Journal of Drug Assessment最新文献

Objective: Femoroacetabular impingement (FAI) is a condition that has been increasingly recognized as a source of hip pain and a possible risk factor to early development of hip osteoarthritis (OA). To our knowledge, the use of HA in the treatment of femoroacetabular FAI has been investigated only by two studies, both using a high molecular weight HA. The aim of this study was to evaluate the efficacy of two weekly injections of an hexadecylamide derivative of HA (HYADD4-G, HYMOVIS, Fidia Farmaceutici) in FAI.

Methods: All patients received two weekly intra-articular injections of Hymovis at baseline and after 7 days. Clinical and functional assessments were performed at baseline and was repeated after 1, 3, 6 and 12 months. Functional measures included visual analogue scale (VAS) for pain, Harris Hip score (HHS), Lequesne Index (LI), Tegner activity level scale (TALS) and monthly consumption of nonsteroidal anti-inflammatory drugs (NSAIDs).

Results: Twenty-one hips (19 patients, 2 bilateral cases) were treated. The variables VAS, HHS as well as Lequesne improved significantly from T0 to T4 (at 12 months) with the best improvement between T0 and T1. At the same time, a reduction in NSAIDs monthly intake was registered. On the other hand, a significant improvement in Tegner scale was not observed. No adverse events were registered.

Conclusion: This study states that one cycle of HYADD4-G could be a safe and effective treatment in patients with FAI, showing significative results in term of pain control as well as hip functionality and quality of life up to 1 year.

Introduction: Medication administration errors (MAEs) are common health problems that threaten patient safety and raise mortality rates, duration of hospital stay, and cost of services. It also influences healthcare professionals performing the procedure and healthcare organizations. Its prevalence in Ethiopia is high ranging from 51.8% to 90.8%.

Objective: This study aimed to assess the magnitude and associated factors of MAE among nurses at Northwest Amhara Region Referral Hospitals.

Methods: An institution-based cross-sectional study was conducted from February to March 2019. A simple random sampling technique was employed to select 348 nurses. Structured pretested self-administered questionnaires and an observational checklist were used to collect data. The data were entered in Epi-info version 7, analyzed using SPSS version 20 (SPSS Inc., Chicago, IL), and presented in tables and graphs. Bivariate and multivariable logistic regressions were computed to identify the factors associated with MAEs. p Values <.05 and adjusted odds ratios were used to declare the significance and strength of the association.

Results: One hundred and seventy-eight (54%) of the respondents made MAEs in the last 12 months. Only 10 (5%) of the 200 observed nurses were administered medications without any breach in any of the six rights of medication administration. Factors like poor knowledge (AOR = 5.98; 95% CI (2.39,14.94)), poor communication (AOR = 2.94; 95% CI (1.34, 6.46)), stress (AOR = 5.41; 95% CI (2.53, 11.57)), interruption during medication administration (AOR = 4.70, 95% CI (2.42, 9.10)), and night shift (AOR = 2.79, 95% CI (1.42, 5.46)) were significantly associated with MAE.

Conclusions: The magnitude of MAE was high. Poor knowledge, poor communication, stress, night shift, and interruption were significantly associated with MAEs. Strengthening institutional medication administration regulations and guidelines and minimizing interruption during medication administration would help minimize MAEs.

Objective: Previous investigations suggest the use of extract from the roots of Pelargonium sidoides (EPs 7630) for improvement of the symptoms of uncomplicated upper airway inflammations, due to its antimicrobial and immunomodulatory actions. The aim of this investigation was to evaluate the effects of EPs 7630 on chemokine production in nasal mucosa and clinical parameters of patients with acute postviral rhinosinusitis (APRS).

Methods: Twenty-six (n = 26) APRS patients and 25 (n = 25) control subjects were included in this prospective study. We measured the concentrations of thirteen chemokines in nasal secretions of APRS patients and controls by flow cytometry. The patients with APRS were treated by EPs 7630 20 mg oral tablets, three times daily for 10 days. We compared the chemokine levels in nasal secretions, nasal symptoms and endoscopic findings in patients, before and after therapy.

Results: We found higher Total Symptom Score (TSS) and higher concentrations of MCP-1, MIP-1α, MIP-1β, MIP-3α, ENA-78 and IL-8 in nasal secretions of APRS patients than in controls. After therapy by EPs 7630, we found significant improvement in all symptoms and endoscopic findings of APRS. The concentrations of MCP-1, IP-10 and MIP-1β were significantly increased and levels of MIP-1α, ENA-78, GROα and IL-8 significantly decreased in nasal fluid samples after therapy. No adverse effects were reported during the treatment.

Conclusion: Our results suggest the presence of modulatory effects of EPs 7630 on production of chemokines regulating the function of neutrophils and monocytes in the site of inflammation of the nasal mucosa in patients with APRS.

Objective: Treatment of dyslipidemia lowers cardiovascular (CV) risk. Although statin use is a cornerstone therapy, many patients are not achieving their risk-specific low-density lipoprotein cholesterol (LDL-C) goals. The proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies have been extensively studied as lipid-lowering therapy (LLT). Herein, we present an updated evidence-based review of the efficacy and safety of PCSK9 monoclonal antibodies in the treatment of familial and non-familial hypercholesterolemia.

Methods: PubMed database was searched to review Phase III studies on PCSK9 monoclonal antibodies. Then, the US National Institutes of Health Registry and the WHO International Clinical Trial Registry Platform were searched to identify and present the ongoing research.

Results: PCSK9 monoclonal antibodies were investigated for the treatment of dyslipidemia, as a single therapeutic agent or as an add-on therapy to the traditional LLT. They proved effective and safe in the treatment of familial and non-familial hypercholesterolemia, and in the prevention of adverse CV events.

Conclusions: The use of PCSK9 monoclonal antibodies in the treatment of dyslipidemia is currently recommended to achieve risk-specific LDL-C goal to reduce adverse CV events. Future results of the ongoing research might expand their clinical generalizability to broader patient populations.

Objective: Pain after coronary artery by-pass (CAB) surgery is severe. Analgesic administration by mouth is unreliable until after gastrointestinal function has recovered. We evaluated the bioavailability of oxycodone co-administered with naloxone by mouth in patients after CAB surgery using either a conventional extracorporeal circulation (CECC) or off-pump surgery (OPCAB).

Methods: Twenty-four patients, 50-73 years, 12 with CECC and 12 with OPCAB, were administered a 10/5 mg oxycodone-naloxone controlled-release tablet by mouth on the preoperative day and for the first seven postoperative days (PODs) thereafter. Blood samples were collected up to 24 h after the preoperative administration, and then randomly either on POD1 and POD3 or on POD2 and POD4. The oxycodone concentration in plasma was analyzed using liquid chromatography-mass spectrometry.

Results: On POD1 oxycodone absorption was markedly delayed in five of six patients after CECC and in all six patients after OPCAB surgery; median of t_max after CECC 630 [range 270-1420] minutes and after OPCAB 1020 [720-1410] minutes, compared to median of 120-315 min preoperatively and on POD2-POD4. The carry-over corrected AUC_0-24 values on the PODs did not differ from the preoperative values, but were higher on POD3 compared with POD1 in both CECC and OPCAB groups. The rate and extent of oxycodone absorption equaled preoperative values on POD2 and onwards in patients with CAB surgery.

Conclusions: Bioavailability of oxycodone by mouth was similar after CAB surgery via CECC or having OPCAB. Data indicate that POD2 is an appropriate time to start oxycodone administration by mouth after CAB surgery.

Objective: The role of the sympathetic nervous system (SNS) in tumor development, progression and metastasis is studied for more than half a century and is attracting more attention during the last years. In this narrative review, we aim to a chronological and methodological presentation of the most interesting and pioneering studies on the subject.

Methods: The complexity of the autonomic nervous system's interaction with the immune system, its direct and indirect effects on tumors and their surrounding tissues, plus the diversity and heterogeneity in the design and methodology of the studies, provide hard-to-interpret data and, at times, controversial findings. Studies are categorized into four main groups regarding the distribution of sympathetic nerve fibers inside the tumor, the effect of sympathectomy on cancer progression, the role of neurotransmitters on tumor growth and the impact of sympathetic adrenergic signaling on the anti-tumor immune response.

Results: Studies from all four categories converge to a common point. There is strong evidence that SNS function plays a role in the development and progression of tumors and subsequently the modification of SNS function, locally or diffusely, can affect the course of tumor growth.

Conclusion: The impact of SNS function on cancer behavior may be exerted in two ways, directly via the sympathetic nerve fibers or through widely distributed neurotransmitters. Modification of them, combined or not with treatments altering the immune function, could be the target for future therapeutic implications.

Objective: Opioid surveillance in response to the opioid epidemic will benefit from scalable, automated algorithms for identifying patients with clinically documented signs of problem prescription opioid use. Existing algorithms lack accuracy. We sought to develop a high-sensitivity, high-specificity classification algorithm based on widely available structured health data to identify patients receiving chronic extended-release/long-acting (ER/LA) therapy with evidence of problem use to support subsequent epidemiologic investigations. Methods: Outpatient medical records of a probability sample of 2,000 Kaiser Permanente Washington patients receiving ≥60 days' supply of ER/LA opioids in a 90-day period from 1 January 2006 to 30 June 2015 were manually reviewed to determine the presence of clinically documented signs of problem use and used as a reference standard for algorithm development. Using 1,400 patients as training data, we constructed candidate predictors from demographic, enrollment, encounter, diagnosis, procedure, and medication data extracted from medical claims records or the equivalent from electronic health record (EHR) systems, and we used adaptive least absolute shrinkage and selection operator (LASSO) regression to develop a model. We evaluated this model in a comparable 600-patient validation set. We compared this model to ICD-9 diagnostic codes for opioid abuse, dependence, and poisoning. This study was registered with ClinicalTrials.gov as study NCT02667262 on 28 January 2016. Results: We operationalized 1,126 potential predictors characterizing patient demographics, procedures, diagnoses, timing, dose, and location of medication dispensing. The final model incorporating 53 predictors had a sensitivity of 0.582 at positive predictive value (PPV) of 0.572. ICD-9 codes for opioid abuse, dependence, and poisoning had a sensitivity of 0.390 at PPV of 0.599 in the same cohort. Conclusions: Scalable methods using widely available structured EHR/claims data to accurately identify problem opioid use among patients receiving long-term ER/LA therapy were unsuccessful. This approach may be useful for identifying patients needing clinical evaluation.

Objectives: To compare the risks of 1-month all-cause, major bleeding (MB)-related and stroke-related readmissions and the associated hospital resource use and costs among patients previously hospitalized for nonvalvular atrial fibrillation (NVAF) and treated with warfarin, rivaroxaban, and dabigatran vs apixaban. Methods: Adult patients hospitalized with NVAF (any discharge diagnosis position) who received apixaban, warfarin, rivaroxaban, or dabigatran during hospitalization were identified from the Premier database (1 January 2013-30 June 2017) and grouped into respective cohorts. Propensity score matching was used to generate cohorts with similar characteristics. In regression analyses the risk of readmissions that occurred within 1 month of discharge were evaluated and the associated length of stay (LOS) and costs compared. Results: NVAF patients treated with warfarin vs apixaban had significantly greater risk of all-cause (odds ratio [OR] = 1.05; confidence interval [CI] = 1.02-1.08; p < .001), MB-related (OR: 1.28; CI: 1.16-1.42; p < .001), and stroke-related (OR: 1.33; CI: 1.11-1.58; p = .002) readmissions; for all readmission categories, average LOS was significantly longer and costs significantly higher for warfarin treated patients. NVAF patients treated with rivaroxaban versus apixaban had significantly greater risk of all-cause (OR: 1.06; CI: 1.02-1.09; p = .001) and MB-related (OR = 1.62; CI = 1.44-1.83; p < .001) readmissions, but not stroke-related readmission; for MB-related readmissions average LOS and costs were higher for rivaroxaban treated patients. Significant differences in risks of all-cause, MB-related, and stroke-related readmissions were not observed between the apixaban and dabigatran cohorts. Conclusion: In this retrospective real-world analysis of NVAF patients, apixaban treatment was associated with better clinical outcomes than warfarin or rivaroxaban and lower hospital resource burden.