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PubMed1991

Relative anti-inflammatory effect of oral dexamethasone-beta-D-glucoside and dexamethasone in experimental inflammatory bowel disease in guinea-pigs.

The relative anti-inflammatory effect of dexamethasone and a prodrug, dexamethasone-beta-D-glucoside, has been assessed in guinea-pigs with experimentally-induced inflammatory bowel disease (IBD). The glucoside prodrug is designed to reach the large intestine following oral administration. The active agent is liberated when the prodrug is hydrolysed by glycosidases of colonic bacteria. Guinea-pigs were administered degraded carrageenan in their drinking water to produce experimental IBD. Starting on day 15, dexamethasone (1.3 mumol kg-1) or dexamethasone-beta-D-glucoside (1.3 or 0.65 mumol kg-1) was administered by gastric intubation once daily for 5 days. Relative to control animals, the drug and prodrug treatments significantly (P less than 0.05) reduced the total number of caecal ulcers. While there was no difference statistically between the drug and prodrug treatments, the data suggest that a lower dose of dexamethasone, administered as its glucoside prodrug, could reduce side-effects without reduced efficacy. These results support the hypothesis that localized delivery of dexamethasone to the large bowel can improve pharmacotherapy of IBD by reducing the side-effects associated with corticosteroids.

Animals↗
PubMed1999

Effects of dexamethasone and dexamethasone plus naltrexone on pituitary response to GnRH and TRH in normal women.

The hypothesis that glucocorticoids have a direct central inhibitory effect on the reproductive axis is sutained by the identification of glucocorticoid receptors on GnRH-secreting neurons and gonadotropic pituitary cells. It has been proposed that glucocorticoids and opioids interact centrally in the regulation of the GnRH-LH axis. The inhibitory effect of glucocorticoids may manifest not only directly through the hormone-receptor link, but also indirectly through an increase in opioid tone. The aim of this study was to evaluate the role of glucocorticoids and glucocorticoids combined with an opioid antagonist, in the regulation of basal and GnRH- and TRH-stimulated secretion of LH, FSH and Prl in 7 women with normal menstrual cycles. Blood samples were obtained every 10 min for an hour. GnRH (50 microgram) and TRH (200 microgram) were administered and blood sampling was continued every 15 min for 2 h (day 1). At 5 a.m. the next day, naltrexone (50 mg) was given and at 8 a.m. the GnRH-TRH test was repeated (day 2). At 5 a.m. on day 3, the patients took 2 mg oral dexamethasone and the test was repeated. At 5 a.m. on day 4, the patients took naltrexone and dexamethasone and at 8 a.m. the GnRH-TRH test was repeated. Administration of naltrexone did not cause significant changes in basal concentrations of LH and FSH and their response to GnRH. The area under the curve of the LH response to GnRH on day 3 was significantly less than on days 1, 2 and 4. Administration of naltrexone (day 2) did not cause any significant increase in basal and TRH-stimulated levels of Prl with respect to day 1. On day 3, dexamethasone caused a reduced response of Prl to TRH. Pretreatment with naltrexone (day 4) prevented this reduction. These results suggest that suppression of the response of LH to GnRH induced by dexamethasone may be partly mediated by endogenous opioids. Dexamethasone led to a reduction in the response of Prl to TRH, and naltrexone blocked this suppression. Hence the suppression of Prl and LH by dexamethasone must be partly mediated by endogenous opioids, which must therefore inhibit pituitary secretion of Prl.

Adult↗
PubMed1989

Results of the 8 a.m. dexamethasone suppression test constitute a suitable tool for confirming the diagnosis of melancholia. A test unaffected by the variations in the bioavailability of dexamethasone.

This prospective study was conducted in order (1) to examine which postdexamethasone cortisol value i.e., 8 a.m., 4 p.m. or peak cortisol - is most suitable as a laboratory test to help confirm the diagnosis of melancholia and (2) to investigate the influence of the dexamethasone levels in the results of the dexamethasone suppression test (DST). To this end we administered the DST to 48 controls and 115 depressed inpatients categorized according to DSM-III. The 8 a.m. and 4 p.m. dexamethasone levels were determined in 100 subjects. We found that an 8 a.m. postdexamethasone cortisol value greater than or equal to 3.5 micrograms/dl was of the most significant diagnostic value in order to separate melancholia from normal controls and/or minor depressives. The 8 a.m. and 4 p.m. dexamethasone values did not differ between healthy controls, minor and severely depressed patients. Although cortisol nonsuppressors exhibited significantly lower dexamethasone values, the predictive value of the DST for melancholia was not affected by the large variation in the bioavailability of dexamethasone.

Adult↗
PubMed1992

Ondansetron + dexamethasone vs metoclopramide + dexamethasone + diphenhydramine in prevention of cisplatin-induced emesis. Italian Group For Antiemetic Research.

Ondansetron, a selective serotonin-receptor antagonist, is an effective antiemetic for patients receiving high-dose cisplatin chemotherapy. However, no comparison has been made between a combination of a serotonin antagonist and dexamethasone, which also has antiemetic properties, with currently available antiemetic regimens. 289 consecutive cancer patients receiving cisplatin chemotherapy (much greater than 50 mg/m2) were randomised to receive one of the following intravenous antiemetic regimens: ondansetron 0.15 mg/kg, before and after cisplatin, + dexamethasone 20 mg before cisplatin (treatment A) or metoclopramide 3 mg/kg, before and after cisplatin, + dexamethasone + diphenhydramine 50 mg before cisplatin (treatment B). From day 2 to day 4, all patients received oral metoclopramide and intramuscular dexamethasone. 267 patients (136 receiving treatment A and 131 treatment (B) were available for analysis. Complete protection against emesis was achieved in 107 (78.7%) and 78 (59.5%) patients, respectively (p less than 0.002). Complete protection was also significantly superior for treatment A on day 2 (83.9% vs 68.0%; p less than 0.006). Complete protection from acute nausea (first 24 h) was achieved in 105 patients (77.2%) with treatment A and in 86 (65.6%) with treatment B (p less than 0.051); complete protection from nausea and emesis was achieved in 94 (69.1%) patients and 66 (50.4%), respectively (p less than 0.003). Patients receiving treatment B noted significantly more sedation than patients receiving treatment A (11.8% vs 2.1%; p less than 0.005). Extrapyramidal reactions were present only with treatment B (2.7%). Ondansetron + dexamethasone is more effective and better tolerated than metoclopramide + dexamethasone + diphenhydramine in the prevention of cisplatin-induced nausea and emesis.

Administration, Oral↗
PubMed1987

[Detection of glucocorticoid receptors in leukemia cells by dexamethasone-induced cytolysis and [3H]-dexamethasone binding].

The presence of glucocorticoid receptors on the leukemic cells of 33 patients affected with acute lymphatic leukemia (ALL) and 6 patients affected with acute myeloic leukemia (AML) was investigated by dexamethasone-induced cytolysis and [3H] dexamethasone binding. The tests undertaken proved that after 20 hours of incubation 9 of 26 non-T-non-B-ALL (c-ALL and unclassified ALL) and 2 of AML were lysed with dexamethasone; blood lymphocytes and bone marrow leukocytes of healthy donors, however, were not affected. Non-T-non-B-ALL and AML were able to bind essentially more [3H] dexamethasone than T-ALL. There existed no correlation between dexamethasone binding and dexamethasone-induced cytolysis.

Cell Survival↗
PubMed1987

Effects of dexamethasone, levamisole, and dexamethasone-levamisole combination on neutrophil function in female goats.

Effects of dexamethasone, levamisole, or combined dexamethasone-levamisole administration on polymorphonuclear neutrophil (PMN) function in healthy, adult female goats were studied. Goats were assigned to treated (n = 6) and control (n = 6) groups. In experiment 1, treated goats were given levamisole (6 mg/kg of body weight, IM). In experiment 2, treated goats were given 0.1 mg of dexamethasone/kg, IV, for 3 consecutive days, 1 mg of dexamethasone/kg, IV, for 6 consecutive days, and 6 mg of levamisole/kg, IM, with a 4th injection of 1 mg of dexamethasone/kg. All injections were administered 12 hours before blood collection. The PMN were evaluated for random migration and chemotaxis under agarose, ingestion of Staphylococcus aureus, cytochrome C reduction, iodination, and antibody-dependent cell-mediated cytotoxicity. Levamisole alone did not alter the function of caprine PMN. Both doses of dexamethasone caused increased random migration and decreased cytochrome C reduction and iodination. Dexamethasone resulted in no changes in chemotaxis, S aureus ingestion, and antibody-dependent cell-mediated cytotoxicity. Random migration and cytochrome C reduction returned toward base line in cells from dexamethasone and levamisole-treated goats. Although iodination activity in cells from dexamethasone-treated goats remained significantly (P less than 0.05) lower than those of controls after levamisole administration, a rebound toward base-line activity occurred.

Animals↗
PubMed2001

Randomised comparison of ondansetron plus dexamethasone with dexamethasone alone for the control of delayed cisplatin-induced emesis.

The role of 5-hydroxytryptamine(3) (HT(3)) antagonists in the treatment of delayed emesis is still controversial. To evaluate whether 5-HT(3) antagonists can add to the efficacy of corticosteroids in controlling delayed emesis, we performed a randomised, prospective, open study comparing ondansetron plus dexamethasone with dexamethasone alone in cisplatin-treated patients. 149 cisplatin-naïve patients with lung cancer received at least 60 mg/m(2) of cisplatin and were treated with dexamethasone 32 mg intravenously (i.v.) and granisetron 3 mg i.v. on day 1. Patients were randomly assigned to receive either dexamethasone 16 mg i.v. alone (arm A) or dexamethasone plus ondansetron 8 mg daily (arm B) on days 2-4. None of the efficacy variables related to control of delayed emesis differed significantly between the two arms. In conclusion, there does not appear to be sufficient evidence to support the prolonged use of 5-HT(3) receptor antagonists after 24 h of cisplatin-containing chemotherapy.

Administration, Oral↗
PubMed1996

The antiemetic efficacy of tropisetron plus dexamethasone as compared with conventional metoclopramide-dexamethasone combination in Orientals receiving cisplatin chemotherapy: a randomized crossover trial.

1. We report a single-blind randomized crossover trial comparing the efficacy of tropisetron plus dexamethasone (TROPDEX) vs conventional combination of metoclopramide, dexamethasone and diphenhydramine (METDEX) in prevention of acute and delayed vomiting in Chinese patients receiving high dose cisplatin. 2. Thirty-six consecutive patients with nasopharyngeal carcinoma were entered into the study, all received cisplatin at a dose range of 60-100 mg/m2. Patients were randomized in the sequence of antiemetic regimens used in two consecutive cycles. 3. The TROPDEX regimen consisting of tropisetron 5 mg i.v. and dexamethasone 20 mg i.v. given on day 1 of chemotherapy, followed by oral maintenance with tropisetron 5 mg daily and dexamethasone 4 mg twice daily from day 2 to 6. The METDEX regimen consisting of metoclopramide 1 mg kg-1 i.v., dexamethasone 20 mg i.v. and diphenhydramine 25 mg i.v. given before chemotherapy and then 2 hourly for two more doses on day 1, followed by oral metoclopramide 20 mg 6 hourly from day 2 to 6. 4. Complete control of acute vomiting was observed in 64% of patients with TROPDEX as compared with 14% with METDEX (P < 0.01). While complete plus major control of acute vomiting was observed in 84% with TROPDEX as compared with 58% with METDEX. The mean vomiting episodes on day 1 were 1.4 with TROPDEX as compared with 3.5 with METDEX (P < 0.01). There was, however, no significant difference between the two regimens in the control of delayed vomiting. 5. When patients randomized to TROPDEX in the second cycle were compared with those with TROPDEX in the first cycle, the antiemetic efficacy was reduced, with mean acute vomiting episodes of 2 in the former compared with 0.8 in the latter (P < 0.01). 6. The most common adverse effect observed was headache in TROPDEX (27%) and dizziness in METDEX (40%). 7. In conclusion, the antiemetic regimen TROPDEX is effective in Chinese patients receiving high dose cisplatin chemotherapy and is well tolerated. It is better than conventional METDEX regimen in the control of acute vomiting, but not in the control of delayed vomiting.

Antiemetics↗
PubMed1988

Comparison of soluble dexamethasone sodium phosphate with free dexamethasone and indomethacin in treatment of experimental neoplastic spinal cord compression.

In an experimental rat model of neoplastic spinal cord compression, the in vivo effect of steroidal and nonsteroidal anti-inflammatory agents on the water content, prostaglandin E2 (PGE2) production, and specific gravity of the compressed cord segments were assessed, as well as the effect on the course of the disease. Paraplegic animals presented a consistent increase in the water content, PGE2 synthesis, and specific gravity in the compressed cord segments. The effect of treatment given on onset of paraplegia with either dexamethasone sodium phosphate (Dex-p; 10 mg/kg twice daily), or free dexamethasone (F-dex; 8.25 mg/kg twice daily) or indomethacin (10 mg/kg twice daily), was evaluated after 30 hours of therapy. Both F-dex and indomethacin eliminated spinal cord edema but varied in the rate of inhibitory effect on PGE2 production (dexamethasone less than indomethacin). Dexamethasone sodium phosphate failed to reduce spinal cord edema and PGE2 synthesis, but specific gravity changes were corrected by each of the administered agents. Evaluation of the effect of treatment on the course of the disease required dose reduction by 50% for Dex-p and F-dex, and to 25% for indomethacin, to avoid lethal toxicity. Treatment was started on appearance of the first sign of neurologic dysfunction (Grade 1) and continued to paraplegia (Grade 5). In the saline-treated rats, the mean time interval between Grades 1 and 5 was 2.7 +/- 0.3 days. Free dexamethasone, Dex-p, and indomethacin significantly prolonged this interval by 57%, 54%, and 48% respectively (P less than 0.005). The three agents differed in their ability to control the increases in water content and in PGE2 production, but proved almost equally effective in the prompt control of the specific gravity changes.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed2005

An RNA interference model of RPS19 deficiency in Diamond-Blackfan anemia recapitulates defective hematopoiesis and rescue by dexamethasone: identification of dexamethasone-responsive genes by microarray.

Diamond-Blackfan anemia (DBA), a congenital erythroblastopenia, is a model disease for the study of erythroid differentiation but is poorly understood. RPS19 is the only gene yet to have been associated with DBA, but its relevance to erythroid differentiation is unclear. The molecular basis for the stimulation of erythropoiesis by glucocorticoids in patients with DBA has not been identified. We demonstrate that targeted degradation of the RPS19 transcript, through retroviral expression of short hairpin RNAs (shRNAs), blocks the proliferation and differentiation of erythroid progenitor cells in cultured human CD34(+) cells. Treatment of RPS19-deficient cells with dexamethasone restores erythroid differentiation to normal levels. We investigated the molecular basis of pharmacologic therapies for DBA using oligonucleotide microarrays to survey gene expression in CD34(+) cells treated with combinations of dexamethasone, erythropoietin, stem cell factor, and interleukin-3. Dexamethasone did not alter expression of RPS19 but activated a genetic program that includes a set of key hematopoietic regulatory genes. Genes specific to erythroid progenitor cells were up-regulated by dexamethasone, while genes specific to nonerythroid lineages were down-regulated. Deficiency of RPS19 therefore blocks proliferation of immature erythroid progenitor cells, and dexamethasone activates proliferation of the same cell population through mechanisms independent of RPS19.

Anemia, Diamond-Blackfan↗
PubMed2001

Comparison of ondansetron-dexamethasone-lorazepam versus metoclopramide-dexamethasone-lorazepam in the control of cisplatin induced emesis.

The antiemetic effect of ondansetron-dexamethasone-lorazepam versus those of metoclopramide-dexamethasone-lorazepam were evaluated in 30 ovarian cancer patients undergoing treatment with the same chemotherapeutic regimen (cisplatin 60 mg/m2 and cyclophosphamide 700 mg/m2). Patients were randomly selected to receive either the ondansetron arm or the metoclopramide arm in their first cycle of chemotherapy, but were given an alternative combination in the second cycle. In the ondansetron arm, ondansetron was given 8 mg intravenously (i.v.) plus dexamethasone 20 mg i.v. and lorazepam 0.5 mg oral. For the metoclopramide arm, metoclopramide 10 mg was given i.v. plus dexamethasone 20 mg i.v. and lorazepam 0.5 mg oral. All antiemetics were given twice; 30 minutes before and 6 hours after chemotherapy. In the metoclopramide arm, metoclopramide 40 mg continuous infusion was also administered. During the acute phase, the ondansetron combination was significantly superior to the metoclopramide combination for all evaluation parameters. Complete control of emesis was 90 per cent vs 36.7 per cent, complete protection from nausea was 80 per cent vs 43.3 per cent, and complete protection from both nausea and vomiting was 73.3 per cent vs 30.0 per cent. Forty per cent of patients in the ondansetron arm did not complain of any adverse reaction compared to 13.4 per cent in the metoclopramide arm. It can be concluded, therefore, that a combination of ondansetron, dexamethasone and lorazepam appears to provide a significantly better emetic control with less adverse reaction than the metoclopramide combination in the acute nausea-vomiting phase after receiving cisplatin.

Adult↗
PubMed2003

[The effect of antiinflammatory therapy with dexamethasone and dexamethasone with pentoxifylline on the course of bacterial meningitis].

Despite of antimicrobial therapy mortality rate in the bacterial meningitis (BM) is high. The aim of the study was to assess the influence of anti-inflammatory treatment with dexamethasone and dexamethasone with pentoxifylline on the course of this disease and concentration of proinflammatory cytokines TNF-alpha, IL-1 beta, II-8 in the cerebrospinal fluid (CSF). 42 patients with the BM were analysed. They were divided into three groups on the basis of applied therapy: A--treated only with antibiotics, A+D--treated with antibiotics and dexamethasone, A+D+P--treated with antibiotics, dexamethasone and pentoxifylline. Anti-inflammatory therapy did not have impact on the resolution of inflammation (pleocytosis, protein and glucose level) in the CSF. However, it was established that adjuvant treatment with dexa-methasone and pentoxifylline has beneficial effect on the course of the BM. In this group 61.5% of patients recovered, in comparison with 28.6% in the group A+D and 26.7% in the group A. Mortality rate was: in the group A--33%, A+D--21.4%, A+D+P--7.7% (p = 0.01). Correlation between the outcome of the BM in the investigated groups and cytokines concentration in CSF was observed. In the group A+D+P all patients responded to the therapy with decrease of cytokine concentration, and coefficients of variation were low (TNF-alpha--1%, IL-1 beta--23.6%, IL-8--18.9%). Also in the group A+D decrease of cytokines concentration in the CSF was observed, however was not such significant in all cases. In the group of patients treated only with antibiotics concentration of cytokines in the CSF varied, even increased in some of them. Our investigation indicates that inhibition of cytokines production in central nervous system (CNS) with dexamethasone and pentoxifylline improves the outcome of BM and is associated with the reduction of neurological sequels and deaths.

Adult↗
PubMed1979

Quantitative dexamethasone and dexamethasone sodium phosphate determinations in pharmaceutical dosage forms by high-pressure liquid chromatography.

A high-pressure liquid chromatographic procedure for quantitative dexamethasone and dexamethasone sodium phosphate determinations in all types of commercially available pharmaceutical dosage forms was developed. The method also separates dexamethasone from its phosphate salt and separates dexamethasone or its salt from a number of inactive ingredients such as benzoic acid, benzyl alcohol, some colors, creatinine, and parabens. Inactive ingredient concentrations may be estimated without additional cost. Part of the parabens present in the commercial injections may be adsorbed by the rubber closures.

Chromatography, High Pressure Liquid↗
PubMed2002

Dexamethasone incorporating liposomes: an in vitro study of their applicability as a slow releasing delivery system of dexamethasone from covered metallic stents.

AIM: To investigate the possibility of covering PET-covered commercially available metallic stents, with liposomal dexamethasone that will act as a slow releasing drug-depot at the site of interest. METHODS: Large multilamellar (MLV), sonicated (SUV) and dried reconstituted (DRV) liposomes entrapping dexamethasone were prepared by thin film hydration, sonication and the DRV method, respectively, and applied on stents using a simple evaporation technique. Drug encapsulation and retention in liposomes were measured by HPLC. The presence of liposomes on the stent surface was confirmed by scanning electron microscopy, while the release of dexamethasone and lipid from the liposome-covered stent was evaluated under different conditions (flow rate, presence of plasma proteins), in an in vitro assembly that was developed to simulate in vivo conditions. RESULTS: The release of dexamethasone from liposome-covered stents ranged from 25% to 50% after 48 h of incubation in buffer, depending on the type of liposome. The release was highest from stents covered with DRV liposomes. When increasing the flow rate from 2 to 6 ml/min a slight increase in release of drug was observed, while a higher release was measured when stents were incubated in plasma proteins. Liposome size does not affect liposome placement on stents. CONCLUSION: The basic characteristics that should be considered when preparing liposomes to cover stents should be their drug loading capacity and their stability under the conditions prevailing at the site of interest. By preparing the appropriate formulation, it is possible that liposomal drugs may be used to cover stents and serve as drug releasing depots at the site of interest. Further in vitro and in vivo studies are needed in order to exploit the possible applications of this methodology.

Biocompatible Materials↗
PubMed2004

Comparison of topical tobramycin-dexamethasone with dexamethasone-neomycin-polymyxin and neomycin-polymyxin-gramicidin for control of inflammation after cataract surgery: results of a multicenter, prospective, three-arm, randomized, double-masked, controlled, parallel-group study.

BACKGROUND: Intraocular inflammation is typically treated with a combination of anti-inflammatory and anti-infective drugs. Tobramycin-dexamethasone (TD) has not been associated with any serious adverse events, indicating good tolerability. OBJECTIVE: The aims of this study were the following: (1) to demonstrate noninferiority of TD compared with dexamethasone-neomycin-polymyxin (DNP) in terms of anti-inflammatory efficacy, (2) to compare the anti-inflammatory efficacy of TD and DNP with that of a "placebo" control (antibiotic without anti-inflammatory agent), and (3) to provide additional safety data on TD. METHODS: This prospective, double-masked, parallel-group study was conducted at 22 ophthalmology clinics across Europe and Brazil. Patients aged > 18 years undergoing cataract surgery were randomly assigned, in a 2:2:1 ratio, to receive tobramycin 3 mg/mL plus dexamethasone 1 mg/mL, dexamethasone 1 mg/mL plus neomycin sulfate 3500 IU/mL plus polymyxin B sulfate 6000 IU/mL, or neomycin sulfate 3500 IU/mL plus polymyxin B sulfate 7500 IU/mL plus gramicidin 20 microg/mL. All treatments were given as 1 drop instilled in the operated eye q.i.d. for 21 days. The primary efficacy end point, intraocular inflammation (determined using the sum of scores on anterior chamber cells and aqueous flare), was assessed at days 3, 8, 14, and 21 after surgery. RESULTS: A total of 271 patients were enrolled (158 women, 113 men; age range 42-90 years) (TD, 104 patients; DNP, 110 patients; and neomycin-polymyxin-gramicidin [NPG], 57 patients). Intraocular inflammation was similar in the TD and DNP groups at all time points. At days 8, 14, and 21, inflammation scores were significantly lower with TD than with NPG (all, P < 0.05). At day 8, the inflammation score was significantly lower with DNP than with NPG (P < 0.05). A greater number of patients receiving NPG experienced treatment-related ocular allergic reactions compared with patients receiving TD (P < 0.05). One patient receiving TD (1.0%) and 5 given NPG (9.0%) were withdrawn due to ocular allergic reactions. None of the patients experienced an increase in intraocular pressure > or =10 mm Hg from baseline. CONCLUSIONS: In this study of patients undergoing cataract surgery combination therapy with TD was noninferior to DNP and was well tolerated.

Administration, Topical↗
PubMed2001

Prospective randomized, double-blind comparative study of dexamethasone, ondansetron, and ondansetron plus dexamethasone as prophylactic antiemetic therapy in patients undergoing day-case gynaecological surgery.

Dexamethasone alone and in combination with selective 5-hydroxytryptamine receptor antagonists is of benefit in the prophylaxis of post-operative nausea and vomiting. In this study, the effectiveness of such a combination in comparison to either drug alone is investigated in day case gynaecological surgery. A total of 177 patients were randomized to three treatment groups: dexamethasone 8 mg, ondansetron 4 mg, and dexamethasone 8 mg plus ondansetron 4 mg. The only significant difference between groups was seen in the first 3 h when failure of prophylaxis was more frequent in patients who had received dexamethasone alone (P=0.0085; Fisher's exact probability test). Confidence interval analysis indicates a modest treatment effect for the combination and the decision whether to perform a larger study depends upon whether such an effect is clinically relevant.

Adult↗
PubMed1994

A randomized double-blind trial of ondansetron alone versus in combination with dexamethasone versus in combination with dexamethasone and lorazepam in the prevention of emesis due to cisplatin-based chemotherapy.

OBJECTIVE: To compare the effectiveness and side effects of antiemetic regimens using ondansetron alone (O) versus ondansetron plus dexamethasone (OD) versus ondansetron plus dexamethasone plus lorazepam (ODA) in the prevention of emesis induced by cisplatin-based chemotherapy. DESIGN: Randomized, double-blind trial. PATIENTS AND METHODS: In this study, 75 patients who were receiving cisplatin (60 mg/m2) on day 1 and 5-fluorouracil (1,000 mg/m2) on day 2 to day 6 were enrolled. Patients were randomized to one of three treatment regimens: O, OD, or ODA. The patients assigned to O regimen received ondansetron 8 mg intravenously as a loading dose 15 minutes prior to cisplatin, then 1 mg/h continuous i.v. infusion (24 mg/day) for 48 hours. OD regimen consisted of ondansetron given as above plus dexamethasone administered at a dose of 10 mg i.v. injection every 12 hours for 3 days. ODA regimen was OD regimen plus lorazepam administered at a dose of 0.5 mg orally every 6 hours for 3 days. To ensure blinding, O group patients received 10 ml placebo-saline i.v. injection every 12 hours for 3 days, and O and OD group patients received placebo tablets orally every 6 hours for 3 days. RESULTS: One patient did not receive assigned antiemetic regimen and was excluded from the analysis. In the acute phase, complete control of emesis was seen in 85% of all patients, and there was no significant difference among the three groups (p = .442). Complete control of nausea during the acute phase was achieved in 10 patients (41.2%) treated with O regimen alone, in 23 patients (92.0%) treated with OD regimen, and in 16 patients (64.0%) treated with ODA regimen (p < .001). In the delayed phase, 68% of patients who received the three-drug combination (ODA) and 56% of patients who received the two-drug combination (OD) obtained complete control of emesis, as opposed to 29% who were given ondansetron alone (p < .021). The incidences of headache, flushing, dry mouth, hiccups, and constipation were mild and tolerable and did not differ among the three groups. DISCUSSION: Ondansetron was very effective in the prevention of nausea and vomiting during the acute phase after cisplatin administration. In treating delayed nausea and vomiting, although the results of three regimens were still disappointing, the combination of ondansetron plus dexamethasone or plus lorazepam provided superior results. Patients who received the lorazepam-containing regimen appeared more comfortable and less restless than those who were given other regimens.

Adult↗
PubMed2006

Vincristine, doxorubicin, and dexamethasone or thalidomide plus dexamethasone for newly diagnosed patients with multiple myeloma?

Multiple myeloma (MM) is a malignant plasma cell tumor that is distributed at multiple sites within the bone marrow compartments. High-dose dexamethasone regimens [including vincristine, doxorubicin, and dexamethasone (VAD) chemotherapy] induce rapid responses, and have resulted in improved survival for many patients when followed by intensive therapy with autologous stem cell support early in the disease course. However, VAD have several disadvantages including the need for an intravenous indwelling catheter, which predisposes patients to catheter-related sepsis and thrombosis; most of the activity of VAD was from high-dose dexamethasone component. We enrolled all patients who fulfilled entire criteria for MM during the period between January 1997 and December 2005. The present study is a descriptive, retrospective, longitudinal, and observational one. The frequency of response (CR, VGPR/NCR, and PR) in the group of thalidomide and dexamethasone was 84.3% (CR 18.75% VGPR/NCR 18.75%, and PR 46.8%) being higher than VAD, 55% (CR 16%, VGPR/NCR 5%, and PR 34%). P = 0.0005. In summary, we conclude Thal/dex is an effective therapy in newly diagnosed MM inducing objective responses in over 84.3%.

Aged↗