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Standard Regimen (standard + regimen)
Selected AbstractsOriginal Article: Prospective comparative study of single dose versus 3-day administration of antimicrobial prophylaxis in minimum incision endoscopic radical prostatectomyINTERNATIONAL JOURNAL OF UROLOGY, Issue 4 2008Mizuaki Sakura Objective: From the critical stand point against the overuse of antimicrobial agents, appropriate reduction of antimicrobial prophylaxis (AMP) should be considered. We have prospectively reduced AMP and evaluated the occurrence of surgical site infection (SSI) following radical retropubic prostatectomy (RRP) by minimum incision endoscopic surgery (MIES). Methods: A total of 101 consecutive patients who underwent MIES-RRP for prostate carcinoma were classified into two groups according to AMP dose. The 3-day group of 52 patients received tazobactam sodium/piperacillin sodium (TAZ/PIPC) 2.5 g intravenously before the operation and continued twice daily until postoperative day 2, and the single dose group of 49 patients received TAZ/PIPC 2.5 g intravenously only once before the operation. Additional antimicrobial agents were given only when SSI occurred. The occurrence of SSI and remote infection (RI) were analyzed. Results: There was no significant difference in the rate of SSI occurrence between the 3-day group (3.8%) and single dose group (6.1%) (P = 0.6). RI did not increase in the single dose group. Conclusion: Antimicrobial prophylaxis dose was successfully reduced without increasing SSI or RI. A single dose of AMP is feasible to prevent SSI and RI and would be a standard regimen in MIES-RRP. Active surveillance of postoperative infection is mandatory to promptly administer antimicrobial treatment as the need arises. [source] Changes in HIV RNA viral load, CD4+ T-cell counts, and levels of immune activation markers associated with anti-tuberculosis therapy and cotrimoxazole prophylaxis among HIV-infected tuberculosis patients in Abidjan, Côte d'IvoireJOURNAL OF MEDICAL VIROLOGY, Issue 2 2005Mireille Kalou We analyzed changes in plasma human immunodeficiency virus (HIV)-1 viral load, CD4+ T-cell count, and markers of immune activation markers at start of treatment of tuberculosis and 12 months after among 44 HIV-1-infected patients with newly diagnosed, sputum-smear positive for Mycobacterium tuberculosis pulmonary in fection. All patients received a standard regimen of 6 months of rifampicin and isoniazid with first 2 months of pyrazinamid with or without cotrimoxazole. Compared with values at start of treatment, median viral load increased by a median of 0.64 log10 copies/ml after 12 months of follow-up (P,=,0.0002). Median CD4+ T-cell counts were 393 cells/L at start of treatment and 370 cells/L after 12 months of follow-up (P,=,0.61). Levels of serum activation markers decreased significantly at 12 months of follow-up of the patients for both patients on standard and cotrimoxazole treatment. Levels of viral load, CD4+ T-cell counts, and markers of immune activation were not different for patients on standard treatment of tuberculosis compared with those on standard and cotrimoxazole treatment. Levels of serum activation markers decreased significantly at 12 months of follow-up of the patients for both patients on standard and cotrimoxazole treatment. Because viral load is a predictor of disease progression, its persistent elevated levels in blood of HIV-infected patients co-infected with tuberculosis, who successfully complete TB treatment, may account for the high mortality observed in this population. J. Med. Virol. 75:202,208, 2005. © 2004 Wiley-Liss, Inc. [source] Varenicline for smoking cessation: A placebo-controlled, randomized studyRESPIROLOGY, Issue 3 2009Chen WANG ABSTRACT Background and objective: Varenicline tartrate, a novel, selective, nicotinic acetylcholine receptor partial agonist, has been developed specifically as a smoking cessation drug. This study evaluated the efficacy of a standard regimen of varenicline compared with placebo for smoking cessation in 333 subjects in China, Singapore and Thailand. Methods: This 24-week, randomized, double-blind, placebo-controlled trial of varenicline, 1 mg bd, consisted of a 12-week treatment period followed by a 12-week non-treatment follow-up period. The primary study end-point was the 4-week continuous abstinence rate defined as the proportion of subjects who reported total abstinence from smoking and other nicotine products from weeks 9,12. A key secondary end-point was the continuous abstinence rate from weeks 9,24, defined as the proportion of subjects who achieved the primary end-point as well as total abstinence from all tobacco products from weeks 13,24. Results: Both end-points were achieved by a significantly higher proportion of subjects in the varenicline group than in the placebo group. The 4-week continuous abstinence end-point was achieved by 50.3% and 31.6% in the varenicline and placebo groups, respectively (P = 0.0003), while continuous abstinence from weeks 9,24 was achieved by 38.2% and 25.0% of subjects, respectively (P = 0.0080). The treatment effect was generalizable by treatment centre and country. Varenicline was safe and appeared to be well tolerated by most subjects. Conclusion: Varenicline was significantly more efficacious for smoking cessation than placebo over a 12-week treatment period and a further 12-week non-treatment follow-up period in smokers from China, Singapore and Thailand. No significant side-effects were noted. [source] Low-dose etanercept therapy in moderate to severe psoriasis in KoreanTHE JOURNAL OF DERMATOLOGY, Issue 8 2008Jung Im NA ABSTRACT Etanercept is a fully humanized soluble tumor necrosis factor (TNF)-, receptor that competitively inhibits the interaction of TNF-, with cell-surface receptors. It was approved as monotherapy for psoriasis in the USA in 2004, but in Korea, no clinical reports on its use for psoriasis are available. We performed a retrospective analysis of 26 moderate-to-severe psoriasis patients who had been treated with etanercept. Patients received twice-weekly injections of 25 mg etanercept s.c. for at least 4 weeks. When the patients achieved a 50% reduction of the psoriasis area severity index (PASI 50) they received once-weekly injections, then biweekly injections were provided for maintenance. Patients were evaluated biweekly by clinical photographs and PASI scoring. Treatment efficacy was as follows. A PASI 75 was achieved in 14 patients (54%) and the mean number of injections before achieving a PASI 75 was 10 ± 7.5. Patients whose initial PASI was less than 10 (iPASI < 10) showed an earlier response (2.6 ± 1.3 weeks) and a higher PASI 75 rate (63%), than with iPASI , 10 (6.9 ± 4.5 weeks, 50%). Eight patients (31%) received additional phototherapy or systemic therapy because of insufficient responses or for faster improvements and they were excluded in the efficacy evaluation. Adverse events were observed in eight patients (31%), but were not serious. This is the first report on the effectiveness of low-dose etanercept regimen on Asian psoriasis patients. Results in this study showed that low-dose etanercept therapy is effective for moderate-to-severe Asian psoriasis patients, and it may be a valuable treatment option even for relatively moderate psoriasis patients not responsive to conventional treatment. In addition, the medical cost was relatively low compared to that of the standard regimen for white patients. [source] Experience with a Novel Efalizumab-Based Immunosuppressive Regimen to Facilitate Single Donor Islet Cell TransplantationAMERICAN JOURNAL OF TRANSPLANTATION, Issue 9 2010N. A. Turgeon Islet transplantation is an experimental therapy for selected patients with type 1 diabetes (T1DM). It remains limited by immunosuppressive drug toxicity, progressive loss of insulin independence, allosensitization and the need for multiple islet donors. We describe our experience with an efalizumab-based immunosuppressive regimen as compared to the prevailing standard regimen, the Edmonton protocol. Twelve patients with T1DM received islet transplants: eight were treated with the Edmonton protocol; four were treated with daclizumab induction, a 6-month course of tacrolimus, and maintenance with efalizumab and mycophenolate mofetil. The primary endpoint was insulin independence after one islet infusion. Only two Edmonton protocol treated patients achieved the primary endpoint; six required islets from multiple donors, and all experienced leukopenia, mouth ulcers, anemia, diarrhea and hypertransaminasemia. Four became allosensitized. All patients treated with the efalizumab-based regimen achieved insulin independence with normal hemoglobin A1c after a single islet cell infusion and remained insulin independent while on efalizumab. These patients experienced significantly fewer side effects and none became allosensitized. Trial continuation was terminated by withdrawal of efalizumab from the market. These data suggest that this efalizumab-based regimen prevents islet rejection, is well tolerated, and allows for single donor islet transplantation. [source] High-dose cyclophosphamide versus monthly intravenous cyclophosphamide for systemic lupus erythematosus: A prospective randomized trial,ARTHRITIS & RHEUMATISM, Issue 5 2010Michelle Petri Objective Monthly intravenous (IV) cyclophosphamide for 6 months has been the standard induction regimen for lupus nephritis, followed by a maintenance regimen of quarterly infusions for 2 years. We undertook this study to compare the efficacy and safety of the standard regimen versus a high-dose IV cyclophosphamide regimen. Methods We performed a prospective randomized trial comparing monthly IV cyclophosphamide at 750 mg/m2 body surface area for 6 months followed by quarterly IV cyclophosphamide for 2 years (traditional treatment) against high-dose IV cyclophosphamide (50 mg/kg daily for 4 days) (high-dose treatment). Entry criteria included renal lupus, neurologic lupus, or other organ system involvement with moderate-to-severe activity. Results Fifty-one patients were randomized; 3 withdrew before treatment and 1 committed suicide after 2 months of high-dose treatment. Twenty-two had renal lupus, 14 had neurologic lupus, and 11 had other organ involvement. The outcome measure was the Responder Index for Lupus Erythematosus (complete response, partial response, no change, or worsening). At 6 months (the end of induction), 11 of 21 patients (52%) in the high-dose treatment group had a complete response compared with 9 of 26 patients (35%) in the traditional treatment group (P = 0.13). At the final visit (30 months), 10 of 21 patients (48%) in the high-dose treatment group had a complete response compared with 13 of 20 patients (65%) who continued with traditional treatment (P = 0.13). Six patients crossed over from traditional treatment to high-dose treatment because of lack of response, and 3 of those patients became complete responders. Conclusion There was not strong evidence that monthly IV cyclophosphamide and high-dose IV cyclophosphamide differed in complete or in any (complete or partial) response to induction or maintenance therapy. However, nonresponders to monthly IV cyclophosphamide can sometimes be rescued with high-dose IV cyclophosphamide. [source] Randomised double-blind trial of the effect of vitamin C on dyspareunia and vaginal discharge in women receiving doxycycline and triple sulfa for chlamydial cervicitisAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 5 2009Marjan KHAJEHEI Background:,Chlamydia trachomatis is the most common bacterial cause of cervicitis. Aim:, The aim of this randomised, double-blind trial was to compare the effect of vitamin C on dyspareunia and vaginal discharge in women receiving doxycycline and triple sulfa for chlamydial cervicitis. Methods:, Eighty women with increased anti- C. trachomatis IgM, reporting abnormal vaginal discharge and dyspareunia, demonstrating signs of cervical oedema and erythema and friability of cervix were included. Thirty-nine women received doxycycline capsules 100 mg twice daily plus triple sulfa vaginal cream once daily for ten days, and 41 received doxycycline capsules 100 mg twice,daily and triple sulfa vaginal cream once daily plus vitamin C tablets 250 mg once daily for ten days. Women were evaluated at follow-up visit, eleventh day, following completion of intervention. Analysis:, The effect of treatment was assessed regarding clinical criteria (presence of endocervical mucopus and cervical severity score) and presence of dyspareunia. Statistical analysis was carried out using spss version 11.5. Results:, The mean age of women was 30.6 ± 8.4 years. There was no relationship between demographics and dyspareunia and discharge (P > 0.05). There was statistically significant difference between the effect of ,doxycycline plus triple sulfa' and ,doxycycline, triple sulfa plus vitamin C' on discharge and dyspareunia (P = 0.005, P < 0.001, respectively). Most frequently reported drug-related adverse event in both groups was heartburn. Conclusion:, Adding vitamin C to doxycycline and triple sulfa was more efficient than standard regimen (doxycycline and triple sulfa without vitamin C) in treating chlamydial cervicitis. [source] Comparison of outcomes for elderly patients treated with weekly paclitaxel in combination with carboplatin versus the standard 3-weekly paclitaxel and carboplatin for advanced nonsmall cell lung cancer,CANCER, Issue 3 2008Suresh Ramalingam MD Abstract BACKGROUND. The purpose of this study was to compare the outcomes between elderly (aged ,70 years) patients treated with paclitaxel on a weekly basis and with carboplatin (every 4 weeks) versus the standard 3-weekly regimen of carboplatin and paclitaxel for first-line therapy of advanced nonsmall cell lung cancer. METHODS. Of the 444 patients enrolled, 136 (31%) were aged ,70 years. Seventy-two patients were randomized to the weekly schedule (paclitaxel, 100 mg/m2 weekly for 3 of 4 weeks; carboplatin, area under the curve [AUC] = 6 mg/mL·min on Day 1 every 4 weeks), and 64 patients were randomized to the standard schedule (paclitaxel, 225 mg/m2; carboplatin, AUC = 6 mg/mL·min on Day 1 every 21 days). Patients with stable disease or objective response after 4 cycles of therapy were eligible for maintenance therapy with weekly paclitaxel (70 mg/m2, 3 of 4 weeks). RESULTS. The response rate for elderly patients was 26% on the weekly regimen and 19% on the standard schedule. The median survival duration for the weekly and the standard schedules was 37 weeks and 31 weeks, respectively. The 1-year survival rates were similar at 31% and 33%. Grade 3 to 4 anemia was more common on the weekly schedule (16% vs 6%), whereas grade 3 neuropathy was less common (5.5% vs 9.5%). Nausea and emesis were also less frequent on the weekly schedule. CONCLUSIONS. Efficacy was similar between the weekly regimen and the standard regimen of carboplatin and paclitaxel for elderly patients with advanced NSCLC and may be advantageous based on its favorable tolerability profile. Cancer 2008. © 2008 American Cancer Society. [source] Establishing the dose of the oral NK1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomitingCANCER, Issue 9 2003Sant P. Chawla M.D. Abstract BACKGROUND The neurokinin-1 antagonist aprepitant (EMENDÔ; Merck Research Laboratories, West Point, PA) has been shown to reduce chemotherapy-induced nausea and vomiting when it is given with a 5-hydroxytryptamine-3 receptor antagonist and dexamethasone. The current study sought to define the most appropriate dose regimen of oral aprepitant. METHODS This multicenter, randomized, double-blind, placebo-controlled study was conducted in patients with cancer who were receiving initial cisplatin (, 70mg/m2) and standard antiemetic therapy (intravenous ondansetron plus oral dexamethasone). Patients were randomized to receive standard therapy plus either aprepitant 375 mg on Day 1 and 250 mg on Days 2,5, aprepitant 125 mg on Day 1 and 80 mg on Days 2,5, or placebo. Due to an apparent interaction with dexamethasone suggested by pharmacokinetic data obtained while the study was ongoing, the aprepitant 375/250 mg dose was discontinued and replaced with aprepitant 40 mg on Day 1 and 25 mg on Days 2,5, and a new randomization schedule was generated. Patients recorded nausea and emesis in a diary. The primary endpoint was complete response (no emesis and no rescue therapy), which was analyzed using an intent-to-treat approach with data obtained after the dose adjustment. Treatment comparisons were made using logistic regression models. Tolerability was assessed by reported adverse events and physical and laboratory assessments, and included all available data. RESULTS The percentages of patients who achieved a complete response in the overall study period were 71.0% for the aprepitant 125/80-mg group (n = 131 patients), 58.8% for the aprepitant 40/25-mg group (n = 119 patients), and 43.7% for the standard therapy group (n = 126 patients; P < 0.05 for either aprepitant regimen vs. standard therapy). Rates for Day 1 were 83.2% for the aprepitant 125/80-mg group, 75.6% for aprepitant 40/25-mg group, and 71.4% for the standard therapy group (P < 0.05 for aprepitant 125/80 mg vs. standard therapy), and rates on Days 2,5 were 72.7% for the aprepitant 125/80-mg group, 63.9% for the aprepitant 40/25-mg group, and 45.2% for the standard therapy group (P < 0.01 for either aprepitant group vs. standard therapy). The efficacy of the aprepitant 375/250-mg regimen was similar to that of the aprepitant 125/80-mg regimen. The overall incidence of adverse events was generally similar across treatment groups: 85% in the aprepitant 375/250-mg group (n = 34 patients), 76% in the aprepitant 125/80-mg group (n = 214 patients), 71% in the aprepitant 40/25-mg group (n = 120 patients), and 72% in the standard therapy group (n = 212 patients), with the exception of a higher incidence of infection in the aprepitant 125/80-mg group (13%) compared with the standard therapy group (4%). CONCLUSIONS When it was added to a standard regimen of intravenous ondansetron and oral dexamethasone in the current study, aprepitant reduced chemotherapy-induced nausea and vomiting and was generally well tolerated, although increases in infection were noted that were assumed to be due to elevated dexamethasone levels as a result of the pharmacokinetic interaction. The aprepitant 125/80-mg regimen had the most favorable benefit:risk profile. Cancer 2003;97:2290,300. © 2003 American Cancer Society. DOI 10.1002/cncr.11320 [source] A 6-year follow-up of dosing, coagulation factor levels and bleedings in relation to joint status in the prophylactic treatment of haemophiliaHAEMOPHILIA, Issue 6 2004J. Ahnström Summary., The primary aim of this study was to investigate the possible relationship between coagulation factor level and bleeding frequency during prophylactic treatment of haemophilia after stratification of the patients according to joint scores. The secondary aim was to obtain a systematic overview of the doses of coagulation factors prescribed for prophylaxis at the Malmö haemophilia treatment centre during a 6-year period. A retrospective survey of medical records for the years 1997,2002 and pharmacokinetic study results from the 1990s was complemented by collection of blood samples for coagulation factor assay when needed. Information on the dosing and plasma levels of factor VIII or factor IX, joint scores and incidence of bleedings (joint bleeds and ,other bleeds') was compiled. The patients were stratified by age (0,6, 7,12, 13,18, 19,36 and >36 years) and joint score (0, 1,6 and >6). Individual pharmacokinetic parameters of plasma coagulation factor activities (FVIII:C and FIX:C) were estimated. Trough levels during the treatment were calculated, as well as the number of hours per week of treatment during which plasma FVIII:C/FIX:C fell below a 1, 2 or 3% target level. Fifty-one patients with haemophilia A (two moderate, 49 severe) and 13 with haemophilia B (all severe) were included, yielding data for 364 patient-years of treatment. There was a wide range of dosing schedules, the most common ones being three times a week or every other day for FVIII and twice a week or every third day for FIX. The overall relationship between FVIII:C/FIX:C levels and incidence of joint bleeding was very weak, even after stratification of the patients according to joint score. There was no relationship between coagulation factor level and incidence of other bleeds. In this cohort of patients on high-dose prophylactic treatment, dosing was based more on clinical outcome in terms of bleeding frequency than on the aim to maintain a 1% target level of FVIII:C/FIX:C. Some patients did not bleed in spite of a trough level of <1% and others did in spite of trough levels >3%. The practical implication of our findings is that dosing in prophylactic treatment of haemophilia should be individualized. Thus, proposed standard regimens should be implemented only after careful clinical consideration, with a high readiness for re-assessment and individual dose tailoring. [source] Stem cells and regenerative medicine for the treatment of type 1 diabetes: the challenges lying aheadPEDIATRIC DIABETES, Issue 2004Andreas Lechner Abstract:, The differentiation of insulin-producing cells in vitro from embryonic or adult stem cells offers potential new treatment options for type 1 diabetes. Progress toward this goal has been made in the recent years, but substantial obstacles still remain. In order to be advantageous over the current standard regimens with exogenous insulin, any stem cell-based therapy would have to restore normal or near normal metabolic control. To achieve this, many of the complex regulatory mechanisms that control physiologic insulin secretion would have to be recreated with in vitro -generated tissue. An alternative approach would be to use the insights gained through stem cell research to develop pharmacologic agents that can induce regeneration of endogenous pancreatic islets in patients with type 1 diabetes. Such a therapy also requires extensive further research, but it could have principal advantages over tissue transplantation. [source] Hyperbaric oxygen therapy for radiation-induced haemorrhagic cystitisBJU INTERNATIONAL, Issue 1 2005Amos Neheman OBJECTIVE To assess the efficacy of hyperbaric oxygen (HBO) for treating haemorrhagic cystitis. PATIENTS AND METHODS From February 1997 to April 2004, seven patients with radiation-induced haemorrhagic cystitis were treated with HBO; they received a mean (range) of 30 (18,57) HBO treatments and the follow-up was 24 (3,53) months. RESULTS The haematuria resolved completely in all seven patients shortly after treatment; one had an improvement but died from complications relating to cancer shortly after completing treatment, and two had recurrence of gross haematuria. They were re-treated with HBO until the haematuria resolved. CONCLUSIONS Radiation-induced haemorrhagic cystitis can be treated successfully with HBO primarily or after failure of standard regimens. This method was well tolerated even in patients debilitated by advanced cancer and blood loss. Long-term remission is possible in most patients, and re-treatment effectively manages recurrent bleeding. [source] ChlVPP/ABVVP, a first line ,hybrid' combination chemotherapy for advanced Hodgkin's lymphoma: a retrospective analysisBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2004G. Martinelli Summary We retrospectively analysed toxicities and clinical results of 61 Hodgkin's lymphoma patients treated with chlorambucil, vinblastine, procarbazine, doxorubicin, bleomycin, vincristine and etoposide (ChlVPP/ABVVP), delivered in a weekly alternate schedule. Of 61 patients, 33 were in stages III,IV, 21 in stage IIB and seven in stage IIA with bulky disease or extranodal presentation. ChlVPP/ABVVP was administered for 6,8 cycles. Involved field radiotherapy (IFRT) (30,35 Gy) was delivered to 31 patients with residual disease after chemotherapy or bulky disease at diagnosis. Of 61 patients, 58 (95%) achieved complete clinical or radiological remission after chemotherapy and IFRT. With a median follow-up of 60 months, 5-year overall survival, relapse- and event-free survival were 78·8% (95% CI 68·2,91·1%), 81% (95% CI 70·6,92·2%) and 71·9% (95% CI 68·2,82·2%) respectively. Grades 3,4 neutropenia was the most relevant haematological toxicity and occurred in 82% of patients. Non-haematological toxicities were mild and reversible. No toxic deaths were recorded. One patient developed secondary acute myeloid leukaemia 1 year after ChlVPP/ABVVP. Due to the retrospective nature of this study, no definitive conclusions could be drawn about the clinical activity of ChlVPP/ABVVP. Nonetheless, clinical results seem better than those reported with standard regimens [ABVD (doxorubicin, bleomycin, vincristine, dacarbazine), MOPP (methotrexate, vincristine, procarbazine, prednisone), MOPP/ABVD] and as good as those reported using standard or escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone), with a lower degree of haematological and non-haematological toxicity. Long-term results of the ongoing randomized trial, comparing ABVD versus high-dose intensity weekly regimens will be useful to confirm our results. [source] | |||||||||||||||||||