Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia.

Previous observational studies suggest that rituximab may be useful in the treatment of primary immune thrombocytopenia (ITP). This randomized trial investigated rituximab efficacy in previously untreated adult ITP patients with a platelet count of 20 x 10(9)/L or less. One hundred three patients were randomly assigned to receive 40 mg/d dexamethasone for 4 days with or without 375 mg/m(2) rituximab weekly for 4 weeks. Patients who were refractory to dexamethasone alone received salvage therapy with dexamethasone plus rituximab. Sustained response (ie, platelet count > or = 50 x 10(9)/L at month 6 after treatment initiation), evaluable in 101 patients, was greater in patients treated with dexamethasone plus rituximab (n = 49) than in those treated with dexamethasone alone (n = 52; 63% vs 36%, P = .004, 95% confidence interval [95% CI], 0.079-0.455). Patients in the experimental arm showed increased incidences of grade 3 to 4 adverse events (10% vs 2%, P = .082, 95% CI, -0.010 to 0.175), but incidences of serious adverse events were similar in both arms (6% vs 2%, P = .284, 95% CI, -0.035 to 0.119). Dexamethasone plus rituximab was an effective salvage therapy in 56% of patients refractory to dexamethasone. The combination of dexamethasone and rituximab improved platelet counts compared with dexamethasone alone. Thus, combination therapy may represent an effective treatment option before splenectomy. This study is registered at http://clinicaltrials.gov as NCT00770562.

Steatosis of the hepatic graft as a risk factor for post-transplant biliary complications.

BACKGROUND: Despite recent advances in organ preservation, immunosuppression, and surgical techniques, the biliary tree is still considered the Achilles' heel of liver transplantation. The aim of this study is to retrospectively analyze the incidence of biliary complications and identify risk factors that might predispose to the development of biliary problems. METHODS: From January 2004 to December 2007, 117 consecutive liver transplantations were retrospectively analyzed for the development of biliary complications by the review of medical records. Patients were divided into group 1 with biliary complications (n = 43) and group 2 without biliary complications (n = 74). RESULTS: The overall biliary complication rate was 36.8% (leakage 6% and stricture 30.8%). Univariate analysis indicated that significant predictors of biliary complications were the time interval between portal and arterial reperfusion (p = 0.037) and macrovacuolar steatosis of the graft > 25% (p = 0.004). Stepwise logistic regression model demonstrated that a macrosteatosis of the graft > 25% (OR = 5.21 CI 95% [1.79-15.15], p = 0.002) was the only independent risk factor predicting biliary complications after liver transplantation. No differences in patient's and graft's survival were noted between the two groups. CONCLUSION: According to our experience, transplanting a liver with > 25% of steatosis is a risk factor for the development of biliary complication.

Allogeneic hematopoietic stem cell transplantation in myelofibrosis: the 20-year experience of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO).

BACKGROUND: Allogeneic stem cell transplantation is a potentially curative treatment for myelofibrosis, although its use is limited by a high rate of transplant-related mortality. In this study, we evaluated the outcome of patients with myelofibrosis who underwent allogeneic stem cell transplantation, and the impact of prognostic factors. DESIGN AND METHODS: One hundred patients were transplanted in 26 Italian centers between 1986 and 2006. We analyzed the influence of the patients' characteristics and the clinical features of their disease before stem cell transplantation and of transplant procedures on transplant-related mortality, overall survival, and relapse-free survival by means of univariate and multivariate analyses. RESULTS: The median age of the patients at the time of stem cell transplantation was 49 years (range, 21-68) and 90% of them had an intermediate or high Dupriez score. Forty-eight percent received a myeloablative conditioning regimen and 78% received stem cells from matched sibling donors. The cumulative incidence of engraftment at day 90 after transplant was 87% (95% CI, 0.87-0.97). The cumulative 1-year and 3-year incidences of transplant-related mortality were 35% and 43%, respectively. The estimated 3-year overall and relapse-free survival rates after stem cell transplantation were 42% and 35%, respectively. In multivariate analysis, negative predictors of transplant-related mortality were year of stem cell transplantation before 1995, unrelated donor, and a long interval between diagnosis and transplantation. There was a trend towards longer overall and relapse-free survival in patients receiving peripheral blood stem cells rather than bone marrow as the source of their graft (p=0.070 and p=0.077, respectively). The intensity of the conditioning regimen (myeloablative versus reduced intensity regimens) did not significantly influence the outcome. CONCLUSIONS: We conclude that the outcome of myelofibrosis patients who underwent allogeneic stem cell transplantation significantly improved after 1996 due to the reduction in transplant-related mortality. We observed that a reduction in transplant-related mortality was associated with the choice of a matched sibling donor, whereas longer overall survival was associated with the use of peripheral blood as the source of stem cells.

Lower dose rituximab is active in adults patients with idiopathic thrombocytopenic purpura.

Rituximab 375 mg/m(2) weekly for four weeks has significant activity in patients with immune thrombocytopenia. We evaluated the activity of lower dose rituximab (100 mg iv weekly for 4 weeks) in 28 adults with idiopathic thrombocytopenic purpura. Overall (platelet count > 50 x 10(9)/L) and complete responses (platelet count > 100 x 10(9)/L) were achieved in 21/28 (75%) and 12/28 (43%) patients respectively. The median time to response and time to complete response were 31 and 44 days respectively. After a median follow-up of 11 months (range 3-18), 7/21 (33%) patients relapsed and 3 needed further treatments. In patients with idiopathic thrombocytopenic purpura, lower dose rituximab seems to show similar activity to standard dose.

Rituximab therapy in adult patients with relapsed or refractory immune thrombocytopenic purpura: long-term follow-up results.

OBJECTIVE: To evaluate the long-term activity and toxicity profile of rituximab in adult patients with idiopathic immune thrombocytopenic purpura (ITP). PATIENTS AND METHODS: Twenty-six patients with active and symptomatic ITP relapsed or refractory received weekly infusions of rituximab 375 mg/m(2) for 4 wk. Median time from diagnosis to rituximab was 34.5 months. The following parameters of efficacy and toxicity were considered: complete response (CR) and partial response (PR), relapse rate, relapse-free survival (RFS), therapy-free survival (TFS), short- and long-term toxicity. RESULTS: CR and PR were 14/26 (54%) and 4/26 (15%), respectively. Median time of observation was 56.5 months (range 39-77). Nine of the 18 responding patients relapsed after a median of 21 months (range 8-66); 9/26 patients (35%) maintained the response, with a median follow-up of 57 months (range 39-69), and 11/26 (42%) did not necessitate further therapy; estimated 5 yr RFS and TFS were 61% and 72%, respectively. Younger age and shorter interval from diagnosis to rituximab appeared indicators of better outcome. Rituximab administration was associated with two episodes of short-term toxicity, with one case of serum sickness syndrome; no infectious or other significant long-term complications were documented. CONCLUSION: Rituximab therapy may achieve long-lasting remission in nearly one-third of patients with relapsed or refractory ITP, with a good safety profile.

Effect of posture on the diurnal variation in clinically significant diabetic macular edema.

PURPOSE: To investigate the role of posture and other systemic factors in the diurnal variation of clinically significant diabetic macular edema (CSDME). METHODS: Ten eyes of 10 diabetic subjects with CSDME underwent four OCT foveal thickness measurements with StratusOCT at 9 AM and 12, 3, and 6 PM consecutively on two different days, with the subject in an upright position on one and in a recumbent position on the other. For the "recumbent-position" measurements, the patients were admitted the night before and remained in bed during the entire day of testing. Clinical laboratory results at baseline included HbA1c, urinary albumin, and serum creatinine. Refraction and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity were also measured before each OCT measurement was taken. Variations in blood pressure, body temperature, plasma glucose, renin, aldosterone, and cortisol levels were measured and then correlated with macular thickness. RESULTS: Foveal thickening decreased in all cases over the course of the day. The decrease, however, was significantly greater for the upright-position measurements (relative mean +/- SD decrease of 20.6% +/- 6.5% in the upright position and 6.2% +/- 4.6% in the recumbent position). Visual acuity improved by at least 1 ETDRS line in three eyes in the upright position as opposed to only one eye in the recumbent position. There seemed to be no association between any of the systemic factors studied and foveal thickening, with the exception of cortisol. CONCLUSIONS: The results support the hypothesis that posture and hydrostatic pressure play a major role in determining time-related shifts in CSDME and suggest that the forces of Starling's law can in part, account for CSDME formation.

Role of pre-surgical breast MRI in the management of invasive breast carcinoma.

The purpose of the study was to assess the role of preoperative breast magnetic resonance imaging (MRI) as a complementary tool to routine imaging methods in the management of women affected by invasive breast carcinoma. Mammograms, sonograms and biopsy results of 121 breasts in 118 women affected by invasive breast carcinoma, who underwent pre-surgical breast MR, were re-examined to identify patients theoretically eligible for conservative surgery instead of radical mastectomy. Surgery effectively performed was evaluated to identify cases for which MRI determined a change in management. The gold standard was the final pathology. Breast MRI determined an overall change in management in 22 out of 121 breasts (18.2%), and in two out of 87 breasts (25.3%) in patients eligible for conservative surgery. In the evaluation of single breasts, MRI resulted in true-positive in 22 out of 29 breasts (75.9%), false-positive in 7 out of 29 breasts (24.1%), leading to over-treatment in women whose treatment was changed from conservative surgery to radical mastectomy. MRI sensitivity in the detection of additional foci not seen on conventional imaging was 57.4%, overall sensitivity 87.4%, sensitivity for invasive cancers 93.1%, while for ductal carcinoma in situ it was 58.8%. In conclusion, breast MRI determines a significant change in the management of patients affected by invasive breast carcinoma, particularly in patients eligible for conservative surgery after standard breast examination.

Effects of alcohol withdrawal on blood pressure in hypertensive heavy drinkers.

BACKGROUND: Epidemiological investigations have demonstrated a close association between heavy alcohol consumption and hypertension. The mechanisms of this association, however, remain elusive. We studied the effects of alcohol withdrawal on blood pressure, hormonal parameters, and circulating markers of endothelial activity. METHODS: In 14 hypertensive heavy alcohol consumers (> 200 g/day) who agreed to participate in a hospital withdrawal programme we monitored, for 30 days, blood pressure, plasma levels of renin, aldosterone, cortisol, endothelin, and plasminogen activator inhibitor 1 (PAI-1), and urinary levels of catecholamines. Patients in the withdrawal group were compared with eight hypertensive heavy drinkers who refused to participate in the programme and maintained regular alcohol consumption and 11 normotensive teetotalers. RESULTS: By the third day after withdrawal, blood pressure was significantly decreased and the normalization of levels was obtained in 13 of 14 patients by the end of the study. Alcohol withdrawal significantly decreased plasma aldosterone and cortisol levels, but did not affect levels of active renin and fractionated urinary catecholamines. At baseline, plasma endothelin and PAI-1 levels were significantly higher in alcoholic individuals than in teetotalers, and after the cessation of alcohol intake decreased progressively, reaching levels different from baseline within 1 week. A significant correlation was found between changes in endothelin and PAI-1, and blood pressure variations during alcohol abstinence that remained significant only for endothelin with the multivariate approach. CONCLUSION: Hypertension is rapidly reversible in the majority of heavy drinkers after the withdrawal of alcohol consumption. In these patients, hypertension is associated with an increased release of endothelial factors that might contribute to the increase in blood pressure.

Contrast-enhanced breast MRI in patients with suspicious microcalcifications on mammography: results of a multicenter trial.

OBJECTIVE: The objective of our study was to test dynamic MRI in evaluating mammographically detected suspicious microcalcifications. MATERIALS AND METHODS: One hundred twelve patients with mammographically detected microcalcifications with BI-RADS category 5 (n = 78) or 4 (n = 34) lesions were studied at 17 centers a using 3D gradient-echo dynamic coronal technique (< or = 3 mm thickness) and 0.1 mmol/kg of gadoteridol. A pathologic sample was obtained in all cases. Agreement between the major diameter measured on mammography, MRI, or both and the major diameter measured at pathologic examination was calculated in 62 cases. RESULTS: Of the 112 lesions, pathologic examination revealed 37 benign lesions, 33 ductal carcinoma in situ (DCIS), and 42 invasive carcinomas. The specificity of MRI for benign lesions was 68%. Considering the subgroups of calcifications alone and calcifications associated with masses, the specificity values became 79% and 33%, respectively. The sensitivity of MRI for DCIS was 79%. Analysis of the two subgroups showed sensitivity values of 68% for calcifications alone and of 1% for calcifications associated with masses. The sensitivity for invasive carcinomas was 93%. Analysis of the two subgroups showed sensitivity values to be 92% for calcifications alone and 94% for calcifications associated with masses. Considering the overall results, the sensitivity of MRI was 87%; specificity, 68%; positive predictive value, 84%; negative predictive value, 71%; and accuracy, 80%. Considering the subgroups of calcifications alone and calcifications associated with masses, the sensitivity values became 80% and 97%; the positive predictive values, 86% and 82%; the negative predictive values, 71% and 75% (95% confidence interval [CI], 0.19-0.99); and the accuracy values, 80% and 82% (95% CI, 0.66-0.92), respectively. An odds ratio (OR) of 13.54 (95% CI, 5.20-35.28) showed a raised risk of malignant breast tumor in subjects with positive MR examination of mammographically detected suspicious clusters of microcalcifications. The statistical analysis on each subgroup showed an OR of 15.07 (95% CI, 4.73-48.08) for calcifications alone and an OR of 14.00 (95% CI, 1.23-158.84) for calcifications associated with masses. Any significant improvement in the predictive ability of dynamic MRI depending on the extent of calcifications on mammography was not proved. Considering the 62 cases of proved malignancy with measured maximal diameter at pathologic examination, both mammography and MR examination seem to overestimate tumor extent. CONCLUSION: The not-perfect sensitivity of MRI (87%), when applying our interpretation criteria and imaging sequences, is a crucial point that prevents us from clinical use of MRI in the diagnosis of mammographically detected microcalcifications.

-238 and +489 TNF-alpha along with TNF-RII gene polymorphisms associate with the diffuse phenotype in patients with Systemic Sclerosis.

OBJECTIVE: To investigate possible associations of TNF-alpha and TNF-RII gene polymorphisms with diffuse or limited skin involvement phenotype in a cohort of Systemic Sclerosis (SSc) patients. METHODS: One-hundred and fourteen consecutive SSc patients attending the referral centres of three academic hospitals in Italy (University of Naples, Pavia and Udine), 56 with the diffuse (dcSSc) and 58 with limited (lcSSc) skin involvement subsets, and 170 healthy blood donors (HBDs) were included in the study. The extracted DNA was genotyped for the following polymorphisms: TNF-alpha (-238, +489) and TNF-RII (+196), using the polymerase chain reaction (PCR) and the restriction enzymes BamHI, HpyCH4 IV and NlaIII, respectively. RESULTS: The AG/AA (presence of allele A) genotypes in position -238 and the AG genotype in position +489 of the TNF-alpha gene were found significantly increased in SSc, as a whole, when compared with healthy blood donors (chi(nu=2)(2)=4.48, p=0.03 for -238 and chi(nu=2)(2)=7.82, p=0.02 for +489, respectively). The rare GG genotype in exon 6 (codon 196) of the TNF-RII gene was also found increased in SSc compared to HBDs, even though the difference did not show statistical significance (chi(nu=2)(2)=3.56, p=0.17). The strength of the association was mainly due to the dcSSc phenotype (Fisher test, p=0.04 for -238, chi(nu=2)(2)=10.07, p<0.01 for +489 and chi(nu=2)(2)=6.25, p=0.04 for the +196 TNF-RII, respectively). CONCLUSIONS: TNF-alpha and TNF-RII gene polymorphisms seem to contribute to the development of SSc and in particular to the diffuse phenotype.

A proposal for a new scoring system to evaluate pelvic masses: Pelvic Masses Score (PMS).

OBJECTIVES: Ovarian cancer is the fourth leading cause of death among neoplastic diseases in women. In spite of constant improvement in surgical, chemotherapeutic and immunologic techniques, which can induce long remission periods, the five-year survival rate has not really changed over the past thirty years. We tried to create a sonographic scoring system, called PMS, that could be helpful in diagnosis of pelvic masses. STUDY DESIGN: The three most commonly used and validated indexes--Sassone score, Ovarian Tumor Index (OTI), and Risk of Malignancy Index 3 (RMI3)--were applied to a population of 102 women with adnexal masses. We developed a new scoring system, named Pelvic Masses Score (PMS), that takes into account the ultrasound morphological pattern, the Doppler flowmetry of the pelvic mass, the CA125 serum level and the menopausal status. We then applied this scoring system to a population of 160 women for validation of the score. RESULTS: Statistical analysis of the data obtained from the new scoring system reveals that sensitivity, specificity, positive and negative predictive values (PPV and NPV) are higher than in the case of data separately derived from the Sassone score, OTI index or RMI index. CONCLUSIONS: Our preliminary data showed good results in term of sensitivity, specify and predictive values compared to other old scoring systems. A larger prospective study is required to confirm these preliminary data. The number of cases will be expanded to permit a better evaluation of PMS.

Relevance of b-values in evaluating liver fibrosis: a study in healthy and cirrhotic subjects using two single-shot spin-echo echo-planar diffusion-weighted sequences.

PURPOSE: To investigate the relevance of increasing b-values in evaluating liver fibrosis through the agreement of two diffusion-weighted (DW) sequences. MATERIALS AND METHODS: A total of 29 cirrhotic patients and 29 healthy volunteers were studied on a 1.5T system. Two single-shot spin-echo echo-planar sequences were acquired using sets of increasing b-values: 0, 150, 250, and 400 seconds/mm(2) (first sequence: DW1a) and 0, 150, 250, 400, 600, and 800 seconds/mm(2) (second sequence: DW2a). Apparent diffusion coefficients (ADCs) of the hepatic parenchyma were calculated on ADC maps. Noise-scaled single-point ADCs were calculated for each sequence from b = 400 seconds/mm(2). RESULTS: ADCs resulted significantly lower in cirrhotic patients compared to controls using both DW1a (mean 1.14 +/- 0.20 x 10(-3)mm(2)/second vs. 1.54 +/- 0.12 x 10(-3)mm(2)/second; P < 0.0001) and DW2a (mean 0.91 +/- 0.18 x 10(-3)mm(2)/second vs. 1.04 +/- 0.18 x 10(-3)mm(2)/second; P = 0.0089). DW1 and DW2, respectively significantly differed in diagnostic performance at receiver operating characteristic (ROC) curve analysis (P = 0.003), showing AUCs of 0.93 (sensitivity 89.7%, specificity 100%) and 0.73 (sensitivity 62.1%, specificity 79.3%), respectively. Noise-scaled single-point ADCs showed a progressive convergence to similar values in cirrhotic and healthy livers at b = 800 seconds/mm(2) (1.12 +/- 0.27 x 10(-3)mm(2)/second vs. 1.13 +/- 0.17 x 10(-3)mm(2)/second). CONCLUSION: A DW sequence is accurate in assessing liver fibrosis using intermediate (400 seconds/mm(2)) rather than high (800 seconds/mm(2)) maximum b-values, but after proper recalculation of ADCs the effects of perfusion rather than diffusion should be considered responsible for the higher accuracy at lower b-values.

Superiority of transplantation versus resection for the treatment of small hepatocellular carcinoma.

The best therapy for hepatocellular carcinoma (HCC) is still debated. Hepatic resection (HR) is the treatment of choice for single HCC in Child A patients, whereas liver transplantation (LT) is usually reserved for Child B and C patients with single or multiple nodules. The aim of this study was to compare HR and LT for HCC within the Milan criteria on an intention-to-treat basis. Forty-eight patients were treated by LT and 38 by HR. The median time on the waiting list for transplantation was 118 days. The estimated overall survival was significantly higher (P = 0.005) in the LT group than in the HR one. The estimated freedom from recurrence was also significantly higher (P < 0.0001) for LT patients than for HR ones. Indeed, the probability of HCC recurrence after resection was higher than after transplantation achieving 31% and 76% for HR and 2% and 2% for LT at 3 and 5 years after surgery. Multivariate analysis confirmed that transplantation was superior to resection in terms of patient's survival and risk of HCC recurrence. We conclude that LT is superior to HR for small HCC in cirrhotic patients assuming that LT should be performed within 6-10 months after listing to reduce the dropouts for reasons of tumor progression.

Influence of passive leg elevation on the right ventricular function in anaesthetized coronary patients.

INTRODUCTION: The aim of the present study was to evaluate the haemodynamic effects of passive leg elevation on the right ventricular function in two groups of patients, one with a normal right ventricular ejection fraction (RVEF) and one with a reduced RVEF. METHODS: Twenty coronary patients undergoing elective coronary artery bypass grafting surgery were studied by a RVEF pulmonary artery catheter. The haemodynamic data reported were collected before the induction of anaesthesia (time point 1), just before (time point 2) and 1 min (time point 3) after the legs were simultaneously raised at 60 degrees, and 1 min after the legs were lowered (time point 4). The patients were divided into two groups: group A, with preinduction RVEF > 45%; and group B, with preinduction RVEF < 40%. RESULTS: In group A (n = 10), at time point 3 compared with time point 2, the heart rate significantly decreased (from 75 +/- 10 to 66 +/- 7 beats/min). The right ventricular end diastolic volume index (from 105 +/- 17 to 133 +/- 29 ml/m2), the right ventricular end systolic volume index (from 61 +/- 13 to 77 +/- 24 ml/m2), the systolic systemic arterial/right ventricular pressure gradient (from 93 +/- 24 to 113 +/- 22 mmHg) and the diastolic systemic arterial/right ventricular pressure gradient (from 58 +/- 11 to 66 +/- 12 mmHg) significantly increased. Also in group A, the cardiac index did not significantly increase (from 3.28 +/- 0.6 to 3.62 +/- 0.6 l/min/m2), the RVEF was unchanged, and the right ventricular end diastolic volume/pressure ratio (RVED V/P) did not significantly decrease (from 48 +/- 26 to 37 +/- 13 ml/mmHg). In group B (n = 6) at the same time, the heart rate (from 72 +/- 15 to 66 +/- 12 beats/min), the right ventricular end diastolic volume index (from 171 +/- 50 to 142 +/- 32 ml/m2) and the RVED V/P (from 71 +/- 24 to 39 +/- 7 ml/mmHg) significantly decreased. The cardiac index and the diastolic systemic arterial/right ventricular pressure gradient were unchanged in group B, while the RVEF and the systolic systemic arterial/right ventricular pressure gradient did not significantly increase, and the right ventricular end-systolic volume index did not significantly decrease. All results are expressed as mean +/- standard deviation. CONCLUSIONS: We conclude that passive leg elevation caused a worse condition in the right ventricle of group B because, with stable values of cardiac index, of systolic systemic arterial/right ventricular pressure gradient and of diastolic systemic arterial/right ventricular pressure gradient (which supply oxygen), the RVED V/P (to which oxygen consumption is inversely related) markedly decreased. This is as opposed to group A, where the cardiac index, the systolic systemic arterial/right ventricular pressure gradient and the diastolic systemic arterial/right ventricular pressure gradient increased, and the RVED V/P slightly decreased. Passive leg elevation must therefore be performed cautiously in coronary patients with a reduced RVEF.

Descriptive epidemiology of head injury in Romagna and Trentino. Comparison between two geographically different Italian regions.

We studied the occurrence of head injury in two different Italian regions: Romagna and Trentino. Both geographical areas attract large numbers of seasonal tourists. The study was carried out over 1 year (January 1, 1998 to December 31, 1998), prospectively in Romagna and retrospectively in Trentino because of their different head injury management protocols. The study was based on all admissions to hospital extracted by medical staff from the case records, and all cases were identified by the ICD-9 codes (ranges: 800.0-800.3, 801.0-801.3, 803.0-803.3, 850, 851.0-851.1, 852.0-852.1, 853.0-853.1, 854.0-854.1). The annual incidence of hospitalization for head injury was 314/100,000, 297 for Romagna and 332 for Trentino. The causes of head trauma and the type of injuries were similar to those reported in the international literature, and so were the characteristics of the population at risk. Romagna recorded a higher incidence of head injury among the elderly, probably due to the widespread use of bicycles without safety helmets. In Romagna, where neurosurgery departments exist, hospital mortality was low (8/100,000/year). Based on similar international literature findings, different prevention measures are suggested to reduce the occurrence and severity of head injury.

Stability of maxillary advancement for correction of skeletal Class III malocclusion after combined maxillary and mandibular procedures: preliminary results of an active control equivalence trial for semirigid and rigid fixation of the maxilla.

In this paper preliminary results are presented of a prospective study designed to examine the effect of maxillary fixation methods on postoperative stability. The purpose of this study was to evaluate the stability of Le Fort I osteotomy stabilized with semirigid fixation of the maxilla (SRMF) or rigid fixation of the maxilla (RMF). All patients had skeletal Class III malocclusion and underwent bimaxillary surgery (Le Fort I maxillary advancement with or without superior repositioning and bilateral sagittal split osteotomies of the mandible). Standardized cephalometric analysis was performed on serial radiographs of 42 patients immediately before surgery, 1 week after surgery, after release of fixation, and 1 year postoperatively. The patients were randomized into 2 treatment groups: 23 patients received RMF (group A), and 19 patients received SRMF (group B). Within the groups, patients showed good stability with regard to their baseline characteristics. To show the therapeutic equivalence of the 2 treatments, analysis of the recorded data followed the approach for an equivalence trial. The mean surgical advancement was 5.34 +/- 1.50 mm for group A and 4.51 +/- 1.37 mm for group B. The mean amount of postsurgical relapse was 0.98 +/- 1.27 mm for group A and 0.30 +/- 1.04 mm for group B. Group A patients experienced 93% of their relapse (0.92 mm) during fixation, while group B patients experienced 96% of their relapse (0.29 mm) after release of fixation. RMF provided better stability than SRMF for all maxillary landmarks in the vertical plane. All considered points both in horizontal and vertical plane exhibited full equivalence for 95% confidence intervals, which seems to indicate equivalent stability between the surgical procedures.