Biomedical subjects

T Persson

Publications and source records attributed to T Persson.

At least 19 recordsLinked to original sources

PubMed1999

Interaction between voluntary and postural motor commands during perturbed lifting.

STUDY DESIGN: An experimental study was conducted to evaluate the effect of an unexpected postural perturbation during a lifting task. OBJECTIVES: To investigate electromyographic responses in the erector spinae to a postural perturbation, simulating slipping, during an ongoing voluntary lifting movement. It was hypothesized that specific combinations of voluntary movement and postural perturbation present a situation in which injury caused by a rapid switch between conflicting motor commands can occur. SUMMARY OF BACKGROUND DATA: Studies of postural perturbations have mainly focused on behavior during static tasks such as quiet, upright standing. To date, there are no published studies of the effect of a perturbation during an ongoing voluntary lifting movement. METHODS: Subjects standing on a movable platform were exposed to random perturbations while lifting a 20-kg load. Muscle activity was recorded from flexor and extensor muscles of the trunk and hip. Trunk flexion angle in the sagittal plane was recorded with a video system. RESULTS: Perturbations forward were followed by an increased activity in erector spinae superimposed on the background activation present during the lift, indicating that both the voluntary and postural motor programs caused an activation of erector spinae. During backward perturbation, however, there was a sudden cessation of erector spinae activity followed by an extended period of rapid electromyographic amplitude fluctuations while the trunk was flexing, indicating an eccentric contraction of the erector spinae. CONCLUSIONS: This erratic behavior with large electromyographic amplitude fluctuations in the erector spinae after a backward slip during lifting may indicate a rapid switch between voluntary and postural motor programs that require conflicting functions of the back muscles. This may cause rapid force changes in load-carrying tissue, particularly in those surrounding the spine, thus increasing the risk of slip-and-fall-related back injuries.

Adult↗

PubMed1999

Oral budesonide for prevention of postsurgical recurrence in Crohn's disease. The IOIBD Budesonide Study Group.

BACKGROUND & AIMS: Prevention of postoperative recurrence after resection for Crohn's disease (CD) would be of great clinical benefit. The efficacy of oral budesonide for prevention of endoscopic recurrence was evaluated in patients undergoing resection for ileal or ileocecal CD. METHODS: Sixty-three patients received budesonide and 66 received placebo in a double-blind, randomized trial with parallel groups. Ileocolonoscopy, including biopsy, was performed after 3 and 12 months. Indications for surgery were fibrostenosis (78 patients), disease activity (41), and other reasons (10). RESULTS: The frequency of endoscopic recurrence did not differ between the groups at 3 and 12 months. In patients with disease activity as indication for surgery, the endoscopic recurrence rate at the anastomosis was lower in the budesonide group at 3 months, although not significantly (21% vs. 47%; P = 0.11), and at 12 months (32% vs. 65%; P = 0.047). There was no such difference with respect to fibrostenosis as indication for surgery. No differences in adverse event patterns were found between the two groups. CONCLUSIONS: Oral budesonide, 6 mg daily, offered no benefit in prevention of endoscopic recurrence after surgery for ileal/ileocecal fibrostenotic CD but decreased the recurrence rate in patients who had undergone surgery for disease activity.

Adolescent↗

PubMed1999

Occupational magnetic field exposure and site-specific cancer incidence: a Swedish cohort study.

OBJECTIVE: Based on 1,596,959 men and 806,278 women, site-specific cancer incidence during 1971 through 1984 was analyzed in relation to occupational magnetic field exposure. The objective was to explore potential associations for cancer diseases beyond those extensively studied before (leukemia and brain tumors). METHODS: Exposure was assessed from Census information on occupations that were linked to a job exposure matrix based on measurements. In a basic analysis, three levels of exposure were used. In addition, subjects with a more definite low exposure were compared with an aggregate of occupations with more definite exposures. RESULTS: Observed associations were weak and there were no evident exposure-response relationships. For all cancer, an approximate 10% increase in risk was seen in the medium and high exposure groups. Several types of cancer were associated with exposure among men, including cancer of the colon, biliary passages and liver, larynx and lung, testis, kidney, urinary organs, malignant melanoma, non-melanoma skin cancer, astrocytoma III-IV. For women, associations were seen for cancer of the lung, breast, corpus uteri, malignant melanoma and chronic lymphocytic leukemia. CONCLUSIONS: In the analysis of occupations with a more definite exposure, the most notable finding for men was an increased risk of testicular cancer in young workers, and for women a clear association emerged for cancer of the corpus uteri. The outcome suggests an interaction with the endocrine/immune system.

Adult↗

PubMed1999

Oral prednisolone followed by inhaled budesonide in newly diagnosed pulmonary sarcoidosis: a double-blind, placebo-controlled multicenter study. Finnish Pulmonary Sarcoidosis Study Group.

STUDY OBJECTIVE: To evaluate the efficacy of oral prednisolone, followed by inhaled budesonide, in patients with newly diagnosed (<3 months) stage I and stage II pulmonary sarcoidosis. DESIGN: Double-blind, placebo-controlled, parallel-group, multicenter study. SETTING: Twenty pulmonary medicine departments in Finland. PATIENTS: One hundred eighty-nine adult patients were randomized to treatment. Patients with erythema nodosum or stage IV sarcoidosis (pulmonary fibrosis), and patients requiring immediate treatment with oral corticosteroids for extrapulmonary lesions or chronic illnesses were excluded. TREATMENT: The patients received either oral prednisolone for 3 months (20 mg/d for 8 weeks, 15 mg/d for 2 weeks, and 10 mg/d for 2 weeks) followed by inhaled budesonide (Pulmicort Turbuhaler; Astra Draco; Lund, Sweden) for 15 months at 800 microg bid, or placebo tablets followed by placebo inhaler therapy. MEASUREMENTS: Chest radiographs, lung volumes (FVC), diffusing capacity of the lung for carbon monoxide (D(LCO)), serum angiotensin-converting enzyme (SACE), and beta2-microglobulin at 3-month intervals. RESULTS: After 3 months of treatment, radiographic improvements were seen in the active-treatment group when compared to the placebo-treatment group. At 6 months, the difference was still statistically significant. Later, no differences were found. In patients with initial stage I lesions, neither the FVC nor the D(LCO) (the percent predicted mean values) changed during the study, as they were normal from the beginning. In patients with initial stage II disease, the difference in the FVC mean values between the groups also remained unchanged throughout the study. In stage II patients treated for 18 months, but not earlier, the difference in D(LCO) became statistically significant; the largest differences were seen in patients with initial FVC values <80% of predicted and D(LCO) values <75% of predicted. The decrease in SACE in the active-treated stage II patients was significantly larger than in the placebo-treated patients. No difference was observed in adverse events between the active-treated patients and the placebo-treated patients. CONCLUSION: Treatment is not required for patients with stage I disease. An initial treatment with prednisolone followed by long-term inhalation of budesonide is more effective than placebo in patients with stage II disease. Sequential oral and inhaled corticosteroid therapy may be an alternative treatment regimen for stage II sarcoidosis patients, rather than long-term oral corticosteroid therapy alone.

Administration, Inhalation↗

PubMed1999

Tetracycline and niacinamide: treatment alternatives in ocular cicatricial pemphigoid.

Cicatricial pemphigoid (CP) is one of the subepidermal autoimmune bullous dermatoses in which pathologic separation occurs between the epidermis and dermis. Ocular findings characteristic of CP include conjunctival cicatrization, subepithelial fibrosis, and symblepharon formation, which may progress to blindness. Ocular CP (OCP) is usually treated with steroids or immunosuppressive agents, which are problematic in and of themselves within the elderly population, which is most often afflicted with OCP. We describe the utility and effectiveness of therapy with tetracycline and niacinamide in elderly patients with OCP.

Administration, Oral↗

PubMed1998

A comparison of budesonide and mesalamine for active Crohn's disease. International Budesonide-Mesalamine Study Group.

BACKGROUND: Crohn's disease is often treated with glucocorticoids or mesalamine. We compared the efficacy and safety of controlled-ileal-release budesonide capsules and slow-release mesalamine tablets in patients with active Crohn's disease affecting the ileum, the ascending colon, or both. METHODS: In a double-blind, multicenter trial, we enrolled 182 patients with scores of 200 to 400 on the Crohn's Disease Activity Index (with higher scores indicating greater disease activity) and randomly assigned 93 to receive 9 mg of budesonide once daily and 89 to receive 2 g of mesalamine twice daily for 16 weeks. The primary efficacy variable was clinical remission, defined as a score of 150 or less on the Crohn's Disease Activity Index. RESULTS: In the analysis of all patients who received at least one dose of study drug, the rates of remission after 8 weeks of treatment were 69 percent in the budesonide group and 45 percent in the mesalamine group (P=0.001); the respective rates after 16 weeks of treatment were 62 percent and 36 percent (P<0.001). Seventy-seven patients in the budesonide group completed the 16 weeks of treatment, as compared with 50 patients in the mesalamine group (P<0.001). The numbers of patients with adverse events were similar in the two groups, but those assigned to budesonide had fewer severe adverse events. Among patients who completed 16 weeks of treatment, the morning plasma cortisol value was normal in 67 percent of budesonide-treated patients and 83 percent of mesalamine-treated patients (P=0.06); 90 percent and 100 percent, respectively, had normal increases in cortisol in response to cosyntropin (P=0.02). CONCLUSIONS: In patients with active Crohn's disease affecting the ileum, the ascending colon, or both, a controlled-ileal-release formulation of budesonide was more effective in inducing remission than a slow-release formulation of mesalamine.

Administration, Topical↗

PubMed1998

The complete triphosphate moiety of non-hydrolyzable substrate analogues is required for a conformational shift of the flexible C-terminus in E. coli dUTP pyrophosphatase.

The molecular mechanism of substrate analogue interaction with Escherichia coli dUTPase was investigated, using the non-hydrolyzable 2'-deoxyuridine 5'-(alpha,beta-imido)triphosphate (alpha,beta-imido-dUTP). Binding of this analogue induces a difference in the far UV circular dichroism (CD) spectrum arguing for a significant change in protein conformation. The spectral shift is strictly Mg2+-dependent, does not appear with dUDP instead of alpha,beta-imido-dUTP and is not elicited if the flexible C-terminal arm is deleted from the protein by limited tryptic digestion. Involvement of the C-terminal arm in alpha,beta-imido-dUTP binding is consistent with the finding that this analogue protects against tryptic hydrolysis at Arg-141. Near UV CD of ligand-enzyme complexes reveals a characteristic difference in the microenvironments of enzyme-bound dUDP and alpha,beta-imido-dUTP, a difference not observable in C-terminally truncated dUTPase. The results suggest that (i) closing of the active site during the catalytic cycle, through the movement of the C-terminal arm, requires the presence of the complete triphosphate moiety of the substrate in complex with Mg2+, and (ii) after catalytic cleavage the active site pops open to facilitate product release.

Binding Sites↗

PubMed1998

Budesonide enema for the treatment of active, distal ulcerative colitis and proctitis: a dose-ranging study. U.S. Budesonide enema study group.

BACKGROUND & AIMS: Budesonide is a highly potent topical glucocorticosteroid that is characterized by low systemic availability as a result of high first-pass hepatic metabolism. The aim of this study was to evaluate the efficacy and safety of three doses of an enema preparation of budesonide in patients with active distal ulcerative colitis/proctitis. METHODS: In a double-blind multicenter trial, 233 patients were randomized to receive either a placebo enema or budesonide enema at a dose of 0.5 mg/100 mL, 2.0 mg/100 mL, or 8.0 mg/100 mL. The primary efficacy variables were an improvement of sigmoidoscopic inflammation grade, total histopathology score, and remission rates. Effects on cortisol concentrations were also assessed. RESULTS: After 6 weeks of treatment, there was significant improvement in sigmoidoscopy and histopathology scores in the budesonide 2.0-mg and 8.0-mg dose groups compared with placebo. Remission was achieved in 19% of patients in the 2.0-mg budesonide group (P </= 0.050) and 27% of patients in the 8.0-mg budesonide group (P </= 0.001) compared with 4% in the placebo group. More than 90% of all budesonide patients had a normal adrenocorticotropin (ACTH)-stimulated cortisol response at the last visit. The budesonide enemas were well tolerated. CONCLUSIONS: Budesonide enema is both effective and safe for the treatment of active distal ulcerative colitis/proctitis. A dose of 2. 0 mg/100 mL budesonide is the lowest effective dose.

Adult↗

PubMed1998

Determination of 2'-hydroxyl and phosphate groups important for aminoacylation of Escherichia coli tRNAAsp: a nucleotide analogue interference study.

2'-Deoxynucleoside 5'-a-thiotriphosphates have been incorporated randomly, replacing any of the four nucleotides separately and at a low level in Escherichia colitRNA(AsP)transcripts. After some tRNAs were charged with the cognate aminoacyl-tRNA synthetase and biotinylated, charged and uncharged tRNAs were separated by binding to Streptavidin. A comparison of the iodine cleavage pattern of charged and uncharged tRNAs indicated positions of 2'-deoxyphosphorothioate interference with charging. To separate the 2'-deoxy from the phosphorothioate effect, the same sequence of reactions was performed with the corresponding NTPalphaS. Several positions were identified with a 2'-deoxy or a phosphorothioate effect. tRNAs with single deoxy substitutions at the identified positions were prepared by enzymatic ligation of chemically synthesized halves. The kinetics of charging these tRNAs were determined. The 2'-deoxy effects identified by the interference assay were confirmed, showing a reduction in charging efficiency of between 2.5-6-fold, except for the terminal A76 with a 25-fold reduction. Inspection of the X-ray structure of the tRNA-synthetase complex showed consistency of most of these findings. Critical 2'-deoxy groups are localized mainly on the proposed contact surface with the synthetase or at the interface of the two tRNA domains. The same overall picture emerged for critical phosphorothioates. With the exception of 2'-deoxy-adenosine-containing tRNAs, multiple 2'-deoxy-substituted tRNAs, prepared by ligation of halves, showed a much larger reduction in charging efficiency than the mono-substituted tRNAs, indicating an additive effect.

Adenosine↗

PubMed1998

Oral budesonide as maintenance therapy in Crohn's disease--results of a 12-month study. Global Budesonide Study Group.

BACKGROUND: Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid inactivation. We have assessed the efficacy and safety of an oral controlled ileal release (CIR) preparation of budesonide for maintenance of remission in patients with ileal or ileocaecal Crohn's disease. METHODS: In a double-blind, multicentre trial, 75 patients in clinical remission (Crohn's Disease Activity Index, CDAI, < or = 150) were randomly assigned to receive placebo, budesonide 3 mg or budesonide 6 mg daily for 12 months. Trial drugs were given at a fixed dose and without concomitant medication. The primary outcome measure was relapse, defined as a CDAI > 150 together with an increase of at least 60 units from entry. A patient was also considered to have a relapse if withdrawn from the study due to clinical deterioration, whether or not a CDAI value could be calculated at that time. RESULTS: There were no statistically significant differences in the relapse rate at any time-point throughout the study. By 12 months the proportion of patients having relapsed were 48, 46 and 60% in those patients treated with budesonide 6 mg, 3 mg and placebo, respectively (N.S.). Treatments were well tolerated, and the proportion of patients with suppressed adrenal function (according to predetermined criteria) were 50% (6 mg), 26% (3 mg) and 17% (placebo) (P = 0.096). CONCLUSIONS: In the present study, relapse rate and time to relapse were similar in the patients treated with budesonide CIR, 6 mg daily or 3 mg daily or with placebo, throughout 12 months. This is in contrast to the two previous trials with identical design, where a significant effect of budesonide CIR in prolonging the median time to relapse was found. Possible reasons for the negative results of the present study include small sample size, and the fact that there was a high placebo response.

Adolescent↗

PubMed1997

The ankle strategy for postural control--a comparison between a model-based and a marker-based method.

When analysing postural control statistical characteristics of the centre of pressure or the ground reaction force are often used. A complement would be to analyse movement strategies as well. The purpose of this study was to determine to what extent the ankle strategy is used to maintain the balance in standing. One important question is if it is sufficient to use only force plate data in this determination, or if markers have to be used. To answer this question we studied two different methods--a marker-based method and a model-based method. The latter needs force plate data only as input to an inverted pendulum model. Different measures were calculated and used to draw conclusions of to what extent the ankle strategy was used. Experiments demonstrated that the data from the two methods provided the same general conclusions, although there were some differences in the estimated measures. By using the model-based method instead of tracking markers we can increase the clinical effectiveness considerably, get a lesser amount of data, and still get results comparable to the marker-based method.

Ankle↗

PubMed1997

Estimation of the knee joint location using colour video.

Analysis of the knee joint moment might be useful for predicting the risk of prosthetic loosening. The moment can be estimated if the location of the centre of pressure in the knee joint and the ground reaction force vector are known. Usually, skin mounted markers are used to locate the knee joint centre. Since marker based methods have several drawbacks investigations of alternative methods are needed. A new method for location of the knee joint is outlined in this paper. The subject is video filmed during gait with an elastic blue band wrapped around the knee. The band is located by splitting the video images into the RGB-components, and the centroid of the band is used as an estimate of the knee joint centre location. The band is easier to mount than markers, and it is not sensitive for axial leg rotation like markers are, which simplifies the analysis. If desired, the axial leg rotation can be determined by attaching a circular cyan marker on the band. The centroid of the marker relative to the band centroid gives an approximation of the leg rotation. In this study, the band could easily be located in the images and the leg axial rotation estimated in the frontal and the sagittal view showed the same trend. Further, the band-based results were found to be comparable to results where a marker was used to locate the knee joint centre.

Adult↗

PubMed1997

Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group.

BACKGROUND: The use of corticosteroids in active Crohn's disease often becomes limited by side effects. Budesonide is a potent corticosteroid with low systemic bioavailability due to an extensive first pass liver metabolism. AIMS: To compare the efficacy and safety of two dosage regimens of budesonide and prednisolone in patients with active Crohn's disease affecting the ileum and/or the ascending colon. PATIENTS AND METHODS: One hundred and seventy eight patients were randomised to receive budesonide controlled ileal release (CIR) capsules 9 mg once daily or 4.5 mg twice daily, or prednisolone tablets 40 mg once daily. The treatment period was 12 weeks. The primary efficacy variable was clinical remission, defined as a Crohn's Disease Activity Index (CDAI) of 150 or less. RESULTS: After eight weeks of treatment, remission occurred in 60% of patients receiving budesonide once daily or prednisolone and in 42% of those receiving budesonide twice daily (p = 0.062). The presence of glucocorticoid associated side effects was similar in all groups; however, moon face was more common in the prednisolone group (p = 0.0005). The highest frequency of impaired adrenal function, as measured by a short ACTH test, was found in the prednisolone group (p = 0.0023). CONCLUSIONS: Budesonide CIR, administered at 9 mg once daily or 4.5 mg twice daily, is comparable to prednisolone in inducing remission in active Crohn's disease. The single dose administration is as promptly effective as prednisolone and represents a simpler and safer therapeutic approach, with a considerable reduction in side effects.

Acute Disease↗

PubMed1996

A marker-free method for tracking human lower limb segments based on model matching.

A 2D marker-free method for tracking the human lower limb segments has been developed and tested. The method is based on model matching using distance transformations, and is intended for use in analysis of human gait. The model used consists of five line segments, which are matched to the contours of the lower limb segments. Experiments have been made on two different kinds of objects: a rigid model of a leg and a human leg. Only movement in the sagittal plane has been considered. An image sequence of the moving object was captured, and the method was used for tracking the segments of the object in each image. The results were then compared to data obtained using markers mounted at the ankle joint, the knee joint and the hip joint. The experiments on the rigid body were done to assess the accuracy of the method under perfect conditions. The average difference between the estimated joint positions and the reference positions was found to be less than 2 mm for all three joints, with a standard deviation of less than 1 mm. To test the method in a more realistic situation, it was applied to a human leg during the stance phase of walking. Measurements were made on three healthy male subjects. The average differences between the estimated joint positions and the reference marker positions were less than 6 mm, 10 mm and 22 mm, for the ankle joint, the knee joint, and the hip joint, respectively. The corresponding standard deviations were less than 4 mm, 7 mm and 9 mm, respectively. The satisfying results, though obtained controlled laboratory conditions, show that this method might be useful in gait analysis.

Adult↗

PubMed1996

Synthesis of 2'-deoxyuridine 5'-(alpha,beta-imido) triphosphate: a substrate analogue and potent inhibitor of dUTPase.

The dUDP analogue, 2'-deoxyuridine 5'-(alpha,beta-imido)diphosphate (dUPNP) was synthesized. The corresponding triphosphate analogue (dUPNPP) was prepared by enzymic phosphorylation of dUPNP using the enzyme pyruvate kinase and phosphoenolpyruvate as the phosphate donor. This method was successful in phosphorylating the imidodiphosphate analogue of 2'-deoxythymidine (dTPNP) to 2'-deoxythymidine 5'-(alpha, beta-imido)triphosphate (dTPNPP), in contradiction to a previous report. The properties of dUPNPP have been tested using the enzyme dUTPase from Escherichia coli. This enzyme, having a crucial role in nucleotide metabolism, is strictly specific for its substrate (dUTP) and catalyzes the hydrolysis of the alpha, beta-bridge, resulting in dUMP and pyrophosphate. Replacement of the alpha, beta-bridging oxygen in dUTP with an imido group resulted in a nonhydrolyzable substrate analogue and a potent competitive inhibitor of dUTPase (Ki = 5 microM). The analogue prepared (dUPNPP) may be utilized in crystallographic studies of the active site of dUTPase to provide knowledge about specific interactions involved in substrate binding and as a parental compound in design of dUTPase inhibition for medical purposes.

Creatine Kinase↗

PubMed1996

Oral budesonide as maintenance treatment for Crohn's disease: a placebo-controlled, dose-ranging study. Canadian Inflammatory Bowel Disease Study Group.

BACKGROUND & AIMS: Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid hepatic metabolism. The efficacy and safety of an oral controlled-release preparation of budesonide for maintenance of remission was evaluated in patients with ileal or ileocecal Crohn's disease. METHODS: In a double-blind, multicenter trial, 105 patients were randomly assigned to receive placebo or budesonide at doses of 3 or 6 mg daily for 1 year. The primary outcome measure was relapse defined by a Crohn's Disease Activity Index score of > 150 and a minimum increase of 60 points. RESULTS: Patients receiving 6 mg of budesonide had a median time to relapse or discontinuation of therapy of 178 days compared with 124 days in those receiving 3 mg of budesonide and 39 days in those receiving placebo. However, at 1 year, the rate of relapse in the group receiving 6 mg of budesonide was similar to the rates in the 3-mg and placebo groups. Basal plasma cortisol levels and incidence of corticosteroid-associated effects were similar in the three groups. CONCLUSIONS: Oral controlled-release budesonide (6 mg/day) was well tolerated and prolonged remission in Crohn's disease of the ileum and proximal colon, but this effect was not sustained at 1-year follow-up.

Administration, Oral↗

PubMed1996

Oral budesonide versus prednisolone in patients with active extensive and left-sided ulcerative colitis.

BACKGROUND & AIMS: Systemic glucocorticosteroids (GCSs) have proven efficacy in active ulcerative colitis but cause undesired systemic side effects. Therefore, new GCSs with high topical activity and a high rate of metabolism may be of clinical value in this condition. The aim of this study was to explore the efficacy and safety of the topically acting GCS budesonide in an oral controlled-release formulation in extensive or left-sided, mild to moderately active ulcerative colitis. METHODS: A 9-week, randomized, double-blind, controlled trial was performed, and treatments with 10 mg budesonide or 40 mg prednisolone daily, both gradually tapered, were compared. Endoscopic improvement and effect on endogenous plasma cortisol were assessed. RESULTS: Thirty-four patients were administered budesonide, and 38 patients were administered prednisolone. Mean endoscopic scores improved significantly in both groups but without difference between the groups. Five patients in the budesonide group and 7 patients in the prednisolone group deteriorated and were withdrawn from the study. Morning plasma cortisol levels were suppressed in the prednisolone group (entry, 449 nmol/L; 2 weeks, 116 nmol/L; 4 weeks, 195 nmol/L) but were unchanged in the budesonide group. CONCLUSIONS: The GCS budesonide administered in an oral controlled-release formulation seems to give an overall treatment result in active ulcerative colitis approaching that of prednisolone but without suppression of plasma cortisol levels. This concept merits further evaluation.

Administration, Oral↗

PubMed1996

Budesonide prolongs time to relapse in ileal and ileocaecal Crohn's disease. A placebo controlled one year study.

BACKGROUND AND AIMS: To evaluate the efficacy and safety of the topical corticosteroid budesonide, given in an oral controlled release formulation for maintenance of remission in patients with ileal and ileocaecal Crohn's disease (CD). PATIENTS AND METHODS: Out of 176 patients with active CD who had achieved remission (CD activity index score < or = 150) after 10 weeks' treatment with either budesonide or prednisolone, 90 were randomised to continue with once daily treatment of 6 mg budesonide, or 3 mg budesonide or placebo for up to 12 months in a double blind, multicentre trial. Time to symptomatic relapse was calculated using Kaplan-Meier estimates. Morning plasma cortisol was measured at clinic visits and a corticotropin stimulation test was performed after three months of treatment. RESULTS: Thirty two patients were allocated to the 6 mg budesonide group, 31 to the 3 mg group, and 27 to the placebo group. After three months, 19 per cent of the patients in the 6 mg group had relapsed, compared with 45 per cent in the 3 mg group and 44 per cent in the placebo group (p = 0.047). The corresponding results after 12 months was 59 per cent in the 6 mg budesonide group, 74 per cent in the 3 mg group, and 63 per cent in the placebo group (p = 0.44). The median time to relapse or discontinuation was 258 days in the 6 mg group, 139 days in the 3 mg group, and 92 days in the placebo group (p = 0.021). Mean morning plasma cortisol values increased from entry in all three groups with no statistically significant differences at 12 months. All 13 patients remaining in the placebo group after three months had a normal corticotropin stimulation response, compared with 18 of 23 patients in the 6 mg, and 19 of 21 in the 3 mg budesonide groups (p = 0.14). Acne and moon face were slightly more common in the budesonide groups. CONCLUSION: 6 mg budesonide once daily is significantly more efficacious than placebo in prolonging time to relapse in CD, and causes only minor systemic side effects.

Administration, Oral↗