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PubMedDate not supplied

Orbital pseudotumor as an initial manifestation of multicentric Castleman's disease.

BACKGROUND: To report on a patient with multicentric Castleman's disease (MCD) who showed an orbital pseudotumor as an initial manifestation. CASE: A Japanese male patient, 65 years old, initially exhibited swelling of the left eyelid. Computed tomography and magnetic resonance imaging showed an infiltrating orbital mass around the left eye. OBSERVATIONS: The patient was treated several times with short courses of oral corticosteroids without significant response. Eight years after the first examination, he was referred to our neuroophthalmology clinic owing to persistent eyelid swelling. He exhibited an accelerated erythrosedimentation rate, polyclonal hypergammaglobulinemia, and multiple cervical and thoracic mediastinal lymphadenopathies. Histopathological examination revealed mixed-type MCD from a cervical lymph node and chronic inflammatory cell infiltration from eyelid swelling. Four months after his first visit, the patient's condition was complicated by fever, general fatigue, and hypoxemia. A cell marker study of the swollen lymph node showed monoclonality, indicating the development of non-Hodgkin's lymphoma. CONCLUSIONS: The clinical course in this case suggests that an inflammatory reaction in the orbital tissue was initially present, before MCD, and that non-Hodgkin's lymphoma subsequently developed.

Aged↗
PubMed2005

A multicentre phase II study on gefitinib in taxane- and anthracycline-pretreated metastatic breast cancer.

BACKGROUND: Epidermal growth factor receptor (EGFR) is considered to be a viable drug target in a variety of solid tumors. The clinical benefit and safety of the EGFR tyrosine kinase inhibitor gefitinib ('Iressa')1 was evaluated in this Phase II, multicentre study of patients with taxane and anthracycline pretreated, metastatic breast cancer. METHODS: Gefitinib (500 mg/day) was given to 58 patients until disease progression. Primary endpoint was the clinical response rate to the study treatment. RESULTS: One patient (1.7%) had objective partial tumor response of her liver and pleural metastasis. Fifty-seven patients (98.3%) were non-responders with 52 patients (89.7%) having progressive disease and five patients (8.6%) were not evaluable. Two patients reported a significant improvement in pain at metastatic sites (1 liver, 1 bone). The median time to progression was 61 days (95% CI : 54-82 days) and the proportion of patients alive and progression free at 6 months at trial closure was 1.8% (95% CI : 0.0-5.2%). The median survival time was 357 days (95% CI : 257-441 days). Fifty-four patients (93.1%) discontinued study medication prematurely due to disease progression and three (5.2%) due to adverse events (diarrhea, pruritus, peripheral edema). CONCLUSIONS: Gefitinib monotherapy at 500 mg daily did not appear to be efficacious in the treatment of heavily pretreated metastatic breast cancer patients. It was well tolerated and the side effect profile was as expected from current knowledge of the drug. There was no correlation between EGFR expression and response in this study.

Adult↗
PubMed2005

Subjective versus interviewer assessment of global quality of life among persons with schizophrenia living in the community: a Nordic multicentre study.

BACKGROUND: Few studies have investigated differences between subjective and externally assessed quality of life in individuals with a severe mental illness. In a sample of 387 patients with schizophrenia living in the community the present study investigated the association between subjective and interviewer-rated quality of life, clinical and sociodemographic factors related to the two assessments, and if discrepancies in the assessments were related to any clinical or social features of the patients. METHOD: The study was a Nordic multicentre study with a cross-sectional design. Instruments used were the Lancashire Quality of Life Profile, the Brief Psychiatric Rating Scale, the Interview Schedule for Social Interaction, Camberwell Assessment of Needs and General Assessment of Functioning. RESULTS: The correlation between subjective and interviewer-rated quality of life was moderate (ICC = 0.33). More severe affective symptoms, fewer emotional relations and a lower monthly income were related to poorer subjectively rated quality of life but in a stepwise multiple regression analysis accounted for only 14.1% of the variance. Poorer interviewer-rated quality of life was mainly related to a more severe psychopathology but also to a lower monthly income, fewer emotional relations and not being employed. Together these factors accounted for 45.5% of the variance. A greater discrepancy between the subjective and the interviewer rating was found in patients with less affective symptoms, unemployment, and a better social network. CONCLUSION: Only a moderate correlation between subjective and interviewer-assessed global quality of life was found, implying that the sources of assessment differed, as was also shown in subsequent regression models. It is concluded that both perspectives on the patient's quality of life may be valuable for treatment planning, especially in cases where differences in quality of life assessment related to the patient's psychopathology may be expected.

Adult↗
PubMed2004

AIDS, multicentric Castleman's disease, and plasmablastic leukemia: report of a long-term survival.

Plasmablastic leukemia (PL) as a complication of human herpes virus 8 (HHV8)-associated Castleman's disease is marked by a rapid and fatal outcome. In patients with AIDS, survival of 7 to 14 days after diagnosis has been reported. Prompt splenectomy and chemotherapy might lead to a significant survival benefit. Here we report a case of long-term survival in a patient with AIDS and multicentric Castleman's disease (MCD) complicated by PL.

AIDS-Related Opportunistic Infections↗
PubMed2006

Piperacillin/tazobactam vs imipenem/cilastatin in the treatment of nosocomial pneumonia--a double blind prospective multicentre study.

BACKGROUND: Piperacillin/tazobactam (P/T) with its broad spectrum of antibacterial activity is used widely for the treatment of moderate to severe polymicrobial nosocomial infections. PATIENTS AND METHODS: The efficacy and safety of P/T was compared with imipenem/cilastatin (I/C) in patients with established nosocomial pneumonia. This multicentre study took place from January 1999 to December 2001. Due to difficulties in recruiting sufficient patients it was terminated prematurely. In all, 221 patients were randomly assigned to either P/T at 4 g/0.5 g (n = 110) or I/C at 1 g/1 g (n = 111). Additional aminoglycoside therapy was mandatory if Pseudomonas aeruginosa was present. The ITT population (107 P/T and 110 I/C patients) was used for the analysis of efficacy. RESULTS: The clinical efficacy was equally good for the P/T and I/C groups; 71% [95% CI 61.3, 79.2] vs 77.3% [95% CI 68.1, 84.5] at the end of therapy, 66.4% [95% CI 56.5, 75] vs 70% [95% CI 60.4, 78.2] on day 3, a nd 59.8% [95% CI 49.9, 69] vs 66.4% [95% CI 56.6, 74.9] on day 14 after therapy, respectively. Proven or assumed bacterial eradication at the end of therapy was 45.8% (P/T) and 52.7% (I/C). Treatment-related adverse events (AE) were recorded in 30% of P/T patients and 25.2% I/C patients. There were ten serious treatment-related AEs in the P/T group and five in the I/C group. CONCLUSION: Although numbers were inadequate for full statistical evaluation, P/T and I/C were similarly effective in the treatment of severe nosocomially acquired pneumonia.

Adult↗
PubMed1976

Three-day therapy of vulvovaginal candidiasis with econazole: a multicentric study comprising 996 cases.

Within the scope of three open multicentric studies, effect and tolerability of 150 mg. econazole vaginal suppositories were tested in a total of 996 women, 13 to 74 years old (mean age, 29 years). Vaginal candidiasis had been mycologically demonstrated in every patient prior to therapy, and the total cure rate of 93.4 per cent in Studies I and II (880 patients) was also mycologically confirmed. The tolerability was tested by checking of 30 laboratory variables before and after the treatment of 116 patients (Study III); no therapy-related adverse changes were recorded. Connections between therapeutic results, age distribution, initial hormonal situation, and conception of the therapy are pointed out.

Adolescent↗
PubMed1986

Congenital generalized multicentric myofibromatosis with orbital involvement.

We studied a rare case of congenital myofibromatosis of the orbit as part of a generalized multicentric disease in a 5-month-old boy. The ultrasonographic and computed tomographic findings were those of a low-reflective, firm, vascularized, lesion with heterogeneous internal structure. The histopathologic findings showed vascular channels with large polygonal cells and transition toward myofibroblasts with interwoven collagen fiber bundles.

Follow-Up Studies↗
PubMed1986

Multicentricity in nonpalpable breast carcinoma and its implications for treatment.

During a 9 year period, 300 consecutive women underwent breast biopsies solely because of nonpalpable, mammographically suspicous findings. One hundred clinically occult breast carcinomas were found, 65 of which were invasive and 35 noninvasive. Eighty-three mastectomy specimens were evaluable for evidence of multifocal carcinoma in another quadrant of the breast or at a distance of 5 cm and residual cancer outside the excisional biopsy cavity. Multicentricity was present in 47 percent and residual tumor in 60 percent of the whole group. When only clinically occult invasive carcinomas were considered, other foci of invasive carcinoma were demonstrated in 26 percent of the patients and residual invasive cancer in 35 percent. The rate of bilaterality was 14 percent, occurring synchronously in 11 percent of the patients. Any therapeutic procedure for nonpalpable breast carcinoma, whether invasive or noninvasive ductal carcinoma, should be directed to the whole breast. Mammography of the contralateral side should be an integral part of the preoperative work-up of patients with palpable lesions ipsilaterally.

Adult↗
PubMed1994

Multicentric granular cell tumor of the heart presenting with aortic dissection.

A 43-year-old woman with a history of cutaneous granular cell tumor presented with severe aortic regurgitation due to a type A aortic dissection. During repair, multiple masses were found on the surface of the heart, which later were identified to be granular cell tumor. We present an extremely rare case of multicentric granular cell tumor of the skin and heart, manifested over a 23-year period.

Adult↗
PubMed1988

Triglyceride lowering effect of MaxEPA fish lipid concentrate: a multicentre placebo controlled double blind study.

A multicentre, double blind, randomised between-group study comparing the triglyceride lowering effect of MaxEPA, a natural marine oil, and a placebo control is described. Eighty-six patients with hypertriglyceridaemia (fasting serum triglyceride greater than or equal to 2 mmol/l) were studied for three months. There were no significant differences between the groups (48 active, 38 control) in respect of age, sex, height or weight, smoking habits or alcohol consumption. After one month triglyceride levels were reduced significantly from baseline in the treatment group and there was also a highly significant difference between the groups in favour of the marine oil. There was no significant change in serum total cholesterol in either group but there were fluctuations in high density lipoprotein (HDL) in both groups. Minor gastrointestinal side effects were reported by patients in both groups. Standard haematological and biochemical tests were done and there were no significant changes from baseline.

Adolescent↗
PubMed1978

Use of intra- and extra-amniotic prostaglandins for the termination of pregnancies--report of multicentric trial in India.

The Indian Council of Medical Research initiated a multicentric trial with prostaglandins in 1976 to assess the safety and efficacy of their use in midtrimester abortions. PGF2 alpha and 15-Me-PGF2 alpha were compared using the intra-amniotic (I.A.) route. 15-Me-PGF2 alpha was also evaluated by extra-amniotic (E.A.) route. With intra-amniotic instillation, success rate was 88.1 per cent with PGF2 alpha and 93.0 per cent with 15-Me-PGF2 alpha within 48 hours and by the extra-amniotic route it was 78.1 per cent within 36 hours. The mean induction-abortion interval was 19 hours with I.A. and 14.8 hours with E.A. Abortions were complete in 48.8 per cent of the women following I.A. PGF2 alpha, 56.0 per cent following I.A. 15-Me-PGF2 alpha and only 23.0 per cent following E.A. administration. Vomiting and diarrhoea were the most commonly reported side effects. Cervical injuries were 4.7 per cent with I.A. PGF2 alpha, 1.4 per cent with I.A. 15-Me-PGF2 alpha and only 0.6 per cent with E.A. route.

Abortifacient Agents↗
PubMed1982

Two oral contraceptives, efficacy, serum proteins, and lipid metabolism. A comparative multicentre study on a triphasic and a fixed dose combination.

A triphasic, combined oral contraceptive containing 30 - 40 - 30 micrograms ethinyloestradiol (EE), and 50 - 75 - 125 micrograms levonorgestrel was compared with a fixed dose combination containing 30 micrograms EE and 150 micrograms desogestrel in a randomized multicentre trial in 193/199 women and 1 063/1 073 cycles, respectively. The duration of the trial was six months. Eleven centres in Denmark, Sweden, and Norway participated. Contraceptive reliability, bleeding control and side effects were evaluated. Influence on serum sex hormone binding globulin (SHBG) and transcortin was assayed as well as lipid metabolism. Three pregnancies occurred in the group using the triphasic regimen but none in the fixed dose regimen. Two of the three pregnancies were considered drug failures and the third a possible interaction. Possible reasons for the triphasic contraceptive failure are discussed with special reference to a British report on eight pregnancies. Bleeding control appeared to be equally good for the two preparations. However, the number of cycles with spotting, breakthrough bleeding and missed withdrawal bleeding were above the levels reported earlier on the triphasic regimen. About 80 per cent of the women completed the planned six months on either combination. Side effects were generally mild and in accordance with earlier reports on low dose oral contraceptives. Metabolically the triphasic levonorgestrel combination increased SHBG 100 per cent versus 200 per cent for the fixed desogestrel combination. Transcortin rose about 98 and 110 per cent, respectively. Both preparations induced similar changes in the levels of lipids and lipoproteins with the exception of a significant increase in the arachidonic content of cholesterol during treatment with the desogestrel-containing preparation.

Adolescent↗
PubMed1982

Interval iud insertion in parous women: a randomized multicentre comparative trial of the Lippes Loop D, TCu220c and the Copper 7.

A multicentre randomized clinical trial of the TCu220C, Lippes Loop D and Copper 7 was undertaken in nine WHO Collaborating centres for Clinical Research in Human Reproduction. A total of 984, 992 and 994 devices, respectively, were inserted between 1976 and 1978. The subjects were followed for two years. At this time 18,743, 17,013 and 17,927 woman-months experience had been accumulated with each device, respectively. The Lippes Loop consistently failed to perform as well as the TCu220C regardless of age or parity. The TCu220C had statistically significantly lower pregnancy rates at one and two years of use than either of the other two devices as well as lower expulsion rates. The TCu220C had lower removal rates at one and two years than the Lippes Loop and Copper 7. At one and two years the TCu220C had significantly higher continuation rates than the other two devices. It is concluded that the TCu220C is the device of choice amongst the three devices studied.

Adult↗
PubMed1987

Clinical performance of copper-T-200, multiload-250 and Nova-T: A comparative multicentre study.

A randomized multicentre study of Copper-T-200 (CuT), Multiload-250 (ML) and Nova-T (NoT) was conducted to evaluate the clinical performance of these three IUDs in the hands of general practitioners with varying experience in the different insertion techniques. After 36 months of use a total of 19,821 treatment cycles was accumulated. The continuation rate was 69.7% for CuT, 60.9% for ML and 61.8% for NoT. The cumulative expulsion rate after 36 months was 5.0% and equally distributed among centres and types of IUD. Removal for medical reasons was 11.4% and also equally distributed among the centres and the types of IUD. The pregnancy rate was insignificantly higher for the NoT compared with the two other types.

Clinical Trials as Topic↗
PubMed1989

A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns. World Health Organization Task Force on Long-Acting Systemic Agents for Fertility Regulation.

A multicentred Phase III clinical trial was conducted in 12 countries to compare HRP112 (depot-medroxyprogesterone acetate, 25 mg and estradiol cypionate, 5 mg) and HRP102 (norethisterone enantate, 50 mg and estradiol valerate, 5 mg) given every 28 days. Contraceptive efficacy and side-effects of both regimens were reported previously. Their effect on vaginal bleeding patterns is the object of this paper. A total of 2320 women were randomly assigned to each drug and 2000 of them provided a menstrual diary. The comparison of the bleeding patterns is made using a 90-day reference period approach and following the guidelines published by WHO. The analysis failed to identify any major difference in the vaginal bleeding patterns induced by both contraceptive preparations. For both drugs, the first bleeding episode following the first injection occurs early. For 70% of users, this is followed by a regular vaginal bleeding pattern similar to an untreated pattern. Others experience irregular bleeding and a few have either infrequent or frequent bleeding. The extremes of amenorrhea and prolonged bleeding are rare. There are no major trends in vaginal bleeding patterns with prolonged use of either preparation. Women with the worst vaginal bleeding patterns discontinue early in the clinical trial and the last three months of experience have the most influence in their decision to stop using the contraceptive method. The analysis suggests how the life-table analysis of discontinuation reasons underestimates the true incidence of vaginal bleeding irregularities in a clinical trial.

Amenorrhea↗
PubMed1990

Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial. I. Contraceptive efficacy and side effects. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation.

A multicentre clinical trial, including 19 centres in 13 countries, assessed the contraceptive efficacy and clinical acceptability of a Silastic 382 vaginal ring releasing 20 micrograms of levonorgestrel for at least 90 days. A total of 1005 women entered the study and 8176.74 woman-months of experience was gathered. The rate of intrauterine pregnancy at one year of use was 3.6 per 100 women (95% confidence interval 2.2-5.0), and of ectopic pregnancy, 0.2% (one case). The principal reasons for discontinuation were menstrual disturbances (17.2% at one year), vaginal symptoms (6.0%) and repeated expulsion of the ring (7.1%). The pregnancy rate with this 20 micrograms levonorgestrel-releasing vaginal ring compares favourably with that of a low estrogen combination oral contraceptive tested by WHO and is less than half that of a progestogen-only oral contraceptive in a WHO randomized study. It is concluded that the WHO intravaginal ring releasing an average of 20 micrograms of levonorgestrel per 24 hours is an effective method of contraception for at least one year of use.

Administration, Intravaginal↗
PubMed1990

Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial. IV. Bleeding patterns. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation.

A multicentred clinical trial was conducted in 12 countries to assess the contraceptive efficacy and side effects of a low-dose levonorgestrel-releasing vaginal ring. Contraceptive efficacy and side effects, expulsions and removals, and the relation between pregnancy rate and admission body weight of the women have been reported previously. The effect of ring use on vaginal bleeding patterns as observed from daily menstrual diaries kept by the women is the object of this paper. A total of 1005 women were fitted with the ring and 702 of them provided a menstrual diary suitable for analysis. The description of the bleeding patterns is made using a 90-day reference period approach and following the guidelines published by WHO. In addition the longest bleeding/spotting episode and longest bleeding/spotting-free interval are calculated over the entire diary length. Half of the ring users have vaginal bleeding patterns similar to normal untreated patterns. A quarter experience irregular bleeding, 10% have prolonged cycles and 10% have shortened cycles. Over one year of continuous use, there appears to be no significant trend in these patterns. Users with the worst bleeding patterns tend to discontinue first during the clinical trial and are influenced by their more recent experience of vaginal bleeding irregularities. Life-table analysis of discontinuation rates gives an underestimation of the true incidence of bleeding irregularities. Some comments are made on the limitations of the methods of analysis of menstrual diaries.

Clinical Trials as Topic↗
PubMed1994

Termination of early pregnancy by two regimens of mifepristone with misoprostol and mifepristone with PG05--a multicentre randomized clinical trial in China.

A multicentre randomized open clinical trial was conducted to compare the efficacy and side effects of two regimens of mifepristone with misoprostol, and mifepristone with PG05 for termination of early pregnancy (amenorrhoea < = 49 days). Six-hundred women in early pregnancy, who requested medical abortion were randomly allocated into 3 groups. In group 1 (n = 301), an initial dose of mifepristone 50 mg was given, followed by 25 mg every 12 hours up to a total dose of 150 mg mifepristone, plus a single oral dose of misoprostol 600 micrograms in the morning of the third day. In group 2 (n = 150), the same regimen of mifepristone was given, but dl-15-methyl PGF2 alpha (PG05) 1 mg vaginal suppository was inserted on the third day. In group 3 (n = 149), a single dose of mifepristone 200 mg was given and misoprostol 600 micrograms was used as in group 1. The complete abortion rate were 94.4%, 97.3%, and 94.6% for group 1, 2 and 3, respectively. 3.0, 2.0 and 2.7% of women had incomplete abortion, and 1.7, 0.7 and 2.0% of women in the 3 groups were treatment failures; in the remaining 1% in group 1 and 0.7% in group 3, treatment outcome could not be determined. There were no significant differences among the 3 groups. Lower abdominal pain was the main complaint which was reported by 82% of the subjects after PGs administration. The incidence of diarrhoea in PG05 group (38.7%) was significantly higher than that in the other two groups (21.6 and 20.1%) (P < 0.001), and so was vomiting. It was concluded that misoprostol, as an orally effective prostaglandin, in combination with mifepristone for induced abortion of early pregnancy was as effective as PG05 vaginal suppository. Besides, it has advantages of convenience of use, less side effects, easy storage and transfer, and low cost.

Abdominal Pain↗