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Objectives: Development of therapies for systemic lupus erythematosus (SLE) has in part been limited by the lack of suitable outcome measures in clinical trials. In the present post-hoc analysis of two clinical trials of belimumab, we investigated two potential outcomes, the Lupus Low Disease Activity State (LLDAS) and clinical SLE disease activity index 2000 (cSLEDAI-2K) zero, in relation to SLE responder index 4 (SRI-4).

Methods: A total of 1684 SLE patients from the BLISS-52 (n = 865) and BLISS-76 (n = 819) trials were surveyed. Physician’s Global Assessment (PGA) scores <0.5 (3-point scale) were used for comparisons. We used the chi-square test for comparisons and the phi coefficient for correlations.

Results: At week 52, LLDAS was achieved by 8.6% of patients, cSLEDAI-2K = 0 by 34.5% and SRI-4 by 45.1%. cSLEDAI-2K = 0 showed the strongest correlation with PGA <0.5 (rφ = 0.36, P < 0.001). cSLEDAI-2K = 0 unveiled the superiority of belimumab 10 mg/kg over placebo (P = 0.003) with a magnitude which was comparable to that of SRI-4 (P < 0.001). LLDAS displayed a more moderate separation (P = 0.033).

Conclusions: LLDAS was a stringent measure. cSLEDAI-2K = 0 showed the strongest correlation with the clinician-based evaluation. Being based on the SLEDAI-2K only, cSLEDAI-2K = 0 may be considered a more pragmatic outcome measure in SLE studies compared with composite tools.  相似文献   

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A particularly facile synthetic route to mussel‐inspired oligo(ethylene glycol) catecholates is described, yielding high purity materials with minimal purification. The oligocatecholates show remarkable thermal and rheological properties for their actual chain length, suggesting the operation of non‐covalent interactions between their l ‐DOPA‐bearing chain ends. This end‐group effect is more pronounced in the shorter oligomers (M n of ethylene glycol chain of 200 and 400 Da), where the end‐group density is higher. Various surfaces (glass, stainless steel) are modified with the oligocatecholates, using a dip‐coating approach from dilute aqueous solutions. Water contact angle measurements and X‐ray photoelectron spectroscopy confirm the presence of a hydrophilic surface coating layer. The potential of these materials for application as antifouling coatings and viscosity modifiers is highlighted.  相似文献   
996.
This study investigated the question whether spatial working memory related to movement plans (motor working memory) and spatial working memory related to spatial attention and perceptual processes (perceptual spatial working memory) share the same neurophysiological substrate or there is evidence for separate motor and perceptual working memory streams of processing. Towards this aim, ten healthy human subjects performed delayed responses to visual targets presented at different spatial locations. Two tasks were attained, one in which the spatial location of the target was the goal for a pointing movement and one in which the spatial location of the target was used for a perceptual (yes or no) change detection. Each task involved two conditions: a memory condition in which the target remained visible only for the first 250 ms of the delay period and a delay condition in which the target location remained visible throughout the delay period. The amplitude spectrum analysis of the EEG revealed that the alpha (8–12 Hz) band signal was smaller, while the beta (13–30 Hz) and gamma (30–45 Hz) band signals were larger in the memory compared to the non-memory condition. The alpha band signal difference was confined to the frontal midline area; the beta band signal difference extended over the right hemisphere and midline central area, and the gamma band signal difference was confined to the right occipitoparietal area. Importantly, both in beta and gamma bands, we observed a significant increase in the movement-related compared to the perceptual-related memory-specific amplitude spectrum signal in the central midline area. This result provides clear evidence for the dissociation of motor and perceptual spatial working memory.  相似文献   
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Regression of congenital nevi is usually associated with loss of pigment or halo formation. In rare cases, regression is characterized by sclerosis and hair loss. We describe a rare case of a sclerotic hypopigmented large congenital melanocytic nevus in which a localized scleroderma‐like reaction process of regression seemed to have started in utero and progressed throughout early childhood.  相似文献   
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BACKGROUND Coronavirus disease 2019(COVID-19) significantly affected endoscopy practice,as gastrointestinal endoscopy is considered a risky procedure for transmission of infection to patients and personnel of endoscopy units(PEU).AIM To assess the impact of COVID-19 on endoscopy during the first European lockdown(March-May 2020).METHODS Patients undergoing endoscopy in nine endoscopy units across six European countries during the period of the first European lockdown for COVID-19(MarchMay 2020) were included. Prior to the endoscopy procedure, participants were stratified as low-or high-risk for potential COVID-19 infection according to the European Society of Gastrointestinal Endoscopy(ESGE) and the European Society of Gastroenterology and Endoscopy Nurses and Associates(ESGENA) joint statement, and contacted 7-14 d later to assess COVID-19 infection status. PEU were questioned regarding COVID-19 symptoms and/or infection via questionnaire, while information regarding hospitalizations, intensive care unitadmissions and COVID-19-related deaths were collected. The number of weekly endoscopies at each center during the lockdown period was also recorded.RESULTS A total of 1267 endoscopies were performed in 1222 individuals across nine European endoscopy departments in six countries. Eighty-seven(7%) were excluded because of initial positive testing. Of the 1135 pre-endoscopy low risk or polymerase chain reaction negative for COVID-19, 254(22.4%) were tested post endoscopy and 8 were eventually found positive, resulting in an infection rate of 0.7% [(95%CI: 0.2-0.12]. The majority(6 of the 8 patients, 75%) had undergone esophagogastroduodenoscopy. Of the 163 PEU, 5 [3%;(95%CI: 0.4-5.7)] tested positive during the study period. A decrease of 68.7%(95%CI: 64.8-72.7) in the number of weekly endoscopies was recorded in all centers after March 2020. All centers implemented appropriate personal protective measures(PPM) from the initial phases of the lockdown.CONCLUSION COVID-19 transmission in endoscopy units is highly unlikely in a lockdown setting, provided endoscopies are restricted to emergency cases and PPM are implemented.  相似文献   
999.
An increasing number of childbearing agewomen undergo liver transplantation (LT) in the United States. Transplantation in this patient subgroup poses a significant challenge regarding the plans for future fertility, particularly in terms of immunosuppression and optimal timing of conception. Intrapartum LT is only rarely performed as the outcome is commonly dismal for the mother or more commonly the fetus. On the other hand, the outcomes of pregnancy in LT recipients are favorable, and children born to LT recipients are relatively healthy. Counseling on pregnancy should start before LT and continue after LT up until pregnancy, while all pregnant LT recipients must be managed by amultidisciplinary team, including both an obstetrician and a transplant hepatologist. Additionally, an interval of at least 1-2 years after successful LT is recommended before considering pregnancy. Pregnancy-induced hypertension, pre-eclampsia, and gestational diabetes mellitus are reported more commonly during the pregnancies of LT recipients than in the pregnancies of non-transplant patients. As adverse fetal outcomes, such asmiscarriage, abortion, stillbirth, or ectopic pregnancy, may occur more often than in the non-transplant population, early planning or delivery either through a planned induction of labor or cesarean section is critical to minimize the risk of complications. No significant long-term physical or phycological abnormalities have been reported in children born to LT recipients.  相似文献   
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