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PubMed2002

Comparison of B-mode and conventional colour/power Doppler ultrasound, contrast-enhanced Doppler ultrasound and spiral CT in the diagnosis of focal lesions of the liver: Results of a multicentre study.

AIM: In patients with lesions of the liver we compared diagnoses based on different methods of ultrasound as well as spiral CT with the final diagnosis reached at the time of the patient's discharge from hospital. METHOD: From records of a prospective multicentre study including 90 liver lesions investigated with B-mode baseline and conventional colour/power Doppler ultrasound, contrast-enhanced colour/power Doppler ultrasound and spiral-CT, we evaluated only those where diagnoses for all modalities were available, and where the diagnosis at discharge comprising all clinical, laboratory and imaging data as well as histologic proof was at least "highly probable". RESULTS: 60 lesions met the inclusion criteria. 20 lesions were ultimately diagnosed as benign, and 40 as malignant. With respect to the diagnosis of malignancy, sensitivity was 92.5 % (37/40) with B-mode and unenhanced conventional colour/power Doppler US ultrasound, 97.5 % (39/40) with contrast-enhanced colour/ power Doppler ultrasound, and 100 % with CT; the corresponding specificities were 65 % (13/20), 85 % (17/20) and 80 % (16/20). 4 of 7 false positive, and 2 of 3 false negative results in the unenhanced technique were diagnosed correctly with contrast-enhanced Doppler ultrasound. CONCLUSION: Compared to conventional ultrasound, contrast-enhanced Doppler ultrasound improved the diagnostic accuracy in 10 % of the cases. Its accuracy in our study was equal to that of CT.

Contrast Media↗
PubMed2003

A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes.

AIMS: The aim of the trial was to compare the efficacy and safety of the new, long-acting basal insulin, insulin glargine (LANTUS(R)), with NPH human insulin, each administered in a combination regimen with oral antidiabetic drugs in patients with Type 2 diabetes. METHODS: In a multicentre, open, randomised study, 570 patients with Type 2 diabetes, aged 34 - 80 years, were treated for 52 weeks with insulin glargine or NPH insulin given once daily at bedtime. Previous oral antidiabetic therapy was continued throughout the study. RESULTS: There was a clinically relevant decrease in glycosylated haemoglobin (GHb) values from baseline to endpoint with both drugs (insulin glargine: - 0.46 %; NPH insulin: - 0.38 %; p = 0.415); also, this difference was statistically significant in the subgroup of overweight patients with BMI > 28 kg/m 2 (insulin glargine: - 0.42 %, NPH insulin: - 0.11 %; p = 0.0237). Over the entire treatment period, NPH insulin-treated patients (41 %) and insulin glargine-treated patients (35 %) experienced a similar level of symptomatic hypoglycaemia. A statistically significant difference was observed in the number of patients treated with NPH insulin who reported at least one episode of nocturnal hypoglycaemia compared with those treated with insulin glargine in the overall population and in the overweight subgroup (overall: 24 % vs. 12 %, p = 0.002; overweight: 22.2 % vs. 9.5 %, p = 0.0006), using the Cochran-Mantel-Haenszel test. These differences were most pronounced in insulin-naïve and overweight (BMI > 28 kg/m 2) sub-groups. The incidence of adverse events was similar for the two treatments. CONCLUSIONS: This study demonstrated that insulin glargine is as effective as NPH insulin in achieving glycaemic control in patients with Type 2 diabetes, and is associated with fewer episodes of symptomatic hypoglycaemia, particularly nocturnal episodes.

Adult↗
PubMed2004

[Primary multicentric cutaneous epithelioid angiosarcoma of the hand. Case report and review of the literature].

CASE: The case of a primary multicentric cutaneous epithelioid angiosarcoma is described. A 39-year-old female patient presented with a tumor on the left distal forearm and the fourth finger of the left hand. Partial amputation of the left hand and local excision of the tumor on the left forearm were performed. For the next three years the patient was free of local or systemic recurrence. After this time period, a left shoulder exarticulation had to be performed because of tumor recurrence in the left axilla. The patient died 64 months after diagnosis. CONCLUSION: Cutaneous epithelioid angiosarcoma is a highly malignant tumor which has only been described once on the hand. The treatment primarily is a surgical one. If possible, the function of the extremity should be preserved as long as possible.

Adult↗
PubMed2004

[Bupropion SR for weaning from smoking in relapsed smokers: results of an open multicentre trial in Germany].

BACKGROUND: After initially successful smoking cessation the majority of patients relapse which stresses the addiction character of nicotine dependence. The patient and the physician, in therapeutic nihilism will not make another attempt for smoking cessation. In two randomised, double-blind, placebo-controlled trials in the US and Canada relapsed smokers, who had initially successfully quit smoking under Bupropion SR (Zyban), were again treated with Bupropion SR for smoking cessation. The encouraging results prompted us to perform a study in Germany under the conditions and temporal restraints of a routine medical practice. METHODS/PATIENTS: In this open multicentre study 321 patients of a total of 365 patients at 62 study sites were included. The patients represented a healthy population (= free of severe chronic disease) of smokers, who had relapsed after a smoking cessation attempt with Bupropion SR or nicotine replacement therapy and were currently smoking at least 20 cig./d for > 3 months. The treatment with Bupropion SR (300 mg/d) lasted 7 weeks, with initial run-in of 150 mg/d for the first three days; motivational counselling was provided during 4 clinical visits within the study duration of 26 weeks. RESULTS: 55.4 % of the patients were heavily or very heavily nicotine dependent as detected by the Fagerström Tolerance Questionnaire (score 6 - 11). The continuous abstinence rates for week 4 - 7 were 29.6 % (ITT) the point prevalence rates for week 26 were 30.5 % (ITT). Patients who showed a relapse had less daily cigarette consumption even after 26 weeks (10.3 cig./d versus 26.9 cig./d pretreatment). Nicotine craving reached a low plateau not earlier than week 6. Bupropion SR was well tolerated, only 9.7 % of the patients (ITT) withdrew from the study due to an adverse event. The most frequent adverse events were pain of the musculoskeletal system and insomnia. CONCLUSIONS: Bupropion SR was effective and well tolerated when given as an aid in smoking cessation in relapsed smokers.

Adult↗
PubMedDate not supplied

[Multicentric extra-abdominal fibromatosis: a rare case].

Extra-abdominal aggressive fibromatosis is a benign fibroblastic neoplasia with an infiltrative nature and a high tendency of local recurrence. Here, we report on a very rare case of multicentric fibromatosis. Low complaints led to considerable size of the tumours. The aim of the multimodal treatment was a limb salvage procedure. Adjuvant radiation therapy and chemotherapy was necessary because of the renunciation of wide resections in favour of the functionality of the limb.

Abdomen↗
PubMed2006

[Effects of a programme for structured outpatient follow-up care after inpatient rehabilitation of obese children and adolescents--a multicentre, randomized study].

INTRODUCTION: Inpatient rehabilitation is an important contributor to the treatment of child and adolescent obesity with comorbidity in Germany. Thus far outpatient follow-up care has not been subject to research. The main goal of this study is the development and longer-term evaluation of a programme for structured outpatient follow-up care by primary care physicians after inpatient rehabilitation of obese children and adolescents. METHODS: This multicentre, randomized, parallel controlled clinical trial enrolled 521 children and adolescents aged 9 - 16 (avg. 13.3) years in 7 cooperating specialized rehabilitation facilities. The patients were randomized at the end of their multimodal inpatient treatment that lasted for 5.9 (+/- 1.2) weeks. The intervention consisted of 12 half-hour outpatient consultations by the primary care physicians utilizing a modular consultation guideline and an internet-based training programme. The control group received standard care. Outcome variables included anthropometric measures, questionnaires on eating behaviour, physical activity, quality of life, self-efficacy and subjective rating of the intervention. Measurements were performed at the beginning (t1) and end (t2) of inpatient rehabilitation as well as 6 (t3) and 12 (t4) months after discharge. RESULTS: There was a highly significant improvement of BMI-z-score (standard deviation score of the Body Mass Index), relevant behaviour, quality of life and self-efficacy between t1 and t4. On intention to treat analysis no differences were detected between intervention and control groups. The intervention was utilized by only 50 % of entitled. The BMI-z-score reached a minimum at t3 (6-month follow-up). Predictors of longer-term BMI-z-score decline were psychological suffering, poor eating behaviour, low physical activity and high socio-economic status. In multivariate linear regression improvement of eating behaviour and physical activity correlated with the improvement of BMI-z-score. DISCUSSION: This low-level outpatient intervention did not improve the demonstrated longer-term effectiveness of inpatient rehabilitation. An interdisciplinary outpatient follow-up care in groups with inclusion of the parents is recommended.

Adolescent↗
PubMed2006

Nonparasitic splenic cysts in children: a multicentric study.

PURPOSE: Nonparasitic splenic cysts (NPSCs) are uncommon in children. The aim of this multinational and multicentric study was to present the authors' experience as well as the changing trends in the management of NPSCs over the last 25 years. MATERIAL AND METHODS: From 1981 to 2005, 50 children or adolescents were surgically treated for NPSCs in 6 paediatric surgical centres in four European countries. The medical records of these 50 patients with NPSCs were reviewed retrospectively. RESULTS: Twenty-six male and 24 female patients were operated on. Age at surgery ranged from 1 to 17 years (mean 11.9). Seventeen patients were symptomatic. Six total (4 open and 2 laparoscopic) and 26 partial (22 open and 4 laparoscopic) splenectomies were performed. Laparoscopic fenestration or deroofing and open cystectomy was carried out in 9 patients, respectively. Histological findings revealed the lesion to be an epidermoid cyst (n = 28), a pseudocyst (n = 15) or a mesothelial cyst (n = 2). In 5 patients haemangioma or lymphangioma was the pathological diagnosis. At a mean follow-up of 2.9 years, residual cysts were found in 8 laparoscopically treated patients, 4 of whom required re-do laparoscopy or open surgery. CONCLUSIONS: Over the last two decades, the surgical treatment of NPSCs has changed from a formerly customary total splenectomy to spleen-conserving procedures, such as total cystectomy with or without partial splenectomy or partial cystectomy. These therapeutic modalities can be performed laparoscopically, if technically possible. Fenestration or deroofing of the cyst resulted in a high recurrence rate (7/9).

Adolescent↗
PubMed2006

Comparative efficacy and safety of a once-daily dosage of hypericum extract STW3-VI and citalopram in patients with moderate depression: a double-blind, randomised, multicentre, placebo-controlled study.

OBJECTIVE: The objective of this double-blind, randomised, placebo-controlled, multicentre clinical study was to demonstrate the non-inferiority and safety of the hypericum extract STW3-VI in a once-daily dosage regime in the treatment of moderate depression. During the 6-week treatment phase, the course of depression was documented by use of HAMD (items 1-17), the von Zerssen's Adjective Mood Scale (BfS) and the CGI scales. The primary objective of this 3-arm design study was to demonstrate the non-inferiority of hypericum extract STW3-VI (900 mg) to the SSRI citalopram (20 mg) and superiority of hypericum over placebo. METHODS: Outpatients (N = 388) suffering from moderate depression were enrolled. The safety and tolerability of hypericum extract in comparison to citalopram and placebo was investigated on the basis of CGI, the occurrence of adverse events and the investigation of laboratory parameters and vital signs. RESULTS: From almost identical baseline values of 21.9 +/- 1.2 points (hypericum extract), 21.8 +/- 1.2 points (citalopram) and 22.0 +/- 1.2 points (placebo), the HAMD score was reduced to 10.3 +/- 6.4 (hypericum extract), 10.3 +/- 6.4 (citalopram) and 13.0 +/- 6.9 (placebo), respectively. Based on this data, the statistical significant therapeutic equivalence of hypericum extract STW3-VI to citalopram (p < 0.0001) and the superiority of this hypericum extract over placebo (p < 0.0001) was demonstrated. At the end of treatment 54.2 % (hypericum extract), 55.9 % (citalopram) and 39.2 % (placebo) of the patients were assessed as therapy responders. The secondary efficacy parameters, change in BfS, CGI and amount of therapy responders showed that the hypericum group was not statistically different from the citalopram group, and significantly superior to the placebo group. Significantly more adverse events with "certain", "probable" or "possible" relation to study medication were documented in the citalopram group (hypericum: 17.2 %, citalopram: 53.2 %, placebo: 30 %). In most cases, the investigators assessed the tolerability of hypericum extract, citalopram and placebo as "good" or "very good". CONCLUSION: The non-inferiority of hypericum extract as compared to citalopram and the superiority of both active compounds to placebo were demonstrated, as well as a better safety and tolerability of hypericum extract in comparison to citalopram. These results revealed that hypericum extract STW3-VI is a good alternative to chemically defined antidepressants in the treatment of outpatients with moderate depression.

Adult↗
PubMed1991

A double-blind comparative multicentre study of controlled-release remoxipride, immediate-release remoxipride and haloperidol in schizophrenia.

A double-blind multicentre study comparing the efficacy and safety of remoxipride in controlled-release formulation (REM-CR), given once a day, and immediate-release formulation (REM-IR) and haloperidol, given twice daily, was conducted in patients with schizophrenic illness. In total, 150 inpatients were randomized: 49, 51 and 50 in the REM-CR, REM-IR, and haloperidol groups, respectively. The mean daily dose of REM-CR during the last week of treatment was 361 mg, that of REM-IR 332 mg. In the haloperidol group the corresponding dose was 12.5mg per day. The study treatment period was four weeks. The median BPRS total score was 37.5 in the REM-CR group at start of treatment, and 14.5 at last rating (n = 38). For the REM-IR group and the haloperidol group the corresponding figures were 36.0 and 38.0 at start of treatment and 18.0 (n = 43) and 16.5 (n = 40) at last rating. No statistically significant differences were found between the treatments. Therapy-emergent extrapyramidal symptoms (Simpson & Angus rating scale) were significantly (p less than 0.05) more frequent and more severe during haloperidol than during REM-CR and REM-IR treatment, despite significantly higher concurrent use of anticholinergic drugs in the haloperidol group.--REM-CR was comparable in efficacy and tolerability to REM-IR. The tolerability profile favoured both remoxipride formulations over haloperidol. Evaluation of the clinical chemistry, haematology, and cardiovascular data showed no clinically significant deleterious effects on any organ system for either drug.

Adolescent↗
PubMed1987

Zuclopenthixol and perphenazine in patients with acute psychotic states. A double-blind multicentre study.

Fifty-four patients with acute psychotic states were included in a double-blind multicentre study of zuclopenthixol and perphenazine given orally. Fourteen patients had not received test preparations for a minimum of 3 weeks as stated in the protocol, and were excluded. The remaining 40 patients received the test preparations for 3 to 12 weeks, with an average of 49 days for patients receiving zuclopenthixol and 45 days for patients receiving perphenazine. Clinical evaluations were done at baseline and at weeks 1, 2, 4, 6, 8, and 12 including the CGI, a CPRS subscale for schizophrenia, and the UKU Side Effects Rating Scale. The patients received on average 37 mg zuclopenthixol or 30 mg perphenazine daily. Statistically, significant reductions on the CGI, severity of illness, and on the CPRS (total score) were found for both drugs when comparing baseline with later scores. No significant differences between the drugs were found. It was also impossible to demonstrate a difference in clinical profile between the two drugs on the basis of the single items on the CPRS. Although small differences between the two drugs were found, as regards number and type of side effects, it is concluded that the pattern of side effects was almost identical in the two treatment groups.

Clopenthixol↗
PubMed1985

A German multicentre study on the long-term treatment of schizophrenic outpatients.

Planning a major, multicentre study on effects of neuroleptic treatment in schizophrenic outpatients requires attention to many methodological, ethical and administrative matters. This report describes the study planned by the German neuroleptic therapy study group. Three types of treatment have been chosen: prophylactic maintenance medication, neuroleptic crisis intervention and prophylactic early intervention. Patients who meet the criteria for inclusion in the study are assigned to each treatment on a random basis, provided their informed consent has been obtained. Their psychopathological symptoms, social status and physical condition are measured by means of standardised examinations and rating scales. The study is expected to continue during five years, after which computerised data analysis will be carried out to test the central hypotheses for the study.

Antipsychotic Agents↗
PubMedDate not supplied

[Idiopathic multicentric osteolysis and the delimitation of the cranio-carpal-tarsal-osteolysis syndrome].

It is shown in the example of a 36 year old female patient with progressive but mainly carpotarsal osteolysis to analyse the radiological and clinical delimitation to other osteolysis-syndromes. Over 35 years during infancy and adolescence the clinical picture was incorrectly related to the "Freeman-Sheldon-Syndrome" and was twice the cause for fruitless attempts to classify. Although no standardized classification or rather grouping of the osteolysis exist, now with means of systematically radiological diagnostic and by long clinical follow-up of over 35 years a definite enrollment of the case represented, proved to be an extreme rare form of idiopathic multicentric osteolysis with nephropathy. It can be listed now as the 13th case in the literature.

Abnormalities, Multiple↗
PubMed1996

[Multicentric gastric carcinoid in autoimmune gastritis].

HISTORY AND FINDINGS: A now 54-year-old woman was 32 years ago found to have immune thrombocytopenia and 3 years ago ANA-positive and HBsAg-negative hepatitis with cirrhotic metaplasia. Numerous small asymptomatic carcinoids with marked hypergastrinaemia (1626 ng/l) were also first found 3 years ago. No gastrinoma could be found. Severe arthralgia was the main symptom on admission. INVESTIGATIONS: Gastroscopy revealed a polypoid carcinoid, 1 cm in diameter. There was total achlorhydria. No pernicious anaemia or carcinoid syndrome was found. TREATMENT AND COURSE: Total gastrectomy with construction of a jejunal substitute stomach was performed. Histology showed typical chronic-atrophic gastritis type A, all stages of an argyrophilic endocrine cell hyperplasia, as well as microcarcinoidosis and multicentric carcinoid, in part with submucosal infiltration and lymph node metastases. Immunohistology revealed immune reaction for the global endocrine marker. No specific hormones were demonstrable in the carcinoid cells. The postoperative course was without complications. Serum gastrin levels have since been normal. CONCLUSIONS: The case confirms the possibility of an achlorhydria-hypergastrinaemia-carcinoid sequence. Now new stage-related therapeutic guidelines for this disease are needed.

Achlorhydria↗
PubMed1994

Laparoscopy and impalpable testis--a prospective multicentric study (232 cases). GECI. Groupe d'Etude en Coeliochirurgie Infantile.

The value of laparoscopy in managing the impalpable testis remains controversial. Several reports have been published on this topic but series are usually short and rather heterogeneous in their presentation, so that critical analysis is not easy to perform. Therefore, the Groupe d'Etude en Coeliochirurgie Infantile started a multicentric prospective study in May 1991 with two objectives: what are the laparoscopic findings and what are the correlations between laparoscopy and surgery? In addition, this study tried to estimate the therapeutic implications. Two hundred and one boys underwent laparoscopy accounting for two hundred and thirty-two impalpable testis. Laparoscopic findings were mainly of three types: intra-abdominal testis (36%), abdominal blind ending cord structures (14%) and cord structures entering the deep inguinal ring (49%); rarely, there was absence of testis and cord structures (1%). Crossed testicular ectopia was not found in this series. One hundred and eighty-seven impalpable testis were operated on to control laparoscopic findings and correlations laparoscopy-surgery were excellent provided that laparoscopic exploration could be entirely performed in good conditions. Moreover, it could be evaluated that forty-seven per cent of impalpable testes could take advantage of laparoscopy.

Adolescent↗
PubMed1997

Monoclonal origin of multicentric Kaposi's sarcoma lesions.

BACKGROUND: Kaposi's sarcoma has features of both hyperplastic proliferation and neoplastic growth. Multiple lesions, in which spindle cells are prominent, often arise synchronously over widely dispersed areas. We tested the hypothesis that the spindle cells in these multicentric lesions originate from a single clone of precursor cells. METHODS: To determine whether Kaposi's sarcoma is a monoclonal disorder, we assessed the methylation patterns of the androgen-receptor gene (HUMARA) in multiple lesions from women with the acquired immunodeficiency syndrome. In polyclonal tissues, about half the copies of each HUMARA allele are methylated, whereas in cells derived from a single clone all the copies of only one allele are methylated. To minimize contamination by normal DNA, we used microdissection to isolate areas composed primarily of spindle cells, the putative tumor cells. RESULTS: Eight patients with a total of 32 tumors were studied. Of these tumors, 28 had highly unbalanced methylation patterns (i.e., predominant methylation of one HUMARA allele). In all the tumors that had unbalanced methylation from a given patient, the same allele predominated. CONCLUSIONS: These data indicate that Kaposi's sarcoma is a disseminated monoclonal cancer and that the changes that permit the clonal outgrowth of spindle cells occur before the disease spreads.

Acquired Immunodeficiency Syndrome↗
PubMed2001

Multicentric reticulohistiocytosis with neurofibroma-like nodules.

We describe a patient with multicentric reticulohistiocytosis (MR), who presented with 2 different clinical types of lesions. Some were characteristic for MR in that they were deeply set, small, firm papules. Many others were larger, soft, and even sessile, like neurofibromas. Histopathologic features of both types of lesions revealed MR. To our knowledge, this is the first report of lesions of MR mimicking neurofibromas.

Adrenal Cortex Hormones↗
PubMed2003

Occlusal rehabilitation of a patient with hereditary multicentric osteolysis.

This article describes the fixed prosthodontic rehabilitation of a 53-year-old male patient with multicentric osteolysis. Before treatment, the patient exhibited signs and symptoms of temporomandibular disorder and had recurrent tension-type headaches and pain in the neck and shoulder area. One of his chief complaints was frequent fracture of restorations. After extensive occlusal rehabilitation, occurrence of headache and pain ceased, and other signs and symptoms of TMD diminished. The long-term prognosis depends on the stage of the genetic disorder, which cannot be determined.

Dental Care for Persons with Disabilities↗
PubMed1999

Distribution of human herpesvirus-8 latently infected cells in Kaposi's sarcoma, multicentric Castleman's disease, and primary effusion lymphoma.

Human herpesvirus 8 (HHV-8, also called KSHV) is linked to the etiopathogenesis of Kaposi's sarcoma (KS), multicentric Castleman's disease (MCD), and primary effusion lymphoma (PEL). The universal presence of HHV-8 in early KS has not yet been shown. We used a mAb (LN53) against latent nuclear antigen-1 (LNA-1) of HHV-8 encoded by ORF73 to study the distribution of the cell types latently infected by HHV-8 in patch, plaque, and nodular KS, MCD, and PEL. In early KS, HHV-8 is present in <10% of cells forming the walls of ectatic vessels. In nodular KS, HHV-8 is present in cells surrounding slit-like vessels and in >90% of spindle cells, but not in normal vascular endothelium. In addition, HHV-8 colocalizes with vascular endothelial growth factor receptor-3 (VEGFR-3), a marker of lymphatic and precursor endothelium. In early KS lesions, VEGFR-3 is more extensively expressed than LNA-1, indicating that HHV-8 is not inducing the proliferation of VEGFR-3-positive endothelium directly. In MCD, HHV-8 is present in mantle zone large immunoblastic B cells. No staining for LNA-1 is seen in samples from multiple myeloma, prostate cancer, and angiosarcoma, supporting the absence of any etiological link between these diseases and HHV-8.

Antigens, CD↗