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Complete Responders (complete + responder)
Selected AbstractsMesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitisINFLAMMATORY BOWEL DISEASES, Issue 3 2001Dr. Per G. Farup Abstract Background High doses of mesalazine usually result in an inconvenient dosage schedule and reduced compliance. The goal of this trial was to compare the effects of mesalazine 4 g daily given as prolonged-release granules in packets of 1 g with that of prolonged-release tablets of 0.5 g. Methods Two hundred twenty-seven patients with mild-to-moderate ulcerative colitis were randomized to treatment with two packets twice daily (Gr-b.i.d.), 1 packet four times daily (Gr-q.i.d.) or 2 tablets four times daily (Ta-q.i.d.) for 8 weeks. A disease activity index (ulcerative colitis disease activity index; UC-DAI) was calculated, and the granules were defined as noninferior to the tablets if the lower limit of the 95% CI for the differences was more than ,1 UC-DAI score unit. Results Noninferiority of the granules compared with the tablets was demonstrated. The mean improvement in the UC-DAI in the treatment groups Gr-b.i.d., Gr-q.i.d., and Ta-q.i.d. were 3.2, 2.9, and 2.4, respectively; the proportion of complete responders in the three groups 39%, 37%, and 31%, respectively. There were no differences in side effects. Conclusion Mesalazine 4 g daily given as prolonged-release granules twice and four times daily is at least as effective as prolonged-release tablets four times daily in patients with mild to moderate ulcerative colitis. The patients preferred the twice daily dosing. [source] Prevalence, Predictors, and Prognosis of Atrial Fibrillation Early After Pulmonary Vein Isolation: Findings from 3 Months of Continuous Automatic ECG Loop RecordingsJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 10 2009SANDEEP JOSHI M.D. Introduction: Following pulmonary vein isolation (PVI) for atrial fibrillation (AF), early recurrences are frequent, benign and classified as a part of a "blanking period." This study characterizes early recurrences and determines implications of early AF following PVI. Methods and Results: Seventy-two consecutive patients (59.8 ± 10.7 years, 69% male) were studied following PVI for paroxysmal or persistent AF. Subjects were fitted with an external loop recorder for automatic, continuous detection of AF recurrence for 3 months. AF prevalence was highest 2 weeks after PVI (54%) and declined to an eventual low of 22%. A significant number (488, 34%) of recurrences were asymptomatic; however, all patients with ,1 AF event had ,1 symptomatic event. No clear predictor of early recurrence was identified. Forty-seven (65%) patients had at least 1 AF episode, predominantly (39 of 47 patients, 83%) within 2 weeks of PVI. Of the 33 patients who did not experience AF within the first 2 weeks, 85% (28/33) were complete responders (P = 0.03) at 12 months. Recurrence at any time within 3 months was not associated with procedural success or failure. Conclusions: Early AF recurrence peaks within the first few weeks after PVI, but continues at a lower level until the completion of monitoring. A blanking period of 3 months is justified to identify patients with AF recurrences that do not portend procedure failure. Freedom from AF in the first 2 weeks following ablation significantly predicts long-term AF freedom. [source] Efficacy of interferon-, treatment in Japanese children with chronic hepatitis CJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 4 2003EISUKE NAKASHIMA Abstract Background: We investigated the efficacy of natural interferon (IFN)-, treatment in 34 Japanese children with chronic hepatitis C. Methods: Thirty-four children completed 6 months of therapy with natural IFN-, and were followed for 12 months or longer. We examined the serum hepatitis C virus (HCV) RNA titer and liver histology before, during, and after IFN treatment. Results: At 6 months after the cessation of IFN-, treatment, 16 patients (47%) had normal serum alanine aminotransferase concentration and no detectable serum HCV RNA. There were no major side-effects, excluding some influenza-like symptoms during the IFN-, treatment. Most genotype 2a patients had a complete response (80%). Moreover, patients who had a low HCV RNA titer (<102 copies/mL) after 1 month of IFN-, treatment became complete responders at 6 months after the cessation of treatment. Histological improvement was observed in almost all patients after IFN-, treatment. Conclusion: Interferon-, treatment is safe and effective for children with chronic hepatitis C and has no serious side-effects. A HCV RNA concentration of <102 copies/mL after 1 month of IFN-, treatment and genotype 2a may be useful predictors of long-term IFN efficacy. © 2003 Blackwell Publishing Asia Pty Ltd [source] Clinical outcome after 4 years follow-up of HIV-seropositive subjects with incomplete virologic or immunologic response to HAARTJOURNAL OF MEDICAL VIROLOGY, Issue 2 2005Emanuele Nicastri Abstract The duration of the clinical, virologic, and immunologic response to HAART, is not well defined. In this observational multi-center study 2,143 patients were enrolled classified according to virologic suppression (<500 cp/ml) and immune recovery (>100 CD4+ cells/,l from baseline) at month 12 of HAART as complete responders, virologic only responders, immunologic only responders and non-responders. Kaplan Meyer curves, multivariate and politomous regression analysis were used. Complete responders patients were 781 (36.4%), immunologic only responders 441 (20.6%), virologic only responders 336 (15.7%), and non-responders 585 (27.3%). Using multivariate analysis, being antiretroviral-naïve increased the probability of having both a virologic only or a complete response and reduced the probability of an immunologic only response (P,<,0.001 for all tests). Older age was associated directly with a virologic only response and inversely associated with an immunologic only response (P,=,0.027 and P,=,0.035, respectively). Using politomous analysis, patients baseline HIV-RNA level more than 5 log cp/ml had a 1.9-fold higher probability of an immunologic response than of a complete response (P,=,0.001). After 4 years, the clinical progression rate was six times greater in non-responders, 1.9 times greater in virologic only responders, and 2.3 times greater in immunologic only responders than for responders. However, patients with virologic only response or with immunologic only response had a significantly reduced risk for clinical progression than non-responders (P,<,0.001). After 4 years of HAART, the risk of clinical progression in patients with immunologic only or virologic only response is low but still higher than in complete responder patients. J. Med. Virol. 76:153,160, 2005. © 2005 Wiley-Liss, Inc. [source] The effect of 595,nm pulsed dye laser on superficial and nodular basal cell carcinomasLASERS IN SURGERY AND MEDICINE, Issue 6 2009Sonali M. Shah MD Abstract Background and Objective Basal cell carcinomas (BCCs) have supporting vasculature that could serve as a target for 595,nm pulsed dye laser (PDL). The objective of this study was to determine the effect of repeated PDL treatments on BCCs of superficial and nodular subtypes and of varying diameters. Study Design/Materials and Methods Twenty biopsy-proven BCCs received four 595,nm PDL treatments at 2-week intervals. The tumor and 4,mm of peripheral skin were treated using a set of previously optimized laser parameters: one pass, 15,J/cm2 energy, 3,ms pulse length, no cooling, and 7,mm spot size with 10% overlap. The treated area was excised and evaluated histologically for residual tumor. Histologic response rates of the PDL treated BCCs were compared with that of non-PDL treated, matched control tumors. Results Nearly all BCCs <1.5,cm in diameter (n,=,12) showed complete response to four PDL treatments (91.7%; n,=,11/12) versus 16.7% of controls (n,=,2/12, P -value,= 0.0003). BCCs ,1.5,cm in diameter (n,=,8) showed a complete response rate of 25% (n,=,2/8) versus 0% of controls (n,=,0/8, P -value,=,0.2). Mean clinical tumor diameter of the complete responders was 1.1,cm (n,=,13) versus 2.2,cm (n,=,7) for incomplete responders (P -value,=,0.005). Tumor histologic types among the complete responders included superficial, nodular, micronodular, and keratinizing. Incompletely responding BCCs showed a significant reduction in tumor burden after PDL treatment, with residual histologic tumor burden ranging from <1% to 29% of the original clinical tumor diameter, compared to 13,68% residual tumor burden for the corresponding controls (P -value,=,0.05). Conclusions PDL is an effective means of reducing tumor burden in patients with large BCCs and may be an alternative therapy in BCCs <1.5,cm in diameter. Lasers Surg. Med. 41:417,422, 2009. © 2009 Wiley-Liss, Inc. [source] Prognostic value of bone marrow angiogenesis in multiple myeloma: Use of light microscopy as well as computerized image analyzer in the assessment of microvessel density and total vascular area in multiple myeloma and its correlation with various clinical, histological, and laboratory parametersAMERICAN JOURNAL OF HEMATOLOGY, Issue 9 2006Sahibinder Singh Bhatti Abstract We studied the prognostic value of parameters of angiogenesis on bone marrow biopsies in newly diagnosed multiple myeloma (MM) patients. Angiogenesis parameters studied were the microvessel count done manually on light microscopy (MVD-A), microvessel count done by using computerized image analyzer (MVD-B), and total vascular area (TVA) measured by computerized image analyzer. One hundred ten newly diagnosed cases of MM treated at Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, were analyzed with respect to clinical features, laboratory findings, histological features, angiogenesis parameters, and responses to the treatment on follow-up. Twenty age- and sex-matched controls were studied for comparing with angiogenesis of the test cases. Bone marrow microvessels were examined using immunohistochemical staining for CD34. MVD-A (range 4.9,85.2; mean 28.2; SD 19.4), MVD-B (range 2.0,26.9; mean 11.7; SD 5.9), and TVA measured in percentage (range 0.1,17.1; mean 2.4; SD 2.5) were measured for test cases (n = 110). Grading of angiogenesis parameters of the test cases were done; such that angiogenesis parameters of controls (taken as baseline) were grade I. There was a statistically highly significant correlation between (MVD-A vs MVD-B, pcc = 0.92; MVD-A vs TVA, pcc = 0.78; MVD-B vs TVA, pcc = 0.76). The myeloma cases had significantly higher angiogenesis parameters when compared with controls (Kruskall-Wallis test, P < 0.001). "Complete responders" (n = 38/110) had significant lower angiogenesis (Mann-Whitney U test, P < 0.001) than "nonresponders" (n = 72/110). On treatment follow-up "rapid disease progressors" had the highest levels of angiogenesis (mean rank for MVD-A = 84.7, MVD-B = 82.1, and TVA = 81.1). On multivariate (logistic regression) analysis, factors found to have independent prognostic significance in complete responders (adjusted odd ratio (95% CI, P value)] were: (a) MVD-B grade I [0.134 (0.10,0.16, P < 0.001)], (b) clinical substage A [0.163 (0.12,0.19, P = 0.008)], (c) Bartl's histological stage II & I [0.262 (0.2,0.32, P = 0.021)], (d) MVD-A grade I [0.28 (0.22,0.36, P = 0.03)], (e) ,2 microglobulin levels less than 3,400 ng/dl [0.31 (0.23,0.42, P = 0.04)]. Kaplan-Meier survival analysis for myeloma-related death (n = 16) shows a mean survival time (in months) of 24.75; SE = 3; 95% CI = 21,28. We conclude that MVD (particularly MVD-B) is a very good predictor for the complete response in patients of MM and should be done routinely on bone marrow biopsies. Am. J. Hematol., 2006. © 2006 Wiley-Liss, Inc. [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] Treatment of lentigo maligna with topical imiquimodBRITISH JOURNAL OF DERMATOLOGY, Issue 2003M.F. Naylor Summary A published case report and anecdotal experience suggested that topical imiquimod is an effective treatment for stage 0 melanoma (lentigo maligna). To gauge the efficacy of this therapy, we undertook a trial of topical imiquimod in 30 subjects with histologically confirmed lentigo maligna. Thirty subjects with lentigo maligna were recruited for an open-labelled efficacy trial with daily topical application of imiquimod 5% cream for 3 months. Study subjects were enrolled from the Dermatology service of the University of Oklahoma, the Oklahoma City Veteran's Administration Hospital Dermatology service and from referrals for the study from other practitioners. In order to determine an initial response rate, a four-quadrant biopsy was carried out on all patients 1 month after cessation of treatment, targeting the most clinically and dermatoscopically suspicious areas. Of 28 evaluable subjects who have completed the 3-month treatment phase, 26 (93%) were complete responders and two were treatment failures at the time of the 4-quadrant biopsy. Over 80% of the 28 subjects that completed treatment have been followed for more than 1 year with no relapses. The results of this study demonstrate that topical imiquimod produces a high complete response rate in lentigo maligna when applied daily for 3 months. [source] The prognostic value of lymph node metastases and tumour regression grade in rectal cancer patients treated with long-course preoperative chemoradiotherapyCOLORECTAL DISEASE, Issue 3 2009J. Lindebjerg Abstract Objective, The purpose of the present study was to investigate the impact of tumour regression and the post-treatment lymph node status on the prognosis of rectal cancer treated by preoperative neoadjuvant chemoradiotherapy. Method, One hundred and thirty-five patients with locally advanced T3 and T4 rectal tumours received preoperative long-course chemoradiation, to a dose of 60 Gy external radiation and oral 5-fluorouracil 300 mg/m2 daily and Leukovorin 22.5 mg/day 5 days a week. Surgery was performed 8 weeks after the end of treatment. The tumour response was evaluated according to the tumour regression grade system and lymph node status in the surgical specimen was assessed. The prognostic value of clinico-pathological parameters was analysed using univariate analysis and Kaplan,Meier methods for comparison of groups. Results, All patients responded to treatment and 47% had a major response, including 25 (19%) complete responders. The median follow-up was 26 months (range 12,94 months). The cancer specific survival was 82% and there was a significant lower survival rate in the group of patients with post-treatment lymph node metastases compared to lymph-node negative patients [63% and 87% respectively (P = 0.007)]. Furthermore patients with a major tumour response and no lymph node metastases in the surgical specimen after treatment had a survival rate of 100% compared with 60% in the group of patients with major response but lymph node metastases after surgery (P < 0.01). Conclusion, The combined assessment of lymph-node status and tumour response has strong prognostic value in locally advanced rectal cancer patient treated with preoperative long-course chemoradiation. [source] | ||||||||||