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PubMed2002

Retarding fluoride accumulation in Amaranthes viridis through liming and implications of phosphorous treatment.

With an objective to retard fluoride being taken up by the plants from soil, a study was carried out on Amaranthes viridis. Four groups of treatment were carried out vis-à-vis fluoride alone, fluoride and calcium, fluoride and phosphorous and fluoride, calcium and phosphorous together at three different concentration levels vis-à-vis 1, 10 and 25 mg/kg soil of each. Sampling was carried out first on day 45 and at the end of reproductive phase on leaf and seed for accumulation of fluoride in the plants. It was observed that fluoride accumulation in plants could be averted through soil amendment by calcium treatment in the form of calcium carbonate thereby reducing the risk of human and livestock exposure to abnormal levels of fluoride through food chain other than protecting plants from getting affected. At the same time, fertilizing the soil contaminated with fluoride by superphosphate would aggravate fluoride accumulation and exacerbate fluorosis problem in human and livestock through food chain. Therefore it is recommended to use acid water-soluble orthophosphate or anhydrous dicalcium phosphate or soluble pyrophosphate fertilizers as an alternative.

Amaranthaceae↗
PubMed2003

Contraceptive efficacy of a depot progestin and androgen combination in men.

WHO studies provided proof of concept for hormonal male contraception using a prototype androgen-alone regimen. Combined testosterone plus progestin regimens offer more practical promise, but no contraceptive efficacy studies have been completed. The objective of this study was to establish the proof of principle for depot hormonal androgen/progestin combination as a male contraceptive. We performed a contraceptive efficacy study of 55 healthy men in stable fertile relationships seeking a change in contraceptive method. Testosterone (four 200-mg implants, every 4 or 6 months) and 300 mg depot medroxyprogesterone acetate, im, every 3 months were administered. Once sperm output was suppressed (<1 million/ml for 2 consecutive months), men entered a 12-month contraceptive efficacy period, ceasing other contraception. The main outcome measure was contraceptive failure (pregnancy) rate. No pregnancies occurred in 426 person-months (35.5 person-years; 95% confidence limits for contraceptive failure rate, 0-8%/annum), superior to the first year failure rate of condoms, the only reversible male method. Sperm density fell rapidly, so 94% of men entered the efficacy phase by 3 months, with only 2 of 55 (3.6%) men not sufficiently suppressed to enter efficacy. A few men treated with testosterone implants at 6-month intervals demonstrated androgen deficiency symptoms and/or escape of gonadotropin and spermatogenic suppression between months 5 and 6; after a protocol amendment, all men receiving testosterone implants at 4-month intervals avoided androgen deficiency or loss of gonadotropin and sperm output suppression. Recovery was complete (median, 3.6 months to sperm reappearance and 5.0 months to 20 million sperm/ml) in all but one man with an incidental testicular disorder. Discontinuations were for protocol-related reasons (n = 15) or altered personal circumstances (n = 12), but there were no serious adverse effects related to drug exposure. The first male contraceptive efficacy study using a prototype depot androgen/progestin combination demonstrates high contraceptive efficacy with satisfactory short-term safety and recovery of spermatogenesis. Further studies of purpose-developed products are required to extend the overall safety and efficacy experience with depot androgen/progestin combinations, the most promising approach to hormonal male contraception.

Adolescent↗
PubMed2005

The reliability and validity of the therapeutic activity index.

PURPOSE: To assess the psychometric properties of the Simplified Therapeutic Intervention Scoring System (TISS 28) scale. MATERIALS AND METHODS: A prospective observational design was used. Patients were recruited from a medical-surgical intensive care unit (ICU) and 4 rehabilitation wards of 2 university-affiliated hospitals in Hong Kong. RESULTS: Data necessary for the calculation of the TISS 28, the Therapeutic Intervention Scoring System (TISS 76), and severity of illness scoring system (Simplified Acute Physiology Score [SAPS II]) were recorded for each patient during the first 24 hours after his/her admission to an ICU. A significant positive correlation was found between the TISS 76 and the TISS 28 scores as well as the TISS 28 and the SAPS II scores. There was a significant difference between the TISS 28 scores among ICU patients and patients in rehabilitation wards. A significant correlation was found between the TISS 28 scores of the first and second set of TISS 28 scores. CONCLUSIONS: Although the findings supported the validity and reliability of the TISS 28, there were limitations of the TISS 28 in measuring nursing workload in ICUs. Hence, continued amendment and validation of the TISS 28 on larger samples in different ICUs would be required so as to provide clinical nurses with a valid and reliable assessment of nursing workload.

Adolescent↗
PubMed1994

Hand, eye, and head coordination while pointing to perturbed targets.

Normal human subjects were required to manually point to small visual targets that suddenly changed location upon finger movement initiation. They pointed either as fast or as accurately as possible. Movements of the eyes were measured by electrooculography, and the movements of the unrestrained limb and head were monitored by an optoelectric system (WATSMART), which allowed for the analysis of kinematic parameters in three-dimensional space. The temporal and kinematic reorganization of each body part in response to the target perturbations were variable, which indicated independent control for each part of the system. That is, the timing and nature of the reorganization varied for each body part. In addition, the pattern of reorganization depended upon the speed and accuracy demands of the movement task. As well, the movement termination patterns (eyes finished first, the finger reached the target, then the head stopped moving) were extremely consistent, indicating that movement termination may be a controlled variable. Finally, no evidence was found to suggest that visual information was used to amend arm movements early (before peak velocity) in the trajectory.

Journal Article↗
PubMedDate not supplied

Nitrogen, phosphorus, and potassium uptake by wheat and their distribution in soil following successive, annual compost applications.

The overall objective of the present study was to determine the loading limits of composts that should be applied annually to irrigated wheat. We conducted a container experiment in a greenhouse during four years. It included eight treatments: sewage sludge compost (SSC) and cattle manure compost (CMC), each applied annually to a sandy soil, at rates equivalent to 3, 6, and 12 kg m(-2), and two controls, one fertilized and one unfertilized. Total dry matter (DM), grain production, and the amount of N, P, and K taken up by plants increased with increasing compost rate. Nitrogen uptake by the plants of the fertilized control was much higher than by the plants of the highest compost rate. Phosphorus and K uptake by the plants amended with the highest compost rate was much higher than by the fertilized control plants. Inorganic N quantity in the soil increased with increasing compost rate and with successive applications. The net N mineralization during the first year of wheat growth was very low, less than 3.5% of the applied organic N under all compost application rates. The contribution of the organic N mineralization increased during the second and third years. Most of the N increase in the compost treatment was found in the upper layer of 0 to 15 cm, whereas in the fertilized treatment N accumulated from the surface to the bottom of the container, 0 to 55 cm. The successive application of high rates of composts resulted in P and K accumulation in the soil profile.

Agriculture↗
PubMed1989

Postrecovery experience of disabled-worker beneficiaries.

This study followed a 1972 cohort of newly entitled beneficiaries from January 1, 1981, when they left the Disability Insurance program because of a recovery, to June 1986. This recovery group represents about 11 percent of the cohort of disabled-worker beneficiaries entitled in 1972. Three outcomes or next events were of specific interest: Return to the DI program, death, and attaining age 62 (considered retirement for the purposes of this study). The tendency toward reentitlement and the tendency toward death were modeled and then combined with retirement age to project the percentages of recovered beneficiaries who end the postrecovery period by reentitlement, death, or retirement. About 43 percent of these recovered beneficiaries are expected to become reentitled some time after leaving the program, and 52 percent are expected to reach retirement age before dying or becoming reentitled. Of the 43 percent projected too return to the program, 23 percent are expected to become reentitled within the first 5 years of recovery. The tendency to return to the DI program drops sharply at the fifth year of the postrecovery period. There may be program-based reasons for this pattern. The Social Security Amendments of 1980 may provide incentives to return to the DI program within 5 years. When covariates were examined, the covariate PIA had a strong effect on the reentitlement tendency. For those in the high PIA group ($500 or more), it is projected that 65 percent will return to the DI program. This projection is considerably higher than the 34 percent projection for those in the low PIA group (less than $500). Projected median time to reentitlement is quite different for the two PIA groups. The median time to reentitlement is 10 years for the low PIA group and only 3 years for the high PIA group. The PIA was also important in modeling the death tendency as the next event in the postrecovery period. For those in the low PIA group, death is the next event projected for 3 percent of the individuals; in the high PIA group, the projected proportion is 11 percent. It is suspected that the PIA may be acting as a proxy for the severity of the disabling condition, but this hypothesis cannot be tested with the available data. These descriptions of the reentitlement and death tendencies and the project percentages provide a global picture of the DI program reentitlement process. Further research will continue by comparing this pre-1980's cohort with a later cohort and studying the causal mechanisms underlying the recovery and reentitlement processes.

Adult↗
PubMedDate not supplied

[Post-traumatic stress disorder].

A traumatic experience outside the scope of the usual human experience (flood, earthquake, industrial disaster, fire, road accident, death camp, torture and bombing) results in a certain number of people in a traumatic disorder which was described for the first time in 1980. The third edition of the Diagnostic and Statistical Manual (DSM-III) of mental illnesses published by the American Psychiatric Society gave a definition of post-traumatic stress disorder which was amended in 1987 in the revised edition of the same manual. The same definition has been accepted by the International Classification of Diseases and Causes of Death (ICD-10). The disorder is observed in 30-80% of the survivors of catastrophic events, in 18-54% of the war veterans, in 17-67% of the prisoners of war, and the prevalence in the course of life is 9.2%. The symptoms include reliving the experience of the traumatic event, avoidance of stimuli related to the trauma, generally dulled reactions and a lack of alertness. PTSD etiology comprises the following: stressor (strength, duration and circumstances of occurrence), personality (age, personality traits, previous experience, genetic predisposition, and available social support) and organic factors (effects of autonomic nervous system and neurobiological changes in the brain). The etiology of the understanding of the disorder is supported by the psychoanalytical theories (primary and secondary gain, anxiety neurosis and conflict neurosis) together with the behavioural cognitive theories based on conditioning and the theory of learning.(ABSTRACT TRUNCATED AT 250 WORDS)

Humans↗
PubMed2000

Phase I trial of paclitaxel and etoposide for recurrent ovarian carcinoma: a Gynecologic Oncology Group Study.

A phase I study was performed to determine the maximum tolerated doses of intravenous etoposide and paclitaxel for women with previously treated persistent or recurrent ovarian cancer. Starting doses were paclitaxel 135 mg/m2 during 24 hours and etoposide 50 mg/m2/day for 3 consecutive days. The study was designed to escalate first the dose of etoposide, and then the dose of paclitaxel, in successive cohorts of patients. In an attempt to determine whether toxicity was affected by sequence of the drugs, the order of administration of the two drugs was reversed on alternate cycles. The starting doses of paclitaxel (135 mg/m2/24 hours) and etoposide (50 mg/m2/day x 3) caused severe neutropenia even with the addition of granulocyte colony-stimulating factor, and the trial was amended to administer the paclitaxel during 3 hours. However, this also proved too myelosuppressive without growth factor support. Twenty-one women were treated. A complete response was observed in one of nine patients with measurable disease, and a major decrease in CA-125 was noted in two patients who did not have measurable disease. Because of the severe myelosuppression observed in most patients, dose reduction was often required after the first cycle. The power to detect sequence-dependent variation in toxicity was minimal; however, no large differences were observed. A combination of the usual doses of these drugs will be difficult to administer in patients who have received previous chemotherapy for ovarian cancer.

Adult↗
PubMed2003

Phase I study with pharmacokinetics of S-1 on an oral daily schedule for 28 days in patients with solid tumors.

PURPOSE: Our purpose in the study was to determine the maximum tolerated dose and dose-limiting toxicity and investigate the clinical pharmacology of S-1, a combination of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), and potassium oxonate. EXPERIMENTAL DESIGN: Eligible patients had advanced solid tumors, adequate organ function, and no anticancer therapy in the preceding 4 weeks. Dose level 1 was 30 mg/m(2)/dose, level 2 was 40 mg/m(2)/dose, and level 3 was 35 allmg/m(2)/dose, all of the levels comprising two daily doses. S-1 was administered as a single dose at each level, and its pharmacology was studied. The first course was begun 3 days later and consisted of 28 consecutive treatment days, followed by a 1-week rest. RESULTS: Sixteen patients were enrolled; toxicity could be assessed in all of the 16 and response in 15. At dose level 1, two of nine patients developed grade 3 hyperbilirubinemia or diarrhea. Dose-limiting toxicity (diarrhea) occurred in all three of the patients at dose level 2. The protocol was, therefore, amended to include an intermediate dose level (level 3), which caused grade 3 or 4 diarrhea or hyperbilirubinemia in three of four patients. Dose level 1 was thus considered as the maximum tolerated dose. Other grade 3 or 4 toxic effects at dose level 2 or 3 were granulocytopenia, nausea, and vomiting. The pharmacology of tegafur, CDHP, potassium oxonate, and fluorouracil (a metabolite of tegafur) was characterized by rapid absorption and was consistent with first-order kinetics. One patient with colorectal cancer had a durable partial response. CONCLUSIONS: The recommended S-1 dose for future studies is 30 mg/m(2) twice daily, and diarrhea is the most frequent toxic effect. Additional trials of S-1 in the treatment of patients with solid tumors are warranted.

Adult↗
PubMed2006

A field trial for an ex-situ bioremediation of a drilling mud-polluted site.

The remediation of drilling mud-polluted sites in the Southeast of Mexico is a top priority for Mexican oil industry. The objective of this work was to find a technology to remediate these sites. A field trial was performed by composting in biopiles, where four 1ton soil-biopiles were established, one treatment in triplicate and one unamended biopile. Amended biopiles were added with nutrients to get a C/N/P ratio of 100/3/0.5 plus a bulking agent (straw) at a soil/straw ratio of 97/3. Moisture content was maintained around 30-35%. Results showed that, after 180 d, total petroleum hydrocarbon (TPH) concentrations decreased from 99300+/-23000mgTPHkg(-1) soil to 5500+/-770mgTPHkg(-1) for amended biopiles and to 22900+/-7800mgTPHkg(-1) for unamended biopile. An undisturbed soil control showed no change in TPH concentrations. Gas chromatographic analysis showed residual alkyl dibenzothiophene type compounds. Highest bacterial counts were observed during the first 30 d which correlated with highest TPH removal, whereas fungal count increased at the end of the experimentation period. Results suggested an important role of the straw, nutrient addition and water content in stimulating aerobic microbial activity and thus hydrocarbon removal. This finding opens an opportunity to remediate old polluted sites with recalcitrant and high TPH concentration.

Bacteria, Aerobic↗
PubMed2001

Prevalence, characteristics and clinical implications of regular atrial tachyarrhythmias in patients with atrial fibrillation: insights from a study using a new implantable device.

OBJECTIVES: This study prospectively analyzed atrial tachyarrhythmia (AT) organization and antitachycardia pacing (ATP) success in patients with an implanted device for AT therapy. BACKGROUND: In patients with atrial fibrillation (AF), the incidence of regular, slow ATs amendable by ATP is unknown. METHODS: Forty patients with previously documented AT (70% with AF) received a new pacemaker with atrial electrogram (AEG) storage and atrial ATP capabilities for standard pacing indications. The AEGs acquired during the first month (study phase 1) were classified into high (type I), intermediate (type II) and low (type III) degrees of organization. Atrial ATP was then activated, and treated AT episodes were retrieved three and six months after implantation (study phase 2). RESULTS: Of 824 AEGs retrieved before ATP activation (study phase 1), 351 (43%) were classified as type 1, 47% as type II and 10% as type III. Episodes of AT starting as type I (35%) and type II or III (65%) maintained their type over 1 min in 73%. All patients with an exclusive history of AF also showed type I AEGs. In 361 subsequently treated AT episodes (study phase 2), ATP was successful in 62% of type I and 34% of type II episodes, but not in type III (p < 0.0001). CONCLUSIONS: The majority of patients with a history of AF show not only disorganized but also highly organized AT episodes, which can be successfully terminated by ATP.

Aged↗
PubMed1998

Linking research and policy to ensure children's environmental health.

The U.S. Environmental Protection Agency (U.S. EPA) has made protecting children's environmental health its highest priority. Data on how and when children may be at risk are vital for accomplishing this goal. Recent examples of the link between research and policy include U.S. EPA actions to carry out the recommendations of the National Academy of Sciences on pesticides in children's food, reduce and prevent childhood lead poisoning, and revise national ambient air quality standards for ozone and particulate matter. Today, the Food Quality Protection Act (FQPA), which makes protecting children from pesticide residues in food a national priority, is contributing to the growing need for data for decision making. Further impetus comes from provisions in the FQPA and 1996 Safe Drinking Water Act Amendments for establishing a screening and testing program for potential risks from endocrine disruptors. Another factor is the analysis that will be required under President William J. Clinton's executive order directing all federal agencies, for the first time, to reduce environmental health and safety risks to children. Success of the U.S. international commitment to protect children is directly tied to the strength and availability of environmental data. To meet such challenges, the U.S. EPA is revising key science policies, expanding research opportunities, and adding to the public's right-to-know tools. In this dynamic climate, there are growing opportunities for the research community to play a greater role in helping ensure the well-being of children living today and in generations to come.

Child↗
PubMed2002

Omalizumab: anti-IgE monoclonal antibody E25, E25, humanised anti-IgE MAb, IGE 025, monoclonal antibody E25, Olizumab, Xolair, rhuMAb-E25.

UNLABELLED: Omalizumab [anti-IgE monoclonal antibody E25, E25, humanised anti-IgE MAb, IGE 025, monoclonal antibody E25, olizumab, rhuMAb-E25, Xolair] is a chimeric monoclonal antibody. It binds specifically to the Cepsilon3 domain of immunoglobulin E (IgE). Cepsilon3 is the site of high-affinity IgE receptor binding. IgE plays a major role in allergic disease by causing the release of histamine and other inflammatory mediators from mast cells. Omalizumab binds to and neutralises circulating IgE by preventing IgE from binding to its high-affinity mast-cell receptor. In addition, omalizumab does not bind to or induce histamine release from basophils, nor does it bind to or recognise IgG. The immune complexes formed between IgE and omalizumab in vivo are relatively small (molecular weight <1 million) and are therefore unlikely to cause organ damage. COLLABORATION BETWEEN GENETECH NOVARTIS AND TANOX: omalizumab is very similar to the Tanox product CGP 51901. Genentech (Roche), Novartis and Tanox (formerly Tanox Biosystems) were developing both antibodies in phase II studies, with an agreement to collaborate on phase III development of the most promising one. The Genentech product, omalizumab, was selected for further development. Tanox has marketing rights to the drug in some Asian markets. Novartis and Genentech have marketing rights in the USA. Roche has an option to participate in the commercialisation of omalizumab and other anti-IgE products of the collaboration in Japan and Europe. Roche may exercise this option if specific events relating to commercialisation of the product occur; Roche has waived this option for omalizumab in Japan. If Genentech withdraws from the collaboration, Roche has an option to assume its place. Either Novartis or Genentech may withdraw from the collaboration on short notice, in which case rights to omalizumab revert to Tanox and the remaining collaborator unless Roche exercises its option in the event of withdrawal by Genentech. PATENTS: Protein Design Labs holds fundamental antibody humanisation patents. Protein Design Labs stated in its Annual Report for 2000 that Genentech may elect to take a patent licence for Xolair under a 1998 patent rights agreement. CLINICAL TRIALS: Phase III clinical trials of omalizumab for the treatment of allergic rhinitis and allergic asthma were in progress with Genentech (Roche) in the USA, Canada, Europe and Japan, and are now completed. In New Zealand, the antibody was investigated in clinical trials for the treatment of allergic asthma at the Wellington School of Medicine. In the phase III trials, omalizumab was administered as a subcutaneous injection. It may also be administered intravenously. In additional phase I and II studies, the safety and efficacy of aerosol administration for allergic asthma was tested. Initial results of these studies indicated that aerosol administration is less effective than intravenous or subcutaneous administration. TEMPORARY SUSPENSION OF TRIALS: In September 2000, the US FDA requested that Genentech and Novartis suspend new trials of omalizumab. Existing long-term trials, however, could continue. The hold on new trials was due to concerns about the preclinical toxicity of omalizumab and the follow-up antibody E26. Thrombocytopenia was reported in studies in monkeys for omalizumab at 5-27 times the maximum clinical dose and for E26 at 3-15 times the maximum dose. In response to FDA requests, Novartis and Genentech carried out additional preclinical trials so that a specific explanation of the toxicity could be obtained; Novartis suspected a species specificity for the adverse events, as no thrombocytopenic events occurred in the completed phase III clinical trials. The supplementary data were submitted to the FDA and the hold on clinical trials was lifted in November 2000. REGULATORY FILINGS: in June 2000, Genentech, Novartis and Tanox submitted a Biologics Licence Application (BLA) to the US FDA for approval of omalizumab for the treatment of allergic asthma and allergic rhinitis. Novartis fileiled for marketing approval of omalizumab in the European Union, Switzerland, Australia and New Zealand. INDICATION NARROWED TO ADULT ALLERGIC ASTHMA: In July 2001, the FDA requested additional data, both preclinical and clinical, for Xolair, as well as more detailed information concerning the effect of prolonged action of the drug. Genentech is to satisfy the FDA's request with data from the ALTO platelet monitoring safety study and with ongoing open-label studies. Genentech, Novartis and Tanox believe that substantial information can be provided from continuing trials, but additional trials on specific subgroups may be necessary. The new data will be submitted to both the US FDA and the EMEA in the European Union. The application for approval of Xolair that was submitted to the EMEA was withdrawn when it became clear that there would be a delay in approval in the USA. Tanox had originally anticipated that Xolair would be launched in mid-2001 in the USA and Europe. In November 2001, Genentech and Novartis stated that an amended BLA would be submitted to the FDA in the fourth quarter of 2002. The amended approval application will focus on the use of Xolair in adults only with allergic asthma. The original application was for treatment of both adults and children, and included allergic rhinitis. Genentech has stated that it will first pursue the narrower indication before filing supplemental BLAs. Approval of the drug in the USA may now be delayed until as late as the end of 2003. In Europe, Novartis is planning to develop Xolair for use only in asthmatic patients who are classed as being 'at risk', i.e. those who have been hospitalised or have visited an emergency department. Clinical studies are to be carried out, with submission for regulatory approval planned for 2003. APPROVAL IN AUSTRALIA: In June 2002, Xolair was approved by the Therapeutic Goods Administration in Australia for the treatment of adults and adolescents with moderate allergic asthma. This is the first marketing approval for Xolair.

Antibodies, Anti-Idiotypic↗
PubMed2004

Fate of Escherichia coli O157:H7 in manure compost-amended soil and on carrots and onions grown in an environmentally controlled growth chamber.

Studies were done to determine the fate of Escherichia coli O157:H7 in manure compost-amended soil and on carrots and green onions grown in an environmentally controlled growth chamber. Commercial dairy cattle manure compost was inoculated with a five-strain mixture of green fluorescent protein-labeled E. coli O157:H7 at 10(7) CFU g(-1) and mixed with unsterilized Tifton sandy loam soil at a ratio of 1:5. Baby carrot or green onion seedlings were planted into the manure compost-amended soil in pots, and soil samples surrounding the plant, edible carrot roots and onion bulb samples, and soil immediately beneath the roots were assayed for E. coli O157:H7 in triplicate at weekly intervals for the first 4 weeks, and every 2 weeks for the remainder of the plant growth cycle (up to 3 months). E. coli O157:H7 cell numbers decreased within 64 days by 3 log CFU/g in soil and soil beneath the roots of green onions and by more than 2 log CFU/g on onions. E. coli O157:H7 survived better during the production of carrots, with a 2.3-log CFU/g reduction in soil and a 1.7-log CFU/g reduction on carrots within 84 days. These results indicate that the type of plant grown is an important factor influencing the survival of E. coli O157:H7 both on the vegetable and in the soil in which the vegetable is grown.

Agriculture↗
PubMed2006

Trace element availability and plant growth in a mine-spill-contaminated soil under assisted natural remediation II. Plants.

In this second part, we evaluated the effects of different amendments on plant growth (Agrostis stolonifera L.), and trace element accumulation and removal by plants in a trace element (As, Cd, Cu, Pb and Zn) contaminated soil. Description of the various treatments is given in Part I of this work. The plants were grown for consecutive periods (2002, 2003, 2004), 5 months each and harvested twice in each period. Results showed that plant growth was enhanced and trace element concentrations in plant were reduced in SL, MWC, BC and LEO treatments in the first period. No significant differences were observed in subsequent periods. This seemed to be related with changes in soil pH. Removal of trace elements was higher in SL, MWC, BC and LEO treatments due to higher biomass production in the first period. In following years no significant differences between treatments were found. Data from Part I of this study were also used to compare trace element bioavailable concentrations extracted with 0.01 M CaCl2 and 0.05 M EDTA with trace elements in plant. We observed that 0.01 M CaCl2 was more suitable for determination of bioavailable concentrations and that extraction with EDTA overestimated biovailability of trace elements in amended treatments, especially in those where composts were added.

Agrostis↗
PubMed1987

The beneficial effect of pretransplant blood transfusions in cyclosporine-treated cadaver renal allograft recipients.

212 cyclosporine-treated recipients of mismatched first cadaveric renal allografts are evaluated with respect to the effect of pretransplant random blood transfusions. It is determined that transfusions do not effect patient survival or morbidity. Pretransplant random blood transfusions correlate with significantly improved allograft success. There is also a trend, although not statistically significant, for further improvement of allograft survival with increasing numbers of transfusions. The transfusion effect is not related to the time at which the transfusions are given up to 2 years prior to transplantation. Transfused patients have a higher percent reactive antibody (PRA) than untransfused patients, but this does not cause them to wait for a cadaveric allograft significantly longer than the untransfused patients. Rejections are less severe in transfused patients. It is concluded that cyclosporine-treated recipients of first cadaveric renal allografts benefit from pretransplant blood transfusions.

Blood Transfusion↗
PubMed2004

Final report of the amended safety assessment of PEG-5, -10, -16, -25, -30, and -40 soy sterol.

PEGs Soy Sterol are polyethylene glycol (PEG) derivatives of soybean oil sterols used in a variety of cosmetic formulations as surfactants and emulsifying agents, skin-conditioning agents, and cleansing and solubilizing agents. When the safety of these ingredients were first reviewed, the available data were insufficient to support safety. New data have since been received and the safety of these ingredients in cosmetics has been substantiated. Current concentration of use ranges from a low of 0.05% in makeup preparations to 2% in moisturizers and several other products. PEGs Soy Sterol are produced by the reaction of the soy sterol hydroxyl with ethylene oxide. In general, ethoxylated fatty acids can contain 1,4-dioxane as a byproduct of ethoxylation. The soy sterols include campesterol, stigmasterol, and beta-sitosterol. The distribution of sterols found in oils derived from common plants is similar, with beta-sitosterol comprising a major component. Impurities include sterol hydrocarbons and cholesterol (4% to 6%) and triterpine alcohols, keto-steroids, and other steroid-like substances (4% to 6%). No pesticide residues were detected. PEGS: Because PEGs are an underlying structure in PEGs Soy Sterols, the previous assessment of PEGs was considered. It is generally recognized that the PEG monomer, ethylene glycol, and certain of its monoalkyl ethers are reproductive and developmental toxins. Given the methods of manufacture of PEGs Soy Sterol, there is no likelihood of ethylene glycol or its alkyl ethers being present. Also, the soybean oil sterol ethers in this ingredient are chemically different from the ethylene glycol alkyl ethers of concern. PEGs are not carcinogenic, although sensitization and nephrotoxicity were observed in burn patients treated with a PEG-based cream. No evidence of systemic toxicity or sensitization was found in studies with intact skin. Plant Phytosterols: Intestinal absorption of ingested plant phytosterols is on the order of 5%, with 95% of the material entering the colon. Absorbed plant phytosterols are transported to the blood. Although there are some data suggesting that sulfates of beta-sitosterol can act as abortifacients in rats and rabbits, other studies of well-characterized plant phytosterols and phytosterol esters demonstrated no effect in an estrogen-binding study, a recombinant yeast assay for estrogen or estrogen-like activity, or a juvenile rat uterotrophic assay for estrogen or estrogen-like activity. In a two-generation reproduction study using rats, plant phytosterol esters in the diet had no effect on any parameter of reproduction or fertility. Subcutaneous injections of beta-sitosterol did reduce sperm concentrations and fertility in rats. Sitosterol inhibited tumor promoting activity of 12-O-tetradecanoylphorbol-13-acetate (TPA) in mice after initiation with 7,12-dimethylbenz[a]anthracene (DMBA), and reduced the tumors produced by N-methylnitrosourea in rats. Phytosterols were not genotoxic in several bacterial, mammalian, and in vitro assay systems. Phytosterols decreased epithelial cell proliferation in the colon of mice and rats, and were cytotoxic for human epidermoid carcinoma of the nasopharynx. PEGs Soy Sterols: The acute oral LD50 in rats of PEG-5-25 Soy Sterol was >10 g/kg. The acute dermal LD50 of a liquid eyeliner containing 2%PEG-5 Soy Sterol was >2 g/kg in rabbits. PEG-5-25 Soy Sterol was not a primary irritant in rabbits when applied undiluted. Undiluted PEG-5 Soy Sterol did not cause sensitization in guinea pigs. PEGs Soy Sterol did not produce ocular toxicity in rabbits. PEG-5 Soy Sterol was negative in the Ames mutagenicity test, with or without metabolic activation. PEG-5 Soy Sterol, at concentrations up to 2%in formulation, did not cause dermal or ocular irritation, dermal sensitization, or photosensitization in clinical studies. Because of the possible presence of 1,4-dioxane reaction product and unreacted ethylene oxide residues, it was considered necessary to use appropriate procedures to remove these from PEGs Soy Sterol before blending them into cosmetic formulations. Based on the systemic toxicity and sensitization seen with PEGs applied to damaged skin, it was recommended that PEGs Soy Sterol should not be used in cosmetic products applied to damaged skin. Although no dermal absorption data were available, oral studies demonstrate that phytosterols and phytosterol esters are not significantly absorbed and do not result in significant systemic exposure. Some small amounts did appear in the ovaries, however. This raises a concern about the potential presence of free phytosterols and beta-Sitosterol, which could have antiestrogenic, antiprogestational, gonadotrophic, antigonadotrophic, and antiandrogenic effects in PEG sterols. These concerns are alleviated by the extensive data showing that well-defined phytosterols and phytosterol esters are not estrogenic and do not pose a hazard to reproduction. Likewise, the absence of impurities in plant phytosterols and phytosterol esters and extensive data demonstrating the absence of any genotoxicity in bacterial and mammalian systems mitigate against the possibility of any carcinogenic effect with those same well-characterized materials. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the PEGs Soy Sterol are safe as used in cosmetic products.

Animals↗