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PubMed2002

Reduction of the risk of relapse after withdrawal of medical therapy for Graves' disease.

It has been a continuing challenge to try and identify those patients with hyperthyroid Graves' disease likely to remain in remission after an antithyroid drug course or to manage the medical treatment so as to increase the chance of remission. On average, the overall relapse rate is approximately 50% and any significant reduction of this figure would be of practical as well as theoretical value. The numerous controlled prospective studies performed in many parts of the world, with varying iodine intakes, have all confirmed that the main initial features related to the subsequent risk of relapse are: young age, male gender, goiter larger than 40 mL, hypoechogenic and hypervascular gland, high level of anti-thyrotropin receptor antibody (TRAb), detected either with radioreceptor assay (TBII: >40 U/L) or the biologic stimulation assay (thyroid-stimulating antibodies [TSAb]; >300%), severity of hyperthyroidism, and possibly the presence of ophthalmopathy. Alone, each of these has a low predictive value, but together they allow evaluation of the risk of relapse, thus helping treatment choice. As to the modalities of antithyroid drug treatment, dose of the drug or addition of levothyroxine does not affect posttreatment outcome. In contrast, significantly fewer relapses occur for drug courses longer than at least 1 year. Persistence of high levels of TRAb after medical treatment is strongly predictive of relapse but this is of limited value because in most patients, TRAb levels are low or even undetectable at the end of treatment, which does not indicate for further outcome. Smoking is a significant independent risk factor for relapse. In conclusion, reduction of the risk of relapse in patients with medically treated hyperthyroid Graves' disease relies on clinical competence and appropriate management taking into account an array of factors none of which alone has definite predictive value.

Antithyroid Agents↗

PubMed2005

Cologne high-dose sequential chemotherapy in relapsed and refractory Hodgkin lymphoma: results of a large multicenter study of the German Hodgkin Lymphoma Study Group (GHSG).

BACKGROUND: We designed a dose- and time-intensified high-dose sequential chemotherapy regimen for patients with relapsed and refractory Hodgkin lymphoma (HD). PATIENTS AND METHODS: Eligibility criteria included age 18-65 years, histologically proven primary progressive (PD) or relapsed HD. Treatment consisted of two cycles DHAP (dexamethasone, high-dose cytarabine, cisplatinum); patients with chemosensitive disease received cyclophosphamide followed by peripheral blood stem cell harvest; methotrexate plus vincristine, etoposide and BEAM plus peripheral blood stem cell transplantation (PBSCT). RESULTS: A total of 102 patients (median age 34 years, range 18-64) were enrolled. The response rate was 80% (72% complete response, 8% partial response). With a median follow-up of 30 months (range 3-61 months), freedom from second failure (FF2F) and overall survival (OS) were 59% and 78% for all patients, respectively. FF2F and OS for patients with early relapse were 62% and 81%, for late relapse 65% and 81%; for PD 41% and 48%, and for multiple relapse 39% and 48%, respectively. In multivariate analysis response after DHAP (P <0.0001) and duration of first remission (PD and multiple relapse versus early and late relapse; P=0.0127) were prognostic factors for FF2F. Response after DHAP (P <0.0081), duration of first remission (P=0.0017) and anemia (P=0.019) were significant for OS. CONCLUSION: Based on the promising results of this study, a prospective randomized European intergroup study was started comparing this intensified regimen with two courses of DHAP followed by BEAM (HD-R2 protocol).

Adolescent↗

PubMed2005

High-dose sequential chemotherapy followed by autologous stem cell transplantation in relapsed and refractory aggressive non-Hodgkin's lymphoma: results of a multicenter phase II study.

BACKGROUND: Combination chemotherapy can cure patients with non-Hodgkin's lymphoma (NHL), but those who suffer treatment failure or relapse still have a poor prognosis. High-dose chemotherapy (HDCT) with autologous stem cell transplantation (ASCT) can improve the outcome of these patients. We evaluated an intensified high-dose sequential chemotherapy program with a final myeloablative course. PATIENTS AND METHODS: Inclusion criteria were age 18-65 years, histologically proven primary progressive or relapsed aggressive NHL and eligibility for HDCT. The therapy consists of two cycles DHAP: dexamethasone 40 mg (day 1-4), high-dose cytarabine 2 g/m2 12q (day 2), cisplatin 100 mg/m2 (day 51); patients with partial (PR) or complete remission (CR) received cyclophosphamide 4 g/m2 (day 37), followed by peripheral blood stem cell (PBSC) harvest; methotrexate 8 g/m2 (day 1) plus vincristine 1.4 mg/m2 (day 51); and etoposide 500 mg/m2 (day 58-62). The final myeloblative course was BEAM: cytarabine 200 mg/m2 12q (day 81-84), etoposide 150 mg/m2 12q (day 81-84), melphalan 140 mg/m2 (day 80), carmustin 300 mg/m2 (day 80) followed by PBSCT. RESULTS: Fifty-seven patients (median age 43 years, range 24-65) were enrolled: 23 (40%) patients were refractory to primary therapy and 34 (60%) patients had relapsed NHL. The response rate (RR) after 2 cycles of DHAP was 72% (9% CR, 63% PR) and at the final evaluation (100 days post transplantation) 43% (32% CR, 11% PR). Toxicity was tolerable. Median follow-up was 25 months (range 1-76 months). Freedom from second failure (FF2F) and overall survival (OS) at 2 years were 25% and 47% for all patients, respectively. FF2F at 2 years for patients with relapse and for patients refractory to primary therapy were 35% and 9% (P=0.0006), respectively. OS at 2 years for patients with relapse and for patients refractory to primary therapy were 58% and 24% (P=0.0044), respectively. CONCLUSIONS: We conclude that this regimen is feasible, tolerable and effective in patients with relapsed NHL. In contrast, the results in patients with progressive disease are unsatisfactory. This program is currently being modified by addition of rituximab for patients with relapsed aggressive NHL.

Adolescent↗

PubMed1995

Characteristics of and risk factors for relapse of brucellosis in humans.

For 16 years we prospectively observed 530 adult patients with brucellosis to analyze the characteristics of and risk factors for relapse. Clinical and laboratory findings from 86 relapsed patients were milder during the relapse episode when compared with those for the same patients during the initial disease. Blood cultures were positive for Brucella melitensis in 65% of cases during relapse and in approximately 80% of cases during the initial disease. Risk factors that were identified as being independently associated with relapse (by logistic regression analysis) were "less-effective" antibiotic therapy (OR, 8.3; 95% CI, 4.6-15.1), positive blood cultures during initial disease (OR, 2.7; 95% CI, 1.2-6.2), < or = 10-day duration of the disease before treatment (OR, 1.9; 95% CI, 1.1-3.6), male sex (OR, 1.8; 95% CI, 1.02-3.8) and a platelet count of < or = 150 x 10(3)/mm3 (OR, 1.7; 95% CI, 1.1-2.8). These data show that relapse of brucellosis is sometimes difficult to diagnose and that it can be an insidious disease. In addition to inappropriate antibiotic therapy, other factors, such as those indicating a more aggressive disease and/or a deficient immunologic response, seem to play an important role in the relapse of brucellosis.

Adolescent↗

PubMed1985

Relapse following cessation of antibiotic therapy for mouse typhoid in resistant and susceptible mice infected with salmonellae of differing virulence.

Relapse after cessation of ampicillin therapy in inbred mice infected with salmonellae was studied. The incidence of relapse was influenced by the following. (A) The mouse strain, with gentically susceptible animals more likely to relapse than genetically resistant animals; a possible role for the Ity gene was observed. (B) The virulence of the infecting organism, with a more virulent strain causing relapse in both resistant and susceptible mice, a less virulent strain causing relapse in neither resistant nor susceptible mice, and an intermediate strain causing relapse in susceptible mice but not in resistant mice. (C) The duration of antibiotic therapy, with prolonged treatment preventing relapse seen after short-term therapy. In all cases, ampicillin failed to clear the infection, and the mice remained carriers.

Ampicillin↗

PubMed1997

Second-line chemotherapy for relapsed small cell lung cancer.

Between January 1985 and August 1991, 159 patients with small cell lung cancer received first-line chemotherapy and 123 (77%) were responders. Of these, 88 relapsed, the remainder having died of other or unknown diseases or being alive without carrying cancer. The relapsed patients were examined to evaluate the outcome of the treatment for relapsed small cell lung cancer and to identify the factors that would contribute to the response rates and the survival durations. Forty-eight of 88 relapsed patients received second-line chemotherapy. Of the 48, 3 were evaluated as showing a complete response, 13 as partial response, 9 as no change, 15 as progressive disease and 8 as not evaluable. The response rate was 33% (95% confidence interval 20.4-48.4%). The median survival time was 146 days. The duration and rate of response in first-line chemotherapy affected the response rates of the second-line chemotherapy, but without statistical significance (P = 0.058 and 0.067 respectively). Increased response duration, time off chemotherapy and previous response to first-line chemotherapy all had a positive effect on the survival times (P < 0.01). Relapsed small cell lung cancer still shows a response to second-line chemotherapy without lessening survival time, and thus clinical trials of new drugs or combination chemotherapeutic regimens for relapsed small cell lung cancer cases would be reasonably justified. Randomized comparative studies are warranted for determining the benefits of second-line chemotherapy for relapsed small cell lung cancer cases.

Adult↗

PubMed2003

Idiopathic minimal change nephrotic syndrome in older adults: steroid responsiveness and pattern of relapses.

INTRODUCTION: Minimal change nephrotic syndrome (MCNS) is a common form of nephrotic syndrome in children and young adults. We investigated its clinical presentations, steroid responsiveness, subsequent clinical course and patterns of relapse in older adults in whom it was diagnosed after the age of 50 years. METHODS: The clinical records of renal patients followed-up in a single out patient clinic were retrieved and those patients with biopsy-proven MCNS were included. Patients in the 18-50-year age range (Group A) at the time of biopsy were compared with those older than 50 years (Group B) with regard to baseline demographic data, clinical features and outcome of treatment. RESULTS: In all, 50 patients were studied, 35 in Group A (age at diagnosis: 38.8+/-11.91 years) and 15 in Group B (age at diagnosis: 70+/-6.85 years), with an overall follow-up duration of 72.08+/-63.42 months. Group B had a higher prevalence of hypertension and lower creatinine clearance at presentation, but the values of creatinine clearance for both groups were comparable with age-matched controls. One patient from Group B and two from Group A had spontaneous remission. Complete remission was achieved in 9.09, 45.45, 90.91 and 100% of Group B patients and 15.63, 62.5, 87.5 and 93.75% of Group A patients after 2, 4, 8 and 16 weeks of steroid therapy, respectively. The median time to complete remission and the duration of steroid treatment were similar for both groups. From Group B five patients and 22 patients from Group A relapsed during follow-up (P=0.055), with similar proportions of each group being early relapsers or frequent relapsers. The average number of relapses was 2.06 episodes for Group A, compared with 0.87 episodes for group B (P=0.062). Second agents were used in 20 Group A and four Group B patients (P=0.048). Complications of treatment were more common in Group A. None of the patients developed doubling of serum creatinine during follow-up. CONCLUSIONS: Clinical presentations of older patients with MCNS were similar to younger patients apart from the age-related decline of renal function and higher prevalence of hypertension. Both groups have similar steroid responsiveness, but older patients tend to have fewer relapses and require fewer second agents for treatment of relapses.

Adolescent↗

PubMed2002

Duration of imipramine therapy and relapse in panic disorder with agoraphobia.

It has been suggested that maintenance treatment of patients who have remitted panic disorder with agoraphobia beyond the six months of acute phase imipramine treatment may decrease the risk of relapse. This study further explores the relationship between relapse and duration of imipramine treatment in this population.Fifty-one patients, all in remission at the end of six months acute phase open trial with imipramine 2.25 mg/kg/day and randomized to double-blind maintenance or placebo substitution, discontinued imipramine treatment eventually and were followed over a 12-month risk period: 27 during first year placebo substitution, 7 after 12 months of imipramine maintenance in placebo substitution, and 17 after variable durations of imipramine maintenance in open discontinuation. There were no behaviorally oriented interventions or instructions at any time during the acute and maintenance phases of treatment or during imipramine discontinuation. Duration of imipramine treatment, the method of discontinuation (open versus placebo substitution), or any of the 9 variables from the demographic, clinical, and open treatment domains that were entered in a Cox proportional hazard model did not predict relapse. The rate of relapse after only 6 months of treatment (10 out of 27, 37%) was identical to the rate of relapse after 12 to 30 months of treatment (9 out of 24, 37.5%). The results suggest a lack of specific protective effects beyond prophylaxis and underscore the difficulty in predicting relapse in fully remitted panic disorder with agoraphobia patients. Early detection of relapse in patients who discontinue treatment may be a viable alternative to prediction.

Adult↗

PubMed2004

Which patients with chronic hepatitis B are more likely to relapse after interferon alpha-induced hepatitis B e antigen loss in Korea?

BACKGROUND AND AIMS: Although hepatitis B e antigen (HBeAg) loss after interferon-alpha (IFN-alpha) therapy in patients with chronic hepatitis B is durable in whites, frequent relapse of hepatitis B virus (HBV) has been reported in endemic areas. This study was to evaluate the durability of interferon-induced HBeAg loss and find the risk factors for relapse. METHODS: We retrospectively analyzed 32 patients with IFN-alpha-induced HBeAg loss. They were followed up to 50 months. Age, sex, presumed route of infection, pretreatment levels of serum alanine aminotransferase and HBV DNA, and histologic findings were evaluated as potential risk factors for relapse. RESULTS: The cumulative relapse rates at 1-, 2- and 3-year were 25.5%, 35.7%, and 43.5%, respectively. They were higher in the older patients (>37 years) than in the younger ones (43.5% vs. 6.7% at 1-year, 50.6% vs. 20% at 2-year, and 64.7% vs. 20% at 3-year; P = 0.017). Patients with presumed vertical HBV infection tended to have a higher relapse rate (P = 0.11). Old age and presumed vertical infection were 2 independent risk factors for relapse. CONCLUSION: Relapse after IFN-alpha-induced HBeAg loss was common in this endemic area, especially in old patients and in those with presumed vertical HBV infection. Intensive surveillance and other therapeutic modalities would be necessary for these patients.

Adolescent↗

PubMed1992

Relapsing hepatitis A. Review of 14 cases and literature survey.

We have reviewed our experience with 14 cases of relapsing hepatitis A (RH-A), as well as 68 cases reported in the literature. Relapse occurs in 3 to 20% of patients with acute hepatitis A, and rarely takes the form of a polyphasic disease (multiple relapses). After a stage of typical hepatitis A, remission phase ensues, with partial or complete resolution of clinical and biochemical manifestations. Relapse usually occurs after a short period (usually less than 3 weeks). Relapse is usually clinically milder than the first phase, with variable liver function abnormalities and a tendency toward more marked cholestatic features. Not uncommonly, immune manifestations occur during this phase, including purpura, nephritis, and arthralgia, with common laboratory findings of rheumatoid factor as well as false-positive reaction to HCV-EIA tests. The clinical course in relapsing hepatitis A is almost always benign, and uneventful recovery is the rule with few exceptions. Steroid treatment, first reported in the present series, resulted in marked clinical improvement. Preliminary results suggest that R-HA is associated with a continuing viremia as well as shedding of virus in stools during the relapse phase. The pathogenesis of R-HA probably involves an interaction between persistent viral infection and immune mechanisms responding to the continuing antigenic stimulation.

Adult↗

PubMedDate not supplied

Anterior tibial tendon transfer in relapsing congenital clubfoot: long-term follow-up study of two series treated with a different protocol.

Two series of patients with relapsing congenital clubfoot were treated by transfer of the anterior tibial tendon to the third cuneiform under the extensor retinaculum. The two series were reviewed at the end of skeletal growth to evaluate the effectiveness of the surgical procedure. The first series included 19 clubfeet and the second 16. The two series of clubfeet were initially treated by two different manipulative techniques and two different complementary soft tissue release operations. In relapsing clubfeet, the foot dorsiflexion/eversion activity of the tibialis anterior was suppressed and the muscle functioned as an invertor. At follow-up the functional results of the second series of patients, in whom the relapsing deformity was passively correctable at the time of surgery, were better than those of the first series of patients, in whom the relapsing deformity was sometimes less passively correctable. None of the operated patients had a further relapse. In both series, the angles formed by the longitudinal axis of the navicular and the first cuneiform, the calcaneus and the fifth metatarsal, and the calcaneus and the cuboid, evaluated both by plain radiographs and by CT scan, were smaller than in normal feet and in the clubfeet that did not relapse. Transfer of the anterior tibial tendon to the third cuneiform underneath the extensor retinaculum corrects and stabilizes relapsing clubfeet by restoring their normal function of foot dorsiflexion/eversion. As a consequence, the cuneiforms and the cuboid were shifted more laterally than normal, as shown by both x-rays and CT scan.

Adolescent↗

PubMed2004

Fluoxetine treatment for prevention of relapse of depression in children and adolescents: a double-blind, placebo-controlled study.

OBJECTIVE: To compare fluoxetine 20 to 60 mg/day with placebo for prevention of relapse of major depressive disorder in children and adolescents who had achieved Children's Depression Rating Scale, Revised scores of < or =28 during treatment with fluoxetine 20 to 60 mg. METHOD: In this 32-week relapse-prevention phase of a double-blind, multicenter, placebo-controlled 51-week study, 20 patients continued to receive their fixed dose of fluoxetine (F/F group), while 20 similar patients were switched to placebo (F/P group). Definition of relapse for the primary analysis was a Children's Depression Rating Scale, Revised score of >40 with a 2-week history of clinical deterioration or relapse in the opinion of the physician. Adverse events were compared between treatment groups to assess discontinuation-emergent adverse events. RESULTS: Mean time to relapse was longer in the F/F recipients than in the F/P recipients (p=.046). Relapse occurred in an estimated 34% in the F/F cohort and 60% in the F/P cohort. Incidence of adverse events and tolerability were similar in the F/F and F/P groups, suggesting that fluoxetine is not associated with significant discontinuation events. CONCLUSIONS: Fluoxetine 20 to 60 mg/day was well tolerated and can significantly delay relapse of major depressive disorder symptoms in children and adolescents.

Administration, Oral↗

PubMed2006

A simple biological score for predicting low risk of short-term relapse in Crohn's disease.

BACKGROUND: In Crohn's disease, studies have evaluated the ability of biological markers to predict relapse in the next 12 to 18 months, without differentiating early from late relapses. The aim of this study was to look for biological markers of short-term relapse. MATERIALS AND METHODS: In a previous therapeutic trial, patients with a medically induced clinical remission had biological markers evaluated and updated every 6 weeks. A Cox model with time-dependent covariates was used for analysis. RESULTS: Among the 71 patients, 38 had a relapse. Multivariate analysis selected 2 markers predictive of relapse: C-reactive protein >20 mg/L and erythrocyte sedimentation rate >15 mm. A binary biological predictive score was derived: "negative" when both were lower than their limits, "positive" when otherwise. The relative risk of short-term relapse for patients with a positive score compared to those with a negative score was 8.0 (95% confidence interval 2.8-22.9). Sensitivity of the score was 89% and specificity was 43%. Assuming a 10% relapse rate every 6 weeks, negative and positive predictive values were 97% and 15%, respectively. CONCLUSIONS: This simple biological score can predict short-term maintenance of remission in Crohn's disease and may help physicians in the follow-up of patients in clinical remission.

Adult↗

PubMed2004

Tissue microarray analysis reveals prognostic significance of COX-2 expression for local relapse in T1-2N0 larynx cancer treated with primary radiation therapy.

OBJECTIVE: The purpose of this analysis is to determine whether a significant correlation exists between cyclooxygenase-2 (COX-2) expression and local relapse in a large cohort of patients with T1 to 2N0 laryngeal cancer treated with primary radiation therapy. METHODS AND MATERIALS: Clinical and molecular analyses were conducted on 123 patients with biopsy-proven T1 to 2N0 laryngeal cancer. Clinical prognostic factors included pretreatment hemoglobin, age, sex, race, T stage, tumor subsite, beam energy, biologically equivalent dose, therapy duration, and treatment date. Molecular prognostic factors included COX-2, p53, and Ki-67 expression. Expression levels were determined by immunohistochemistry on paraffin-embedded tissues arrayed on tissue microarrays. Multivariate analysis was done with the Cox proportional hazards model. RESULTS: Thirty-two patients have locally relapsed, for an actuarial 5-year local relapse-free rate of 70.4%. On multivariate analysis, positive COX-2 expression predicted local relapse after radiation therapy. The relative risk (RR) for local relapse with COX-2 positivity was 2.57 (95% CI, 1.21-5.47; P = .01). Other prognostic factors for local relapse included negative Ki-67 expression (RR = 5.72; 95% CI, 2.04-16.1; P < .001), T2 stage (RR = 2.98; 95% CI, 1.39-6.38; P = .005), and therapy duration greater than 43 days (RR = 6.04; 95% CI, 1.37-26.7; P = .02). CONCLUSIONS: Positive COX-2 expression predicts for local relapse in T1 to 2N0 larynx cancer in a multivariate model. This relationship may have potential therapeutic implications regarding the use of COX-2 inhibitors during radiation therapy for optimal outcome.

Adult↗

PubMed2006

Cleft maxillary distraction versus orthognathic surgery: clinical morbidities and surgical relapse.

BACKGROUND: This is the first randomized controlled study aiming to compare the postoperative clinical morbidities in cleft lip and palate patients treated with distraction osteogenesis versus conventional orthognathic surgery. METHODS: Twenty-nine cleft lip and palate patients with moderate maxillary hypoplasia requiring a maxillary Le Fort I advancement of 4 to 10 mm were randomized into two groups for either internal maxillary distractors or immediate fragment transposition using miniplates and screw fixation. Clinical morbidities were recorded using standardized questionnaires. Skeletal and dental relapses were assessed using lateral cephalometric landmarks. RESULTS: In the distraction group, two of 15 patients developed infection around the distractors and one patient had an occlusal relapse. Among the 14 patients who received conventional orthognathic surgery, the complications included intraoperative hemorrhage (n = 1), plate exposure leading to sinusitis (n = 1), and occlusal relapse (n = 1). In the skeletal relapses of the osteotomy group, a statistically significant vertical relapse of the A point was noted during the second to twelfth weeks when compared with the distraction group. A statistically significant horizontal relapse of the A and P points during the eighth to twelfth weeks was noted when the osteotomy group was compared with the distraction group. CONCLUSIONS: There were no major differences in the clinical morbidities between the osteotomy and distraction groups. Distraction provided better skeletal stability, whereas there was a significant amount of skeletal relapse in the first 12 weeks after conventional cleft maxillary osteotomy.

Adolescent↗

PubMed2004

Shape of the relapse curve and long-term abstinence among untreated smokers.

OBJECTIVE: To describe the relapse curve and rate of long-term prolonged abstinence among smokers who try to quit without treatment. METHOD: Systematic literature review. DATA SOURCES: Cochrane Reviews, Dissertation Abstracts, Excerpt Medica, Medline, Psych Abstracts and US Center for Disease Control databases plus bibliographies of articles and requests of scientists. STUDY SELECTION: Prospective studies of self-quitters or studies that included a no-treatment control group. DATA EXTRACTION: Two reviewers independently extracted data in a non-blind manner. DATA SYNTHESIS: The number of studies was too small and the data too heterogeneous for meta-analysis or other statistical techniques. RESULTS: There is a paucity of studies reporting relapse curves of self-quitters. The existing eight relapse curves from two studies of self-quitters and five no-treatment control groups indicate most relapse occurs in the first 8 days. These relapse curves were heterogeneous even when the final outcome was made similar. In terms of prolonged abstinence rates, a prior summary of 10 self-quitting studies, two other studies of self-quitters and three no-treatment control groups indicate 3-5% of self-quitters achieve prolonged abstinence for 6-12 month after a given quit attempt. CONCLUSIONS: More reports of relapse curves of self-quitters are needed. Smoking cessation interventions should focus on the first week of abstinence. Interventions that produce abstinence rates of 5-10% may be effective. Cessation studies should report relapse curves.

Humans↗

PubMed1993

Relapse rate of patients after healing of oesophagitis--a prospective study of alginate as self-care treatment for 6 months. French Co-operative Study Group.

In order to estimate the rate of symptomatic relapse and to identify factors associated with this relapse, 1030 patients were included in a multicentre study. All patients included had clinically and endoscopically healed oesophagitis (grade I (erosion, 57%), grade II (confluent erosion, 33%) or grade III (circular erosion, 9%)) after treatment with an H2-blocker or omeprazole. Patients were given conservative advice and were told to take sodium alginate only in response to pain. Relapse was defined as pain justifying more than eight sodium alginate sachets over 48 hours or treatment with another drug, or the need for a new endoscopy. Forty risk factors were recorded initially and patients were seen every 2 months; they filled out diary-cards describing symptoms and drug consumption. Data were available for 883 patients during follow up. The cumulative percentage of patients without relapse at 6 months estimated by Kaplan Meier method was 76 +/- 2% (mean +/- S.E.M.). Among these patients without relapse, 95% took less than two sachets per day. Only two factors were identified as associated with relapse--the grade of oesophagitis (P < 0.007), and the occurrence of stress during follow-up (P < 0.05). The percentage of patients free from relapse at six months was 85 +/- 2% in patients with grade I oesophagitis, 69 +/- 3% in patients with grade II, and 56 +/- 6% in patients with grade III oesophagitis (P < 0.0001).

Adolescent↗

PubMed1995

Treatment and prevention of relapse of mild oesophagitis with omeprazole and cisapride: comparison of two strategies.

BACKGROUND: Oesophagitis is usually a chronic condition. Healing with omeprazole is often followed by early relapse. Combination treatment and subsequent maintenance treatment with the prokinetic cisapride may be of benefit in relapse prevention. METHODS: Patients with endoscopically proven oesophagitis, grade I (n = 120) or grade II (n = 105), were randomized in an open fashion to receive 8 weeks of healing treatment with omeprazole 20 mg daily (OM) followed by 12 months of follow-up without maintenance treatment, or 8 weeks of combined treatment of omeprazole 20 mg daily plus cisapride 5 mg t.d.s. (OMCIS) followed by 12 months of maintenance treatment with cisapride 5 mg t.d.s. (CIS). Only the patients healed after acute treatment were included in the 12-month follow-up study for evaluation of endoscopic relapse. RESULTS: In the group of patients with oesophagitis grade I (n = 58 receiving OM, n = 62 receiving OMCIS), healing rates were comparable for both acute treatment regimens. In the group of patients with grade II (n = 54 receiving OM, n = 51 receiving OMCIS), the healing rates were slightly but not significantly in favour of OMCIS after 4 and 8 weeks of treatment. During the 12 months of follow-up, CIS maintenance treatment was associated with a significant reduction of relapse. In the group of patients with initial grade I oesophagitis, the relapse rates after 3 months were 20% in the OMCIS group receiving CIS maintenance treatment, compared to 48% in the group healed on OM without further maintenance treatment (P = 0.04). After 6 months, these relapse rates were 31% and 85% respectively (P < 0.001), and after 12 months 40% and 96% (P < 0.001). In the group of patients with initial grade II oesophagitis, they were, respectively, 20% vs. 39% after 3 months (P = 0.056), 41% vs. 78% after 6 months (P < 0.001) and 52% vs. 95% after 12 months (P < 0.001). CONCLUSIONS: The results of this open study indicate that continued treatment with cisapride 5 mg t.d.s. (after initial healing with omeprazole 20 mg daily plus cisapride 5 mg t.d.s.) is beneficial in the long-term management of grade I and II oesophagitis: this treatment approach significantly reduces the high relapse rate observed after stopping healing treatment with omeprazole.

Adult↗