Drug-induced Adverse Events

Exponential growth of drug overdose poisoning and opportunities for intervention

Mon, 2022-04-04 06:00

Addiction. 2022 May;117(5):1200-1202. doi: 10.1111/add.15841.

NO ABSTRACT

PMID:35373482 | DOI:10.1111/add.15841

Categories: Literature Watch

Clinical Aspects of Drug-Drug Interaction and Drug Nephrotoxicity at Renal Organic Cation Transporters 2 (OCT2) and Multidrug and Toxin Exclusion 1, and 2-K (MATE1/MATE2-K)

Mon, 2022-04-04 06:00

Biol Pharm Bull. 2022;45(4):382-393. doi: 10.1248/bpb.b21-00916.

ABSTRACT

The organic cation transporter 2 (OCT2) belongs to the SLC22 family, while the multidrug and toxin extrusion 1 and 2-K (MATE1/MATE2-K) belong to the SLC47 family, are localized to the basolateral and apical membrane of human renal proximal tubular epithelial cells, respectively. They are polyspecific transporters that enable the transit of structurally diversified drugs with overlapping selectivity across plasma membranes. OCT2 and MATE1/2-K are critically involved in renal secretion, pharmacokinetics (PK), and toxicity of cationic drugs. Drug-drug interactions (DDIs) at OCT2 and/or MATE1/2-K have been shown to result in clinical impacts on PK, therapeutic efficacy and are probably involved in the renal accumulation of drugs. Sites of OCT2 and MATE1/2-K expression and function play an essential role in the pharmacokinetics and toxicity of drugs, such as cisplatin. Thus, knowing the sites (basolateral vs. apical) of the interaction of two drugs at transporters is essential to understanding whether this interaction helps prevent or enhance drug-induced nephrotoxicity. In this work, an overview of OCT2 and MATE1/2-K is presented. Primary structure, membrane location, functional properties, and clinical impact of OCT2 and MATE1/2-K are presented. In addition, clinical aspects of DDIs in OCT2 and MATE1/2-K and their involvement in drug nephrotoxicity are compiled.

PMID:35370262 | DOI:10.1248/bpb.b21-00916

Categories: Literature Watch

Analysis of Information on Drug Adverse Reactions Using U.S. Food and Drug Administration Adverse Event Reporting System (FAERS)

Mon, 2022-04-04 06:00

Yakugaku Zasshi. 2022;142(4):341-344. doi: 10.1248/yakushi.21-00178-5.

ABSTRACT

Nowadays, medical big data has been developed and made available in a variety of fields such as epidemiology and pharmacovigilance. Spontaneous reporting databases are one category of medical big data and that has been adequate for analysing events related to side effects that rarely occur in general practice. These data are freely available in several countries. In Japan, the Pharmaceuticals and Medical Devices Agency has developed the Japanese Adverse Drug Event Report (JADER), and the Food and Drug Administration (FDA) developed the FDA Adverse Events Reporting System (FAERS) in the United States. Since the release of these medical big data, many researchers in academic and research setting have accessed them, but it is still difficult for many medical professionals to analyse these data due to costs and operation of requisite statistical software. In this section, we give some tips to study spontaneous reporting databases resulting from our learning experiences.

PMID:35370189 | DOI:10.1248/yakushi.21-00178-5

Categories: Literature Watch

Common Presentations of Rare Drug Reactions and Atypical Presentations of Common Drug Reactions in the Intensive Care Unit

Mon, 2022-04-04 06:00

Crit Care Clin. 2022 Apr;38(2):287-299. doi: 10.1016/j.ccc.2021.11.005.

ABSTRACT

Adverse drug events (ADRs) are a significant source of iatrogenic injury that may be challenging to diagnose and treat. Patient outcomes range from mild symptoms to death. Critically ill children are at unique risk for ADR development because of age-dependent pharmacokinetic differences and off-label prescribing.

PMID:35369948 | DOI:10.1016/j.ccc.2021.11.005

Categories: Literature Watch

Efficacy and Safety of Omalizumab for the Treatment of Severe or Poorly Controlled Allergic Diseases in Children: A Systematic Review and Meta-Analysis

Mon, 2022-04-04 06:00

Front Pediatr. 2022 Mar 15;10:851177. doi: 10.3389/fped.2022.851177. eCollection 2022.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of omalizumab in the treatment of severe or uncontrolled allergic diseases in children.

METHODS: We conducted a systematic search of the PubMed, Embase, CENTRAL, and clinicaltrials.gov databases up to 23rd July 2021, with no language limitations. Randomised controlled trials (RCTs) comparing omalizumab with other treatments or placebo in children with severe or inadequately controlled allergic diseases were considered. The primary outcomes of interest were asthma exacerbation rate, allergic symptom score, desensitisation achievement for food allergy (FA), and incidence of serious adverse events (SAEs). The study selection and data extraction were conducted independently by two researchers. Quality assessments were conducted using the Cochrane risk-of-bias tool, and data were pooled using a random-effects model if I 2 was 50% or greater in the Cochrane Review Manager.

RESULTS: Overall, 10 RCTs [six on severe asthma, one on atopic dermatitis (AD), one on seasonal allergic rhinitis [SAR], and one on FA] consisting of 2,376 participants met the inclusion criteria. For severe asthma, omalizumab may reduce exacerbations at 12 weeks [risk ratio (RR), 0.52; 95% confidence interval (CI), 0.31-0.89], 24 weeks (RR, 0.69; 95% CI, 0.55-0.85; GRADE: moderate-quality evidence), and 52 weeks (RR, 0.62; 95% CI, 0.40-0.94; GRADE: moderate-quality evidence) and reduce the dose of inhalation corticosteroid compared with placebo. For severe AD, the association between omalizumab and allergic symptom improvement [i.e., SCORing Atopic Dermatitis or Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)] was not confirmed. For severe SAR, omalizumab showed greater improvement in symptom load scores and saved rescue medication days. For FA, omalizumab demonstrated superiority in desensitisation compared with placebo. To date, no clinically significant drug-related SAEs have been reported.

CONCLUSION: For severe or uncontrolled asthma, AD, SAR, and FA, omalizumab may be associated with improved allergic symptoms and safety in children. Future studies should focus on the benefits and pharmacoeconomic evaluation of omalizumab in multiple allergic diseases compared with other treatments.

SYSTEMATIC REVIEW REGISTRATION: [https://www.crd.york.ac.uk/PROSPERO], identifier [CRD42021271863].

PMID:35372142 | PMC:PMC8965060 | DOI:10.3389/fped.2022.851177

Categories: Literature Watch

Generalized Papulovesicular Eruption as a Side Effect of the Pfizer-BioNTech COVID-19 Vaccine

Mon, 2022-04-04 06:00

Cureus. 2022 Feb 20;14(2):e22414. doi: 10.7759/cureus.22414. eCollection 2022 Feb.

ABSTRACT

COVID-19 is inflicted by SARS-CoV-2 and resulted in a global health crisis that necessitated the urgency of vaccine development to prevent its spreading among the public. Pfizer-BioNTech COVID-19 is one of the emergency use authorized (EUA) vaccines. This vaccine is efficacious against the SARS-CoV-2 virus; nonetheless, recipients have frequently reported side effects. Recipients of this vaccine experienced miscellaneous side effects like fatigue and headache. However, cutaneous eruptions of varying degrees of severity and involvements have been manifesting post-vaccination. Dermatological eruptions following vaccination against COVID-19 disease are poorly recognized. Dermatological manifestations triggered post-vaccination differ in the clinical context and patient's demographic features. The only constant factor is various clinical and histopathological relations to establish the diagnosis of cutaneous eruption post-vaccination. Herein, we report a case of an 18-year-old male with T-cell acute lymphocytic lymphoma (ALL) in remission since August 2018 and other comorbidities. After the administration of the first dose of the Pfizer-BioNTech COVID-19 vaccine, the patient developed pruritic eczematous eruption presenting as grouped erythematous-violaceous papulovesicular lesions with fine scales over his upper and lower extremities. These eruptions started two days after the administration of the vaccine. This eruption became generalized 21 days after receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine. Clinical suspicion of the drug-induced vesicular eruption was suspected; thus, a biopsy was obtained and showed erosions and mixed inflammatory cell infiltrate. From a clinical and histopathological correlation, vesicular eruption following vaccination with Pfizer-BioNTech COVID-19 was confirmed. Nevertheless, other diagnoses cannot be ruled out, but from the clinical-histopathological association, the vaccine-inflicted eruption is the likely culprit. Reports are crucial to understanding the nature of such dermatological manifestation after emerging diseases and counteractions like vaccinations. The dermatological manifestations are vaguely recognized; thus, by reporting on the cases similar to the case in this report, more data will be available to understand the nature and underlying cause of such eruptions.

PMID:35371700 | PMC:PMC8941327 | DOI:10.7759/cureus.22414

Categories: Literature Watch

Pantoprazole-Associated Thrombocytopenia: A Literature Review and Case Report

Mon, 2022-04-04 06:00

Cureus. 2022 Feb 17;14(2):e22326. doi: 10.7759/cureus.22326. eCollection 2022 Feb.

ABSTRACT

Proton-pump inhibitors (PPIs) are commonly utilized in the treatment of upper gastrointestinal bleeds (UGIBs) due to their ability to stabilize blood clot formation. PPIs have been shown to reduce rebleeding after endoscopic hemostasis and reduce signs of bleeding at index endoscopy. While PPIs are well-tolerated and commonly administered to patients suffering from acute UGIBs, significant adverse effects may occur. Patients have reported various mild systemic symptoms during short-term PPI use, including headache, rash, dizziness, nausea, abdominal pain, flatulence, constipation, and diarrhea. In general, serious side effects of PPIs tend to be mild during treatment periods under two weeks; however, as the treatment duration increases, side effects have been observed to increase in frequency and severity. PPI-induced thrombocytopenia is an exceedingly rarely reported adverse reaction that remains largely unstudied due to the dearth of patient cases. This adverse effect continues to be a diagnosis of exclusion, and there are no current evidence-based recommendations to approach this complication. Thrombocytopenia increases the risk of rebleeding and hemodynamic instability, which may be devastating to patients suffering from UGIBs. Here, we present a case of thrombocytopenia that began after the introduction of pantoprazole in the setting of a UGIB. The thrombocytopenia resolved promptly after cessation of the medication. We highlight this case to increase awareness of this rare finding given the lack of recommendations for short-term PPI-induced thrombocytopenia.

PMID:35371663 | PMC:PMC8936297 | DOI:10.7759/cureus.22326

Categories: Literature Watch

A Randomized Open-Labeled Trial of Methotrexate as a Steroid-Sparing Agent for Patients With Generalized Myasthenia Gravis

Mon, 2022-04-04 06:00

Front Immunol. 2022 Mar 18;13:839075. doi: 10.3389/fimmu.2022.839075. eCollection 2022.

ABSTRACT

BACKGROUND AND PURPOSE: Two clinical trials assessing the steroid-sparing effect of methotrexate (MTX) yielded conflicting results. Our objective was to investigate whether MTX would show a steroid-sparing effect in the treatment of generalized myasthenia gravis (MG) patients who fitted Myasthenia Gravis Foundation of America (MGFA) Class II and Class III.

METHODS: We performed an 18-month prospective, randomized, open-labeled trial of prednisone combined with MTX 10 mg orally every week versus prednisone alone in 40 recently diagnosed MG patients of MGFA Class II and Class III between July 2014 and July 2018. The primary endpoint was the prednisone area under the dose-time curve (AUDTC) from months 3 to 18. Secondary endpoints included changes of the Quantitative Myasthenia Gravis Score (QMG), the Myasthenia Gravis Activity of Daily Living Score (MG-ADL), initial time of prednisone reduction, the median prednisone daily dose in each month, adverse events, and treatment failures in each group.

RESULTS: Forty participants were included; among those, 5 individuals withdrew. A total of 35 participants completed 18 months of follow-up (18 in prednisone+MTX, 17 in prednisone group). Combined use of MTX reduced the month 3-18 prednisone AUDTC (prednisone+MTX 5,663.44 ± 1,678.08 mg, prednisone 6,683.94 ± 678.08 mg, p = 0.03, 95% confidence interval -1916.01 to -124.98). The initial times of prednisone reduction were 4.34 ± 1.44 months in the prednisone+MTX group and 5.56 ± 2.05 months in the prednisone group (p = 0.04, 95% CI -2.41 to -0.03). The median daily prednisone dose was significantly lower in the prednisone+MTX group at month 6 and months 9-18. No significant differences were found in QMG and MG-ADL scores between the two groups. No serious drug-related adverse events were observed in both groups.

CONCLUSIONS: This study provides evidence that MTX has the steroid-sparing ability in generalized MG patients of MGFA Class II and Class III.

CLINICAL TRIAL REGISTRATION: http://www.chictr.org.cn/showproj.aspx?proj=10563 identifier ChiCTR-IPR-15006081.

PMID:35371086 | PMC:PMC8971191 | DOI:10.3389/fimmu.2022.839075

Categories: Literature Watch

A Pharmacoinformatics Analysis of Artemisinin Targets and <em>de novo</em> Design of Hits for Treating Ulcerative Colitis

Mon, 2022-04-04 06:00

Front Pharmacol. 2022 Mar 18;13:843043. doi: 10.3389/fphar.2022.843043. eCollection 2022.

ABSTRACT

Ulcerative colitis (UC), as an intractably treated disease, seriously affects the quality of life of patients and has an increase in terms of incidence and prevalence annually. However, due to the lack of a direct etiology and drug-induced side effects, the medical treatment of UC falls into a bottleneck. There are many natural phytochemicals with the potential to regulate immune function in nature. Herein, a potential mechanism of artemisinin in the treatment of UC and potential druggability compounds with an artemisinin peroxide bond were discussed and predicted based on computer-aided drug design (CADD) technology by using the methods of network pharmacology, molecular docking, de novo drug structure design and molecular dynamics through the integration of artemisinin related targets from TCMSP, ChEMBL and HERB databases. The networks were constructed based on 50 artemisinin-disease intersection targets related to inflammation, cytokines, proliferation and apoptosis, showing the importance of GALNT2, BMP7 and TGFBR2 in the treatment of disease, which may be due to the occupation of the ricin B-type lectin domain of GALNT2 by artemisinin compounds or de novo designed candidates. This result could guide the direction of experiments and actual case studies in the future. This study provides a new route for the application of artemisinin and the development of drugs.

PMID:35370688 | PMC:PMC8971781 | DOI:10.3389/fphar.2022.843043

Categories: Literature Watch

Analysis of Drug-Induced Liver Injury from Bofutsushosan Administration Using Japanese Adverse Drug Event Report (JADER) Database

Mon, 2022-04-04 06:00

Biol Pharm Bull. 2022;45(4):460-466. doi: 10.1248/bpb.b21-00887.

ABSTRACT

Bofutsushosan is a traditional Japanese Kampo medicine. In recent years, it has been reported to be effective in the treatment of lifestyle-related diseases, and its use is increasing. However, side effects from bofutsushosan administration are common, with drug-induced liver injury being the most frequently reported complication. In this study, we analyzed the Japanese Adverse Drug Event Report (JADER) database regarding the occurrence of liver injury after bofutsushosan administration. The results showed that bofutsushosan presented a significant reporting odds ratio (ROR) signal [crude ROR 14, 95% confidence interval (CI) 12-17; p < 0.001], indicating liver injury. Furthermore, the incidents of adverse events following bofutsushosan administration, as recorded in the JADER database, were higher in women aged between 30 and 59 years. The results of logistic regression analysis in patients taking this agent showed that females in the aforementioned age range had higher odds of developing drug-induced liver injury (adjusted ROR 5.5, 95% CI 2.8-11; p < 0.001). Therefore, although bofutsushosan is a useful drug for lifestyle-related diseases, it may be necessary to refrain from its overuse, and caution should be taken during its occasional use to avoid severe adverse events.

PMID:35370270 | DOI:10.1248/bpb.b21-00887

Categories: Literature Watch

Prevalence and factors associated with adverse drug events among patients on dolutegravir-based regimen at the Immune Suppression Syndrome Clinic of Mbarara Regional Referral Hospital, Uganda: a mixed design study

Sun, 2022-04-03 06:00

AIDS Res Ther. 2022 Apr 2;19(1):18. doi: 10.1186/s12981-022-00442-7.

ABSTRACT

BACKGROUND: In low income countries such as Uganda progress has been made towards achieving the United Nations AIDS programme 95-95-95 target however efforts are still impeded by pretreatment drug resistance and adverse drug events (ADEs) hence introduction of dolutegravir-based antiretroviral therapy as first-line treatment due to a higher genetic barrier to resistance, better tolerability and safety profile. However, recent studies have raised concerns regarding its safety in real-clinical settings due to ADEs and being a recently introduced drug there is need to actively monitor for ADEs, hence this study aimed to establish the prevalence and factors associated with ADEs among patients on dolutegravir-based regimen at the Immune Suppression Syndrome (ISS) Clinic- Mbarara Regional Referral Hospital (MRRH).

METHODS: A mixed design study was conducted at ISS Clinic-MRRH among 375 randomly selected patients who had been exposed to DTG-based regimen for at-least 12 weeks. These were interviewed to obtain data on socio-demographics, dietary habits and their files reviewed for ADEs. Data entry was done using Epi-data 3.0 and exported to SPSS 25.0 for analysis. Prevalence was determined as a percentage, and ADE associated factors assessed using bivariate analysis, those found significant were further subjected to multivariate analysis and considered significant at P < 0.05.

RESULTS: The prevalence of ADEs among patients on DTG-based regimen was found to be 33.1% (124/375) with 5.6% (7/124) participants discontinued from treatment due ADEs, 4 due to hyperglycemia and 3 liver toxicity. The commonly experienced ADE was allergy at 36.3%. Male sex (AOR 1.571, 95% CI 1.433-1.984), WHO stage one at entry to care (AOR 4.586, 95% CI 1.649-12.754), stage two (AOR 4.536, 95% CI 1.611-12.776), stage three (AOR 3.638, 95% CI 1.262-10.488), were significantly associated with ADEs. Patients with undetectable viral load at initiation of DTG-based regimen were 67.6% less likely to experience ADEs (AOR = 0.324, 95% CI 0.1167-0.629).

CONCLUSION: This study reports a prevalence of 33.1% of ADEs among patients on DTG-based regimen. The most commonly experienced ADE was allergy. Male sex, early HIV disease stage at entry into care and detectable viral load at initiation of DTG-based regimen were significantly associated with ADEs. It is crucial to actively monitor patients with these characteristics for ADEs.

PMID:35366917 | DOI:10.1186/s12981-022-00442-7

Categories: Literature Watch

Complementary and alternative medicine modalities used to treat adverse effects of anti-cancer treatment among children and young adults: a systematic review and meta-analysis of randomized controlled trials

Sun, 2022-04-03 06:00

BMC Complement Med Ther. 2022 Apr 2;22(1):97. doi: 10.1186/s12906-022-03537-w.

ABSTRACT

BACKGROUND: Dealing with the symptom burden of cancer diagnosis and treatment has led parents to seek different self-management strategies including Alternative and Complementary Medicine (CAM). The aim of this study was to perform a systematic review and meta-analysis about the use and effect of CAM modalities to treat adverse effects of conventional cancer treatment among children and young adults.

METHODS: Six scientific research databases were used to identify randomized controlled trials (RCTs) from 1990 to September 2020. Included studies investigated the use of CAM to treat cancer treatment related adverse effects in children and young adults compared to controls.

RESULTS: Twenty RCTs comprising 1,069 participants were included in this review. The included studies investigated acupuncture, mind-body therapies, supplements, and vitamins for chemotherapy-induced nausea and vomiting (CINV), oral mucositis, and anxiety among children and young adults who underwent conventional cancer treatment. Seven studies (315 participants) were included in the meta-analysis. The overall effect of CAM (including acupuncture and hypnosis only) on chemotherapy-induced nausea and/or vomiting and controls was statistically significant with a standard mean difference of -0.54, 95% CI [-0.77, -0.31] I2 = 0% (p < 0.00001). There was a significant difference between acupuncture and controls (n = 5) for intensity and/or episodes of CINV with an SMD -0.59, 95% CI [-0.85, -0.33] (p < 0.00001). No significant difference was found between hypnosis and controls (n = 2) for severity or episodes of CINV with an SMD -0.41, 95% CI [-1.09, 0.27] I2 = 41% (p = 0.19).

CONCLUSION: Current evidence from this meta-analysis of randomized controlled trials shows that CAM, including acupuncture and hypnosis only, is effective in reducing chemotherapy-induced nausea and vomiting in children and young adults. More rigorous trials and long-term effects should be investigated if acupuncture and hypnosis are to be recommended for clinical use.

PMID:35366871 | DOI:10.1186/s12906-022-03537-w

Categories: Literature Watch

Top Myths of Diagnosis &amp; Management of Infectious Diseases in Hospital Medicine

Sun, 2022-04-03 06:00

Am J Med. 2022 Mar 30:S0002-9343(22)00246-7. doi: 10.1016/j.amjmed.2022.03.019. Online ahead of print.

ABSTRACT

Antimicrobial agents are among the most frequently prescribed medications during hospitalization. However, approximately 30 to 50% or more of inpatient antimicrobial use is unnecessary or suboptimal. Herein, we describe ten common myths of diagnosis and management that often occur in the hospital setting. Further, we discuss supporting data to dispel each of these myths. This analysis will provide hospitalists and other clinicians with a foundation for rational decision-making regarding antimicrobial use and support antimicrobial stewardship efforts at both the patient and institutional levels.

PMID:35367180 | DOI:10.1016/j.amjmed.2022.03.019

Categories: Literature Watch

The efficacy and safety of roxadustat for the treatment of anemia in non-dialysis dependent chronic kidney disease patients: An updated systematic review and meta-analysis of randomized clinical trials

Fri, 2022-04-01 06:00

PLoS One. 2022 Apr 1;17(4):e0266243. doi: 10.1371/journal.pone.0266243. eCollection 2022.

ABSTRACT

BACKGROUND: Roxadustat (ROX) is a new medication for anemia as a complication of chronic kidney disease (CKD). Our meta-analysis aims to evaluate the efficacy and safety of ROX, especially on the cardiovascular risks, for anemia in NDD-CKD patients.

METHODS: Electronic databases were searched systematically from inception to July 2021 to look for randomized control trials (RCTs) that evaluated ROX NDD-CKD patients. Hemoglobin level and iron utilization parameters, including ferritin, serum iron, transferrin saturation (TSAT), total iron-binding capacity (TIBC), transferrin, and hepcidin were analyzed for efficacy. Pooled risk ratios (RRs) and standardized mean differences (SMDs) were calculated and presented with their 95% confidential intervals (CIs).

RESULTS: Nine RCTs included a total of 3,175 patients in the ROX group and 2,446 patients in the control group. When compared the control group, ROX increased Hb level significantly (SMD: 1.65; 95% CI: 1.08, 2.22; P< 0.00001) and improved iron utilization parameters by decreasing ferritin (SMD: -0.32; 95% CI: -0.51, -0.14; P = 0.0006), TSAT (SMD: -0.19; 95% CI: -0.32, -0.07; P = 0.003), and hepcidin (SMD: -0.74; 95% CI: -1.09, -0.39; P< 0.0001) and increasing TIBC (SMD: 0.99; 95% CI: 0.76, 1.22; P< 0.00001) and transferrin (SMD: 1.20; 95% CI: 0.70, 1.71; P< 0.00001). As for safety, ROX was associated with higher serious adverse effects (RR: 1.07; 95% CI: 1.01, 1.13; P = 0.01), deep venous thrombosis (DVT) (RR: 3.80; 95% CI: 1.5, 9.64; P = 0.08), and hypertension (HTN) (RR: 1.37; 95% CI: 1.13, 1.65; P = 0.001).

CONCLUSION: We concluded that ROX increased Hb level and improved iron utilization parameters in NDD-CKD patients, but ROX was associated with higher serious adverse effects, especially DVT and HTN. Our results support the use of ROX for NDD-CKD patients with anemia. However, higher-quality RCTs are still needed to ensure its safety and risk of thrombosis.

PMID:35363823 | PMC:PMC8974992 | DOI:10.1371/journal.pone.0266243

Categories: Literature Watch

Reevaluation of adverse drug reactions of psychiatric drugs under the chinese drug volume-based procurement policy

Fri, 2022-04-01 06:00

BMC Health Serv Res. 2022 Mar 31;22(1):424. doi: 10.1186/s12913-022-07851-4.

ABSTRACT

BACKGROUND: The "4 + 7" volume-based procurement is a "large group purchase" led by the Chinese government, with the aim of reducing the price of medicines by trading volume for price. Although the "4 + 7" drugs had passed the national consistency evaluation, the adverse drug reactions need to be further evaluated to ensure the safety of the "4 + 7" drugs with low prices. We aimed to analyze the occurrence characteristics and related influencing factors of adverse reactions of psychiatric drugs under the chinese drug volume-based procurement policy(4 + 7 policy), and provide references for clinical medication.

METHODS: 137 cases of adverse drug reactions of four psychotropic drugs reported under the "4 + 7" policy in Wuxi Mental Health Center in 2020 were collected. The gender and age of patients, related "4 + 7" drugs, involving organs / systems, clinical manifestations, distribution of new / serious adverse reactions, clinic outcomes were analyzed.

RESULTS: Among the 137 cases of adverse drug reactions, the incidence of adverse drug reactions was the highest in patients aged 61-70 (25.38%). Mainly involved 4 "4 + 7" psychiatric drugs, of which olanzapine tablets caused the most adverse reactions (54, 39.24%). The adverse reactions mainly involved the digestive system, nervous system, cardiovascular system, blood and lymphatic system, among which the digestive system was the most common (61, 44.53%). A total of 8 cases (6.16%) of new and 26 cases of serious adverse reactions were reported, all of which led to the prolongation of disease course. Except for the transient side effects, most of that were improved or cured with no death, disability or teratogenicity after stopping or reducing the dose with symptomatic treatment.

CONCLUSION: Since more and more drugs will be included in "4 + 7" for clinic, clinical pharmacists should strengthen the publicity and training of the knowledge of "4 + 7" drugs, strengthen the monitoring of adverse drug reactions, and provide timely feedback to the clinic, in order to achieve early prevention, early identification, timely diagnosis and reasonable intervention of the adverse drug reactions under the context of "4 + 7" policy.

PMID:35361211 | PMC:PMC8969372 | DOI:10.1186/s12913-022-07851-4

Categories: Literature Watch

Cancer Chemotherapy via Natural Bioactive Compounds

Fri, 2022-04-01 06:00

Curr Drug Discov Technol. 2022 Mar 31. doi: 10.2174/1570163819666220331095744. Online ahead of print.

ABSTRACT

BACKGROUND: Cancer-induced mortality is increasingly prevalent globally which skyrocketed the necessity to discover new/novel safe and effective anticancer drugs. Cancer is characterized by the continuous multiplication of cells in the human which is unable to control. Scientific research is drawing its attention towards naturally-derived bioactive compounds as they have fewer side effects compared to the current synthetic drugs used for chemotherapy.

OBJECTIVE: Drugs isolated from natural sources and their role in the manipulation of epigenetic markers in cancer are discussed briefly in this review article.

METHODS: With advancing medicinal plant biotechnology and microbiology in the past century, several anticancer phytomedicines were developed. Modern pharmacopeia contains at least 25% herbal-based remedy including clinically used anticancer drugs. These drugs mainly include the podophyllotoxin derivatives vinca alkaloids, curcumin, mistletoe plant extracts, taxanes, camptothecin, combretastatin, and others including colchicine, artesunate, homoharringtonine, ellipticine, roscovitine, maytanasin, tapsigargin,andbruceantin.

RESULTS: Compounds (psammaplin, didemnin, dolastin, ecteinascidin,and halichondrin) isolated from marine sources and animals such as microalgae, cyanobacteria, heterotrophic bacteria, invertebrates. They have been evaluated for their anticancer activity on cells and experimental animal models and used chemotherapy.Drug induced manipulation of epigenetic markers plays an important role in the treatment of cancer.

CONCLUSION: The development of a new drug from isolated bioactive compounds of plant sources has been a feasible way to lower the toxicity and increase their effectiveness against cancer. Potential anticancer therapeutic leads obtained from various ethnomedicinal plants, foods, marine, and microorganisms are showing effective yet realistically safe pharmacological activity. This review will highlight important plant-based bioactive compounds like curcumin, stilbenes, terpenes, other polyphenolic phyto-compounds, and structurally related families that are used to prevent/ ameliorate cancer. However, a contribution from all possible fields of science is still a prerequisite for discovering safe and effective anticancer drugs.

PMID:35362385 | DOI:10.2174/1570163819666220331095744

Categories: Literature Watch

Corticosteroid plus glycyrrhizin therapy for chronic drug- or herb-induced liver injury achieves biochemical and histological improvements: A randomised open-label trial

Fri, 2022-04-01 06:00

Aliment Pharmacol Ther. 2022 Mar 31. doi: 10.1111/apt.16902. Online ahead of print.

ABSTRACT

BACKGROUND: Treatment of chronic drug-induced liver injury (DILI) or herb-induced liver injury(HILI) is an important and unresolved challenge. There is no consensus regarding the indications for corticosteroids for chronic DILI/HILI.

AIMS: To investigate the efficacy and safety of corticosteroid plus glycyrrhizin for patients with chronic DILI/HILI.

METHODS: This was a randomised open-label trial. Eligible patients with causality assessment using the updated RUCAM were randomly assigned (1:1) either to the steroid treatment group (48-week stepwise dose reduction of methylprednisolone plus glycyrrhizin) or control group (glycyrrhizin alone). Liver biopsies were performed at baseline and at the end of the 48-week treatment period. The primary outcome was the proportion of patients with sustained biochemical response (SBR). The secondary outcomes were improvement in liver histology, time to biochemical normalisation and safety.

RESULTS: Of 80 participants, 70 (87.5%) completed the trial. The patients were predominantly female (77.5%), aged >40 years (77.5%) and had a hepatocellular injury pattern of DILI (71.2%). Compared to the control group, the treatment group showed a higher proportion of SBR (94.3% vs. 71.4%, p = 0.023), shorter biochemical normalisation time and histological improvements in both histological activity and fibrosis. The DILI and HILI subgroups, as well as the autoimmune hepatitis (AIH)-like DILI and non-AIH-like subgroups, showed comparable responses. No severe adverse events were observed during the trial.

CONCLUSION: This study provides the first clinical evidence that corticosteroid plus glycyrrhizin therapy for chronic DILI with or without AIH-like features can achieve both biochemical response and histological improvements with good safety. (ClinicalTrials.gov, NCT02651350).

PMID:35362188 | DOI:10.1111/apt.16902

Categories: Literature Watch

DTB at 60

Fri, 2022-04-01 06:00

Drug Ther Bull. 2022 Apr;60(4):e1. doi: 10.1136/dtb.2022.000016.

NO ABSTRACT

PMID:35361658 | DOI:10.1136/dtb.2022.000016

Categories: Literature Watch

Treating hypertension with a pill containing very low doses of four antihypertensive agents compared with standard dose irbesartan

Fri, 2022-04-01 06:00

Drug Ther Bull. 2022 Apr;60(4):56-58. doi: 10.1136/dtb.2022.000014.

ABSTRACT

Commentary on: Chow CK, Atkins ER, Hillis GS, et al Initial treatment with a single pill containing quadruple combination of quarter doses of blood pressure medicines versus standard dose monotherapy in patients with hypertension (QUARTET): a phase 3, randomised, double-blind, active-controlled trial. Lancet 2021;398:1043-52. Series co-ordinator: Dr Teck Khong, DTB Associate Editor Clinical Pharmacology, St George's, University of London, UK.

PMID:35361657 | DOI:10.1136/dtb.2022.000014

Categories: Literature Watch

Pompholyx as a side effect of intravenous immunoglobulin (IVIg)

Thu, 2022-03-31 06:00

BMJ Case Rep. 2022 Mar 30;15(3):e248772. doi: 10.1136/bcr-2022-248772.

ABSTRACT

Intravenous immunoglobulin (IVIg) is increasingly used across multiple specialties for the treatment of inflammatory and autoimmune diseases. Cutaneous reactions to IVIg are generally minor. Pompholyx is a common eruption of small vesicles on the palms, soles, and/or lateral aspects of the fingers. It has a multifactorial aetiology but is rarely attributed to being a drug-related side effect. We describe a 43-year-old woman presenting with peripheral sensory neuropathy who developed pompholyx eczema on both palms following treatment with IVIg.

PMID:35354565 | DOI:10.1136/bcr-2022-248772

Categories: Literature Watch

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