Home About us Contact
|
Home About us Contact | ||
|
|
||
Severe Adverse Events (severe + adverse_event)
Selected AbstractsComplications of Sclerotherapy: An UpdateDERMATOLOGIC SURGERY, Issue 2010FACPH, JEAN-JÉRÔME GUEX MD OBJECTIVES To describe, determine the incidence of, and explain the adverse reactions associated with the use of sclerotherapy and sclerosing agents. MATERIAL AND METHODS Review of current literature and personal research, with special attention to the French registry of 12,173 sclerotherapy sessions. RESULTS The nature and incidence of side effects of sclerosing agents vary according to the injection form: liquid or foam. They must be differentiated from complications of the method, which are less specific and often related to an inappropriate technique. Severe adverse events are rare, especially in relation to the billions of injections administered. CONCLUSION Complications and side effects of sclerotherapy are uncommon; the method has demonstrated its safety, with 0.22% of complications per session with liquid sclerosant and 0.58% with foamed sclerosant, but several points remain unclear, and more research is needed. Patient's informed consent can be better obtained thanks to the current knowledge herein summarized. Jean-Jérôme Guex, MD, FACPh, has received an honorarium from Bioform (USA). [source] Adverse events during use of intranasal desmopressin acetate for haemophilia A and von Willebrand disease: a case report and review of 40 patientsHAEMOPHILIA, Issue 1 2000Dunn We report our experience with the incidence of adverse events during the use of Stimate® brand intranasal desmopressin acetate (IN DDAVP) for patients with haemophilia A (HA) or von Willebrand disease (vWD) after noting two severe adverse events in one adult patient. All patients with documented vWD (type 1 or 2 A) or haemophilia A (mild, moderate or symptomatic carrier) from the Emory Comprehensive Hemophilia Center who had IN DDAVP challenge testing or were using Stimate® for treatment of bleeding were evaluated for adverse events by patient report or nursing observation of clinical signs and symptoms. Forty patients were studied. Sixty-eight per cent (27/40) experienced clinical signs and/or symptoms. The majority of these symptoms were mild, however several patients reported moderate to severe side-effects and one adult patient required medical intervention for symptomatic hyponatraemia. In our experience, two-thirds of patients tested experienced adverse signs and/or symptoms with the use of Stimate®; considerably higher than that reported from preliminary results in the literature. Young age did not correlate positively with adverse reactions. Severe adverse events requiring medical intervention were rare, however symptoms such as moderate to severe headache, nausea, vomiting and weakness may necessitate evaluation for hyponatraemia. This is the first report of symptomatic hyponatraemia in an adult patient with recommended dosing of Stimate®. Side-effects may be minimized if patients adhere to instructions regarding fluid intake and composition while using IN DDAVP. [source] A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myelomaBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2006Axel Glasmacher Summary The activity of thalidomide in relapsed or refractory multiple myeloma is widely accepted but not yet demonstrated in a randomised-controlled trial. A systematic review of the published clinical trials of these patients could reduce the possible bias of single phase-II studies. A systematic search identified 42 communications reporting on 1674 patients. Thirty-two trials used an escalating dosing regimen and four a fixed dose regimen (one dose with 50 mg/d, three doses with 200 mg/d). The target dose in the dose escalating trials was 800 mg/d in 17 trials, 400,600 mg/d in 10 and 200 mg/d in one trial. The intention-to-treat population for efficacy was 1629 patients with a median age of 62 years. The complete and partial (>50% reduction in monoclonal protein) response rate was 29·4% (95%-confidence interval, 27,32%). The rates for minor responses or stable disease were 13·8% (12,16%) and 11·0% (9,13%). Progressive disease was reported in 9·9% (8,11%). The median overall survival from all trials was reported at 14 months. Severe adverse events (grade III,IV) included somnolence 11%, constipation 16%, neuropathy 6%, rash 3%, thrombo-embolism 3%, cardiac 2%. In conclusion, thalidomide monotherapy achieved complete and partial responses in 29·4% of patients with relapsed or refractory multiple myeloma. [source] Imatinib compared with chemotherapy as front-line treatment of elderly patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL),CANCER, Issue 10 2007Oliver G. Ottmann MD Abstract BACKGROUND Elderly patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) have a poor prognosis, with a low complete remission (CR) rate, high induction mortality, and short remission duration. Imatinib (IM) has a favorable toxicity profile but limited antileukemic activity in advanced Ph+ALL. Imatinib in combination with intensive chemotherapy has yielded promising results as front-line therapy, but its value as monotherapy in newly diagnosed Ph+ALL is not known. METHODS Patients with de novo Ph+ALL were randomly assigned to induction therapy with either imatinib (IndIM) or multiagent, age-adapted chemotherapy (Indchemo). Imatinib was subsequently coadministered with consolidation chemotherapy. RESULTS In all, 55 patients (median age, 68 years) were enrolled. The overall CR rate was 96.3% in patients randomly assigned to IndIM and 50% in patients allocated to Indchemo (P = .0001). Nine patients (34.6%) were refractory and 2 patients died during Indchemo; none failed imatinib induction. Severe adverse events were significantly more frequent during Indchemo (90% vs 39%; P = .005). The estimated overall survival (OS) of all patients was 42% ± 8% at 24 months, with no significant difference between the 2 cohorts. Median disease-free survival was significantly longer in the 43% of patients (21 of 49 evaluable) in whom BCR-ABL transcripts became undetectable (18.3 months vs 7.2 months; P = .002). CONCLUSIONS In elderly patients with de novo Ph+ALL, imatinib induction results in a significantly higher CR rate and lower toxicity than induction chemotherapy. With subsequent combined imatinib and chemotherapy consolidation, this initial benefit does not translate into improved survival compared with chemotherapy induction. Cancer 2007. © 2007 American Cancer Society. [source] A randomised comparison of oral desmopressin lyophilisate (MELT) and tablet formulations in children and adolescents with primary nocturnal enuresisINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 9 2007H. Lottmann Summary Aims:, Desmopressin is a useful treatment for primary nocturnal enuresis (PNE), a common childhood condition that can persist into adolescence. This open-label, randomised, cross-over study evaluated the preference of children and adolescents with PNE for sublingual desmopressin oral lyophilisate (MELT) vs. tablet treatment, and the efficacy, safety, compliance and ease of use associated with each formulation. In total, 221 patients aged 5,15 years who were already receiving desmopressin tablets were randomised 1 : 1 to receive desmopressin treatment in the order MELT/tablet (n = 110) or tablet/MELT (n = 111) for 3 weeks each. Each formulation was administered in bioequivalent doses (0.2/0.4 mg tablets , 120/240 ,g MELT). Following treatment, patients were questioned regarding treatment preference. Diary card data and 100 mm Visual Analogue Scale scores were also recorded. Results:, Overall, patients preferred the MELT formulation to the tablet (56% vs. 44%; p = 0.112). This preference was age dependent (p = 0.006); patients aged < 12 years had a statistically significant preference for desmopressin MELT (p = 0.0089). Efficacy was similar for both formulations (MELT: 1.88 ± 1.94 bedwetting episodes/week; tablet: 1.90 ± 1.85 episodes/week). Ease of use of both formulations was high. Compliance (, 80%) was 94.5% for MELT patients vs. 88.9% for the tablet (p = 0.059). No serious/severe adverse events were reported. Conclusions:, There was an overall preference for the MELT, and a statistically significant preference for desmopressin MELT in children aged 5,11 years. Desmopressin MELT had similar levels of efficacy and safety at lower dosing levels than the tablet, and therefore facilitates early initiation of PNE treatment in children aged 5,6 years. [source] Immediate and Midterm Complications of Sclerotherapy: Report of a Prospective Multicenter Registry of 12,173 Sclerotherapy SessionsDERMATOLOGIC SURGERY, Issue 2 2005FACPH, Jean-Jérôme Guex MD Background Growing interest in sclerotherapy has emphasized the need for complete knowledge of all aspects of this method. Objective To precisely delineate the actual incidence of immediate and delayed untoward events of daily sclerotherapy. Methods A multicenter prospective registry was established in 22 phlebology clinics to report their activity and complications. Results During the study period, 12,173 sessions of sclerotherapy were carried out, 5,434 with liquid, 6,395 with foam, and 344 using both. Four thousand eighty-eight (33.9%) sessions were carried out with ultrasound guidance. Forty-nine incidents or accidents (0.4%) occurred, of which 12 were with liquid and 37 with foam. These were reported during the time of the study and an additional 1-month follow-up. Most numerous were 20 cases of visual disturbances (in 19 cases, foam or air block was used); all resolved shortly, without any after-effects. A femoral vein thrombosis was the only severe adverse event in this study. Conclusions This study demonstrates that sclerotherapy is a safe technique. FUNDING FOR RESEARCH WAS PROVIDED BY THE FRENCH SOCIETY OF PHLEBOLOGY, A NONPROFIT ORGANIZATION. [source] Efficacy of infliximab in pediatric Crohn's disease: A randomized multicenter open-label trial comparing scheduled to on demand maintenance therapyINFLAMMATORY BOWEL DISEASES, Issue 3 2009Frank M. Ruemmele MD Abstract Background: Infliximab (IFX) is efficacious in inducing remission in severe forms of pediatric Crohn's disease (CD). Adult studies indicate that IFX is also safe and well tolerated as maintenance therapy. The present study aimed to evaluate in a prospective manner the efficacy and safety of IFX as maintenance therapy of severe pediatric CD comparing scheduled and "on demand" treatment strategies. Methods: Forty children with CD (nonpenetrating, nonstricturing as well as penetrating forms, mean age: 13.9 ± 2.2 years) with a severe flare-up (Harvey,Bradshaw Index [HBI] ,5, erythrocyte sedimentation rate [ESR] >20 mm/h) despite well-conducted immunomodulator therapy (n = 36 azathioprine, n = 1 mercaptopurine, n = 3 methotrexate) combined with steroids were included in this randomized, multicenter, open-label study. Three IFX infusions (5 mg/kg) were administered at week (W)0/W2/W6. At W10, clinical remission (HBI <5) and steroid withdrawal were analyzed and IFX responders were randomized to maintenance therapy over 1 year: group A, scheduled every 2 months; group B, "on demand" on relapse. Results: In all, 34/40 children came into remission during IFX induction therapy (HBI: 6.7 ± 2.5 (WO) vs. 1.1 ± 1.5 (W10); P < 0.001). At the end of phase 2, 15/18 (83%) patients were in remission in group A compared to 8/13 (61%) children in group B (P < 0.01), with a mean HBI of 0.5 versus 3.2 points (group A versus B, P = 0.011). In group A, 3/13 (23.1%) children experienced a relapse compared to 11/12 (92%) children in group B. No severe adverse event occurred during this trial. Conclusions: IFX is well tolerated and safe as maintenance therapy for pediatric CD, with a clear advantage when used on a scheduled 2-month basis compared to an "on demand" basis. (Inflamm Bowel Dis 2009) [source] Idiosyncratic drug-induced agranulocytosis: Possible mechanisms and management,AMERICAN JOURNAL OF HEMATOLOGY, Issue 7 2009Daniel Tesfa The incidence of drug-induced neutropenia has not changed in the western hemisphere over the last 30 years. Yet, the drug panorama has changed considerably. This implies that host factors may play an intriguing role for this idiosyncratic reaction. The knowledge as to mechanisms for the reaction has advanced with emerging understanding of neutropoiesis and immune regulation. Nonetheless, it is still remarkably difficult to pinpoint why and how a drug causes this unexpected, severe adverse event in a patient. Patient characteristics, e.g. genetics, appear to be keys for better understanding, predictions and prevention. Am. J. Hematol. 2009. © 2009 Wiley-Liss, Inc. [source] Efficacy and safety of subcutaneous immunotherapy with a biologically standardized extract of Ambrosia artemisiifolia pollen: a double-blind, placebo-controlled studyCLINICAL & EXPERIMENTAL ALLERGY, Issue 9 2004C. Mirone Summary Background The allergological relevance of Ambrosia in Europe is growing but the efficacy of the injective immunotherapy for this allergen has been documented only in Northern America. Objective We sought to study the safety and efficacy of injective immunotherapy in European patients sensitized to Ambrosia artemisiifolia. Methods Thirty-two patients (18 M/14 F, mean age 36.78, range 23,60 years) suffering from rhinoconjunctivitis and/or asthma and sensitized to Ambrosia were enrolled and randomized in a double-blind, placebo-controlled (DBPC) study lasting 1 year. A maintenance dose corresponding to 7.2 ,g of Amb a 1 was administered at 4-week intervals after the build-up. During the second and the third year, all patients were under active therapy in an open fashion. Symptom and medication scores, skin reactivity to Ambrosia (parallel line biological assay), and pollen counts were assessed throughout the trial. Results Twenty-three patients completed the trial. No severe adverse event was observed. During the DBPC phase, actively treated patients showed an improvement in asthmatic symptoms (P=0.02) and drug (P=0.0068) scores days with asthmatic symptoms (P=0.003), days with rhinitis symptoms (P=0.05), and days with intake of drugs (P=0.0058), as compared to before therapy. No improvement for any of these parameters was detected in the placebo group. Moreover, the number of days with rhinitis and asthma was significantly higher in the placebo as compared to the active group (P=0.048 and P<0.0001, respectively). Patients who switched from placebo to active therapy improved in rhinoconjunctivitis, asthma, and drug intake. The skin reactivity decreased significantly (12.2-fold, P=0.0001) in the active group whereas a slight increase (1.07-fold, P=0.87) was observed in the placebo group after the DBPC phase. After switching to active therapy, patients previously under placebo showed a significant decrease of this parameter (4.78-fold, P=0.002). Conclusion Injective immunotherapy is safe and clinically effective in European patients sensitized to Ambrosia. [source] Neurotoxicity upon infusion of dimethylsulfoxide-cryopreserved peripheral blood stem cells in patients with and without pre-existing cerebral diseaseEUROPEAN JOURNAL OF HAEMATOLOGY, Issue 6 2007Lutz P. Mueller Abstract Objective:, Toxicity related to the infusion of dimethylsulfoxide (DMSO)-cryopreserved peripheral blood stem cells (DMSO-PBSC) mainly comprises cardiovascular events. Fatal neurotoxicity has been reported in a few cases. DMSO represents the putative causative agent of such rare toxicities and elaborate strategies to replace DMSO would benefit from the identification of predisposing factors for DMSO-related toxicities. Methods:, Here, we report on DMSO-related neurotoxicity in a series of patients (n = 51) receiving DMSO-PBSC. The analyzed patient-series included eight patients with pre-existing cerebral disease, partially with a history of epileptic seizures. Results:, Neurotoxicity was observed in only one patient who suffered from a generalized tonic seizure upon infusion of DMSO-PBSC and for which the clinical course is reported herein. No neurotoxicity was observed in the group of patients with pre-existing neurological disease. Furthermore, no neurotoxicity was observed in patients who received particularly large volumes of DMSO. In all patients, mild non-neurological side effects occurred but besides the reported seizure no other severe adverse events were observed upon PBSC-infusion. Conclusions:, To our knowledge, this is the first report addressing the identification of predisposing factors for DMSO-related neurotoxicty. We conclude that infusion of DMSO-PBSC can be performed safely in patients with pre-existing cerebral disease despite the rare occurrence of severe neurotoxicity. Retrospective multicenter studies are warranted to identify patients who would benefit from elaborate methods of DMSO-replacement. [source] Adverse events during use of intranasal desmopressin acetate for haemophilia A and von Willebrand disease: a case report and review of 40 patientsHAEMOPHILIA, Issue 1 2000Dunn We report our experience with the incidence of adverse events during the use of Stimate® brand intranasal desmopressin acetate (IN DDAVP) for patients with haemophilia A (HA) or von Willebrand disease (vWD) after noting two severe adverse events in one adult patient. All patients with documented vWD (type 1 or 2 A) or haemophilia A (mild, moderate or symptomatic carrier) from the Emory Comprehensive Hemophilia Center who had IN DDAVP challenge testing or were using Stimate® for treatment of bleeding were evaluated for adverse events by patient report or nursing observation of clinical signs and symptoms. Forty patients were studied. Sixty-eight per cent (27/40) experienced clinical signs and/or symptoms. The majority of these symptoms were mild, however several patients reported moderate to severe side-effects and one adult patient required medical intervention for symptomatic hyponatraemia. In our experience, two-thirds of patients tested experienced adverse signs and/or symptoms with the use of Stimate®; considerably higher than that reported from preliminary results in the literature. Young age did not correlate positively with adverse reactions. Severe adverse events requiring medical intervention were rare, however symptoms such as moderate to severe headache, nausea, vomiting and weakness may necessitate evaluation for hyponatraemia. This is the first report of symptomatic hyponatraemia in an adult patient with recommended dosing of Stimate®. Side-effects may be minimized if patients adhere to instructions regarding fluid intake and composition while using IN DDAVP. [source] Predictors of complications in therapeutic plasma exchangeJOURNAL OF CLINICAL APHERESIS, Issue 6 2009Carsten P. Bramlage Abstract Plasma exchange (PE) is used for blood purification to modulate proteins involved in pathological processes. As the number of patients receiving PE treatment and the heterogeneity of the underlying diseases is steadily increasing, we evaluated the most frequent complications and analyzed causes leading to adverse reactions. 883 PE procedures in 113 patients between the years 2000 to 2006 were retrospectively analyzed with respect to complications. Additionally, underlying diseases and settings of PE procedure were analyzed to identify high-risk patients and respective PE settings. A total of 226 adverse reactions were recorded (25.6% of all PE procedures). Most complications were mild (n = 121, 13.7%) or moderate (n = 98, 11.0%). In seven cases (n = 7, 0.7%), severe, life-threatening adverse events were induced by PE either due to severe allergic reactions (n = 4, 0.5%) or to sepsis (n = 3, 0.3%). Patients with neurologic diseases had a significantly higher risk to develop complications compared to those with internal diseases (P = 0.013). This was due to a higher rate of PE associated adverse events (in particular hypotension) and complications associated with vascular access. Among patients from internal medicine those with hemolytic uremic syndrome (HUS) and thrombotic thrombocytopenic purpura (TTP) had the highest risk to develop complications. Patients with neurological diseases compared to those with medical conditions and patients with HUS/TTP compared to those with other diseases had a higher risk to develop complications. However, severe adverse events are rare. Thus, PE seems to be a safe and recommendable procedure. J. Clin. Apheresis, 2009. © 2009 Wiley-Liss, Inc. [source] The effectiveness of silver-releasing dressings in the management of non-healing chronic wounds: a meta-analysisJOURNAL OF CLINICAL NURSING, Issue 5 2009Shu-Fen Lo Aim., The purpose of this study was to examine the efficacy of silver-releasing dressings in the management of non-healing chronic wounds. Background., Non-healing chronic wounds often have a negative physical impact on patients and place a financial burden on healthcare systems. Silver dressings are wound products designed to control infection and provide a wound environment conducive to healing. However, validation of the clinical efficacy of these dressings is lacking. Design., Systematic review and meta-analysis. Methods., A systematic search of the major electronic databases PubMed, CINAHL, Cochrane, MEDLINE, British Nursing Index, EBSCO, OCLC and Proquest between 1950,June 2007 was conducted. Hand searches of selected periodicals, textbooks and checking reference lists and contacting experts was also performed. Results., Eight studies were selected from a potentially relevant 1957 references screened. Analysis incorporated data from 1399 participants in the eight randomised control trials. We found that silver dressings significantly improved wound healing (CI95: 0·16,0·39, p < 0·001), reduced odour (CI95: 0·24,0·52, p < 0·001) and pain-related symptoms (CI95: 0·18,0·47, p < 0·001), decreased wound exudates (CI95: 0·17,0·44, p < 0·001) and had a prolonged dressing wear time (CI95: 0·19,0·48, p = 0·028) when compared with alternative wound management approaches. An analysis of sensitivity in these studies by subgroup analysis generally supported these associations. Furthermore, studies indicated an improvement in quality of life (CI95: 0·04,0·33, p = 0·013) using silver dressings in wound management with no associated severe adverse events. Conclusion., This meta-analysis confirms the effectiveness of silver dressings in wound healing and improving patients' quality of life. However, it also highlights the need for additional well-designed randomised controlled trials to evaluate the effectiveness of silver-related dressings further. Relevance to clinical practice., The results of this study provide objective data on the effectiveness of silver-related dressing when applied to non-healing chronic wounds. [source] Systematic review: the short-term and long-term efficacy of adalimumab following discontinuation of infliximabALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2009C. MA Summary Background, Therapy with adalimumab has been shown to be effective in Crohn's disease (CD) patients who have lost response or are intolerant to infliximab. Aim, To determine the efficacy of adalimumab in CD patients who discontinued infliximab through a systematic review. Methods, Electronic searches of EMBASE and MEDLINE databases up to May 1, 2009, as well as abstracts from the AGA (2006,2008), ACG (2006,2007), UEGW (2006,2008) and CDDW (2006,2009) identified randomized-controlled trials (RCT) or open-labelled cohorts (OLC) evaluating the short-term and/or long-term efficacy of adalimumab in infliximab failures. The response rates for short-term (clinical response and remission at 4 weeks) and long-term (remission at 6 and 12 months) efficacy were considered. Results, A total of 1810 CD patients were identified among the 15 studies (2 RCT and 13 OLC). The majority of studies evaluated CD patients who either lost response or were intolerable to infliximab, although five OLCs permitted patients refractory to infliximab. Short-term clinical response (n = 9 articles) ranged from 41% to 83%. Long-term clinical remission at 12 months (n = 8 articles) ranged from 19% to 68%. The occurrence of severe adverse events ranged from 0% to 19% and four patients died. Conclusions, Current RCT and OLC evidence suggest that adalimumab is an efficacious therapy for CD patients who discontinue infliximab. [source] Alcohol use in congenital central hypoventilation syndromePEDIATRIC PULMONOLOGY, Issue 3 2006Maida Lynn Chen MD Abstract Congenital central hypoventilation syndrome (CCHS) is a rare disorder where there is failure of automatic control of breathing. With improved recognition of CCHS, more children are appropriately diagnosed and treated in infancy, allowing survival into adult years. Because most of these children are able to participate in regular school, they are exposed to common adolescent behaviors, such as abusing alcohol and drugs. Alcohol and many illicit substances are known respiratory depressants. We report on 3 cases of adolescents/young adults with CCHS who had severe adverse events related to alcohol, including coma and death. This series illustrates the dangers of alcohol abuse in CCHS. We speculate that adolescents with CCHS may be less able to perceive the risks of substance abuse and impulsive behavior, leading to increased morbidity and mortality. Patients with CCHS appear to lack anxiety and the awareness that their inability to perceive physiologically dangerous levels of hypercarbia and hypoxia deprives them of important protective mechanisms. Pediatr Pulmonol. © 2006 Wiley-Liss, Inc. [source] Mefloquine prescriptions in the presence of contraindications: prevalence among US military personnel deployed to Afghanistan, 2007,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2010Remington L. Nevin MD Abstract Purpose Contraindications to mefloquine use include a history of certain prevalent neuropsychiatric disorders, which are thought to increase the risk of severe adverse events including anxiety, paranoia, depression, hallucinations, psychosis, and possibly suicide. Within the US military, the continued availability and use of mefloquine is subject to administrative policies dating to 2002 that require clinicians to exercise added caution during prescribing. This analysis was performed to quantify the effectiveness of these policies in ensuring health care provider compliance with package insert prescribing guidance. Methods A previously identified cohort consisting of 11,725 active duty US military personnel, among whom 1127 (9.6%) had contraindications to mefloquine use identified through medical surveillance and pharmaceutical databases, was examined to identify individuals receiving prescriptions for mefloquine in the 45 days prior to a combat deployment in 2007. Results Among the 11,725 cohort members, 4505 (38.4% of the cohort) received a prescription for mefloquine. Among the 1127 cohort members with contraindications, 155 (1.3% of the cohort) were prescribed mefloquine, comprising 13.8% of those with contraindications. Conclusions Despite the longstanding administrative policies meant to reduce such events, approximately one in seven individuals with neuropsychiatric contraindications received a prescription for mefloquine prior to a recent combat deployment, significantly increasing the risk of subsequent adverse events. Given the prevalence of neuropsychiatric disorders among US military personnel and the continued availability of mefloquine, additional study is recommended to describe and quantify the nature and extent of mefloquine-associated adverse events experienced among this group. Published in 2009 by John Wiley & Sons, Ltd. [source] Nimotuzumab combined with radiotherapy reduces primary tumor and nodal volume in advanced undifferentiated nasopharyngeal carcinomaASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 3 2009Soehartati GONDHOWIARDJO Abstract Aim: A high expression of epidermal growth factor receptor (EGFR) is found in most human epithelial tumors, including nasopharyngeal carcinomas (NPC). The overexpression of EGFR has been shown to play an influential role in tumorigenesis and the progression of malignant tumors. Therefore, blocking EGFR might be a potential targeted treatment for NPC. Nimotuzumab is an anti-EGFR monoclonal antibody that exhibits remarkable anti-proliferative, anti-angiogenic, and pro-apoptotic effects. Methods: Here we report five patients with loco-regionally advanced NPC, treated with nimotuzumab 100 mg i.v./week for 8 weeks in combination with radiotherapy in a total dose of 70,74 Gy. Results: A computed tomography evaluation of all five patients showed that the primary tumor volume was reduced, ranging from 64.1 to 98% and the nodal volume was reduced by 90.7,100%. No severe adverse events related to nimotuzumab were observed. Conclusion: The use of nimotuzumab in combination with radiotherapy was potentially beneficial and safe for patients with advanced NPC. [source] Boron Neutron Capture Therapy for glioblastoma multiforme: advantage of prolonged infusion of BPA-fACTA NEUROLOGICA SCANDINAVICA, Issue 1 2010K. Sköld Sköld K, H-Stenstam B, Diaz AZ, Giusti V, Pellettieri L, Hopewell JW. Boron Neutron Capture Therapy for glioblastoma multiforme: advantage of prolonged infusion of BPA-f. Acta Neurol Scand: 2010: 122: 58,62. © 2009 The Authors Journal compilation © 2009 Blackwell Munksgaard. Objectives,,, To assess possible improved efficacy of Boron Neutron Capture Therapy (BNCT) for glioblastoma multiforme (GBM) using prolonged infusion and a correspondingly higher dose of l-boronophenylalanine, as the fructose complex (BPA-f). Materials and methods,,, The benefit of prolonged infusion was analyzed by comparing the results from a Phase II study using 6 h infusion of BPA-f with those obtained from a Phase I/II study using 2 h of infusion. Median survival time (MST) from diagnosis, patient baseline characteristics, salvage treatment and severe adverse events were considered in the comparison. Results,,, MST increased significantly, from 12.8 (95% confidence interval or CI: 10.3,14.0) months with 2 h infusion to 17.7 (95% CI: 13.6,19.9) months with 6 h of infusion. The fraction of patients with WHO grade 3,4 adverse events was similar in the two studies at 13% and 14%, respectively. Conclusion,,, Prolonged infusion was found to be beneficial for the efficacy of BNCT and it is suggested that 6 h infusion of BPA-f should be used in future trials of BNCT for GBM. BNCT, which is a single-day treatment with mild side effects, should be assessed in a controlled trial, as an alternative to 30 daily fractions of conventional fractionated photon therapy over a period of 6 weeks. [source] Effect of 0.03% tacrolimus ointment on conjunctival cytology in patients with severe atopic blepharoconjunctivitis: a retrospective studyACTA OPHTHALMOLOGICA, Issue 5 2006Hannele M. Virtanen Abstract. Purpose:, To evaluate the efficacy and effect of tacrolimus ointment on conjunctival cytology in patients with atopic blepharoconjunctivitis or keratoconjunctivitis. Methods:, Ten patients with severe atopic blepharoconjunctivitis treated with 0.03% tacrolimus ointment once daily as an intermittent treatment were analysed retrospectively. The main outcome measures were clinical response to topical tacrolimus, adverse events and changes in the inflammatory cells obtained from conjunctival brush samples. Results:, Marked clinical responses in blepharitis and conjunctivitis symptoms were seen after a mean follow-up time of 6 weeks. Clinical scores decreased by 67% in blepharitis and 74% in conjunctivitis symptoms. No severe adverse events or signs of immunosuppression such as herpes simplex infections occurred. No significant changes occurred in visual acuity, refraction, anterior chamber, retina or intraocular pressure. Median decreases were 85% (p =0.01) in conjunctival eosinophils, 50% (p = 0.01) in neutrophils and 58% (p = 0.02) in lymphocytes. Conclusions:, Tacrolimus ointment is potentially a safe and effective treatment for atopic blepharoconjunctivitis. Regular treatment of the eyelids once daily may also lead to clinical and cytological improvement of the conjunctivitis. [source] | |||||||||||||||||||||||||