BMC Infect Dis. 2023 Jun 27;23(1):437. doi: 10.1186/s12879-023-08341-6.

ABSTRACT

BACKGROUND: The emergence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and subsequent Coronavirus Disease 2019 (COVID-19) pandemic has resulted in a significant global public health burden, leading to an urgent need for effective therapeutic strategies. Monoclonal antibodies (mAbs) are a potentially effective therapeutic option. We identified a potent antibody JMB2002 against the SARS-CoV-2 receptor binding domain. JMB2002 has demonstrated therapeutic efficacy in a SARS-CoV-2 infected rhesus macaque model.

METHODS: We conducted a randomized, double-blind, phase 1 trial to evaluate the JMB2002's safety, tolerability, pharmacokinetics, and immunogenicity in healthy Chinese adults. Participants were randomly assigned to one of four cohorts with sequential dose, administrated intravenously with JMB2002 or placebo, and followed up for 85 ± 5 days.

RESULTS: 40 participants were recruited and completed in the study. Eight (25.0%) participants experienced 13 treatment emergent adverse events (TEAEs) that were drug-related. No serious adverse events (SAEs), dose limiting events (DLTs), or adverse events of special interest (AESIs), such as infusion related/allergic reactions, were observed, and no drop out due to adverse events (AEs) occurred. There was no significant safety difference observed between JMB2002 and the placebo, suggesting it was well tolerated. The AUC0-∞, AUC0 - t of JMB2002 infusion increased dose-dependently from 5 mg/kg to 50 mg/kg while there is also a linear trend between doses and Cmax.

CONCLUSION: Therefore, JMB2002 was well tolerated after administration of a single dose in the range of 5 mg/kg to 50 mg/kg in healthy Chinese adults.

TRIAL REGISTRATION: ChiCTR2100042150 at https://www.chictr.org.cn/searchproj.aspx (14/01/2021).

PMID:37370000 | DOI:10.1186/s12879-023-08341-6

Eur J Hosp Pharm. 2023 Jun 27:ejhpharm-2023-003819. doi: 10.1136/ejhpharm-2023-003819. Online ahead of print.

ABSTRACT

Moxifloxacin is a broad-spectrum antimicrobial agent that is commonly used in clinical practice. Here we report an unusual case of a patient with persistent hiccups caused by moxifloxacin. A man aged in his 40s was treated with moxifloxacin for tuberculous pleurisy. Hiccups occurred 2 hours after intravenous injection of moxifloxacin and lasted into evening. On the second day after injection, hiccups occurred again and made it difficult for him to fall asleep. The clinician ruled out gastrointestinal disease, nervous system disease, electrolyte disturbance and other factors. On assessing causality of the adverse drug reaction, the Naranjo scale for moxifloxacin was six, indicating a probable relationship of hiccups with moxifloxacin. Hiccups stopped 2 min after intramuscular injection of metoclopramide. To our knowledge, this is the first case report about moxifloxacin-induced persistent hiccups. Clinicians should be aware of the rare adverse reaction.

PMID:37369596 | DOI:10.1136/ejhpharm-2023-003819

Eur J Hosp Pharm. 2023 Jun 27:ejhpharm-2022-003582. doi: 10.1136/ejhpharm-2022-003582. Online ahead of print.

ABSTRACT

BACKGROUND: Antimicrobials are widely used in hospitals and are often associated with adverse drug reactions (ADRs). The objective of this study was to determine the incidence of ADRs caused by antimicrobials and classify them according to the type of reaction, the class of antimicrobials used, causality, severity and avoidability.

METHODS: A prospective cohort study was carried out with paediatric patients for 6 months. Causality was verified using the Naranjo and Liverpool algorithms, the severity was verified with the adapted scale of Hartwig and the avoidability was verified with the Liverpool Avoidability Assessment Tool.

RESULTS: A total of 303 patients were followed, and 18.2% (55/303) of them had one or more ADRs during the hospital stay. Just over half of the patients (28/55) had diarrhea. The most used antimicrobials were beta-lactams and second-generation cephalosporins. Suspicions were classified mainly as possible 78.6% (55/70) according to the Naranjo algorithm, and as probable 48.6% (34/70) according to the Liverpool algorithm. The antimicrobial most involved with ADRs was cefepime. The risk of manifesting ADR was greater with the use of some antimicrobials such as clindamycin (relative risk (RR) 3.0, CI 1.67 to 5.4), as well as with the increase in hospitalisation days (OR 1.022, CI 1.008 to 1.036) and in the number of antimicrobials prescribed (OR 1.649, CI 1.360 to 2.001).

CONCLUSION: ADRs were observed in approximately one-fifth of patients and were mostly gastrointestinal, moderate, unavoidable and with variable causality, depending on the algorithm used.

PMID:37369595 | DOI:10.1136/ejhpharm-2022-003582

Medicines (Basel). 2023 Jun 9;10(6):35. doi: 10.3390/medicines10060035.

ABSTRACT

Background: Adverse effects of antiseizure medications (ASMs) remain one of the major causes of non-adherence. Cosmetic side effects (CSEs) are among the most commonly reported side effects of ASMs. In this context, alopecia is one of the CSEs that has a high intolerance rate leading to poor therapeutical compliance. Methods: We performed a literature review concerning alopecia as a secondary effect of ASMs. Results: There are 1656 individuals reported with ASM-induced alopecia. Valproate (983), lamotrigine (355), and carbamazepine (225) have been extensively reported. Other ASMs associated with alopecia were cenobamate (18), levetiracetam (14), topiramate (13), lacosamide (7), vigabatrin (6), phenobarbital (5), gabapentin (5), phenytoin (4), pregabalin (4), eslicarbazepine (3), brivaracetam (2), clobazam (2), perampanel (2), trimethadione (2), rufinamide (2), zonisamide (2), primidone (1), and tiagabine (1). There were no reports of oxcarbazepine and felbamate with drug-induced alopecia. Hair loss seen with ASMs was diffuse and non-scarring. Telogen effluvium was the most common cause of alopecia. A characteristic feature was the reversibility of alopecia after ASM dose adjustment. Conclusions: Alopecia should be considered one important adverse effect of ASMs. Patients reporting hair loss with ASM therapy should be further investigated, and specialist consultation is recommended.

PMID:37367730 | DOI:10.3390/medicines10060035

Medicines (Basel). 2023 May 25;10(6):33. doi: 10.3390/medicines10060033.

ABSTRACT

BACKGROUND: Fluoroquinolones (FQNs) are related to several central nervous system side effects. This review aims to evaluate the clinical-epidemiological profile, pathophysiological mechanisms, and management of FQNs-associated movement disorders (MDs).

METHODS: Two reviewers identified and assessed relevant reports in six databases without language restriction between 1988 and 2022.

RESULTS: A total of 45 reports containing 51 cases who developed MDs secondary to FQNs were reported. The MDs included 25 myoclonus, 13 dyskinesias, 7 dystonias, 2 cerebellar syndromes, 1 ataxia, 1 tic, and 2 undefined cases. The FQNs reported were ciprofloxacin, ofloxacin, gatifloxacin, moxifloxacin, levofloxacin, gemifloxacin, and pefloxacin. The mean and median age were 64.54 (SD: 15.45) and 67 years (range: 25-87 years). The predominant sex was male (54.16%). The mean and median time of MD onset were 6.02 (SD: 10.87) and 3 days (range: 1-68 days). The mean and median recovery time after MD treatment was 5.71 (SD: 9.01) and 3 days (range: 1-56 days). A complete recovery was achieved within one week of drug withdrawal in 80.95% of the patients. Overall, 95.83% of the individuals fully recovered after management.

CONCLUSIONS: Future cases need to describe the long-term follow-up of the individuals. Additionally, FQN-induced myoclonus should include electrodiagnostic studies.

PMID:37367728 | DOI:10.3390/medicines10060033

Dtsch Med Wochenschr. 2023 Jul;148(13):828-835. doi: 10.1055/a-1871-6426. Epub 2023 Jun 26.

ABSTRACT

Drug-induced toxic hepatopathies and drug-induced liver injury, DILI, are characterized by a variety of clinical manifestations and therefore represent a significant diagnostic challenge. This article shows how DILI is diagnosed and what therapy options exist. Current special cases of DILI genesis are also discussed (DOACs, IBD drugs, tyrosine kinase inhibitors). These newer substances and corresponding hepatotoxic effects are not yet fully understood. The internationally recognized and online available RUCAM score (Roussel Uclaf Causality Assessment Method) helps to assess the probability of drug-related toxic liver damage.

PMID:37364577 | DOI:10.1055/a-1871-6426

Drug Des Devel Ther. 2023 Jun 19;17:1831-1846. doi: 10.2147/DDDT.S406551. eCollection 2023.

ABSTRACT

BACKGROUND: Arisaematis Rhizome (AR) has been used as a damp-drying, phlegm-resolving, wind-expelling, pain-alleviating, and swelling-relieving drug for thousands of years. However, the toxicity limits its clinical applications. Therefore, AR is usually processed (Paozhi in Chinese) prior to clinical use. In this study, the integration of ultra-high performance liquid chromatography-quadrupole/ time-of-flight mass spectrometry-based metabolomics and network analysis was adopted to investigate the metabolic shifts induced by AR and explore the processing mechanism.

MATERIALS AND METHODS: Extracts of crude and processed AR products (1g/kg) were intragastrically administered to rats once daily for four consecutive weeks. The renal function was evaluated by blood urea nitrogen, creatinine, interleukin-1 beta (IL-1β) and tumor necrosis factor-alpha (TNF-α), malondialdehyde (MDA), super oxide dismutase (SOD), the ratio of glutathione/glutathione disulfide (GSH/GSSH), glutathione peroxidase (GSH-Px) and histopathological examination. Furthermore, the chemical composition of AR was clarified by ultra-high performance liquid chromatography-quadrupole/ time-of-flight mass spectrometry, after which the integration of metabolomics and network analysis was adopted to investigate the metabolic shifts induced by AR and explore the processing mechanism.

RESULTS: Crude AR caused renal damage by stimulating inflammation and oxidative stress, as confirmed by the increased production of IL-1β, TNF-α and MDA, and decreased levels of SOD, GSH/GSSH and GSH-Px. Processing with ginger juice, alumen and bile juice alleviated the damage to kidney. Metabolomics results showed that a total of 35 potential biomarkers enriched in amino acid metabolism, glycerophospholipid metabolism, fatty acid-related pathways, etc. were deduced to be responsible for the nephrotoxicity of AR and the toxicity-reducing effect of processing.

CONCLUSION: This work provided theoretical and data support for the in-depth study of the processing mechanism, showing that processing reduces AR nephrotoxicity through multiple metabolic pathways.

PMID:37360574 | PMC:PMC10289099 | DOI:10.2147/DDDT.S406551

Rev Med Chil. 2022 Oct;150(10):1317-1324. doi: 10.4067/S0034-98872022001001317.

ABSTRACT

BACKGROUND: Mycophenolate mofetil (MMF) is a largely used immunosuppressive agent in the prevention of transplant rejection and lupus nephritis. Its use has been extended to other immune-mediated diseases (ID).

AIM: To assess the off-label use of MMF, its performance as a glucocorticoid sparing agent, the therapeutic response, and its adverse effects.

MATERIAL AND METHODS: A retrospective study was performed. One hundred-seven patients aged 58 ± 16 years (83% females) who received MMF for ID in off label uses between 2016 and 2018 were included. The study variables were cause of MMF indication, sex, age, use as a first- or second-line treatment and maintenance dosing. The cumulative doses of glucocorticoids six months before and after MMF indication were compared.

RESULTS: MMF was used as a second-line therapy in 66 patients (62%). The mean maintenance dose of MMF was 1,500 ± 540 mg/day. Prednisone cumulative doses were 3,908 ± 2,173 and 1,672 ± 1,083 milligrams six months before and six months after starting MMF, respectively (p < 0.01). Adverse effects were identified in 21 (20%) cases, none of them serious.

CONCLUSIONS: Mycophenolate has a favorable response profile as a second line immunosuppressive agent. It is effective as a glucocorticoid sparing drug. The safety profile is also favorable as adverse effects were scanty and mild.

PMID:37358090 | DOI:10.4067/S0034-98872022001001317

Reg Anesth Pain Med. 2023 Jun 26:rapm-2023-104452. doi: 10.1136/rapm-2023-104452. Online ahead of print.

ABSTRACT

INTRODUCTION: The substantial compression of the dural sac and the subsequent cranial shift of cerebrospinal fluid caused by a high-volume caudal block has been shown to significantly but transiently reduce cerebral blood flow. The aim of the present study was to determine whether this reduction in cerebral perfusion is significant enough to alter brain function, as assessed by electroencephalography (EEG).

METHODS: Following ethics approval and parental informed consent, 11 infants (0-3 months) scheduled to undergo inguinal hernia repair were included in the study. EEG electrodes (using nine electrodes according to the 10-20 standard) were applied following anesthesia induction. Following a 5 min baseline period, a caudal block was performed (1.5 mL/kg), whereafter the EEG, hemodynamic, and cerebral near-infrared spectroscopy responses were followed during a 20 min observation period that was divided into four 5 min segments. Special attention was given to alterations in delta power activity since this may indicate cerebral ischemia.

RESULTS: All 11 infants displayed transient EEG changes, mainly represented by increased relative delta power, during the initial 5-10 min postinjection. The observed changes had returned close to baseline values 15 min postinjection. Heart rate and blood pressure remained stable throughout the study.

CONCLUSION: A high-volume caudal block appears to increase intracranial pressure, thereby reducing cerebral blood flow, to the extent that it transiently will affect cerebral function as assessed by EEG (increased delta power activity) in approximately 90% of small infants.

TRIAL REGISTRATION NUMBER: ACTRN12620000420943.

PMID:37364921 | DOI:10.1136/rapm-2023-104452

Arch Endocrinol Metab. 2023 Jun 19;67(6):e000654. doi: 10.20945/2359-3997000000654.

ABSTRACT

OBJECTIVE: To evaluate the association between the patients' characteristics and the development of endocrine toxicity and to assess the association between endocrine-related adverse effects (ERAE) development and mortality.

SUBJECTS AND METHODS: A retrospective observational study was conducted in 98 patients submitted to immunotherapy in our centre since its introduction in 2015 until March 2021. We excluded patients for which data regarding the corticotroph axis evaluation was missing. We used linear and logistic regression models to address our aims.

RESULTS: We observed a significant negative association between ERAE development and death (OR 0.32; p = 0.028). We detected no associations between ERAE and the following characteristics: age at immune checkpoint inhibitors (ICI) initiation, sex, diabetes mellitus, medical history, immunotherapy duration and ICI type.

CONCLUSION: The development of an ERAE may be associated with a better overall survival rate in advanced oncologic disease, supporting the role of an unleashed immune system response to malignant cells.

PMID:37364153 | DOI:10.20945/2359-3997000000654

Front Immunol. 2023 Jun 9;14:1166299. doi: 10.3389/fimmu.2023.1166299. eCollection 2023.

ABSTRACT

OBJECTIVE: This review aims to determine the incidence and risk of pancreatic adverse events (AEs) associated with immune checkpoint inhibitors (ICIs) therapy for solid tumors.

METHODS: We conducted a comprehensive systematic literature search in PubMed, Embase, and Cochrane Library up to March 15, 2023, to identify all randomized controlled trials comparing ICIs with standard treatment in solid tumors. We included studies that reported immune-related pancreatitis or elevation of serum amylase or lipase levels. Following protocol registration in PROSPERO, we conducted a systematic review and meta-analysis.

RESULTS: 59 unique randomized controlled trials with at least one ICI-containing arm (41 757 patients) were retrieved. The incidences for all-grade pancreatitis, amylase elevation and lipase elevation were 0.93% (95% CI 0.77-1.13), 2.57% (95% CI 1.83-3.60) and 2.78% (95% CI 1.83-4.19), respectively. The incidences for grade ≥3 pancreatitis, amylase elevation and lipase elevation were 0.68% (95% CI 0.54-0.85), 1.17% (95% CI 0.83-1.64) and 1.71% (95% CI 1.18-2.49), respectively. The use of ICIs was associated with an increased risk of all-grade pancreatic immune-related AEs (irAEs) including pancreatitis (OR=2.04, 95% CI 1.42-2.94, P =0.0001), amylase elevation (OR=1.91, 95% CI 1.47-2.49, P < 0.0001) and lipase elevation (OR=1.77, 95% CI 1.37-2.29, P < 0.0001). In addition to these, the post-hoc analysis found that PD-1 inhibitors had a significant higher risk of pancreatic AEs compared with PD-L1 inhibitors and the patients undergoing dual ICI therapy were at a significantly higher risk of pancreatic AEs than the patients receiving single ICI therapy.

CONCLUSION: Our study provides an overview of the incidence and risk of ICI-associated pancreatitis and pancreatic enzyme elevations in the treatment of solid tumors. Our findings may help raise awareness among clinicians of the potential for ICI-associated pancreatic AEs in clinical practice.

SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO, identifier 345350.

PMID:37359551 | PMC:PMC10289552 | DOI:10.3389/fimmu.2023.1166299

Onco Targets Ther. 2023 Jun 20;16:441-464. doi: 10.2147/OTT.S370880. eCollection 2023.

ABSTRACT

Relapsed/refractory multiple myeloma remains a challenging disease necessitating the development of more effective treatment options. In the past decade, myeloma therapies have made significant advancements with the introduction of new treatment modalities. One of the new major targets for these novel therapeutics has been B-cell maturation antigen (BCMA), which is expressed on mature B-lymphocytes and plasma cells. There are three main categories of BCMA-targeted therapies currently available, including bispecific antibodies (BsAbs), antibody drug conjugates (ADCs), and chimeric antigen receptor (CAR) T-cell therapies. In this review, we discuss the existing BCMA-targeted therapies and provide insights into currently available treatment and future developments, with a particular focus on clinical efficacy and common drug-related adverse events.

PMID:37359353 | PMC:PMC10290473 | DOI:10.2147/OTT.S370880

Int J Tuberc Lung Dis. 2023 Jul 1;27(7):506-519. doi: 10.5588/ijtld.23.0078.

ABSTRACT

BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE.METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards.RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitivity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research.CONCLUSION: These standards provide a person-centred, consensus-based approach to minimise the impact of AE during TB treatment.

PMID:37353868 | DOI:10.5588/ijtld.23.0078

J Hepatol. 2023 Jun 5:S0168-8278(23)00342-2. doi: 10.1016/j.jhep.2023.05.013. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: This study assessed the effects of the GLP-1/glucagon receptor co-agonist efinopegdutide relative to the selective GLP-1 receptor agonist semaglutide on liver fat content (LFC) in patients with nonalcoholic fatty liver disease (NAFLD).

METHODS: This was a Phase 2a, randomized, active-comparator-controlled, parallel-group, open-label study. A magnetic resonance imaging-estimated proton density fat fraction assessment was performed to determine LFC at screening and Week 24. Participants with an LFC of ≥10% at screening were randomized 1:1 to open-label efinopegdutide 10 mg subcutaneous (SC) once weekly or semaglutide 1 mg SC once weekly for 24 weeks, stratified according to concurrent diagnosis of type 2 diabetes. Both drugs were titrated to the target dose over an 8-week time period. The primary efficacy endpoint was relative reduction from baseline in LFC (%) after 24 weeks of treatment.

RESULTS: Among 145 randomized participants (efinopegdutide N=72, semaglutide N=73), 33.1% had T2DM. At baseline, mean body mass index was 34.3 kg/m2and mean LFC was 20.3%. The least squares (LS) mean relative reduction from baseline in LFC at Week 24 was significantly (p<0.001) greater with efinopegdutide (72.7% [90% CI: 66.8, 78.7]) than with semaglutide (42.3% [90% CI: 36.5, 48.1]). Both treatment groups had an LS mean percent reduction from baseline in body weight at Week 24 (efinopegdutide 8.5% vs semaglutide 7.1%; p=0.085). Slightly higher incidences of adverse events and drug-related adverse events were observed in the efinopegdutide group compared with the semaglutide group, primarily related to an imbalance in gastrointestinal adverse events.

CONCLUSIONS: In patients with NAFLD, treatment with efinopegdutide 10 mg weekly led to a significantly greater reduction in LFC than semaglutide 1 mg weekly. (EudraCT: 2020-005136-30; NCT: 04944992) IMPACT AND IMPLICATIONS: Currently, there are no approved therapies for nonalcoholic steatohepatitis (NASH). The weight loss associated with glucagon-like peptide-1 (GLP-1) receptor agonists has been shown to decrease hepatic inflammation in patients with NASH. In addition to reducing liver fat content (LFC) indirectly through weight loss, glucagon receptor agonism may also reduce LFC by acting on the liver directly to stimulate fatty acid oxidation and reduce lipogenesis. This study demonstrated that treatment of nonalcoholic fatty liver disease (NAFLD) patients with the GLP-1/glucagon receptor co-agonist efinopegdutide at 10 mg weekly led to a significantly greater reduction in LFC compared with the GLP-1 receptor agonist semaglutide at 1 mg weekly, suggesting that efinopegdutide may be an effective treatment for NASH.

CLINICAL TRIAL NUMBER: EudraCT: 2020-005136-30; NCT: 04944992.

PMID:37355043 | DOI:10.1016/j.jhep.2023.05.013

Medicine (Baltimore). 2023 Jun 23;102(25):e34044. doi: 10.1097/MD.0000000000034044.

ABSTRACT

BACKGROUND: Correction of calcium, phosphorus, and parathyroid hormone disorders is the standard of treatment in nondialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD). However, the side effects and adverse reactions are still the main problems. Moreover, the lack of protection of kidney function in the treatment dramatically affects patients' health. Although Traditional Chinese Medicine, specifically tonifying kidney and strengthen bone (TKSB) therapy, is wildly applied to patients with CKD-MBD in China, the evidence of TKSB therapy in the treatment of CKD-MBD is limited. Thus, we conducted this meta-analysis to evaluate the efficacy and safety of TKSB therapy combined with Western medicine (WM) for nondialysis patients with CKD-MBD.

METHODS: Two investigators conducted systematic research of randomized controlled trials of TKSB therapy for CKD-MBD from 7 electronic databases. Methodological quality evaluations were performed using the Cochrane collaboration tool, and data analysis was conducted by RevMan v5.3 software and STATA v15.0.

RESULTS: In total, 8 randomized controlled trials involving 310 patients met the criteria of meta-analysis. The complete results showed that compared with WM alone, TKSB treatment could improve the clinical efficacy rate (risk ratio = 4.49, 95% confidence interval [CI]: [2.64, 7.61], P .00001), calcium (weighted mean difference [WMD] = 0.11, 95% CI: [0.08, 0.14], P < .00001), serum creatinine (WMD = 45.58, 95% CI: [32.35, 58.8], P < .00001) phosphorus (WMD = 0.11, 95% CI: [0.08, 0.13], P < .00001), parathyroid hormone (WMD = 16.72, 95% CI: [12.89, 20.55], P < .00001), blood urea nitrogen levels (WMD = 0.95, 95% CI: [0.26, 1.64], P = .007) on nondialysis patients with CKD-MBD, which was beneficial to improve the patients' bone metabolic state and renal function. In addition, evidence shows that, compared with WM alone, TKSB treatment is safe and does not increase side effects.

CONCLUSION: The systematic review found that TKSB therapy combined with WM has a positive effect on improving renal function and correcting bone metabolism disorder in nondialysis patients with CKD-MBD, which shows that Traditional Chinese Medicine is effective and safe in treating CKD-MBD. However, more high-quality, large-sample, multicenter clinical trials should be conducted to assess the safety and efficacy of TKSB therapy in treating nondialysis patients with CKD-MBD.Systematic review registration: INPLASY2020120086.

PMID:37352066 | PMC:PMC10289535 | DOI:10.1097/MD.0000000000034044

Medicine (Baltimore). 2023 Jun 23;102(25):e34037. doi: 10.1097/MD.0000000000034037.

ABSTRACT

RATIONALE: This study aimed to evaluate the efficacy of topical application of Aloe vera gel in preventing chemotherapy-induced hyperpigmentation (CIH). CIH is a common side effect of chemotherapy that causes skin irritation, redness, and itching. Aloe vera has been studied for its potential use in treating radiation-induced dermatitis, which may help alleviate some of the symptoms associated with this condition.

PATIENT CONCERNS: In this study, 4 children requiring curative chemotherapy were prospectively enrolled and treated with Aloe vera gel.

DIAGNOSIS: Acute skin reactions were monitored and classified according to the Common Terminology Criteria for Adverse Events Grading Scale.

INTERVENTIONS: Patients were asked to use the gel on one-half of the body field twice daily from the beginning of treatment until 4 weeks after the completion of chemotherapy, with no medication to be used on the other half.

OUTCOMES: The results indicate that applying Aloe vera gel may reduce the visibility of hyperpigmentation at subsequent time points. The most important observation was that the continued application of Aloe vera gel 4 weeks after the completion of chemotherapy was effective in reducing the grading of CIH.

LESSONS: These effects highlight the potential of Aloe vera gel as a topical onconutraceutical treatment for CIH.

PMID:37352058 | PMC:PMC10289538 | DOI:10.1097/MD.0000000000034037

Drug Ther Bull. 2023 Jun 23:dtb-2023-000034. doi: 10.1136/dtb.2023.000034. Online ahead of print.

NO ABSTRACT

PMID:37353308 | DOI:10.1136/dtb.2023.000034

Anticancer Res. 2023 Jul;43(7):3203-3212. doi: 10.21873/anticanres.16494.

ABSTRACT

BACKGROUND/AIM: Ramucirumab has been approved for the management of hepatocellular carcinoma (HCC) after progression on sorafenib; however, the data on ramucirumab in heavily pretreated HCC are limited. This study aimed to investigate the real-world efficacy and safety of ramucirumab in patients with heavily pretreated advanced HCC.

PATIENTS AND METHODS: Patients with advanced HCC who received intravenous ramucirumab as second-line and later therapy were retrospectively reviewed. Kaplan-Meier method was used to analyze progression-free survival (PFS) and overall survival (OS). Additionally, prognostic factors were estimated using hazard ratios with 95% confidence intervals.

RESULTS: In total, 31 patients with advanced HCC who received ramucirumab were enrolled, including 11 patients with second-line treatment and 20 with third-line and later-line treatment. The objective response rate was 3.2% with a disease control rate (DCR) of 45.2%, and the DCR of ramucirumab between the second-line group and the third-line and later-line groups did not differ. The median PFS and OS were 2.1 months and 6.7 months, respectively, in the whole population. In the multivariate analyses, alpha-fetoprotein <1,000 ng/ml was an independent prognostic factor for better PFS and OS. All adverse events were classified as grade 1-2 without grade 3-4 toxicities or drug-related mortality. Additionally, 51.6% of patients received subsequent therapy after progression on ramucirumab.

CONCLUSION: The results of our study show the efficacy and safety of ramucirumab in patients with heavily pretreated HCC in real-world practice.

PMID:37351980 | DOI:10.21873/anticanres.16494

Cureus. 2023 May 22;15(5):e39348. doi: 10.7759/cureus.39348. eCollection 2023 May.

ABSTRACT

Vancomycin, a glycopeptide antibiotic, is widely used for Gram-positive cocci or bacilli bacteria-induced serious infections. Although considered safe and effective, it still causes adverse events. Vancomycin-induced immune thrombocytopenia is a rarely reported adverse event, manifesting from asymptomatic thrombocytopenia to life-threatening bleeding. We underline a case of a 56-year-old male with a diabetic foot with an infected exudating purulent ulcer. He experienced a significant drop in platelet count after commencing vancomycin, and discontinuing vancomycin resulted in improved platelet count with positive vancomycin-induced anti-platelet antibodies. After ruling out other possible causes of thrombocytopenia, a presumptive diagnosis of vancomycin-induced thrombocytopenia was made.

PMID:37351249 | PMC:PMC10284564 | DOI:10.7759/cureus.39348

Ther Apher Dial. 2023 Jun 22. doi: 10.1111/1744-9987.14028. Online ahead of print.

ABSTRACT

BACKGROUND: The effects of tenapanor in reducing serum phosphorus in hemodialysis patients with hyperphosphatemia are uncertain and no relevant meta-analysis has been conducted. We performed a meta-analysis of randomized placebo-controlled trials to evaluate the efficacy and safety of tenapanor.

METHODS: All randomized controlled trials of tenapanor were searched up to 1 August 2022. The primary endpoint was the change in serum phosphorus level from baseline with tenapanor and placebo. Data on drug-related adverse events (AEs), gastrointestinal AEs and diarrhea were collected to determine the safety of tenapanor.

RESULTS: There were 533 patients throughout five trials that were eligible. Tenapanor significantly lowered blood phosphorus level by 1.79 mg/dl in the mean difference than the placebo. Diarrhea, gastrointestinal AEs, and drug-related AEs were more severe than placebo.

CONCLUSIONS: This meta-analysis showed that although drug side effects were common, tenapanor significantly reduced serum phosphorus level in hemodialysis patients.

PMID:37349983 | DOI:10.1111/1744-9987.14028