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Six healthy males, the EMSInauts, were isolated in hyperbaric chambers for a period of 28 days at 5-msw overpressure. During that period they had to carry out meaningful operational and research tasks in addition to monitoring their psychological and physiological reactions. The actual workload was evaluated and compared with the planned workload, and its effects on symptomatology and psychobiology. The perceived workload and its effects on psychosomatic symptomatology and on some biological indices were monitored. Thus it was possible to evaluate how the workload carried during 4 weeks of isolation affected the psychological and biological well-being of the six EMSInauts. The following three types of assessments were performed: 1. Workload assessment: The objective workload was calculated based on the schedule which was revised daily, and the actual load calculated by the commander. A workload questionnaire was administered daily after each working session. 2. Psychosomatic assessment: Morning and evening questionnaires were administered daily. The state of health and of anxiety were also evaluated. 3. Biological indices: Cortisol, testosterone, adrenalin, and noradrenaline were determined once a week. In addition, cardiac activity was monitored every day. The workload assessment showed that on the average the planned workload was accomplished in slightly less than the scheduled time. The workload was not perceived as severe in terms of cognitive, emotional, and physical load. The group rated the support received from each other and from the mission control personnel as average, with minor changes during the isolation period. They gave a high rating to the amount of control they had over their activities. Fatigue and tension were scored in the middle range. The psychosomatic assessment showed that there were few symptoms, and these were mostly of low severity. The most common symptom was general fatigue. Furthermore, minor dizziness, headache and light tremor was in some cases reported. The sleep quality was good, but complaints about poor sleep increased somewhat with the passing of time. Few and mostly minor health problems were experienced during isolation. Only one EMSInaut had to miss one day of work due to a bout of flu. The state of anxiety was below that of the general population throughout the isolation period. The biological indices used showed no evidence of stress from the workload handled during the isolation period. The level of the "stress hormone" cortisol actually decreased during isolation. The adrenalin excretion, which tends to go up during acute stress, remained unchanged during this period. Neither was there any evidence of changes in cardiac activity throughout the isolation period.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:European isolation and confinement study. Workload and stress: effects on psychosomatic and psychobiological reaction patterns. 816 54

The frequency and intensity of undesirable side effects after protective vaccination against influenza with a commercially available vaccine were studied. 82 gainfully employed persons of both sexes were questioned in respect of local reactions such as weal and flare reactions, itching, sensation of heat, tenderness on pressure, and impeded movement, as well as systemic reactions e.g. elevated temperature or fever, profound sweating, headache, malaise, and insomnia. In 61 of 82 questioned persons local reactions occurred within 24 hours after vaccination, mainly weal and flare reactions and tenderness on pressure. 10 persons had systemic reactions, chiefly headache and fever, 39 of the questioned persons who reported on undesirable effects considered these impairments to be slight, whereas 28 of the group did not feel that the impairments disturbed or upset them in any way.
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PMID:[Tolerance of preventive influenza vaccination with a subunit vaccine]. 828 99

Interleukin 3 (IL-3) is a multipotent hematopoietic growth factor which became available as a recombinant (rh) growth factor for use in the clinic a few years ago. In dose-finding studies, this hematopoietic growth factor has been evaluated without and after standard chemotherapy. Stimulatory effects on leukocytes, neutrophils, eosinophils, monocytes, reticulocytes and platelets were observed in some studies. Chemotherapy postponement due to insufficient bone marrow recovery was less frequent when IL-3 was administered. There are some clinical studies available in which rhIL-3 is combined with rh granulocyte-macrophage colony-stimulating factor (GM-CSF). The results do not clearly suggest superiority of these combinations over rhGM-CSF alone, but this may be partly due to the time scheduling of the growth factors. Administration s.c. is not inferior to i.v. Side effects mainly consist of flu-like symptoms and headache. The role of rhIL-3 after high-dose chemotherapy and autologous bone marrow reinfusion is still questionable. The addition of rhIL-3 to rhGM-CSF both administered after chemotherapy may allow a very high yield of peripheral stem cells suitable for bone marrow reconstitution after high-dose chemotherapy. rhIL-3 can stimulate leukemia tumor cell proliferation in vitro as well as proliferation of solid tumor cell lines. It is not yet clear in which way rhIL-3 combined with chemotherapy will effect tumor response and patient survival. It is too early to define the exact place of rhIL-3 in oncology. Additional studies with rhIL-3 alone and in combination with other growth factors are needed.
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PMID:Recombinant human interleukin 3 in clinical oncology. 845 87

Normal volunteers received single doses of recombinant human interleukin-10 (rhIL-10; n = 6 per group) or placebo (n = 3 per group) by intravenous injection to characterize pharmacokinetics, tolerability, and immunomodulatory effects. Dosages were 0.1, 0.5, 1.0, 2.5, 5.0, 10.0, 25.0, 50.0, and 100.0 micrograms/kg. Dose-related adverse effects consisted of a mild-to-moderate flu-like syndrome characterized by fever with chills, headache, and myalgias at the highest dose. The mean terminal phase t1/2 ranged from 2.3 +/- 0.5 to 3.7 +/- 0.8 hours. Dose-related effects of rhIL-10 included transient increases of circulating neutrophils and monocytes and decreases of lymphocytes. rhIL-10 markedly suppressed, in a time- and dose-dependent manner, the synthesis of the inflammatory cytokines IL-1 beta and tumor necrosis factor alpha by whole blood stimulated ex vivo with bacterial lipopolysaccharide. Circulating numbers of CD14+/HLA-DR+ cells at 24 hours after the dose were increased in a dose-dependent manner. Effects on expression of HLA-DR by CD14+ cells were variable. There was no apparent effect on HLA-DR expression by CD20+ cells. The immunomodulatory effects of rhIL-10 merit further clinical investigation.
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PMID:Pharmacokinetics and immunomodulatory properties of intravenously administered recombinant human interleukin-10 in healthy volunteers. 855 93

Massage and Acupression have a history of many years of use by the Vietnamese people in the treatment of diseases, and they can give wonderful therapeutic effects in painful syndromes and chronic diseases, etc. On the other hand, some methods of Chrono-Acupuncture based on chronobiological theory and the holistic concept of traditional medicine are studied and applied in clinical applications. This paper presents the therapy advice system based on Chrono-Massage and Acupression using the method of ZiWuLiuZhu called CHROMASSI. The system includes four major parts. Massage and Acupression Teaching: This part can provide the user with some background in Massage and Acupression theory such as the pathology of the meridians, the classification of points and their function, the therapeutic properties of points, the methods of Massage and Acupression (including Pression, Friction, Rubbing, Light Massage, Petrissage, Rolling and Rubbing, Percussion and Vibration), and the direction of the meridians circulation, displaying AcuPoints represented by color pictures of the 12 main meridians and 2 vessels. More than 330 popular AcuPoints are used in the system. Open AcuPoint Calculating: This module can help us to calculate open AcuPoints based on data about days, months, years and hours using the special method of ZiWuLiuZhu. The Points adopted by ZiWuLiuZhu are the Five Shu Points and Source Points including 66 points (all of them are located below the elbows and knees). The effectiveness of these points becomes particularly evident when they are needled or punctured at optimum time intervals. For example, at 9:00 a.m., September 22, 1994, the open Points by the ZiWuLiuZhu method will be the points K2 (Nhien Coc) and K10 (Am Coc). According to the chronotherapeutic method, first we have to pressure (or puncture) the above points in order to attain the sensation RDac KhiS (arrival of energy), then pressure the other treating points as in ordinary Massage and Acupression. Therapy Consultation: Knowledge of the system was provided by Prof. Nguyen Van Thang and Doctor Nguyen Nhu Oanh at the Vietnam National Institute of Oriental Medicine. CHROMASSI is able to advise on ways to treat about 153 diseases and symptoms in the following fields: Aches and Pains, Insomnia, Common Cold and Influenza, Sexual Disturbances, Medical Aesthetics in Face, Breast and Buttock, Hygiene, Cardio-Vascular Tract, Digestive Tract, Urinary Tract, Respiratory Tract, Genital Tract, Ear-Nose-Throat Tract, Nervous Tract. The system can provide information about Remarks, Acupoints formulas for treating by Massage and Acupression with colour pictures of meridians. Explanation: The CHROMASSI system can explain why the AcuPoints are used for treating diseases based on the theoretical bases of traditional Vietnamese medicine and on the meridians and collaterals system theory. The colour pictures representing the circulation of vital energy in the meridians are used for explanation. The CHROMASSI system was developed in TURBO-PROLOG and TURBO-PASCAL and can run on IBM PC/AT computers and compatibles. The system can be used for teaching and for clinics of Massage and Acupression combined with Chronotherapeutics. At present the system is used by some physicians for clinical applications. The first results indicate that, in 20 cases of generalized headache compared with the control group, the combining of chronoacupression using the ZiWuLiuZhu method and ordinary Massage and Acupression gave better effects than that obtained by either method alone.
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PMID:CHROMASSI: a therapy advice system based on chrono-massage and acupression using the method of ZiWuLiuZhu. 859 9

To determine which patients are prone to side effects from interferon beta-1b and which side effects are most troublesome, we studied 72 patients with clinically definite MS who were started on interferon beta-1b after its release and found that the side effects significantly associated with treatment included skin reactions, flu-like symptoms, fatigue, leukopenia, new or worsened depression, and new or worsened headache. Of these, only fatigue and depression were significantly associated with discontinuance of therapy. Moreover, the course of disease before initiation of treatment also had a significant impact on the likelihood of discontinuing medication. Thus, despite an apparently similar therapeutic benefit (as judged by the similarly reduced attack rate in each group), patients with a secondary chronic progressive course were more likely to discontinue treatment (63%) than patients with either a relapsing/progressive course (18%) or a remitting/relapsing course (7%). Indeed, in the final regression equation, the only factors significantly related (r = 0.875) to the discontinuance of therapy were fatigue (p < 0.0001), a fatigue-depression interaction (p < 0.0001), and a chronic progressive course of disease (p<0.0001). Thus, if future clinical trials are to provide useful information on the value of interferon beta-1b in progressive MS, the side effects of fatigue and depression will need to be ameliorated to limit the drop-out rate from such trials.
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PMID:Side effect profile of interferon beta-1b in MS: results of an open label trial. 861 31

A number of cytokines are used as haemopoietic growth factors and this review focuses on toxicities associated with granulocyte-macrophage colony-stimulating factor (GM-CSF), granulocyte colony-stimulating factor (G-CSF), interleukin (IL)-1, IL-3, IL-4, IL-6 and macrophage colony-stimulating factor (M-CSF). Both GM-CSF and G-CSF, currently approved for clinical use, are generally well tolerated by the majority of patients during short term administration. Constitutional symptoms and bone pain are the most frequently reported adverse effects, but they are rarely treatment-limiting. Reactivation of rheumatoid symptoms, and exacerbation of autoimmune thyroiditis or autoimmune haematological disorders have sometimes been described. Severe cardiovascular complications include the possibility for arterial thromboses and the vascular leak syndrome, which is more specifically observed with GM-CSF. Reports of several cases and small series of patients have suggested that growth factors might increase the pulmonary toxicity of chemotherapy, a possibility that remains debated and requires further attention. Generalised or local cutaneous reactions are frequently noted with GM-CSF. Leukocytoclastic vasculitis was observed with both growth factors, while neutrophilic dermatoses have been mostly described with G-CSF. Exacerbation of psoriasis and isolated anaphylactic reactions have appeared with GM-CSF and G-CSF. The hepatotoxic potential of the growth factors is not clearly established, but the occurrence of coagulation abnormalities has recently been reported. Renal and biological disturbances are usually transient. Long term treatment with GM-CSF and G-CSF also seems to be well tolerated, but the possible occurrence of several adverse events, i.e. bone disorders, leukaemia, unmasking or acceleration of underlying disease, require further investigation in patients receiving prolonged treatment, as in myelodysplasia. Finally, antibodies against growth factors have been reported only with GM-CSF. Other cytokines are still under investigation. Flu-like and constitutional symptoms, sometimes dose-limiting, have been reported with IL-1, IL-3, IL-4 and IL-6, while M-CSF was occasionally associated with such adverse effects. More specific adverse events, also frequently considered as dose-limiting toxicities, include hypotension with IL-1, severe headache or skin rash with IL-3, and nasal congestion and gastroduodenal lesions with IL-4. Severe capillary leak syndrome has been reported only with IL-4. M-CSF toxicity is minimal and limited to reversible but sometimes dose-limiting thrombocytopenia and ophthalmological symptoms with the recombinant product. Again, the safety of long term administration of these cytokines has not yet been determined, and IL-3-induced disease progression in myelodysplastic patients has been suggested.
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PMID:Clinical toxicity of cytokines used as haemopoietic growth factors. 865 81

This double-blind study was conducted to investigate the efficacy, safety and tolerability of three dose levels of moexipril in comparison to placebo as add-on therapy to hydrochlorothiazide (HCTZ) in patients with moderate to severe hypertension. Two hundred patients who did not respond adequately to a 4-week monotherapy with HCTZ-sitting diastolic blood pressure between 95 and 114 mm Hg- entered the 8-week double-blind period. Patients were randomized to once daily placebo or moexipril 3.75, 7.5 or 15 mg as add-on therapy to open-label HCTZ 25 mg. At biweekly visits, blood pressure and heart rate measurements were obtained and the occurrence of adverse experiences was documented. At the 8-week endpoint, adjusted mean reductions from baseline were significantly (p = 0.003) greater in patients receiving moexipril 3.75, 7.5 and 15 mg compared to placebo (-8.4, -8.8 and -8.9 vs. -4.6 mm Hg). No significant differences between the three dose levels of moexipril could be observed. Moexipril was generally well tolerated. The most frequently reported adverse events for moexipril and placebo were headache, flu syndrome and dizziness (6, 7, 5 vs. 4, 0, 4%). The results indicate that the combination of moexipril and HCTZ is a clinically valuable combination in the treatment of patients with moderate to severe hypertension.
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PMID:Moexipril as add-on therapy to hydrochlorothiazide in moderate to severe hypertension. 879 66

Influenza is an epidemic respiratory illness caused by one of three viral subtypes: A, B, or C. Influenza A causes higher mortality than influenza B and C and is often responsible for pandemics and yearly epidemics of this common, infectious disease. Clinically, patients with influenza present with an abrupt onset of fever, malaise, headache, and a dry, hoarse cough. These symptoms usually last three to five days. Amantadine and rimantadine may be used to prevent and to treat influenza A infection, but not B or C. Ribavirin, however, may be effective treatment for severe influenza pneumonia caused by either A or B subtype, although it is not FDA approved for this application. Annual influenza vaccination should be administered between mid-October and mid-November to any person at increased risk for complications. Health-care workers, those in close contact with high-risk individuals, and personnel vital to community function should also be immunized.
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PMID:Influenza. More than mom and chicken soup. 884 75

An outbreak of diarrhea due to infection with Cryptosporidium occurred among the staff members and customers who visited one of the 10 public houses or a dancing school in a building in Hiratsuka, Kanagawa Prefecture, at the end of summer in 1994. The epidemiological surveys by a questionnaire revealed that 461 out of 736 persons investigated complained of cholera-like or flu-like illness. The clinical manifestations included mucous and/or watery diarrhea (96.7%), abdominal pain (61.6%), fever (54.2%: lower than 39 degrees C = 84.1%, higher than 39 degrees C = 15.9%), malaise (37.1%), nausea (32.8%) and headache (29.3%). The polluted drinking water was strongly suspected to be the immediate cause of infection. Although several species of pathogenic bacteria were isolated both from stool and water samples, they were not supposed to be linked to the outbreak. No known enteropathogenic virus was found in either of the samples. Oocysts of Cryptosporidium parvum were identified in 12 (48.0%) of the 25 stool samples. The oocysts were also found in tap water and other water samples from a receiving tank which was directly connected with the public waterworks, and an elevated tank on the roof, a wastewater pits, a soil pit and artesianspring water tank. These tanks and pits except for the elevated tank were built adjucent to each other on an underground floor of the building. These tanks and pits were connected with openings in the upperpart of the tank walls. These openings might have functioned to discharge excess of drinking water in the receiving tank to the wastewater pit. The water level of the wastewater pit is kept down below the openings by pumping out the sanitary sewage to the public drain. According to the declaration of the owner of the building, however, the wastewater pump was broken at the time of outbreak. Accidental malfunction of the drainage system caused contamination of drinking water with sanitary sewage through the connecting pipes.
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PMID:[An outbreak of waterborne Cryptosporidiosis in Kanagawa, Japan]. 885 85


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