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PubMed1995

Suspension therapy in acute schizophrenia. Clinical and neuroendocrine/biochemical effects of abrupt discontinuation of neuroleptic medication.

22 acutely schizophrenic patients with partial remission under standard haloperidol therapy (reduction in BPRS total score by 50% or less) were included in this prospective study. There was a significant correlation between the BPRS total score or the BPRS factors Anxiety/depression and Anergia and extrapyramidal side effects at the end of the 3-week neuroleptic treatment phase. In these patients abrupt discontinuation of neuroleptic medication (suspension therapy) brings about a significant further reduction in BPRS total scores together with a favorable effect on the BPRS factors Anxiety/depression, Anergia and Thought disturbance. There was a trend towards low serum prolactin values before neuroleptic discontinuation being linked with a favorable effect of subsequent suspension therapy. Urinary dopamine and homovanillic acid excretion before neuroleptic discontinuation did not predict the clinical suspension effect. Thus peripheral neuroendocrine and biochemical effects of haloperidol-induced dopamine blockade and their changes after discontinuation of neuroleptic medication seem not to be linked with the clinical effect of suspension therapy in acute schizophrenia. There was, however, a significant relationship between low urinary epinephrine, norepinephrine, vanillylmandelic acid and cortisol excretion before suspension therapy and a favorable suspension effect. On the other hand, the more pronounced a nonspecific stress constellation (catecholamines, cortisol) was in patients with an unsatisfactory remission under neuroleptics, the less favorable was the clinical effect of suspension therapy. Until now, the treatment courses of suspension therapy have been evaluated in 43 schizophrenic patients. According to both clinical aspects and observer rating, three types of therapeutic suspension effects have been distinguished in one-third of the cases respectively; none (at best temporary remission, no improvement in the overall treatment situation); partial (substantial remission, neuroleptic medication resumed for therapeutic reasons), and favorable (almost complete remission, neuroleptic medication resumed for prophylactic reasons).

Acute Disease↗
PubMed1987

Measurements of viscosity of synthetic erythrocyte suspensions.

Measurements were made of the viscosity of suspensions of synthetic erythrocytes composed of hemoglobin solutions encapsulated in liposomes, as a function of shear rate, temperature, suspension concentration, lipid membrane composition, and the viscosity of the suspending medium. It was found that the viscous behavior of the synthetic erythrocyte suspensions was non-Newtonian and nearly the same as that of suspensions of natural erythrocytes prepared similarly, with the major difference being that synthetic erythrocyte suspensions are somewhat more viscous. Suspensions of Fluosol FC-43 prepared similarly were found to be essentially Newtonian fluids, and substantially different and more viscous than either erythrocyte suspension. The higher viscosity of synthetic erythrocyte suspensions probably accounts for the ability of these suspensions to maintain normal systemic vascular resistance in transfusion experiments, in spite of the fact that synthetic erythrocytes are smaller than natural erythrocytes.

Blood Proteins↗
PubMed2000

[The establishment of two new evaluation criteria for cell state of plant cell suspension cultures].

An experiment on suspending rice cell cultures in sucrose solution and on optical density (OD) value in culture solution at 576 nm wave width was carried out, the result indicates that suspension rate (%) of suspensions, while suspending in 0.76 mol/L sucrose solution for 15 minutes at room temperature, can be employed as an judgment criterion of cell state. Suspending cell suspension in 0.76 mol/L sucrose solution is also a good approach on selecting cells from suspension cell mass, as a result, it is beneficial to establishing cell suspension. The browning of cell suspension is related to the necrosis degree of suspension cells. OD value of cell suspension liquid at 576 nm can be taken as a criterion with which the necrosis degree of cell suspension can be evaluated.

Cell Culture Techniques↗
PubMed2003

Comparison of the bioavailability and systemic effects of beclometasone dipropionate suspension for nebulization and beclometasone dipropionate via a metered-dose inhaler after single-dose administration in healthy male volunteers.

Pharmacokinetic properties of a drug, and selection and correct usage of an appropriate delivery device, are factors that can affect the outcome of inhaled therapyThe use of nebulization can overcome problems that are associated with other delivery systems used for inhalation therapyThe objective of this open, randomized, single-dose study was to compare the systemic exposure and safety of beclometasone dipropionate (BDP) suspension for nebulization with BDP via metered-dose inhaler (MDI) in healthy subjects. Following a run-in period to assess basal 24-h serum cortisol levels and cortisol urinary excretion, 12 healthy males were administered BDP 1,600 microg given via MDI and were then randomized to receive a single dose of either 1,600 microg (n = 6) or 3,200 microg BDP (n = 6) suspension for nebulization given via a nebulizer Results with respect to systemic exposure to beclometasone-17-monopropionate (B17MP) (the active metabolite of BDP) and systemic effects on the hypothalamic-pituitary-adrenal (HPA) axis were determined by evaluation of a number of pharmacokinetic parameters for plasma B17MP and serum and urinary cortisol, respectively. A statistically significantly greater peak plasma concentration (Cmax) of B17MP was reported with BDP via MDI (1,587 pg ml(-1)) compared with BDP 1,600 microg (455 pg ml(-1)) and BDP 3,200 microg suspensions for nebulization (758 pg ml(-1)), and was achieved more rapidly (Tmax) (1.3 h, 3 h, and 2.5 h, respectively). In addition, elimination half-life (t 1/2(el)) was statistically significantly shorter with BDP via MDI (4.6 h) than with both dosages of BDP suspensions for nebulization (7.4 h and 6.3 h with 1600 microg and 3,200 microg, respectively), as was mean residence time (MRT) (5.4 h, 11.1 h, and 10.0 h, respectively). Total systemic exposure to B17MP (as determined by the area under the concentration-time curve: AUCinfinity) was comparable for BDP via MDI (6,883 pg ml(-1) h(-1)) and BDP 3,200 microg suspension for nebulization (8,201 pg ml(-1) h(-1)), but significantly greater than with BDP 1,600 microg suspension for nebulization (4,870 pg ml(-1); P < 0.05 vs BDP via MDI). All treatments were well tolerated, and no significant differences were found between them with respect to the serum or urinary cortisol pharmacokinetic parameters assessed. In conclusion, the results of this study demonstrate that BDP suspension for nebulization 3,200 microg given via a nebulizer and BDP 1,600 microg given via an MDI are equivalent in terms of systemic exposure to B17MP and systemic effects on the HPA axis, with BDP suspension for nebulization having a potentially more prolonged activity. It confirms that use of a double dose of BDP suspension for nebulization administered by nebulizer compared with BDP given via metered-dose inhalation is justified and poses no risk with regard to safety.

Administration, Inhalation↗
PubMed1990

Suspension culture of mammalian cells.

Mammalian cell suspension culture systems are being used increasingly in the biotechnology industry. This is due to their many advantages including simplicity and homogeneity of culture. Suspension systems are very adaptable (e.g., for microcarrier, microencapsulation, or other methods of culture). Their engineering is thoroughly understood and standardized at large scale, and automation and cleaning procedures are well established. Suspension systems offer the possibility of quick implementation of production protocols due to their ability to be scaled easily once the basic culture parameters are understood. The only main disadvantage of the suspension culture systems to date is their inapplicability for the production of human vaccines from either primary cell lines or from normal human diploid cell lines (Hayflick et al., 1987 and references therein). One of the great advantages of suspension culture is the opportunity it provides to study interactions of metabolic and production phenomena in chemostat or turbidostat steady-state systems. Furthermore, in suspension culture systems from which cell number and cell mass measurements are easy to obtain, rigorous and quantitative estimations of the effects of growth conditions or perturbations of metabolic homeostasis can be made. Such studies can speed up the development of optimal processes. With our increasing understanding of factors influencing expression in mammalian cells (Cohen and Levinson, 1988; Santoro et al., 1988) and the direct application of new methods in suspension culture (Rhodes and Birch, 1988), its usefulness and importance is likely to increase in the future. In this chapter, we have described some of the potential uses of the various suspension culture systems and have covered most of the established technology and literature. Due to the rapid developments and needs in the biotechnology industry and the versatility of suspension culture systems, it is probable that many more variations on this theme will evolve in the near future at both the pilot and production scales.

Animals↗
PubMedDate not supplied

Effect of terminal sterilization by irradiation on amber Type I and Type III glass containers containing veterinary oxytetracycline suspension.

The purpose of this study is to determine the effect of terminal sterilization by gamma irradiation on 500-mL amber Type I and Type III glass containers (bottles) containing oxytetracycline (OTC) (25% W/V) suspension formulated using 20% (W/V) phospholipids syrup. The formulation was developed for veterinary parenteral administration. The results of terminal sterilization were used to assess the acceptability for this suspension product. OTC is light-sensitive and needs to be stored in amber glass containers. Amber Type I and Type III glass containers were considered for this formulation during development. Type I is a highly resistant, borosilicate glass (oxidized glass). Type III, which is soda-lime glass (reduced glass, see Materials and Methods), may also be used for parenteral products. The amber Type I and Type III glass containers, containing the suspension, were irradiated at 20-40 kGy for 150 min. In order to determine the sterility of the suspension, ampoules of the biological indicator, Bacillus pumilus, were placed in a number of bottles of the suspension. The bottles with the biological indicators were then positioned among the rest of the production bottles as per a radiation dose-mapping study conducted at the sterilization facility. Potency determination and stability evaluations for OTC were performed using high pressure liquid chromatography (HPLC). The results indicate that the gamma irradiation dose of 20-40 kGy for 150 min was able to inactivate 10(6) Bacillus pumilus spores in ampoules. After gamma sterilization, OTC concentration, pH, particle size, endotoxins, and sterility were evaluated. The assay results were comparable for the suspension in amber Type I and Type III glass containers. Sterility and pyrogenicity were measured by the USP Membrane Filtration Method and USP Bacterial Endotoxins Test, respectively. The suspension in the amber Type III glass container was also chemically (HPLC) and physically (suspension mean particle size, viscosity, density, and syringeability) stable for at least 12 months at room temperature. However, amber Type I glass darkened following irradiation, leading to a substantial reduction in glass transparency. The appearance of amber Type III glass was acceptable. Thus, the "reduced" glass, such as soda-lime, was found to be much less susceptible to darkening than the highly oxidized borosilicate amber. Due to the potential aesthetic concerns with Type I glass, the amber Type III glass container was selected for this suspension formulation.

Chromatography, High Pressure Liquid↗
PubMed2005

[Study on quantified relationship between contents of active components in Forsythia suspense and nutrition of soil].

OBJECTIVE: To sift the main effective factors of active component of Forsythia suspense. METHOD: The active component of F. suspense was mensurated by HPLC, and the contents of nutrition in soil was determined by conventional methods. The active component of F. suspense and the nutrition of soil collected from different regions was analyzed by SPSS 11.0 for windows software package. Accounted the partial correlation coefficients of soil factor to the active component of F. suspense, and established regression equations. RESULT: Soil available phosphorus is the most important factor that effected forsythiaside content in the seeds of F. suspense, followed by kalium, pH, FACT; Forsythin in the seeds of F. suspense is mainly effected by soil abailable kalium and FACT; pH is the important factor effected Forsythinin in F. suspense, followed by soil available phosphorus, soil available kalium, and FACT; and the main effectivefactors of forsythiaside in F. suspense are soil available phosphorus, soil available kalium. CONCLUSION: The contents of nutrition in soil is one of important factors which affect the active component of F. suspense.

China↗
PubMed1992

Assessment of chemoembolization therapy for primary liver cancer using a stabilized adriamycin-lipiodol suspension.

We formulated a new lipiodol-Adriamycin suspension (ADM/lipiodol, 50 mg/10 ml) that remained stable for 48 h (half-life, 25 +/- 3 days). In five cases of hepatocellular carcinoma (HCC) resected after intra-arterial infusion of this agent, the ADM concentration in the tumor was quite high and the tumor necrosis rate was more than 80% on histological examination. Over a 5-year period, 180 patients with unresectable HCC underwent transcatheter arterial embolization therapy (TAE) in the presence or absence of this agent. The regimens consisted of suspension injection alone (A, n = 54), suspension injection + TAE using gelatin sponge (B, n = 29), TAE followed by suspension injection (C, n = 34), and TAE alone (D, n = 63). The estimated 1-year survival values determined for patients treated with these regimens were 70%, 73%, 43%, and 39% respectively, and the corresponding 3-year survival values were 27%, 31%, 15%, and 10%. The survival achieved using suspension injection was thus superior to that obtained using conventional TAE, and combined therapy with suspension injection followed by TAE seemed to enhance survival, although there were some biases in tumor size and in the stage of tumor progression. For patients with tumors measuring 5 cm or more in diameter, the survival obtained using regimen A was lower than that achieved using regimen D, but the combination of TAE and suspension injection improved the 1-year survival value obtained using regimen D from 34% to 52%. For patients with tumors measuring less than 5 cm in diameter, the survival achieved using regimen A was markedly better than that obtained using regimen D, although no difference was found between the survival value achieved using regimen A and that obtained using regimens B and C. On the basis of these results, our newly formulated ADM-lipiodol suspension was surmised to be effective by itself against relatively small HCC tumors, whereas it enhanced the efficacy of conventional TAE in large lesions.

Aged↗
PubMed1999

Inadequate suspension of neutral protamine Hagendorn (NPH) insulin in pens.

BACKGROUND: Neutral protamine Hagedorn (NPH) insulin is one of the most commonly used insulins in insulin pens. NPH in pen cartridges is in a two-phase solution with either a solvent or a short-acting insulin, and needs adequate mixing for complete resuspension. We assessed whether NPH insulin is accurately resuspended by patients and the association of suspension errors with diabetes control. METHODS: 109 patients (39 with type 1 diabetes) who had received conventional diabetic education had the NPH content of their cartridges measured by an optical system; a control cartridge was designated as 100%. A questionnaire was used to assess clinical details and insulin suspension habits. After the information about residual insulin error was known, all 109 patients were instructed to resuspend their insulin by rolling and tipping the pen 20 times. 52 patients were randomly selected to have cartridges re-analysed 3 months or 6 months later and to complete another questionnaire. FINDINGS: Only 10 (9%) of 109 patients tipped and rolled their pen more than ten times. NPH insulin content ranged from 5% to 214% and varied by more than 20% in 71 (65%) of 109 cartridges. There was no relation between inadequate suspension and the frequency of hypoglycaemic episodes (r=0.2, p=0.08). For all patients, there was a correlation between the absolute error of NPH suspension and cycles of rolling and tipping the pen (r=-0.23, p<0.05). After education on resuspending the pen's contents, data were available from 44 of 52 patients; suspension errors decreased in 35 (80%), were unchanged in three (7%), and increased in six (13%). The 35 patients with improved NPH insulin suspension had fewer mean hypoglycaemic episodes per month compared with the previous period (0.4 [SD 0.1] vs 1.0 [0.3], p<0.05). Mean HbA1c values in patients with improved suspension quality did not differ from baseline (8.4% [0.3] vs 8.9% [0.4], p=0.07). Mixing of NPH insulin by a mechanical device showed that at least 20 cycles were necessary before complete resuspension was obtained. INTERPRETATION: Inadequate NPH insulin suspension is common. We recommended that patients tip pens that contain NPH insulin at least 20 times, since inadequate mixing may impair diabetes control.

Adult↗
PubMed2002

A novel method of producing a microcrystalline beta-sitosterol suspension in oil.

This paper describes a novel method of producing a microcrystalline oral suspension containing beta-sitosterol in oil for the treatment of hypercholesterolaemia. beta-Sitosterol pseudopolymorphs with different water contents were crystallized from acetone and acetone-water solutions. Structural analyses of the crystals were performed by Karl-Fisher titration, thermogravimetric analyses, X-ray diffraction and near infrared spectroscopy. The suspensions studied were composed of different concentrations of beta-sitosterol, oil and water. Suspensions were prepared by crystallization of hot concentrated solution of beta-sitosterol in oil by cooling with simultaneous agitation and water addition. The structural analyses of the suspensions were performed by X-ray diffraction, near infrared spectroscopy and optical microscopy. The viscosity of the suspensions was analysed as a function of shear stress. beta-Sitosterol was observed to exist in three different forms: anhydrous, hemihydrated and monohydrated crystals. By changing both the beta-sitosterol and the water concentration of the suspension, the crystal size and shape could be controlled. Addition of water resulted in the formation of monohydrated needle-shaped crystals instead of platy-like anhydrous crystals. Needle-shaped particles formed structured suspensions with shear thinning behaviour. By increasing the volume fraction of solid particles in suspension by increasing the water and/or sterol concentration, the viscosity increased. A high sterol concentration resulted in high supersaturation and thus formation of small crystals.

Administration, Oral↗
PubMed2004

Safety profile of budesonide inhalation suspension in the pediatric population: worldwide experience.

OBJECTIVE: To review the worldwide safety data for budesonide inhalation suspension (Pulmicort Respules) to provide a budesonide inhalation suspension pediatric tolerability profile. DATA SOURCES: Clinical study data were obtained from AstraZeneca safety databases used by the US Food and Drug Administration to support the approval of budesonide inhalation suspension and from postmarketing surveillance reports (January 1, 1990, through June 30, 2002). STUDY SELECTION: Completed parallel-group studies of patients with asthma 18 years and younger. RESULTS: Safety data for budesonide inhalation suspension were pooled from 3 US, 12-week, randomized, double-blind, placebo-controlled studies (n = 1,018); data from their open-label extensions (n = 670) were pooled with data from a fourth US open-label study (n = 335). Data for 333 patients 18 years and younger enrolled in 5 non-US studies also were analyzed. No posterior subcapsular cataracts were reported in any study, and the frequencies of oropharyngeal events and infection with budesonide inhalation suspension were comparable with those of reference treatments. No increased risk of varicella or upper respiratory tract infection was apparent, and budesonide inhalation suspension did not cause significant adrenal suppression in studies assessing this variable. There were small differences in short-term growth velocity between children who received budesonide inhalation suspension and those who received reference treatment in 2 of 5 trials that evaluated this variable. No increased risk of adverse events was apparent from postmarketing reports. CONCLUSIONS: Short- and long-term treatment with budesonide inhalation suspension, using a wide range of doses, is safe and well tolerated in children with asthma.

Administration, Inhalation↗
PubMed1995

Local injection of methotrexate dissolved in saline versus methotrexate suspensions for the conservative treatment of ectopic pregnancy.

To compare the local injection of methotrexate (MTX) dissolved in saline and MTX suspensions for the laparoscopic treatment of ectopic pregnancy in terms of success rate and postoperative tubal patency. A total of 26 patients with unruptured ectopic pregnancies were selected from among 60 women with ectopic pregnancies admitted to the Nagasaki University clinic. Of these patients, 12 were treated with MTX dissolved in saline solution (solution group) and 14 with MTX suspensions consisting of lipiodol (LPD) with phosphatidylcholine (PC) added as a dispersing stabilizer (suspension group). Except for one case treated under transvaginal guidance, all the patients were treated by laparoscopy. Persistent ectopic pregnancy was recognized in seven cases (58%) in the solution group but in only two cases (14%) in the suspension group. Moreover, rupture occurred in two cases in the solution group but in no case in the suspension group. A patent treated tube was found in seven of 10 cases in the saline group and in 10 of 12 cases in the suspension group. During the follow-up period of 6-31 months, five women in the saline group and three women in the suspension group had an intrauterine pregnancy. In this study, the local injection of MTX is considered to be a reasonable method for the treatment of unruptured ectopic pregnancy, and the MTX suspension seems to be more effective and useful than MTX solution.

Adolescent↗
PubMed2005

Randomized, double-blind comparison of immediate-release omeprazole oral suspension versus intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients.

OBJECTIVE: To demonstrate that a new immediate-release omeprazole oral suspension is effective in preventing upper gastrointestinal bleeding in critically ill patients. DESIGN: A noninferiority analysis was used to compare rates of clinically significant upper gastrointestinal bleeding in a prospective, phase 3, double-blind trial with parallel omeprazole suspension and cimetidine treatment groups. SETTING: A total of 47 intensive care units in the United States. PATIENTS: A total of 359 critically ill patients who required mechanical ventilation for > or =48 hrs, had an Acute Physiology and Chronic Health Evaluation score of > or =11 at baseline, had an intact stomach with a nasogastric or orogastric tube in place, and had at least one additional risk factor for upper gastrointestinal bleeding. INTERVENTIONS: Patients were randomized to treatment with omeprazole suspension (two 40-mg doses on day 1, via orogastric or nasogastric tube, and 40 mg each day thereafter) or intravenous cimetidine (300-mg bolus and 50 mg/hr thereafter) for up to 14 days. Gastric aspirates were sampled for bleeding and pH. Medication doses were doubled for failure of pH control (two successive aspirates with pH < or = 4). MEASUREMENTS AND MAIN RESULTS: Clinically significant upper gastrointestinal bleeding (bright red blood not clearing after 5-10 mins of lavage or persistent Gastroccult-positive "coffee-grounds" material for 8 hrs on days 1-2 or for 2-4 hrs on days 3-14 and not clearing with > or =100 mL of lavage) was the primary end point of the trial. The rate of clinically significant bleeding in the per-protocol population was 4.5% with omeprazole suspension and 6.8% with cimetidine, meeting the criteria for the noninferiority of omeprazole suspension. Median gastric pH was > or =6 on all trial days with omeprazole suspension treatment and on 50% of days with cimetidine treatment (p < .001, all trial days). In the omeprazole suspension group, median gastric pH was >4 on each trial day in 95% of patients. CONCLUSIONS: Immediate-release omeprazole suspension is effective in preventing upper gastrointestinal bleeding and more effective than intravenous cimetidine in maintaining gastric pH of >4 in critically ill patients.

Administration, Oral↗
PubMed1994

Effect of preparation method and storage on rifampin concentration in suspensions.

OBJECTIVE: To determine the effect of four preparation methods and extended storage on rifampin concentration in extemporaneously prepared suspensions. DESIGN: Four preparation methods were used: mixing intravenous (i.v.) rifampin in syrup (A); manufacturer's recommended technique of mixing capsule (Rifadin) contents in syrup (B); triturating capsule contents in syrup into a paste and adding remaining syrup while mixing (C); and triturating capsule contents in syrup into a paste, adding syrup, retriturating the slurry, and adding remaining syrup while mixing (D). Samples were drawn from each of five bottles of each of the four preparations stored at 4 degrees C, immediately after mixing (day 0), and on days 7, 14, 28, 42, 56, 70, and 91 days during storage. Rifampin was measured by a stability-indicating HPLC method. RESULTS: The measured mean concentrations of rifampin were nearly 100 percent of the initial concentration in the suspension prepared from i.v. rifampin solution (method A) during the first 56 days of storage. In contrast, the measured concentrations were substantially lower than expected in the suspensions prepared by methods B, C, and D. The mean rifampin concentrations in suspensions prepared by methods B, C, and D were only 14.5, 38.6, and 68 percent, respectively, of the initial concentration achieved by method A. The rifampin concentrations increased with storage time in suspensions prepared by methods B, C, and D. The mean rifampin concentration was lower than 90 percent during the first 14 days with methods B and C, and the first 7 days with method D. The highest mean concentrations were observed on day 42 with method B, and on day 28 with methods C and D. All methods yielded 90% of the labeled potency (10 mg/mL) on day 56. CONCLUSIONS: Our results showed that preparation method can influence the dispersion, and thus the measured concentration, of rifampin in aliquots of suspensions prepared from capsules and stored in plastic bottles. Suspensions prepared from capsules led to lower-than-expected rifampin concentrations; those prepared from i.v. rifampin did not. Rifampin was stable in each type of suspension for 56 days at 4 degrees C.

Chemistry, Pharmaceutical↗
PubMed2003

Effects of budesonide inhalation suspension compared with cromolyn sodium nebulizer solution on health status and caregiver quality of life in childhood asthma.

OBJECTIVE: To compare the effects of 2 nebulizable controller asthma medications on caregiver and pediatric quality of life. METHODS: In this 52-week, randomized trial, children aged 2 to 6 years with mild to moderate persistent asthma received budesonide inhalation suspension 0.5 mg (total daily dose) once or twice daily (n = 168) or cromolyn sodium nebulizer solution 20 mg 4 times daily (n = 167) for 8 weeks, with dosage adjustment thereafter at the investigators' discretion. The Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), Compliance/Caregiver Satisfaction Questionnaire (CCSQ), Modified Child Health Questionnaire-Parent Form 50 (CHQ-PF50), and Functional Status-II(R) (FS-II[R]) Questionnaire were administered at baseline and weeks 8, 28, and 52. Global assessments of ease of asthma management and child health status were obtained from caregivers and physicians at the end of the study. RESULTS: Improvements from baseline in domain-specific (activities and emotional function) and total PACQLQ scores were greater at each time point (weeks 8, 28, and 52) for caregivers of patients treated with budesonide compared with caregivers of patients receiving cromolyn sodium. Only the budesonide group met the criterion for a clinically important improvement (>or=0.5 unit change) in all PACQLQ domains by week 8, which was maintained at weeks 28 and 52. Moreover, improvements surpassed the criterion for moderate clinical importance (1.0 unit change) in all PACQLQ domains for the budesonide group, but this level of improvement was only achieved in the activities domain (at week 28) for the cromolyn sodium group. Based on the CCSQ, budesonide resulted in greater caregiver satisfaction, treatment convenience, ease of use, and compliance compared with cromolyn sodium. Thus, 90.7% of caregivers in the budesonide group were "completely or very satisfied" compared with 53.4% in the cromolyn sodium group. Over half (54.6%) of caregivers in the budesonide group rated budesonide "highly or very convenient" compared with 23% for cromolyn sodium; 77% rated budesonide "extremely or very easy" to use compared with 47% for cromolyn. Adherence with daily medication regimens was reported for 76% of children in the budesonide group compared with 57% in the cromolyn sodium group. Child health status, as indicated by mean FS-II(R) scores, showed improvements from baseline in both groups at weeks 8, 28, and 52. There was a trend for these improvements to be superior in the budesonide group. Additionally, budesonide was superior to cromolyn sodium in caregiver and physician global assessments. At the end of the study, 76% of caregivers of children receiving budesonide reported asthma management to be "a great deal easier" compared with the start of the study, and 74% rated the overall health status of their child as "much better now than 1 year ago." In contrast, only 29% and 37% of caregivers whose children received cromolyn sodium provided these respective ratings. CONCLUSIONS: Budesonide inhalation suspension improved the quality of life for caregivers of children with asthma. Caregivers of children treated with budesonide had significantly fewer limitations in daily activities and emotional functioning compared with caregivers of children treated with cromolyn sodium nebulizer solution. The improvements in caregiver quality of life occurred earlier with budesonide compared with cromolyn sodium. Only caregivers in the budesonide group had a clinically important mean change from baseline in all PACQLQ domains by week 8. These benefits were maintained at week 52. Children treated with budesonide inhalation suspension and cromolyn sodium experienced improvements in health status, assessed using the FS-II(R). The greatest differences between treatments were seen in the disease-specific portion of the FS-II(R), which relates impairments in functional status to the child's illness. Caregiver and physician global assessment indicated significantly better overall child health after 1 year of treatment with budesonide, supporting an improvement in health status. Clinical trials in children 4 to 16 years of age with asthma have demonstrated greater effectiveness of inhaled corticosteroids versus cromolyn sodium on several clinical measures of efficacy. Measures of asthma control in this study, reported in detail elsewhere [Leflein et al. Pediatrics 2002;109:866-872], also have shown greater improvements with budesonide therapy. Treatment with budesonide inhalation suspension resulted in a significantly lower mean rate of asthma exacerbations, significantly longer times to first asthma exacerbation, significantly longer times to first additional use of chronic asthma therapy, and significant improvements in asthma symptom scores and breakthrough medication use compared with cromolyn sodium therapy. Additionally, children receiving budesonide inhalation suspension experienced more symptom-free days and episode-free days compared with children receiving cromolyn sodium. Safety profiles were similar between the 2 treatment groups. Budesonide inhalation suspension was associated with significantly greater caregiver satisfaction, convenience, ease of use, and compliance compared with cromolyn sodium nebulizer solution. This greater caregiver satisfaction and quality of life may be related to the greater asthma control achieved in children treated with budesonide therapy compared with cromolyn sodium. In addition, the convenience of once- or twice-daily dosing with budesonide inhalation suspension, compared with 3- or 4-times-daily dosing of cromolyn sodium, may decrease caregiver burden and enhance the willingness of caregivers to adhere to treatment regimens prescribed for their young children with asthma. This effect on caregiver adherence could further improve treatment effectiveness. This is the first clinical trial comparing the effects of a nebulized corticosteroid with that of an alternative nebulized therapy on quality of life in young children with asthma and their families. Compared with nebulized cromolyn sodium, budesonide inhalation suspension not only provides better overall child health status and asthma management, but greater caregiver quality of life and greater caregiver satisfaction, convenience, ease of use, and compliance.

Administration, Inhalation↗
PubMed1999

Influence of centrifugation and hindlimb suspension on testosterone and corticosterone excretion in rats.

BACKGROUND: Alterations in mass loading have been shown to stimulate the pituitary-gonadal and pituitary-adrenal axes resulting in changes in testosterone (T) and corticosterone (B) production which may account for the previously reported variations in muscle mass under these conditions. HYPOTHESIS: Centrifugation and hindlimb suspension will induce opposing effects on testosterone and corticosterone excretion. METHODS: Effects of mass loading (centrifugation at -2Gx) and unloading (hindlimb suspension, HLS) on excreted T and B levels, and testicular mass were examined in Sprague-Dawley rats. For 12 d, 16 (8 controls and 8 centrifuged) rats and 20 (10 unsuspended controls and 10 suspended) rats were studied during the centrifugation and suspension portions of the study, respectively. Following the completion of each study, testicular mass was measured. RESULTS: Absolute testicular mass was not different, following 12 d of centrifugation. Excreted T was elevated between days 1 and 6 of centrifugation. Excreted B levels were elevated for the first 4 d of centrifugation. Suspension reduced absolute and relative testicular mass. Excreted T levels were reduced from days 3-12 of suspension, while excreted B levels were only elevated on the first day of suspension. CONCLUSIONS: Centrifugation stimulated an increase in T excretion despite a lack of a change in absolute testicular mass. Conversely, suspension resulted in a reduction in T excretion which may have been associated with a decrease in absolute testicular mass. The centrifugation-induced increase in T excretion is consistent with previously reported increases in lean body mass following centrifugation, while the HLS-induced reduction in T excretion correlates with previously reported decreases in lean body mass following suspension.

Adrenal Glands↗
PubMed1993

Urinary excretion of stress hormones of rats in tail-suspension.

Tail-suspension of rats has been employed for the study of disuse atrophy of hindlimb muscles and bones. From our study, it is suggested that stress exacerbates muscle and bone atrophy; however, the determination of stress hormones has been inappropriately performed. For assessing the effect of tail suspension on stress hormone secretion, suspension was performed for 7 days in a metabolic cage. Urinary excretions of corticosterone, catecholamines and antidiuretic hormone were determined during the 7-day suspension. Urine volume was unchanged during the suspension period, whereas water consumption was decreased during suspension. Urinary excretion of corticosterone and catecholamines increased significantly during the initial 3 days of suspension. The excretion of antidiuretic hormone increased throughout the suspension period. Our results demonstrated that the determination of urinary excretion of these hormones is useful for evaluating the stress reaction.

Adrenal Glands↗
PubMed2000

Changes in calcium, PTH and 1,25(OH)2 vitamin D3 during tail-suspension in ovariectomized rats: effects of estrogen administration.

It is well known that estrogen deficiency results in osteoporosis in human and experimental animals. However, how its deficiency affects the development of disuse atrophy is not well understood. We thus investigated how estrogen deficiency caused by ovariectomy and estrogen supplements affect serum levels of calcium, parathyroid hormone (PTH), and 1,25-dihydroxy vitamin D3 (1,25(OH)2D3) in tail-suspended rats. Five-week-old female Wistar rats were ovariectomized and divided into two groups. One group received an intramuscular injection of estradiol dipropionate once a week (OVX-E2 group), and the other received the vehicle alone (OVX group). After the third injection, the rats were subjected to tail-suspension in metabolic cages for 1, 3, 5 or 7 days. In the OVX group, urinary excretion of deoxypyridinoline (D-Pyr) tended to increase on day 1 after tail-suspension. In the OVX-E2 group, basal excretion was lower than that in the OVX group, and no increase was observed after the suspension. Serum concentrations of ionized calcium significantly increased on day 1 after the suspension in both groups. However, in the OVX-E2 group, the level tended to be higher than those in the OVX group from day 0 to day 3. Serum PTH tended to decrease on day 1 after suspension in the OVX group. In the OVX-E2 group, it did not change during the suspension, but the levels were higher than those in the OVX group during the experiment. Serum 1,25(OH)2D3 transiently and significantly increased on day 1 after suspension in both groups. However, in the OVX group, the level was significantly higher than that in the OVX-E2 group. These data indicate that estrogen treatment of ovariectomized rats modifies the changes in calcium metabolism induced by tail-suspension.

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