RESUMEN
OBJECTIVE: Opioid-induced constipation (OIC) is a frequent adverse event among patients receiving chronic pain therapy that is requiring opioids. Naldemedine was approved by the Food and Drug Administration to treat OIC and appears to be more efficient than any other peripherally acting µ-opioid receptor antagonist. This meta-analysis aimed at assessing the available data on naldemedine in terms of efficacy. METHODS: We searched the Cochrane Library, PubMed and ClinicalTrials on 24 May 2022 to identify randomised controlled trials (RCTs) comparing naldemedine to placebo among patients reporting OIC. RESULTS: Evaluation of 6 RCTs enrolling 2769 participants showed significantly greater respondence to treatment (OR=2.48; 95% CI: 2.02 to 3.06; p<0.00001), change in weekly spontaneous bowel movements (SBMs) (mean difference=1.45; 95% CI: 1.14 to 1.76; p<0.00001), complete SBMs (mean difference=0.89; 95% CI: 0.62 to 1.17; p<0.00001) and SBMs without straining (mean difference=0.89; 95% CI: 0.61 to 1.17; p<0.00001) for patients treated with naldemedine. We found no difference in numeric pain rating scales after one (mean difference=0.05; 95% CI: -0.22 to 0.31; p=0.73) and two weeks of treatment (mean difference= -0.04; 95% CI: -0.31 to 0.22; p=0.75). Funding and clinical diversity were possible risks of bias. CONCLUSIONS: Naldemedine improves a variety of bowel function parameters while preserving analgesia, confirming its efficacy for patients with OIC. However, head-to-head trials are needed to establish naldemedine as treatment of first choice for laxative-refractory OIC. PROSPERO REGISTRATION NUMBER: CRD42022281353.
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Patients with immune-mediated diseases (IMID) such as systemic sclerosis (SSc), who are treated with B cell depleting treatments, are at risk for developing severe COVID-19 due to inadequate humoral immune response. During B cell depletion, therapeutic substitution of neutralizing monoclonal antibodies against the SARS-CoV-2 spike protein (mAbs) might be helpful to prevent severe COVID-19. It has been shown, that in non-IMID patients mABs reduce SARS-CoV-2 viral load and lower the risk of COVID-19 associated hospitalization or death. However, there are limited data on the effect of mAbs in IMID patients after exposure, especially in patients treated with B cell depleting agents. Herein, we report a case of a rituximab treated SSc patient who developed COVID-19 and was successfully treated with a combination of mAbs (casirivimab/imdevimab). With this case we show that IMID patients may benefit from post-exposure administration of mAbs. In our case treatment with neutralizing autoantibodies was safe and a possible contributor in protecting the patient from mechanical ventilation and eventually death. We frame this case within the current evidence from the literature and provide a perspective on the future potential role of mAbs for treating IMID patients suffering from COVID-19.
RESUMEN
BACKGROUND: Patients suffering from inflammatory bowel disease (IBD) frequently need long-term medical treatment. Mobile apps promise to complement and improve IBD management, but so far there has been no scientific analysis of their quality. OBJECTIVE: This study evaluated the quality of German mobile apps targeting IBD patients and physicians treating IBD patients using the Mobile Application Rating Scale (MARS). METHODS: The German Apple App Store and Google Play Store were systematically searched to identify German IBD mobile apps for patient and physician use. MARS was used by 6 physicians (3 using Android smartphones and 3 using iPhones) to independently assess app quality. Apps were randomly assigned so that the 4 apps with the most downloads were rated by all raters and the remaining apps were rated by 1 Android and 1 iOS user. RESULTS: In total, we identified 1764 apps in the Apple App Store and Google Play Store. After removing apps that were not related to IBD (n=1386) or not available in German (n=317), 61 apps remained. After removing duplicates (n=3) and apps for congresses (n=7), journals (n=4), and clinical studies (n=6), as well as excluding apps that were available in only 1 of the 2 app stores (n=20) and apps that could only be used with an additional device (n=7), we included a total of 14 apps. The app "CED Dokumentation und Tipps" had the highest overall median MARS score at 4.11/5. On the whole, the median MARS scores of the 14 apps ranged between 2.38/5 and 4.11/5. As there was no significant difference between iPhone and Android raters, we used the Wilcoxon comparison test to calculate P values. CONCLUSIONS: The MARS ratings showed that the quality of German IBD apps varied. We also discovered a discrepancy between app store ratings and MARS ratings, highlighting the difficulty of assessing perceived app quality. Despite promising results from international studies, there is little evidence for the clinical benefits of German IBD apps. Clinical studies and patient inclusion in the app development process are needed to effectively implement mobile apps in routine care.
