Objective  To investigate the incidence and adverse effects of abnormal uterine bleeding (AUB) during oral anticoagulation therapy in women with thrombophilia.  Methods  The female patients with thrombophilia who received oral anticoagulation therapy with rivaroxaban or warfarin in the Department of Hematology of Peking Union Medical College Hospital from January 2013 to May 2023 were selected as the study subjects. Their demographic characteristics, disease related data and AUB before and after anticoagulant therapy were retrospectively collected. The patients were divided into rivaroxaban treatment group and warfarin treatment group according to anticoagulant drugs. The generalized estimating equation was used to analyze the difference in the incidence of AUB before and after anticoagulant therapy, and explore the effect of different anticoagulant therapy on AUB.  Results  A total of 106 female patients with thrombophilia were included, and we found that oral anticoagulation significantly increased the incidence of AUB (56.6% vs. 26.4%, P < 0.001), predominantly characterized by excessive menstruation (48.1%) and prolonged periods (21.7%). Rivaroxaban was more likely to cause AUB than warfarin (OR=3.3, 95% CI: 1.5-7.4, P=0.003). Of the patients who experienced excessive menstruation and prolonged periods, 72.2%(39/54) required intervention, with suspension of anticoagulants during menstruation as the main intervention (37.0%). The patients taking rivaroxaban were more likely to stop taking them during menstruation compared to those taking warfarin (OR=10.4, 95% CI: 1.2-87.2, P=0.019).  Conclusions  Oral anticoagulation therapy significantly increased the incidence of AUB in women with thrombophilia and the risk of AUB associated with rivaroxaban was significantly higher than that with warfarin.

Objective·To analyze the development trend and current situation of high-level clinical research at Shanghai Jiao Tong University School of Medicine(SJTUSM)from 2015 to 2023,and to summarize the strategies for improving clinical research capability of SJTUSM,aiming to provide reference and inspiration for medical universities to promote high-level clinical research.Methods·Papers published by first authors from SJTUSM or its affiliated hospitals during this period were retrieved in the Web of Science core collection database.General descriptive methods were used to quantify the number of clinical research papers,registered clinical trials,clinical research talent teams,and the current status of clinical research cooperation.Bibliometric methods were used to visualize the international collaboration and topic distribution of retrieved clinical research papers.The differences in the number of clinical research publications,Q1 publications,publications in top clinical medical journals,and full-time researchers between the periods of 2015?2018 and 2019?2023 were compared and analyzed.Results·From 2015 to 2023,a total of 9 468 clinical research papers were published by SJTUSM or its affiliated hospitals as the first author's institution,showing an increasing trend year by year.During this period,the number of Q1 publications of SJTUSM's clinical research,publications in top clinical medical journals,clinical studies registered on the United States Clinical Trial Registry website,clinical studies registered on the Chinese Clinical Trial Registry website,clinical guidelines and expert consensus publications,full-time research team members,and newly added national-level talents all showed an overall upward trend.Tumors,cardiovascular and cerebrovascular diseases,major chronic diseases,and mental illnesses were the main research hotspots.A total of 1 308 papers(13.82%)were international collaborative papers.Developed countries/regions such as the United States(733 papers),Australia(137 papers),and the United Kingdom(99 papers)were closely cooperating with SJTUSM.From 2019 to 2023,there was a significant increase in the number of clinical research papers,Q1 publications,publications in top clinical medical journals,and newly added full-time research team members in affiliated hospitals compared to the period from 2015 to 2018(all P<0.05).Conclusion·SJTUSM has strengthened top-level design,conducted in-depth major diseases,and constructed a systematic,integrated and closed-loop model for enhancing clinical research level along the"platform-talent-methodology"pathway,resulting in a number of high-quality clinical research outcomes.

Purpose/Significance To solve the problem that regional clinical research data are difficult to integrate efficiently,and to promote"Chinese evidence"and"Chinese protocol"in the global clinical research community.Method/Process Based on the standard-ization theory,the data standardization system is proposed,and the construction and application methods of the regional clinical research data platform are explored with the integration of multi-center clinical research data as the starting point.Result/Conclusion The theo-retical framework of the regional clinical research data platform has been preliminarily established,and the clinical research capabilities of tertiary hospitals in Shanghai have been significantly improved.

Objective:To investigate the different types of renal artery involvement in Stanford type B aortic dissection (TBAD) and the comparison of clinical effecacy after thoracic endovascular aortic repair (TEVAR).Methods:This is a retrospective cohort study included 330 patients with TBAD and renal artery involvement treated with TEVAR from June 2002 to September 2021 in General Hospital of Northern Theater Command of the PLA. According to aortic CTA image, unilateral renal artery involvement conditions were divided into 5 types: the true lumen type (renal artery opening completely from the true lumen), false lumen type (renal artery opening completely from the false lumen), double lumen type (renal artery opening from the true and false double lumen), compression type (renal artery opening connected with the true lumen, but the renal artery opening was extremely squeezed by the inner membrane), open type (renal artery opening with intimal tear). There were seven types of bilateral renal artery involvement: true-true type (true lumen-true lumen type), true and false type (true lumen-false lumen type), true-double type (true lumen-double lumen type), true-opening type (true lumen-opening type), false-false type (false lumen-false lumen type), false-compression type (false lumen-compression type), double-double type (double lumen-double lumen type). The primary observation index of this study was the comparison of postoperative renal function and the incidence of clinical adverse events of different types of renal artery involvement. One-way ANOVA test, Kruskal-Wallis H test and paired sample rank sum test were used to compare postoperative renal function between different types of bilateral renal artery involvement. The Chi-square test or Fisher′s exact probability test were used to compare the near and long term adverse events between different types of bilateral renal artery involvement. Kaplan-Meier method was used to compare the all-cause mortality of patients with severe renal functional injury and non-severe renal functional injury before surgery. Results:The average age of the patients included in this study was (53±11) years, including 276 males (83.6%) and 54 females (16.4%). There were statistical difference in the level of serum creatinine (preoperative: H=18.686, P=0.005, postoperative: H=18.101, P=0.006) and cystatin C (preoperative: H=17.566, P=0.007, postoperative: H=10.433, P=0.016), pre-and post-operative, between the seven groups of TBAD patients with different renal artery involvement types ( P<0.05), and the false-false type group shown the worst kidney function. However, no statistically significant differences were shown when comparing their pre- and post-operative change values ( P>0.05). The 30-day follow-up result showed that there were statistically significant differences in the incidence of postoperative acute kidney injury ( χ2=15.623, P=0.007), aorta-related adverse events ( χ2=15.523, P=0.010), and intraoperative endoleak ( χ2=17.935, P=0.004) among the seven groups, and the false-false group was the highest (2/9, 5/9 and 5/9, respectively). In terms of long-term follow-up results, there were statistically significant differences in all-cause death ( χ2=14.772, P=0.011) and non-aortic death ( χ2=15.589, P=0.008) among the seven groups. Kaplan-Meier survival analysis showed that patients with worse pre-operative renal function showed higher long-term all cause death (17.7% vs. 4.8%, P=0.009). Conclusions:For TBAD patients with renal artery involvement, there were differences in renal function among different types, and TEVAR showed no significant effect on renal function in TBAD patients. The long-term all cause death was higher in patients with worse renal function pre-operative.

Objective:To analyze the efficacy of second-line regimens and prognostic factors in patients with first-relapsed multiple myeloma (MM) treated with bortezomib, cyclophosphamide, and dexamethasone (BCD).Methods:A retrospective cohort study. Clinical data were collected in first-relapsed MM patients after BCD treatment from three tertiary hospitals in north China from July 2009 to October 2022. Patients were classified according to the second-line regimen into the immunotherapy group, single novel agent group [either proteasome inhibitor (PI) or immunomodulatory drug (IMiD)], combination treatment group (both PI+IMiD), and traditional treatment group. Responses to second-line regimens and survival data were analyzed. The Kaplan-Meier method was used for survival analysis and the Cox proportional risk model was used for univariate and multivariate analyses.Results:A total of 217 patients were enrolled including 8.8% (19/217) in the immunotherapy group, 48.4% (105/217) in the PI/IMiD group, 29.9% (65/217) in the PI+IMiD group, and 12.9% (28/217) in the traditional treatment group. The median age was 62 years (range 31-83 years) and 56.2% (122/217) were males. The overall response rates (ORRs) in the four groups were 94.7% (18/19) vs. 56.2% (59/105) vs. 73.8% (48/65) vs. 32.1% (9/28) ( χ2=24.55; P<0.001), respectively. The progression-free survival (PFS) of the second-line regimens (2ndPFS) was 17.7 vs. 9.0 vs. 9.2 vs. 4.6 months ( χ2=22.74; P<0.001), respectively, among which patients in the PI/IMiD and PI+IMiD groups had comparable 2ndPFS ( χ2=1.76; P=0.923). Patients with high-risk cytogenetic abnormalities (HRCAs) achieved the longest 2ndPFS of 22.0 months in the immunotherapy group ( χ2=15.03; P=0.002). Multivariate analysis suggested that immunotherapy ( HR=0.11, 95% CI 0.05-0.27), achievement of efficacy of partial response or better ( HR=0.47, 95% CI 0.34-0.66), and non-aggressive relapse ( HR=0.25, 95% CI 0.17-0.37) were independent prognostic factors of 2ndPFS. Conclusion:In this real-world study, immunotherapy was associated with a more favorable efficacy and PFS for first-relapsed MM patients after BCD treatment, with similar outcomes in patients with HRCAs.

China/epidemiology* ; Humans ; Pemphigoid, Bullous/epidemiology* ; Retrospective Studies

Objective:Investigator Initiated Trials (IIT) play a key role in promoting comprehensively the development and homogeneity of clinical diagnosis and treatment, thus, this article aims to explore a set of recommendations for the construction and management of clinical research institutes that support IIT.Methods:Through the combination of literature review and institutional construction practice cases, based on the experience of domestic and foreign universities and well-functioning medical institutions in building clinical research centers, as well as summarizing the construction cases of the clinical research institute of Shanghai Jiao Tong University School of Medicine, to discuss the construction and management plan of such centers.Results:Propose recommendations for the construction and management standards of clinical research centers that support IIT, covering the principles of center construction, basic settings, organizational structure, functional departments, basic platforms, staffing, document management and institutional evaluation.Conclusions:We hope this study can provide reference to universities and medical institutions for the construction of the clinical research institute.

Objective:To survey the status quo of awareness, demands and satisfaction of Traditional Chinese Medicine (TCM) service among the elderly residents in nursing home.Methods:A randomized survey on the status quo of TCM service was conducted from May to July 2019 among 237 elderly in 9 long-term care facilities close to a TCM hospital in Pudong New Area. The awareness, demands, satisfaction and influencing factors were analyzed.Results:Among 237 participants, only 1(0.4%)knew the TCM and its care well, however, 195 (82.3%) showed demands of TCM service. There were significant differences in the scores of demands and satisfaction of TCM among participants with different age, education level, marital status, medical insurance and health level ( P<0.05). Among the 16 TCM services, the three with top demand scores were acupoint massage (3.54±1.21), TCM health education (3.29±1.08), TCM drug iontophoresis (3.23±1.26); the three with top satisfaction scores were TCM health education (3.38±0.94), traditional health exercise (3.33±0.95), moxibustion (3.32±1.15). The demands and satisfactory were most correlated with each other in the guidance TCM medication ( r=0.996) and TCM herb tea ( r=0.988); and least correlated in the identification of TCM constitution ( r=0.305) and acupoint massage ( r=0.484). Conclusions:Among the elderly in long-term care facilities the awareness of TCM is at a low level, while the demands of TCM service are high. It is necessary to promote TCM service for elderly in long-term care facilities through TCM health education and developing the TCM products and appropriate techniques.

Objective:To analyze the arsenic exposure of industrial residents and its influencing factors, so as to provide scientific basis for protecting the health of industrial residents.Methods:In 2017, the samples of PM 2.5, drinking water and soil were collected by using cross-sectional survey and were tested for arsenic contents in Xigu District, Lanzhou City. The environmental arsenic exposure was analyzed by using Environmental Protection Agency of USA health risk assessment models. The levels of urinary arsenic and blood arsenic were measured in residents who included adults, children and teenagers. The internal exposure level of arsenic and its influencing factors were analyzed. The correlation between arsenic and internal and external exposure factors were also analyzed. The content of arsenic was expressed by geometric mean. Results:A total of 84 samples of PM 2.5 were collected, and the content of air arsenic was 7.53 ng/m 3. A total of 108 samples of drinking water were collected, and the content of water arsenic was 0.002 2 mg/L. A total of 40 samples of soil were collected, and the content of soil arsenic was 0.14 mg/kg. The total non-carcinogenic risk of environmental arsenic was 0.39, which was lower than the acceptable level of non-carcinogenic risk (1.00). The total carcinogenic risk of environmental arsenic was 6.59 × 10 -5. The total carcinogenic risk of arsenic was the highest through drinking water exposure and followed by the respiratory inhalation exposure, accounting for 78.60% [(5.18 × 10 -5)/(6.59 × 10 -5)] and 20.79% [(1.37 × 10 -5)/(6.59 × 10 -5)] of the total carcinogenic risk of environmental arsenic, respectively. There were 135 subjects, and 135 blood samples were collected. The content of blood arsenic was 0.92 μg/L. The level of blood arsenic of adults (1.05 μg/L) was higher than that of children and teenagers (0.75 μg/L, U = - 3.594, P < 0.05). One hundred and thirty-five urinary samples were collected, and the content of urinary arsenic was 14.17 μg/L. There was a positive correlation between urinary arsenic and blood arsenic ( r = 0.357, P < 0.05). Blood arsenic levels were positively correlated with the total carcinogenic risk and the risk of carcinogenesis through respiratory, oral and skin exposures ( r = 0.252, 0.244, 0.255, 0.255, P < 0.05). Conclusion:Arsenic in the environment of industrial areas has a potential carcinogenic risk to the residents, so the intake of arsenic in drinking water through oral exposure and respiratory inhalation exposure should be limited.

Objectives:To cross-sectionally analyze the clinical characteristics of primary antiphospholipid syndrome (PAPS) patients with thrombocytopenia, risk factors associated with thrombocytopenia, and risk of symptom recurrence in these patients.Methods:The inpatients with PAPS were retrospectively analyzed in Peking Union Medical College Hospital from 2009 to 2019. Using the collected clinical and laboratory data, the clinical characteristics and risk of symptom recurrence in the PAPS patients with thrombocytopenia were compared with those in the PAPS patients with normal platelet counts. Univariate and multivariate logistic regression analyses were performed to screen the risk factors for thrombocytopenia.Results:In this study, 127 patients with PAPS were enrolled, of which 36 (28.3% ) had thrombocytopenia, with a median age of 38 years, and 63.9% were female. In the thrombocytopenia group, the average platelet count was (58.9±27.0) ×10 9/L, and the prevalence of thrombosis and morbid pregnancy was not significantly different from that in the normal platelet group. However, the thrombocytopenia group had higher incidence rate of autoimmune hemolytic anemia (19.4% vs 3.3% ) , livedo reticularis (16.7% vs 3.3% ) , chronic kidney disease (25% vs 8.8% ) and antiphospholipid antibodies triple positiveness (61.1% vs 37.4% ) , lower complement levels (C3 of 0.87 g/L vs 1.07 g/L, C4 of 0.12 g/L vs 0.18 g/L, P<0.05) , and higher adjusted Global APS Score (median score of 13 vs 9, P=0.037) than the normal platelet group. In multivariate logistic regression analysis, hypocomplementemia ( OR value 5.032, 95% CI 3.118-22.095) is an independent risk factor for thrombocytopenia. Conclusions:In patients with PAPS, thrombocytopenia is mostly mild to moderate. Hypocomplementemia may be the independent risk factor for thrombocytopenia in PAPS patients. The PAPS patients with thrombocytopenia may have a higher risk of symptom recurrence.