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Comparison of ablation centration in initial and retreatment active eye-tracker-assisted laser in situ keratomileusis and the effect on visual outcome.

PURPOSE: To evaluate the relationship between initial and retreatment ablation centers in active eye-tracker-assisted myopic laser in situ keratomileusis (LASIK) and determine whether the relationship between the 2 ablation centers influences the visual outcome after retreatment. SETTING: Department of Ophthalmology, China Medical University Hospital, Taichung, Taiwan. METHODS: This retrospective study comprised 21 eyes of 15 patients who had retreatment at least 3 months after primary myopic LASIK by lifting the initial flap. Corneal topography and best corrected visual acuity (BCVA) were evaluated preoperatively and 3 months postoperatively. The ablation centration was analyzed by corneal topography preoperatively and at 3 months. RESULTS: The mean decentration of the primary treatment was 0.43 mm +/- 0.21 (SD) and of the retreatment, 0.34 +/- 0.15 mm. There was no significant difference between them (P =.07). The 2 ablation centers were close each other. The mean distance between the 2 ablation centers was 0.29 +/- 0.18 mm and the mean angle between them, 39.7 +/- 46.2 degrees. The BCVA was unchanged after retreatment regardless of the relationship between the 2 ablation centers. CONCLUSIONS: With an active eye-tracking system, the retreatment center was not only close to the pupil center but also close to the primary ablation center. Regardless of the relationship between the 2 ablation centers, the BCVA did not change if the retreatment ablation was well centered.

Adult↗

Retreatment after wavefront-guided and standard myopic LASIK.

PURPOSE: To assess and compare the clinical outcomes of conventional LASIK retreatments after primary wavefront-guided and standard myopic LASIK. DESIGN: Retrospective review of interventional case series. PARTICIPANTS: One hundred fifty-four eyes of 114 consecutive patients underwent a conventional LASIK retreatment after previous wavefront-guided and standard myopic LASIK. The eyes were divided into two groups: standard conventional myopic LASIK (SM) (n = 101) and wavefront-guided myopic LASIK (WM) (n = 53). INTERVENTION: Retreatment LASIK was performed by lifting the original flap and using an excimer laser. MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, and complications were evaluated at a mean follow-up of 7.8+/-5.5 months after retreatment (range, 3-26). RESULTS: At the last visit, mean spherical equivalents (SEs) were -0.17+/-0.42 diopters (D) in the SM group and -0.11+/-0.34 D in the WM group (P = 0.394). An SE of +/-0.50 D was achieved in 87% (88/101) of SM eyes and 91% (49/53) of WM eyes. Seventy-five percent of eyes in both groups had UCVA> or =20/20. All eyes in the WM group and 98% of eyes in the SM group had 20/30 or better UCVA. All eyes in both groups had a postoperative BSCVA of 20/25 or better. No eyes lost 2 lines of BSCVA in either group. No sight-threatening complications were encountered. The number of eyes with pre-retreatment optical symptoms was reduced to half after retreatment. CONCLUSIONS: Our results suggest that retreatment with conventional LASIK is a safe, effective, predictable way of dealing with different types of residual refractive errors after both wavefront-guided and standard myopic LASIK.

Adult↗

Retreatment with nafarelin for recurrent endometriosis symptoms: efficacy, safety, and bone mineral density.

OBJECTIVE: To assess the efficacy, safety, and effect on bone mineral density of a 3-month course of retreatment with intranasal nafarelin acetate for recurrent symptoms of endometriosis. DESIGN: Multicenter, open-label, nonrandomized clinical trial. SETTING: Eleven hospital-based and private practices. PATIENT(S): Thirty-six women with endometriosis symptoms recurring after 3 or 6 months of treatment with nafarelin. INTERVENTION(S): Nasal nafarelin 200 micrograms twice daily for 3 months. MAIN OUTCOME MEASURE(S): Assessments for dysmenorrhea, dyspareunia, pelvic pain, tenderness, and induration. Measurement of bone mineral density of the lumbar spine. RESULT(S): Improvements from admission to the end of retreatment were significant for dysmenorrhea, pelvic pain, tenderness, induration, and dyspareunia. Three months after retreatment ended, mean symptom scores for dysmenorrhea and pelvic tenderness, although worse than at the end of retreatment, were still significantly better than scores at admission. Mean bone mineral density 3 months after retreatment was 0.56% lower than before retreatment and 1.94% lower than before initial treatment. CONCLUSION(S): Three-month nafarelin retreatment for recurrent endometriosis symptoms was effective and safe.

Administration, Intranasal↗

Retreatment efficacy 3 months after obturation using glass ionomer cement, zinc oxide-eugenol, and epoxy resin sealers.

The efficacy of ultrasonic retreatment, 3 months after obturation, in conjunction with Ketac-Endo, Roth's 801, and AH26 sealers was evaluated. Seventy-two root canals were prepared and obturated with gutta-percha and one of the sealers mentioned above. After 90 days, the canals were retreated by an ultrasonic technique and the retreatment time was recorded. The roots were split and the amount of debris that remained on the canal walls in three separate levels was scored. Compared by one-way and two-way analysis of variance, the mean scores of remaining debris at the different canal levels for the three sealer groups, as well as for each group, were not significantly different. The only significant difference was found in retreatment time for which Ketac-Endo was significantly slower to retreat than the other two sealers (p < 0.002). Thus, the results of this study showed that the amount of debris remaining on the root canal walls following retreatment 3 months after obturation is similar for Ketac-Endo, Roth's 801, and AH26 sealers, but the retreatment time for Ketac-Endo is significantly longer.

Analysis of Variance↗

Thermafil retreatment with and without chloroform solvent.

A previous study reported that retreatment of Thermafil-obturated canals resulted in significantly more remaining gutta-percha than retreatment of those obturated with laterally condensed gutta-percha. The purpose of this study was to evaluate two retreatment methods in Thermafil-obturated canals. Thirty canals were cleaned and shaped. They were obturated with Thermafil and sealer. One-half were retreated using chloroform to aid in gutta-percha removal (group 1). The others were retreated without chloroform (group 2). The ease or difficulty of removing the metal carrier was assessed during each retreatment. The teeth were split longitudinally; the canal area and remaining gutta-percha area were measured in the coronal, middle, and apical thirds. The results were analyzed by analysis of variance. In each group, seven Thermafil devices were easy to remove and eight were difficult. No significant differences were found in comparing the two groups. However, when the factor of ease of removal was added there were significant differences. Group 2 had significantly less gutta-percha in the apical third (5.9%) when the device was easily removed than when it was hard to remove (54.2%). Group 2 canals were significantly cleaner in the apical third than group 1 canals whether the device was difficult (38.3%) or easy to remove (42.5%). Adequacy of Thermafil retreatment may be related more to the ability to easily remove the carrier than to the technique of gutta-percha removal.

Analysis of Variance↗

Retreatment with argon laser trabeculoplasty.

Forty eyes in 37 patients that had previously successful 360 degrees argon laser trabeculoplasty were again found to have uncontrolled intraocular pressure (IOP) on maximally tolerated medical therapy and were retreated with argon laser trabeculoplasty to 180 degrees of the trabecular circumference. Successful retreatment was considered a decrease in IOP of 3 mmHg or more and sufficient to avoid further laser therapy or invasive glaucoma surgery. Laser trabeculoplasty retreatment was successful in 13 of the eyes treated (32%). Retreatment failed to control IOP in 27 of the retreated eyes (68%): either the IOP was not lowered by at least 3 mmHg (4 eyes) or the eyes required further laser therapy or surgery (23 eyes). The probability of successful IOP control 1 year after retreatment was 33% and only 14% after 1.75 years. No IOP elevations greater than 6 mmHg were recognized in the postlaser period. Although retreatment with argon laser trabeculoplasty can safely be used to control the IOP in some glaucomatous eyes, the likelihood of success is low.

Aged↗

Apical nodular subepithelial corneal scar after retreatment in hyperopic photorefractive keratectomy.

PURPOSE: To report a complication, apical nodular subepithelial corneal scar, that can occur after hyperopic photorefractive keratectomy (PRK) retreatment. SETTING: Istanbul University Eye Research Center, Istanbul, Turkey. METHODS: Twelve eyes of 6 patients with apical nodular subepithelial corneal scar were retrospectively studied. Mean age of the 5 men and 1 woman was 30.2 years +/- 5.4 (SD). All eyes had hyperopic PRK retreatment for regression 9.5 +/- 1.44 months after primary hyperopic PRK. Mean spherical equivalent refraction of the residual hyperopia before retreatment was +4.67 +/- 0.81 diopters (D). All patients had a corneal haze grade of less than 1+. Hyperopic PRK retreatment was performed with a 193 nm excimer laser (Chiron Technolas Keracor 116). RESULTS: Apical nodular subepithelial corneal scars developed within the first month of hyperopic PRK retreatment and progressed until the third month in 12 eyes of 6 patients. The lesion was round and symmetrical in both eyes, smaller than 2.0 mm, and centrally located. During the mean 40.66 +/- 2.46 month follow-up, the lesion did not change in size or density. Mean spherical equivalent refraction after retreatment was 2.88 +/- 0.88 D (range +1.50 to +4.00 D) at 1 month and +4.36 +/- 1.83 D at last follow-up. Refraction was unmeasurable in 3 eyes. Five eyes lost 1 line of best spectacle-corrected visual acuity and 7 eyes, 2 or more lines. The surface regularity indexes were higher than 2.00 in all the eyes. CONCLUSION: Hyperopic PRK retreatment may cause the sight-threatening complication of apical nodular subepithelial corneal scar. This complication behaves unlike corneal haze and does not resolve spontaneously over time.

Adult↗

Retreatment of patients with the same chemotherapy: implications for clinical mechanisms of drug resistance.

BACKGROUND: Patients who relapse after adjutant chemotherapy, or after attaining remission following treatment of advanced disease, are sometimes retreated with the same type of chemotherapy. The objective of the current review of published reports was to assess the probability of response to retreatment, and to examine evidence for transient rather than stable forms of clinical drug resistance. METHODS: A Medline review of published clinical series where patients were retreated with the same chemotherapy that they had received previously. RESULTS: We located 15 reports of patients with advanced disease who were retreated with the same chemotherapy following complete remission and subsequent relapse, and three reports where patients received the same chemotherapy that was given previously as adjuvant treatment for breast cancer. For patients with advanced disease the median time off-treatment was 48 weeks; response rates to retreatment using appropriate criteria were in the range of 18%-100% (median 51%), with a substantial proportion of second complete responses. For patients retreated after adjuvant chemotherapy for breast cancer the median interval between treatments was 84 weeks and the response rates were in the range of 40%-51%. CONCLUSIONS: With the caveat that this type of review is subject to publication bias, retreatment of patients who relapse after complete response to initial therapy, or after adjuvant therapy, is associated with a substantial probability of response. Together with evidence that more prolonged or intensive initial therapy rarely leads to more frequent or more prolonged responses, the current review suggests that some patients may develop transient resistance to chemotherapy.

Antineoplastic Combined Chemotherapy Protocols↗

Long-term retreatment in chronic hepatitis C patients who were non-responders to an initial course of interferon-alpha 2b.

Nineteen patients with chronic hepatitis C who were virological non-responders (seven responder/relapse and 12 no response) to an initial 24-week course of interferon-alpha 2b (IFN-alpha 2b) at a dose of 3 million units (MU) thrice weekly were retreated for an additional 48 weeks at the same dosing schedule and followed-up for another 24 weeks post-therapy. At the end of follow-up (week 72), six (32%) of the 19 patients were hepatitis C virus (HCV) RNA negative and were virological complete responders to retreatment. The viral genotypes in these six patients included two each with 1b and 3a, one with 2b, and another with 2a/2b; five of the six virological responder patients had cirrhosis. Significant predictors for successful retreatment included lower baseline HCV RNA concentrations prior to the first course of therapy, 2 log10 reductions in serum HCV RNA during the initial treatment and classification into the virological 'responder/relapse' category after the first course of IFN (P < 0.01 for all observations). When the above factors were used to construct a predictive model to determine response to retreatment, it was found that the absence of a 2 log10 drop in HCV RNA concentrations during the first course of IFN therapy was the most reliable indicator of non-response to retreatment (likelihood ratio = 10, P = 0.0014). In addition, the presence of HCV RNA at week 12 of retreatment was 100% predictive of virological non-response to the 48-week course of therapy. Our findings indicate that an additional 48-week course of IFN-alpha 2b therapy at 3 MU thrice weekly will achieve a virological complete response in 60% of patients who had a 2 log10 drop in HCV RNA during their first course of treatment, and measurement of week-12 HCV RNA during retreatment to identify non-responders is beneficial to patients as well as being cost-effective. Thus, a second course of IFN remains a viable option in a subgroup of non-responder patients, regardless of genotype or the presence of compensated cirrhosis.

Adult↗

Molecular genetic markers provide no evidence for reproductive isolation among retreat building phenotypes of the net-spinning caddisfly Macrostemum carolina.

Larvae of the stream-dwelling, filter-feeding caddisfly Macrostemum carolina construct silken catchnets within protective retreats. In the Savannah River, M. carolina individuals make three different retreats, each with a distinct water entrance hole: (i) at the end of a silken tube; (ii) with a approximately 180 degrees silken backstop; and (iii) flush with the top of the retreat. To resolve whether these different retreats represent alternative behavioural phenotypes within a single panmictic population or fixed phenotypes within three genetically distinct populations or species, we compared the allele frequencies at three polymorphic nuclear loci (allozyme electrophoresis for Gpi, Mpi and Pgm) and the mitochondrial DNA (mtDNA) haplotype frequencies among individuals displaying the three retreat morphs. We also calculated pairwise exact tests of population differentiation using the allozyme and mtDNA allele frequencies. No significant genetic differentiation was detected among caddisflies exhibiting the different retreat morphs. Therefore, these morphs apparently represent a single panmictic population in the Savannah River. Consequently, additional study is required to assess whether this retreat polymorphism is a phenotypically plastic trait under conditional control, or is mediated by alternative alleles at a Mendelian gene or genes (or a combination of the two).

Animals↗

Successful retreatment of allograft rejection with OKT3.

OKT3 is a murine monoclonal antibody to the CD3 antigen of human T lymphocytes. The production of human antimurine antibodies after treatment with OKT3 has been perceived as a major limitation to its extended use and reuse. Treatment of 142 patients with 168 courses of OKT3 resulted in the development of antimouse antibody in 28% of the patients. Twenty-six patients (16 kidney, 6 liver, 3 heart, 1 pancreas) have been retreated with 27 courses of OKT3. Eighteen patients had no antimurine antibodies present, and the rejection reversal rate was 83% (15/18). Six patients had a low-titer antimurine antibody present, and rejection reversal occurred in 5 (83%). Rejection was not reversed in 2 patients with a high-titer antibody. Development of antimurine antibody was more frequent in renal transplant recipients (33%) than in hepatic (12%) or cardiac transplant recipients (18%). We believe that this reflects the fact that concomitant immunosuppressive therapy is more likely to be reduced during OKT3 therapy in renal transplant recipients than in hepatic or cardiac transplant recipients. Retreatment of patients with no anti-OKT3 antibody resulted in depletion of CD3+ cells from the peripheral blood, but it took longer than in patients being treated with OKT3 for the first time. Similarly, serum OKT3 levels rose more slowly in retreated patients compared to first treatment. In retreating patients with a low-titer antimurine antibody, it often was necessary to increase the dose of OKT3 in order to achieve adequate serum OKT3 levels and to deplete CD3+ cells. De novo antimurine antibody developed in 4 of the 18 (22%) antibody-negative patients who were retreated. In conclusion, retreatment with OKT3 should not be considered unless the antibody status of the patient is known. Development of low-titer antibodies does not preclude successful retreatment with OKT3; however, alternate antirejection therapy should be used in patients with high-titer antimurine responses.

Antibodies, Anti-Idiotypic↗

Retreatment with interferon plus ribavirin of chronic hepatitis C non-responders to interferon monotherapy: a meta-analysis of individual patient data.

BACKGROUND AND AIMS: Retreatment with a combination of alpha interferon (IFN) plus ribavirin of patients with chronic hepatitis C who did not respond to IFN monotherapy has not been assessed in large controlled studies. METHODS: To assess the effectiveness and tolerability of IFN/ribavirin retreatment of non-responders to IFN and to identify predictors of complete (biochemical and virological) sustained response, we performed a meta-analysis of individual data on 581 patients from 10 centres. Retreatment with various IFN schedules (mean total dose 544 mega units) and a fixed ribavirin dose (1000-1200 mg/daily depending on body weight) was given for 24-60 (mean 39.5) weeks. RESULTS: Biochemical end of treatment and sustained responses were observed in 271/581 (46.6%; 95% confidence interval (CI) 42.6-50.7%) and in 109/581 (18.7%; 95% CI 15.6-22.0%) cases, respectively. Two hundred and six of 532 patients (38.7%; 95% CI 34.6-42.9%) had an end of treatment complete response to retreatment while a complete sustained response occurred in 88 of 559 (15.7%; 95% CI 12.8-18.8%). Fifty four of 581 patients (9.2%; 95% CI 7.0-11.7%) stopped retreatment due to adverse effects. By logistic regression, complete sustained response was predicted independently by age <45 years (p=0.04), by normal pretreatment gamma-glutamyltransferase levels (p=0.01), and by a second course total IFN dose of at least 432 mega units (p=0.008). CONCLUSIONS: The overall low probability of effectiveness argues against indiscriminate retreatment of all IFN monotherapy non-responders with IFN/ribavirin. Patients less than 45 years old with normal gamma-glutamyltransferase levels who were retreated with high dose long course combination therapy had a complete sustained response rate of 30%.

Adult↗

Lift-flap retreatment after laser in situ keratomileusis.

PURPOSE: To demonstrate the effectiveness of lifting the flap for retreatment of undercorrected eyes after laser in situ keratomileusis (LASIK). METHODS: We reviewed the results of 11 LASIK patients (12 eyes) who underwent retreatment for residual myopia by lifting the previously cut flap. This was followed by treatment with the Summit Apex excimer laser and repositioning of the flap. Average time prior to retreatment was 5 months (range, 1 to 9 mo). Follow-up was 100% at 3 months after retreatment. RESULTS: The average preoperative spherical equivalent refraction was -8.73 D; average prior to retreatment was -2.24 D (range, -0.67 to -5.75 D). At 1 month after retreatment, average deviation from intended correction was 0.08 D; at 3 months it was -0.12 D. Eleven of 12 treated eyes (92%) had uncorrected visual acuity of 20/40 or better and 4 eyes (33%) saw 20/20 or better without correction. Six eyes (50%) were within +/- 0.50 D of intended correction at 3 months. No patients lost any lines of spectacle-corrected visual acuity. CONCLUSION: Retreatment of residual myopia after LASIK by lifting the flap appears to be effective and associated with minimal complications.

Adult↗

Laser in situ keratomileusis retreatment for residual myopia and astigmatism.

PURPOSE: To evaluate the visual and refractive results of laser in situ keratomileusis (LASIK) retreatment on eyes with residual myopia with or without astigmatism. METHODS: LASIK retreatment was performed on 35 eyes of 23 patients for correction of residual myopia, with or without astigmatism, with a mean manifest spherical equivalent refraction of -2.17+/-0.82 D (range, -1.00 to -3.87 D) and mean refractive astigmatism of -0.55+/-0.61 D (range, 0 to -1.75 D). Retreatment was performed 3 to 18 months after primary LASIK (mean, 5.1+/-2.6 mo). The corneal flap of the previous LASIK was lifted and laser ablation was performed using the Chiron-Technolas Keracor 116 excimer laser. Follow-up was 12 months for all eyes. RESULTS: At 1 year after retreatment, manifest spherical equivalent refraction was reduced to a mean -0.23+/-0.28 D (range, 0 to -0.87 D), and refractive astigmatism was reduced to a mean -0.16+/-0.25 D (range, 0 to -0.75 D). Thirty-two eyes (91.5%) had a manifest spherical equivalent refraction within +/-0.50 D of emmetropia, and 33 eyes (94.3%) had 0 to 0.50 D of refractive astigmatism. Uncorrected visual acuity was 20/20 or better in 11 eyes (31.4%). Spectacle-corrected visual acuity was not reduced in any eye after retreatment. There were no significant complications. CONCLUSION: LASIK retreatment was effective for correction of residual myopia or astigmatism after primary LASIK. Refractive results were predictable with good stability after 3 months. Lifting the flap during LASIK retreatment was relatively easy to perform and did not result in visual morbidity in eyes treated from 3 up to 18 months after primary LASIK.

Adult↗

Interferon retreatment of patients with chronic hepatitis C. A long-term follow-up.

BACKGROUND/AIMS: We retrospectively evaluated the long-term efficacy of interferon retreatment in patients with chronic hepatitis C, who did not have a sustained response to a 1st cycle of treatment. METHODOLOGY: Sixty-six patients, 43 non-responder and 23 relapser to alpha interferon treatment, were retreated with alpha interferon, 6 MU thrice weekly for 12 months. Response was defined as negative HCV viremia. Responders underwent long-term follow-up (27-43 months). RESULTS: The response rates were 14% and 35% at the end of retreatment, 7% and 22% at 6 months, and 2% and 13% at long-term follow-up in non-responders and relapsers respectively. The outcome of retreatment was not statistically influenced by age, cirrhosis, viral genotype, dose and duration of previous treatment. CONCLUSIONS: Interferon retreatment, for sustained viral eradication, is not effective in non-responders and useful in few relapsers. Whereas, retreatment could prove effective in slowing down the activity of the disease and reducing the incidence of hepatocarcinoma, since some relapses occur late during the follow-up. Therefore, retreatment should be confined to relapsers with contraindications to new more efficient therapeutic strategies.

Adult↗

Improving cancer surgery in Ontario: recommendations from a strategic planning retreat.

INTRODUCTION: The Ministry of Health and Long-Term Care mandated a rapid and thorough change in the delivery of cancer services in Ontario to integrate ambulatory services offered by Cancer Care Ontario (CCO) with the inpatient services of affiliated hospitals. The CCO Surgical Oncology Program held a strategic planning retreat to establish the basis upon which to implement surgery-specific changes. METHODS: Participants completed a pre-retreat survey. Based on survey results, the retreat was organized around 4 themes: role of the Surgical Oncology Program; knowledge transfer; funding for cancer surgery; and research priorities. These topics were discussed in small breakout groups and by the entire assembly. RESULTS: Retreat participants (n = 55) included hospital CEOs, vice-presidents of cancer services, surgeons from cancer centres and community hospitals, academic chairs of surgery, clinician researchers and managers from CCO. Responses to the pre-retreat survey (n = 38) and recommendations made by retreat participants showed strong support for the Surgical Oncology Program to take a leadership role in the development and monitoring of quality indicators, research related to cancer surgery and the creation of regional communities of practice. Funding mechanisms for cancer surgeons and hospitals performing cancer surgery were also highlighted. CONCLUSION: The Surgical Oncology Program used the results to develop a strategic plan that was approved by retreat participants and the board of the CCO. The program has embarked on a multifaceted approach to facilitate, monitor and report on the organization and delivery of cancer surgery in Ontario.

Data Collection↗

Comparison of the effects of LASIK retreatment techniques on epithelial ingrowth rates.

PURPOSE: To compare the incidence of postoperative epithelial ingrowth using 3 different surgical LASIK retreatment techniques. DESIGN: Retrospective consecutive case series. PARTICIPANTS AND CONTROLS: Thirty consecutive eyes that underwent LASIK retreatments by a single surgeon. METHODS: The first 10 eyes underwent LASIK retreatment using the surgeon's routine surgical technique (forceps lift group), the next 10 retreated eyes had a bandage contact lens placed after surgery and removed the following day (contact lens group), and the next 10 patients had retreatment performed using a Pinelli spatula to cleave the circumference of the flap edge before lifting the flap and no contact lens placed after surgery (spatula cleaving group). The retreatment technique did not vary apart from these modifications. MAIN OUTCOME MEASURES: Incidence of postoperative epithelial ingrowth. RESULTS: The incidence of epithelial ingrowth was 40% in the contact lens group, 20% in the forceps lift group, and 10% in the spatula cleaving group. There was a trend toward a significant difference between the contact lens and spatula cleaving groups (P = 0.12). The patients with epithelial ingrowth showed a trend toward being older, with a mean age of 53+/-8.5 years compared with a mean age of 44+/-13 years for the patients without epithelial ingrowth (P = 0.07). Incidence of ingrowth was not related to the preoperative spherical equivalent. CONCLUSIONS: There was an increased incidence of epithelial ingrowth with use of an overnight bandage contact lens in our series. The Pinelli spatula may reduce trauma to the epithelium at the flap edge. The incidence of epithelial ingrowth was not related to the preoperative spherical equivalent. Increasing age may be a risk factor for epithelial ingrowth, but further study is warranted.

Adult↗

Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn's disease.

BACKGROUND & AIMS: Infliximab, an anti-tumor necrosis factor monoclonal antibody, rapidly reduces signs and symptoms of active Crohn's disease. The aim of this study was to determine whether repeated infusions of infliximab would effectively and safely maintain the remitting benefit. METHODS: The efficacy, safety, pharmacokinetics, and immunogenicity of 4 repeated treatments with 10 mg/kg infliximab given every 8 weeks were compared with the effects of placebo in a randomized, double-blind, placebo-controlled, parallel group trial. Seventy-three patients with active Crohn's disease who had not adequately responded to conventional therapies and then had demonstrated a clinical response (>/=70-point decrease in the Crohn's Disease Activity Index) to an initial infusion of infliximab (or placebo) were studied. RESULTS: Retreatment with infliximab maintained the clinical benefit through the retreatment period and 8 weeks after the last infusion in nearly all patients retreated with infliximab. Median values for Crohn's Disease Activity Index, inflammatory bowel disease questionnaire (a quality of life measurement), and serum C-reactive protein concentration were maintained at remission levels with infliximab retreatment, but not with placebo retreatment. Retreatment with infliximab every 8 weeks maintained serum infliximab concentration and was well tolerated with a low incidence of immunogenicity. One case of lymphoma and 1 case of suspected lupus were reported; the complete long-term safety profile of infliximab requires additional clinical investigation. CONCLUSIONS: Long-term treatment with infliximab showed efficacy and tolerability in managing symptoms of patients with active Crohn's disease not responding to conventional treatments.

Adolescent↗