J Transl Med. 2023 Mar 3;21(1):169. doi: 10.1186/s12967-023-03935-9.

ABSTRACT

BACKGROUND: Chemotherapy (CT) is central to the treatment of triple negative breast cancer (TNBC), but drug toxicity and resistance place strong restrictions on treatment regimes. Fasting sensitizes cancer cells to a range of chemotherapeutic agents and also ameliorates CT-associated adverse effects. However, the molecular mechanism(s) by which fasting, or short-term starvation (STS), improves the efficacy of CT is poorly characterized.

METHODS: The differential responses of breast cancer or near normal cell lines to combined STS and CT were assessed by cellular viability and integrity assays (Hoechst and PI staining, MTT or H2DCFDA staining, immunofluorescence), metabolic profiling (Seahorse analysis, metabolomics), gene expression (quantitative real-time PCR) and iRNA-mediated silencing. The clinical significance of the in vitro data was evaluated by bioinformatical integration of transcriptomic data from patient data bases: The Cancer Genome Atlas (TCGA), European Genome-phenome Archive (EGA), Gene Expression Omnibus (GEO) and a TNBC cohort. We further examined the translatability of our findings in vivo by establishing a murine syngeneic orthotopic mammary tumor-bearing model.

RESULTS: We provide mechanistic insights into how preconditioning with STS enhances the susceptibility of breast cancer cells to CT. We showed that combined STS and CT enhanced cell death and increased reactive oxygen species (ROS) levels, in association with higher levels of DNA damage and decreased mRNA levels for the NRF2 targets genes NQO1 and TXNRD1 in TNBC cells compared to near normal cells. ROS enhancement was associated with compromised mitochondrial respiration and changes in the metabolic profile, which have a significant clinical prognostic and predictive value. Furthermore, we validate the safety and efficacy of combined periodic hypocaloric diet and CT in a TNBC mouse model.

CONCLUSIONS: Our in vitro, in vivo and clinical findings provide a robust rationale for clinical trials on the therapeutic benefit of short-term caloric restriction as an adjuvant to CT in triple breast cancer treatment.

PMID:36869333 | PMC:PMC9983166 | DOI:10.1186/s12967-023-03935-9

Sci Data. 2023 Mar 3;10(1):119. doi: 10.1038/s41597-023-02032-2.

ABSTRACT

Tumor microenvironment (TME) plays important roles in prognosis and immune evasion. However, the relationship between TME-related genes and clinical prognosis, immune cell infiltration, and immunotherapy response in breast cancer (BRCA) remains unclear. This study described the TME pattern to construct a TME-related prognosis signature, including risk factors PXDNL, LINC02038 and protective factors SLC27A2, KLRB1, IGHV1-12 and IGKV1OR2-108, as an independent prognostic factor for BRCA. We found that the prognosis signature was negatively correlated with the survival time of BRCA patients, infiltration of immune cells and the expression of immune checkpoints, while positively correlated with tumor mutation burden and adverse treatment effects of immunotherapy. Upregulation of PXDNL and LINC02038 and downregulation of SLC27A2, KLRB1, IGHV1-12 and IGKV1OR2-108 in high-risk score group synergistically contribute to immunosuppressive microenvironment which characterized by immunosuppressive neutrophils, impaired cytotoxic T lymphocytes migration and natural killer cell cytotoxicity. In summary, we identified a TME-related prognostic signature in BRCA, which was connected with immune cell infiltration, immune checkpoints, immunotherapy response and could be developed for immunotherapy targets.

PMID:36869083 | PMC:PMC9984471 | DOI:10.1038/s41597-023-02032-2

PLoS One. 2023 Mar 3;18(3):e0282658. doi: 10.1371/journal.pone.0282658. eCollection 2023.

ABSTRACT

Epilepsy is a common, serious condition. Fortunately, seizure risk decreases with increasing seizure-free time on antiseizure medications (ASMs). Eventually, patients may consider whether to stop ASMs, which requires weighing treatment benefit versus burden. We developed a questionnaire to quantify patient preferences relevant to ASM decision-making. Respondents rated how concerning they would finding relevant items (e.g., seizure risks, side effects, cost) on a Visual Analogue Scale (VAS, 0-100) and then repeatedly chose the most and least concerning item from subsets (best-worst scaling, BWS). We pretested with neurologists, then recruited adults with epilepsy who were seizure-free at least one year. Primary outcomes were recruitment rate, and qualitative and Likert-based feedback. Secondary outcomes included VAS ratings and best-minus-worst scores. Thirty-one of 60 (52%) contacted patients completed the study. Most patients felt VAS questions were clear (28; 90%), easy to use (27; 87%), and assessed preferences well (25; 83%). Corresponding results for BWS questions were 27 (87%), 29 (97%), and 23 (77%). Physicians suggested adding a 'warmup' question showing a completed example and simplifying terminology. Patients suggested ways to clarify instructions. Cost, inconvenience of taking medication, and laboratory monitoring were the least concerning items. Cognitive side effects and a 50% seizure risk in the next year were the most concerning items. Twelve (39%) of patients made at least one 'inconsistent choice' for example ranking a higher seizure risk as lower concern compared with a lower seizure risk, though 'inconsistent choices' represented only 3% of all question blocks. Our recruitment rate was favorable, most patients agreed the survey was clear, and we describe areas for improvement. 'Inconsistent' responses may lead us to collapse seizure probability items into a single 'seizure' category. Evidence regarding how patients weigh benefits and harms may inform care and guideline development.

PMID:36867630 | PMC:PMC9983827 | DOI:10.1371/journal.pone.0282658

PLoS One. 2023 Mar 3;18(3):e0281888. doi: 10.1371/journal.pone.0281888. eCollection 2023.

ABSTRACT

Rapamycin treatment significantly increases lifespan and ameliorates several aging-related diseases in mice, making it a potential anti-aging drug. However, there are several obvious side effects of rapamycin, which may limit the broad applications of this drug. Lipid metabolism disorders such as fatty liver and hyperlipidemia are some of those unwanted side effects. Fatty liver is characterized as ectopic lipid accumulation in livers, which is usually accompanied by increased inflammation levels. Rapamycin is also a well-known anti-inflammation chemical. How rapamycin affects the inflammation level in rapamycin-induced fatty liver remains poorly understood. Here, we show that eight-day rapamycin treatment induced fatty liver and increased liver free fatty acid levels in mice, while the expression levels of inflammatory markers are even lower than those in the control mice. Mechanistically, the upstream of the pro-inflammatory pathway was activated in rapamycin-induced fatty livers, however, there is no increased NFκB nuclear translocation probably because the interaction between p65 and IκBα was enhanced by rapamycin treatment. The lipolysis pathway in the liver is also suppressed by rapamycin. Liver cirrhosis is an adverse consequence of fatty liver, while prolonged rapamycin treatment did not increase liver cirrhosis markers. Our results indicate that although fatty livers are induced by rapamycin, the fatty livers are not accompanied by increased inflammation levels, implying that rapamycin-induced fatty livers might not be as harmful as other types of fatty livers, such as high-fat diet and alcohol-induced fatty livers.

PMID:36867603 | PMC:PMC9983852 | DOI:10.1371/journal.pone.0281888

Home Healthc Now. 2023 Mar-Apr 01;41(2):68-77. doi: 10.1097/NHH.0000000000001146.

ABSTRACT

With potentially curative targeted and immunotherapies for non-small cell lung cancer, long term survival of at least 5 to 10 years is increasingly possible. A personalized, holistic, and multidisciplinary home healthcare treatment plan can help cancer patients transition from acute to chronic disease management. Factors to be considered include the patient's goals, treatment-related risks, the degree of metastasis, acute symptom management needs, and the desire and ability to participate in the treatment plan. The case history illustrates how genetic sequencing and immunohistochemistry testing guide treatment decisions. Strategies for pharmacological and nonpharmacological management of acute pain related to pathological spinal fractures are discussed. Care coordination that includes the patient, home care nurses and therapists, the oncologist, and the oncology nurse navigator is essential to transition the patient with advanced metastatic cancer to the highest possible functional status and quality of life. Discharge teaching should include early recognition and intervention for adverse effects of medications and signs or symptoms that may signal disease reoccurrence. The use of a written, patient-driven survivorship plan is important to assure diagnostic and treatment information is summarized, follow-up tests and scans are scheduled, and screening tests for other types of cancer are included.

PMID:36867479 | DOI:10.1097/NHH.0000000000001146

Sultan Qaboos Univ Med J. 2023 Feb;23(1):13-21. doi: 10.18295/squmj.5.2022.035. Epub 2023 Feb 23.

ABSTRACT

OBJECTIVES: This study aimed to examine the longitudinal association between social relationships and physical functioning among community-dwelling older adults with chronic conditions.

METHODS: Self-reported questionnaires were distributed and collected between 2014 and 2017 from participants ≥65 years old. The Index of Social Interaction was used to evaluate social relationships and the instrumental activities of daily living (IADL) subscale of the Tokyo Metropolitan Institute of Gerontology Index of Competence was used to examine functional status.

RESULTS: A total of 422 participants (190 males and 232 females) were included in the final analysis. High social relationships demonstrated significant adverse effects (odds ratio [OR] = 0.77, 95% confidence interval [CI]: 0.64-0.93) on the decline of IADL in the overall sample, particularly for females (OR = 0.71, 95% CI: 0.55-0.93) but not as much for males (P = 0.131).

CONCLUSION: This finding suggests that functional limitation was influenced by social relationships among disabled older adults and the influence of social relationships on functional limitation differed based on gender.

PMID:36865429 | PMC:PMC9974036 | DOI:10.18295/squmj.5.2022.035

Sultan Qaboos Univ Med J. 2023 Feb;23(1):90-98. doi: 10.18295/squmj.1.2022.007. Epub 2023 Feb 23.

ABSTRACT

OBJECTIVES: This study aimed to assess the knowledge, attitudes and practices regarding traditional medicine (TM) in Oman and examine the factors that necessitate its use.

METHODS: This cross-sectional, questionnaire-based study was conducted among the general population from November 2019 and March 2020. All Omani nationals above the age of 18 were eligible to be enrolled. The questionnaire consisted of questions on the knowledge, attitudes and use regarding traditional medicine in Oman.

RESULTS: A total of 598 responses to the questionnaire were received (response rate: 85.4%), of which 552 were deemed complete. Most responses were received from males (62.5%) and the sample had a mean age of 33.6 ± 7.7 years. A majority of the respondents (90%) were aware of the different types of TM in Oman; a high percentage (81.5%) felt that it was effective. Most (67.8%) had tried at least one method of TM use. Individuals who were older had tried TM compared to those who had not (34.5 ± 7.8 years versus 31.8 ± 7.2 years; P <0.001); in addition, more males than females (72.2% versus 27.8%; P <0.001) and those with full-time employment than those without had tried TM (84.2% versus 14.2%; P <0.001). Herbal medications (65.8%) and traditional massage (60.4%) were the most common forms of TM practice. Among females, herbal medications (69.2%) and massage (63.5%) are most often used; among males, cupping (65.2%) followed by herbal medications (64.4%) and massage (59.3%) were used more often. Notably, back pain (74.3%) was the most common condition for which TM was reportedly used, with only a small percentage (8.3%) reporting any concomitant side-effects.

CONCLUSION: There is widespread use of TM among Oman's urban population. An improved understanding of their benefits will facilitate their incorporation into modern health care services.

PMID:36865426 | PMC:PMC9974033 | DOI:10.18295/squmj.1.2022.007

Am J Mens Health. 2023 Mar-Apr;17(2):15579883231159343. doi: 10.1177/15579883231159343.

ABSTRACT

The sarcoid-like reaction is a rare autoinflammatory disease that can affect lymph nodes or organs but does not meet the diagnostic criteria for systemic sarcoidosis. Several drug classes have been associated with the development of a systemic sarcoid-like reaction, which defines drug-induced sarcoidosis-like reactions and can affect a single organ. Anti-CD20 antibodies (rituximab) have rarely been reported as responsible for this reaction and this adverse effect has mainly been described during the treatment of Hodgkin's lymphoma. We report a unique case of a sarcoid-like reaction complicating rituximab following the treatment of a mantle cell lymphoma and interesting only the kidney. The 60-year-old patient presented with severe acute renal failure 6 months after the end of his r-CHOP protocol and the urgent renal biopsy revealed acute interstitial nephritis rich in granulomas without caseous necrosis. After ruling out other causes of granulomatous nephritis, a sarcoid-like reaction was retained since infiltration was limited to the kidney. The temporal relationship between rituximab administration and the sarcoid-like reaction onset in our patient supported the diagnosis of a rituximab-induced sarcoidosis-like reaction. Oral corticosteroid treatment led to rapid and lasting improvement in renal function. Clinicians should be warned of this adverse effect and regular and prolonged monitoring of renal function should be recommended during the follow-up of patients after the end of treatment with rituximab.

PMID:36864684 | DOI:10.1177/15579883231159343

Medicine (Baltimore). 2023 Mar 3;102(9):e33181. doi: 10.1097/MD.0000000000033181.

ABSTRACT

BACKGROUND: Chronic heart failure (CHF) is the ultimate destination of most cardiovascular diseases and one of the leading causes of death for the elderly. Despite significant advances in the therapy of heart failure, the mortality and rehospitalization rates remain high. Guipi Decoction (GPD) has been reported to be significantly effective on patients with CHF, but it still lacks evidence-based medicine support.

METHODS: Two investigators systematically searched a total of 8 databases including PubMed, Embase, The Cochrane Library, Web of Science, Wanfang, China National Knowledge Infrastructure (CNKI), VIP, and CBM from construction to Nov 2022. Randomized controlled trials that compared GPD or in combination with conventional western medicine versus western medicine alone in the treatment of CHF were eligible for selection. The quality of included studies were evaluated and assigned data were extracted according to the method provided by Cochrane. All analyses used Review Manager 5.3 software.

RESULTS: The search identified 17 studies with a sample size of 1806 patients. Meta-analysis showed that GPD intervention was associated with an improvement in total clinical effective rate with a relative risk of 1.19 (95% confidence interval [CI] [1.15, 1.24]), P < .00001]. In terms of cardiac function and ventricular remodeling, GPT could improve left ventricular ejection fraction (mean difference [MD] = 6.41, 95% CI [4.32, 8.50], P < .00001), reduce left ventricular end diastolic diameter (MD = -6.22, 95% CI [-7.17, -5.28], P < .00001) and left ventricular end systolic diameter (MD = -4.92, 95% CI [-5.93, -3.90], P < .00001). In terms of hematological indices, GPD could decrease the levels of N-terminal pro-brain natriuretic peptide (standardized MD = -2.31, 95% CI [-3.05, -1.58], P < .00001) and C-reactive protein (MD = -3.51, 95% CI [-4.10, -2.92], P < .00001). And the analysis of safety revealed no significant differences in adverse effects between the 2 groups with a relative risk of 0.56 (95% CI [0.20, 0.89], P = .55).

CONCLUSION: GPD can improve cardiac function and inhibit ventricular remodeling with few adverse effects. However, more rigorous and high-quality randomized controlled trials are needed to verify the conclusion.

PMID:36862873 | PMC:PMC9981397 | DOI:10.1097/MD.0000000000033181

PLoS One. 2023 Mar 2;18(3):e0281662. doi: 10.1371/journal.pone.0281662. eCollection 2023.

ABSTRACT

BACKGROUND: Inflammatory skin reactions and skin alterations are still a potential side effect in radiation therapy (RT), which also need attention for patients' health care.

METHOD: In a pre-clinical study we consider alterations in irradiated in-vitro skin models of epidermal and dermal layers. Typical dose regimes in radiation therapy are applied for irradiation. For non-invasive imaging and characterization optical coherence tomography (OCT) is used. Histological staining method is additionally applied for comparison and discussion.

RESULTS: Structural features, such as keratinization, modifications in epidermal cell layer thickness and disorder in the layering-as indications for reactions to ionizing radiation and aging-could be observed by means of OCT and confirmed by histology. We were able to recognize known RT induced changes such as hyper-keratosis, acantholysis, and epidermal hyperplasia as well as disruption and/or demarcation of the dermo-epidermal junction.

CONCLUSION: The results may pave the way for OCT to be considered as a possible adjunctive tool to detect and monitor early skin inflammation and side effects of radiotherapy, thus supporting patient healthcare in the future.

PMID:36862637 | PMC:PMC9980765 | DOI:10.1371/journal.pone.0281662

Drug Deliv. 2023 Dec;30(1):2183821. doi: 10.1080/10717544.2023.2183821.

ABSTRACT

Inflammatory bowel disease (IBD) is one of the most common intestinal disorders, with increasing global incidence and prevalence. Numerous therapeutic drugs are available but require intravenous administration and are associated with high toxicity and insufficient patient compliance. Here, an oral liposome that entraps the activatable corticosteroid anti-inflammatory budesonide was developed for efficacious and safe IBD therapy. The prodrug was produced via the ligation of budesonide with linoleic acid linked by a hydrolytic ester bond, which was further constrained into lipid constituents to form colloidal stable nanoliposomes (termed budsomes). Chemical modification with linoleic acid augmented the compatibility and miscibility of the resulting prodrug in lipid bilayers to provide protection from the harsh environment of the gastrointestinal tract, while liposomal nanoformulation enables preferential accumulation to inflamed vasculature. Hence, when delivered orally, budsomes exhibited high stability with low drug release in the stomach in the presence of ultra-acidic pH but released active budesonide after accumulation in inflamed intestinal tissues. Notably, oral administration of budsomes demonstrated favorable anti-colitis effect with only ∼7% mouse body weight loss, whereas at least ∼16% weight loss was observed in other treatment groups. Overall, budsomes exhibited higher therapeutic efficiency than free budesonide treatment and potently induced remission of acute colitis without any adverse side effects. These data suggest a new and reliable approach for improving the efficacy of budesonide. Our in vivo preclinical data demonstrate the safety and increased efficacy of the budsome platform for IBD treatment, further supporting clinical evaluation of this orally efficacious budesonide therapeutic.

PMID:36861451 | DOI:10.1080/10717544.2023.2183821

Front Immunol. 2023 Feb 10;14:1114368. doi: 10.3389/fimmu.2023.1114368. eCollection 2023.

ABSTRACT

The critical balance between intended and adverse effects in allogeneic hematopoietic stem cell transplantation (alloHSCT) depends on the fate of individual donor T-cells. To this end, we tracked αβT-cell clonotypes during stem cell mobilization treatment with granulocyte-colony stimulating factor (G-CSF) in healthy donors and for six months during immune reconstitution after transfer to transplant recipients. More than 250 αβT-cell clonotypes were tracked from donor to recipient. These clonotypes consisted almost exclusively of CD8+ effector memory T cells (CD8TEM), which exhibited a different transcriptional signature with enhanced effector and cytotoxic functions compared to other CD8TEM. Importantly, these distinct and persisting clonotypes could already be delineated in the donor. We confirmed these phenotypes on the protein level and their potential for selection from the graft. Thus, we identified a transcriptional signature associated with persistence and expansion of donor T-cell clonotypes after alloHSCT that may be exploited for personalized graft manipulation strategies in future studies.

PMID:36860867 | PMC:PMC9969884 | DOI:10.3389/fimmu.2023.1114368

Mo Med. 2023 Jan-Feb;120(1):49-52.

ABSTRACT

Infantile hemangiomas (IHs) are identified in about 5-12% of infants, making them the most common benign tumor of childhood (Figure 1). IHs are vascular growths characterized by an abnormal proliferation of endothelial cells and aberrant blood vessel architecture.1 IHs commonly involute after proliferation, traditionally leading to a non-interventional or "wait and see" management approach. However, a large subset of these growths can become problematic causing morbidities such as ulceration and scarring, disfigurement, or functional impairment. Another subset of these cutaneous hemangiomas may also be markers for visceral involvement or other underlying abnormalities. Historically, treatment options were often rife with unwanted side effects and modest results. However, with newer established treatments which are both safe and effective, there is a time-sensitive need for early identification of high-risk hemangiomas to ensure prompt delivery of treatment for best outcomes. Despite a more recent dissemination of awareness of IHs and these newer treatments, there remains a large subset of infants who still experience a delay in care and poor outcomes which are likely avoidable. There may be some avenues in Missouri to help mitigate these delays.

PMID:36860594 | PMC:PMC9970331

JAAD Case Rep. 2023 Jan 27;33:56-58. doi: 10.1016/j.jdcr.2022.12.023. eCollection 2023 Mar.

NO ABSTRACT

PMID:36860805 | PMC:PMC9969237 | DOI:10.1016/j.jdcr.2022.12.023

Support Care Cancer. 2023 Mar 2;31(3):196. doi: 10.1007/s00520-023-07637-2.

ABSTRACT

BACKGROUND: This study investigates whether high body mass index (BMI) in women diagnosed with early breast cancer (BC) is associated with patient-reported symptom severity during chemotherapy.

METHODS: Women with Stage I-III BC completed toxicity reports for 17 side effects throughout regularly scheduled chemotherapy infusions. Toxicity reports were compared in women with obesity (BMI > = 30) versus no obesity (BMI < 30). Fisher's exact tests and 2-sample t-tests compared baseline patient characteristics. Risk ratios (RR) for women with obesity as compared to no obesity were estimated for individual symptoms that were patient-rated as moderate, severe or very severe (MSVS) severity, adjusting for marital status and race.

RESULTS: In a sample of 286 patients, Black women comprised 23% of the sample. The obesity rate was 76% among Black patients and 31% among White patients (p < .0001). Women with obesity rated an average of 6.9 side effects (standard deviation, SD 4.2) as MSVS vs 5.5 side effects (SD 3.7) among women with no obesity (p = .003). In adjusted analysis, women with obesity had significantly greater risk for MSVS fatigue (RR 1.18, 95% CI 1.01-1.36), dyspnea (RR 1.71, 95% CI 1.09-2.69), arthralgia (RR 1.47, 95% CI 1.10-1.97), peripheral neuropathy (RR 1.45, 95% CI 1.01-2.08), edema of limbs (RR 1.84, 95% CI 1.18-2.88), and abdominal pain (RR 1.75, 95% CI 1.07-2.87). There were no inter-group differences in BC stage or phenotype, chemotherapy treatment modifications, or hospitalizations.

CONCLUSIONS: Among women with early BC, patients with obesity reported higher chemotherapy toxicity as compared to patients without obesity; however, this did not result in differences in treatment completion.

PMID:36859693 | DOI:10.1007/s00520-023-07637-2

Sci Rep. 2023 Mar 1;13(1):3490. doi: 10.1038/s41598-023-29535-7.

ABSTRACT

Calcium channel blockers are among the most commonly used agents in the treatment of cardiovascular diseases. There are several known side-effects associated with their long-term use, whereas other potential adverse effects are yet to be proven. This study aims to evaluate the association between calcium channel blockers exposure and the incidence of second primary malignancy. We established a cohort of 1401 patients with colorectal cancer diagnosed in our institution between January 2003 and December 2016. Patients were followed-up until December 2020. The tumor characteristics and basic clinical data including medication information were obtained from the hospital information system database. Second malignancy was detected in 301 patients (21.5%), and occurred in 27.8% of patients who used calcium channel blockers compared to only 19.9% among non-users. Their use was associated with an increased incidence of bladder cancer in particular. Subanalysis of patients with second malignancy displayed a higher proportion of right-sided colon cancer compared to rectal carcinoma in non-users. Survival analysis revealed significantly better outcomes in early-stage colorectal cancer patients without a history of calcium channel blockers treatment or second primary malignancy.

PMID:36859505 | PMC:PMC9977965 | DOI:10.1038/s41598-023-29535-7

J Ovarian Res. 2023 Mar 1;16(1):47. doi: 10.1186/s13048-023-01120-6.

ABSTRACT

Curcumin, a natural organic component obtained from Curcuma longa's rhizomes, shows abundant anti-tumor, antioxidant and anti-inflammatory pharmacological activities, among others. Notably the anti-tumor activity has aroused widespread attention from scholars worldwide. Numerous studies have reported that curcumin can delay ovarian cancer (OC), increase its sensitivity to chemotherapy, and reduce chemotherapy drugs' side effects. It has been shown considerable anticancer potential by promoting cell apoptosis, suppressing cell cycle progression, inducing autophagy, inhibiting tumor metastasis, and regulating enzyme activity. With an in-depth study of curcumin's anti-OC mechanism, its clinical application will have broader prospects. This review summarizes the latest studies on curcumin's anti-OC activities, and discusses the specific mechanism, hoping to provide references for further research and applications.

PMID:36859398 | PMC:PMC9976389 | DOI:10.1186/s13048-023-01120-6

Trials. 2023 Mar 1;24(1):156. doi: 10.1186/s13063-023-07169-4.

ABSTRACT

INTRODUCTION: So far, the recovery quality after general anesthesia is still unsatisfied. Nalmefene is a drug to treat opioid overdose and reverse opioid actions. We aim to investigate the efficacy of nalmefene on optimizing the recovery quality of patients after general anesthesia.

METHODS: It is a prospective, placebo-controlled, two-arm parallel groups, multicentre, double-blind, randomized (PPPMDR) clinical trial. The participants (n = 520) will be randomly assigned into two groups. Each patient will receive either: a single dose of nalmefene 0.25 µg/kg in the intervention group, or the same volume of 0.9% NaCl solution in the control group at the end of the surgery. The primary outcome will be the time interval between the end of anaesthesia and recovery endpoints achieved (Aldrete recovery score ≥ 9) in post-anesthesia care unit (PACU). The other variables are the time interval from the end of operation to extubation; Richmond Agitation Sedation Scale (RASS) score at extubation; the time at Montreal Cognitive Assessment Scale (MoCA) orientation score ≥ 5; visual analog scale (VAS) score and adverse effects including postoperative nausea and vomiting (PONV), and pruritus in PACU and 24 h postoperatively.

ANALYSIS: This trial aims to study whether small dose of nalmefene can shorten the time from the end of surgery to Aldrete score ≥ 9 and improve opioid-induced side effects.This trial focuses on providing the reliable clinical evidence for satisfactory quality of recovery.

ETHICS AND DISSEMINATION: This clinical trial has been approved and supported by the ethics committee of the Renji Hospital, Shanghai Jiaotong University, School of Medicine (KY2020-150); Shanghai Tongren Hospital (2021-030-01);The First Affiliated Hospital of Guangxi Medical University (2021-032); and The First Affiliated Hospital of Zhengzhou University(2021-KY-0495-003). Analysis of the study results will be submitted to a peer-reviewed journal for publication.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT04713358, Registered on September 23, 2021.

PMID:36859316 | PMC:PMC9976492 | DOI:10.1186/s13063-023-07169-4

Ceska Slov Farm. 2023 Winter;72(1):45-54.

ABSTRACT

Controlling the pandemic is primarily achieved through vaccination against COVID-19. Although various COVID-19 vaccines are used worldwide, little is known about their safety and side effects. As a result, the objectives of this research are to identify the shortterm side effects of the different COVID-19 vaccines used in Iraq. Furthermore, exploring the association between experienced side effects and the brand of vaccine received. The current study evaluated the shortterm side effects of Pfizer, Sinopharm and AstraZeneca vaccines among healthcare workers in Iraq. The study used a questionnaire that consisted of dedicated sections to collect demographic data, the brand of COVID-19 vaccine received, the short-term side effects, and the willingness to receive a third booster dose. Regarding the post-vaccination side effects, the studied COVID-19 vaccines showed a comparable range of side effects, such as headaches, fever, muscle pain, joint pain, malaise, tenderness, redness, as well as pain at the site of vaccination. However, the Pfizer vaccine showed a higher incidence of pain and tenderness at the site of injection and fever compared to AstraZeneca and Sinopharm, respectively. On the other hand, the Sinopharm vaccine was associated with a higher occurrence of headaches, muscle pain, joint pain, and malaise in comparison to the Pfizer and AstraZeneca vaccines, respectively. In summary, the short-term side effects of the three vaccines were comparable; however, the AstraZeneca vaccine was associated with a lower risk of side effects.

PMID:36858979

Yakugaku Zasshi. 2023;143(3):229-232. doi: 10.1248/yakushi.22-00160-4.

ABSTRACT

As a patient safety management practice in outpatient cancer drug therapy at community pharmacies, continuous follow-up after the dispensing of medication is required. In 2013, QOL Pharmacy Kohoku and its affiliated stores started the "Telephone Follow-up for Cancer Patients" program, which utilizes telephones and information communication devices to communicate with patients and provide information to hospitals. Specifically, follow-up, including phone calls, is used to ascertain medication status and side effects before the next visit to the hospital, and feedback is provided to the prescribing source using trace reports. In some cases, this initiative has led to an early detection of side effects, reduction in the usage of anticancer drugs, and enhancement of supportive care, leading to patient safety and security. In addition, on August 1, 2021, a new pharmacy accreditation system was launched with two new functional categories, namely "Community Cooperative Pharmacies" and "Specialty Medical Institution Cooperative Pharmacies." Specialty medical institution-linked pharmacies are defined as pharmacies that can provide specialized and more advanced pharmacological management and dispensing of medications in cooperation with other pharmacies and medical institutions for patients who require specialized pharmacological management, such as in the case of cancer. Following our certification as a specialized medical institution collaborative pharmacy, we intend to continue the efforts we have invested to date and create a community that can assume a prevailing role in patient safety management.

PMID:36858553 | DOI:10.1248/yakushi.22-00160-4