Current drug safety最新文献

Purpose: The objective of this systematic review is to evaluate the patterns of postsurgical site infections, pre-surgical antibiotics prophylaxis, and related clinical outcomes in the recently published literature.

Methods: This systematic review is registered with PROSPERO registration number CRD42023398963. Several databases and individual journal websites were used to collect data from PubMed/Medline, TRIP, SCOPUS, Elsevier, Springer, ProQuest, and EMBASE. The established criteria of inclusion were RCTs, retrospective, prospective, and cross-sectional studies with patients who had a recent surgical procedure. Excluded from the study designs were systematic reviews, prospective studies, data on pediatrics, and data on disabilities. Quality assessment analysis of the results for randomized controlled trials (RCT) used CONSORT guidelines and STROBE guidelines for cross-sectional and cohort studies.

Results: A total of 328 articles were identified from different databases. Among them, 15 studies were included for data extraction and qualitative analysis. A total of 33,193 patients with an average rate of 11.5% (surgical site infections- SSIs) were identified in these studies during 2008-2022. The mean rate of SSIs among the total number of immunocompromised patients/procedures was 10.2%. The SSI on patients undergoing major surgical procedures with visible incisions was 26.0%. The majority of the studies reported the use of pre-surgical antibiotic prophylaxis. Cefazolin was mostly prescribed antibiotics and administered in 90% of patients. Other antibiotics included ceftriaxone (4%), cloxacillin (3%), and vancomycin (4%). The mean reported rate of SSIs with combination antibiotic prophylaxis therapy was 22.8%.

Conclusion: This systematic review concluded the limited reported data on surgical site infections (SSIs). The overuse of pre-surgical antibiotic prophylaxis has been reported in several studies. This study recommended developing standardized guidelines on the use of antibiotics related to surgical cases rather than co-morbidities.

Introduction: This case study presents a rare and fatal instance of Toxic Epidermal Necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome in a 51-year-old male patient diagnosed with Rheumatoid Arthritis (RA).

Case presentation: The patient was initially treated with sulfasalazine, leflunomide, and hydroxychloroquine, following which he developed a rash, fever, and loose stools. Drug allergy was suspected, and the antirheumatic medications were withdrawn, following which, the patient improved. A subsequent attempt was made to treat the RA with methotrexate, prednisolone, and hydroxychloroquine, following which the rash returned along with an increase in severity, including detachment of the epidermis and mucosa, and systemic involvement, both hepatic and renal. The patient ultimately succumbed to multiple organ dysfunction syndrome and neutropenic sepsis.

Conclusion: This case highlights the possibility of DRESS syndrome and Stevens-Johnson Syndrome (SJS)/TEN following treatment with anti-rheumatic medications. Evidence of this is rare, with the exception of sulfasalazine. This case also considers that the signs of a moderately severe adverse drug reaction could be the early warning signs of DRESS syndrome, which can be difficult to manage and may turn to be fatal. Additionally, this case highlights the need for maintenance of quality health records in low- and middle-income countries due to the failure to identify hydroxychloroquine as a suspected drug inducing the initial adverse reaction that resulted in it being prescribed again, leading to a fatal outcome.

Background: For surgical procedures of the upper limbs, ultrasound-guided supraclavicular brachial plexus block (SCBPB) represents a safe substitute for general anesthesia. The present study evaluated the effectiveness and safety of incorporating 1μg/kg dexmedetomidine (DEX) into 20 ml bupivacaine, as opposed to using 20 ml and 30 ml bupivacaine without additives, in SCBPB.

Methods: This randomized, controlled, double-blind study included 75 patients assigned to elective upper-limb surgery under the mid-humerus level. Patients were randomized into three equal groups to receive US-guided SCBPB with 20 ml bupivacaine 0.5% + 1 μg/kg DEX in group BD, 20 ml bupivacaine 0.5% without additives in group B20, and 30 ml bupivacaine 0.5% in group B30 (control).

Results: Compared to group B20, groups BD and B30 had significantly quicker onset times for sensory and motor blocks. Groups BD and B30 had a more significant block duration than group B20. Group BD experienced considerably lower intraoperative hemodynamics than groups B20 and B30. Groups BD and B30 had a significantly delayed time to first rescue analgesia and consumed less pethidine than group B20. Compared to group B20, the pain score was significantly reduced in groups BD and B30. Comparable levels of pain score, rescue analgesia time, total pethidine consumption, and motor and sensory block onset and duration were seen in the BD and B30 groups.

Conclusion: DEX with a lower volume(20 ml) of bupivacaine reaches the same result as a higher volume of bupivacaine(30ml) in managing perioperative pain and hemodynamic stability without the risk of the high volume of bupivacaine. Further, adding DEX to small dose of bupivacaine (20ml) is more effective than small dose of bupivacaine(20ml) alone without additives in prolonging the duration of sensory and motor block, reducing pain intensity, and delaying the need for rescue analgesia.

Background: The Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a serious adverse reaction that occurs weeks after the onset of drug exposure. DRESS syndrome is commonly associated with antiseizure drugs, sulfa drugs, and antibiotics.

Case presentation: This was a case report of a 20-year-old female who suffered from DRESS due to vancomycin with symptoms similar to the Redman syndrome. The patient had a case of infectious endocarditis due to methicillin-resistant Staphylococcus aureus (MRSA), and vancomycin was intravenously administered. On the 18^th day, during the administration of vancomycin, the patient developed sudden severe flushing over the face and trunk. The offending drug was suspended and treated with antihistamines in view of Redman syndrome. Later, the patient developed uncontrolled fever, desquamating rash all over the body, severe pruritis, and eosinophilia. On applying the RegiScar score, a probable case of DRESS was diagnosed. The patient was managed symptomatically and discharged.

Discussion: The clinical presentation of DRESS includes skin rash, fever, eosinophilia, and organ involvement. But, in this case, there was a varied initial presentation of DRESS with severe flushing, which mimics the Redman syndrome due to vancomycin. Difficulty in establishing organ involvement remained a challenge in diagnosing DRESS.

Conclusion: DRESS can have a varied clinical presentation. Careful monitoring of all vital parameters is important in preventing the misdiagnosis of DRESS syndrome.

Background: The COVID-19 pandemic has called for the rapid development and use of antiviral drugs to effectively control the disease. Nirmatrelvir/Ritonavir (Paxlovid), Molnupiravir, and Remdesivir have been pivotal in therapeutic approaches, although they raise concerns regarding adverse drug reactions (ADRs).

Objective: This study aimed to thoroughly assess the ADRs associated with these drugs by utilizing the Adverse Event Reporting System (FAERS) database of the Food and Drug Administration (FDA).

Methods: ADR reports for Paxlovid, Molnupiravir, and Remdesivir throughout the period of January 2022 to May 2023 were extracted and classified according to the severity, type of reaction, and demographic variables. Reporting Odds Ratios (RORs) with 95% confidence intervals were calculated to evaluate the relationship between antiviral medications and various ADRs.

Results: The study established notable correlations between Paxlovid and the recurrence of the disease (40.08%) and dysgeusia (16.29%). Molnupiravir was linked to gastrointestinal (16.73%) and skin reactions (9.47%), while Remdesivir had impairments in the liver (25.21%) and kidneys (13.34%). ADRs were more commonly observed in female patients treated with Paxlovid (57.95%) and Molnupiravir (49.40%), whereas Remdesivir ADRs were mostly reported in males (58.56%). Paxlovid and Remdesivir ADRs were frequently reported in adults between the ages of 18 and 64 (46.01% and 45.01%), while Molnupiravir ADRs were more common in older individuals aged 65 to 85 (40.38%).

Conclusion: This thorough assessment emphasizes the importance of careful surveillance and control of ADRs linked to COVID-19 antiviral therapies. It is essential to customize treatments by considering specific patient histories, particularly for pre-existing diseases.

Background: Mycophenolate mofetil (MMF) is an immunosuppressant commonly used for treating autoimmune diseases.

Case presentation: We report a diagnostically challenging case of MMF-induced colitis in a patient after 3 years of initiation of MMF therapy. A 76-year-old Caucasian female with a history of Chronic inflammatory demyelinating polyneuropathy receiving MMF presented to the hospital with a 7-weeks history of watery diarrhoea and crampy abdominal pains. Routine blood investigations, CMV-PCR, stool culture, viral PCR, Colonoscopy, and CT scan of the abdomen were broadly within normal limits. Histopathological changes were not significantly diagnostic apart from ischaemic-type changes. Finally, the reduction of the MMF dose caused the cessation of diarrhoea. Diagnosing MMF-induced colitis can be challenging, especially in patients on immunosuppressive medications. Further, long latency periods and non-specific colonoscopic and histopathologic changes add to the diagnostic dilemma.

Conclusion: MMF-induced diarrhoea should be part of the clinician's differentials, and the decision to reduce the dose of MMF needs to be considered once infection and other causes have been ruled out.

Background: Most studies have focused on the impact of medication reconciliation on one of the points of hospital admission or discharge. In this study, we aimed to investigate the impact of medication reconciliation on medication safety in patients hospitalized with acute decompensated heart failure at both admission and discharge.

Methods: This was a prospective, single-center, cohort study conducted in a tertiary care cardiovascular hospital from December 2022 to May 2023 on patients hospitalized with acute decompensated heart failure. Patients were considered eligible if they were taking at least five chronic medications prior to hospital admission. Medication reconciliation was carried out for the study patients by a clinical pharmacy team both at admission and discharge. Additionally, the study patients also received comprehensive discharge counseling as well as post-discharge follow-up and monitoring.

Results: Medication reconciliation was applied for 129 patients at admission and 118 at discharge. The mean time needed for medication reconciliation presses was 32 min per patient at admission and 22 min at discharge. Unintentional medication discrepancies were relatively common at both admission and discharge, but compared to admission, discrepancies were less frequent at discharge (178 versus 72). Based on the consensus review, about 30% of identified errors detected at both admission and discharge were judged to have the potential to cause moderate to severe harm to the patient. Most of the clinical pharmacists' recommendations on unintended discrepancies were accepted by physicians and resulted in changes in medication orders (more than 80%). Further, the majority of the participants were 'very satisfied' or 'satisfied' with the clinical pharmacy services provided to them during hospitalization and after hospital discharge (89.90%).

Conclusion: Our results demonstrated the vulnerability of heart failure patients to medication discrepancies at both admission and discharge. Thus, implementing a comprehensive medication reconciliation by clinical pharmacists could be beneficial for enhancing medication safety in these patients.

Background: There are concerns about indiscriminate prescriptions and the inappropriate use of proton pump inhibitors (PPIs) without any clear indications, especially among noncritically hospitalized patients.

Objective: This study aimed to characterize PPI prescriptions among non-critically hospitalized patients in a tertiary care hospital in Saudi Arabia.

Methods: A retrospective cross-sectional study was conducted at the King Abdulaziz University Hospital between June and August 2021. The data of adult patients who received PPIs on hospital admission in the medical and surgical wards were collected and analyzed for appropriateness based on the current international guidelines and recommendations.

Results: A total of 174 patient records were included in this study. The proportion of patients with appropriate and inappropriate PPI prescriptions was 67.24% (n=117) and 32.76% (n=57), respectively. Female patients (risk=50.00%, 95% CI: 36.89-63.11, p<0.001) were more likely to receive an inappropriate PPI prescription than their male counterparts (risk=33.33%, 95% CI: 24.56-43.43, p<0.001). Intravenous omeprazole 40 mg once daily was the most frequently prescribed PPI (n=62). The hospital length of stay differed significantly between the groups of patients who received appropriate and inappropriate PPIs (24.56 ± 47.14 vs. 13.50 ± 13.84; t=2.34, 95% CI: 1.72-20.4; p=0.02). However, there was no significant difference in the total therapy duration in both the groups (3.76 ± 2.50 vs. 4.75 ± 3.32, t=-1.62, 95%CI: -1.79-0.17; p=0.11).

Conclusion: The findings show a high trend of inappropriate PPI prescriptions. Hence, educational programs are recommended to encourage healthcare professionals to stick to the approved guidelines when prescribing PPIs.

Background: The kidneys, intricate organs responsible for maintaining fluid and electrolyte balance, are susceptible to damage from diverse nephrotoxic insults, including drugs, toxins, and metabolic disorders. In recent years, flavonoids, bioactive compounds abundant in fruits, vegetables, and herbal extracts, have emerged as promising candidates for renal protection due to their potent antioxidant and anti-inflammatory properties.

Methods: We have collected the data that supported this idea to conduct a comprehensive review by using scientific databases, such as Pub Med ®, ScienceDirect ®, Google Scholar ®, and MEDLINE ®. An attempt was made to refer to all English-language articles published between 2000 to 2020 using keywords like flavonoids potential in nephrotoxicity and nephrotoxicity treatment approaches with herbal remedies.

Conclusion: This comprehensive review delves into the molecular mechanisms underlying the reno-protective effects of flavonoids. By scavenging reactive oxygen species, inhibiting inflammatory mediators, and modulating intracellular signalling pathways, flavonoids can mitigate oxidative stress and inflammation, thereby preserving renal function and integrity. Preclinical studies have demonstrated the potential of specific flavonoids in ameliorating drug-induced nephrotoxicity, renal ischemia-reperfusion injury, diabetic nephropathy, and other kidney diseases. Furthermore, epidemiological evidence highlights the inverse relationship between flavonoid intake and the risk of developing kidney diseases. Nevertheless, understanding the molecular mechanisms of flavonoids in nephroprotection offers exciting prospects for developing novel therapeutic strategies to combat kidney diseases and promote kidney health.

Introduction: Myasthenia gravis (MG) is an autoimmune disorder of post-synaptic neuromuscular junction characterised by fatigable muscle weakness and is treated with prednisolone with or without other immunosuppressants, including azathioprine (AZA). Veno-occlusive hepatotoxicity of AZA is a rare complication in MG.

Case report: We report a 35-year-old man with MG, was treated with pyridostigmine, prednisolone, and AZA for 5 years. He presented with abdominal pain and increased fatiguability for 7 days. His serum bilirubin and liver enzymes were elevated, and ultrasound revealed a dilated hepatic vein and portal vein suggestive of veno-occlusive liver disease. The clinical symptoms, liver functions, and ultrasound of the hepatobiliary system normalized after withdrawal of AZA.

Conclusion: A possibility of AZA veno-occlusive hepatoxicity should be considered in a MG patient if presented with abdominal pain, elevated bilirubin and transaminases, and ultrasound showing dilatation of hepatic veins. Physicians should be aware of this complication because this toxicity is reversible following dose reduction or withdrawal of AZA.