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PubMed2006

Oral naltrexone maintenance treatment for opioid dependence.

BACKGROUND: Research on the clinical application of oral naltrexone agrees on several things. From a pharmacological perspective, naltrexone works. From an applied perspective, however, this medication is not used since the medication compliance and the retention rates are very poor. OBJECTIVES: To evaluate the effects of naltrexone maintenance treatment versus placebo or other treatments in preventing relapse in opioid addicts after detoxification. SEARCH STRATEGY: We searched the Cochrane Drugs and Alcohol Group Register of Trials (January 2005), Cochrane Central Register of Controlled Trials (CENTRAL - The Cochrane Library Issue 1, 2005), MEDLINE (1973-first year of naltrexone use in humans- January 2005), EMBASE (1974- January 2005), PsycINFO (OVID-January 1985 to January 2004). We inspected reference lists of relevant articles and we contacted pharmaceutical producers of naltrexone, authors and other Cochrane review groups. SELECTION CRITERIA: All randomised and controlled clinical trials which focus on the use of naltrexone maintenance treatment versus placebo, or other treatments to reach sustained abstinence from opiate drugs DATA COLLECTION AND ANALYSIS: Three reviewers independently assessed studies for inclusion and extracted data. One reviewer carried out the qualitative assessments of the methodology of eligible studies using validated checklists. MAIN RESULTS: Ten studies, 696 participants, met the criteria for inclusion in this review. Only two studies described an adequate allocation concealment. The results show that naltrexone maintenance therapy alone or associated with psychosocial therapy is more efficacious that placebo alone or associated with psychosocial therapy in limiting the use of heroin during the treatment (RR 0,72 95% confidence interval 0.58 to 0.90). If we consider only the studies comparing naltrexone with placebo, the difference do not reach the statistical significancy, RR 0.79 (95%CI 0.59 to 1.06). With respect to the number of participants re incarcerated during the study period, the naltrexone associated with psychosocial therapy is more effective than the psychosocial treatment alone; RR 0.50 (95%CI 0.27 to 0.91). No statistically significant benefit was shown in terms of retention in treatment, side effects or relapse results at follow-up for any of the considered comparisons. AUTHORS' CONCLUSIONS: Unfortunately the studies did not provide an objective evaluation of naltrexone treatment in the field of opioid dependence. The conclusions are also limited due to the heterogeneity of the trials both in the interventions and in the assessment of outcomes.

Administration, Oral↗
PubMed2003

Methadone maintenance at different dosages for opioid dependence.

BACKGROUND: Methadone maintenance treatment (MMT) is a long term opioid replacement therapy, recognised as effective in the management of opioid dependence. Even if MMT at high dosage is recommended as therapy for reducing illicit opioid use and promoting longer retention in treatment, at present day "the organisation and regulation of the methadone maintenance treatment varies widely". OBJECTIVES: To evaluate the efficacy of different dosages of MMT for opioid dependence in modifying health and social outcomes and in promoting patients' familial, occupational and relational functioning. SEARCH STRATEGY: The following sources were scanned: - MEDLINE (OVID 1966-2001)- EMBASE (1988-2001)- ERIC (1988-2001)- Psychinfo (1947-2001)- Cochrane Controlled Trials Register (CCTR) (1947-2001)- Register of the Cochrane Drug and Alcohol Group (CDAG) (1947-2001)The CDAG search strategy was applied together with a specific MESH strategy. Further studies were searched through: letters to the authors of selected trials or to experts in order to obtain unpublished data. check of references of relevant reviews. SELECTION CRITERIA: Randomised Controlled Trials (RCT) and Controlled Prospective Studies (CPS) evaluating methadone maintenance at different dosages in the management of opioid dependence were included in the review. Non-randomised trials were included when proper adjustment for confounding factors was performed at the analysis stage. DATA COLLECTION AND ANALYSIS: Extraction of data was performed separately by two reviewers. Discrepancies were resolved by a third reviewer. RevMan software was used for analysis. Quality assessments of the methodology of studies were carried out using CDAG checklist. MAIN RESULTS: 22 studies were excluded from the review. 21 studies were included; of them, 11 were RCTs with 2279 people randomised and 10 were CPSs with 3715 people followed-up. OUTCOMES: Retention rate - RCTs: High vs low doses at shorter follow-ups: RR=1.36 [1.13,1.63], and at longer ones: RR=1.62 [0.95,2.77]. Opioid use (self reported), times/w - RCTs: high vs low doses WMD= -2.00 [-4.77,0.77] high vs middle doses WMD= -1.89[-3.43, -0.35] Opioid abstinence, (urine based) at >3-4 w - RCTs: high vs low ones: RR=1.59 [1.16,2.18] high vs middle doses RR=1.51[0.63,3.61] Cocaine abstinence (urine based) at >3-4 w - RCTs: high vs low doses RR=1.81 [1.15,2.85]Overdose mortality - CPSs: high dose vs low dose at 6 years follow up: RR=0.29 [0.02-5.34] high dose vs middle dose at 6 years follow up: RR=0.38 [0.02-9.34] middle dose vs low dose at 6 years follow up: RR=0.57 [0.06-5.06] REVIEWER'S CONCLUSIONS: Methadone dosages ranging from 60 to 100 mg/day are more effective than lower dosages in retaining patients and in reducing use of heroin and cocaine during treatment. To find the optimal dose is a clinical ability, but clinician must consider these conclusions in treatment strategies.

Controlled Clinical Trials as Topic↗
PubMed2001

Valproic acid, valproate and divalproex in the maintenance treatment of bipolar disorder.

BACKGROUND: Although lithium has been the most commonly used maintenance treatment in bipolar disorder for several decades, valproate is being used increasingly - especially in the United States of America. There is a need to clarify whether the increasingly prominent prophylactic role of valproate in bipolar disorder is justified. OBJECTIVES: To review the effectiveness of valproate, relative to placebo, other mood stabilisers and antipsychotics, in the prevention and/or attenuation of acute episodes of bipolar disorder. The effectiveness of valproate was considered in terms of mood symptoms, mortality, general health, social functioning, adverse effects and overall acceptability to patients. SEARCH STRATEGY: The CCDAN group search strategy was used. The following databases were searched: The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), The Cochrane Controlled Clinical Trials Register (CCCTR), EMBASE, MEDLINE, LILACS, PsycLIT and Psyndex. Reference lists of relevant papers and major textbooks of mood disorder were examined. Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable published or unpublished trials. SELECTION CRITERIA: Randomised controlled trials which compared valproate with placebo, alternative mood stabilisers (including lithium and carbamazepine) or neuroleptics, where the stated intent of intervention was the maintenance treatment of bipolar disorder. Participants were males and females of all ages with a diagnosis of bipolar disorder however diagnosed, approximating to ICD 10 Code F31 and DSM IV 296, but including patients diagnosed as ICD-9 manic depressive psychosis and DSM-III and DSM-IIIR bipolar disorder. DATA COLLECTION AND ANALYSIS: Data were extracted from the original reports individually by two reviewers. The main outcomes to be assessed were: 1. The effectiveness of valproate treatment in preventing or attenuating further episodes of bipolar disorder, including its effectiveness in rapid cycling disorder. 2. The acceptability of valproate treatment to patients. 3. The prevalence of side-effects. 4. Mortality on valproate treatment. Outcomes concerning relapse/recurrence were analysed excluding data from discontinuation studies, which were to be analysed separately. Sub-group analyses were to be performed to examine the effects of valproate treatment in rapid cycling bipolar disorder and previous mood stabiliser non-responders. Data were analysed using Review Manager version 4.1. MAIN RESULTS: One trial of 12 months duration with 372 participants was identified comparing lithium, divalproex and placebo. It had several methodological limitations. The primary analysis of time to occurrence of mood episode described in the main trial report found no reliable difference between the treatments, although there was a trend for divalproex to be more effective than lithium. In the analysis in this review, patients taking divalproex who left the study because of the occurrence of an mood episode were significantly less in number than those on placebo (RRR 37%; RR 0.63; 95% CI 0.44 to 0.90). There was no significant difference in the numbers of patients in receipt of divalproex compared with those in receipt of lithium who left the study because they suffered any mood episode. (RRR 22%; RR 0.78; 95% C.I. 0.52 to 1.17). There was insufficient information to allow sub-group analyses of rapid-cycling disorder. The divalproex group had significantly more patients suffering tremor (RRI 223%; RR 3.23; 95% C.I. 1.85 to 5.62), weight gain (RRI 187%; RR 2.87; 95% C.I. 1.34 to 6.17) and alopecia (RRI 143%; RR 2.43; 95% C.I. 1.05 to 5.65) than the placebo group. In comparison with the lithium, divalproex was associated with more frequent sedation (RRI 58%; RR 1.58; 95% C.I. 1.08 to 2.32) and infection (RRI 107%; RR 2.07; 95% C.I. 1.16 to 3.68), but less suffered thirst (RRR 62%; RR 0.38; 95% C.I. 0.18 to 0.81) and polyuria (RRR 57%; RR 0.43; 95% C.I. 0.22 to 0.82). REVIEWER'S CONCLUSIONS: In view of the equivocal findings of this review, conclusions about the efficacy and acceptability of valproate compared to placebo and lithium cannot be made with any degree of confidence. With current evidence, patients and clinicians would probably wish to use lithium before valproate for maintenance treatment. At present, the observed shift of prescribing practice to valproate is not based on reliable evidence of efficacy

Antimanic Agents↗
PubMed2005

Heroin maintenance for chronic heroin dependents.

BACKGROUND: Many medications have been used for stabilizing heroin users: Methadone, Buprenorphine and LAAM. The present review focus on the prescription of heroin to heroin dependents. OBJECTIVES: To assess the efficacy and acceptability of heroin maintenance versus methadone or other substitution treatments for opioid dependence, in retaining patients in treatment; reducing the use of illicit substances and improving health and social functioning. SEARCH STRATEGY: The Cochrane Central Register of Trials (CENTRAL) issue 1, 2005; MEDLINE 1966-2005, EMBASE 1980-2005 and CINAHL till 2005 (on OVID) were searched. There was no language or publication year restrictions. Many researchers were contacted for information. SELECTION CRITERIA: Randomised controlled trials of heroin (alone or combined with methadone) maintenance treatment compared with any other pharmacological treatments for heroin dependents. DATA COLLECTION AND ANALYSIS: The trials were independently assessed for inclusion and methodological quality by the reviewers. Data were extracted independently and double checked. Studies were not pooled together because of heterogeneity. MAIN RESULTS: 2400 references were obtained and 20 studies were eligible, 4 met the inclusion criteria for a total of 577 patients. The studies could not be analysed cumulatively because of heterogeneity of interventions and outcomes. Retention in treatment: no groups difference was found in two studies; one study (N=96) found RR=2.82 (95% CI 1.70-4.68) favouring heroin; one study (N=235) found RR 0.79 (95%CI 0.68-0.90) favouring methadone. Relapse to illegal heroin use (self- reported): in one study people using heroin in treatment was 64% (heroin group)and 59% (methadone group); in the other study the RR of heroin use was 0.33 (95%CI 0.15-0.72) favouring heroin. Criminal offence: one study showed the potential of heroin prescription in reducing the risk of being charged RR 0.32 (95% CI 0.14-0.78). Social functioning: two studies did not show statistical difference between intervention groups, and two studies considered criminal offence and social functioning as part of a multidomain outcome measure showing improvements among those treated with heroin plus methadone over those on methadone only. AUTHORS' CONCLUSIONS: No definitive conclusions about the overall effectiveness of heroin prescription is possible. Results favouring heroin treatment come from studies conducted in countries where easily accessible Methadone Maintenance Treatment at effective dosages is available. In those studies heroin prescription was addressed to patients who had failed previous methadone treatments. The present review contains information about ongoing trials which results will be integrated as soon as available.

Heroin↗
PubMed2005

Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's Disease.

BACKGROUND: Prevention of relapses is a major issue in the management of Crohn's disease. Corticosteroids, the mainstay of treatment of acute exacerbations are not effective in the maintenance of remission and its chronic use is limited by numerous adverse events. A number of randomised controlled trials comparing various 5-ASA agents with either placebo or other drugs have had conflicting results. OBJECTIVES: To conduct a systematic review to evaluate the efficacy of oral 5-ASA agents for the maintenance of medically-induced remission in Crohn's disease. SEARCH STRATEGY: We searched MEDLINE (1966 to January 2004), EMBASE (1984-January 2004), the Cochrane Central Register of Controlled Trials from the Cochrane Library (Issue 1, 2004) and the IBD Review Group Specialized Trials Register. We hand-searched the articles cited in each publication. SELECTION CRITERIA: We included randomised controlled trials which compared oral 5-ASA agents with either placebo or sulphasalazine, with treatment durations of at least 6 months. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of methodological quality of each study were independently performed by two reviewers. Any disagreement among reviewers was resolved by consensus. The main outcome measure was the occurrence of relapse as defined by the primary studies. Odds ratios of relapse rates and their 95% confidence intervals were calculated. MAIN RESULTS: 5-ASA VERSUS PLACEBO. In the main analysis, we used as the denominator the total number of patients randomised. We assumed that participants who dropped out of the study, and on whom there was no post withdrawal information, had relapsed during the study period. Using the fixed effects model, the odds ratio for 6 studies where participants were followed up for 12 months was 1.00 (95%CI, 0.80 to 1.24). Using the random effects model in a sensitivity analysis had little effect on the results with an OR of 0.93 (95% CI, 0.65 to 1.33). For the seventh study where follow up was for 24 months, the odds ratio was 0.98; 95% CI, 0.51 to 1.90. In further sensitivity analyses, we analysed only participants who completed the study and ignored the dropouts. The odds ratio (fixed effects model) for the 6 studies where follow up was for 12 months was 0.74 (95% CI, 0.57 to 0.96), but using the random effects model, the OR was 0.68 (95% CI 0.45 to 1.02). The OR for the seventh study where follow up was for 24 months (Gendre 1993a), was 0.86; 95% CI, 0.42 to 1.78. 5-ASA VERSUS SULPHASALAZINE. We did not find any study that satisfied the inclusion criteria. AUTHORS' CONCLUSIONS: We found no evidence in this review to suggest that 5-ASA preparations are superior to placebo for the maintenance of medically-induced remission in patients with Crohn's disease. Therefore it appears that additional randomised trials of this regime are not justified.

Administration, Oral↗
PubMed2006

Tiagabine in the maintenance treatment of bipolar disorders.

BACKGROUND: Tiagabine, an anticonvulsant, has been reported to have efficacy in prophylactic treatment of bipolar disorder in case reports and in case series. OBJECTIVES: To review the efficacy and acceptability of tiagabine, relative to placebo, and other agents in the prevention and/or attenuation of episodes of bipolar affective disorder. The efficacy and acceptability of tiagabine were considered in terms of mood symptoms, mortality, general health, social functioning, adverse effects and overall acceptability to patients. SEARCH STRATEGY: The following databases were searched on 13-10-2005. The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Registers (CCDANCTR-Studies and CCDANCTR-References),The Cochrane Controlled Clinical Trials Register (CCCTR),EMBASE,MEDLINE,LILACS,PsycLIT andPsyndex. Reference lists of relevant papers and major textbooks of affective disorder were examined.Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable published or unpublished trials. Specialist journals and conference proceedings were handsearched. SELECTION CRITERIA: Randomised controlled trials which compare tiagabine with placebo, alternative mood stabilisers or antipsychotics, where the stated intent of intervention was the maintenance treatment of bipolar affective disorder, were sought. Bipolar patients, male and female, of all ages were to be included. DATA COLLECTION AND ANALYSIS: Data were to be extracted from the original reports if they met our inclusion criteria. The main outcomes to be assessed were:(1) The efficacy of tiagabine treatment in preventing or attenuating further episodes of bipolar affective disorder, including its efficacy in rapid cycling disorder.(2) The acceptability of tiagabine treatment to patients.(3) The prevalence of side effects.(4) Mortality, if any, on tiagabine treatment.Outcomes concerning relapse or recurrence were to be analysed excluding data from studies using discontinuation protocols, which were to be analysed separately. Sub-group analyses were to be performed to examine the effects of tiagabine treatment in rapid cycling bipolar disorder and previous mood stabiliser non-responders. Data were to be analysed using Review Manager version 4.2.8. MAIN RESULTS: No randomised controlled trials of tiagabine in the maintenance treatment of bipolar disorder were found. AUTHORS' CONCLUSIONS: There is an insufficient methodologically rigorous evidence base to provide guidance on the use of tiagabine in the maintenance treatment of bipolar disorder. There is a need for randomised controlled trials examining the therapeutic potential of this agent in bipolar disorder, after the nature of reported episodes of syncope or seizure in tiagabine-treated bipolar patients has been established.

Antimanic Agents↗
PubMed2002

Defective generation but normal maintenance of memory T cells in old mice.

The ability to maintain memory after encounter with antigen is one of the central features of the immune system. Immune memory generated during young age can be maintained well into old age. However, we know little about maintenance of immune memory generated during old age. In this study, we compared generation and maintenance of memory CD8 T cells in young (2-3-month-old) and aged (22-24-month-old) mice following acute lymphocytic choriomeningitis virus infection. We found that young mice made a more vigorous primary T cell response and generated higher levels of memory cells than old mice. However, once generated, memory CD8 T cells were maintained at stable levels in both young and old mice for more than 5 months. Interestingly, the generation of a secondary effector response in vivo was again slightly compromised in the old mice. Taken together, these results show that generation of T cell responses is compromised in old age, but maintenance of the pool of memory T cells is not affected by the aging process.

Aging↗
PubMed1991

Regenerative capacity of retinal cells and the maintenance of their differentiation.

Mechanisms underlying cell type stability and the capacity of retinal cells for transdifferentiation are discussed. It is shown that cells of amphibian pigmented epithelium can be transformed into retina or lens cells depending on the inducing cell type: the influence of retina enables them to be transformed into retina, the influence of lens epithelium, to lens cells (lentoids or lenses). This led to an attempt to discover the molecular character of cell action by means of transfilter induction in early gastrula ectoderm of Xenopus laevis. The results show that the induced cell types correspond to the main inducing cell type, around which a range of neighbouring cell types is produced; this has been shown for five different cell types. The inducing factors involved seem to show qualitative differences. It is probable that they play a stabilizing role in the maintenance of the differentiated state of tissues, since temporary dissociation into cells leads eye tissues to transdifferentiate into other types. Such molecular factors can play a significant role in the maintenance of the type of differentiation and also in conversion into other cell types. These mechanisms of maintenance are not restricted to interactions between molecules and cells, since membranes on the surface of the retina and pigmented epithelium contribute to their shaping and consequently to the stability of the cell type.

Animals↗
PubMed1990

Alternation of two doses of intravenous gammaglobulin in the maintenance treatment of patients with immune thrombocytopenic purpura: more is not always better.

Intravenous infusion of gammaglobulin (IVGG) has been shown to be effective in the maintenance treatment of children and adults with immune thrombocytopenic purpura (ITP). The objective of this treatment is not to increase the platelet count into the normal range but rather to keep the platelet count above a safe level, usually 20,000-30,000/microliters. This use requires periodic infusion whenever the platelet count falls. The dose of gammaglobulin in previous studies was 1 gm/kg/infusion in the majority of patients. This study compared doses of 0.5 and 1.0 gm/kg/infusion by alternating the two doses in the maintenance treatment of 11 patients with ITP. There was no significant difference in the duration of response following single IVGG infusion between these two doses. This finding suggests that there is no advantage to the greater dose of IVGG and will substantially lower the cost of as well as facilitating IVGG maintenance treatment. It was not possible to determine whether a lower dose would impact adversely on the curative potential of IVGG. This effect of IVGG has never been proved and, if it exists, may be mediated by a different mechanism from the acute platelet response.

Dose-Response Relationship, Drug↗
PubMed2006

Association between the DRD2 A1 allele and response to methadone and buprenorphine maintenance treatments.

The TaqI A polymorphism (A(1)) of the dopamine D(2) receptor gene (DRD2), although not a specific predictor of opioid dependence, has been strongly associated with high levels of prior heroin use and poor treatment outcomes among methadone maintenance patients. The aims of this study were to confirm these findings via a retrospective analysis of A(1) allele frequency in methadone (n = 46) and buprenorphine (n = 25) patients, and non-opioid-dependent controls (n = 95). Subjects were genotyped at the DRD2 TaqI A locus using PCR amplification followed by TaqI restriction enzyme digestion and gel electrophoresis. For methadone and buprenorphine subjects, heroin use (prior to treatment), treatment outcomes, and withdrawal occurrence were determined from comprehensive case notes. No significant differences in A(1) allele frequency (%) were observed between: methadone (19.6%), buprenorphine (18.0%), and control (17.9%) groups (P > 0.7); successful and poor treatment outcome groups, methadone: 20.0% and 19.2%, respectively (P = 1.0); buprenorphine: 18.4% and 20.0%, respectively (P = 1.0). Also, there were no significant relationships between TaqI A genotype and prior heroin use (P = 0.47). However, among the successful methadone subjects, significantly fewer A(1) allele carriers experienced withdrawal than non-A(1) carriers (P = 0.04). In conclusion, the DRD2 genotype effects did not affect opioid maintenance treatment outcomes. This suggests the need for a further prospective investigation into the role of the DRD2 A(1) allele in heroin use and response to maintenance pharmacotherapies for opioid dependence.

Adult↗
PubMed1987

Maintenance of adult rat ventral prostate in organ culture.

Androgens postpone the involution of prostatic tissue cultured in a chemically defined medium. However, after 1 week quantitative changes are accentuated and qualitative signs of involution appear. Other factors in addition to androgens are obviously needed for the adequate maintenance of the tissue. This study was aimed at the improvement of the culture conditions by adding insulin, corticosterone, epidermal growth factor, prolactin, and transferrin alone or in different combinations with testosterone and each other. A morphometric model developed for prostate culture was used, and maintenance and proliferation of the tissue were further followed by weighing the cultured explants and by measuring the incorporation of (3H) thymidine into DNA. The androgen dependency was seen in all the studied morphometric parameters at least for 2 weeks-i.e., in volume density and height of epithelium (VVEP and h), reflecting the epithelial maintenance, in volume density and width of interacinar tissue (VVIT and lambda AP), reflecting stromal tissue, and in volume density and diameter of lumen (VVLU and DLU), reflecting the secretory function. Testosterone (10(-7) M) also prevented partially the quantitative involution of the tissue within 2 weeks. Insulin, acting independently of androgen, was a potent mitogen, which, according to morphometric results, exerted its effect mainly on prostatic epithelium. Stratification of epithelium was frequently seen. Corticosterone had no effect on epithelian proliferation, but it probably stimulated secretion and inhibited the growth of stroma. By combining these three hormones it was possible to maintain not only the structure but also the amounts of tissue components practically unaltered at least for 2 weeks.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1993

Parenchymal cell proliferation and mechanisms for maintenance of granular duct and acinar cell populations in adult male mouse submandibular gland.

To evaluate proliferation as a factor in maintenance of parenchymal cell populations in adult male mouse submandibular glands, a variety of surveys were conducted following a pulse with 3H-thymidine. Striated granular duct (SGD) cells had the highest labeling index, followed by intercalated duct (ID) cells, then acinar (AC) cells, and granular duct (GD) cells had the lowest. These cell types showed from 30% to 60% completion of mitosis by 24 hr, with SGD, AC, and GD showing a likely second wave of mitosis sometime between 2 and 7 days after the pulse. About 40% of the pulse-labeled cells still remained as single cells at 42 days after the pulse. Repeat divisions in daughter cells of the primary labeled cells were very rare. A shift in the pattern of labeled cells at the ID-GD junction indicates that ID and SGD cells in this compartment are differentiating to GD cells. Further comparison of the magnitude of this conversion with the amount of noncompartmental GD cell proliferation provided a basis for calculating that approximately 70% of GD cell population maintenance occurs by self-proliferation, and the remaining 30% is contributed by differentiation from ID and SGD cells. A similar survey at the ID-acinus junction showed no evidence of conversion of ID cells to AC cells indicating that most, if not all, proliferative activity leading to AC cell population maintenance occurs by self-proliferation. Finally, based in part on structural changes at the ID-GD junction during the survey period, a pattern of cell conversion described as "in situ differentiation" is proposed. When this pattern is carried to fruition, this explains several structural features of the secretory complex typical to the male pattern submandibular gland. The proposed mechanism is supported by a three-dimensionally reconstructed sequence of likely intermediate structures.

Animals↗
PubMed1996

Therapy for the maintenance of remission in sixty-five patients with generalized Wegener's granulomatosis. Methotrexate versus trimethoprim/sulfamethoxazole.

OBJECTIVE: To compare the efficacy of low-dose intravenous (IV) methotrexate (MTX; 0.3 mg/kg once weekly), both with and without concomitant prednisone, versus daily oral trimethoprim/sulfamethoxazole (T/S; 160 mg of trimethoprim + 800 mg of sulfamethoxazole twice a day), with and without prednisone, in maintaining remission in patients with generalized Wegener's granulomatosis (WG). METHODS: In this study, 65 patients with generalized WG whose disease had entered remission with cyclophosphamide (CYC) and prednisone therapy were started on one of the following remission-maintenance regimens: MTX alone (group A; n = 22), T/S alone (group B; n = 24), MTX plus concomitant prednisone (group C; n = 11), and T/S plus concomitant prednisone (group D; n = 8). Clinical, radiographic, and seroimmunologic data were evaluated to assess the efficacy of the 4 regimens and to seek possible predictive factors concerning outcome in each group. RESULTS: Partial or complete remission was maintained in 86% of the patients in group A, but in only 58% of those in group B (P < 0.05). In group C, 91% of patients remained in remission, which is in sharp contrast to group D, in which all patients experienced a relapse after a median of 14.5 months (P < 0.005). Side effects occurred twice as often with MTX (n = 12) as with T/S (n = 6) treatment and could usually be resolved by supplemental folinic acid. Two patients taking MTX and 3 patients taking T/S were withdrawn from the study medication because of side effects. In none of the patients were the adverse effects life threatening. No statistically significant factors predictive of poor outcome emerged in any group. CONCLUSION: Low-dose MTX was found to be superior to T/S for the safe and effective maintenance of remission in patients with generalized WG. The use of concomitant prednisone was not associated with a worse outcome with MTX treatment. Since T/S, especially with concomitant prednisone, seemed to increase the chance of relapse, neither T/S alone nor T/S plus prednisone can be recommended for the maintenance of remission in patients with generalized WG.

Adolescent↗
PubMed2004

Mycophenolate mofetil for remission maintenance in the treatment of Wegener's granulomatosis.

OBJECTIVE: To examine the safety of mycophenolate mofetil (MMF) for remission maintenance in patients with Wegener's granulomatosis (WG) who had been treated with daily cyclophosphamide (CYC) and glucocorticoids to induce remission. METHODS: Fourteen patients were treated for active WG using a standardized regimen of CYC and glucocorticoids for induction of remission and MMF for remission maintenance. Outcome was assessed using predetermined definitions based on clinical characteristics and pathologic, laboratory, and radiographic findings. RESULTS: Remission occurred in all 14 patients (100%) at a median time of 3 months. The median time to discontinuation of glucocorticoids was 8 months. No patients died during protocol treatment and 6 patients (43%) relapsed at a median of 10 months after achieving remission. MMF was well tolerated and no patients had to be withdrawn as a result of medication toxicity. CONCLUSION: The use of CYC and glucocorticoids for induction of remission and MMF for remission maintenance was well tolerated, but disease relapses were observed.

Adult↗
PubMed2002

Step-down approach using either cyclosporin A or methotrexate as maintenance therapy in early rheumatoid arthritis.

OBJECTIVE: To evaluate the feasibility and outcome of the step-down approach using either cyclosporin A (CSA) or methotrexate (MTX) as maintenance therapy following 6 months treatment with these 2 agents in combination in early, nonerosive rheumatoid arthritis (RA). METHODS: Fifty-seven patients younger than 65 years with early, nonerosive RA were first treated with CSA and MTX in combination for 6 months. They were then randomly stepped down to single-agent maintenance treatment for another 18 months. Safety, clinical efficacy, survival on treatment, and radiographic progression were evaluated. RESULTS: When being treated with combination therapy, 7 of the 57 patients (12.3%) withdrew because of adverse events. Of the remaining 50 patients, 42 (84.0%) were American College of Rheumatology (ACR) 20% responders, 30 (60.0%) were ACR 50% responders, and 23 (46.0%) were ACR 70% responders. At month 6, 22 patients were randomized to CSA and 27 to MTX. During this trial period, the treatment was discontinued by 16 patients taking CSA (mainly because of loss of efficacy) and by 4 taking MTX. At month 24, the probability (+/- SEM) of survival on treatment was 0.273 +/- 0.09 for CSA and 0.852 +/- 0.07 for MTX. Of the 6 CSA patients who completed the trial, 4 (66.7%) were ACR 20% responders, and 3 (50%) were both ACR 50% and ACR 70% responders. Of the 23 completers in the MTX arm, 21 (91.3%) were ACR 20% responders, 18 (78.3%) were ACR 50%, and 10 (43.5%) were ACR 70% responders. The treatment was not responsible for severe adverse events. Radiography showed a slow progression in the damage score and number of eroded joints in both treatment groups. CONCLUSION: Stepping down to single agent maintenance therapy following 6 months of combination treatment with CSA and MTX in early RA was only successful with MTX. Because this treatment did not prevent some radiographic progression, other approaches (e.g., step-up approach) may be more appropriate in early RA.

Adult↗
PubMed1976

Yield and maintenance relations of yeast growth in the chemostat at superoptimal temperatures.

A model is proposed that accounts for the decreases in yield which occur in chemostat cultures of mesophilic yeasts at superoptimal growth temperatures. Two yield depressing effects were identified, one due to increased maintenance requirements by the viable fraction of the population, the other due to energy substrate dissipation by the nonviable function. The two effects are functions of the dilution rate, as is the fraction of nonviable cells. Experimental results were obtained on the yield, maintenance, and dissipation of energy substrate in a glucose-limited chemostat culture of a respiration-deficient mutant of Saccharomyces cerevisiae at 39 degrees C. The rates of glucose utilization for maintenance and for dissipation constituted, respectively, 33-28% and 15-9% of the total glucose utilization rate over the range of dilution rates tested (0.038-0.064 hr-1), while the yield varied over this range from 0.066-0.085 g of biomass (dry wt) per gram of glucose.

Glucose↗
PubMed2006

Inflammatory breast cancer outcome with epirubicin-based induction and maintenance chemotherapy: ten-year results from the French Adjuvant Study Group GETIS 02 Trial.

BACKGROUND: The authors evaluated the long-term efficacy and side effects in patients with nonmetastatic, unilateral, inflammatory breast cancer (IBC) who received homogeneous treatment with intensive induction chemotherapy followed by a maintenance regimen. METHODS: One hundred twenty patients were randomized to receive high-dose fluorouracil, epirubicin, and cyclophosphamide (FEC-HD) (fluorouracil 750 mg/m(2) on Days 1 to 4, epirubicin 35 mg/m(2) on Days 2 to 4, and cyclophosphamide 400 mg/m(2) on Days 2 to 4 for 4 cycles every 21 days) with or without lenograstim. Locoregional treatment consisted of surgery and/or radiotherapy. Maintenance chemotherapy was FEC 75 (fluorouracil 500 mg/m(2), epirubicin 75 mg/m(2), and cyclophosphamide 500 mg/m(2) on Day 1 every 21 days for 4 cycles). No hormone treatment was allowed. RESULTS: The safety of the FEC-HD regimen was described previously. Among 102 patients who underwent surgery, a pathologic complete response (pCR) was achieved by 23.5% of patients with breast tumors and by 31.4% of patients with involved axillary lymph nodes. The overall pCR rate was 14.7%. One hundred nine patients received FEC 75. After a median 10 years of follow-up, the disease-free survival (DFS) and overall survival (OS) rates were 35.7% and 41.2%, respectively. The median DFS was 39 months (95% confidence interval [95% CI], 25-53 months), and the median survival was 61 months (95% CI, 43-79 months). Five patients developed a temporary decrease in left ventricular ejection fraction without congestive heart failure. In the lenograstim group, 1 patient developed acute myeloblastic leukemia M2, and 1 patient developed myelodysplastic syndrome. CONCLUSIONS: FEC-HD induction chemotherapy followed by FEC 75 maintenance regimen had moderate and acute long-term toxicities and lead to high DFS and OS rates in patients with IBC.

Antineoplastic Combined Chemotherapy Protocols↗
PubMedDate not supplied

Maintenance cultures of Kupffer cells isolated from rats of various ages: ultrastructure, enzyme cytochemistry, and endocytosis.

Sinusoidal liver cells were isolated from the livers of 3-, 12-, 30-, and 36-month-old female BN/BiRij rats by enzymatic digestion. The Kupffer cells in the sinusoidal cel suspensions were purified by centrifugal elutriation and kept in maintenance culture for periods of up to about 3 weeks. The viability and yield of Kupffer cells per gram of body weight did not change with the age of the donor rat. The ultrastructural, cytochemical, and functional characteristics of Kupffer cells as observed in perfusion-fixed liver were retained during several days of maintenance culture. The consistent observation of worm-like structures in cultured Kupffer cells indicated the reformation of the specific fuzzy coat of the cells during culture. Endogenous peroxidatic and acid phosphatase activities were evident in cultured Kupffer cells and showed the same localization as observed in perfusion-fixed liver. Kupffer cells in culture were able to endocytose colloidal carbon, latex particles (0.8 micron), horseradish peroxidase, and endotoxin, indicating the reappearance of different types of specific membrane receptors. The ultrastructural appearance of Kupffer cells was not markedly influenced by the age of the donor rat. However, with increasing age, the lysosomes showed increasing amounts of electron dense lipid-like material and iron in the form of ferritin. No qualitative age-related changes in the enzymes tested or in the endocytic capacity of the Kupffer cells were observed. On the basis of these observations, maintenance cultures of purified Kupffer cells can be considered as a valuable model for studying Kupffer cell functions, also in relation to aging phenomena.

Aging↗