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At least 1,117 records · Page 62Linked to original sources
PubMed2000

A UK multicentre phase II study of rituximab (chimaeric anti-CD20 monoclonal antibody) in patients with follicular lymphoma, with PCR monitoring of molecular response.

Follicular lymphoma (FL) cells express CD20 and are associated in most cases with the t(14;18) chromosomal translocation. A multicentre study was undertaken between January 1997 and January 1998 to assess the complete response rate (CR) and overall response rate (RR) to rituximab, a chimaeric anti-CD20 monoclonal antibody. Seventy patients with previously treated FL received rituximab (375 mg/m2/week x4, by intravenous infusion). Restaging studies were performed 1 and 2 months after therapy. Molecular monitoring for the presence of cells harbouring the Bcl-2/JH gene rearrangement in the peripheral blood (PB) and bone marrow (BM) was performed before and after treatment using a two-step semi-nested polymerase chain reaction (PCR) assay. The overall RR was 32/70 (46%), being highest in patients who had received only one previous treatment (12/15, 80%). However, only two patients achieved a CR. The median duration of response was 11 months. Thirteen of 21 evaluable 'PCR-positive' patients (62%) became 'PCR-negative' in PB and/or BM samples 1 month after rituximab, although this did not correlate with clinical response. Treatment was generally well tolerated, although one patient developed Stevens-Johnson syndrome. Rituximab was shown to be active in FL, and in some cases PB and/or BM became PCR negative. Studies in combination with cytotoxic chemotherapy to increase the CR rate are warranted.

Adult↗
PubMed2001

Prognostic impact of bone marrow erythropoietic precursor cells and myelofibrosis at diagnosis of Ph1+ chronic myelogenous leukaemia--a multicentre study on 495 patients.

A multicentre clinicopathological study was performed on 495 patients with chronic-phase Ph1+ chronic myelogenous leukaemia (CML) to determine bone marrow characteristics that exert a significant impact on survival under standard treatment regimens. Immunohistochemical and morphometric techniques were applied to identify nucleated erythroid precursor cells in the bone marrow and to quantify argyrophilic fibre density. Application of the Sokal index and another recently proposed CML score failed to distinguish three clearly defined risk groups. A borderline increase in fibre content (i.e. doubling of the normal density) and a relevant reduction of medullary erythropoiesis proved to be important predictors for survival, even in low-risk classified patients, according to both clinical scores. With regard to optimal treatment strategies, patients with manifest myelofibrosis showed no significant difference in survival rates under interferon or hydroxyurea treatment. Multivariate analysis confirmed the prognostic value of histological features. A risk model based on three variables (fibre density, erythropoietic precursors and spleen size) was constructed that enabled a distinct discrimination of risk profiles. In conclusion, the presented data provide compelling evidence that bone marrow features at diagnosis exert a significant impact on prognosis in CML. In this context, the generally clinical-based multivariate risk classification can be improved by consideration of morphological variables that are acting independently of treatment modalities.

Adult↗
PubMed2001

Allogeneic peripheral blood stem cell transplantation with reduced-intensity conditioning: results of a prospective multicentre study.

Reduced-intensity conditioning (RIC) regimens for allogeneic haematopoietic stem cell transplantation (SCT) have been shown to lead to engraftment of donor stem cells without the severe extra-haematological toxicities of traditional myeloablative transplants. Between December 1998 and December 2000, 76 patients underwent a RIC peripheral blood SCT in a prospective multicentre study. The median age was 53 years, and 57 patients were beyond the early phase of their disease. The conditioning regimens consisted of fludarabine (150 mg/m2) plus melphalan (140 mg/m2) or busulphan (10 mg/kg). Graft-versus-host disease (GVHD) prophylaxis consisted of cyclosporin A plus short-course methotrexate. The preparative regimens were well tolerated. All patients experienced severe pancytopenia, but haematological recovery was prompt in all but two cases (early deaths). The 100-d probability of developing grade II-IV acute GVHD was 32% (10% grade III-IV), and the 1-year probability of developing chronic extensive GVHD was 43%. Early complete donor chimaerism was observed in 52/68 patients, and 16 evaluable patients were in complete chimaerism 1 year post transplant. With a median follow-up of 283 d (355 in 48 survivors), the 1-year probability of transplant-related mortality was 20%, and the 1-year overall and progression-free survivals were 60% and 55% respectively. In conclusion, RIC regimens lead to low early toxicity after allografting, with stable donor haematopoietic engraftment, with an apparent low risk of acute GVHD. Chronic GVHD, however, develops in a significant proportion of patients.

Adolescent↗
PubMed2002

Efficacy of granulocyte colony-stimulating factor in the treatment of acute myelogenous leukaemia: a multicentre randomized study.

To investigate the efficacy and safety of granulocyte colony-stimulating factor (G-CSF) in patients with acute myelogenous leukaemia, a multicentre randomized study was performed. From October 1993 to September 1996, 270 patients with newly diagnosed acute myelogenous leukaemia were randomized to G-CSF or control groups after remission induction therapy. The G-CSF group received G-CSF (Filgrastim) from 48 h after the completing chemotherapy until the absolute neutrophil count exceeded 1.5 x 10(9)/l. The control group did not receive G-CSF unless severe infection occurred. There were 245 evaluable patients (120 and 125 in the G-CSF and control groups respectively). The complete remission rate was similar in the G-CSF and control groups (80.8% versus 76.8%), as was the 5-year probability of disease-free survival (34.5% versus 33.6%) and overall survival (42.7% versus 35.6%). Neutrophil recovery was significantly faster in the G-CSF group than in the control group (12 d versus 18 d, P = 0.0001). The median duration of febrile neutropenia was significantly shorter in the G-CSF group than in the control group (3 d versus 4 d, P = 0.0001). In conclusion, prophylactic administration of G-CSF after remission induction therapy for acute myelogenous leukaemia is safe and useful even in patients without infection on completing chemotherapy.

Adolescent↗
PubMed2003

Detection of human herpesvirus-8 in peripheral blood mononuclear cells from adult Japanese patients with multicentric Castleman's disease.

Human herpesvirus-8 (HHV-8) encodes viral homologues of cellular genes, including viral interleukin 6 (vIL-6), which induces endogenous human IL-6 (hIL-6) secretion. Unregulated overproduction of hIL-6 in lymph nodes (LN) is thought to be responsible for the systemic manifestations of multicentric Castleman's disease (MCD). In the present study, we assessed the presence of HHV-8 and HHV-8-encoded viral homologues in LN and peripheral blood mononuclear cells (PBMC) from adult Japanese patients with MCD. HHV-8 DNA was amplified by nested polymerase chain reaction (PCR) and was detected in LN from 13 out of 16 MCD patients (81%). HHV-8 DNA was also detected in PBMC from six out of seven patients (86%) whose LN were positive for HHV-8 DNA. Because mRNA could not be successfully extracted from LN sections that were either formalin-fixed or embedded in paraffin, we examined the expression of mRNA for HHV-8-encoded viral homologues, such as vIL-6, vBCL-2, vCyclin-D and viral G-protein-coupled receptor (vGPCR) by nested reverse transcription (RT)-PCR in PBMC from 10 MCD patients. However, mRNA of these HHV-8-encoded viral homologues was not detected in any patients tested. Although our results do not indicate a role for HHV-8-encoded viral homologues in the pathogenesis of MCD, they do suggest that HHV-8 infection may be associated with MCD in adult Japanese patients.

Adult↗
PubMed1998

Randomized multicentre trial of the influence of recombinant human erythropoietin on intraoperative and postoperative transfusion need in anaemic patients undergoing right hemicolectomy for carcinoma.

BACKGROUND: The possible immunosuppressive effect of blood transfusion and its influence on survival after surgery for cancer makes it worthwhile to seek methods to avoid transfusion wherever possible. Patients with right-sided colonic cancer are frequently anaemic. Such patients were entered into a study that employed erythropoietin to avoid homologous transfusion. METHODS: In a prospectively randomized double-blind placebo-controlled multicentre trial, patients with moderate anaemia (haemoglobin concentration greater than 8.5 g/dl and less than or equal to 13.5 g/dl) presenting with right-sided colonic cancer and scheduled for hemicolectomy were treated with recombinant human erythropoietin (epoetin beta) 20,000 units/day subcutaneously or placebo for at least 10 days over the operative period. RESULTS: Perioperative treatment with epoetin beta was well tolerated and there were no significant differences in morbidity and mortality. Following hemicolectomy, median cumulative blood loss in the two groups was similar (epoetin beta 440 ml versus placebo 345 ml). Sixteen (33 per cent) of 48 patients treated with epoetin beta and 15 (28 per cent) of 54 in the placebo group received perioperative blood transfusions (P not significant). The increase in reticulocyte count between baseline and the last preoperative value was more pronounced in the epoetin beta group than in those receiving placebo (P = 0.036). CONCLUSION: Despite the perioperative administration of 20,000 units erythropoietin per day for at least 10 days, it was not possible to reduce the intraoperative and postoperative transfusion need. None the less, a positive change in the haematological variables of treated patients was clearly discernible. The negative result may be due to the short treatment interval and to iron deficiency, which was present in the majority of patients. The general change of attitude towards allogeneic blood transfusion is demonstrated by the overall low frequency of blood transfusion in this study.

Aged↗
PubMed1999

Prospective randomized multicentre study of laparoscopic versus open appendicectomy.

BACKGROUND: A prospective randomized multicentre study was performed to compare the outcome of laparoscopic and open appendicectomy in patients with suspected acute appendicitis. METHODS: A total of 523 patients was randomized, but because of 23 withdrawals the outcome in 500 patients is reported, 244 in the laparoscopic group and 256 in the open group. RESULTS: Patients having laparoscopic appendicectomy recovered more quickly than those having open surgery (13 versus 21 days, P < 0.001). There was no significant difference in duration of sick leave after operation (laparoscopic group 11 days versus open group 14 days). Postoperative pain (at 24 h, 7 days and 14 days) was less after laparoscopic operations and a functional index 1 week after operation was more favourable in these patients (P < 0.001). Operating time was significantly longer in the laparoscopic group (60 versus 35 min, P < 0.01). Hospital stay and complications did not differ between the groups. Thirty laparoscopic procedures (12 per cent) were converted to open appendicectomy. CONCLUSION: Laparoscopic appendicectomy is as safe as open appendicectomy and has the advantage of allowing a quicker recovery.

Acute Disease↗
PubMed1999

Preliminary results of a multicentre trial of the electrically stimulated gracilis neoanal sphincter.

BACKGROUND: The electrically stimulated gracilis neoanal sphincter was initially developed to treat refractory incontinence. Good early results were reported from the two centres that pioneered the technique. The aim of this study was to assess the operation in a prospective multicentre setting. METHODS: The procedure was performed on 64 patients from seven centres worldwide and was performed in stages. All patients were evaluated clinically and manometrically before and after operation. RESULTS: There was a high incidence of infective and hardware-related complications. At a median of 10 months following closure of the defunctioning stoma 56 per cent had experienced a good functional result. The major functional problems comprised evacuatory difficulties experienced by 25 per cent. CONCLUSION: The technique is effective in treating otherwise refractory incontinence. It is, however, a complex procedure and the morbidity rate may be high, particularly during the learning curve, factors that necessitate careful patient selection. Presented to the Association of Surgeons of Great Britain and Ireland in Bournemouth, UK, April 1997 and the European Council of Coloproctology in Edinburgh, UK, June 1997; and published in abstract form as Br J Surg 1997; 88(Suppl): 39 and Int J Colorectal Dis 1997; 12: 144

Adolescent↗
PubMed2001

Cost-utility analysis of open versus laparoscopic groin hernia repair: results from a multicentre randomized clinical trial.

BACKGROUND: This study was a pragmatic economic evaluation carried out alongside a multicentre randomized controlled trial comparing laparoscopic with open groin hernia repair. The primary economic evaluation framework employed was a cost-utility analysis. METHODS: At 26 hospitals in the UK and Ireland, 928 patients with a groin hernia were assigned randomly to laparoscopic or open repair. Cost data were identified and measured both within and outwith the trial. Cost data were combined with quality-adjusted life years (QALYs) from the EQ-5D questionnaire to obtain cost-per-QALY ratios. RESULTS: The mean cost of laparoscopic hernia repair was pound1112.64, compared with pound788.79 for the open operation. The extra cost of pound323.85 in the laparoscopic group was mainly due to additional theatre time and increased equipment and sterilization costs. The estimated incremental cost per QALY of the laparoscopic over the open method was pound55 548.00 (95 per cent confidence interval pound47 216.00- pound63 885.00). CONCLUSION: While the results show that a high cost was incurred to produce an additional QALY by using laparoscopic over open hernia repair, sensitivity analyses show that there are specific situations in which laparoscopic repair may be a viable alternative, such as when reusable equipment is employed.

Cost-Benefit Analysis↗
PubMed1996

Heat shock-enhanced T cell apoptosis with heat shock protein 70 on T cell surface in multicentric Castleman's disease.

We report here that T cells from patients with multicentric Castleman's disease (MCD) are sensitive to hyperthermia. T cells from two of three patients with MCD revealed DNA ladder formation and chromatin condensation following heat shock (30 min at 41.5 degrees C). Peripheral blood mononuclear cells (PBMC) from the same MCD patients exhibited high levels of spontaneous apoptosis after 72 h in culture and elevated apoptosis after heat shock, as evaluated by a quantitative flow cytometric assay. Heat shock protein 70 (hsp70) was detected on the cell surface of T cells in all three patients after heat shock. Furthermore, hsp70 was detected on T cells in the two MCD patients with apoptosis even in the absence of heat shock. T cells from normal samples did not show either heat-shock-induced expression of cell-surface hsp70 or apoptosis. Thus, heat shock treatment augmented hsp70 expression on the cell surface of T cells and enhanced apoptosis. Our studies suggest that hyperthermia may influence the clinical course of MCD.

Antigens, Surface↗
PubMed1997

Final height in non-growth hormone deficient children treated with growth hormone. The Italian Multicentre Study Group.

OBJECTIVE: To evaluate the final height of nongrowth hormone deficient (N-GHD) children treated with growth hormone (GH). DESIGN: Multicentre retrospective study. PATIENTS: 71 (54M/17F) N-GHD children (peak GH after pharmacological stimulation > 14-24 mU/l) who had been treated for 4.19 +/- 0.14 years with GH (0.69 +/- 0.02 IU/kg/week). MEASUREMENTS: Height (H) and height velocity (HV) expressed as standard deviation score (SDS) for chronological age (CA) and bone age (BA), BA/CA ratio, and predicted adult height (PAHSDS) were evaluated before and during treatment, and at each pubertal stage. Target height (TH), and final height (FH) were also calculated, and expressed as SDS. RESULTS: In the whole group, HSDS for CA increased significantly after the first year on GH, and remained significantly increased for 4 years. This did not occur to HSDS for BA, owing to a significant increase in BA/CA after the first year of therapy. In addition, this increase coincided with stages 4 and 5 of puberty. HVSDS for CA and BA also increased significantly after the first year of treatment, and remained significantly elevated for 4 years. PAHSDS did not change significantly during treatment. FHSDS (-1.69 +/- 0.07) was similar to PAHSDS (-1.6 +/- 0.12) and target height (THSDS) (-1.46 +/- 0.08). FHSDS was > or = THSDS in 36.6% of the patients, and > or = initial PAHSDS in 34.5%. Male patients were subdivided into 2 groups (A and B). Patients in Group A (n = 26) started treatment at puberty, while group B (n = 28) consisted of subjects who started therapy during prepubertal years. Height, height velocity and predicted adult height showed the same pattern as in the whole group, in each subgroup. BA/CA advanced significantly in group A after the second year on GH and in group B, after at least 3 years of therapy. FHSDS, THSDS, and PAHSDS were similar in both groups (-1. 7 +/- 0.13, -1.29 +/- 0.2 and -1.39 +/- 0.15 in group A and -1.48 +/- 0.11, -1.85 +/- 0.15 and -1.36 +/- 0.12 in group B, respectively). However, in group B (prepubertal), FHSDS was > or = initial PAHSDS in 60% of the patients and > or = THSDS in 40.7%, while in group A (pubertal), FHSDS was > or = initial PAHSDS only in 22.7% of the patients and > or = THSDS in 34.6%. FHSDS was found to be correlated with THSDS, PAHSDS at the onset of treatment, and after 1 year of treatment. The age at the beginning of puberty, and the duration of puberty were appropriate in all groups. CONCLUSIONS: GH treatment was effective in increasing height velocity of short non-GH-deficient children, but final height was not definitely improved with respect to initial predicted adult height.

Adolescent↗
PubMed1999

Usefulness of routine pre-operative chest radiography for anaesthetic management: a prospective multicentre pilot study.

A prospective multicentre pilot study was undertaken in 20 Italian hospitals to assess the influence of a routine pre-operative chest radiograph on anaesthetic management and to characterise which patients might benefit from it. A total of 6111 patients undergoing elective surgery and submitted for routine pre-operative chest radiograph were enrolled. Abnormal preoperative chest radiographs were reported in 1116 patients (18.3%). Pre-operative chest radiograph altered the anaesthetic management (i.e. useful pre-operative chest radiograph) in 313 patients (5.1%). Male sex, age > 60 years, ASA classes > or = 3, respiratory diseases, and the presence of two or more co-existing diseases were significantly related to the probability of a useful pre-operative chest radiograph using multivariate analysis (P < 0.01). The classification of the surgical intervention and, of the co-existing diseases, the presence of cardiac disease had a very low influence when determining the probability that a pre-operative chest radiograph would be useful. A simple equation includes the effects of all the variables studied and allows calculation of the probability of a useful pre-operative chest radiograph. This study indicates that in healthy, female, < or = 60-year-old patients, submitted for standard surgery, the probability of a useful pre-operative chest radiograph ranges from 0.2% to 3.5% according to the hospital. The probability increases in male or elderly subjects, or in the presence of co-existing respiratory diseases, or in ASA classes > or = 3, but there is a wide variation between hospitals.

Anesthesia, Inhalation↗
PubMed2003

An evidence-based specialist breast nurse role in practice: a multicentre implementation study.

The objective of this study was to examine the feasibility, implementation, acceptability and impact of an evidence-based specialist breast care nurse (SBN) model of care in Australia. Primary data were collected from four diverse Australian breast cancer treatment centres over a 12-month period. The design was a multicentre demonstration project. Information about the provision of care and patient needs was collected through prospective logs. Structured interviews were conducted with women who received the SBN intervention (N = 167) and with a control group of women treated prior to the intervention period (N = 133). Health professionals (N = 47) were interviewed about their experience of the SBN. Almost all women had contact with an SBN at five scheduled consultations and 67% of women in the intervention group requested at least one additional consultation with the SBN. Women in the intervention group were more likely to receive hospital fact sheets and to be told about and participate in clinical trials. Ninety-eight per cent of women reported that the availability of an SBN would affect their choice of hospital, with 48% indicating that they would recommend only a hospital with a SBN available. Health professionals reported that SBNs improved continuity of care, information and support for the women, and resulted in more appropriate referrals and use of the time of other members of the team. In conclusion, the SBN model is feasible and acceptable within diverse Australian treatment centres; there is evidence that some aspects of care were improved by the SBN.

Adolescent↗
PubMed2003

Topical butyrate improves efficacy of 5-ASA in refractory distal ulcerative colitis: results of a multicentre trial.

BACKGROUND: The treatment of distal ulcerative colitis, refractory to conventional 5-ASA/steroid treatment, is still a matter of debate. The present study aimed at confirming, with adequate statistical power, previous data indicating the usefulness of topical butyrate and 5-ASA in the treatment of this condition. DESIGN: Double-blind, placebo-controlled, multicentre study. A total of 51 patients with distal (< 65 cm) ulcerative colitis, refractory to topical 5-ASA/cortisone, were randomly allocated to receive topical 5-ASA 2 g and 80 mM L-1 sodium-butyrate bid (Group A; 24 patients) or 5-ASA 2 g and 80 mL saline bid (Group B; 27 patients) for 6 weeks. Sigmoidoscopy with biopsies, as well as clinical and laboratory evaluations, were carried out at enrollment and at the end of the trial. Primary endpoints: remission or marked improvement in endoscopic, histologic and clinical findings. RESULTS: Most parameters showed a significant improvement vs. baseline in both groups. Remission in six patients and improvement in 12 patients in Group A vs. one remission and 13 with improvement in Group B (P < 0.05). A significant difference in favour of Group A was recorded regarding the number of bowel movements (P < 0.01), urgency (P < 0.05) and the patients' self evaluation (P < 0.01). DISCUSSION: The combined treatment with topical butyrate and 5-ASA is significantly more effective than 5-ASA alone in the management of refractory distal colitis. Further improvements in the treatment of refractory distal ulcerative colitis may be feasible based on the identification of patient subgroups and the association of two or more active drugs. Butyrate may well be one of them.

Adult↗
PubMed2000

Assessing structure, process and outcome in palliative day care: a pilot study for a multicentre trial.

Palliative day care is an expanding service which remains under-researched. Study designs need to be developed to evaluate the costs and outcomes of the service in ways which are meaningful to patients, clinicians and policy-makers. At the same time, these must be open to the same criteria for rigour and reliability as techniques used elsewhere in health and social service evaluation. To this end, a developmental stage of exploratory research was undertaken at the start of a major multicentre trial of palliative day care to meet two clear aims: to understand more about the structure and processes of palliative day care, and to identify ways in which service outcomes could be evaluated and measured. In-depth observations at five palliative day care centres were undertaken across one health region. This provided a better understanding of the models, outcomes and processes of palliative day care in five different environments. Centres represented the spectrum of medical and social care models and findings were analysed using an organisational systems approach. The findings showed that, despite the lack of a national strategic approach to developing the service, the centres all provided a core set of services which were broadly similar. However, differences in philosophy, ownership, and organisation affected how the services were provided and may have an impact on the costs of the service. The study has provided a more in-depth understanding of palliative day care services in order to design an effective research strategy for evaluating a service which crosses the boundaries of health and social care.

Journal Article↗
PubMed2003

Calibration of immunohistochemistry for assessment of HER2 in breast cancer: results of the French multicentre GEFPICS study.

AIMS: HER2 protein is over-expressed in 15-30% of breast carcinomas. Immunohistochemistry (IHC) is a common and inexpensive method able to specifically detect HER2 protein. However, lack of standardization of IHC has been considered responsible for discrepancies in HER2 status assessment performed by IHC and fluorescence in-situ hybridization (FISH). This prompted us to perform a multicentric IHC calibration test to achieve a maximum accuracy of HER2-IHC compared with HER2-FISH taken as the reference method. METHODS AND RESULTS: Twelve French laboratories participated in this study, including 119 cases of invasive breast carcinomas for which both fixed and frozen tissues were available. HER2 expression was determined in fixed tissues by individual in-house IHC techniques, using either CB11 (Novocastra, Newcastle, UK) or A0485 (Dako, Glostrup, Denmark) anti-HER2 antibodies. Two cut-off values were used: 10% and 60% of immunostained cells. In 116 of the 119 cases, HER2 gene status could also be determined by FISH on frozen sections, performed in a single laboratory. Results were centralized and compared. When suboptimal concordance between IHC and FISH was observed, IHC was calibrated and a second run was performed. The specificity, sensitivity and accuracy of IHC compared with FISH were noted before and after calibration. Forty-four out of 116 (38%) tumours showed HER2 gene amplification. Accuracy of IHC was complete in the first run for 6/12 laboratories. Calibration, necessary for the six others, relied mainly on the combination of a heat-induced epitope retrieval step with an increase of dilution of the primary antibody. In the second run, HER2 over-expression was found in 46 (40%) and 44 (38%) of the 116 cases, using 10% or 60% of stained cells as cut-offs, respectively. The corresponding accuracy rates were 93% and 95%. CONCLUSIONS: This study showed that a high accuracy of IHC could be obtained for the determination of HER2 status in all laboratories using their in-house IHC technique, provided that a calibration process was performed. Antigen retrieval procedure, high dilutions of anti-HER2 antibody and the use of specific controls were crucial for HER2-IHC calibration. A 95% accuracy rate of IHC, using FISH as gold standard, was obtained by considering immunolabelling HER2-IHC results as a continuous variable, and taking 60% invasive stained cells as the cut-off for HER2 over-expression.

Adenocarcinoma↗
PubMed1996

A multicentre comparison of once-daily subcutaneous dalteparin (low molecular weight heparin) and continuous intravenous heparin in the treatment of deep vein thrombosis.

OBJECTIVES: To compare the efficacy and safety of the low molecular weight heparin (LMWH) dalteparin with unfractionated heparin (UFH) in the acute treatment of DVT patients who had not previously received UFH. DESIGN: An open randomized multicentre trial with blinded analysis of venograms. SETTING: Seven hospitals in Sweden, Finland and the USA. SUBJECTS: A total of 330 patients, of 20 years or older, with suspected DVT, verified using venography. INTERVENTIONS: Fixed-dose dalteparin (200 IU kg-1) given as a once-daily subcutaneous injection, or aPTT adjusted i.v. UFH infusion for 6 to 10 days. MAIN OUTCOME MEASURES: Change in Marder score in patients with confirmed DVT and two evaluable venograms; PE, bleeding events and follow-up. RESULTS: Marder scores improved in 51% (95% CI 42-60%) of 92 patients treated with dalteparin and in 62% (95% CI 53-70%) of 98 patients treated with UFH (P = 0.152). One dalteparin-treated patient had a PE confirmed by V/Q scan; another had progressive thrombosis with swelling in the affected limb. Bleeding complications occurred in six patients in each group. One patient treated with dalteparin and five treated with UFH died during the 6-month follow-up period as a result of underlying malignancy or heart disease. The 6-month recurrence rate was low with both treatments (dalteparin, 3/97; UFH, 2/103). CONCLUSIONS: Fixed-dose subcutaneous dalteparin given once daily from the start of treatment is of equivalent efficacy and safety to conventional UFH therapy in the routine management of DVT.

Adult↗
PubMed1997

First clinical experiences with specific sheep Fab fragments in snake bite. Report of a multicentre study of Vipera berus envenoming.

OBJECTIVES: To evaluate the efficacy and safety of specific, ovine Fab fragments in the treatment of envenoming by the common adder, Vipera berus. DESIGN: Open study with historical controls. SETTING: Multicentre study involving patients (n = 30) with V. berus envenoming, treated in 18 Swedish hospitals during 1991-94. MAIN OUTCOME MEASURES: Initial symptoms, clinical course after treatment, duration of hospital stay and adverse effects of the antivenom were evaluated. Two earlier studied patient groups, given either equine F(ab)2 antivenom (n = 30) or no antivenom (n = 16), were used as controls. RESULTS: Specific ovine Fab fragments influenced favourably the acute symptomatology as well as the long term clinical course. Acute symptoms such as hypotension, shock, vomiting, diarrhoea and CNS-depression resolved quickly. The incidence of extensive swelling involving the trunk and the length of hospital stay were both reduced significantly compared to nontreated patients (23 vs. 88% and 3.5 vs. 6 days). Also the incidence of anaemia was reduced (23 vs. 44%). These results were consistent with those obtained with equine F(ab')2 antivenom, but with ovine Fab there were no immediate anaphylactic reactions or serum sickness. CONCLUSION: Specific Fab fragments produced from sheep immunized with V. berus venom were safe and effective in counteracting the effects of V. berus bite in humans. These results justify further studies of this new treatment for snake envenoming.

Adolescent↗