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An international collaborative study on the First International Standard of bovine luteinizing hormone for immunoassay.

An ampouled freeze-dried preparation of bovine pituitary luteinizing hormone (bLH), coded EHC-bLH-1, has been evaluated in an international collaborative study and shown to be suitable and sufficiently stable to serve as a standard for bLH. Eight laboratories provided immunoassay data, one laboratory provided receptor assay data, and bioassay data were obtained from 4 laboratories. The geometric mean potency estimate obtained by immunoassays, expressed as milliunits of the USDA bLH-B-5 preparation per ampoule, was 25.6, which is consistent with the result obtained by in-vivo bioassays. The geometric mean estimate obtained by receptor assays or by in-vitro bioassays was lower, i.e. 13.2 milliunits per ampoule. The reason for this discrepancy is currently under investigation. With the authorization of the Expert Committee on Biological Standardization of the World Health Organization this preparation was established in 1985 as the International Standard for Luteinizing Hormone, Bovine, for Immunoassay with a unitage of 25 mi.u. per ampoule.

Animals↗

International Reference Preparation of human prolactin for immunoassay: definition of the International Unit, report of a collaborative study and comparison of estimates of human prolactin made in various laboratories.

As authorized by the World Health Organization 29th Expert Committee on Biological Standardization, the preparation of human prolactin in ampoules coded 75/504 has been established as the International Reference Preparation (IRP) of human prolactin for immunoassay. From the results of a collaborative study, to which 15 laboratories in nine countries contributed, with the agreement of the participants, the content of each ampoule is defined as 0.650 International Units (i.u.; 650 mi.u.) immunoassay. The results of this collaborative study show that the IRP is adequately stable and suitable for use as a standard for the determination of prolactin in human plasma and serum. Estimates of the prolactin content of human plasma and serum made in the various laboratories have been compared and show good agreement in ranking order, but only fair agreement in the numerical value of the estimates. Numerical agreement is poor between estimates of the human prolactin content of two samples identical except for coding; this shows the difficulty in achieving continuity of estimates when any laboratory calibrates a replacement standard.

Female↗

International collaborative effort (ICE) on birth weight, plurality, perinatal, and infant mortality. III: A method of grouping underlying causes of infant death to aid international comparisons.

Underlying causes of infant death, as coded in the ninth revision of the International Classification of Diseases, have been grouped into a system of seven functional categories plus one additional group of "other and unclassifiable" diagnoses. The groups comprise congenital anomalies, asphyxia related conditions, immaturity related conditions, infections, sudden death, deaths due to external causes, and other specific conditions. The groups were constructed by using a frequency distribution of underlying cause of death in 200,000 infant deaths in 1980-84 in the U.S.A. When analysed according to age at death and according to birth weight, the distribution of the functional groups had patterns which corresponded to what might be expected clinically. Each functional group has common features which require intervention at a specific time for prevention and treatment. We propose that it is used as a tool in epidemiological surveillance and to guide health authorities in priorities for disease control. International comparisons of time trends will be undertaken.

Asphyxia Neonatorum↗

A prospective randomized trial comparing stenting to internal mammary artery grafting for proximal, isolated de novo left anterior coronary artery stenosis: the SIMA trial. Stenting vs Internal Mammary Artery.

OBJECTIVE: To compare coronary artery bypass grafting (CABG) with percutaneous transluminal coronary angioplasty (PTCA) in patients with proximal, isolated de novo left anterior descending coronary artery disease and left ventricular ejection fraction of 45%. PATIENTS AND METHODS: In the multicenter Stenting vs Internal Mammary Artery (SIMA) study, patients were randomly assigned to PTCA and stent implantation or to CABG (using the internal mammary artery). The primary clinical composite end point was event-free survival, including death, myocardial infarction, and the need for additional revascularization. Secondary end points were functional class, antianginal treatment, and quality of life. Analyses were by intention to treat. RESULTS: Of 123 patients who accepted randomization, 59 underwent CABG, and 62 were treated with stent implantation (2 patients were excluded because of protocol violation). At a mean +/- SD follow-up of 2.4+/-0.9 years, a primary end point had occurred in 19 patients (31%) in the stent group and in 4 (7%) in the CABG group (P<.001). This significant difference in clinical outcome is due to a higher incidence of additional revascularization in the stent group, the incidence of death and myocardial infarction being similar (7% vs 7%, respectively; P=.90). The functional class, need for antianginal drug, and quality-of-life assessment showed no significant differences. CONCLUSIONS: Both stent implantation and CABG are safe and highly effective treatments to relieve symptoms in patients with isolated, proximal left anterior descending coronary artery stenosis. Both are associated with a low and comparable incidence of death and myocardial infarction. However, similar to PTCA alone, a percutaneous approach using elective stent placement remains hampered by a higher need for repeated intervention because of restenosis.

Adult↗

National Study of Internal Medicine Manpower: IX. Internal medicine residency and fellowship training: 1984 update.

After 12 years of annual expansion, the number of entrants into internal medicine training did not increase in 1983-84. In addition, the number of United States citizens with medical degrees from other countries entering first-year residency positions in internal medicine declined in 1983-84 for the first time in many years. The number of trainees who, upon completion of residency training, chose to become subspecialty fellows increased, and the period of subspecialty training has lengthened to 3 years for one third of the fellows. The total budgets for residency stipends have not increased in real dollars since 1976-77 despite substantial rises in the number of trainees. In fact, stipend levels per resident and fellow have declined in real dollars. Internists make up about 25% of all practicing physicians. With the continuing growth in the number of practicing internists and the high rate of their subspecialization, some adjustments will be made in practice patterns over the next 2 decades.

Demography↗

National Study of Internal Medicine Manpower: XIII. The financing of internal medicine residency and fellowship training, 1985 to 1986.

Hospital revenue is the most important source for residency and fellowship stipends in internal medicine. Medicare is especially important for residency programs in voluntary hospitals and hospitals not closely affiliated with a medical school. In the last decade state and local government support and federal training grant support for residency stipends declined, whereas Veterans Administration support increased. Fellowship stipend sources are much more diverse; federal training grants, professional fees, foundations, medical school funds, and research grants contribute significantly. Medicare support appears to be focused on subspecialties particularly important to the elderly, including critical care, rheumatology, cardiology, hematology, gastroenterology, and nephrology. Geriatric medicine, however, receives substantial Veterans Administration support. With growing revenue constraints and increasing concerns about excess physicians we need to monitor the impact of government regulations and other factors on funds available for training internal medicine specialists.

Economics, Hospital↗

National study of Internal Medicine Manpower: VIII. Internal medicine residency and fellowship training: 1983 update.

A national census of internal medicine residency and fellowship training programs was done in 1981 and 1982, a continuation of surveys conducted annually since 1976. The number of residents in training continues to rise in relation to the increasing number of U.S. medical school graduates. U.S. citizens who are graduates of foreign medical schools comprise a rising number of the residents, 11.6% of the first-year trainees in 1982-1983. Foreign-born graduates of foreign medical schools have declined in the last 2 years to 9.9% of all first-year trainees. The number of blacks in residency training remains less than 5% of the trainee population. More than half of the residents entered subspecialty fellowship training after the completion of residency training. This finding predicts a continuing increase in the ratio of subspecialty internists to general internists in the practicing internal medicine population. The implications of these results for public policy are discussed.

Education, Medical, Graduate↗

[Myocardial revascularization with arterial conduits: comparison of bilateral internal mammary artery and single internal mammary artery].

The use of bilateral internal mammary artery (BIMA) grafting for myocardial revascularization has been demonstrated to provide long-term benefits compared to revascularization using single left internal mammary artery (SIMA) and venous conduits. However, it is still controversial whether the use of BIMA is associated with a higher hospital mortality and morbidity. The present study retrospectively evaluated the possible advantages related to the use of BIMA at 3-year follow-up and whether the presence of operative risk factors in patients with BIMA could limit the application of the procedure in myocardial revascularization. We compared two groups of 100 patients matched for preoperative clinical characteristics, who underwent myocardial revascularization on the left coronary system with BIMA (93 males and 7 females, mean age 59 +/- 4 years) or with SIMA and venous conduits (86 males and 14 females, mean age 63 +/- 6 years). Hospital mortality rate was 2% in both groups, the use of BIMA being not a significant risk factor for hospital mortality and morbidity. The mean follow-up was 36 +/- 6 months for the BIMA group and 40 +/- 10 months for the SIMA group. At 3 years, there was no significant differences in the actuarial freedom from cardiac death (96 +/- 2% for BIMA vs 94 +/- 2% for SIMA patients), myocardial infarction (98 +/- 2 vs 97 +/- 2%), angina (93 +/- 2 vs 91 +/- 2%), symptomatic heart failure (92 +/- 3 vs 92 +/- 2%), coronary angioplasty/reoperation (96 +/- 2 vs 97 +/- 2% ), and total cardiac events (80 +/- 4 vs 76 +/- 4%). BIMA grafting was not an independent predictor of late cardiac events. In 66 patients who underwent a late angiographic or echo-Doppler study, the patency rate was 100% for the left mammary artery, 94% for the right mammary artery and 69% for venous conduits. In conclusion, myocardial revascularization with BIMA in situ is associated with low hospital mortality and morbidity, good clinical outcome and excellent patency rate at 3 years, with apparently no significant differences when compared to the use of SIMA and venous conduits. The low hospital mortality and morbidity and the satisfactory medium-term results in our opinion justify a more extensive use of BIMA in myocardial revascularization.

Aged↗

International law and human rights: trends concerning international migrants and refugees.

Not with standing human rights linkages, migrants and refugees are often on the periphery of effective international protection. State sovereignty and self-regarding notions of community are used to deny or dilute substantive and procedural guarantees. Recently, even non- discrimination as a fundamental principle has been questioned, as has the system of refugee protection. This article located both migrants and refugees squarely within the human rights context, contrasting both inalienable rights with the demands of sovereignty, and juxtaposing the 2 in a context of existing and developing international standards. Migration and refugee flows will go on, and the developed world, in particular, must address the consequences - legal, humanitarian, socioeconomic, and cultural. Racism and institutional denials of basic rights daily challenge the common interest. This article shows how the law must evolve, responding coherently to contemporary problems, if the structure of rights and freedoms is to be maintained.

Demography↗

[Sournia as president of the International Society for History of Medicine and chairman of the International Congress in Paris].

During the last quarter of the century, Sournia took an active part in the life of the International Society for History of Medicine as he introduced English as a second official language and he modernised some procedures. In 1982 he organized an international congress in Paris about two themes close to his heart: the history of public health and of communication in medical area. So the I.S.H.M. became well known all around the world and Sournia remained a wise advise until his death.

France↗

Evaluation of the International Organization for Standardization-International Dairy Federation (ISO-IDF) draft standard method for detection of Enterobacter sakazakii in powdered infant food formulas.

As a result of the growing recognition of Enterobacter sakazakii as an emergent pathogen, the International Dairy Federation (IDF) and the International Organization for Standardization (ISO) have standardized a reference method for the detection of E. sakazakii in milk powder products and powdered infant food formulas (IFF). The objectives of this study were to assess the applicability of the ISO-IDF draft standard, and to compare several chromogenic selective media for E. sakazakii [ready-to-use ESIATM, homemade E. sakazakii isolation agar, and Druggan-Forsythe-lversen (DFI) agar], and a selective media for Enterobacteriaceae Violet Red Bile Glucose (VRBG). We found that the method is sensitive, selective, and applicable to the analysis of powdered IFF, provided that some modifications are added. In particular, definition of typical colonies on chromogenic media should be less restrictive, and the possibility of using chromogenic media other than ESIA should be introduced. Any of the chromogenic media tested here could be used initially, since their performances were similar. In these media, alpha-glucosidase-positive but non-yellow-pigmented isolates should be also considered. Consequently, the yellow pigmentation test should be abandoned, or completed with another test in order to select colonies to confirm. Although the specificity of VRBG was relatively poor, it could be used as a second nonchromogenic medium.

Bacteriological Techniques↗

International collaborative assay of the international reference preparation of anti-yellow-fever serum.

A yellow fever immune serum was established in 1962 by the WHO Expert Committee on Biological Standardization as the International Reference Preparation of Anti-Yellow-Fever Serum, intended to serve as an immune reference serum in the mouse protection test used in the control of yellow fever vaccines.Before its establishment as the International Reference Preparation, the proposed material was assayed in eleven laboratories in ten countries against a number of other immune and non-immune sera, and was found stable. Neutralization test results were consistent and the relative potency was sufficiently high. This paper not only reports on the collaborative assay, but also discusses errors in the testing method and problems connected with the distribution of mouse deaths during the observation period and with the preparation of dilutions.

Biological Assay↗

[Integration of psychosomatics with internal medicine. A diagnostic and therapeutic strategy for psychosomatic-internal medicine patients].

The high incidence of contributory psychosocial factors in developmental aspects of internal diseases makes it necessary to give up traditional forms of cooperation between internal and psychosomatic medicine, such as consultations, in favour of more intensive cooperation, in the course of which psychosocial aspects would be taken more into account in diagnosis and therapy of all patients in medical wards and clinics. A new method of treatment integrated into the medical department is presented, which favours not only patients, but also team-centered approach. The referral frequency of the new service, the diagnostic distribution and the therapeutic management of the first 270 patients is discussed. Special staff training, the key function of the first interview, the attainable cooperation and pre-selection of referred patients and the importance of the referral talk are emphasized.

Humans↗

Interim report of results from an international collaborative study of the Proposed International Reference Preparation of porcine pancreatic kininogenase.

A collaborative study of the ampouled preparation of porcine pancreatic kininogenase, the Proposed International Reference Preparation (PIRP), was carried out, on behalf of the World Health Organization, by 19 laboratories in seven countries. The PIRP was studied using in vivo bioassays, immunoassays and in vitro enzyme assays involving natural protein substrate and small molecular ester and peptide substrates. An analysis of results obtained from a majority of the participating laboratories is presented. Comparison of the PIRP with the widely used Bayer house standard of porcine pancreatic kininogenase showed general agreement for estimates of relative activity, although differences were detected in some assay systems. The PIRP was shown to be stable and appears to be suitable to serve as an international reference preparation. Comparison of the PIRP with a preparation of highly purified human urinary kininogenase showed a wide diversity of estimates so that no general comparison of activities for these preparations is possible.

Animals↗

[Internal fixation of thoracolumbar, lumbar and lumbosacral spine with internal fixators].

The report is a review of the literature on fully implantable transpedicular fixation device known under the general name internal fixator, and designed for short (one to three segments) internal fixation of the spine in various pathologies. The implants are found in a routine clinical use throughout many European countries and have become more familiar to spine surgeons in the U.S. The authors present a general description of the fixators, indications and contraindications to their implantation, the implantation technique and possibilities of intraoperative reposition of the spine. The advantages of usage of the fixators and the history of their development are presented.

Equipment Design↗

[Emergency admissions to a department of internal medicine. Are departments of internal medicine used optimally, and how would observation units affect the management of the department?].

279 consecutive emergency admissions to our Department of Internal Medicine were reviewed. Admission was appropriate for 58%. These patients consumed 88% of the "ward-days" during the period studied. Of the remaining patients, 22% could have been treated adequately in an observation unit, 10% need not have been hospitalized, and 10% should have been admitted to a different department. All stays in hospital lasting more than 50 days were due to lack of a place in a nursing home. If no patient had to wait more than 50 days, this would release 23% of the total "ward-day" capacity. The pressure on Departments of Internal Medicine could be reduced substantially by establishing observation units, and reducing the waiting time for a place in a nursing home.

Aged↗

Apolipoprotein B and A-I values in 147576 Swedish males and females, standardized according to the World Health Organization-International Federation of Clinical Chemistry First International Reference Materials.

Serum concentrations of apolipoprotein (apo) B and apo A-I were measured from 1985-1996 in a Swedish population sample of 83 112 males and 64 464 females, ages <20 to >80 years, using an automated immunoturbidimetric method calibrated against fresh pools of human serum and commercial calibrators. All values were recalculated in 1997 after calibration against the WHO-IFCC First International Reference Materials. The recalculation factor was 1.059 for apo B, whereas for apo A-I, the correction was: y = 0.989x + 0.101. The total CVs for both apo B and A-I were generally <7%. The mean value (+/- SD) for apo B was 1.31 +/- 0.35 g/L in all males and 1.22 +/- 0.36 g/L in all females. The mean apo A-I concentration was 1.36 +/- 0.22 g/L in males-10% lower than in females (1.51 +/- 0.24 g/L). The mean value of apo B increased up to 60 years of age in males and up to 70 years of age in females. apo A-I concentrations changed only slightly with age in both males and females. apo A-I concentrations among Swedes are nearly identical to those reported recently by two American studies and those obtained in a Finnish population sample. Mean apo B concentrations differ somewhat between the populations but mirror-as expected-differences in total cholesterol concentrations. The highest values were noted in Swedish subjects. The Swedish sample population is, to our knowledge, the largest describing the distribution of apo B and A-I in a general population of adult males and females of all ages determined with procedures standardized and traceable to the WHO-IFCC First International Reference Materials.

Adult↗