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Evaluable Data (evaluable + data)
Selected AbstractsPilot study of continuous co-infusion of morphine and naloxone in children with sickle cell pain crisisAMERICAN JOURNAL OF HEMATOLOGY, Issue 9 2008Josh Koch Patients with sickle cell disease experience painful crises that often require hospitalization for a continuous infusion of morphine that may cause significant pruritus. We conducted a pilot study to determine the feasibility of simultaneous continuous co-infusion of naloxone with morphine, test novel assessment instruments for pruritus, and explore whether pruritus could be reduced while maintaining effective analgesia. Patients with sickle cell disease and painful crisis requiring continuous infusion morphine received continuous co-infusion of naloxone at 0.25 (low dose) or 1.0 mcg/kg·hr (high dose). Pain scores were obtained using the FACES scale and a 100-mm visual analog scale (VAS). Itching was quantified by a modified VAS score. Evaluable data were obtained on 16 patients. Simultaneous co-infusion of naloxone and morphine was feasible, did not seem to reduce the analgesic efficacy of morphine, and was associated with no adverse effects. The high dose group reported a lower median "VAS worst itch" score than the low dose group (4.8 vs. 7.3, P = 0.08). Simultaneous continuous infusion of naloxone with morphine in pediatric patients with sickle cell disease and pain crisis was feasible and well tolerated. A quantitative pruritus score allowed us to systematically measure pruritus. Further evaluation by randomized, placebo-controlled study of 1 mcg/kg·hr naloxone in this setting is required. Am. J. Hematol., 2008. © 2008 Wiley-Liss, Inc. [source] Health-related utility among adults with atopic dermatitis treated with 0·1% tacrolimus ointment as maintenance therapy over the long term: findings from the Protopic® CONTROL studyBRITISH JOURNAL OF DERMATOLOGY, Issue 6 2009C.D. Poole Summary Background, Long-term maintenance treatment with 0·1% tacrolimus ointment for the prevention of flares has been demonstrated to be well tolerated and effective in adults for the treatment of atopic dermatitis (AD) but its impact on health-related utility has not been reported. Objectives, The purpose of this study was to estimate utility changes associated with the use of tacrolimus ointment in the maintenance treatment of adults with AD. Methods, Data were collected from a clinical trial investigating long-term maintenance treatment with 0·1% tacrolimus ointment in adults with AD. All patients were treated with twice-daily tacrolimus ointment during an open-label period (OLP) of up to 6 weeks, with subsequent randomization to a double-blind disease-control period (DCP) of 12 months comparing tacrolimus ointment, used twice weekly as maintenance treatment, vs. the emollient vehicle as standard treatment. Health-related utility (EQ-5Dindex) was estimated by Monte Carlo simulation from SF-12 responses by application of a published response mapping algorithm and the U.K. tariff for EQ-5D responses and SF-6D responses, respectively. Results, Evaluable data were available for 257 patients stratified into mild, moderate or severe AD with a median age at screening of 28 years [interquartile range (IQR) 22,38] and 40% male. At screening the median EQ-5Dindex across the strata was 0·848 units (IQR 0·704,0·882) for mild cases, 0·796 (0·737,0·876) for moderate cases, and 0·760 (0·661,0·823, P < 0·001) for those with severe disease. At the end of the OLP, mean utility improvement across all strata was 0·027 [95% confidence interval (CI) ,0·011 to 0·065, P = 0·165] for mild cases, 0·046 (95% CI 0·015,0·064, P = 0·002) for moderate cases and 0·076 (95% CI 0·035,0·118, P < 0·001) for those with severe disease. At the end of the blinded DCP, repeated measures analysis showed an age- and sex-adjusted mean change of 0·045 units (P < 0·001) for subjects treated with tacrolimus ointment over those treated with emollient vehicle. Conclusions, Patients with AD of all severities showed considerable decrements in health-related utility. However, treatment with 0·1% tacrolimus ointment was associated with clinically significant improvement in health-related utility for patients with moderate and severe AD, which was sustained over a 12-month maintenance period compared with those using standard treatment with an emollient vehicle. [source] Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive oesophagitisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2007P. O. KATZ Summary Aim, To assess the relationship between the percentage of time intragastric pH >4.0 and healing of erosive oesophagitis. Methods, In this proof-of-concept study, adults with endoscopically verified Los Angeles grade C or grade D erosive oesophagitis were randomly assigned to oral esomeprazole 10 or 40 mg once daily for 4 weeks. On day 5, patients underwent 24-h pH monitoring. At 4 weeks, erosive oesophagitis healing status was endoscopically assessed. Investigators scored gastro-oesophageal reflux disease symptoms on a 4-point scale [none to severe (0,3)] before and 4 weeks after treatment. The percentage of time intragastric pH was >4.0 and healing status were correlated and tested for significance using a Spearman rank correlation (r). Results, 103 patients had evaluable data (mean age, 48.7 years; 65% men). Mean percentages of time with intragastric pH >4.0 on day 5 in patients with healed and unhealed erosive oesophagitis were 61% and 42%, respectively (P = 0.0002), indicating that erosive oesophagitis healing rates were positively related to the percentage of time intragastric pH was >4.0. Greater intragastric acid control correlated with lower final daytime and night-time heartburn and acid regurgitation symptom scores (r = ,0.029, ,0.029 and ,0.021; P = 0.003, 0.003 and 0.032, respectively). Conclusion, A positive relationship between intragastric acid control and erosive oesophagitis healing was demonstrated. [source] Cancer patients' expectations of experiencing treatment-related side effectsCANCER, Issue 4 2004A University of Rochester Cancer Center-Community Clinical Oncology Program study of 938 patients from community practices Abstract BACKGROUND Adequate management of treatment-related side effects is important for patients and challenging for clinicians. Side effects generated by various treatments have been characterized reasonably well. However, to the authors' knowledge, less is known regarding what patients expect to experience regarding these side effects and how patient characteristics are related to these expectations. METHODS Patients with cancer (n = 1015 patients) from 17 Community Clinical Oncology Program (CCOP) institutions affiliated with the University of Rochester Cancer Center CCOP Research Base were surveyed regarding their expectations of experiencing side effects associated with cancer treatment, with 938 patients providing evaluable data. Patients responded to the item, "Indicate your expectations of having this side effect" for 12 common side effects. Patients rated their expectations using a 5-point Likert scale, from 1 ("I definitely will not have this") to 5 ("I definitely will have this"). RESULTS The median number of symptoms expected (characterized by any value other than one) was nine. The six most expected symptoms were fatigue, nausea, sleep disturbance, weight loss, hair loss, and skin problems. Patients age > 60 years expected to have fewer symptoms than younger patients; female patients expected more side effects than male patients; and patients who had some college education expected more side effects than patients who were high school graduates or had not completed high school. CONCLUSIONS Patients with cancer clearly exhibit expectations regarding treatment-related side effects; and age, gender, and education level appear to influence these expectations. Further careful characterization of patient expectations and how expectations relate to experience may lead to earlier and more effective management of side effects. Cancer 2004. © 2004 American Cancer Society. [source] Crystalloid or colloid for partial exchange transfusion in neonatal polycythemia: A systematic review and meta-analysisACTA PAEDIATRICA, Issue 11 2005EUGENE M. DEMPSEY Abstract Aims: To determine whether crystalloid solutions are as effective as colloid solutions when a partial exchange transfusion is performed in newborns with polycythemia. Methods: We searched MEDLINE, EMBASE, and the Cochrane Controlled Trials Register of the Cochrane Library (1966,2004). Keywords used were: polycythemia, partial exchange transfusion, hyperviscosity, and limited to newborn. Randomized studies in newborns with polycythemia were selected for evaluation. Outcomes examined were: long-term neurodevelopment; short-term physiological effects; improvement in clinical symptoms; reduction in haematocrit at 4,6 h; haematocrit at 24 h; and frequency of serious complications. Results: Four randomized controlled clinical trials, including 200 patients in total, with evaluable data, which satisfied our criteria, were found. There were no data on long-term outcomes. There is no reported important difference in short-term physiologic effects. Use of crystalloid was as effective as colloid in both correction of haematological values and reduction of clinical symptoms following partial exchange transfusion. Conclusion: Crystalloid solutions are as effective as colloid solutions for partial exchange transfusion. When crystalloid solutions are used for this purpose, there is no risk of transmission of blood-borne diseases, there is no risk of anaphylaxis, they are rapidly and easily available, and are less expensive. The use of crystalloid should become the standard for partial exchange transfusion. [source] | ||||||||||