Behçet’s syndrome (BS), a chronic vasculitis, leads to recurrent oral ulcers, severely impacting quality of life. Here we report the results of a randomized, double-blind, placebo-controlled trial (NCT04065672) to evaluate the efficacy and safety of low-dose interleukin-2 (LD-IL-2) in BS patients. 60 participants with active oral ulcers are randomly assigned to receive LD-IL-2 or placebo. The primary endpoint is the oral ulcer count at week 12. The LD-IL-2 group has significantly fewer oral ulcers than the placebo group (0.69 ± 1.05 vs. 1.57 ± 0.90, P = 0.001) with greater improvements in ulcer pain, disease activity, and quality of life. No infections or severe adverse events are observed in either group. LD-IL-2 expands regulatory T (Treg) cells and decreased the ratio of effector T cell to Treg cells. Thus, LD-IL-2 therapy might be an effective and safe treatment in BS patients and is associated with the modulation of CD4 + T cell populations. Behçet’s syndrome is a chronic inflammatory disease with oral ulcers being the most common symptom. Here authors present results from a phase 2 randomized double-blind placebo-controlled clinical trial that shows that systemic low dose interleukin-2 could be safely administered to these patients, and the therapy may improve their quality of life.
PROBLEM:Recurrent implantation failure (RIF) remains a significant challenge in reproductive medicine, with immune dysfunction being a key contributing factor to implantation failure. However, data on the effectiveness of immunomodulatory therapy in RIF patients remain limited. This study aimed to assess the impact of immunomodulatory therapy on pregnancy outcomes in women with RIF undergoing in Vitro fertilization-embryo transfer (IVF-ET). METHOD OF STUDY:This retrospective cohort study included women with RIF between 2016 and 2019. Patients in the treatment group received hydroxychloroquine (HCQ)-based immunomodulatory therapy after immunological evaluation, while those in the control group did not receive immunomodulatory treatment. Generalized estimating equations assessed the association between HCQ-based immunomodulatory therapy and pregnancy outcomes. Additionally, patients were stratified based on autoimmune antibody status, and subgroup analyses were conducted to further evaluate treatment effects. RESULTS:A total of 320 patients were included in the study, with 74 receiving HCQ-based immunomodulatory therapy (treatment group) and 246 undergoing IVF-ET alone (control group). The treatment group showed higher biochemical pregnancy (49.5% vs. 31.7%, p < 0.001), clinical pregnancy (43.8% vs. 24.3%, p < 0.001), embryo implantation (30.7% vs. 17.3%, p < 0.001), and live birth rates (33.3% vs. 12.6%, p < 0.001). Multivariate regression identified HCQ-based immunomodulatory therapy as an independent predictor of biochemical pregnancy (OR = 2.049, 95% CI: 1.440-2.915, P<0.001), clinical pregnancy (OR = 2.424, 95% CI: 1.613-3.644, P<0.001), and live birth (OR = 3.555, 95% CI: 2.235-5.652, P<0.001). Stratified analysis confirmed its benefit in both autoimmune antibody positive and negative patients. CONCLUSIONS:Real-world evidence revealed the potential role of HCQ-based immunomodulatory therapy in improving pregnancy outcomes in IVF-ET in patients with RIF.
Abstract Lupus retinopathy (LR) is one of the most frequent and serious ocular complications of systemic lupus erythematosus (SLE), because it may cause irreversible visual impairment. The aim of this study was to evaluate the association between serum anti-retinal antibodies levels of SLE patients and the incidence of LR. Levels of serum anti-α-enolase antibody (Ab), anti-arrestin Ab, anti-recoverin Ab and anti-IRBP3 Ab were detected in 89 SLE patients (divided into LR group and non-LR group) and 81 healthy controls by enzyme-linked immunosorbent assay (ELISA). The correlation between these four anti-retinal Ab, SLE activity and the incidence of LR was evaluated. LR group had a higher SLE disease activity index (average SLEDAI score, 18 (7) versus 9 (5), P < 0.001), higher frequency of pleurisy (40% versus 20.4%, P = 0.044) and lower level of hemoglobin (102.343 ± 23.157 versus 112.759 ± 19.678, P = 0.025) comparing to non-LR group. LR group had higher levels of anti-α-enolase than non-LR group (P = 0.033) and control group (P < 0.0001). The levels of anti-recoverin in LR group was higher than non-LR group (P = 0.036) and control group (P < 0.0001), while the difference was not significant between non-LR group and control group (P = 0.109). Using combination of anti-α-enolase Ab and anti-recoverin Ab to diagnose LR in SLE patients is more effective (with area under the receiver operating characteristic curve (AUC): 72.68%) than use anti-α-enolase Ab (AUC: 65.65%) or anti-recoverin (AUC: 61.96%) only. Our results suggested that anti-α-enolase and anti-recoverin may be used as potential biomarkers of lupus retinopathy in SLE patients.
OBJECTIVE:Idiopathic retroperitoneal fibrosis (RPF) is considered a 'silent disease' due to the lack of distinct disease biomarker. Our purpose was to study characteristic changes in circulating lymphocytes in RPF patients and explore their roles in etiopathogenesis. METHODS:Twenty-three RPF patients were enrolled and followed up for 48 weeks of treatment. Changes of T and B lymphocyte subsets in their peripheral blood were measured, and their associations with disease activity and severity were evaluated. The proliferation, secretion and chemotactic functions of circulating follicular helper T (cTFH) cells were assessed by flow cytometry and RNA sequencing following CD4+ T cell sorting. RESULTS:Among the changed lymphocytes, cTFH cells present a distinct pattern compared with other autoimmune conditions. They were significantly reduced in RPF patients but positively correlated with disease severity and TFH expansion in fibrotic tissues. Remarkably, they were further declined upon disease amelioration, indicating their potential as a disease marker. Further investigation revealed unchanged proliferation and low cytokine secretion in these cTFH cells. Instead, chemokine CXCL13 expression was markedly elevated in CD4+ T cells isolated from both fibrotic tissues and peripheral blood of RPF patients, whereas key cytokines IL-21, IL-6 and Bcl were elevated only in the fibrotic tissues. CONCLUSION:Our findings suggest that cTFH cells in the circulating blood of RPF do not expand but may undergo chemotactic migration to fibrotic tissues, marking a distinct feature of RPF and may serve as a potential biomarker.
This study aimed to evaluate the utility of ANCA specificity as a primary criterion for classifying AAV subtypes to simplify the diagnostic process without compromising accuracy. A retrospective cohort study was conducted involving 310 patients diagnosed with AAV between January 2015 and December 2023 across three tertiary care centers affiliated with Peking University. Patients were reclassified using three methods: the European Medicines Agency (EMA) algorithm, the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) criteria, and ANCA specificity-based classification. Concordance between classification systems was assessed using Cohen’s kappa coefficients. ANCA specificity-based classification demonstrated substantial to almost perfect agreement with the 2022 ACR/EULAR criteria for MPA/MPO-AAV (kappa = 0.806) and GPA/PR3-AAV (kappa = 0.663). Many patients initially classified as GPA under the EMA algorithm were reclassified as MPA when using ANCA specificity. EGPA classification remained consistent across all methods (kappa = 0.725 between EMA and ACR/EULAR), suggesting that ANCA specificity is less critical for EGPA. The use of ANCA specificity simplified the classification process, aligning closely with the underlying pathophysiology of AAV subtypes. ANCA specificity serves as a valuable adjunct in the classification of AAV, particularly for distinguishing between MPA and GPA. Utilizing ANCA serotypes can simplify the diagnostic process, potentially facilitating earlier diagnosis and targeted treatment. For EGPA, traditional classification criteria remain effective. Incorporating ANCA specificity into clinical practice may enhance diagnostic accuracy and improve patient outcomes in AAV management.
Environmental factors contribute to approximately 41
BACKGROUND:Musculoskeletal (MSK) disorders are a leading cause of disability worldwide, particularly prevalent among women of childbearing age (WCBA). Our aim is to comprehensively assess the global, regional, and national burden of MSK disorders in WCBA, and examine the burden of MSK disorders among WCBA at varying levels of the Socio-demographic Index (SDI), then to project the burden of these disorders through to 2045. METHODS:This study utilized data from the Global Burden of Disease (GBD) 2021 project, focusing on MSK disorders among WCBA (15-49 years). Age-standardized rate was calculated using the World Standard Population proportions. Descriptive analysis was conducted at global, regional, and national levels. SDI associations were explored using smoothing spline models. Projections to 2045 employed age-period-cohort models using R software. RESULTS:In 2021, the estimated global age-standardized incidence, prevalence, deaths, Years of Life Lost, Years Lived with Disability, and Disability-Adjusted Life Years (DALYs) rates per 100 000 population of MSK disorders in WCBA were 4933.9 (95% UI 3683.7-6454.4), 20145.9 (17 082.6-23 564.4), 0.7 (0.6-0.8), 40.7 (34.1-45.7), 2090.4 (1414.8-2896.2), and 2131.1 (1455.8-2936.8), respectively. From 1990 to 2021, a total of 183 countries exhibited an increase in prevalence rate and 166 countries showed an upward trend in DALYs rate. Between 1990 and 2021, there was a positive association between the SDI and age-standardized DALYs rate for MSK disorders in WCBA, both globally and regionally. By 2045, the age-standardized number of DALYs for MSK disorders in WCBA is expected to reach 48.8 million, with an age-standardized DALYs rate of 2160 per 100,000 population. CONCLUSION:The burden of MSK disorders among WCBA is already substantial and is expected to increase further in the future. Despite the observed decline in age-standardized incidence rate of MSK disorders among WCBA in half of the regions and countries globally, the age-standardized prevalence and DALYs rates have shown an adverse increasing trend. By 2045, the global number of DALYs for MSK disorders in WCBA is projected to exceed 48 million. To mitigate the future burden of MSK disorders in WCBA, stratified and targeted healthcare strategies are essential to improve early diagnosis and treatment.
LLMs like GPT-4 show promise in medical consultations but face challenges in non-English or real-time contexts. The new GPT-4o, with improved text processing and faster responses, may better address rare diseases like retroperitoneal fibrosis (RPF). Performance of GPT-4o in providing real-time medical consultations for patients with rare disease remains underexplored, which is generally a challenge in clinical practice. We evaluate the competency of GPT-4o to generate responses to a rare autoimmune RPF on accuracy, completeness, readability, and quality, using a 7-point Likert scale. A total of 103 real-world RPF patients queries were collected from diverse sources. Responses were generated using the newly released version of GPT-4o (2024/5/17). All questions were also stratified and randomly divided into six groups. Six attending rheumatologists were assigned to answer one set of questions, then generated new responses with assistance of GPT-4o. All the responses were assessed blindly by three experts in RPF. GPT-4o scored significantly higher than rheumatologists in accuracy (6.39 ± 0.50 vs. 4.99 ± 0.62), completeness (6.51 ± 0.44 vs. 4.55 ± 0.60), readability (6.45 ± 0.42 vs. 4.93 ± 0.59), and quality (6.42 ± 0.46 vs. 4.78 ± 0.55) (p < 0.001). Competency of rheumatologists + GPT-4o was better than that of rheumatologists alone (accuracy: 6.13 ± 0.63, completeness: 5.99 ± 0.81, readability: 6.05 ± 0.67, quality: 6.01 ± 0.71. p < 0.001), and physician revisions generally reduced the competency of GPT-4o. Subgroup analysis showed no significant difference on accuracy between GPT-4o and rheumatologists + GPT-4o in answering complex questions, but any type of revision lowered the competency of GPT-4o. GPT-4o has the potential to provide real-time medical consultations for RPF in the Chinese clinical environment.
Background: Pregnancy complications of antiphospholipid syndrome (APS) are up to 20–30%. It is of great value to identify well-recognized predictors of adverse pregnancy outcomes (APOs) in APS. This study aims to explore the risk factors for APOs in patients with obstetric APS. Methods: This study included 142 women with APS delivered at Peking University People’s Hospital from February 2014 to August 2022. APOs included fetal death, neonatal death due to complications related to prematurity, preterm delivery <37 weeks due to placental insufficiency, hypertension, or preeclampsia, and small for gestational age (SGA) <10%. The association between pregnancy outcomes and clinical variables was assessed and the risk factors for APOs were analyzed. Results: APO occurred in 42.7% of pregnancies, including preterm delivery (23.4%), SGA (18.5%), and fetal death (6.5%). Patients in the APO group showed a significantly higher prevalence of underlying autoimmune disease (17% vs. 4.2%, p = 0.017) and lupus anticoagulant (LA) positivity (41.5% vs. 23.9%, p = 0.037) than those without APO. A significantly lower proportion of patients in the APO group were treated with low molecular weight heparin (LMWH) (58.5% vs. 76.1%, p = 0.037) and LMWH + low dose aspirin (LDA) (34.0% vs. 54.9%, p = 0.020) than in the non-APO group. Underlying autoimmune disease (odds ratio (OR): 5.147, 95% confidence interval (95% CI): 1.049–25.254, p = 0.043) was a risk factor for APOs and regular outpatient follow-up at the Department of Rheumatology and Immunology (OR: 0.429, 95% CI: 0.190–0.967, p = 0.041) was a protective factor for APOs. Conclusions: Underlying autoimmune disease is a risk factor for APOs and regular outpatient follow-up at the Department of Rheumatology and Immunology could be a protective factor for APOs.
ObjectiveRetroperitoneal fibrosis (RPF) is a rare disease characterized by the presence of fibroinflammatory tissue that surrounds the abdominal aorta and the iliac arteries and often entraps the ureters. Hydronephrosis is a common complication of RPF, however, its clinical features and outcomes have not been well elucidated.MethodsA total of 115 RPF-related hydronephrosis patients have been recruited from 9 clinical centers in China since March 2010. They were followed up until death or September 2021, whichever came first.ResultsThe mean age at diagnosis was 58.83 ± 12.13 years, and 80 patients (69.57%) were men. The median disease duration was 3.00 (1.00, 9.00) months. Renal impairment was observed in 88.35% of the patients, and 49.57% showed bilateral ureteral involvement. Elevated ESR and CRP were presented in 80.28 and 62.02% of the patients, respectively. Overall, 28.21% (11/39) of the patients had increased IgG4 levels, and 41.38% (12/29) showed positive pathological IgG4 staining (IgG4+/IgG+ ≥ 40% or IgG4+ ≥ 10/HPF). Among them, three patients were diagnosed as IgG4RD. After 60.43 ± 34.53 months of follow-up, 36 patients had poor prognosis, which was associated with severe kidney impairment, bilateral hydronephrosis and inflammation status (elevated ESR and IgG) at diagnosis by case–control study. eGFR and creatinine were independent risk factors after adjusting for all other significant associations (p = 0.002 and p = 0.067, respectively). Glucocorticoid-based therapy could reduce the time of stenting, decrease the need for long-term ureteral stenting/percutaneous nephrostomy (PNS)/ureterolysis, increase the rate of mass shrinkage, and reduce the new requirement of hemodialysis compared to surgery-only strategy for RPF-related hydronephrosis patients in need of renal drainage, but did not reduce new-onset renal atrophy.ConclusionSeverity of kidney dysfunction and inflammation status were related to the poor prognosis of hydronephrosis induced by RPF. More efficient interventions and strategies are needed to further improve outcomes.
OBJECTIVE:To investigate the fetal and maternal outcomes, risk factors of disease progression and adverse pregnancy outcomes (APOs) in patients with undifferentiated connective tissue disease (UCTD).METHODS:This retrospective study described the outcomes of 106 pregnancies in patients with UCTD. The patients were divided into APOs group (n=53) and non-APOs group (n=53). The APOs were defined as miscarriage, premature birth, pre-eclampsia, premature rupture of membranes (PROM), intrauterine growth restriction (IUGR), postpartum hemorrhage (PPH), and stillbirth, small for gestational age infant (SGA), low birth weight infant (LBW) and birth defects. The differences in clinical manifestations, laboratory data and pregnancy outcomes between the two groups were compared. Logistic regression analysis was performed to analyze the risk factors for APOs and the progression of UCTD to definitive CTD.RESULTS:There were 99 (93.39%) live births, 4 (3.77%) stillbirths and 3 (2.83%) miscarriage, 20 (18.86%) preterm delivery, 6 (5.66%) SGA, 17 (16.03%) LBW, 11 (10.37%) pre-eclampsia, 7 (6.60%) cases IUGR, 19 (17.92%) cases PROM, 10 (9.43%) cases PPH. Compared with the patients without APOs, the patients with APOs had a higher positive rate of anti-SSA antibodies (73.58% vs. 54.71%, P=0.036), higher rate of leukopenia (15.09% vs. 3.77%, P=0.046), lower haemoglobin level [109.00 (99.50, 118.00) g/L vs. 124.00 (111.50, 132.00) g/L, P < 0.001].Multivariate Logistic regression analysis showed that leucopenia (OR=0.82, 95%CI: 0.688-0.994) was an independent risk factors for APOs in UCTD (P=0.042). Within a mean follow-up time of 5.00 (3.00, 7.00) years, the rate of disease progression to a definite CTD was 14.15%, including 8 (7.54%) Sjögren's syndrome, 4 (3.77%) systemic lupus erythematosus (SLE), 4 (3.77%) rheumatoid arthritis and 1 (0.94%) mixed connective tissue disease. Multivariate Cox proportional risk regression analysis showed that Raynaud phenomenon (HR=40.157, 95%CI: 3.172-508.326) was an independent risk factor for progression to SLE.CONCLUSION:Leukopenia is an independent risk factor for the development of APOs in patients with UCTD. Raynaud's phenmon is a risk factor for the progression of SLE. Tight disease monitoring and regular follow-up are the key measures to prevent adverse pregnancy outcomes and predict disease progression in UCTD patients with pregnancy.
To the Editor: Systemic lupus erythematosus (SLE) is an autoimmune disease that tends to affect females of childbearing age. There are nearly 4 million people in China currently suffering from SLE, which can cause multiple organ damage in its early stages and seriously affect patients’ quality of life.[1,2] Menstrual disorders are common in SLE patients and vary from heavy menstrual bleeding to amenorrhea. The etiology of menstrual irregularities includes the disease activity itself, glucocorticoids (GCs) treatment, and the use of some immunosuppressants.[3] This multicenter, cross-sectional, web-based observational study investigated menstrual irregularity, pregnancy outcomes, and birth outcomes on SLE patients across China. The research was approved by the Ethics Committee of Peking University People's Hospital, China (No. 2019PHB253-01). The patients were informed that consent was implied with completion of the questionnaire, and the process was anonymous and voluntary. A total of 3964 SLE female patients ranging in age between 15 years and 49 years were recruited from 157 hospitals across China [Supplementary Figure 1, https://links.lww.com/CM9/B404]. The patients answered the standardized questionnaire via email or text message under the guidance of a rheumatologist over the phone. Clinical data were collected through questionnaires [Supplementary Materials, https://links.lww.com/CM9/B404], including basic features, menstruation after diagnosis, medications, marriage and fertility status, reproductive history, adverse pregnancy outcomes (APO), and adverse birth outcomes (ABO). The categorized variables were shown as frequency or percentage, and continuous variables were demonstrated as mean ± standard deviation. The Mann–Whitney and chi-squared tests were used to determine any statistical difference between the means and proportions of the two groups. The variables were tested for normality and homogeneity of variance before the Mann–Whitney and chi-squared tests were carried out. Univariate and multivariate logistic regression analyses were used to assess associations between clinical characteristics and menstruation, pregnancy, and neonatal outcomes. A 95% confidence interval (CI) was calculated to identify the independent variable in the binary logistic regression analysis. Differences were considered statistically significant when P < 0.05. Statistical Package for Social Sciences (SPSS 26.0, IBM Corp, Armonk, NY, USA) was used to analyze all data. The mean age of the participants was 30.42 ± 7.40 years. Of these patients, 75.55% experienced menstrual disorders, including light menstrual bleeding (48.99%), shortened menstrual bleeding (23.31%), prolonged menstrual bleeding (13.65%), amenorrhea (10.85%), and heavy menstrual bleeding (7.11%). The proportions of GCs, cyclophosphamide (CYC), and mycophenolate mofetil (MMF) in these patients were 55.17%, 27.22%, and 28.58%, respectively. The percentage of CYC in combination with GC and GC with MMF was 24.09% and 20.51%, respectively. Compared with patients who experienced normal menstruation, patients experiencing abnormal menstruation were older (31.17 ± 7.59 vs. 28.12 ± 6.25 years, P < 0.001), had a higher average body mass index (BMI) (21.69 ± 3.32 vs. 21.32 ± 3.46 kg/m2, P = 0.003), and experienced a longer disease duration (6.28 ± 5.49 vs. 5.38 ± 4.72 year, P < 0.001). The treatment of CYC (37.67% vs. 21.88%, P < 0.001), GCs (75.84% vs. 51.56%, P < 0.001), and MMF (39.67% vs. 21.35%, P < 0.001) were all significantly higher in patients with abnormal menstruation [Supplementary Table 1, https://links.lww.com/CM9/B404]. Binary logistic regression demonstrated that older patients (Odds ratio [OR]: 1.039, 95% CI: 1.016–1.062, P = 0.001), longer disease duration (OR: 1.041, 95% CI: 1.004–1.079, P = 0.029), CYC treatment (OR: 1.830, 95% CI: 1.273–2.630, P = 0.001), and GCs treatment (OR: 2.721, 95% CI: 2.008–3.686, P < 0.001) were independently related to menstrual disorders [Figure 1].Figure 1: Risk factors of menstrual disorders. ∗P < 0.05. BMI: Body Mass Index; CI: Confidence interval; CYC: Cyclophosphamide; GCs: Glucocorticoids; MMF: Mycophenolate Mofetil; SLE: Systemic lupus erythematosus.Among subjects with pregnancy history, the incidence of preterm delivery, miscarriage, fetal growth restriction, placental abruption, and hypertensive disease of pregnancy was 14.05%, 9.95%, 7.87%, 4.40%, and 2.26%, respectively [Supplementary Table 2, https://links.lww.com/CM9/B404]. There were no significant differences in age (34.83 ± 6.71 vs. 34.50 ± 6.61 years, P = 0.326), BMI (22.11 ± 3.18 vs. 22.21 ± 3.40 kg/m2, P = 0.558), disease duration (6.43 ± 5.37 vs. 6.06 ± 5.03 years, P = 0.146), history of CYC treatment (39.46% vs. 40.27%, P = 0.770), GCs treatment (73.70% vs. 72.86%, P = 0.739), or history of MMF treatment (38.00% vs. 35.15%, P = 0.295) between patients with and without APO [Supplementary Table 3, https://links.lww.com/CM9/B404]. Of the 1250 births in women, 70.48% were full-term normal births, 19.44% were born prematurely, 8.96% were small for gestational age neonates, 7.76% had neonatal pathological jaundice, and 1.44% had neonatal lupus. Patients in the ABO group were younger (32.59 ± 5.57 vs. 34.73 ± 6.52 years, P < 0.001) and experienced longer disease duration (7.53 ± 5.66 vs. 6.18 ± 5.02 years, P < 0.001) than patients without ABO. History of CYC treatment (24.39% vs. 48.03%, P < 0.001), GCs treatment (48.79% vs. 100%, P < 0.001), and MMF treatment (16.80% vs. 52.49%, P < 0.001) were significantly lower in the ABO group [Supplementary Table 4, https://links.lww.com/CM9/B404]. Binary logistic regression demonstrated that age (OR: 0.951, 95% CI: 0.912–0.991, P = 0.017) might be a protective factor associated with ABO. We conducted a large, cross-sectional study that investigated menstrual irregularity, pregnancy outcomes, and birth outcomes in SLE patients in China, and the results revealed that >75% of SLE patients experienced menstruation irregularity. Risk factors for menstrual irregularity included age, CYC treatment, and GCs treatment. This study found that age, BMI, disease duration, and treatment were not significantly associated with APO. The CYC, MMF, and GCs treatment may be associated with a low prevalence of ABO. Menstrual irregularity is common in SLE patients. In this study, nearly 50% of the patients experienced light menstrual bleeding, >20% of patients experienced shortened menstrual bleeding, and 10% experienced amenorrhea. This is consistent with previous studies.[4,5] Additionally, premature ovarian failure is associated with specific SLE-related autoantibodies (anti-Sm, anti-RNP, anti-cardiolipin, and lupus anticoagulant) and the use of immunosuppressants, particularly the use of CYC.[6,7] This study indicates that CYC treatment might be a risk factor for menstrual irregularity. Women with SLE have poorer maternal-fetal outcome compared with healthy individuals.[8] The rate of fetal loss has ranged from 3% to 43%. The rate of fetal loss in SLE pregnancies has decreased from an average of 43% to 17% over the past 40 years.[9] Disease flares, pregnancy loss, preeclampsia, preterm delivery, and intrauterine growth restrictions remain the primary complications during pregnancy.[10] This study has some limitations. It is a cross-sectional observational study that is unable to identify a clear cause–effect relationship. Additionally, the questionnaire could result in time, selection, recall, and reporting bias. At the same time, the timing of medication administration was unclear, which was a limitation of our study. However, this study included a large number of multicenter SLE patients, which helped avoid selection bias. Despite these limitations, the results of our study represent the current status of SLE patients in China. In conclusion, female SLE patients of childbearing age have a high proportion of menstrual abnormalities, APO, and ABO. Acknowledgements We would like to thank all the rheumatologists, gynecologists, and patients that participated in this study. We were especially grateful to an out-of-hospital patient management platform called “MIJIAN.” Funding This study was supported by grants from the research project from the Beijing Natural Science Foundation (No. 7192211) and China International Medical Foundation (No. Z-2018-40-2101).
The Pregnancy Outcomes of Patients With Antinuclear Antibodies or Antiphospholipid Antibodies Positive Undergo In Vitro Fertilization
Correspondence: Xuewu Zhang, Department of Rheumatology, Peking University People’s Hospital, Beijing, People’s Republic of China, Tel +8613681573403, Fax +86-010-88366323, Email xuewulore@163.com; Yingyao Chen, National Health Commission Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai, 200032, People’s Republic of China, Tel +86-21-33565183, Fax +86-21-64169552, Email yychen@shmu.edu.cn
目的 探讨影响类风湿关节炎(RA)患者实现临床深度缓解的相关因素.方法 回顾性分析2015年1月至2020年12月北京大学人民医院收治的767例RA患者的临床资料,其中103例达到临床深度缓解的患者为观察组,按照随机数字表法选取205例未达到临床深度缓解患者为对照组.分析观察组患者的临床特征,并通过logistic回归分析临床深度缓解的预测因素.结果 观察组中年龄<60岁和无晨僵的患者比例明显高于对照组(P均<0.01);对照组28个肿胀关节(SJC28)≥2、28个压痛关节≥2、合并其他慢性病、血红蛋白降低、红细胞沉降率(ESR)与C-反应蛋白升高和高IgA血症患者比例显著高于观察组(P=0.02).多因素Logistic分析结果显示,年龄<60岁、无晨僵是RA患者达到临床深度缓解的独立预测因素,而SJC28≥2、ESR升高为不利因素(P均<0.05).结论 年轻、无晨僵以及疾病活动度较低,有利于临床深度缓解.
Objective Rheumatoid arthritis (RA) is increasingly treated with biologics, which is commonly administered by injection devices. The aim of this study is to evaluate patients’ preferences for self-injection devices in RA, and to elicit their willingness to pay (WTP) for injector devices in China. Methods RA patients were recruited from Beijing, Shanghai, Guangzhou, Chengdu, Wuhan and Xi’an in China. A discrete choice experiment (DCE) was employed to elicit patient preferences. Patients were presented with 15 choice sets that consisted of seven attributes, which were developed based on literature review and further validated by physicians. The seven attributes were as follows: operation steps, injection pain, feedback indication, needle visibility, needle protection, size and out-of-pocket costs. A mixed logit model was used to analyze the relative importance of seven attributes and to calculate the WTP for a changed attribute level. Results Analyses included 114 adults with RA (mean age of 44.6 years old). When choosing the injection device, all attributes had significant influence. Among nonmonetary attributes, very slight injection pain was the most preferred for patients, followed by auto-injection method, thicker size, hidden needle, with needle protection and multiple feedback indication. Patients had a negative preference for increasing out-of-pocket costs. Patients were willing to pay CNY 45.26 for improving slight injection pain to very slight injection pain, CNY 13.26 for the auto-injection method, CNY 12.22 for the thicker size, CNY 10.06 for the hidden needle, CNY 9.82 for needle protection, and CNY 9.70 for multiple feedback indicators. Conclusion The results suggested that injection pain was the most important attribute for RA patients. Meanwhile, all other enhanced attributes of self-injection devices also significantly influence patients’ selection on injection devices. Findings suggested that there is significant potential value in developing self-injection devices that could further help improve treatment adherence and promote patient-centered care in autoimmune diseases.
OBJECTIVE:To evaluate the safety and efficacy of suprapubic liposuction combined with modified Devine surgery in adult patients with concealed penis caused by obesity.METHODS:The clinical data of 26 adult patients with buried penis admitted to the Department of Urology of Peking University People' s Hospital and the Department of Surgery of Beijing Eden Hospital from September 2017 to June 2020 were analyzed retrospectively. The average age of the patients was (33.0 ± 5.7) years, the average body mass index (BMI) was (29.0±5.4) kg/m2, and the penis length in the supine position was (2.9±1.3) cm. All the patients were treated with suprapubic liposuction combined with modified Devine operation. The improvement of penis length and complications were statistically analyzed after operation, and the satisfaction of the patients was followed up, 1 = dissatisfied; 2 = basically satisfied; 3 = satisfied; 4 = very satisfied. The measurement data were expressed in (mean±SD), nonparametric Friedman tests and multiplex analysis methods were used for data comparison.RESULTS:The average liposuction volume of the 26 patients was (450.0±90.2) mL. Immediately after operation: the penis length was (7.4±2.1) cm, increased by (4.5±1.6) cm compared with that before operation; three months after operation: the penis length was (5.3±1.8) cm, increased by (2.4±0.7) cm compared with that before operation. There was significant difference in penis length before operation, immediately after operation and three months after operation (P < 0.01). All the patients had no sexual intercourse disorder or dysuria. Postoperative edema occurred in 11 cases (42.3%), ecchymosis in 7 cases (26.9%), poor healing of prepuce wound in 2 cases (7.8%), hematoma in 1 case (3.8%), 5 cases (19.2%) without postoperative complications, and no patient had wound infection. Seventeen patients (65.4%) were very satisfied with the appearance and function of the penis, 6 patients (23.1%) were satisfied, 3 patients (11.5%) were basically satisfied, and no patients were dissatisfied. The average score of all the patients' satisfaction with postoperative penis appearance and function was (3.5±0.7).CONCLUSION:Suprapubic liposuction combined with modified Devine operation is safe and effective in the treatment of adult-acquired buried penis.
ObjectiveInfection is a major cause of death in patients with SLE. This study aimed to explore the infection rate in patients with SLE receiving a low dose of intravenous cyclophosphamide (IV-CYC).MethodsClinical parameters of 1022 patients with SLE from 24 hospitals in China were collected. Patients were divided into the short-interval and lower-dose (SILD, 400 mg every 2 weeks) IV-CYC group and the high-dose (HD, 500 mg/m(2) of body surface area every month) IV-CYC group. The clinical data and infection rate between the two groups were compared.ResultsCompared with HD IV-CYC, the infection rate of the SILD IV-CYC group was significantly lower (13.04% vs 22.27%, p=0.001). Respiratory tract infection (10.28% vs 15.23%, p=0.046) and skin/soft tissue infection (1.78% vs 4.3%, p=0.040) were significantly decreased in the SILD IV-CYC group. Moreover, infections occurred most likely in patients with SLE with leucopenia (OR 2.266, 95% CI 1.322 to 3.887, p=0.003), pulmonary arterial hypertension (OR 2.756, 95% CI 1.249 to 6.080, p=0.012) and >15 mg/day of glucocorticoid (OR 2.220, 95% CI 1.097 to 4.489, p=0.027).ConclusionsSILD IV-CYC showed a lower frequency of infection events than high-dose IV-CYC in patients with SLE.