tsDMARDs. With the increasing number of clinical trials, it is of great significance to strengthen the quality control of clinical trials. This paper analyzes the key points and difficulties in practice that the investigator should pay attention to in the b/tsDMARDs clinical trials, as well as the quality control concerns of the clinical trials of such drugs. Some methods are put forward to solve questions above in order to help improve the quality of such clinical trials.

Study on the relationship between soil and quality of Astragalus membranaceus in Minle, Gansu / 药学实践杂志

Objective To study the relationship between the quality of Astragalus membranaceus and soil in Gansu Minle. Methods we sampled the medicinal materials and soils of Astragalus membranaceus in Minle County, and determined the medicinal quality, soil factors and heavy metal elements by high performance liquid chromatography, ultraviolet spectrophotometry, atomic absorption spectrophotometry, and etc. Results The quality of Minle Astragalus meets the requirements of the Pharmacopoeia standards and is low on the risk of heavy metal pollution. There was a significant negative correlation between the extract and the available potassium. There was a significant positive correlation between the astragaloside IV and the available potassium. There was a highly significant positive correlation between calycosin-7-glucoside and soluble salt. There was a significant positive correlation with available potassium, and a significant negative correlation with pH. Among them, soil pH value is the most important factor affecting the content of astragalus extract, astragaloside IV and verrucous glucoside, followed by total phosphorus, organic matter and total nitrogen. Conclusion The results revealed that the soil factors is the main influencing factor of the quality of Astragalus membranaceus in Minle County, which can provide a theoretical basis for the standardized cultivation of Astragalus membranaceus in Minle County.