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Multicentric reticulohistiocytosis associated with recurrent breast carcinoma.

Multicentric reticulohistiocytosis (MRH) is a rare systemic disorder that most often affects women in the fourth to fifth decades of life and is characterized by widespread cutaneous papules and nodules, often associated with a destructive arthritis. The characteristic histologic feature of the skin lesions, and of other affected organs, is the presence of histiocytes and multinucleated giant cells containing abundant eosinophilic cytoplasm with a "ground glass appearance." Approximately 30% of the patients have an underlying malignancy suggesting MRH may be a paraneoplastic phenomenon. We describe a case of MRH associated with recurrent, metastatic breast carcinoma.

Adult↗

Long distance transport for primary angioplasty vs immediate thrombolysis in acute myocardial infarction. Final results of the randomized national multicentre trial--PRAGUE-2.

BACKGROUND: Primary percutaneous coronary intervention (PCI) is shown to be the most effective reperfusion strategy in acute myocardial infarction. The aim of this multicentre national randomized mortality trial was to test whether the nationwide change in treatment guidelines (transportation of all patients to PCI centres) was warranted. METHODS: The PRAGUE-2 study randomized 850 patients with acute ST elevation myocardial infarction presenting within <12 h to the nearest community hospital without a catheter laboratory to either thrombolysis in this hospital (TL group, n=421) or immediate transport for primary percutaneous coronary intervention (PCI group, n=429). The primary end-point was 30-day mortality. Secondary end-points were: death/reinfarction/stroke at 30 days (combined end-point) and 30-day mortality among patients treated within 0-3 h and 3-12 h after symptom onset. Maximum transport distance was 120 km. RESULTS: Five complications (1.2%) occurred during the transport. Randomization-balloon time in the PCI group was 97+/-27 min, and randomization-needle time in the TL group was 12+/-10 min. Mortality at 30 days was 10.0% in the TL group compared to 6.8% mortality in the PCI group (P=0.12, intention-to-treat analysis). Mortality of 380 patients who actually underwent PCI was 6.0% vs 10.4% mortality in 424 patients who finally received TL (P<0.05). Among 299 patients randomized >3 h after the onset of symptoms, the mortality of the TL group reached 15.3% compared to 6% in the PCI group (P<0.02). Patients randomized within <3 h of symptom onset (n=551) had no difference in mortality whether treated by TL (7.4%) or transferred to PCI (7.3%). A combined end-point occurred in 15.2% of the TL group vs 8.4% of the PCI group (P<0.003). CONCLUSIONS: Long distance transport from a community hospital to a tertiary PCI centre in the acute phase of AMI is safe. This strategy markedly decreases mortality in patients presenting >3 h after symptom onset. For patients presenting within <3 h of symptoms, TL results are similar results to long distance transport for PCI.

Angioplasty, Balloon, Coronary↗

Bupropion SR for smoking cessation in smokers with cardiovascular disease: a multicentre, randomised study.

AIMS: To investigate the safety and efficacy of bupropion sustained release (bupropion SR) in promoting abstinence from smoking in subjects with cardiovascular disease (CVD). METHODS: Six hundred twenty-nine subjects with CVD who smoked >/=10 cigarettes/day were randomised in a double-blind, multicentre study to receive bupropion SR (150 mg twice daily) or placebo for 7 weeks, with a follow-up of 52 weeks. Primary efficacy endpoint: continuous abstinence from smoking from weeks 4 to 7. Secondary endpoints: continuous abstinence (weeks 4-12, 4-26 and 4-52) and weekly point prevalence abstinence. All participants received brief motivational support. Safety was evaluated throughout the study. RESULTS: Continuous smoking abstinence rates from weeks 4 to 7 were significantly higher in subjects receiving bupropion SR compared with placebo (43 vs. 19%, odds ratio [OR]=3.27, 95% confidence interval [CI] 2.24-4.84; P<0.001). Continuous abstinence rates from weeks 4 to 26 and 4 to 52 continued to be more than double for bupropion SR compared with placebo (27 vs. 11%; 22 vs. 9%, P<0.001). Weekly point prevalence abstinence was significantly higher for participants who received bupropion SR compared with placebo at weeks 3, 7, 26 and 52 (P<0.001). In both groups, there were no clinically significant changes in blood pressure and heart rate throughout the treatment phase. Overall, 6% of the participants (n=36) discontinued study medication due to an adverse event (bupropion SR, n=17; placebo, n=19). CONCLUSIONS: After 7 weeks of bupropion SR treatment, more than twice as many smokers with CVD had quit smoking at 1 year compared with placebo. The safety profile of bupropion SR was similar to that previously observed in general smoking populations.

Adult↗

Single-dose amoxycillin-clavulanic acid vs. cefotetan for prophylaxis in elective colorectal surgery: a multicentre, prospective, randomized study. The PRODIGE Group.

A prospective, multicentre, randomized trial was carried out in 19 hospitals in order to compare the efficacy of amoxycillin-clavulanic acid with cefotetan as antibiotic prophylaxis in patients undergoing elective colorectal surgery. Since the main purpose of the study was to demonstrate equivalence between the two regimens, the protocol planned the inclusion of 200 patients. Eligible patients were randomly assigned to receive either amoxycillin-clavulanic acid (2.2 g) or cefotetan (2 g) in a single infusion on the induction of anaesthesia. Failure of prophylaxis was defined as occurrence of infection of intestinal origin, either minor (wound cellulitis) or major (abscess, peritonitis, septicaemia) within the 30-day postoperative period. Among 221 randomized patients, 208 (105 amoxycillin-clavulanic acid, 103 cefotetan) aged 66 +/- 12 years (mean +/- SD) were evaluated while 13 were withdrawn. Colorectal cancer was the indication for surgery in 73% of cases. Eleven (10 +/- 6%, 95% confidence interval) and 13 (13 +/- 7%) failures were observed in the amoxycillin-clavulanic acid and cefotetan groups (P = 0.63 chi-square test) respectively. Most infections occurred before the 10th postoperative day (8% failures at this time, estimated by the Kaplan-Meier method). The results of the trial demonstrate that amoxycillin-clavulanic acid and cefotetan have similar efficacy when used for prophylaxis of infection after elective colorectal surgery.

Adult↗

[Multicentric reticulohistiocytosis: report of a case with systemic disease].

Multicentric reticulohistiocytosis (RHM) is a rare non Langherhans cell histiocytosis with skin and joint involvment. Nearly all organs can be involved. Association with cancer occurs in about 25% of cases. Association with auto-immune diseases has also been recorded. Microscopic examination shows a histiocytic nodular infiltrate made of giant cells with ground-glass appearance and PAS positive cytoplasm. Immunostaining shows cell positivity for CD68 and negativity for CD1a and S100 protein. No Birbeck granules are found at ultrastructural examination.

Adult↗

[Multicentric reticulohistiocytosis. A new case].

Multicentric reticulohistiocytosis is a rare disorder of the skin and joints that possesses distinctive histologic findings. A case is reported with typical features, and ulceration, an unusual outcome of "skin" lesions.

Aged↗

A multicentre audit of unilateral fractures of the mandibular condyle.

OBJECTIVE: To audit a series of isolated unilateral fractures of the mandibular condyle treated in a number of units in the United Kingdom. DESIGN: Prospective confidential multicentre audit with review by a single external examiner between July 1993 and January 1994. SETTING: Nine Maxillofacial units. Pro-formas were alphanumerically coded. Units are referred to by code letter. SUBJECTS: 142 patients with fractures of the mandibular condyle. MAIN OUTCOME MEASURES: Pain, crepitus, interincisal opening, mandibular deviation on movement, occlusion and posteroanterior and lateral radiographic analysis by a single examiner. RESULTS: Of the 142 patients, 135 over the age of 12 years had unilateral condylar fractures. Seventy-three attended appointments at both 6 and 12 weeks. Forty-one had identifiable symptoms attributable to the injury at 12 weeks, and most of these had fracture displacements or dislocations which had not been openly reduced. There was a 50-85% positive correlation between radiographic findings of the first clinician and the external auditor. Open reduction and internal fixation was uncommon. CONCLUSIONS: Follow-up studies of trauma patients are difficult because of poor attendance. Fractures of the mandibular condyle should be treated by specialists in the management of facial fractures. Accurate clinical and radiographic diagnosis is more difficult than commonly supposed. Fracture displacements and dislocations have a suboptimal outcome in nearly 30% of cases. More should be spent to improve care of these patients. A consensus on objective indicators of satisfactory outcome is needed to establish a 'gold standard' and close the audit loop.

Adolescent↗

Multicentric papillary renal carcinoma in renal allograft.

A renal transplant recipient with 13 years of excellent allograft function was found incidentally to have a malignant mass in his transplanted kidney. After resection, pathological analysis showed 29 separate lesions of renal cell carcinoma. All tumors were confined within the renal capsule. The majority of tumors (21 of 29 tumors) were chromophil basophilic carcinoma with papillary architecture, 5 tumors were clear cell, 2 tumors were mixed cell type, and 1 tumor was chromophil eosinophilic papillary carcinoma. These histological findings are similar to those reported in hereditary papillary renal carcinoma. To our knowledge, this is the first case of multicentric papillary renal carcinoma occurring in the renal allograft. We speculate that the allograft in this case is predisposed to malignant changes because of preexisting genetic mutations, as well as prolonged immunosuppression.

Adenocarcinoma, Clear Cell↗

Efficacy and safety of levodopa with entacapone in Parkinson's disease patients suboptimally controlled with levodopa alone, in daily clinical practice: an international, multicentre, open-label study.

The combination of entacapone with levodopa is effective in the treatment of Parkinson's disease (PD), providing significant improvements in 'on' time and Unified Parkinson's Disease Rating Scale (UPDRS) motor and ADL scores in controlled clinical trials. This multicentre, open-label study was designed to further evaluate the effectiveness of levodopa combined with entacapone 200 mg in routine clinical practice. Patients experiencing end-of-dose wearing-off were treated for 8 weeks (treatment phase), with an optional extension phase up to 20 weeks. The primary efficacy parameter was the Investigators' Global Assessment of Change; secondary efficacy parameters included UPDRS, 'off' time (from patient diaries), Patients' Global Assessment of Change, quality of life (QoL), SF-36 Health Assessment Questionnaire and Parkinson's Disease Questionnaire 39 (PDQ-39). Of the 479 patients who entered this study, 427 (89.1%) completed the treatment phase and 374 (78.1%) continued into the extension phase. Based on the Investigators' Assessment of Change, 380 (79.7%) patients showed an improvement with entacapone during the treatment phase. This improvement was maintained into the extension phase, and at Week 20, 301 (82.2%) patients continued to show an improvement. A positive treatment effect with entacapone was also seen with all secondary efficacy parameters, including QoL. Mean change in the total PDQ-39 scores showed improvements from baseline of -4.0 score points to the end of the treatment phase (n=182) and -3.1 score points at the end of the extension phase (n=152). Entacapone in combination with levodopa was generally well tolerated: 40 patients (8.4%) discontinued treatment due to adverse events (AEs) by the end of the extension phase. This study in a daily clinical practice setting confirmed the efficacy of coadministering entacapone with levodopa shown in controlled clinical trials and suggests that the combination is useful in improving the disability and QoL in patients with PD.

Administration, Oral↗

Delayed delivery of second twin: a multicentre study of 35 cases.

OBJECTIVE: The aim of this study was to conduct a statistical analysis to determine the outcome of conservative treatment after delivery of a first fetus in multiple pregnancy and thus define new prognostic factors. STUDY DESIGN: Multicentre retrospective study involving 12 centers over a 10-year period. RESULTS: Twenty-eight twin pregnancies and seven triplet pregnancies which were managed conservatively. In twin pregnancies, 79% of the delayed-delivery fetuses survived; only 7% of the first delivered fetuses survived. The mean interval between deliveries was 47 days. No statistical difference was found concerning cerclage, antibiotic therapy, tocolysis and hospitalization. Earlier delivery of the first twin and premature rupture of membranes for the second twin were significantly related to a longer interval between deliveries. CONCLUSION: Delayed delivery in multifetal pregnancies can be successful if there are no contraindications and these pregnancies are managed in a tertiary perinatal center. Publications limited to successful cases have undoubtedly introduced some bias in assessment.

Anti-Bacterial Agents↗

Case history: multicentric glioma with involvement of the optic chiasm.

The case is reported of a man, aged 68, with a right-sided temporal glioblastoma multiform and a left sided chiasmal anaplastic glioma, as well as an occipital tumor, presumably of glial nature. The patient had a complete prostatectomy of adenocarcinoma a year before. The coincidence of multicentric gliomas and prostate cancer is briefly discussed.

Adenocarcinoma↗

Hepatic lesions of vascular origin in multicentric Castleman's disease, plasma cell type: report of one case with peliosis hepatis and another with perisinusoidal fibrosis and nodular regenerative hyperplasia.

We report two cases of multicentric Castleman's disease, plasma cell type, associated with three different liver lesions. Peliosis hepatis was observed in one case and perisinusoidal fibrosis with nodular regenerative hyperplasia in the other. These observations give some evidence that Castleman's disease, per se, may be involved in these three presumably interrelated liver vascular lesions. These changes, already described in monoclonal lymphoproliferations such as myeloma and Waldenström's disease, may also be recorded in a disease characterized by a strong polyclonal plasma cell hyperplasia.

Adult↗

Multicentric papillomavirus infection of the female genital tract. A study of morphologic pattern, possible risk factors and viral prevalence.

We have investigated 103 biopsy specimens obtained from 50 women (average 28.1 years, range 16-66) with multicentric condylomatosis of the genital tract, including the uterine cervix (48 samples), the vagina (23), and the vulva (32). Each patient had at least 2 biopsies. A positive in situ hybridization for a Human Papilloma Virus (HPV) cocktail was observed in samples from 38 patients: in these multiplicity of lesions regarded the cervix and vulva (22 cases), cervix and vagina (12), vulva and vagina (1), cervix, vulva and vagina (3). Viral types 6,11 were more prevalent in simple condylomata. Both low- and high grade lesions of cervix, vagina, and vulva showed prevalence of types 16, 18 and 31, 33, 35. Signaling for more than one probe cocktail was detected in 14 (13.6%) samples. Partner's condylomatosis was referred to by a sizeable minority of patients. It is concluded that the spectrum of HPV infection in the female genital tract reflects a multiplicity of factors, including involved viral type and site, immunitary reaction of the host, perpetration or reactivation of latent infections.

Adolescent↗

[Acceptability of intrauterine levonorgestrel delivery system (Mirena 52mg) after estrogen-progesterone oral contraception: results of a prospective multicentric study of 211 patients aged 25-35 years].

INTRODUCTION: Use of an intrauterine levonorgestrel (SIU-LNG) delivery system (Mirena 52mg has become popular in recent years, particularly among younger women. Mirena is currently the contraceptive method of choice used as an alternative to classical copper-containing intrauterine devices after oral contraception. The purpose of this study was to evaluate patient satisfaction among young women during the first year of use of the intrauterine hormonal system. MATERIAL AND METHODS: This multicentric phase IV trial with a non-comparative methodology was conducted among 211 young women aged 25-35 years. The SIU-LNG was prescribed for women who wanted to change their contraception after oral estrogen progesterone taken for at least three months prior to inclusion in the study. A total of 211 patients were included and review was planned at one year: 197 patients (93.36%) were reviewed. RESULTS: Mean patient age was 31.48+/-3.25 years. The SIU-LNG was inserted successfully at the first attempt in 99.05% of women. The continuation rate ws 85.65% at one year. Evaluation of cycle characteristics showed less voluminous blood loss and fewer dysmenorrheal phenomena as well as, in 40%, the development of amenorrhea. At the last visit, 85% of women were satisfied or very satisfied with this method of contraception. CONCLUSION: As has been demonstrated in earlier studies, Mirena offers a contraception with a reliability equivalent to that of oral estrogen progesterone (IP: 0 - 0.2), with very few hormonal side effects due to the low plasma passage of levonorgestrel. Mirena is particularly well adapted for young women who desire a reliable long-term easty-to-use contraception after taking oral contraception.

Adult↗

Complications of stapled hemorrhoidectomy: a French multicentric study.

OBJECTIVES: The aim of this retrospective multicentric study was to assess the complications of the Longo technique for the treatment of haemorrhoidal disease. METHODS: From March 1999 to April 2003, 550 patients underwent a stapled hemorrhoidectomy following Longo's technique in 12 surgical units in the Rhone-Alpes Region. The operative indications were the same as for conventional hemorrhoidectomy. Complications were divided into early or late complications depending on whether they occurred before or after the 7th day. For each patient, the most serious complication was retained for analysis. RESULTS: One hundred and five patients (19%), mean age 51 years, experienced complications. The early complications were bleeding (1.8%), severe anal pain (2.3%), urinary retention (0.9%) and sepsis (0.5%). Late complications were chronic anal pain (1.6%), suture dehiscence (1.6%), anal stricture (1.6%), anal fissure (0.9%), external thrombosis (0.9%), fistulae and intramural abscesses (0.9%), anal incontinence (0.3%), haemorrhoidal disease symptoms persistence or recurrence (3.2%). Strictures were successfully dilated, fissures were treated by sphincterotomy, external thromboses were excised and fistulae were laid open. Most of the recurrences were treated with the Milligan-Morgan hemorroidectomy technique. CONCLUSION: Complications may occur after stapled hemorrhoidopexy, some are particularly serious, especially bleeding and sepsis.

Female↗

Magnetic resonance imaging screening in women at genetic risk of breast cancer: imaging and analysis protocol for the UK multicentre study. UK MRI Breast Screening Study Advisory Group.

The imaging and analysis protocol of the UK multicentre study of magnetic resonance imaging (MRI) as a method of screening for breast cancer in women at genetic risk is described. The study will compare the sensitivity and specificity of contrast-enhanced MRI with two-view x-ray mammography. Approximately 500 women below the age of 50 at high genetic risk of breast cancer will be recruited per year for three years, with annual MRI and x-ray mammography continuing for up to 5 years. A symptomatic cohort will be measured in the first year to ensure consistent reporting between centres. The MRI examination comprises a high-sensitivity three-dimensional contrast-enhanced assessment, followed by a high-specificity contrast-enhanced study in equivocal cases. Multiparametric analysis will encompass morphological assessment, the kinetics of contrast agent uptake and determination of quantitative pharmacokinetic parameters. Retrospective analysis will identify the most specific indicators of malignancy. Sensitivity and specificity, together with diagnostic performance, diagnostic impact and therapeutic impact will be assessed with reference to pathology, follow-up and changes in diagnostic certainty and therapeutic decisions. Mammography, lesion localisation, pathology and cytology will be performed in accordance with the UK NHS Breast Screening Programme quality assurance standards. Similar standards of quality assurance will be applied for MR measurements and evaluation.

Adult↗

Absolute metabolite quantification by in vivo NMR spectroscopy: II. A multicentre trial of protocols for in vivo localised proton studies of human brain.

We have performed a multicentre trial to assess the performance of three techniques for absolute quantification of cerebral metabolites using in vivo proton nuclear magnetic resonance (NMR). The techniques included were 1) an internal water standard method, 2) an external standard method based on phantom replacement, and 3) a more sophisticated method incorporating elements of both the internal and external standard approaches, together with compartmental analysis of brain water. Only the internal water standard technique could be readily implemented at all participating sites and gave acceptable precision and interlaboratory reproducibility. This method was insensitive to many of the experimental factors affecting the performance of the alternative techniques, including effects related to loading, standing waves and B1 inhomogeneities; and practical issues of phantom positioning, user expertise and examination duration. However, the internal water standard method assumes a value for the concentration of NMR-visible water within the spectroscopic volume of interest. In general, it is necessary to modify this assumed concentration on the basis of the grey matter, white matter and cerebrospinal fluid (CSF) content of the volume, and the NMR-visible water content of the grey and white matter fractions. Combining data from 11 sites, the concentrations of the principal NMR-visible metabolites in the brains of healthy subjects (age range 20-35 years) determined using the internal water standard method were (mean+/-SD): [NAA]=10.0+/-3.4 mM (n=53), [tCho]=1.9+/-1.0 mM (n=51), [Cr + PCr]=6.5+/-3.7 mM (n=51). Evidence of system instability and other sources of error at some participating sites reinforces the need for rigorous quality assurance in quantitative spectroscopy.

Adult↗

Multicentre magnetic resonance texture analysis trial using reticulated foam test objects.

Texture analysis in magnetic resonance imaging has the ability to provide useful diagnostic information with respect to the discrimination of disease states of a single tissue or the separation of different tissues. However, for widespread use it is necessary to determine how texture measurements carried out in one center relate to those carried out in another. To this end, a multicentre trial has been performed where reticulated foam test objects have been scanned in six European centers according to a fixed protocol. It has been concluded that texture measurements are not transportable between centers. Principal component models calculated from the texture parameters collected in one center do not fit the data collected in another. Further trials are to investigate whether the reticulated foam test objects may be used to normalize tissue texture data collected in different centers.

Europe↗