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Background

We have recently shown that human epididymis protein 4 (HE4) levels correlate with the severity of cystic fibrosis (CF) lung disease. However, there are no data on how HE4 levels alter in patients receiving CFTR modulating therapy.

Methods

In this retrospective clinical study, 3 independent CF patient cohorts (US-American: 29, Australian: 12 and Irish: 19 cases) were enrolled carrying at least one Class III CFTR CF-causing mutation (p.Gly551Asp) and being treated with CFTR potentiator ivacaftor. Plasma HE4 was measured by immunoassay before treatment (baseline) and 1–6?months after commencement of ivacaftor, and were correlated with FEV1 (% predicted), sweat chloride, C-reactive protein (CRP) and body mass index (BMI).

Results

After 1?month of therapy, HE4 levels were significantly lower than at baseline and remained decreased up to 6?months. A significant inverse correlation between absolute and delta values of HE4 and FEV1 (r?=??0.5376; P?<?.001 and r?=??0.3285; P?<?.001), was retrospectively observed in pooled groups, including an independent association of HE4 with FEV1 by multiple regression analysis (β?=??0.57, P?=?.019). Substantial area under the receiver operating characteristic curve (ROC-AUC) value was determined for HE4 when 7% mean change of FEV1 (0.722 [95% CI 0.581–0.863]; P?=?.029) were used as classifier, especially in the first 2?months of treatment (0.806 [95% CI 0.665–0.947]; P?<?.001).

Conclusions

This study shows that plasma HE4 levels inversely correlate with lung function improvement in CF patients receiving ivacaftor. Overall, this potential biomarker may be of value for routine clinical and laboratory follow-up of CFTR modulating therapy.  相似文献   
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HEC Forum - Studies on end-of-life care reveal different practices regarding withholding and/or withdrawing life-sustaining treatments between countries and regions. Available data about...  相似文献   
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OBJECTIVE: This research systematically evaluated the use of a clinically proven desensitizing dentifrice prior to a bleaching regimen in a randomized, multi-center, parallel group, open label clinical study following Good Clinical Practice guidelines. METHODOLOGY: Fourteen dental offices in West Palm Beach, Florida participated in the study during April/May 2004. Fourteen days prior to bleaching, impressions and oral soft tissue assessments were performed, and patients were randomized to either a KNO3 plus fluoride dentifrice (Sensodyne Fresh Mint), or a standard fluoride dentifrice (Crest Regular), brushing 2x per day. On Day 14, patients returned to the dental office for their custom tray and the dispensation of a bleaching kit (Day White Excel 3; 9.5% hydrogen peroxide and KNO3). This was used daily according to the manufacturer's instructions for 30 minutes, and normal oral hygiene continued to be performed using the assigned toothbrush and dentifrice, brushing 2x per day. At the end of each bleaching day, patients answered diary questions about the occurrence and intensity of sensitivity. At the conclusion of the 14-day bleaching period (Day 28), patients returned to their dental office for re-examination, returning all products and diaries. Within seven days of completing the study, patients answered a telephone patient satisfaction survey. RESULTS: A total of 202 patients in fourteen (14) dental offices completed all aspects of the study and were used for the analysis. The professionally dispensed bleaching product provided an improvement of approximately 4.4 Vita shades, regardless of whether it was used with the KNO3 plus fluoride (Sensodyne) or a standard fluoride (Crest) dentifrice. The patient perception of increased sensitivity caused by the bleaching treatment was low but measurable. In the first week of the bleaching, significantly more patients using the KNO3 plus fluoride dentifrice were free from sensitivity (58%) than the standard fluoride dentifrice group (42%). During the 14-day bleaching treatment period, the KNO3 dentifrice patients experienced significantly more "sensitivity free days" (average = 10.1) compared to the standard fluoride dentifrice group (average = 8.6). CONCLUSION: The use of the KNO3 plus fluoride dentifrice (Sensodyne), two weeks prior to and throughout bleaching, may be a useful adjunct for the management of sensitivity caused by professionally dispensed bleaching products. With the bleaching-induced tooth sensitivity, those patients in the KNO3 plus fluoride toothpaste group were significantly more satisfied with their whitening experience and willing to repeat the bleaching treatment.  相似文献   
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Background  Osteoarthritis at the thumb carpometacarpal joint can have a profound impact on quality of life. Here, we evaluate radiographic outcomes in patients who have had open complete trapeziectomy, ligament reconstruction with tendon interposition, and acellular dermal matrix (GraftJacket) interposition—Group A, and compare them with those without GraftJacket interposition—Group B. Materials and Methods  Thirty patients who had undergone operative treatment for thumb basal joint arthritis by a single surgeon from 2009 to 2016 were identified, and charts were retrospectively reviewed for demographic data, surgical and radiographic outcomes, and complications. Results  There was no significant difference in pre- and postoperative radial abduction or pre- and postoperative palmar abduction. The difference in intraoperative joint space was significant ( p = 0.006), but the difference in postoperative joint space was not ( p = 0.310). The average amount of metacarpal settling was 6.9 versus 3.7 mm ( p = 0.035) (Groups A and B, respectively). Three patients in Group A developed an inflammatory reaction to the GraftJacket, and one required reoperation for allograft removal. Conclusion  This study suggests that thumb basal joint arthroplasty with GraftJacket interposition does not lead to more favorable radiographic outcomes at long-term follow-up. The increased costs associated with GraftJacket use may not be justified in light of these outcomes.  相似文献   
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