Close Monitoring For Adverse Effects Research Articles

Efficacy and safety of co-trimoxazole in device-related bone and joint infections: a CRIOGO multicentre case-control study.

Co-trimoxazole could be an alternative antibiotic to treat device-related bone and joint infection (BJI) but there are few published data about its efficacy and safety in this complex scenario to treat infection. The objective was to compare the outcome of patients with device-related BJI treated with an antibiotic regimen including co-trimoxazole versus a regimen without co-trimoxazole. This multicentre case-control study included consecutive adult patients diagnosed with device-related BJI. Each patient receiving co-trimoxazole was included in the co-trimoxazole group and was matched with two control patients, with stratification on microbial aetiology and age. The primary outcome was composite and defined by death or treatment failure during the follow-up. In this study, 150 patients were included, 50 in the co-trimoxazole group and 100 in the control group. The rate of reaching the primary endpoint was 18% in the co-trimoxazole group (9/50 cases) versus 21% in the control group (21/100) (P = 0.66). Co-trimoxazole use was not associated with an unfavourable outcome in the multivariate analysis (adjusted OR 0.8, 95% CI 0.31-2.06, P = 0.64). Although no significant difference was observed in premature discontinuation of treatment due to an adverse event between both groups (14 versus 12%, P = 0.73), treatment-related adverse events were significantly more frequently reported in patients of the co-trimoxazole group than the control group [34% (17/50) versus 18% (18/100), P = 0.03]. Co-trimoxazole appears to be an effective alternative for the treatment of BJI, even when it occurs on a device, but the safety profile requires close monitoring of adverse effects.

Acute and preventive medical treatment of cluster headache in Taiwan: A narrative review.

Cluster headache (CH) is a debilitating neurological disorder characterized by severe, unilateral pain and ipsilateral autonomic symptoms. Chronic CH is exceedingly rare in Taiwan, constituting approximately 1% of all CH cases. This narrative review provides an up-to-date overview of the acute and preventive treatment strategies for CH in Taiwan, focusing on currently available pharmacological options in the country. The treatment approach for CH in Taiwan involves a stepwise strategy. High-flow oxygen and triptan nasal sprays are the mainstays of acute treatment, providing rapid relief and good tolerability. Transitional treatments, such as oral steroids and suboccipital steroid injections, serve as a crucial bridge between acute and long-term preventive therapies, offering temporary relief while minimizing side effects through a carefully limited duration. For preventive treatment, verapamil is the first-line option, with lithium and topiramate being the second-line alternatives. Among the CGRP monoclonal antibodies, galcanezumab has demonstrated efficacy in the prevention of episodic CH. Preventive treatments are personalized to individual patients, starting with low doses and close monitoring for adverse effects. Neuromodulatory therapies, such as non-invasive vagus nerve stimulation, show promise for chronic and refractory CH but have limited availability in Taiwan. In conclusion, despite the availability of various acute and preventive treatment options, unmet needs in the management of CH in Taiwan remain. In particular, increased awareness and education among healthcare professionals to improve the diagnosis and management of CH in Taiwan should be implemented.

Multifaceted role of erlotinib in various cancer: nanotechnology intervention, patent landscape, and advancements in clinical trials.

Erlotinib (ELB) is a tyrosine kinase inhibitor that targets the activity of Epidermal Growth Factor Receptor (EGFR) protein found in both healthy and cancerous cells. It binds reversibly to the ATP-binding site of the EGFR tyrosine kinase. ELB was approved by the US Food and Drug Administration (FDA) in 2004 for advanced non-small cell lung cancer (NSCLC) treatment in patients who relapsed after at least one other therapy. It was authorized for use with gemcitabine in 2005 for the treatment of advanced pancreatic cancer. In addition to lung cancer, ELB has shown promising results in the treatment of other cancers, including breast, prostate, colon, pancreatic, cervical, ovarian, and head and neck cancers. However, its limited water solubility, as a BCS class II drug, presents biopharmaceutical problems. Nanoformulations have been developed to overcome these issues, including increased solubility, controlled release, enhanced stability, tumor accumulation, reduced toxicity, and overcoming drug resistance. In older patients, ELB management should involve individualized dosing based on age-related changes in drug metabolism and close monitoring for adverse effects. Regular assessments of renal and hepatic functions are essential. This review provides an overview of ELB's role of ELB in treating various cancers, its associated biopharmaceutical issues, and the latest developments in ELB-related nanotechnology interventions. It also covers ELB patents granted in previous years and the ongoing clinical trials.

Unveiling Novel Drug Targets and Emerging Therapies for Rheumatoid Arthritis: A Comprehensive Review.

Rheumatoid arthritis (RA) is a chronic debilitating autoimmune disease, that causes joint damage, deformities, and decreased functionality. In addition, RA can also impact organs like the skin, lungs, eyes, and blood vessels. This autoimmune condition arises when the immune system erroneously targets the joint synovial membrane, resulting in synovitis, pannus formation, and cartilage damage. RA treatment is often holistic, integrating medication, physical therapy, and lifestyle modifications. Its main objective is to achieve remission or low disease activity by utilizing a "treat-to-target" approach that optimizes drug usage and dose adjustments based on clinical response and disease activity markers. The primary RA treatment uses disease-modifying antirheumatic drugs (DMARDs) that help to interrupt the inflammatory process. When there is an inadequate response, a combination of biologicals and DMARDs is recommended. Biological therapies target inflammatory pathways and have shown promising results in managing RA symptoms. Close monitoring for adverse effects and disease progression is critical to ensure optimal treatment outcomes. A deeper understanding of the pathways and mechanisms will allow new treatment strategies that minimize adverse effects and maintain quality of life. This review discusses the potential targets that can be used for designing and implementing precision medicine in RA treatment, spotlighting the latest breakthroughs in biologics, JAK inhibitors, IL-6 receptor antagonists, TNF blockers, and disease-modifying noncoding RNAs.

Clinical and electroencephalographic correlates of carbamazepine-associated hiccups in epileptic patients.

Carbamazepine, a commonly prescribed antiepileptic drug, is known to induce hiccups in a subset of epileptic patients. Although relatively uncommon, can have significant clinical implications. This comprehensive review delves into the clinical and electroencephalographic correlates of carbamazepine-associated hiccups, aiming to enhance understanding and management of this neurological side effect. The authors' review synthesizes qualitative epidemiological data, revealing that carbamazepine-induced hiccups occur in a subset of patients receiving the medication, with reported incidence rates ranging from 2.5 to 40%. Despite its relatively low prevalence, hiccups pose substantial challenges for patients and healthcare providers. Complications associated with carbamazepine-induced hiccups include disruption of sleep, impaired social functioning, and decreased quality of life, underscoring the clinical significance of this side effect. Effective management strategies can be implemented through a multidisciplinary approach, including collaboration among neurologists, pharmacists, and other healthcare professionals. These may include dose adjustments, medication discontinuation, and adjunctive therapies such as diaphragmatic breathing exercises or acupuncture. Additionally, close monitoring for adverse effects and timely intervention are essential to mitigate the impact of hiccups on patient well-being. Essentially, carbamazepine-induced hiccups represent a clinically relevant phenomenon that warrants attention in the management of epilepsy. By recognizing the clinical manifestations, understanding the underlying pathophysiology, and implementing evidence-based management strategies, healthcare providers can optimize patient care and improve outcomes in this patient population.

Shortened Treatment Regimens for Drug Sensitive TB.

Tuberculosis (TB) has remained a global health challenge despite the availability of effective anti-tubercular drugs and various treatment strategies. Apart from the complications related to TB disease per se, adverse effects of antitubercular therapy (ATT) also contribute to morbidity. In addition to the adverse effects, the long duration of the treatment regimen also reduces the patient's acceptability of ATT. The available "short-course treatment regimens" are still relatively long, thereby adversely affecting treatment compliance. There is a need for effective, safe, short and intensive regimens for TB which can reduce the treatment cost and adverse effects, thereby improving its acceptance. With the emergence of new evidence, the World Health Organization (WHO) has recently endorsed 4 mo short duration ATT regimen for non-severe, drug-sensitive cases of tuberculosis. Even in severe forms of disease like tubercular meningitis (TBM), trials are underway evaluating efficacy and safety of shorter regimens. Inclusion of fluroquinolones and rifapentine help shorten the regimens. These shortened regimens, however, need more close monitoring for adverse effects and may need to be converted to longer course if there is inadequate clinical response. Thus, shorter regimens for pediatric TB are likely to not only decrease the burden on patients and healthcare but also improve compliance and lower the side effects of the drugs due to prolonged exposure. This article reviews the current evidence and the guidelines pertaining to the shortened, intensive regimens for drug-sensitive tuberculosis.

Successful implementation of outpatient R ± DHAX (rituximab, dexamethasone, oxaliplatin, cytarabine) for select patients with lymphoma: a single-center experience

R ± DHAX has been traditionally administered to inpatient due to the timing of chemotherapy administration and the perceived need for close monitoring of adverse effects. To administer R ± DHAX outpatient, a multidisciplinary task force created clinical and educational guidelines which were implemented through two phases: pilot and expansion. The pilot program determined the feasibility of transitioning R ± DHAX outpatient at a single infusion site. The expansion phase led to a service-wide implementation across all outpatient sites. A total of 40 patients were included, of which 23 patients completed all cycles, outpatient, 12 transitioned inpatient to outpatient administration, and 5 transitioned outpatient to inpatient administration. The success rate of outpatient R ± DHAX administration was 90% (36 patients successfully completed outpatient administration/40 total patients). No cytarabine-related cerebellar or ophthalmic toxicity was reported. Outpatient R ± DHAX saved 192 hospital days. R ± DHAX could be successfully administered outpatient with minimal safety concerns and reduced hospital bed utilization.

Guidelines for the Acute Treatment of Cerebral Edema in Neurocritical Care Patients

BackgroundAcute treatment of cerebral edema and elevated intracranial pressure is a common issue in patients with neurological injury. Practical recommendations regarding selection and monitoring of therapies for initial management of cerebral edema for optimal efficacy and safety are generally lacking. This guideline evaluates the role of hyperosmolar agents (mannitol, HTS), corticosteroids, and selected non-pharmacologic therapies in the acute treatment of cerebral edema. Clinicians must be able to select appropriate therapies for initial cerebral edema management based on available evidence while balancing efficacy and safety.MethodsThe Neurocritical Care Society recruited experts in neurocritical care, nursing, and pharmacy to create a panel in 2017. The group generated 16 clinical questions related to initial management of cerebral edema in various neurological insults using the PICO format. A research librarian executed a comprehensive literature search through July 2018. The panel screened the identified articles for inclusion related to each specific PICO question and abstracted necessary information for pertinent publications. The panel used GRADE methodology to categorize the quality of evidence as high, moderate, low, or very low based on their confidence that the findings of each publication approximate the true effect of the therapy.ResultsThe panel generated recommendations regarding initial management of cerebral edema in neurocritical care patients with subarachnoid hemorrhage, traumatic brain injury, acute ischemic stroke, intracerebral hemorrhage, bacterial meningitis, and hepatic encephalopathy.ConclusionThe available evidence suggests hyperosmolar therapy may be helpful in reducing ICP elevations or cerebral edema in patients with SAH, TBI, AIS, ICH, and HE, although neurological outcomes do not appear to be affected. Corticosteroids appear to be helpful in reducing cerebral edema in patients with bacterial meningitis, but not ICH. Differences in therapeutic response and safety may exist between HTS and mannitol. The use of these agents in these critical clinical situations merits close monitoring for adverse effects. There is a dire need for high-quality research to better inform clinicians of the best options for individualized care of patients with cerebral edema.

Therapeutic effect of intravenous sodium thiosulfate for uremic pruritus in hemodialysis patients

Objectives This study aimed to compare the efficacy of intravenous sodium thiosulfate (IV STS) with that of loratadine in the treatment of uremic pruritus in hemodialysis (HD) patients. Methods This retrospective study included 44 HD patients with pruritus aged over 18 years between June 2018 and January 2020 at the Aerospace Center Hospital of China. Twenty-four HD patients received 3.2 g IV STS treatment three times per week at the end of each HD session for 8 weeks. Twenty HD patients received loratadine (10 mg/day) for 8 weeks. Pruritus intensity was measured using a visual analog scale (VAS) and the detailed pruritus score (DPS) at three time points. The safety of STS was evaluated according to adverse event symptoms and biological variable changes. Results There was no significant difference between the STS and loratadine groups in age, sex, characteristics of pruritus, or other clinical variables before treatment. After 8 weeks of treatment, the VAS score (7.07 ± 2.56 and 2.67 ± 2.01) and DPS (30.72 ± 4.81 and 8.04 ± 2.86) decreased significantly in the STS group (p < 0.05). The mean decrease in VAS score (6.89 ± 1.98 and 6.34 ± 2.35) and DPS (28.90 ± 3.24 and 26.92 ± 2.41) in the loratadine group was not statistically significant (p > 0.05). There were no morbidities or mortalities associated with the use of either drug. All biological variables remained stable after therapy. Conclusions STS can improve uremic pruritus in HD patients. However, literature on the subject remains lacking. Close monitoring for adverse effects is advised.

Quality of life in healthy siblings of patients with first episode of psychotic illness and its predictors

Families of patients with first episode of psychotic illness are exposed to numerous distress factors related to the care of their relative. It has been shown that these families experience higher levels of anxiety, depression, economic strain, and helplessness. According to the prior studies, long-term psychotic illness can also have negative impact on quality of life (QoL) in healthy siblings [1]. The aim of our study was to assess QoL in siblings of patients with first episode of psychosis and to examine effects of sibling-related and illness-related variables on QoL. Study sample consisted of first-episode psychosis patients (n = 20) and their healthy siblings (n = 20). All subjects were administered World Health Organisation Quality of Life Questionnaire Scale Brief (WHOQOL-Brief). Duration of untreated psychosis, medication adherence (Hayward scale) and severity of positive psychotic symptomatology (evaluated by Positive and Negative Symptom Scale) were used as illness-related variables, birth order served as a sibling–related variable. QoL has been accepted as a valuable outcome measure in many psychiatric conditions; thus, identification of contributing factors may help to improve overall outcome. Moreover, close monitoring of adverse effects of illness on QoL in healthy siblings may become a part of larger prevention strategies.Supported by the grant projects MH CR AZV 15-28998A, MEYS NPU4NUDZ: LO1611.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Clinical practice guidelines for Obsessive-Compulsive Disorder.

Obsessive-compulsive disorder (OCD) is a common psychiatric illness with lifetime prevalence of 1-3% [1]. It is the fourth-most common psychiatric illness and a leading cause of disability. OCD is associated with significant impairment in functioning, quality of life and disability. If untreated, OCD is a chronic illness with a waxing and waning of symptoms. A recent meta-analysis of long-term naturalistic prospective studies demonstrated that nearly a half of patients experience remission with much higher rates of remission in Indian patients compared to those in the west [2]. Early diagnosis and appropriate treatment may improve outcomes. Despite OCD being a common mental illness, most seek treatment after several years of suffering. Those who suffer from OCD tend to be secretive about their symptoms and suffer from shame and embarrassment. Less than a third of OCD sufferers receive appropriate pharmacotherapy and even less receive evidence-based psychotherapy. Symptoms The hallmarks of OCD are presence of obsessions and compulsions. Obsessions are repetitive, unwanted, intrusive thoughts, images or urges that are mostly ego-dystonic and cause severe distress or anxiety. Compulsions (or rituals) are repetitive behaviours or mental acts that are performed in response to an obsession to reduce anxiety/distress or prevent a dreaded consequence. Obsessions and compulsions are time consuming, distressing and are often resisted unsuccessfully. Clinical manifestations of OCD are remarkably similar across cultures and geographic locations. Common obsessions and compulsions and symptom dimensions identified through factor-analytical studies are shown in Table 1. Table 1 Common symptoms of OCD

Antidepressant use in children and adolescents: Practice touch points to guide paediatricians

Depression in children and youth is common, and requires an understanding of its developmental character and associated comorbid conditions. Initial treatment of mild depression involves active supportive measures with a focus on symptom reduction and improved daily function. Where pharmacotherapy is warranted, evidence supports the use of selective serotonin reuptake inhibitor (SSRI) antidepressants, particularly fluoxetine, to manage moderate/severe depression. SSRI treatment should include a comprehensive management plan in the context of interdisciplinary care, an understanding of its pharmacology and clearly articulated goals for symptom reduction, functional status tracking (school, home and peers) and monitoring for the emergence of suicidal ideation/behaviour. For children with more severe symptoms or complicating factors (comorbid conditions), referral to mental health clinicians should be considered. Use of an SSRI should be associated with family/patient education about medication effects, specific social and health goals that promote self-esteem, improved function and close monitoring for adverse effects.

Depression in children

This summary of literature published during the past year focuses on research into factors that may contribute to development of childhood-onset depression and on appropriate assessment and treatment. The recent literature suggests that investigating risk factors and gene-environment interactions could be fruitful in elucidating the aetiology of childhood-onset depression and could have implications for developing preventive (selective or targeted programmes) and therapeutic strategies. These strategies clearly should involve interventions to improve parent-child relationships and parenting style, especially in children at high risk early in their lives. Cognitive-behavioural therapy, interpersonal therapy and (in the case of severe depression) selective serotonin reuptake inhibitor medications (fluoxetine as the first-line option, with close monitoring for adverse effects during treatment) appear to be effective in the management of depression in children. However, recent reports on psychotherapies yield a less clear picture about their effectiveness in childhood depression than was previously indicated. Controlled trial data and evidence-based guidelines for management of depressed children are limited with respect to pharmacological and psychotherapeutic options, especially in prepubertal and preschool children. Further research in this area is therefore warranted.

Oral Tacrolimus for Steroid‐dependent and Steroid‐resistant Ulcerative Colitis in Children

To evaluate tacrolimus in 3 situations: for the induction of remission in children with severe steroid-resistant ulcerative colitis (UC); for steroid sparing in children with steroid-dependent UC in whom treatment with other immunosuppressants fails; and for the maintenance of remission in children with steroid-dependent and steroid-resistant UC. We retrospectively evaluated 18 consecutive patients (13 with pancolitis) who were treated with oral tacrolimus at our institution from May 1999 to October 2005. Nine patients had steroid-resistant UC and 9 patients were steroid-dependent. We started patients initially on tacrolimus 0.2 mg/kg divided twice daily, with a goal plasma trough level of 10 to 15 ng/mL for the first 2 weeks, and then titrated doses to achieve plasma levels between 7 and 12 ng/mL after induction. Of the 18 patients in this study, 17 showed a positive response to tacrolimus therapy (ie, cessation of diarrhea and other symptoms) and 5 showed a prolonged response to tacrolimus. The mean time from initiation of tacrolimus therapy until response was 8.5 days. The mean duration of response was 260 days. Eleven of 18 patients required colectomy, including all of the patients with steroid-resistant UC, but only 2 of 9 who were steroid-dependent. The mean time from initiation of tacrolimus until colectomy was 392 days. It is possible that tacrolimus may benefit selected patients with steroid-dependent UC, including those who are intolerant of 6-mercaptopurine or azathioprine. Conversely, patients with steroid-resistant UC are unlikely to sustain a prolonged clinical response to tacrolimus and seem to require colectomy eventually. Careful considerations of risk versus benefit, as well as close monitoring for adverse effects, are essential in all patients.

Terapia hipolipemiante em situações especiais: síndrome de imunodeficiência adquirida

Lipid alterations can be observed early among patients with AIDS disease. Commonly, these lipid abnormalities include low HDL-C and modest increase in triglyceride plasma levels. Highly Active Anti-Retroviral Therapy (HAART) in these patients may aggravate the dyslipidemia, with notable increases in triglycerides as well as in LDL-C. There are several mechanisms proposed to explain the mixed hyperlipidemia observed in these subjects, including different steps in lipid metabolism. The importance of the treatment of dyslipidemia became evident with the increased life expectancy and reports of cardiovascular complications in these individuals. There is an insulin resistance state in patients with AIDS disease under treatment with HAART, who present with lipodystrophy, hypertriglyceridemia, low levels of HDL-C. Antiretroviral drugs are metabolized by CYP P450 3A4 and interactions with some statins, especially with simvastatin are expected to occur. Treatment with lipid-lowering agents should be based on lipid profile and coronary risk. For hypertriglyceridemias, fibrates (mainly fenofibrate or bezafibrate) should be the drugs of choice, as well as statins (mainly pravastatin). Combined treatment using fibrates plus statins are recommended for severe mixed hyperlipidemias under very close monitoring for adverse effects.

Monitoring lithium in breast milk: an individualized approach for breast-feeding mothers.

Lithium is a drug of choice for the management of bipolar disorder, a disease frequently affecting women in their childbearing years. Unfortunately, this drug has typically been contraindicated in nursing women. Data in humans are limited with respect to the use of this drug in lactating women, and early reports suggest high excretion into milk. The purpose of this report was to verify the excretion of lithium into human milk and to assess infant safety after breast-feeding. The authors found wide interpatient variability in lithium dose offered to the infant through breast milk (from 0% to 30% of maternal weight-adjusted dose), indicating that therapeutic drug monitoring of lithium in milk and/or in infant's blood, coupled with close monitoring of adverse effects, is a rational approach. Since therapeutic drug monitoring of lithium is routine, physicians caring for these women and infants should be encouraged to individualize their recommendations.

Rheumatoid arthritis in the aged. Incidence and optimal management.

Rheumatoid arthritis (RA) is estimated to occur in 0.3 to 3% of the general population. Up to one-third of RA patients first present for treatment after the age of 60 years (elderly-onset RA). The overall frequency in individuals older than 65 is increased, so that 30 to 40% of RA patients treated in rheumatology centres are > 60 years of age. Optimal management of all RA patients includes physical therapy, medications, both nonsteroidal anti- inflammatory drugs (NSAIDs) and remittive agents, and, in some cases, surgery. In the elderly, these treatment modalities at times need to be altered to accommodate age-related changes in body mechanics and organ function. Thus, the approach to physical therapy in older patients is different than in the young. There are fewer rest periods and more passive exercises. Drug treatment must also be modified, since NSAIDs and several remittive agents are more hazardous in elderly patients. Indications for orthopaedic procedures may also be different. The long term management of RA requires a delicate balance of benefit and risk. It is wise to begin with the least toxic medications. However, if necessary, potentially toxic medications can be given cautiously, with close monitoring for adverse effects.