Anticoagulant effectiveness and safety of new oral anticoagulants versus warfarin after heart valve replacement ： a meta-analysis / 中国药房

OBJECTIVE To compare the anticoagulant effectiveness and safety of new oral anticoagulants （NOACs）and warfarin after heart valve replacement ，and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed，Cochrane Library ，Embase，Web of Science ，CNKI，Wanfang database and VIP ，clinical studies about the use of NOACs versus warfarin after heart valve replacement were collected during the inception to July 2021. After literature screening and data extrac tion，the quality of included randomized controlled trials （RCTs）were evaluat ed by bias risk assessment tool recommended by Cochrane system evaluator manual 5.2.0. After the quality of the included cohort studies was evaluated by Newcastle-Ottawa scale （NOS），RevMan 5.3 software was used for meta-analysis and sensitivity analysis. RESULTS A E-mail：carolmeng_0813@163.com total of 9 studies involving 4 962 patients were included ，of which 7 were RCTs and 2 were cohort studie s. Results of meta-analysis showed that after biological valve replacement/repair ，the incidence of stroke and systemic embolism （SSE）[OR＝0.71，95％CI（0.52，0.97），P＝0.03]，major bleeding [OR ＝0.40，95％CI （0.30，0.54），P＜0.000 01] and intracranial hemorrhage [OR ＝0.20，95％CI（0.04，0.95），P＝0.04] in trial group were significantly lower than warfarin group ；there was no significant difference in all-cause mortality between 2 groups [OR ＝1.25，95％CI（0.88， 1.79），P＝0.22]. After mechanical valve replacement/repair ，there were no significant difference in the incidence of SSE [OR ＝1.52， 95％CI（0.04，60.29），P＝0.82] or all-cause mortality [OR ＝0.26，95％CI（0.04，1.84），P＝0.18] between 2 groups. The results of subgroup analysis according to the follow-up time showed that after biological valve replacement/repair ，the incidence of SSE in trial group was significantly lower than that in control group when the follow-up time was ≤3 months [OR ＝0.20，95％CI（0.06， 0.74），P＝0.03]；but there was no significant difference in the incidence of major bleeding between 2 groups [OR ＝0.67，95％CI （0.19，2.38），P＝0.53]；when the follow-up time was longer than 3 months，there was no statistical significance in the incidence of SSE between 2 groups [OR ＝0.74，95％CI（0.54，1.02），P＝0.07]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.39，95％CI（0.29，0.52），P＜0.001]. Subgroup analysis by study type showed that after biological valve replacement/repair ，the incidence of SSE in the RCT in trial group was significantly lower than that in control group [OR ＝0.51，95％CI（0.29，0.92），P＝0.03]，but there was no significant difference in the incidence of major bleeding between 2 groups[OR＝0.58，95％CI（0.33，1.03），P＝0.06]. In cohort study ，there was no significant difference in the incidence of SSE between 2 groups [OR ＝1.03，95％CI（0.40，2.66），P＝0.95]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.20，95％CI（0.06，0.74），P＜0.001]. Sensitivity analysis results showed that the results of the above-mentioned meta-analysis were relatively robust. CONCLUSIONS For the patients underwent biological valve replacement/repair，the effectiveness and safety of NOACs are better than or similar to those of warfarin ；for the patients underwent mechanical valve replacement/repair ，there is no significant difference in the effectiveness and safety between NOACs and warfarin.

Clinical characteristics, imaging phenotypes and events free survival in Takayasu arteritis patients with hypertension.

BACKGROUND: Hypertension occurred in 30-80% of Takayasu arteritis (TAK) patients around the world and the occurrence of hypertension might worsen the disease prognosis. This study aimed to investigate the clinical characteristics and imaging phenotypes, as well as their associations with events free survival (EFS) in Chinese TAK patients with hypertension. METHODS: This current research was based on a prospectively ongoing observational cohort-the East China Takayasu Arteritis (ECTA) cohort, centered in Zhongshan Hospital, Fudan University. Totally, 204 TAK patients with hypertension were enrolled between January 2013 and December 2019. Clinical characteristics and imaging phenotypes of each case were evaluated and their associations with the EFS by the end of August 30, 2020, were analyzed. RESULTS: Severe hypertension accounted for 46.1% of the entire population. Three specific imaging phenotypes were identified: Cluster 1: involvement of the abdominal aorta and/or renal artery (27.5%); Cluster 2: involvement of the ascending aorta, thoracic aorta, the aortic arch, and/or its branches (18.6%); and Cluster 3: combined involvement of Cluster 1 and 2 (53.9%). Clinical characteristics, especially hypertensive severity, differed greatly among the three imaging clusters. In all, 187 patients were followed up for a median of 46 (9-102) months; 72 events were observed in 60 patients (1-3 per person). The overall blood pressure control rate was 50.8%, and the EFS was 67.9% by the end of the follow-up. Multivariate Cox regression indicated that controlled blood pressure (HR = 2.13, 95% CI 1.32-3.74), Cluster 1 (HR = 0.69, 95% CI 0.48-0.92) and Cluster 3 (HR = 0.72, 95% CI 0.43-0.94) imaging phenotype was associated with the EFS. Kaplan-Meier curves showed that patients with controlled blood pressure showed better EFS (p = 0.043). Furthermore, using cases with Cluster 1 imaging phenotype and controlled blood pressure as reference, better EFS was observed in patients with Cluster 2 phenotype and controlled blood pressure (HR = 2.21, 95%CI 1.47-4.32), while the case with Cluster 1 phenotype plus uncontrolled blood pressure (HR = 0.64, 95%CI 0.52-0.89) and those with Cluster 3 phenotype and uncontrolled blood pressure (HR = 0.83, 95%CI 0.76-0.92) suffered worse EFS. CONCLUSION: Blood pressure control status and imaging phenotypes showed significant effects on the EFS for TAK patients with hypertension.

Improved clinical outcomes of tocilizumab versus cyclophosphamide for IgG4-related disease: insights from a prospective IgG4-related disease registry.

OBJECTIVE: To compare the clinical outcomes of patients with active immunoglobulin G (IgG) 4 related disease (IgG4-RD) receiving tocilizumab versus those receiving cyclophosphamide (CYC). METHODS: This IgG4-RD registry study was a prospective cohort study conducted among patients with active IgG4-RD hospitalized at Zhongshan Hospital, Fudan University. Patients who were treated with tocilizumab or CYC along with glucocorticoids (GCs) were enrolled. All participants were followed up at the hospital clinic at 3 and 6 months after discharge. Primary clinical outcomes were measured via the IgG4-RD responder index (RI), complete response (CR), and partial response (PR), as well as side effects. RESULTS: From January 2015 to June 2020, 29 patients enrolled. Fourteen and 15 patients were treated with tocilizumab and CYC, respectively. At the 6-month follow-up, disease activity parameters including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), IgG4, and IgG4-RD RI, decreased significantly in both groups. At 6 months, tocilizumab demonstrated its superiority, with 50% of patients achieving CR in the Tocilizumab group versus 20% in the CYC group. However, no statistical significance was identified (p = 0.128). The GC dosage at 6 months was significantly lower in the tocilizumab group than in the CYC group [10 (9.4-15) mg/d versus 15 (15-15) mg/d, p = 0.025]. In the CYC group, two patients experienced lumbar vertebral compression fractures related to GCs. Other patients in both groups showed mild adverse effects. CONCLUSIONS: Tocilizumab could be a better steroid-sparing agent, with a comparable curative effect and tolerance, than CYC, in the treatment of IgG4-RD.

Effect of hydroxychloroquine on angiographic progression in routine treatment of Takayasu arteritis.

OBJECTIVES: Hydroxychloroquine (HCQ), an anti-malarial drug, is widely used in the treatment of rheumatic diseases. However, the benefits of HCQ in the treatment of Takayasu arteritis (TA) remain unclear, especially in terms of alleviation of vascular progression. METHODS: This longitudinal observational retrospective study was based on the East China TA cohort. Patients received routine treatment with prednisone and immunosuppressants. Fifty TA patients who underwent magnetic resonance angiography two times within a 1.5-year follow-up period of monitoring vascular changes were divided into HCQ and non-HCQ groups according to whether HCQ was prescribed. Changes in angiographic features were compared. Multivariate Cox regression analysis was employed to further validate the results. RESULTS: Of 50 TA patients, 21 were prescribed HCQ. The two groups shared a similar disease course, vascular types, prednisone with immunosuppressants intervention strategy, globin level, and disease remission rate at 6 months. The HCQ group showed greater reduction in the inflammatory indices erythrocyte sedimentation rate and C-reactive protein (CRP) level (p < .05), and a significantly lower incidence of angiographic progression than the non-HCQ group (19.0% vs. 51.7%, p = .035). After adjustment for age and usage of tocilizumab, angiographic progression was found to be independently associated with CRP (hazard ratio [95% confidence interval], HR [95% CI]: 1.102 [1.000-1.024], p = .046), and the usage of HCQ (HR [95% CI]: 0.266 [0.075-0.940], p = .040). CONCLUSION: HCQ enhanced the anti-inflammatory effect of routine treatment strategies with prednisone and immunosuppressants, and alleviated angiographic progression in TA.

Clinicial features of Takayasu arteritis: a cohort study / 中华风湿病学杂志

Objective:To analyze the characteristics of patients with Takayasu arteritis (TA) in the east China Takayasu arteritis (ECTA) cohort and their subgroups, and evaluate the disease characteristics.Methods:Patients diagnosed with TA in ECTA cohort from January 2009 to October 2019 were enrolled and their data were analyzed. The characteristics were analyzed and compared within subgroups using t-test or Wilcoxon rank sum test or Chi-square test. Results:A total of 454 patients were included, with the male to female ratio of 1∶4.75(79/375), and the main complaint were dizziness/headache, fatigue, and chest tightness/pain. The type Ⅴ and Ⅰ were the most common angiographic pattern, among which the subclavian artery and carotid artery were most vulnerable, manifested as vascular stenosis. Hypertension, tuberculosis and hepatitis B were common complications. In subgroup comparison, symptoms and inflammation index were much more evident in the active group, female group, <40 years old, and newly diagnosed group. C-reactive protein (CRP)[10(2, 33) mg/L vs 3(1, 14) mg/L, Z=-4.49, P<0.01), erythrocyte sedimentation rate (ESR) [(45±33) mm/1 h vs (25±23) mm/1 h, t=-5.82, P<0.01), in the active group were significantly higher than those in the inactive group, while the ESR in female patients was only higher than that in males, but without statistical significant difference. SAA in the young age group, ESR in the newly diagnosed group was significantly higher than that in the other subgroups [19(6, 95) mg/L vs 10(4, 39) mg/L, Z=2.06, P<0.05] [(44±34) mm/1 h vs (32±28) mm/1 h, t=3.77, P<0.01]. Conclusion:The TA patients are mainly young women, and are in active disease when first being diagnosed. The type Ⅴ and Ⅰ are the most common artery involve-ment pattern. Hypertension and tuberculosis are the most frequent complications.

Study on the value of different diagnostic/classification criteria for the diagnosis of Takayasu's arteritis / 中华风湿病学杂志

Objective:To compare the diagnostic efficacy of Chinese diagnostic model, the 1990 American College of Rheumatology (ACR) classification criteria and the 2018 ACR new classification criteria (draft) for Takayasu arteritis (TA).Methods:A total of 196 TA patients who came to our hospital from January 1, 2009 to May 31, 2019 in the TA database of the department of rheumatology and immunology, Zhongshan Hospital, Fudan University and 131 patients with other vascular diseases visited during the same period were selected. General characteristics, clinical data, laboratory tests and imaging tests of all patients were collected. Categorical variables were presented as numbers and percentages, between-group differences were analyzed using the χ2 test. Continuous variables were presented as the Mean± SD for a normal distribution or median and interquartile range (IQR) for a non-normal distribution. Between-group differences were analyzed using the Student's t-test or Mann- Whitney test, as appropriate. The sensitivity, specificity, positive predictive value, negative predictive value, accuracy and receiver operating characteristics of the above diagnostic/classification criteria area under the curve were analyzed. P<0.05 was considered significant. Results:In terms of sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and area under receiver operating characteristic curve (ROC), Chinese diagnostic models was 85.7%, 96.2%, 89.9%, 97.1%, 81.5%, 0.909, 1990 ACR criteria was 47.4%, 97.7%, 67.6%, 96.9%, 55.4%, 0.726, 2018 ACR classification criteria was 79.1%, 98.5%, 86.5%, 98.7%, 75.9%, 0.888. The difference between the Chinese diagnostic model and the 2018 ACR criteria in AUC was not statistically significant ( Z=1.186 , P>0.05). The sensitivity, accuracy and diagnostic efficiency of Chinese diagnostic model was the best, that of the 1990 ACR classification criteria was the worst, and the specificity of the 2018 ACR classification criteria was the highest. The Kappa value of the 2018 ACR classification criteria and the Chinese diagnostic model was 0.719, which had good consistency, and the Kappa value of the consistency between the 1990 ACR classification criteria and the Chinese TA diagnostic model was 0.516. Conclusion:The Chinese diagnostic model, which is based on the clinical characteristics of the Chinese TA population, has a good diagnostic efficacy for the Chinese population. The 2018 ACR classification criteria (draft) is highly consistent with the Chinese TA diagnostic model, and can be promoted and applied in practice.

Clinical significance of PCT,DD,and CRP levels in patients with infection in acute-on-chronic liver fail-ure / 实用医学杂志

Objective To investigate the clinical diagnostic value of serum procalcitonin(PCT),D-dimer (DD),C-reactive protein(CRP)in acute-on-chronic liver failure(ACLF). Methods 124 ACLF patients, 63 chronic hepatitis B patients,32 chronic hepatitis C patients,24 chronic hepatitis E patients and 60 healthy controls from the second affiliated hospital of Nanchang University were enrolled in this study.PCT was detected by a sandwish immunodetection method. D-dimer was detected by Latex Turbidimetry. CRP was detected by rate nephenometry. The detection results were used for analyzing the clinical diagnostic value of ACLF with infection. Results(1)The level of PCT,DD and CRP in ACLF group were significantly higher than non-ACLF group and healthy controls(P<0.05).The levels of PCT,DD and CRP in the infection group were significantly higher than non-infection group(P<0.05).(2)The positive rates of PCT,DD and CRP in the infection group were 93.24%, 78.38%,89.19%,which were significantly higher than the non-infection group and healthy controls respectively (P < 0.05).(3)The sensitivity(93.24%)and specificity(90.00%)of PCT were the highest among all indexes. (4)The area under the ROC curve of PCT,DD,CRP were 0.892,0.715,0.755,respectively.PCT had the highest diagnostic value. Conclusion The levels of serum PCT,DD and CRP have a significant clinical value for the early diagnosis of ACLF with infection.

Effects of different doses of aspirin on renal function in elderly patients with cardiovascular disease / 中国生化药物杂志

Objective Aspirin is a non steroidal anti-inflammatory drugs, whether or not which does harm to renal function in the course of using, there is a big debate at home and abroad.In this paper, The aim of this study was to observe the effects of different doses of aspirin on renal function in elderly patients with cardiovascular disease at different ages.MethodsWe Selected a total of 288 patients with cardiovascular disease from January 2014 to March 2016 in Zhejiang Rongjun hospital.There were 288 cases of cardiovascular disease, including 144 cases of normal uric acid, 144 cases with hyperuricemia (including gout).The two groups according to the age of 60 to 70 years, 71 to 80 years old, over 80 years old respectively into three subgroups, each subgroup of 48 cases;Each subgroup was randomly selected without the use of aspirin (0mg/d) and the use of different doses of aspirin (50mg/d, 100mg/d, 150mg/d) for a total of four groups, each which is 12 patients.We detect patients routine blood tests, liver and kidney function, blood urea nitrogen (BUN), blood creatinine (SCR) levels and glomerular filtration rate (GFR) (MDRD) and blood and urine beta 2-microglobulin used aspirin before and used after 6 months and 12 months.ResultsBefore treatment, there were no significant differences in body mass index (BMI), blood pressure, hemoglobin, serum albumin and platelet count between various groups of the same age group.After treatment for 6 and 12 months,Uric acid normal patients and high uric acid patients with 0mg/d, 50mg/d, 100mg/d or 150mg/d dose of aspirin has no statistical difference in BUN, Scr and eGFR, 2-microglobulin Ccr, blood, urine beta 2-microglobulin.ConclusionRegardless of uric acid, different doses of aspirin had no significant effect on renal function in elderly patients with cardiovascular disease, and can be safely used.