Drug Ther Bull. 2023 Feb 21:dtb-2023-000002. doi: 10.1136/dtb.2023.000002. Online ahead of print.

ABSTRACT

Commentary on: Mackenzie IS, Rogers A, Poulter NR, et al Cardiovascular outcomes in adults with hypertension with evening vs morning dosing of usual antihypertensives in the UK (TIME study): a prospective, randomised, open-label, blinded-endpoint clinical trial. Lancet 2022;400:1417-25.

PMID:36810303 | DOI:10.1136/dtb.2023.000002

J Gynecol Oncol. 2023 Feb 6. doi: 10.3802/jgo.2023.34.e44. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effectiveness and safety of nab-paclitaxel plus platinum as first-line chemotherapy for ovarian cancer (OC).

METHODS: Patients administered platinum combined with nab-paclitaxel as first-line chemotherapy for epithelial OC, fallopian tube cancer, or primary peritoneal cancer from July 2018 to December 2021 were retrospectively evaluated. The primary outcome was progression-free survival (PFS). Adverse events (AEs) were examined. Subgroup analysis was performed.

RESULTS: Seventy-two patients (median age, 54.5 years; range, 20.0-79.0 years) were evaluated, including 12 and 60 administered neoadjuvant therapy and primary surgery with subsequent chemotherapy, respectively. The median follow-up duration was 25.6 months, and the median PFS was 26.7 (95% confidence interval [CI]=24.0-29.3) months in the whole patient population. In the neoadjuvant subgroup, the median PFS was 26.7 (95% CI=22.9-30.5) months vs. 30.1 (95% CI=23.1-37.1) months in the primary surgery subgroup. Twenty-seven patients were administered nab-paclitaxel plus carboplatin and had a median PFS of 30.3 (95% CI=not available [NA]-NA) months. The commonest grade 3-4 AEs included anemia (15.3%), white blood cell decreased (11.1%), and neutrophil count decreased (20.8%). No drug-related hypersensitivity reactions occurred.

CONCLUSION: Nab-paclitaxel plus platinum as first-line treatment in OC was associated with a favorable prognosis and was tolerable in patients with OC.

PMID:36807747 | DOI:10.3802/jgo.2023.34.e44

Actas Dermosifiliogr. 2023 Feb 17:S0001-7310(23)00152-7. doi: 10.1016/j.ad.2021.10.028. Online ahead of print.

NO ABSTRACT

PMID:36806633 | DOI:10.1016/j.ad.2021.10.028

BMJ Case Rep. 2023 Feb 20;16(2):e253647. doi: 10.1136/bcr-2022-253647.

ABSTRACT

Trastuzumab-deruxtecan (T-DXd) is a novel antibody drug conjugate that has improved treatment outcomes in patients with ERBB2-positive cancer, including locally advanced or metastatic gastric and gastro-oesophageal junction adenocarcinoma. One of the reported side effects of this medication is drug-induced pneumonitis. We present in this case report, a diagnostic dilemma of a patient presenting with clinical and radiographical features of drug-induced pneumonitis but was found to have pneumocystis jirovecii pneumonia (PJP). Our case is the first of PJP in a patient treated with T-DXd, highlighting the increasing incidence of this opportunistic infection in patients with solid malignancy. It also highlights the clinical and radiographical similarities between the PJP and drug-induced pneumonitis.

PMID:36805876 | DOI:10.1136/bcr-2022-253647

Rev Esp Geriatr Gerontol. 2023 Feb 17:S0211-139X(23)00009-4. doi: 10.1016/j.regg.2023.01.008. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the appropriateness of medication prescribing and to analyze interventions carried out in polymedicated elderly patients in nursing homes (NHs).

METHODS: Prospective study of potentially inappropriate medication prescribing in polymedicated older adults living in NHs, implemented via a collaborative project between NHs and the geriatric and pharmacy departments of a university hospital. The pharmacist reviewed patients' active medical prescriptions and prepared an individualized report with proposals aimed at therapeutic optimization that was sent for evaluation to the geriatrician in charge of the NH. The drug-related problems (DRPs) were classified according to the Third Consensus of Granada and the potentially inappropriate prescriptions (PIPs) were identified by explicit criteria (STOPP/START, BEERS, LESS-CHRON), implicit criteria (MAI) and CheckTheMeds® software. It was measured the degree of acceptance of the interventions carried out, and the economic impact was calculated from the direct costs of the discontinued drugs.

RESULTS: Of the 210 patients reviewed by the pharmacy department, 105 patients from 10 NHs were analyzed. A total of 510 prescriptions with possible DRPs were identified (38.5% of all prescribed drugs). According to STOPP/START/BEERS or LESS-CHRON criteria, 41.2% were PIPs. The main DRPs identified were: unfavorable risk-benefit ratio, inappropriate dose/regimen, inappropriate treatment duration, probability of adverse events, medication not indicated, and duplicate therapy. Interventions were proposed for 81.5% of the DRPs detected, of which 73.3% were accepted. This resulted in a 23.1% reduction in the number of drugs prescribed per patient and an economic saving of €16,218 per 6-month period.

CONCLUSION: The appropriateness of medication prescribing in polymedicated older adults living in NHs by the pharmacist has made it possible to reduce DRPs and PIPs and to save costs thanks to the high degree of acceptance by geriatricians.

PMID:36805293 | DOI:10.1016/j.regg.2023.01.008

BMC Psychiatry. 2023 Feb 20;23(1):112. doi: 10.1186/s12888-023-04584-4.

ABSTRACT

BACKGROUND: Mental health legislation permits involuntary care of patients with severe mental disorders who meet set legal criteria. The Norwegian Mental Health Act assumes this will improve health and reduce risk of deterioration and death. Professionals have warned against potentially adverse effects of recent initiatives to heighten involuntary care thresholds, but no studies have investigated whether high thresholds have adverse effects.

AIM: To test the hypothesis that areas with lower levels of involuntary care show higher levels of morbidity and mortality in their severe mental disorder populations over time compared to areas with higher levels. Data availability precluded analyses of the effect on health and safety of others.

METHODS: Using national data, we calculated standardized (by age, sex, and urbanicity) involuntary care ratios across Community Mental Health Center areas in Norway. For patients diagnosed with severe mental disorders (ICD10 F20-31), we tested whether lower area ratios in 2015 was associated with 1) case fatality over four years, 2) an increase in inpatient days, and 3) time to first episode of involuntary care over the following two years. We also assessed 4) whether area ratios in 2015 predicted an increase in the number of patients diagnosed with F20-31 in the subsequent two years and whether 5) standardized involuntary care area ratios in 2014-2017 predicted an increase in the standardized suicide ratios in 2014-2018. Analyses were prespecified (ClinicalTrials.gov NCT04655287).

RESULTS: We found no adverse effects on patients' health in areas with lower standardized involuntary care ratios. The standardization variables age, sex, and urbanicity explained 70.5% of the variance in raw rates of involuntary care.

CONCLUSIONS: Lower standardized involuntary care ratios are not associated with adverse effects for patients with severe mental disorders in Norway. This finding merits further research of the way involuntary care works.

PMID:36803444 | DOI:10.1186/s12888-023-04584-4

Hepatol Commun. 2023 Feb 20;7(3):e0063. doi: 10.1097/HC9.0000000000000063. eCollection 2023 Mar 1.

ABSTRACT

BACKGROUND: This systematic review and network meta-analysis aimed to provide a complete hepatotoxicity profile, hepatotoxicity spectrum, and safety ranking of immune checkpoint inhibitor drugs for cancer treatment.

METHODS: PubMed, Embase, Scopus, CINAHL, Web of Science, psycINFO, Cochrane Library, and ClinicalTrials.gov. websites were searched, and a manual search of relevant reviews and trials up to January 1, 2022, was undertaken. Head-to-head III randomized controlled trials comparing any 2 or 3 of the following treatments or different doses of the same immune checkpoint inhibitor drug were included: programmed death 1 (PD-1), programmed death ligand 1, and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors and conventional therapy. We included 106 randomized trials (n=164,782) containing 17 treatment arms.

RESULTS: The overall incidence of hepatotoxicity was 4.06%. The rate of fatal liver adverse events was 0.07%. The programmed death ligand 1 inhibitor+targeted therapy drug+chemotherapy group had the highest risk of treatment-related increases in all-grade alanine aminotransferase and aspartate aminotransferase levels, and the differences were significant. For immune-related hepatotoxicity, no significant difference was found between PD-1 and CTLA-4 inhibitors for all-grade hepatotoxicity; however, CTLA-4 inhibitors were associated with a higher risk of grade 3-5 hepatotoxicity than PD-1 inhibitors.

CONCLUSIONS: The highest incidence of hepatotoxicity and fatality was observed with triple therapy. The overall incidence of hepatotoxicity was similar between different dual regimens. For immune checkpoint inhibitor monotherapy, the overall risk of immune-mediated hepatotoxicity related to CTLA-4 inhibitors did not differ significantly from that of PD-1 inhibitors. There was no direct relationship between the risk of liver injury and drug dose, whether monotherapy or combination therapy was used.

PMID:36802366 | DOI:10.1097/HC9.0000000000000063

BMC Gastroenterol. 2023 Feb 19;23(1):43. doi: 10.1186/s12876-023-02681-y.

ABSTRACT

BACKGROUND: COVID-19 is widely known to induce a variety of extrapulmonary manifestations. Gastrointestinal symptoms have been identified as the most common extra-pulmonary manifestations of COVID-19, with an incidence reported to range from 3 to 61%. Although previous reports have addressed abdominal complications with COVID-19, these have not been adequately elucidated for the omicron variant. The aim of our study was to clarify the diagnosis of concomitant abdominal diseases in patients with mild COVID-19 who presented to hospital with abdominal symptoms during the sixth and seventh waves of the pandemic of the omicron variant in Japan.

METHODS: This study was a retrospective, single-center, descriptive study. In total, 2291 consecutive patients with COVID-19 who visited the Department of Emergency and Critical Care Medicine, Kansai Medical University Medical Center, Osaka, Japan, between January 2022 and September 2022 were potentially eligible for the study. Patients delivered by ambulance or transferred from other hospitals were not included. We collected and described physical examination results, medical history, laboratory data, computed tomography findings and treatments. Data collected included diagnostic characteristics, abdominal symptoms, extra-abdominal symptoms and complicated diagnosis other than that of COVID-19 for abdominal symptoms.

RESULTS: Abdominal symptoms were present in 183 patients with COVID-19. The number of patients with each abdominal symptom were as follows: nausea and vomiting (86/183, 47%), abdominal pain (63/183, 34%), diarrhea (61/183, 33%), gastrointestinal bleeding (20/183, 11%) and anorexia (6/183, 3.3%). Of these patients, 17 were diagnosed as having acute hemorrhagic colitis, five had drug-induced adverse events, two had retroperitoneal hemorrhage, two had appendicitis, two had choledocholithiasis, two had constipation, and two had anuresis, among others. The localization of acute hemorrhagic colitis was the left-sided colon in all cases.

CONCLUSIONS: Our study showed that acute hemorrhagic colitis was characteristic in mild cases of the omicron variant of COVID-19 with gastrointestinal bleeding. When examining patients with mild COVID-19 with gastrointestinal bleeding, the potential for acute hemorrhagic colitis should be kept in mind.

PMID:36800938 | DOI:10.1186/s12876-023-02681-y

Med Sci (Paris). 2023 Feb;39(2):101-104. doi: 10.1051/medsci/2023001. Epub 2023 Feb 17.

NO ABSTRACT

PMID:36799742 | DOI:10.1051/medsci/2023001

JAMA Netw Open. 2023 Feb 1;6(2):e230023. doi: 10.1001/jamanetworkopen.2023.0023.

ABSTRACT

IMPORTANCE: Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infection in children younger than 5 years; effective prevention strategies are urgently needed.

OBJECTIVE: To compare the efficacy and safety of monoclonal antibodies for the prevention of RSV infection in infants and children.

DATA SOURCES: In this systematic review and network meta-analysis, PubMed, Embase, CENTRAL, and ClinicalTrials.gov were searched from database inception to March 2022.

STUDY SELECTION: Randomized clinical trials that enrolled infants at high risk of RSV infection to receive a monoclonal antibody or placebo were included. Keywords and extensive vocabulary related to monoclonal antibodies, RSV, and randomized clinical trials were searched.

DATA EXTRACTION AND SYNTHESIS: The Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline was used. Teams of 2 reviewers independently performed literature screening, data extraction, and risk of bias assessment. The Grading of Recommendations, Assessments, Developments, and Evaluation approach was used to rate the certainty of evidence. A random-effects model network meta-analysis was conducted using a consistency model under the frequentist framework.

MAIN OUTCOMES AND MEASURES: The main outcomes were all-cause mortality, RSV-related hospitalization, RSV-related infection, drug-related adverse events, intensive care unit admission, supplemental oxygen use, and mechanical ventilation use.

RESULTS: Fifteen randomized clinical trials involving 18 395 participants were eligible; 14 were synthesized, with 18 042 total participants (median age at study entry, 3.99 months [IQR, 3.25-6.58 months]; median proportion of males, 52.37% [IQR, 50.49%-53.85%]). Compared with placebo, with moderate- to high-certainty evidence, nirsevimab, palivizumab, and motavizumab were associated with significantly reduced RSV-related infections per 1000 participants (nirsevimab: -123 [95% CI, -138 to -100]; palivizumab: -108 [95% CI, -127 to -82]; motavizumab: -136 [95% CI, -146 to -125]) and RSV-related hospitalizations per 1000 participants (nirsevimab: -54 [95% CI, -64 to -38; palivizumab: -39 [95% CI, -48 to -28]; motavizumab: -48 [95% CI, -58 to -33]). With moderate-certainty evidence, both motavizumab and palivizumab were associated with significant reductions in intensive care unit admissions per 1000 participants (-8 [95% CI, -9 to -4] and -5 [95% CI, -7 to 0], respectively) and supplemental oxygen use per 1000 participants (-59 [95% CI, -63 to -54] and -55 [95% CI, -61 to -41], respectively), and nirsevimab was associated with significantly reduced supplemental oxygen use per 1000 participants (-59 [95% CI, -65 to -40]). No significant differences were found in all-cause mortality and drug-related adverse events. Suptavumab did not show any significant benefits for the outcomes of interest.

CONCLUSIONS AND RELEVANCE: In this study, motavizumab, nirsevimab, and palivizumab were associated with substantial benefits in the prevention of RSV infection, without a significant increase in adverse events compared with placebo. However, more research is needed to confirm the present conclusions, especially for safety and cost-effectiveness.

PMID:36800182 | DOI:10.1001/jamanetworkopen.2023.0023

J Coll Physicians Surg Pak. 2023 Feb;33(2):153-157. doi: 10.29271/jcpsp.2023.02.153.

ABSTRACT

OBJECTIVE: To compare COVID-19 associated mucormycosis cases (CAM) with non-COVID-19 associated mucormycosis (non-CAM) cases followed as in-patients.

STUDY DESIGN: Observational Study.

PLACE AND DURATION OF STUDY: Department of Infectious Diseases and Clinical Microbiology, Adana City Training and Research Hospital, Health Sciences University (HSU), Adana, Turkey, between January 2018 and March 2022.

METHODOLOGY: Patients with a diagnosis of mucormycosis (proven and probable) were dichotomised as COVID-19 associated mucormycosis and non-COVID-19 associated mucormycosis cases. Both groups were compared for underlying malignancy, chemotherapy, antifungal therapy related side effects and overall survival.

RESULTS: Of the 35 cases enrolled in the study, 17 (48.6%) had CAM and 18 (51.4%) had non-CAM. A statistically significant difference was detected between non-CAM and CAM cases in terms of haematological malignancy, receiving chemotherapy, and antifungal therapy-related side effects (p=0.019, p=0.019, and p=0.027 respectively). Steroid use was found as a risk factor for the diabetic CAM cases (p<0.0001). The difference between the CAM and non-CAM cases in terms of overall survival was not statistically significant (p=0.088).

CONCLUSION: Because of the ongoing COVID-19 pandemic and the increasing number of critical patients, treatment of COVID-19 should be performed cautiously in patients who have the risk of developing CAM, particularly those with diabetes and immunosuppression (haematologic malignancy, receiving steroid or chemotherapy, etc.) and these patients should be monitored closely.

KEY WORDS: Mucormycosis, COVID-19, Mucormycosis associated with COVID-19, Diabetes mellitus, Turkey.

PMID:36797623 | DOI:10.29271/jcpsp.2023.02.153

Sci Rep. 2023 Feb 16;13(1):2777. doi: 10.1038/s41598-023-29581-1.

ABSTRACT

We aimed to determine whether knee OA is associated with CVD risk and all-cause death and to evaluate whether the association differs by exercise behavior. We used Korea National Health Insurance Service (KNHIS) database and included 201,466 participants (7572 subjects diagnosed with knee OA) who underwent health screening between 2009 and 2015. Those who had been diagnosed with knee OA or CVD before the index year were excluded. Cox proportional hazard models were used after adjusting for sociodemographic and CVD risk factors to evaluate the association between knee OA and CVD risk and all-cause death. Stratification analysis was further performed to determine the effect of exercise behavior on this relationship. During a median follow-up of 7.06 ± 2.24 years, 8743 CVD (2510 MI and 6553 stroke) cases developed. Individuals with knee OA had increased risks of CVD [hazard ratio (HR) 1.26, 95% confidence interval (CI) 1.15-1.38], myocardial infarction (MI) (HR 1.20, 95% CI 1.00-1.44), and stroke (HR 1.29, 95% CI 1.16-1.43) compared with those without knee OA. Those with knee OA who did not exercise had an increased risk of CVD (HR 1.25, 95% CI 1.11-1.40), whereas no significant increased CVD risk was observed in those with knee OA who exercised at least once a week (HR 1.11, 95% CI 0.96-1.28). There was no association between knee osteoarthritis and all-cause death. Knee OA was independently associated with an increased risk of CVD. Lack of exercise might have a synergistic adverse effect on the association between knee OA and CVD.

PMID:36797339 | PMC:PMC9935498 | DOI:10.1038/s41598-023-29581-1

Front Endocrinol (Lausanne). 2023 Jan 30;14:1098032. doi: 10.3389/fendo.2023.1098032. eCollection 2023.

ABSTRACT

AIM: To identify risk factors predictive of or associated with gastrointestinal side effects (GISE) of liraglutide in patients with type 2 diabetes (T2DM).

METHODS: T2DM patients treated with liraglutide for the first time were obtained and grouped into patients without GSEA and patients with GSEA. Baseline variables, including age, sex, body mass index (BMI), glycemia profiles, alanine aminotransferase, serum creatinine, thyroid hormones, oral hypoglycemic drugs and history of gastrointestinal diseases, were tested for possible associations with GSEA outcome. Significant variables were entered into univariate and multivariate logistic regression (forward LR) analyses. Receiver operating characteristic (ROC) curves to determine clinically useful cutoff values.

RESULTS: A total of 254 patients (95 female) were included in this study. 74 cases (29.13%) reported GSEA and 11 cases (4.33%) discontinued treatment. The results of univariate analyses showed that sex, age, thyroid stimulating hormone (TSH), free triiodothyronine, α-glucosidase inhibitor (AGI), and concomitant gastrointestinal diseases were associated with GSEA occurrence (all p <0.05). In the final regression model, AGI use (adjusted OR=4.01, 95%CI: 1.90-8.45, p<0.001), gastrointestinal diseases (adjusted OR=3.29, 95%CI: 1.51-7.18, p=0.003), TSH (adjusted OR=1.79, 95%CI: 1.28-2.50, p=0.001) and male sex (adjusted OR=0.19, 95%CI: 0.10-0.37, p<0.001) were independently associated with GSEA. Furthermore, ROC curve analysis confirmed that TSH values of 1.33 and 2.30 in females and males, respectively, were useful thresholds for predicting GSEA.

CONCLUSION: This study suggests that the combination of AGI, concomitant gastrointestinal diseases, female sex and higher TSH levels are independent risk factors of GSEA of liraglutide treatment in patients with T2DM. Further research is warranted to elucidate these interactions.

PMID:36793278 | PMC:PMC9922750 | DOI:10.3389/fendo.2023.1098032

Pediatr Rheumatol Online J. 2023 Feb 15;21(1):18. doi: 10.1186/s12969-023-00800-3.

ABSTRACT

OBJECTIVE: To evaluate the efficacy of levofolinic acid (LVF) administered 48 h before methotrexate (MTX) in reducing gastrointestinal side effects without interference with drug efficacy.

METHODS: A prospective observational study was performed including patients with Juvenile Idiopathic Arthritis (JIA) reporting significant gastrointestinal discomfort after MTX despite taking a dose of LVF 48 h after MTX. Patients with anticipatory symptoms were excluded. A LVF supplemental dose was added 48 h before MTX and patients were followed every 3-4 months. At each visit data on gastrointestinal symptoms, disease activity (JADAS, ESR, CRP values) and treatment changes were collected. Friedman test for repeated measures analyzed differences between these variables over time.

RESULTS: Twenty-one patients were recruited and followed for at least 12 months. All patients received MTX subcutaneously (mean 9.54 mg/m2) and LVF 48 h before and after MTX (mean 6.5 mg/dose), 7 received a biological agent too. Complete remission of gastrointestinal side effects was reported in 61.9% of study patients at first visit (T1) and increased over time (85.7%, 95.2%, 85.7% and 100% at T2, T3, T4, T5, respectively). MTX efficacy was maintained as showed by significant reduction of JADAS and CRP (p = 0.006 and 0.008) from T1 to T4 and it was withdrawn for remission in 7/21.

CONCLUSIONS: LVF given 48 h before MTX significantly reduced gastrointestinal side effects and did not reduce drug's efficacy. Our results suggest that this strategy may improve compliance and quality of life in patients with JIA and other rheumatic diseases treated with MTX.

PMID:36793106 | DOI:10.1186/s12969-023-00800-3

Zhonghua Yu Fang Yi Xue Za Zhi. 2023 Feb 6;57(2):273-280. doi: 10.3760/cma.j.cn112150-20220808-00798.

ABSTRACT

Objective: To investigate the clinical efficacy and safety of anti-IgE monoclonal antibody (omazumab) in the treatment of allergic united airway disease (UAD) in the real-wold. Methods: Retrospective cohort study summarizes the case data of patients with allergic united airway disease who were treated with anti IgE monoclonal antibody (omalizumab) for more than 16 weeks from March 1, 2018 to June 30, 2022 in the Peking University First Hospital.The allergic UAD is defined as allergic asthma combined with allergic rhinitis (AA+AR) or allergic asthma combined with chronic sinusitis with nasal polyps (AA+CRSwNP) or allergic asthma combined with allergic rhinitis and nasal polyps (AA+AR+CRSwNP). The control of asthma was evaluated by asthma control test (ACT), lung function test and fractional exhaled nitric oxide (FeNO). The AR was assessed by total nasal symptom score (TNSS). The CRSwNP was evaluated by nasal visual analogue scale (n-VAS), sino-nasal outcome test-22 (SNOT-22), nasal polyps score (TPS) and Lund-Mackay sinus CT grading system. The global evaluation of omalizumab for the treatment of allergic UADwas performed by Global Evaluation of Treatment Effectiveness(GETE).The drug-related side effects were also recorded. Matched t test and Wilcoxon signed-rank test were used to compare the score changes of IgE monoclonal antibody (omazumab) before and after treatment, and multivariate logistic regression analysis was used to determine the influencing factors of IgE monoclonal antibody (omazumab) response. Results: A total of 117 patients with UAD were enrolled, ranging in age from 19 to 77 years; The median age of patients was 48.7 years; Among them, 60 were male, ranging from 19 to 77 years old, with a median age of 49.9 years; There were 57 females, ranging from 19 to 68 years old, with a median age of 47.2 years. There were 32 cases in AA+AR subgroup, 59 cases in AA+CRSwNP subgroup, and 26 cases in AA+AR+CRSwNP subgroup. The total serum IgE level was 190.5 (103.8,391.3) IU/ml. The treatment course of anti IgE monoclonal antibody was 24 (16, 32) weeks. Compared with pre-treatment, omalizumab increased ACT from 20.0 (19.5,22.0) to 24.0 (23.0,25.0) (Z=-8.537, P<0.001), increased pre-bronchodilator FEV1 from 90.2 (74.8,103.0)% predicted value to 95.4 (83.2,106.0)% predicted value (Z=-5.315,P<0.001), increased FEV1/FVC from 80.20 (66.83,88.38)% to 82.72 (71.26,92.25)% (Z=-4.483,P<0.001), decreased FeNO from(49.1±24.8) ppb to (32.8±24.4) ppb (t=5.235, P<0.001), decreased TNSS from (6.5±2.6)to (2.4±1.9) (t=14.171, P<0.001), decreased n-VAS from (6.8±1.2) to (3.4±2.0)(t=14.448, P<0.001), decreased SNOT-22 from (40.0±7.9) to (21.3±10.2)(t=15.360, P<0.001), decreased TPS from (4.1±0.8) to (2.4±1.0)(t=14.718, P<0.001) and decreased Lund-Mackay CT score from (6.0±1.3) to (3.1±1.6)(t=17.012, P<0.001). The global response rate to omalizumab was 67.5%(79/117). The response rate in AA+AR (90.6%,29/32) was significantly higher than that in AA+CRSwNP (61.0%,36/59) and AA+AR+CRSwNP (53.8%,14/26) subgroups (χ2=11.144,P=0.004). Only 4 patients (3.4%,4/117) had mild side effects. Conclusion: The real-world study showed favorable effectiveness and safety of anti-IgE monoclonal antibody for treatment of allergic UAD. To provide basis for preventing the progress and precise treatment of allergic UAD.

PMID:36797588 | DOI:10.3760/cma.j.cn112150-20220808-00798

Phytomedicine. 2023 Feb 5;112:154704. doi: 10.1016/j.phymed.2023.154704. Online ahead of print.

ABSTRACT

BACKGROUND: Yishen Tongbi decoction (YSTB) which is an herbal formula, has been used for the treatment of rheumatoid arthritis (RA) for more than ten years with a better curative effect. Methotrexate (MTX) is an effective anchoring agent used to treat rheumatoid arthritis. There were, however, no head-to-head comparative randomized controlled trials comparing traditional Chinese medicine (TCM) to MTX, Therefore, we performed this double-blind, double-model, randomized controlled trial of the efficacy and safety of YSTB and MTX in the treatment of active RA for 24 weeks.

METHODS: Patients who met the enrollment criteria were randomly selected (1:1) to receive either YSTB therapy (YSTB 150 ml once daily + MTX placebo 7.5-15 mg once weekly) or MTX therapy (MTX 7.5-15 mg once weekly + YSTB placebo 150 ml once daily) in treatment cycles lasting 24 weeks. The percentage of patients who achieve a clinical disease activity index (CDAI) response at week 24 is the primary efficacy outcome. A 10% risk differential non-inferiority margin was previously defined. The Chinese Clinical Trials Registry has recorded this trial (ChiCTR-1,900,024,902, registered on August 3rd 2019, http://www.chictr.org.cn/index.aspx).

RESULTS: Out of 118 patients whose eligibility was determined from September 2019 to May 2022, 100 patients (n = 50 for each group) were enrolled in the research overall. The 24-week trial was completed by 82% (40/49) of the YSTB group's patients and 86% (42/49) of the MTX group's patients. In the intention-to-treat analysis, 67.4% (33/49) of patients in the YSTB group met the main outcome of CDAI response criteria at week 24, compared to 57.1% (28/49) in the MTX group. The risk difference was 0.102 (95% CI -0.089 to 0.293), which demonstrated the non-inferiority of YSTB to MTX. After further testing for superiority, the ratio of CDAI responses achieved by the YSTB and MTX groups was not statistically significant (p = 0.298). At the same time, in week 24, secondary outcomes such as the ACR 20/50/70 response, the European Alliance of Associations for Rheumatology good or moderate response, remission rate, simplified disease activity index response, and low disease activity rate all showed similar statistically significant patterns. There was statistically significant attainment of ACR20 (p = 0.008) and EULAR good or moderate response (p = 0.009) in two groups at week 4. The intention-to-treat analysis results and the per-protocol analysis results were in agreement. The incidence of drug-related adverse events was not statistically different between the two groups (p = 0.487).

CONCLUSIONS: Previous studies have used TCM as an adjunct to conventional therapy, and few of them have directly compared it with MTX. In order to lessen disease activity in RA patients, this trial demonstrated that YSTB compound monotherapy was non-inferior to MTX monotherapy and had superior efficacy following short-term treatment. This study provided evidence-based medicine in the treatment of RA with compound prescriptions of TCM and contributed to promoting phytomedicine use in RA patients.

PMID:36796186 | DOI:10.1016/j.phymed.2023.154704

Oral Dis. 2023 Feb 16. doi: 10.1111/odi.14539. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the prevalence of potential drug-drug interactions involving psychotropics prescribed by dentists, and dispensed by the public healthcare system, as well as to describe the severity and level of evidence of those interactions in the state of Minas Gerais, Brazil.

MATERIALS AND METHODS: We conducted data analysis from pharmaceutical claims in which dental patients received systemic psychotropics in 2017. Data from the Pharmaceutical Management System provided the drug dispensing history of the patients, allowing the identification of those on concomitant medication use. The outcome was the occurrence of potential drug-drug interactions, which were detected according to IBM Micromedex®. Independent variables were the patient's sex, age, and the number of drugs used. Descriptive statistics was performed using SPSS v. 26.

RESULTS: Overall, 1,480 individuals were prescribed psychotropic drugs. The prevalence of potential drug-drug interactions was 24.8% (n=366). The total of 648 interactions was observed and, most of which were of major severity (n=438, 67.6%). Most interactions occurred in female individuals (n=235; 64.2%), with 46.0 (±17.3) years-old, concurrently taking 3.7 (±1.9) drugs.

CONCLUSION: A substantial proportion of dental patients presented potential drug-drug interactions, mostly of major severity, which might be life-threatening.

PMID:36794905 | DOI:10.1111/odi.14539

Acta Derm Venereol. 2023 Feb 14;103:adv00867. doi: 10.2340/actadv.v103.3364.

NO ABSTRACT

PMID:36789755 | DOI:10.2340/actadv.v103.3364

Ital J Pediatr. 2023 Feb 14;49(1):20. doi: 10.1186/s13052-023-01427-6.

ABSTRACT

BACKGROUND: This study aimed to analyze all the patients who contacted the hospital's pediatric poison control center (PPCC) for exposure to ibuprofen and acetaminophen, in order to assess the incidence of any adverse reactions.

METHODS: We retrospectively reported the clinical data of children who accessed the PPCC of the Bambino Gesù Children's Hospital, IRCCS, Rome, from January 1, 2018 to September 30, 2022 due to wrong, accidental or intentional intake of inappropriate doses of acetaminophen and/or ibuprofen. In addition, we compared patients according to the intake of one of the two drugs and reported the trimestral distribution of cases during the study period.

RESULTS: A total of 351 patients accessed the PPCC during the study period. The median age was 3.0 years. Most patients were females (57.8%). The most common reason for inappropriate oral intake of paracetamol or ibuprofen was a wrong use or an accidental intake (78.6%), with a fifth of patients taking the drug with suicidal intent (21.1%). According to the PPCC evaluation, most patients were not intoxicated (70.4%). Hospitalization was required for 30.5% of patients. Adverse reactions were reported in 10.5% of cases, with a similar incidence in patients who took paracetamol or ibuprofen. Nausea and vomiting were the most commonly reported adverse reactions. A higher frequency of moderate intoxication was found in patients who took paracetamol compared to ibuprofen (p = 0.001). The likelihood of intoxication was also higher in the paracetamol cohort. A spike of cases was registered at the end of 2021.

CONCLUSIONS: We analyze exposures to the two most commonly used pediatric molecules, paracetamol and ibuprofen, to assess the frequency of adverse reactions. We demonstrated that these relatively "safe" drugs may be associated with intoxications and adverse reactions when inappropriately administered.

PMID:36788576 | DOI:10.1186/s13052-023-01427-6

BMC Med Inform Decis Mak. 2023 Feb 14;23(1):35. doi: 10.1186/s12911-023-02133-3.

ABSTRACT

BACKGROUND: The measurement of drug similarity has many potential applications for assessing drug therapy similarity, patient similarity, and the success of treatment modalities. To date, a family of computational methods has been employed to predict drug-drug similarity. Here, we announce a computational method for measuring drug-drug similarity based on drug indications and side effects.

METHODS: The model was applied for 2997 drugs in the side effects category and 1437 drugs in the indications category. The corresponding binary vectors were built to determine the Drug-drug similarity for each drug. Various similarity measures were conducted to discover drug-drug similarity.

RESULTS: Among the examined similarity methods, the Jaccard similarity measure was the best in overall performance results. In total, 5,521,272 potential drug pair's similarities were studied in this research. The offered model was able to predict 3,948,378 potential similarities.

CONCLUSION: Based on these results, we propose the current method as a robust, simple, and quick approach to identifying drug similarity.

PMID:36788528 | DOI:10.1186/s12911-023-02133-3