J Am Coll Cardiol. 2022 Oct 18;80(16):1560-1578. doi: 10.1016/j.jacc.2022.08.743.

ABSTRACT

The population of patients with cancer is rapidly expanding, and the diagnosis and monitoring of cardiovascular complications greatly rely on imaging. Numerous advances in the field of cardio-oncology and imaging have occurred in recent years. This review presents updated and practical approaches for multimodality cardiovascular imaging in the cardio-oncology patient and provides recommendations for imaging to detect the myriad of adverse cardiovascular effects associated with antineoplastic therapy, such as cardiomyopathy, atherosclerosis, vascular toxicity, myocarditis, valve disease, and cardiac masses. Uniquely, we address the role of cardiovascular imaging in patients with pre-existing cardiomyopathy, pregnant patients, long-term survivors, and populations with limited resources. We also address future avenues of investigation and opportunities for artificial intelligence applications in cardio-oncology imaging. This review provides a uniform practical approach to cardiovascular imaging for patients with cancer.

PMID:36229093 | DOI:10.1016/j.jacc.2022.08.743

Rev Saude Publica. 2022 Oct 10;56:86. doi: 10.11606/s1518-8787.2022056003913. eCollection 2022.

ABSTRACT

OBJECTIVE: To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data.

METHODS: Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified.

RESULTS: Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes).

CONCLUSIONS: The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.

PMID:36228231 | PMC:PMC9529208 | DOI:10.11606/s1518-8787.2022056003913

PLoS One. 2022 Oct 13;17(10):e0275789. doi: 10.1371/journal.pone.0275789. eCollection 2022.

ABSTRACT

BACKGROUND: Tuberculosis preventive treatment (TPT) is strongly recommended for children following infection with Mycobacterium tuberculosis because of their high risk of progression to active tuberculosis, including severe disseminated disease. We describe the implementation of TPT for children and adolescents with evidence of tuberculosis infection (TBI) at Victoria's largest children's hospital and examine factors affecting treatment completion.

METHODS: We conducted a retrospective clinical audit of all children and adolescents aged <18 years diagnosed with latent TBI at the Royal Children's Hospital, Melbourne, between 2010 and 2016 inclusive. The primary outcome was treatment completion, defined as completing TPT to within one month of a target duration for the specified regimen (for instance, at least five months of a six-month isoniazid course), confirmed by the treating clinician. Factors associated with treatment adherence were evaluated by univariate and multivariate analysis.

RESULTS: Of 402 participants with TBI, 296 (74%) met the criteria for treatment "complete". The most common TPT regimen was six months of daily isoniazid (377, 94%). On multivariate logistic regression analysis, treatment completion was more likely among children and adolescents who had refugee health screening performed (OR 2.31, 95%CI 1.34-4.00) or who were also treated for other medical conditions (OR 1.67 95%CI 1.0-2.85), and less likely among those who experienced side-effects (OR 0.32, 95%CI 0.11-0.94). However, TPT was generally well tolerated with side-effects reported in 15 participants (3.7%).

CONCLUSION: Identification of factors associated with TPT completion and deficiencies in the existing care pathway have informed service provision changes to further improve outcomes for Victorian children and adolescents with TBI.

PMID:36227875 | PMC:PMC9562148 | DOI:10.1371/journal.pone.0275789

Kardiol Pol. 2022 Oct 13. doi: 10.33963/KP.a2022.0233. Online ahead of print.

NO ABSTRACT

PMID:36226760 | DOI:10.33963/KP.a2022.0233

Kardiol Pol. 2022 Oct 13. doi: 10.33963/KP.a2022.0232. Online ahead of print.

ABSTRACT

BACKGROUND: Women have been underrepresented in the large clinical trials in hypertension, and the incidence of adverse drug reactions by gender has been not sufficiently described.

AIMS: The aim of the study was to determine the prevalence of adverse drug reactions in women and men with arterial hypertension and comorbidities, and to assess the specific predisposing factors for adverse drug reaction by gender.

METHODS: The study population comprised consecutive hospitalized patients diagnosed with arterial hypertension and patients treated in an outpatient clinic, whose recruitment started from January 2019 to reaching number of 1000 participants. Structured questionnaire was used to gather the patient's demographic and clinical data, and current or past cases of adverse drug reactions.

RESULTS: The study included 560 women and 440 men, with mean (standard deviation, SD) age 62.84 (14.96) years. Women were older than men, had a longer hypertension history and suffered less frequently of other cardiovascular diseases. Women reported more frequently adverse drug reactions. The risk of drug-induced side effects in women increased with age, P = 0.03 and with coexistence of any respiratory disease, P = 0.04. In the case of male gender the risk of adverse drug reactions increased with the occurrence of hypercholesterolaemia, P = 0.03 and any of analysed metabolic disease, P = 0.04.

CONCLUSIONS: Adverse drug reactions were reported more frequently by women. Older age and the presence of any respiratory disease increased the risk of adverse drug reactions in women, while in men mainly the presence of hypercholesterolaemia or other metabolic diseases.

PMID:36226759 | DOI:10.33963/KP.a2022.0232

J Public Health Res. 2022 Oct 6;11(4):22799036221116177. doi: 10.1177/22799036221116177. eCollection 2022 Oct.

ABSTRACT

BACKGROUND: Drug-induced gingival overgrowth is associated with the intake of three classes of drugs: anticonvulsants, immunosuppressants, and calcium channel blockers. It is clinically characterized by hyperplasia of the gingival connective tissue which appears edematous, bloody, and purplish-red in color. In more severe cases, drug-induced gingival hyperplasia negatively affects the patient's quality of life, making it difficult to eat and practice good oral hygiene. Drug-induced gingival overgrowth therapy is controversial and, in fact, no studies in the literature highlight a well-defined therapeutic protocol. The therapies that are described provide primarily for non-surgical periodontal treatment and second-line surgical treatment. The aim of this work is to highlight a case of drug-induced gingival hyperplasia which was completely resolved thanks to photodynamic therapy which is completely free from side effects.

DESIGN AND METHODS: Photodynamic therapy was performed on an 18 year-old female patient with LEDs at a power of 450-470 nm and 5500 mW/cm2 + 7500 mW/cm2, combined with a Curcuma longa-based photosensitizer. A single session was performed, with applications of approximately 30 s for each interdental papilla.

RESULTS: The patient improved markedly after only one cycle of PDT. There was an absence of clinically detectable inflammation, edema, and rubor of the involved dental papillae. At the 4, 6, and 12 week follow-ups there were no recurrences.

CONCLUSIONS: This case report highlights the first case of drug-induced gingival hypertrophy entirely treated with photodynamic therapy to be described in the literature. Therefore, although it is only a case report, this therapy which is free from side effects should be investigated as an alternative to current therapies.

PMID:36226306 | PMC:PMC9549190 | DOI:10.1177/22799036221116177

Ther Adv Drug Saf. 2022 Oct 8;13:20420986221127503. doi: 10.1177/20420986221127503. eCollection 2022.

ABSTRACT

AIMS: The gene polymorphism of voriconazole metabolism-related liver enzyme is notable in East Asia population. It casts a significant influence on the rational use of voriconazole. We conducted this study to investigate the relationship between steady-state voriconazole trough concentration (Ctrough) and adverse effects (AEs), especially hepatotoxicity.

METHODS: We conducted a real-world study in the Jinling Hospital from January 2015 to June 2020. A total of 140 patients receiving voriconazole were enrolled in this study. The determination and scoring of voriconazole-associated hepatotoxicity were performed according to the Roussel Uclaf Causality Assessment Method scoring scale and the severity of hepatotoxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

RESULTS: Elevated steady-state voriconazole Ctrough with concomitant AEs are the most common reason for dose adjustments during treatment. Compared with the group without any AEs, voriconazole Ctrough was significantly higher in the hepatotoxicity and neurotoxicity groups, and the incidence of both events showed an overall increasing trend with increasing voriconazole Ctrough. Hepatotoxicity occurred in 66.7% of patients within 7 days of the first dose of voriconazole and 94.4% within 15 days of the dose. Steady-state voriconazole Ctrough >3.61 mg/l was associated with an increased incidence of hepatotoxicity (area under the curve = 0.645, p = 0.047). Logistic regression analysis showed that timely voriconazole dose adjustment was a predictor of attenuated hepatotoxicity after adjustment for confounders, but hepatotoxicity was not associated with voriconazole Ctrough measured at a single time point.

CONCLUSION: Hepatotoxicity and neurotoxicity correlate with voriconazole Ctrough, and dose reduction in patients with elevated steady-state voriconazole Ctrough may prevent hepatotoxicity. In patients with early occurrence of hepatotoxicity, initial therapeutic drug monitoring (TDM) might predict the risk of hepatotoxicity. Follow-up TDM may be necessary to predict late onset hepatotoxicity.

PLAIN LANGUAGE SUMMARY: Safety of voriconazole for the treatment of pulmonary fungal diseases Introduction: Several studies have suggested an association between the concentration of voriconazole in the blood and liver damage, but the evidence is weak. This study aimed to investigate relationships between voriconazole drug concentration and side effects and to analyze the factors affecting liver damage caused by voriconazole.Methods: We conducted a study at the Jinling Hospital from January 2015 to June 2020, in which a total of 140 patients were finally enrolled.Results: Voriconazole doses were adjusted in 44 patients due to abnormal voriconazole drug concentration or side effects, 32 patients reduced the dose and 8 patients increased the dose. An elevated liver enzyme level was the most common cause for dose adjustment. After the first dose adjustment, most patients achieved the target drug concentration. A total of 18 patients were determined as probable or highly probable to have drug-induced liver injury from voriconazole. Voriconazole drug concentration was significantly higher in the liver damage and nervous system damage groups as compared with the group without any side effects, and most liver damage events occurred within 14 days of the first dose. Voriconazole drug concentration >3.61 mg/l was associated with an increased incidence of liver damage.Conclusion: In this study, approximately one-third of patients with pulmonary fungal disease needed to adjust their dose after the standard dose of voriconazole treatment. The incidence of liver damage and nervous system damage showed an overall increasing trend with increasing voriconazole baseline concentrations. Initial therapeutic drug monitoring may be predictive of liver damage. Follow-up monitoring of liver enzymes may be needed.

PMID:36225945 | PMC:PMC9549188 | DOI:10.1177/20420986221127503

Sci Rep. 2022 Oct 12;12(1):17107. doi: 10.1038/s41598-022-21515-7.

ABSTRACT

Drug-related problems (DRPs) are a major health concern. A better understanding of the characteristics of DRPs throughout the hospital stay may help to tailor pharmaceutical care services (PCS). This study aims to describe the characteristics of DRPs and to compare DRP pattern in different stages of hospital stay. DRPs were identified by clinical pharmacists as part of their routine services. Pharmacist assessed causality, severity and preventability of DRP. A total of 316 preventable DRPs occurred in 257 patients with the median of 1 (rang 1-3) DRPs per patient. 46.8% of DRPs occurred at discharge than at other stages. The most frequent cause of DRP was no drug treatment in spite of existing indication, accounting for 32.3% of all DRPs. No drug treatment with existing indication was detected frequently at discharge (56.1%) compared with other stages (p-value < 0.001). The common intervention to physician was starting a drug (34.0%) and the acceptance rate was 95.8%. DRPs in hospitalized patients occur at any stage of the hospital stay. Systematic identification of DRP characteristics enables pharmacists to tailor optimal type of PCS required and hence improve patient safety.

PMID:36224350 | DOI:10.1038/s41598-022-21515-7

Khirurgiia (Mosk). 2022;(10):79-98. doi: 10.17116/hirurgia202210179.

ABSTRACT

A systematic review is devoted to epidemiology of adverse events in short-stay hospitals in foreign countries. It is found that dualism is an important feature of medical care, since treatment results can be not only useful, but also harmful (adverse events) associated with medical care per se. Adverse events are diagnosed in 10.68% of patients. Moreover, complications occur at previous stages of treatment in 20.91% of cases. Incidence of adverse events is 2 times higher in surgical departments and intensive care units compared to therapeutic departments. Among all adverse events, 42.83% are associated with open surgery, 16.17% with drug therapy, and 14.10% with manipulations or minimally invasive interventions. Preventable adverse events caused by human factor account for 48.24%. In other cases, adverse events are the result of side effects of medical technologies, exposure to physical environment and unsafe patient behavior. Infection associated with medical care (28.15%) prevails among other adverse events. In 51.45% of cases, adverse events are characterized by mild harm and do not prolong hospital-stay. Moderate harm requiring additional in-hospital treatment develops in 31.80% of cases. In 11.89% of cases, adverse events are life-threatening complications and/or cause disability. Moderate-to-severe harm increases hospital-stay by 8.7 days. Incidence of adverse events followed by unfavorable outcomes is 5.25%. Overall mortality and mortality from adverse events are 6.67% and 0.55%, respectively. Deaths associated with adverse events account for one in five deaths in a hospital and one in ten deaths in population of developed countries.

PMID:36223155 | DOI:10.17116/hirurgia202210179

Pain Ther. 2022 Oct 12. doi: 10.1007/s40122-022-00437-2. Online ahead of print.

ABSTRACT

INTRODUCTION: Currently available treatments for chronic lower back pain (CLBP) do not adequately address both nociceptive and neuropathic components of pain. We evaluated efficacy and safety of fixed-dose combination (FDC) of low-dose pregabalin prolonged release 75 mg-etoricoxib 60 mg to address both pain components.

METHODS: This randomized phase 3 trial conducted at 12 centres across India evaluated efficacy (based on mean change in numeric rating scale [NRS], Roland-Morris disability questionnaire [RDQ], visual analogue scale [VAS], patient global impression of improvement [PGI-I], clinical global impression of improvement [CGI-I] and rescue medication consumption) and safety of FDC in comparison to etoricoxib alone in adult patients with CLBP. Treatment duration was 8 weeks.

RESULTS: Of the 371 patients screened, 319 were randomized and considered for efficacy and safety analysis. Both treatment groups had no significant difference in terms of demography and baseline disease characteristics. Significantly better outcomes with FDC compared to etoricoxib were observed at week 4 onwards. At week 8, both groups showed significant reduction in mean NRS score from baseline (- 4.00 ± 1.65 in FDC; - 2.92 ± 1.59 in etoricoxib) with mean NRS score being significantly less in the FDC group compared to etoricoxib group (3.26 ± 1.56 vs 4.31 ± 1.56; p < 0.0001). The FDC was more effective than etoricoxib in terms of significantly greater reduction in RDQ score (- 9.28 ± 4.48 vs - 6.78 ± 4.34; p < 0.0001) and VAS score (- 37.66 ± 18.7 vs - 28.50 ± 16.31; p < 0.0001) at week 8. The FDC was also better in terms of significantly more patients reporting their condition as 'very much better' (36.9% vs 5.0%; p < 0.0001) and clinicians reporting patient's condition as 'very much improved' (36.3% vs 5.7%; p < 0.0001). Overall, study medications were well tolerated.

CONCLUSION: FDC of pregabalin and etoricoxib provided significant benefits in reducing pain and improving functional status compared with etoricoxib alone in patients with CLBP. Pregabalin prolonged release-etoricoxib FDC could be one of the treatment options for early and sustained pain relief and improvement in quality-of-life in treating CLBP as it addresses both neuropathic and nociceptive components of pain.

TRIAL REGISTRATION: CTRI/2018/10/015886.

PMID:36224489 | DOI:10.1007/s40122-022-00437-2

Clin Cancer Res. 2022 Oct 12:CCR-22-1810. doi: 10.1158/1078-0432.CCR-22-1810. Online ahead of print.

ABSTRACT

PURPOSE: We hypothesized that resistance to hypomethylating agents (HMAs) among patients with myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) would be overcome by combining a PD-L1 antibody with an HMA.

MATERIALS AND METHODS: We conducted a phase 1/2, multicenter clinical trial for patients with MDS not achieving an IWG-response after at least 4 cycles of an HMA "refractory" or progressing after a response "relapsed" with 3+ or higher risk MDS by the revised International Prognostic Scoring System (IPSS-R) and CMML-1 or -2. Phase I consisted of a 3+3 dose escalation design beginning with guadecitabine at 30 mg/m2 and escalating to 60 mg/m2 days 1-5 with fixed-dose atezolizumab: 840mg IV days 8 and 22 of a 28-day cycle. Primary endpoints were safety and tolerability; secondary endpoints were overall response rate (ORR) and survival.

RESULTS: Thirty-three patients, median age 73 (range 54-85), were treated. Thirty patients had MDS and 3 had CMML, with 30% relapsed and 70% refractory. No DLTs were observed in Phase I. There were 3 (9%) deaths in ≤30 days. Five patients (16%) came off study for drug-related toxicity. Immune-related adverse events (IRAEs) occurred in 12 (36%) patients (4 grade 3, 3 grade 2, 5 grade1). ORR was 33% (95% CI: 19, 52%) with 2 complete remission (CR), 3 hematologic improvement (HI), 5 marrow CR, 1 partial remission (PR). Median overall survival (mOS) was 15.1 (95% CI: 8.5, 25.3) months.

CONCLUSION: Guadecitabine with atezolizumab has modest efficacy with manageable IRAEs and typical cytopenia-related safety concerns for patients with R/R MDS and CMML.

PMID:36222848 | DOI:10.1158/1078-0432.CCR-22-1810

Vnitr Lek. 2022 Fall;68(E-4):10-15.

ABSTRACT

Pharmacovigilance is an integral part of medicine. There is always a risk of side effects when using medication; these can be completely trivial, but there are side effects that can be life-threatening or fatal. Pharmacovigilance practices should prevent such side effects, or at least reduce their incidence, especially by developing preventive measures that are based on adverse drug reaction (ADR) data and the evaluations of these. This article discusses the general concept of pharmacovigilance and compares individual pharmacovigilance systems of several countries and regions.

PMID:36220372

Clin Med (Lond). 2022 Jul;22(Suppl 4):90-91. doi: 10.7861/clinmed.22-4-s90.

NO ABSTRACT

PMID:36220218 | DOI:10.7861/clinmed.22-4-s90

Ann Palliat Med. 2022 Sep;11(9):3001-3004. doi: 10.21037/apm-22-807.

ABSTRACT

BACKGROUND: Infliximab is an effective drug for the treatment of Crohn's disease. As a rare and unique adverse effect of infliximab, hypertension should be paid enough attention in clinical work. At present, there is no relevant case report. We report a case of a 38-year-old man with Crohn's disease who had no history of hypertension and developed hypertension symptoms during infliximab treatment.

CASE DESCRIPTION: The patient was treated with 5 mg/kg infliximab on August 27, 2020. From August 27, 2020 to October 20, 2020, the patient underwent 3 treatment sessions. After each injection of infliximab, the patient's blood pressure became elevated, accompanied by dizziness and symmetrical numbness of both lower limbs. Amlodipine benazepril tablets were given orally to control blood pressure. Under close monitoring, 5 mg/kg infliximab was used again. After 10 min of infusion, blood pressure rose to 160/118 mmHg. Infusion was discontinued immediately, after which blood pressure decreased to normal. Adrenal computed tomography did not indicate adrenal hyperplasia or space occupying lesions, and the detection of hypertension related indicators in standing and supine position was abnormal. Since follow up, the patient has stopped using infliximab and has had no hypertension-related symptoms, even without antihypertensives. Measured blood pressure was within the normal range.

CONCLUSIONS: Hypertension, as one of the rare adverse reactions of infliximab in the treatment of Crohn's disease, should be paid enough attention.

PMID:36217627 | DOI:10.21037/apm-22-807

Bull Cancer. 2022 Oct 8:S0007-4551(22)00338-1. doi: 10.1016/j.bulcan.2022.08.003. Online ahead of print.

ABSTRACT

Nausea and vomiting induced by cancer treatment (CINV) remain one of the most common and feared side effects in children despite the use of new drugs to prevent them. The existing recommendations for the prophylaxis and treatment of CINV are based on adult patients in Anglo-Saxon societies. Based on a recent review of the literature, we focused on specific pediatric issues in order to offer recommendations validated by the supportive care committee of the French society for childhood cancer.

PMID:36220696 | DOI:10.1016/j.bulcan.2022.08.003

Drug Ther Bull. 2022 Oct 11:dtb-2022-000054. doi: 10.1136/dtb.2022.000054. Online ahead of print.

ABSTRACT

Overview of: Bjørk MH, Zoega H, Leinonen MK, et al Association of prenatal exposure to antiseizure medication with risk of autism and intellectual disability. JAMA Neurol 2022;79:672-81.

PMID:36220338 | DOI:10.1136/dtb.2022.000054

JAMA. 2022 Oct 11;328(14):1405-1414. doi: 10.1001/jama.2022.17735.

ABSTRACT

IMPORTANCE: Opioids can cause severe respiratory depression by suppressing feedback mechanisms that increase ventilation in response to hypercapnia. Following the addition of boxed warnings to benzodiazepine and opioid products about increased respiratory depression risk with simultaneous use, the US Food and Drug Administration evaluated whether other drugs that might be used in place of benzodiazepines may cause similar effects.

OBJECTIVE: To study whether combining paroxetine or quetiapine with oxycodone, compared with oxycodone alone, decreases the ventilatory response to hypercapnia.

DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, crossover clinical trial at a clinical pharmacology unit (West Bend, Wisconsin) with 25 healthy participants from January 2021 through May 25, 2021.

INTERVENTIONS: Oxycodone 10 mg on days 1 and 5 and the following in a randomized order for 5 days: paroxetine 40 mg daily, quetiapine twice daily (increasing daily doses from 100 mg to 400 mg), or placebo.

MAIN OUTCOMES AND MEASURES: Ventilation at end-tidal carbon dioxide of 55 mm Hg (hypercapnic ventilation) using rebreathing methodology assessed for paroxetine or quetiapine with oxycodone, compared with placebo and oxycodone, on days 1 and 5 (primary) and for paroxetine or quetiapine alone compared with placebo on day 4 (secondary).

RESULTS: Among 25 participants (median age, 35 years [IQR, 30-40 years]; 11 female [44%]), 19 (76%) completed the trial. The mean hypercapnic ventilation was significantly decreased with paroxetine plus oxycodone vs placebo plus oxycodone on day 1 (29.2 vs 34.1 L/min; mean difference [MD], -4.9 L/min [1-sided 97.5% CI, -∞ to -0.6]; P = .01) and day 5 (25.1 vs 35.3 L/min; MD, -10.2 L/min [1-sided 97.5% CI, -∞ to -6.3]; P < .001) but was not significantly decreased with quetiapine plus oxycodone vs placebo plus oxycodone on day 1 (33.0 vs 34.1 L/min; MD, -1.2 L/min [1-sided 97.5% CI, -∞ to 2.8]; P = .28) or on day 5 (34.7 vs 35.3 L/min; MD, -0.6 L/min [1-sided 97.5% CI, -∞ to 3.2]; P = .37). As a secondary outcome, mean hypercapnic ventilation was significantly decreased on day 4 with paroxetine alone vs placebo (32.4 vs 41.7 L/min; MD, -9.3 L/min [1-sided 97.5% CI, -∞ to -3.9]; P < .001), but not with quetiapine alone vs placebo (42.8 vs 41.7 L/min; MD, 1.1 L/min [1-sided 97.5% CI, -∞ to 6.4]; P = .67). No drug-related serious adverse events were reported.

CONCLUSIONS AND RELEVANCE: In this preliminary study involving healthy participants, paroxetine combined with oxycodone, compared with oxycodone alone, significantly decreased the ventilatory response to hypercapnia on days 1 and 5, whereas quetiapine combined with oxycodone did not cause such an effect. Additional investigation is needed to characterize the effects after longer-term treatment and to determine the clinical relevance of these findings.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04310579.

PMID:36219407 | DOI:10.1001/jama.2022.17735

Transl Androl Urol. 2022 Sep;11(9):1292-1303. doi: 10.21037/tau-22-483.

ABSTRACT

BACKGROUND: Compound aluminum sulfate injection (CASI) originated from a Chinese traditional medicine, "Kuzhiye", and has been used in treating non-muscle invasive bladder cancer (NMIBC). Previous studies suggested that CASI was a potential monotherapeutic drug for NMIBC. However, the efficacy and safety of CASI in the treatment of NMIBC, as well as the long-term recurrence after treatment, need to be further evaluated.

METHODS: A multicenter retrospective single-arm cohort study was conducted. From 2006 to 2009, 101 patients (74 men and 27 women, aged 58.9±11.9 years) with T1 or benign NMIBC were enrolled. Each patient was directly injected with CASI through catheter needle into the root of NMIBC. Vital signs, electrocardiography, blood count, blood biochemistry, and urine analysis were re-examined on day 2 and day 14 after CASI injection, together with a cystoscopic examination 4 weeks after CASI treatment was performed for all patients to assess the clinical activity and safety of CASI. To study long-term efficacy, patients in center 2 were followed up for recurrence with a median follow-up time of 13.8 years.

RESULTS: For the 101 patients enrolled in this study, demographic characteristics in the 3 centers showed no significant differences. After CASI, 2 patients showed administration site-dependent, but not dose-dependent, increase in their aluminum concentration in 24 hours without obvious abnormality in blood biochemistry. The overall effective rate was 97.03%, including complete tumor necrosis in 94 patients. Treatment-related adverse events occurred in 20 patients (19.80%), including 9 drug-related and 11 cystoscopy-related adverse events (AEs). All AEs were endurable and disappeared within 2 weeks without any treatment. The maximum tolerated single dose of CASI was 21 mL. Among the 43 patients at center 2, 3 patients were excluded because they changed to other treatment regimen. As of April 2022, of the 40 patients enrolled, 22 had no recurrence and 7 relapsed. The follow-up time was 2-16.2 years. The other 11 patients were lost to follow up.

CONCLUSIONS: CASI may be an effective and safe option for the treatment of NMIBC and is expected to be a potential monotherapy regimen for NMIBC.

PMID:36217405 | PMC:PMC9547166 | DOI:10.21037/tau-22-483

Respir Med Case Rep. 2022 Oct 4;40:101753. doi: 10.1016/j.rmcr.2022.101753. eCollection 2022.

ABSTRACT

In recent years, the combination of platinum-based chemotherapy and immune checkpoint inhibitors (ICIs) has become the standard treatment for patients with lung cancer. Hepatitis is one of the common toxicities following ICI/chemotherapy. When drug-induced hepatitis occurs, the suspected drug must be discontinued. Since it may be difficult to determine the exact drug causing the hepatitis, liver biopsy may help identify this. We report the case of a patient diagnosed with immune-related adverse event hepatitis from liver biopsy and clinical course. A 45-year-old man with lung adenocarcinoma (stage IV, cT4N3M1c) negative for driver gene mutation was treated with carboplatin (CBDCA), pemetrexed (PEM), and pembrolizumab. Elevated blood aspartate aminotransferase and alanine aminotransferase levels after chemotherapy indicated hepatitis induced by cytotoxic anticancer agents and ICIs. As autoimmune hepatitis was also suspected, liver biopsy was performed and the findings suggested ICI-induced hepatitis. Pembrolizumab was discontinued and CBDCA/PEM was resumed, following which, the primary lesion shrank. When drug-induced hepatitis is suspected, clinicians should actively perform liver biopsy to confirm the diagnosis, so that appropriate therapeutic regimen can be administered.

PMID:36217354 | PMC:PMC9547299 | DOI:10.1016/j.rmcr.2022.101753

J Allergy Clin Immunol Pract. 2022 Oct;10(10):2772-2773. doi: 10.1016/j.jaip.2022.07.023.

NO ABSTRACT

PMID:36216464 | DOI:10.1016/j.jaip.2022.07.023