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PubMed1997

The use of combined radiation therapy and hormonal therapy in the management of lymph node-positive prostate cancer.

PURPOSE: To determine the rate of tumor response and patterns of relapse following combined hormonal-radiation therapy of adenocarcinoma of the prostate and to measure the survival in a group of men with tumor metastatic to pelvic lymph nodes. METHODS AND MATERIALS: 66 patients with adenocarcinoma of the prostate with pathologically confirmed pelvic lymph node involvement were treated with combined radiation therapy and hormonal therapy. An additional five patients declined hormonal therapy. The patients treated with combined therapy represented a group with locally advanced disease including 44 patients (67%) with T3 or T4 tumors and 51 patients (80%) had N2 or N3 lymph node metastases. The pelvic lymph nodes were treated to a dose of 45 Gy and the prostate was boosted to a dose of 65 to 71 Gy. Hormonal therapy began up to 2 months before radiation and continued indefinitely. Patients were allowed to select their hormonal therapy and could choose DES (2 patients), orchiectomy (21 patients), LHRH agonist (7 patients) or combined androgen blockade (34 patients). RESULTS: Median follow-up is 49 months (range 12 to 131 months) and 21 patients have been followed for longer than 5 years. There have been 15 recurrences the entire group including three local recurrences in the prostate, seven patients with distant metastases, four patients with biochemical recurrences without clinical evidence of disease, and one patient where the location was unknown. Two of the PSA recurrences occurred in patients who elected to discontinue hormones after less than 3 years of therapy. The overall survival at 5 and 8 years is 94 and 84%, the clinical disease free survival is 85 and 67%, and the biochemical disease-free survival is 78 and 47%. There was no increased toxicity of the combined modality regimen compared to the expected effects of radiation and hormonal therapy. CONCLUSION: Combined hormonal and radiation therapy represents an effective treatment option for patients with adenocarcinoma of the prostate metastatic to pelvic lymph nodes. Combined modality therapy appears to extend the disease-free survival and allow patients to maintain their independent function.

Adenocarcinoma↗
PubMed2000

Four-cycle high-dose therapy with hematopoietic support for metastatic breast cancer: no improvement in outcomes compared with single-course high-dose therapy.

Multiple-cycle high-dose therapy with autologous hematopoietic progenitor cell (AHPC) support has been used to deliver dose-intensive therapy. We have used this approach as well as single-cycle high-dose therapy in treating patients with metastatic breast cancer. We present the outcomes of multiple-cycle high-dose therapies and compare them with those resulting from single-course high-dose therapies performed at a single institution. Fifty-five patients received 4 cycles of intensive chemotherapy with AHPC support. Three multicycle regimens were sequentially applied. Twenty patients were enrolled to receive 4 cycles of high-dose mitoxantrone, thiotepa, and cyclophosphamide. Nineteen subsequent patients received this regimen modified by the incorporation of paclitaxel. Sixteen patients received 2 cycles of high-dose melphalan, thiotepa, and paclitaxel and 2 cycles of mitoxantrone, thiotepa, and paclitaxel. The results of all 3 multiple-cycle therapies are compared with those of 55 contemporaneous patients with metastatic breast cancer who received a single course of high-dose cyclophosphamide and thiotepa or cyclophosphamide, cisplatin, and BCNU (carmustine) with hematopoietic cell rescue. Multiple-cycle therapy was associated with more infectious complications, increased transfusion requirements, and increased hospital admissions. However, there were no significant differences in outcomes between the groups. For 55 patients who received multiple-cycle therapy, the actuarial 3-year overall survival rate was 36% (95% confidence interval [CI] 23%-49%); freedom from progression and event-free survival were both 15% (CI 5%-25%). The median time to disease progression and median survival were 1.0 and 1.6 years, respectively. For the 55 patients who underwent a single course of high-dose therapy, the 3-year overall survival was also 36% (CI 18%-54%), whereas freedom from progression and event-free survival were both 19% (CI 7%-31%). The median time to progression and median survival were 0.8 and 2.2 years, respectively. Within the constraints of this patient population, the outcomes of 4 cycles of high-dose therapy with AHPC support were not superior to those resulting from single courses of high-dose therapy in the treatment of patients with metastatic breast cancer.

Adjuvants, Pharmaceutic↗
PubMed1999

HIV RNA and CD4 cell count response to protease inhibitor therapy in an urban AIDS clinic: response to both initial and salvage therapy.

OBJECTIVE: To determine the HIV RNA and CD4 cell response to both initial and salvage therapy with protease inhibitor-based therapy, and to examine the relationship between the virological response and pre-therapy characteristics. DESIGN: Observational cohort. SETTING: University-based public hospital AIDS clinic. PATIENTS: HIV-infected adults who received at least 16 continuous weeks' therapy with a potent protease inhibitor (indinavir, ritonavir or nelfinavir)-based regimen, and who have had at least 48 weeks of follow-up. MAIN OUTCOME MEASURES: Plasma HIV RNA and CD4 cell count response at week 48 of therapy for patients receiving their first protease inhibitor-containing regimen, and at week 24 of therapy with a salvage regimen. RESULTS: Of the 337 patients analysed, 170 (50.2%) had a successful outcome (HIV RNA <500 copies/ml after 48 weeks of treatment). Independent predictors of virological failure were higher baseline HIV RNA level, lower baseline CD4 cell count and failure to initiate at least one new nucleoside analog simultaneously at the time protease inhibitor therapy was initiated. The risk of failure increased incrementally across most HIV RNA and CD4 cell strata, with significant increases as the HIV RNA increased above 4.5 log10 copies/ml and the CD4 cell count fell below 100 cells/mm3 (P< or =0.01). The CD4 cell count remained above baseline to week 48 in most patients, regardless of the HIV RNA response. Of the 99 patients who experienced virological failure and switched to a salvage regimen, only 22 (22%) achieved an undetectable HIV RNA level 24 weeks after initiating salvage therapy. Independent predictors of failure with salvage therapy included an HIV RNA greater than 4.0 log10 RNA copies/ml at the time of the switch and failure to use a non-nucleoside reverse transcriptase inhibitor (NNRTI) in the salvage regimen. CONCLUSION: Failure of potent protease inhibitor therapy to suppress HIV RNA levels below detectable levels is common in clinical practice, and can often be explained by their suboptimal use. CD4 T cell counts remain above baseline for at least one year in most patients experiencing virological failure. Successful salvage therapy, which was uncommon, was associated with a low plasma HIV RNA at the time of the switch and the use of a new class of antiretroviral agents (NNRTI) in the salvage regimen.

Adult↗
PubMed2002

Cost effectiveness of implantable cardioverter defibrillator therapy versus drug therapy for patients at high risk of sudden cardiac death.

The implantable cardioverter defibrillator (ICD) is a therapy for patients at risk of sudden cardiac death due to ventricular tachycardia (VT) or ventricular fibrillation (VF). But the apparent high cost of ICD therapy relative to antiarrhythmic drugs such as amiodarone has raised questions about the cost effectiveness of ICD therapy versus drug therapy. To inform this debate we reviewed the literature on ICD cost effectiveness. An electronic and manual search was conducted for articles published since 1980 reporting original data on the cost effectiveness of ICD versus drug therapy for patients at risk of VT/VF. Data on costs and life-years gained were abstracted and studies were grouped into those that used decision-analysis models and those that were trial-based analyses. Cost-effectiveness ratios were inflated to 2001 US dollars. Nine studies were included in the review; five studies were modelling studies and four were part of randomised trials of ICD therapy. Studies varied in time horizon, but all except one indicated that ICD therapy was more costly than drug therapy. Early decision models assumed larger survival benefits than those observed in subsequent trials and therefore had attractive incremental cost-effectiveness ratios in the range of dollars US 27000 to dollars US 60000 per life-year gained. Trial-based studies, with the exception of one small trial, indicated cost per life-year gained in the range dollars US 44000 to dollars US 144000. Stratified analysis shows clearly that patients with a greater risk of mortality due to structural heart disease (e.g. left ventricular ejection fraction < or =35%) benefit more from ICD therapy and therefore have a more attractive cost effectiveness ratio than patients at lower risk. ICD therapy is still evolving over time with implant costs declining and device technology improving. Current evidence is that, in selected patients who are at high risk of VT/VF, ICD therapy can be a cost-effective option. Future research should focus on (i) patient selection to optimise benefits for available resources; and (ii) more comprehensive outcome measures to include health-related quality of life.

Anti-Arrhythmia Agents↗
PubMed2002

Successful discontinuation of therapy for disseminated Mycobacterium avium complex infection after effective antiretroviral therapy.

BACKGROUND: Highly active antiretroviral therapy (HAART) is associated with improvement or resolution of several HIV-associated opportunistic infections. Although prophylaxis against disseminated Mycobacterium avium complex infection may be successfully discontinued after a favorable response to HAART, the 1999 guidelines from the U.S. Public Health Service/Infectious Diseases Society of America recommend continuing therapy for disseminated M. avium complex infection, regardless of the response to HAART. OBJECTIVE: To examine the outcome among patients with disseminated M. avium complex infection whose antimycobacterial therapy was discontinued after a favorable response to HAART. DESIGN: Retrospective chart review between May 2000 and May 2001. SETTING: 13 Canadian HIV clinics. PATIENTS: 52 HIV-infected adults (43 men; mean age, 37.3 years) in whom successful antimycobacterial therapy for disseminated M. avium complex infection was discontinued after a favorable virologic response to HAART. MEASUREMENTS: Survival, survival free of disseminated M. avium complex infection, and CD4(+) cell count responses. RESULTS: At the time of diagnosis of disseminated M. avium complex infection, the median CD4(+) cell count was 0.016 x 10(9) cells/L, and the median plasma HIV RNA level was 90 000 copies/mL (plasma HIV RNA levels were available for only 21 patients). The patients received a median of 32 months of antimycobacterial therapy that included ethambutol plus either clarithromycin or azithromycin. When antimycobacterial therapy was discontinued, the median CD4(+) cell count was 0.23 x 10(9) cells/L and the median plasma HIV RNA level was less than 50 copies/mL. A median of 20 months after discontinuation of antimycobacterial therapy, only 1 patient had developed recurrent M. avium complex disease (37 months after stopping antimycobacterial therapy). This patient had stopped HAART 2 months earlier because of uncontrolled HIV viremia. Twenty months after stopping antimycobacterial therapy, the other 51 patients had a median CD4(+) cell count of 0.288 x 10(9) cells/L; 34 (67%) had undetectable plasma HIV RNA levels, and 8 (15%) had plasma HIV RNA levels of 50 to 1000 copies/mL. CONCLUSIONS: Discontinuation of successful disseminated M. avium complex therapy after a successful response to HAART is safe and reduces patients' pill burdens, potential drug adverse effects, drug interactions, and costs of therapy.

AIDS-Related Opportunistic Infections↗
PubMed2005

Comparisons between oral pulse alfacalcidol therapy and daily therapy in maintenance hemodialysis patients with secondary hyperparathyroidism: a randomized, controlled, and multicenter study.

OBJECTIVE: To investigate the efficacy and safety of 1alpha-(OH)-D3 high-dose pulse therapy or daily low-dose therapy in secondary hyperthyroidism in maintenance hemodialysis patients in China. METHODS: Maintenance hemodialysis patients of both gender with intact parathyroid hormone (iPTH) level above 200 pg/mL were randomly divided into a pulse group and a daily group. They were treated for 20 weeks, with 2 microg oral Alfacalcidol twice weekly or thrice weekly in the pulse group, and 0.5 microg oral Alfacalcidol per day in the daily group. The therapeutic end point was parathyroid hormone level < 200 pg/ mL. The iPTH levels during the study were monitored, and parameters representative of calcium and phosphate metabolism and side effects were also observed. RESULTS: One hundred and fifty-eight patients were initially enrolled, 91 in the pulse therapy group and 67 in the daily therapy group. There was no significant difference in age, hemodialysis duration, proportion of diabetic nephropathy and systemic diseases, proportion of patients who had received active vitamin D therapy previously, mean initial iPTH level (pulse group 570.47 +/- 295.86 pg/mL; daily group 498.33 +/- 207.84 pg/mL), serum calcium, serum phosphate, alkaline phosphatase (AKP), and albumin between two groups. In the pulse therapy group there were more patients with iPTH levels of 500 to approximately 1,000 pg/mL and > 1,000 pg/mL, so stratified analysis according to iPTH level was used. In therapeutic end point, iPTH levels in both groups were significantly lower compared with those before therapy (pulse group 261.29 +/- 234.97 pg/mL, P < .01; daily group 262.17 +/- 274.82 pg/mL, P < .01). After 4 weeks, the ratio of reaching end point in the pulse group was 35.2%, which was significantly higher than that (19.4%) in the daily group (P < .05). More obvious change was seen in the 200 to approximately 500 pg/mL subgroup by stratified analysis (P < .05), whereas there was no significant difference between the 500 to approximately 1,000 pg/mL and > 1,000 pg/mL subgroup (P > .05). At therapeutic end point, the total ratio of reaching end point did not differ between the two groups, and there were no obvious differences between each subgroup. In the iPTH 200 to approximately 500 pg/mL subgroup, mean iPTH%/week in the pulse group was significantly higher than that in the daily group, and no obvious difference was seen in other subgroups. AKP levels decreased significantly in both groups at therapeutic end point (pulse group 98.42 +/- 54.52 vs. 74.21 +/- 30.68 IU/L, P < .01; daily group 103.3 +/- 68.04 vs. 75.40 +/- 34.12 IU/L, P < .01). On the 4th week, AKP level in pulse group (82.39 +/- 35.23 IU/L) was significantly lower than the initial level (98.42 +/- 54.52 IU/L, P < .05), whereas in the daily group there was no difference between each week. The mean serum calcium, phosphate, and [Ca2+] x [P3+] levels in both groups did not change greatly. Nine patients in the pulse group (9.9%) and 8 patients in the daily group (11.9%) suffered hypercalcemia at least once. Persistent hypercalcemia occurred in 8 patients in the pulse group (8.8%) and 9 patients in the daily group (13.4%), but the difference in proportion did not show statistical significance. The serum phosphate in the daily group was higher after the therapy (1.74 +/- 0.36 vs. 1.89 +/- 0.36 mmol/L, P < .05), whereas that in the pulse group remained unchanged. At therapeutic end point, [Ca2+] x [P3+] level in the daily group was higher than that before the therapy (48.04 +/- 11.71 vs. 55.46 +/- 12.66, P < .05), whereas in the pulse group there was no significant difference. Side effects for both groups were minimal and well tolerated. CONCLUSIONS: Alfacalcidol [1alpha-(OH)-D3] has good and safe effects on secondary hyperparathyroidism in maintenance hemodialysis patients. The efficacy and early effects of pulse therapy are superior to those of daily therapy in moderate hyperparathyroidism patients.

Administration, Oral↗
PubMed1994

[Efficacy of interferon combined glycyrrhizin therapy in patients with chronic hepatitis C resistant to interferon therapy].

To assess the efficacy of interferon (IFN) combined with a large dose of glycyrrhizin (SNMC) therapy in patients with chronic hepatitis C who were resistant to interferon therapy alone, we studied 8 patients with chronic hepatitis C who did not respond to the initial interferon therapy. Initially all of 8 patients received 6 million units of alpha-IFN intramuscularly, three times a week, for 3 months and their serum alanine transaminase (ALT) did not decrease more than 50% at the end of therapy and returned to pretreatment levels after therapy. Six months later, all of these patients received alpha-IFN (6 MU) combined with 80 ml of SNMC intravenously, three times a week for 6 months. Prior to the initial IFN therapy alone, all of the patients were positive for anti-HCV and HCV RNA in the serum. With IFN therapy, serum HCV RNA became negative in 4 of 8 patients and HAI score decreased significantly although their ALT levels did not decrease more than 50%, while with IFN combined with SNMC therapy, ALT levels decreased approximately 70% in all patients (one became normal), serum HCV RNA became negative in 2 and HAI scores did not change significantly. There was no significant differences in decrease of HCV RNA titers and HAI scores between two therapy except the ALT levels. These findings suggest that IFN combined SNMC therapy does not appear to be more beneficial than IFN therapy alone.

Adult↗
PubMed1998

One-week proton pump inhibitor-based triple therapy eradicates residual Helicobacter pylori after failed dual therapy.

The purposes of this study were to assess the efficacy of a 1-week proton pump inhibitor (PPI)-based triple therapy after failure of dual therapy in Helicobacter pylori eradication, and to compare the effectiveness of clarithromycin and metronidazole in this regimen. Between January 1996 and March 1997, 67 patients with persistent H. pylori infection after a 2-week course of dual therapy (amoxicillin plus omeprazole) were enrolled. They were randomly assigned to receive amoxicillin (1000 mg twice daily) and omeprazole (20 mg twice daily) plus either metronidazole (500 mg twice daily) or clarithromycin (250 mg twice daily). Endoscopy was performed in each patient to assess the status of H. pylori using the rapid urease test (CLOtest) and the histologic findings before dual therapy, after dual therapy, and after triple therapy. H. pylori isolates were tested for antibiotic resistance when triple therapy failed. The 1-week triple therapy was well tolerated in both groups with no adverse effects severe enough to cause withdrawal from the trial. Residual H. pylori was eradicated in 94% (33/35) of patients in the clarithromycin group and 84% (27/32) in the metronidazole group; the difference was not statistically significant. All seven patients in whom triple therapy failed were infected with metronidazole-resistant isolates and two also had clarithromycin-resistant isolates. This 1-week triple therapy is safe and effective in eradicating residual H. pylori after dual therapy failure. Failure of the rescue regimen is related to antimicrobial agent resistance. Because of the high metronidazole resistance rate in Taiwan, clarithromycin appears to be more promising than metronidazole for the control of H. pylori.

Adult↗
PubMed1980

Chromosome studies on lymphocytes of patients under cytostatic therapy. II. Studies Using the BUDR-labelling technique in cytostatic interval therapy.

Lymphocyte cultures from the peripheral blood of 38 patients undergoing a cytostatic interval therapy with a regimen of methyl-CCNU (1-[2-chloroethyl-3-(4-methyl-cyclohexyl)]-1-nitrosourea), 5-fluorouracil, and vincristine (each 5-day course of therapy was followed by a therapy interval of 4 weeks) were supplied with 5-bromodeoxyuridine (BUDR) for the whole culture time to determine the sister chromatid labelling pattern. From a total of 92 individual blood samples sister chromatid exchange (SCE) studies were performed including analyses before the start of the therapy, and immediately and 4 weeks after each course of therapy. In addition, the frequency of first, second, and third metaphases in the 72-h cultures was estimated using the characteristic labelling patterns. A distinct increase of SCE frequency over the control level (i.e., lymphocyte cultures of patients before the start of therapy) was observed at all phases of therapy. It was clearly correlated with the number of courses of therapy up to course 7, later on the SCE rate remained more or less at the level reached. The influence of the composition of each drug regimen on the SCE rate was less pronounced than it was on the breakage rate. Moreover, although a clear correlation existed between the individual rates of breakage and SCE, the formation of the latter appeared to reflect a long-term effect of the therapy rather than did the formation of break aberrations. In addition, as the intercellular variability of the number of SCEs per cell was much higher than that of breaks, the interindividual variability (variation of the mean values for each patient) was small compared to the respective variability of breakage rates. The proportion of first, second, and third metaphases present in 72-h cultures evidently was influenced by single courses of therapy. The observed delay of proliferation was also reflected in different amounts of chromosome damage. Although the BUDR treatment enhanced the cytostatic effect of the therapy on the lymphocytes in culture rendering SCE analysis rather difficult in several cases, the other data of this study and in particular the experiences with the "long-term effect" make it imperative to include BUDR-labelling in further cytogenetic studies in subjects with exceptional exposure to chemicals. However, the SCE method can by no means, replace the classic cytogenetic analysis.

Adult↗
PubMed2005

Comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: a controlled, clinical effectiveness trial.

BACKGROUND: Childhood malnutrition is common in Malawi, and the standard treatment, which follows international guidelines, results in poor recovery rates. Higher recovery rates have been seen in pilot studies of home-based therapy with ready-to-use therapeutic food (RUTF). OBJECTIVE: The objective was to compare the recovery rates among children with moderate and severe wasting, kwashiorkor, or both receiving either home-based therapy with RUTF or standard inpatient therapy. DESIGN: A controlled, comparative, clinical effectiveness trial was conducted in southern Malawi with 1178 malnourished children. Children were systematically allocated to either standard therapy (186 children) or home-based therapy with RUTF (992 children) according to a stepped wedge design to control for bias introduced by the season of the year. Recovery, defined as reaching a weight-for-height z score > -2, and relapse or death were the primary outcomes. The rate of weight gain and the prevalence of fever, cough, and diarrhea were the secondary outcomes. RESULTS: Children who received home-based therapy with RUTF were more likely to achieve a weight-for-height z score > -2 than were those who received standard therapy (79% compared with 46%; P < 0.001) and were less likely to relapse or die (8.7% compared with 16.7%; P < 0.001). Children who received home-based therapy with RUTF had greater rates of weight gain (3.5 compared with 2.0 g . kg(-1) . d(-1); difference: 1.5; 95% CI: 1.0, 2.0 g . kg(-1) . d(-1)) and a lower prevalence of fever, cough, and diarrhea than did children who received standard therapy. CONCLUSION: Home-based therapy with RUTF is associated with better outcomes for childhood malnutrition than is standard therapy.

Child, Preschool↗
PubMed2005

Intravenous dexamethasone-cyclophosphamide pulse therapy in comparison with oral methylprednisolone-azathioprine therapy in patients with pemphigus: results of a multicenter prospectively randomized study.

BACKGROUND: Pemphigus is a potentially life-threatening autoimmune blistering skin disease usually treated with high-dose corticosteroids in combination with immunosuppressive drugs. In a multicenter, prospectively randomized study we compared efficacy and side effects of a dexamethasone-cyclophosphamide (D/C) pulse therapy with a methylprednisolone-azathioprine (M/A) therapy in 22 patients with newly diagnosed pemphigus vulgaris and pemphigus foliaceus. PATIENTS AND METHODS: The 11 patients of the M/A group were treated with daily doses of methylprednisolone (initially 2 mg/kg body weight) and azathioprine (2-2,5 mg/kg body weight) which were subsequently tapered. D/C pulse therapy in 11 patients consisted of intravenous administration of 100 mg dexamethasone/d on 3 consecutive days along with cyclophosphamide (500 mg) on day one. Pulses were initially repeated every 2-4 weeks and then at increasing intervals. In between the pulses, oral cyclophosphamide (50 mg) was given daily for 6 months. RESULTS: Within 24 months after treatment initiation, 5/11 patients of the D/C group had a remission (complete remissions after discontinuation of therapy in 3 patients) and 6/11 patients had a progression. In the M/A group, there were remissions in 9/11 patients (complete remissions after discontinuation of therapy in 3 patients) and progression in 1/11 patients. There were more relapses in M/A therapy after remission than in D/C therapy. Side effects were more common in the M/A group. These differences were not significant (p > 0,05). CONCLUSION: Because of the high number of progressions in patients treated with D/C therapy, we can not confirm the encouraging results of earlier reports about pulse D/C therapy. Nevertheless D/C therapy seemed to be better tolerated and, in case of primary efficacy, was associated with fewer recurrences than M/A therapy.

Administration, Oral↗
PubMed1996

Induction of antinuclear antibody after interferon therapy in patients with type-C chronic hepatitis: its relation to the efficacy of therapy.

BACKGROUND: The prevalence of antinuclear antibody (ANA) and interferon (IFN)-induced ANA has been documented in patients with chronic hepatitis C. In the present study we evaluated whether the induction pattern of ANA after IFN therapy is related to the efficacy of IFN therapy. METHODS: Forty-four patients with chronic hepatitis C were enrolled. Autoimmune hepatitis was excluded in all. ANA was measured every month before, during, and for 6 months after IFN therapy (total dose, 336-480 M units). RESULTS: Eight of the 44 (18%) patients were positive for ANA before IFN therapy (group I). In group I six of the eight ANA-positive patients showed an increase in ANA titers during the therapy. Twenty-two of 36 (61%) ANA-negative patients turned positive for ANA, with titers of 1:80 or less during IFN therapy (group II). In 14 of the 36 (39%) ANA-negative patients ANA remained negative throughout the therapy (group III). The rates of sustained responders with a negativity of serum hepatitis C virus RNA and with normal alanine aminotransferase levels for at least 6 months after the cessation of therapy in groups I, II, and III were 25%, 23%, and 21%, respectively, giving no significant difference in the efficacy of therapy. No serious side effect was observed during the therapy. CONCLUSIONS: Administration of IFN frequently produced an induction of ANA or an increase in its titer, which did not affect the efficacy of IFN therapy.

Antibodies, Antinuclear↗
PubMed2001

[A trial of new interferon therapy for the patients with chronic hepatitis C resistant to interferon therapy].

HCV-RNA clearance rates are reported to be about 30-40% of the patients treated with IFN for less than 6 months. But IFN therapy is ineffective for chronic hepatitis C patients with HCV-genotype 1b and a high virus load. We evaluated the efficacy of different IFN therapy compared with standard IFN therapy for chronic hepatitis C patients resistant to interferon therapy. That is, we assessed the following therapy; 1) prolonged IFN therapy, 2) IFN-beta therapy of twice a day, 3) IFN-beta therapy daily for 24 weeks, 4) combination therapy of IFN-alpha and IFN-beta. In some cases, these IFN therapies were effective than a standard IFN therapy.

Adult↗
PubMed1987

Therapy vs no therapy for bacteriuria in elderly ambulatory nonhospitalized women.

This prospective randomized study was undertaken to determine the efficacy of antimicrobial therapy compared with no therapy for bacteriuria in elderly ambulatory nonhospitalized women. Sixty-one women (mean age, 85.8 years) with bacteriuria were in the no therapy control group and 63 women (mean age, 85.8 years) with bacteriuria were in the therapy group; none had symptoms of urinary tract infection. One short course of antimicrobial therapy achieved a cure rate of 68.3% (43 of 63 women cured) two weeks after treatment. During the six-month follow-up period, ten (16.4%) of 61 women in the no therapy group and five (7.9%) of 63 women in the therapy group developed symptomatic urinary tract infection. At the time of six-month follow-up, 19 (34.5%) of 55 women in the no therapy group and 35 (63.6%) of 55 women in the therapy group did not have bacteriuria. We conclude that for asymptomatic bacteriuria in elderly ambulatory nonhospitalized women, short-course antimicrobial therapy is effective at two-week follow-up and that antimicrobial therapy can eliminate bacteriuria in most of these women for at least a six-month period.

Aged↗
PubMed1997

Comparison between conventional salvage therapy and high-dose therapy with autografting for recurrent or refractory Hodgkin's disease.

Sixty patients with Hodgkin's disease, refractory to or at first recurrence after chemotherapy, received cytoreductive therapy followed by high-dose etoposide, cyclophosphamide and either total body irradiation or carmustine and autografting (median follow-up, 3.6 years; range, 1.1 to 7.5 years). A matched conventional salvage group of 103 patients was selected from patients treated at Stanford University Medical Center between January 1976 and January 1989 (median follow-up, 10.3 years; range, 3.0 to 15.7 years). Overall survival (OS), event-free survival (EFS), and freedom from progression (FFP) at 4 years follow-up favored patients who received high-dose therapy compared with conventional salvage treatment (OS: 54% v 47%, P = .25; EFS: 53% v 27%, P < .01; FFP: 62% v 32%, P < .01). In Cox regression analysis, response to cytoreductive or salvage therapy and B symptoms at relapse were the most important predictors of OS. The use of high-dose therapy at relapse, a longer duration of remission, and favorable response to cytoreductive or salvage therapy were most predictive of superior FFP and EFS. These data from a single institution comparing conventional and high-dose therapy in matched patients demonstrate an advantage for high-dose therapy and autografting in the sustained control of Hodgkin's disease. As with primary therapy, it is difficult to demonstrate a statistically significant survival advantage, despite an apparently superior cure rate. However, patients failing induction therapy or relapsing within 1 year benefited significantly from high-dose therapy by all outcome measures (OS, EFS, FFP). As the transplant-related mortality rates decline in Hodgkin's disease, it is predicted that cure rates and late effects will become ultimate determinants of the success of high-dose therapy and autografting.

Adolescent↗
PubMed1997

[Nasal CPAP therapy of obstructive sleep apnea syndrome with expiratory pressure reduction: a prospective randomized study of acceptance of treatment during therapy initiation].

It is often difficult to achieve adequate acceptance of nasal continuous positive airway pressure (CPAP) therapy by patients with OSA. Many patients find it particularly inconvenient to expire against the treatment pressure. With this in mind, we have attempted to improve acceptance of CPAP therapy by using a bilevel system that reduces the treatment pressure during expiration. 52 patients were randomized either to initial treatment with CPAP therapy followed by bilevel treatment, or to treatment in reversed order. During bilevel therapy the ratio of inspiratory to expiratory pressure was fixed at 1:0.6. After each treatment the patients were interviewed on the basis of visual analogue scales to establish their subjective evaluation of such parameters as general well-being, quality of sleep, comparison of the respective treatment pressures, and possible preference for one of the two systems for long-term treatment. The minimal effective inspiratory treatment pressure during bilevel therapy (IPAP) and the minimal effective CPAP pressure were closely correlated (r = 0.89). There was no difference between the apnoea hypopnoea indices during CPAP therapy as compared with bilevel therapy. Most patients (57%) felt the treatment pressure with the bilevel system to be lower (p = 0.048). There were no differences in patients' well-being early in the morning, or in their assessment of sleep quality. The majority of patients (52%) preferred bilevel therapy for long term treatment, while 38% preferred CPAP therapy (n.s.). In a subgroup of 13 patients with a treatment pressure of > or = 10 mbar during CPAP therapy 10 patients (77%) gave preference to the bilevel system (n.s.). In a considerable number of patients the acceptance of treatment can be improved by using a bilevel system for initiation of nasal positive pressure therapy.

Adult↗
PubMed2000

Ultrasound therapy for acute ankle sprains.

BACKGROUND: Ultrasound is used in the treatment of a wide variety of musculoskeletal disorders. OBJECTIVES: To evaluate the effects of ultrasound therapy in the treatment of acute ankle sprains. SEARCH STRATEGY: MEDLINE and EMBASE up to December 1998 and databases of the Cochrane Rehabilitation and Related Therapies Field and Musculoskeletal Injuries Group were searched. This was supplemented with citation tracking, and contact with colleagues. Date of the most recent search: April 1999. SELECTION CRITERIA: Randomised or pseudo-randomised trials were included in the review if the following conditions were met: at least one study group was treated with active ultrasound; the study included patients with acute lateral ankle sprains; and outcome measures included general improvement, pain, swelling, functional disability, or range of motion. Final selection of papers was conducted by two independent reviewers. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality using a standardised checklist, and extracted data. Whenever possible, the results were analysed on an intention-to-treat basis. Fixed odds ratios together with 95% confidence intervals were calculated for dichotomous outcomes, and weighted or, where different scales were used, standardised mean differences together with 95% confidence intervals for continuous outcome measures. Pooling of data was undertaken where there was clinical homogeneity in terms of subjects, treatments, outcomes, and follow-up time points. MAIN RESULTS: The four included trials, involving 514 patients, were only of modest methodological quality. None of the three placebo-controlled trials (sham ultrasound) could demonstrate statistically significant differences between true and sham ultrasound therapy for any outcome measure at seven days of follow-up. The pooled odds ratio for general improvement was 1.19 (Peto fixed effects model, 95% confidence interval 0.73 to 1.93) for the comparison between ultrasound and sham ultrasound. The differences between intervention groups were generally small, between 0 and 6% for most dichotomous outcomes. However, one trial reported relatively large differences for pain free status (20%) and swelling (25%) in favour of ultrasound treatment. REVIEWER'S CONCLUSIONS: The extent and quality of the available evidence for the effects of ultrasound therapy for acute ankle sprains are limited. The results of three placebo-controlled trials do not support the use of ultrasound in the treatment of ankle sprains. The magnitude of most reported treatment effects appeared to be small, and may be of limited clinical importance. As yet, only few trials are available and no conclusions can be made regarding an optimal and adequate dosage schedule for ultrasound therapy, and whether such a schedule would improve on the reported effectiveness of ultrasound for ankle sprains.

Ankle Injuries↗
PubMedDate not supplied

Modeling the annual costs of postmenopausal prevention therapy: raloxifene, alendronate, or estrogen-progestin therapy.

OBJECTIVE: To estimate the annual cost and outcome impacts attributable to raloxifene, alendronate, and estrogen-progestin therapy as prevention therapies among postmenopausal women over the first 7 years of hormone replacement therapy (HRT). METHODS: A budget-impact model was devised to compare the costs, benefits, and costs per event avoided for various postmenopausal therapies (raloxifene, alendronate, or estrogen-progestin combination therapy), compared to no intervention, taking into account the persistency rates. Net costs are direct medical costs attributable to treatments relative to no intervention. Net benefits are defined as the number of events avoided as a result of therapy. The main outcome measures are annual total net costs, net benefits, and costs per event avoided compared to no intervention among postmenopausal white women with intact uteri and normal baseline risks for osteoporotic hip or vertebral fractures, fatal or nonfatal myocardial infarction, and breast cancer. Data and model assumptions are based on clinical trial data and published retrospective studies. RESULTS: The average annual net cost of therapy declines after the first year of therapy for all interventions, primarily due to discontinuation, and continues to decline over time due to savings in medical costs for events avoided. Net events avoided are greater for raloxifene than alendronate, but HRT use results in net harm. The cost per event avoided is lower for raloxifene than alendronate. Improved persistence improves the cost-effectiveness for both interventions. Sensitivity analyses indicate the model results are most sensitive to the assumed impact of raloxifene on coronary heart disease and breast cancer risk. Alendronate as a prevention intervention is dominated by raloxifene under almost all model scenarios. CONCLUSION: The annual cost of long-term postmenopausal prevention therapy is highest during the first few years of therapy. Long-term prevention does not provide a return on investment in fewer than 3 years, but savings in medical costs partially offset intervention costs after 2 years. For postmenopausal women, pharmacologic interventions with multiple prevention benefits tend to be more cost effective than interventions with a single source of health benefit.

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