Browsing by Subject "CONTROLLED-TRIAL"

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  • Goncalves, Bronner P.; Pett, Helmi; Tiono, Alfred B.; Murry, Daryl; Sirima, Sodiomon B.; Niemi, Mikko; Bousema, Teun; Drakeley, Chris; ter Heine, Rob (2017)
    Low-dose primaquine is recommended to prevent Plasmodium falciparum malaria transmission in areas threatened by artemisinin resistance and areas aiming for malaria elimination. Community treatment campaigns with artemisinin-based combination therapy in combination with the gametocytocidal primaquine dose target all age groups, but no studies thus far have assessed the pharmacokinetics of this gametocytocidal drug in African children. We recruited 40 children participating in a primaquine efficacy trial in Burkina Faso to study primaquine pharmacokinetics. These children received artemether-lumefantrine and either a 0.25- or a 0.40-mg/kg primaquine dose. Seven blood samples were collected from each participant for primaquine and carboxy-primaquine plasma levels determinations: one sample was collected before primaquine administration and six after primaquine administration according to partially overlapping sampling schedules. Physiological population pharmacokinetic modeling was used to assess the impact of weight, age, and CYP2D6 genotype on primaquine and carboxy-primaquine pharmacokinetics. Despite linear weight normalized dosing, the areas under the plasma concentration-time curves and the peak concentrations for both primaquine and carboxy-primaquine increased with age and body weight. Children who were CYP2D6 poor metabolizers had higher levels of the parent compound, indicating a lower primaquine CYP2D6-mediated metabolism. Our data indicate that primaquine and carboxy-primaquine pharmacokinetics are influenced by age, weight, and CYP2D6 genotype and suggest that dosing strategies may have to be reconsidered to maximize the transmission-blocking properties of primaquine.
  • Nurmatov, U.; Dhami, S.; Arasi, S.; Pajno, G. B.; Fernandez-Rivas, M.; Muraro, A.; Roberts, G.; Akdis, C.; Alvaro-Lozano, M.; Beyer, K.; Bindslev-Jensen, C.; Burks, W.; du Toit, G.; Ebisawa, M.; Eigenmann, P.; Knol, E.; Mäkelä, Mika; Nadeau, K. C.; O'Mahony, L.; Papadopoulos, N.; Poulsen, L. K.; Sackesen, C.; Sampson, H.; Santos, A. F.; van Ree, R.; Timmermans, F.; Sheikh, A. (2017)
    Background: The European Academy of Allergy and Clinical Immunology (EAACI) is developing Guidelines for Allergen Immunotherapy (AIT) for IgE-mediated Food Allergy. To inform the development of clinical recommendations, we sought to critically assess evidence on the effectiveness, safety and cost-effectiveness of AIT in the management of food allergy. Methods: We undertook a systematic review and meta-analysis that involved searching nine international electronic databases for randomized controlled trials (RCTs) and nonrandomized studies (NRS). Eligible studies were independently assessed by two reviewers against predefined eligibility criteria. The quality of studies was assessed using the Cochrane Risk of Bias tool for RCTs and the Cochrane ACROBAT-NRS tool for quasi-RCTs. Random-effects meta-analyses were undertaken, with planned subgroup and sensitivity analyses. Results: We identified 1814 potentially relevant papers from which we selected 31 eligible studies, comprising of 25 RCTs and six NRS, studying a total of 1259 patients. Twenty-five trials evaluated oral immunotherapy (OIT), five studies investigated sublingual immunotherapy, and one study evaluated epicutaneous immunotherapy. The majority of these studies were in children. Twenty-seven studies assessed desensitization, and eight studies investigated sustained unresponsiveness postdiscontinuation of AIT. Meta-analyses demonstrated a substantial benefit in terms of desensitization (risk ratio (RR) = 0.16, 95% CI 0.10, 0.26) and suggested, but did not confirm sustained unresponsiveness (RR = 0.29, 95% CI 0.08, 1.13). Only one study reported on disease-specific quality of life (QoL), which reported no comparative results between OIT and control group. Meta-analyses revealed that the risk of experiencing a systemic adverse reaction was higher in those receiving AIT, with a more marked increase in the risk of local adverse reactions. Sensitivity analysis excluding those studies judged to be at high risk of bias demonstrated the robustness of summary estimates of effectiveness and safety of AIT for food allergy. None of the studies reported data on health economic analyses. Conclusions: AIT may be effective in raising the threshold of reactivity to a range of foods in children with IgE-mediated food allergy whilst receiving (i.e. desensitization) and post-discontinuation of AIT. It is, however, associated with a modest increased risk in serious systemic adverse reactions and a substantial increase in minor local adverse reactions. More data are needed in relation to adults, long term effects, the impact on QoL and the cost-effectiveness of AIT.
  • Stephen, Ruth; Liu, Yawu; Ngandu, Tiia; Rinne, Juha O.; Kemppainen, Nina; Parkkola, Riitta; Laatikainen, Tiina; Paajanen, Teemu; Hanninen, Tuomo; Strandberg, Timo; Antikainen, Riitta; Tuomilehto, Jaakko; Keinanen Kiukaanniemi, Sirkka; Vanninen, Ritva; Helisalmi, Seppo; Levalahti, Esko; Kivipelto, Miia; Soininen, Hilkka; Solomon, Alina (2017)
    Background: CAIDE Dementia Risk Score is the first validated tool for estimating dementia risk based on a midlife risk profile. Objectives: This observational study investigated longitudinal associations of CAIDE Dementia Risk Score with brain MRI, amyloid burden evaluated with PIB-PET, and detailed cognition measures. Methods: FINGER participants were at-risk elderly without dementia. CAIDE Risk Score was calculated using data from previous national surveys (mean age 52.4 years). In connection to baseline FINGER visit (on average 17.6 years later, mean age 70.1 years), 132 participants underwent MRI scans, and 48 underwent PIB-PET scans. All 1,260 participants were cognitively assessed (Neuropsychological Test Battery, NTB). Neuroimaging assessments included brain cortical thickness and volumes (Freesurfer 5.0.3), visually rated medial temporal atrophy (MTA), white matter lesions (WML), and amyloid accumulation. Results: Higher CAIDE Dementia Risk Score was related to more pronounced deep WML (OR 1.22, 95% CI 1.05-1.43), lower total gray matter (beta- coefficient -0.29, p = 0.001) and hippocampal volume (beta- coefficient -0.28, p = 0.003), lower cortical thickness (beta-coefficient -0.19, p = 0.042), and poorer cognition (beta-coefficients -0.31 for total NTB score, -0.25 for executive functioning, -0.33 for processing speed, and -0.20 for memory, all p <0.001). Higher CAIDE Dementia Risk Score including APOE genotype was additionally related to more pronounced MTA (OR 1.15,95% CI 1.00-1.30). No associations were found with periventricular WML or amyloid accumulation. Conclusions: The CAIDE Dementia Risk Score was related to indicators of cerebrovascular changes and neurodegeneration on MRI, and cognition. The lack of association with brain amyloid accumulation needs to be verified in studies with larger sample sizes.
  • Snäll, Johanna; Törnwall, Jyrki; Suominen, Anna Liisa; Thoren, Hanna (2018)
    To clarify pre- and postoperative C-reactive protein (CRP) levels in patients with facial fractures and to investigate the influence of perioperatively administered dexamethasone on postoperative CRP levels. Facial fracture patients were randomized to receive perioperatively a total dose of 30 mg of dexamethasone (OradexonA (R)), whereas patients in the control group received no glucocorticoid. The analysis included patients who had CRP measured pre- and postoperatively. A total of 73 adult patients with facial fractures were included in the final analysis. Mean CRP level was elevated preoperatively and the level increased further after surgery. However, postoperative CRP rise was significantly impeded by dexamethasone (p <0.001), regardless of gender, age, treatment delay, site of fracture, surgical approach, and duration of surgery. CRP rise halved on the 1st postoperative day when dexamethasone was used. In addition, dexamethasone resulted in a CRP decrease on the 2nd postoperative day, whereas the CRP rise continued in the control group. CRP rise is a normal body response after facial fracture and surgery that can be markedly reduced with dexamethasone. CRP changes should be considered with caution if perioperative dexamethasone is used.
  • Mustelin, Linda; Kaprio, Jaakko; Keski-Rahkonen, Anna (2018)
    Objective: Binge eating disorder (BED) is a clinical eating disorder that is strongly and bidirectionally related to overweight and obesity. Little is known about how subclinical features of BED relate to weight development in adolescence and young adulthood. Method: Women (n=2825) and men (n=2423) from the community-based longitudinal FinnTwin16 cohort participated. Seven eating-related cognitions and behaviors similar to the defining features of BED were extracted from the Eating Disorder Inventory-2 and were assessed at a mean age of 24. We used linear mixed models to assess the association of features of BED with BMI trajectories across four waves of data collection (mean ages 16, 17, 18, and 24). Results: The number of features of BED at wave 4 (age 24) was significantly associated with BMI from age 16 years onwards. Those reporting more features of BED had gained more weight throughout adolescence and into their twenties. Conclusions: Features of BED in young adulthood were preceded by steeper BMI trajectories in adolescence. A higher number of features were consistently associated with higher BMI and more weight gain.
  • Ahonen, Marko T.; Diaconu, Iulia; Pesonen, Sari; Kanerva, Anna; Baumann, Marc; Parviainen, Suvi T.; Spiller, Brad; Cerullo, Vincenzo; Hemminki, Akseli (2010)
  • Kallio, Sonja E.; Kiiski, Annika; Airaksinen, Marja S. A.; Mäntylä, Antti T.; Kumpusalo-Vauhkonen, Anne E. J.; Järvensivu, Timo P.; Pohjanoksa-Mantyla, Marika K. (2018)
    ObjectivesTo identify medication review interventions for older adults that involve community pharmacists and evidence of outcomes of these interventions. DesignSystematic review. MeasurementsCinahl, MEDLINE (Ovid), Scopus, International Pharmaceutical Abstracts, and Cochrane Library were searched for articles published between January 2000 and February 2016. Articles involving community pharmacists in medication reviews for outpatients aged 65 and older were included. Evidence of economic, clinical, and humanistic outcomes of interventions was summarized. ResultsSixteen articles were found that described 12 medication review interventions, of which 6 were compliance and concordance reviews, 4 were clinical medication reviews, and 2 were prescription reviews according to a previously developed typology. Community pharmacists' contributions to reviewing medications varied from sending the dispensing history to other healthcare providers to comprehensive involvement in medication management. The most commonly assessed outcomes of the interventions were medication changes leading to reduction in actual or potential drug-related problems (n=12) and improved adherence (n=5). ConclusionRegardless of community pharmacists' contributions to interventions, medication review interventions seem to reduce drug-related problems and increase medication adherence. More well-designed, rigorous studies with more sensitive and specific outcomes measures need to be conducted to assess the effect of community pharmacists' contributions to reviewing medications and improving the health of older adults.
  • Douillard, Francois P.; Kant, Ravi; Ritari, Jarmo; Paulin, Lars; Palva, Airi; de Vos, Willem M. (2013)
  • Douillard, Francois P.; Mora, Diego; Eijlander, Robyn T.; Wels, Michiel; de Vos, Willem M. (2018)
    Several probiotic-marketed formulations available for the consumers contain live lactic acid bacteria and/or bifidobacteria. The multispecies product commercialized as VSL#3 has been used for treating various gastro-intestinal disorders. However, like many other products, the bacterial strains present in VSL#3 have only been characterized to a limited extent and their efficacy as well as their predicted mode of action remain unclear, preventing further applications or comparative studies. In this work, the genomes of all eight bacterial strains present in VSL#3 were sequenced and characterized, to advance insights into the possible mode of action of this product and also to serve as a basis for future work and trials. Phylogenetic and genomic data analysis allowed us to identify the 7 species present in the VSL#3 product as specified by the manufacturer. The 8 strains present belong to the species Streptococcus thermophilus, Lactobacillus acidophilus, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus helveticus, Bifidobacterium breve and B. animalis subsp. lactis (two distinct strains). Comparative genomics revealed that the draft genomes of the S. thermophilus and L. helveticus strains were predicted to encode most of the defence systems such as restriction modification and CRISPR-Cas systems. Genes associated with a variety of potential probiotic functions were also identified. Thus, in the three Bifidobacterium spp., gene clusters were predicted to encode tight adherence pili, known to promote bacteria-host interaction and intestinal barrier integrity, and to impact host cell development. Various repertoires of putative signalling proteins were predicted to be encoded by the genomes of the Lactobacillus spp., i.e. surface layer proteins, LPXTG-containing proteins, or sortase-dependent pili that may interact with the intestinal mucosa and dendritic cells. Taken altogether, the individual genomic characterization of the strains present in the VSL#3 product confirmed the product specifications, determined its coding capacity as well as identified potential probiotic functions.
  • Holma, Reetta; Laatikainen, Reijo; Orell, Helena; Joensuu, Heikki; Peuhkuri, Katri; Poussa, Tuija; Korpela, Riitta; Österlund, Pia (2020)
    Chemotherapy-induced mucosal injury of the small intestine may interfere with the enzymes and transporters responsible for the hydrolysis and absorption of dietary carbohydrates causing diarrhoea, abdominal discomfort and pain. The aim of this study was to investigate the association between the consumption of foods rich in FODMAPs (fermentable oligo-, di- and monosaccharides and polyols) and gastrointestinal symptoms in patients receiving adjuvant therapy for colorectal cancer. The patients (n = 52) filled in a 4-day food diary at baseline and during therapy and kept a symptom diary. The intakes of FODMAP-rich foods were calculated as portions and the intakes were divided into two consumption categories. Patients with high consumption of FODMAP-rich foods had diarrhoea more frequently than those with low consumption (for lactose-rich foods the odds ratio (OR) was 2.63, P = 0.03; and for other FODMAP-rich foods 1.82, P = 0.20). Patients with high consumption of both lactose-rich and other FODMAP-rich foods had an over 4-fold risk of developing diarrhoea as compared to those with low consumption of both (OR, 4.18; P = 0.02). These results were confirmed in multivariate models. Conclusion: Consumption of lactose-rich foods results in an increased risk of diarrhoea during adjuvant therapy for colorectal cancer, especially when the consumption of other FODMAP-rich foods is also high.
  • Runeberg-Roos, Pia; Piccinini, Elisa; Penttinen, Anna-Maija; Matlik, Kert; Heikkinen, Hanna; Kuure, Satu; Bespalov, Maxim M.; Peranen, Johan; Garea-Rodriguez, Enrique; Fuchs, Eberhard; Airavaara, Mikko; Kalkkinen, Nisse; Penn, Richard; Saarma, Mart (2016)
    In Parkinson's disease midbrain dopaminergic neurons degenerate and die. Oral medications and deep brain stimulation can relieve the initial symptoms, but the disease continues to progress. Growth factors that might support the survival, enhance the activity, or even regenerate degenerating dopamine neurons have been tried with mixed results in patients. As growth factors do not pass the blood-brain barrier, they have to be delivered intracranially. Therefore their efficient diffusion in brain tissue is of crucial importance. To improve the diffusion of the growth factor neurturin (NRTN), we modified its capacity to attach to heparan sulfates in the extracellular matrix. We present four new, biologically fully active variants with reduced heparin binding. Two of these variants are more stable than WT NRTN in vitro and diffuse better in rat brains. We also show that one of the NRTN variants diffuses better than its close homolog GDNF in monkey brains. The variant with the highest stability and widest diffusion regenerates dopamine fibers and improves the conditions of rats in a 6-hydroxydopamine model of Parkinson's disease more potently than GDNF, which previously showed modest efficacy in clinical trials. The new NRTN variants may help solve the major problem of inadequate distribution of NRTN in human brain tissue. (C) 2016 Elsevier Inc. All rights reserved.
  • Cavonius-Rintahaka, Diana; Aho, Anna Liisa; Billstedt, Eva; Gillberg, Christopher (2021)
    Aim: To describe the development and implementation of a Dialogical Family Guidance (DFG) intervention, aimed at families with a child with neurodevelopmental disorders (NDD). Design: The DFG components are presented and the content of a DFG training course. Professionals' experiences after the DFG training were evaluated. Methods: Dialogical Family Guidance development phases and implementation process are examined. The Revised Standards for Quality Improvement Reporting Excellence checklist (SQUIRE 2.0) was used to provide a framework for reporting new knowledge. Results: The DFG training course seemed to increase possibilities of a more independent role as a nurse to deliver the DFG family intervention. The project showed that the use of dialogue can be difficult for some professionals. Analysis of the questionnaire completed after DFG training reported a high level of satisfaction. DFG training offered a new approach to deliver knowledge and understanding to families using dialogue, including tailored psychoeducation and emotional and practical guidance.
  • Gabay, Cem; Riek, Myriam; Hetland, Merete Lund; Hauge, Ellen-Margrethe; Pavelka, Karel; Tomsic, Matija; Canhao, Helena; Chatzidionysiou, Katerina; Lukina, Galina; Nordstrom, Dan C.; Lie, Elisabeth; Ancuta, Ioan; Victoria Hernandez, M.; van Riel, Piet L. M. C.; van Vollenhoven, Ronald; Kvien, Tore K. (2016)
    Objectives To examine the effectiveness of tocilizumab (TCZ) with and without synthetic disease-modifying antirheumatic drugs (sDMARDs) in a large observational study. Methods Patients with rheumatoid arthritis treated with TCZ who had a baseline visit and information on concomitant sDMARDs were included. According to baseline data, patients were considered as taking TCZ as monotherapy or combination with sDMARDs. Main study outcomes were the change of Clinical Disease Activity Index (CDAI) and TCZ retention. The prescription of TCZ as monotherapy was analysed using logistic regression. CDAI change was analysed with a mixed-effects model for longitudinal data. TCZ retention was analysed with a stratified extended Cox model. Results Multiple-adjusted analysis suggests that prescription of TCZ as monotherapy varied according to age, corticosteroid use, country of the registry and year of treatment initiation. The change of disease activity assessed by CDAI as well as the likelihood to be in remission were not significantly different whether TCZ was used as monotherapy or in combination with sDMARDs in a covariate-adjusted analysis. Estimates for unadjusted median TCZ retention were 2.3 years (95% CI 1.8 to 2.7) for monotherapy and 3.7 years (lower 95% CI limit 3.1, upper limit not estimable) for combination therapies. In a covariate-adjusted analysis, TCZ retention was also reduced when used as monotherapy, with an increasing difference between mono and combination therapy over time after 1.5 years (p=0.002). Conclusions TCZ with or without concomitant sDMARDs resulted in comparable clinical response as assessed by CDAI change, but TCZ retention was shorter under monotherapy of TCZ.
  • Chatzidionysiou, Katerina; Lie, Elisabeth; Nasonov, Evgeny; Lukina, Galina; Hetland, Merete Lund; Tarp, Ulrik; Ancuta, Ioan; Pavelka, Karel; Nordstrom, Dan C.; Gabay, Cem; Canhao, Helene; Tomsic, Matija; van Riel, Piet L. C. M.; Gomez-Reino, Juan; Kvien, Tore K.; van Vollenhoven, Ronald F.; Rheumatic Dis Portuguese Register (2016)
    Background: The approved dose of rituximab (RTX) in rheumatoid arthritis is 1000 mg x 2, but some data have suggested similar clinical efficacy with 500 mg x 2. The purpose of this study was to compare the effectiveness of the regular and low doses given as first treatment course. Methods: Twelve European registries participating in the CERERRA collaboration (The European Collaborative Registries for the Evaluation of Rituximab in Rheumatoid Arthritis) submitted anonymized datasets with demographic, efficacy and treatment data for patients who had started RTX. Treatment effectiveness was assessed by DAS28 reductions and EULAR responses after 6 months. Results: Data on RTX dose were available for 2,873 patients, of whom 2,625 (91.4 %) and 248 (8.6 %) received 1000 mg x 2 and 500 mg x 2, respectively. Patients treated with 500 mg x 2 were significantly older, had longer disease duration, higher number of prior DMARDs, but lower number of prior biologics and lower baseline DAS28 than those treated with 1000 mg x 2. Fewer patients in the low-dose group received concomitant DMARDs but more frequently received concomitant corticosteroids. Both doses led to significant clinical improvements at 6 months. DAS28 reductions at 6 months were comparable in the 2 dose regimens [mean DeltaDAS28 +/- SD -2.0 +/- 1.3 (high dose) vs. -1.7 +/- 1.4 (low dose), p = 0.23 adjusted for baseline differences]. Similar percentages of patients achieved EULAR good response in the two dose groups, 18.4 % vs. 17.3 %, respectively (p = 0.36). Conclusions: In this large observational cohort initial treatment with RTX at 500 mg x 2 and 1000 mg x 2 led to comparable clinical outcomes at 6 months.
  • Lahtinen, Perttu; Mattila, Eero; Anttila, Veli-Jukka; Tillonen, Jyrki; Teittinen, Matti; Nevalainen, Pasi; Salminen, Seppo; Satokari, Reetta; Arkkila, Perttu (2017)
    Fecal microbiota transplantation (FMT) is effective in recurrent Clostridium difficile infection (rCDI). Knowledge of the safety and efficacy of FMT treatment in immune deficient patients is scarce. FMT has been suggested as a potential method for an increasing number of new indications besides rCDI. Among our FMT-treated rCDI patients, we reviewed those with major comorbidities: two human immunodeficiency virus patients, six haemodialysis patients, two kidney transplant patients, two liver transplant patients and a patient with chronic lymphatic leukaemia. We also reviewed those treated with FMT for indications other than rCDI: Salmonella carriage (two patients), trimethylaminuria (two patients), small intestinal bacterial overgrowth (SIBO; one patient), and lymphocytic colitis (one patient), as well as a common variable immunodeficiency patient with chronic norovirus infection and ESBL-producing Escherichia coli (E. coli) carriage. Of the thirteen rCDI patients treated with FMT, eleven cleared the CDI. The observed adverse events were not directly attributable to FMT. Concerning the special indications, both Salmonellas and ESBL-producing E. coli were eradicated. One trimethylaminuria patient and one SIBO-patient reported a reduction of symptoms. Three patients did not experience a benefit from FMT: chronic norovirus, lymphocytic colitis and the other fish malodour syndrome. There were no reported side effects in this group. FMT appeared to be safe and effective for immunocompromised patients with rCDI. FMT showed promise for the eradication of antibiotic-resistant bacteria, but further research is warranted.
  • Hancock, D. B.; Reginsson, G. W.; Gaddis, N. C.; Chen, X.; Saccone, N. L.; Lutz, S. M.; Qaiser, Beenish; Sherva, R.; Steinberg, S.; Zink, F.; Stacey, S. N.; Glasheen, C.; Chen, J.; Gu, F.; Frederiksen, B. N.; Loukola, A.; Gudbjartsson, D. F.; Brueske, I.; Landi, M. T.; Bickeboeller, H.; Madden, P.; Farrer, L.; Kaprio, J.; Kranzler, H. R.; Gelernter, J.; Baker, T. B.; Kraft, P.; Amos, C. I.; Caporaso, N. E.; Hokanson, J. E.; Bierut, L. J.; Thorgeirsson, T. E.; Johnson, E. O.; Stefansson, K. (2015)
    We conducted a 1000 Genomes-imputed genome-wide association study (GWAS) meta-analysis for nicotine dependence, defined by the Fagerstrom Test for Nicotine Dependence in 17 074 ever smokers from five European-ancestry samples. We followed up novel variants in 7469 ever smokers from five independent European-ancestry samples. We identified genome-wide significant association in the alpha-4 nicotinic receptor subunit (CHRNA4) gene on chromosome 20q13: lowest P = 8.0 x 10(-9) across all the samples for rs2273500-C (frequency = 0.15; odds ratio = 1.12 and 95% confidence interval = 1.08-1.17 for severe vs mild dependence). rs2273500-C, a splice site acceptor variant resulting in an alternate CHRNA4 transcript predicted to be targeted for nonsense-mediated decay, was associated with decreased CHRNA4 expression in physiologically normal human brains (lowest P = 7.3 x 10(-4)). Importantly, rs2273500-C was associated with increased lung cancer risk (N = 28 998, odds ratio = 1.06 and 95% confidence interval = 1.00-1.12), likely through its effect on smoking, as rs2273500-C was no longer associated with lung cancer after adjustment for smoking. Using criteria for smoking behavior that encompass more than the single 'cigarettes per day' item, we identified a common CHRNA4 variant with important regulatory properties that contributes to nicotine dependence and smoking-related consequences.
  • Nurminen, Janne; Puustinen, Juha; Lahteenmaki, Ritva; Vahlberg, Tero; Lyles, Alan; Partinen, Markku; Raiha, Ismo; Neuvonen, Pertti J.; Kivelä, Sirkka-Liisa (2014)
  • Jokelainen, Jarno; Udd, Marianne; Kylänpää, Leena; Mustonen, Harri; Halttunen, Jorma; Lindstrom, Outi; Pöyhiä, Reino (2017)
    Objective: Patient-controlled sedation (PCS) has been shown to be a valid choice for sedation during endoscopic retrograde cholangiopancreatography (ERCP) in randomized studies. However, large-scale studies are lacking. Material and methods: A single center, prospective observational study to determine how sedation for ERCP is administered in clinical setting. All 956 patients undergoing 1196 ERCPs in the endoscopy unit of Helsinki University Central Hospital 2012-2013, methods of sedation and adverse events associated with different sedations were recorded. Results: PCS was attempted a total of 685 times (57%), successful use of PCS was achieved with 526 patients (77% of attempts). PCS device was operated by the anesthesiologist or anesthesia nurse 268 times (22%). PCS was more likely chosen for younger (80.6% for <=60 years vs. 63.8% for >60 years, p <.001) patients and by trainee anesthetists. Anesthesiologist administered propofol sedation was used 240 times (20%). The risk of failure of PCS was increased, if systolic arterial pressure was <90mmHg, dosage of PCS > 17 ml, duration of procedure exceeded 23 min. The risk of failure was lower in patients with primary sclerosing cholangitis (PSC) and if sedation was deeper RASS<= -2. Uneventful PCS was associated with less respiratory and cardiovascular depression than other methods. There were no statistically significant differences in safety profiles with all the methods of sedation. Conclusions: PCS is readily implemented in clinical practice, is suitable for younger and low-risk patients and is associated with less cardiorespiratory adverse effects.
  • Seppala, Elina; Sillanpaa, Saara; Nurminen, Noora; Huhtala, Heini; Toppari, Jorma; Ilonen, Jorma; Veijola, Riitta; Knip, Mikael; Sipila, Markku; Laranne, Jussi; Oikarinen, Sami; Hyoty, Heikki (2016)
    BACKGROUND: Human enteroviruses (HEVs) and rhinoviruses (HRVs) have been linked to acute otitis media (AOM). OBJECTIVES:The present study evaluates the aforementioned association in a birth cohort setting. STUDY DESIGN: The cohort included 286 healthy infants (191 boys) followed from birth up to the age of 2 years in the Type 1 Diabetes Prediction and Prevention study in Finland. Stool samples were collected monthly and analyzed for the presence of HRV and HEV RNA using RT-PCR. Clinical symptoms were recorded by a questionnaire every 3-6 months. RESULTS:Altogether 610 AOM episodes were reported during the follow-up. 9.8% of the stool samples were positive for HRV and 6.8% for HEV. HRV positivity peaked at the age of 3-6 months declining gradually after this age, whereas HEV positivity peaked later, at the age of 12-24 months. The risk of AOM was increased in children who were HEV positive at least once at the age of 6-12 months (OR 2.2 [95%CI 1.1-4.2], P=0.023) or who were HRV positive at least once at the age of 18-24 months (OR 2.3 [95%CI 1.0-5.2], P=0.042). Having an older sibling, short breast-feeding and maternal smoking during pregnancy were also significantly associated with AOM. CONCLUSIONS: HRV and HEV infections are frequent during the first months of life. The observed trend for increased risk of AOM in HRV and HEV positive children is in line with the results from hospital series suggesting that these viruses may play an independent role in the pathogenesis of AOM. (C) 2016 Elsevier B.V. All rights reserved.