Objective:Evaluate the safety of the bioresorbable scaffold (BRS) series implanted.Methods:This is a cohort study, which included 377 patients with acute coronary syndrome (ACS) who underwent elective percutaneous coronary intervention (PCI) with Neovas-BRS implantation from July 2019 to April 2022 at the Northern Command General Hospital. The patients were divided into the series BRS group ( n=63) and single BRS group ( n=314). We compared PCI related data between two groups, as well as all-cause death, cardiac death, non-fatal myocardial infarction, target vessel revascularization, stroke, and bleeding of type 2 to 5 defined by the Bleeding Academic Research Consortium of America (BARC) during follow-up. We also compared the major adverse cardiovascular and cerebrovascular events (MACCE), which includes all-cause death, non-fatal myocardial infarction, target vessel revascularization and stroke, as well as the net adverse clinical events (NACE), which includes MACCE and bleeding of BARC type 2 to 5. Procedural immediate success was defined as a residual stenosis of<20% with successful stent implantation and post-PCI target vessel flow grade up to TIMI 3. The images of 11 patients in the series BRS group who underwent optical coherence tomography (OCT) were analyzed. Results:A total of 377 patients were finally enrolled, aged (52.5±10.7) years, including 80.4% (303/377) males . The immediate success rate of PCI was 100% in both groups. The number of ≥50% stenotic lesions, number of target vessels, SYNTAX score, number of post-application expansion balloons, number of guidewires, total stent length, contrast volume and operation time were higher in the series BRS group than in the single BRS group (all P<0.05). There was no significant difference in the proportion of intravascular ultrasound and OCT application between the two groups. One patient in the single BRS group had an ischemic stroke during postoperative hospitalization, but there were no death, non-fatal myocardial infarction, target vessel revascularization, or BARC 2 to 5 bleeding events occurred during hospitalization in both groups. Follow up time was 352.0 (193.0, 421.0) days. There was no statistically significant difference between the two groups in the incidence of all-cause death (0 vs. 0.6% (2/314), P=1.000), cardiogenic death (0 vs. 0.3% (1/314), P=1.000), nonfatal myocardial infarction (0 vs. 1.0% (3/314), P=1.000), target lesion revascularization (3.2% (2/63) vs. 1.6% (5/314), P=0.736), BARC type 2 to 5 bleeding (3.2% (2/63) vs. 5.7% (18/314), P=0.604), MACCE (3.2% (2/63) vs. 2.9% (9/314), P=0.894), and NACE (6.3% (4/63) vs. 8.6% (27/314), P=0.553) during the follow-up period. OCT results of the 11 (17.5%) patients in the series BRS group indicated that 3 patients (27.3%) achieved non-overlapping connection, and the immediate stent expansion rate was (95.47±0.04) %. In 8 patients with BRS overlapping connections, immediate stent expansion rate was (90.32±0.44) %. Conclusion:In patients with low to intermediate-risk ACS, serial implantation of RBS in long coronary lesions is safe and feasible, and achieves the similar short-term outcomes as single BRS implantation.

  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 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.

Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.

Objective:To investigate the clinicopathological features and prognostic factors of primary mediastinal large B-cell lymphoma (PMBL).Methods:The clinical data of 60 patients with PMBL including 44 biopsy cases and 16 consultation cases from September 2000 to November 2019 in the Department of Pathology, China-Japan Friendship Hospital (14 cases) and Peking Union Medical College Hospital (46 cases) were enrolled. Pathologic features, immunophenotype, immunoglobulin (Ig) gene rearrangement and microRNA expression profile were retrospectively studied.Results:Of the 60 patients, 23 were males and 37 were females, age ranged from 15 to 64 years (median 28 years). Immunohistochemical staining showed that the tumor cells were positive for pan-B cell antigens, CD30 (77.4%, 24/31), CD23 (73.1%, 19/26), MUM1 (45.8%, 11/24), Ki-67 index ≥70 % (90.6%, 29/32). EBER in situ hybridization was analyzed in 21 PMBL, only one case (4.8%) was positive. Ig gene rearrangement was performed in 20 cases, and seven were positive (35.0%). MicroRNA gene expression profiles were analyzed in seven cases of PMBL and nine cases of diffuse large B-cell lymphoma, and there were 33 microRNAs with significant difference ( P<0.05). Univariate analysis indicated that the poor prognostic factors included serum lactate dehydrogenase (LDH) level,International Prognostic Index (IPI) score ≥3, stages Ⅲ-Ⅳ, chemotherapy not combined with rituximab and MUM1 positivity ( P<0.05). Multivariate analysis showed that the treatment combined with rituximab was independently related to prognosis ( P<0.05). Conclusions:PMBL is different from diffuse large B-cell lymphoma in clinicopathologic features, immunophenotypic presentation and molecular features. The prognostic factors, molecular genetics and immunological characteristics reveal that this study has enriched our understanding of the biology of PMBL, thus providing evidence and strategies for treatment.

Objective:To explore clinical predictive value of short-term dynamic changes in platelet counts (PLT) for prognosis of sepsis patients in intensive care unit (ICU).Methods:A retrospective cohort study was conducted. The patients aging 18 to 80 years old who were diagnosed by Sepsis-3 admitted to ICU of South Branch of Shanghai General Hospital from November 2015 to October 2018 were enrolled. According to whether the patients died within 28 days, they were divided into death and survival groups. General information and clinical baseline data [including disease severity score, infection biomarkers, PLT and organ function parameters (cardiac, liver, kidney, coagulation) and inflammatory cytokines] between the two groups were compared. Based on clinical indicators which had statistically significance, receiver operating characteristic (ROC) curve was drawn to predict the prognosis of the patients within 28 days. Then, risk factors of 28-day mortality of sepsis patients in ICU were screened by univariate and multivariate Logistic regression analysis. On the basis of multivariate Logistic regression analysis results, a multiparameter model was built, and the ROC curve was drawn to predict its prognosis within 28 days.Results:A total of 220 sepsis patients were enrolled. Among them, 61 patients died and 159 patients survived within 28 days with a 28-day mortality of 27.7%. Compared with the survival group, the patients in the death group were senior in age, more likely to suffer from chronic cardiovascular, chronic kidney and immune system disease, had higher scores in acute physiologic and chronic health evaluation Ⅱ (APACHEⅡ) score, sequential organ failure assessment (SOFA) score, disseminated intravascular coagulation (DIC) score and less PLT on the 1st and 7th day, sustained a higher incidence of persistent thrombocytopenia (PLT were all < 100×10 9/L in the first week after ICU admission) or acquired thrombocytopenia (PLT ≥ 100×10 9/L on the day of ICU admission, but dropped over 50% during the first week after ICU admission), were subjected to higher procalcitonin (PCT) and interleukin-6 (IL-6) levels and endured worse organ function (cardiac, kidney, coagulation) with statistically significant differences. However, there was no significant difference in gender, disease type, infection sites, pathogens or liver function. The ROC curve analysis for the 28-day prognosis of sepsis illustrated that the three disease severity scores could predict the 28-day prognosis of sepsis in ICU, and the area under ROC curve (AUC) of SOFA score was the highest (AUC = 0.878). The AUC of PLT on the 7th day was higher than that on the 1st day (AUC: 0.862 vs. 0.674), and the AUC of other clinical indicators were all < 0.8. Univariate and multivariate Logistic regression analysis showed that SOFA score [odds ratio ( OR) = 1.423, 95% confidence interval (95% CI) was 1.089-1.859, P = 0.010], troponin I (TnI; OR = 2.056, 95% CI was 1.057-3.999, P = 0.034), and persistent or acquired thrombocytopenia ( OR = 13.028, 95% CI was 4.033-42.090, P < 0.001) were three independent risk factors for 28-day mortality of the sepsis patients in ICU. Based on the multivariate Logistic regression analysis results, a multiparameter model was built with SOFA score, TnI and persistent or acquired thrombocytopenia, which showed a AUC of 0.926 to predict the 28-day mortality of sepsis patients in ICU. When the optimum cut-off value was 0.398 in the model, the sensitivity was 76.8%, and the specificity was 92.8%. Conclusions:Persistent or acquired thrombocytopenia within the first week of hospitalization proves to have a relatively momentous clinical predictive value for prognosis of sepsis patients in ICU. Clinical intervention focusing on thrombocytopenia may become a new potential therapy for these sepsis patients.

Objective:To investigate the factors affecting the outcome of surgical treatment for femoral intertrochanteric fractures.Methods:A retrospective case series study was conducted for 424 patients with intertrochanteric fractures admitted to four hospitals in Shanghai from January 2014 to December 2016. There were 200 males and 224 females, aged 45-98 years [(77.8±10.5)years]. Normal union was observed in 326 patients (normal union group), and abnormal union was founded in 98 patients including nonunion in 2 patients (abnormal union group). Data were recorded including the age, gender, injury side, AO classification, Evans-Jesen classification, thickness of femoral lateral wall, medial support, tip-apex distance, and screw position within the femoral head. Fracture healing was assessed. Univariate analysis was conducted to examine differences of the above factors between two groups, and Logistic regression was used to screen the main factors affecting fracture union. At the latest follow-up, the hip joint function was estimated according to the Oxford score system.Results:All patients were followed up for 1-3 years [(2.2±0.3)years]. Univariate analysis showed significant differences between two groups regarding the AO classification, Evans-Jesen classification, medial support, tip-apex distance, and screw position within the femoral head ( P<0.05). Multivariate regression analysis revealed that the simple fracture ( OR=1.030), medial support ( OR=0.395), tip-apex distance ≤25 mm ( OR=0.266) and inferior screw position ( OR=0.986) were significantly related to fracture union. The hip function in normal union group was (42.6±4.5)points, better than (35.4±3.2)points in abnormal union group ( P<0.05). Conclusion:The stability of intertrochanteric fracture is the most important factor for fracture union. The medial support, tip-apex distance ≤25 mm and inferior screw position are helpful to promote fracture healing and recovery of hip joint function.

Objective:To investigate the relationship of Castleman disease (CD) and connective tissue disease (CTD).Methods:Clinical records and laboratory data of 11 patientsdiagnosed with CD and CTD were collected and retrospectively analyzed. All patients were diagnosed at Peking Union Medical College Hospital.Results:① The proportion of CD associated with or mimicking CTD was 5.67% (11/194) in all CD patients during the same period. The average age of these cases at the diagnosis was (51±17) years and the ratio of male to female was 6∶5. ② Lymphadenopathy (10/11), fever (8/11), serosal effusion (6/11), arthralgia (5/11), alopecia (2/11), Raynaud phenomenon (1/11) and photosensitivity (1/11) were the common clinical manifest- ations that could mimic CTD. ③ Elevated ESR (11/11), hypoalbuminemia (11/11), elevated CRP (10/11), elevated IgG (7/11), proteinuria (5/11), hematuria (5/11) and positive ANA(5/11) were commonly found in the patients' laboratory tests. ④ CD was inclined to mimic systemic lupus erythematosus(SLE)(5/11), IgG4-related disease(IgG4-RD)(2/11) and adult onset Still's disease(AOSD)(2/11), as well as 2 cases were associated with Sj?gren's Syndrome(SS)(2/11). ⑤All cases were ultimately diagnosed as multicentric CD, the pathologic subtypes were plasma cell variant (10/11) and mixed(1/11) respectively.Conclusion:CD maybe overlapped with or mimic a variety of clinical manifestations, such as fever, serosal effusion, arthralgia and proteinuria which could mimic CTD. Early biopsy is helpful for the diagnosis and to avoid misdiagnosis and mistreatment.

Three cases of flagellate shiitake mushroom dermatitis caused by Pleurotus ostreatus, Auricularia auricula, and Flammulina velutipes respectively were reported. Case 1, a 45-year-old male patient, developed multiple flagellate erythematous patches and papules on the trunk, axillae and abdomen without any subjective discomfort 8 hours after ingestion of a large amount of grilled Pleurotus ostreatus. Case 2, a 33-year-old female patient, developed multiple flagellate erythematous patches with mild swelling and itching on the back 1.5 days after consuming a fresh Auricularia auricula salad, and millet-sized papules were densely distributed on the erythematous patches. Case 3, a 54-year-old female patient, developed cord-like, flagellate edematous erythema and papules on the neck, trunk and proximal extremities 72 hours after consuming Flammulina velutipes. Histopathological examination of the dorsal lesions in case 3 showed epidermal spongiosis, intraepidermal blisters, papillary dermal edema, superficial dermal vasodilation, erythrocyte extravasation, inflammatory infiltration composed mainly of lymphocytes around dilated blood vessels, and a few scattered eosinophils. The 3 patients were all diagnosed with flagellate shiitake mushroom dermatitis. Case 1 received no treatment, while cases 2 and 3 were symptomatically treated with topical fluticasone propionate ointment, and achieved recovery of skin lesions after 1 week.