An enhanced outpatient modality for the treatment of hemorrhoidal disease: preliminary results.

Surgical treatment of haemorrhoids is, primarily, performed on an outpatient basis, and as so, the reduction of the operative time and the hospitalization duration is necessary. In order to achieve these results, both the surgical procedure and the anaesthesia modality should be optimized. Therefore, in this randomized controlled trial, we proposed the hemorrhoidal arteries ligation under pudendal nerve block, as an enhanced outpatient modality, versus the standard of doppler guided hemorrhoidal arteries ligation under spinal anaesthesia. Preliminary results showed that the experimental group was characterized by a similar to the control arm, symptoms remission rate, a lower operation duration and an improved postoperative recovery.

Safety and effectiveness of alveolar recruitment maneuvers and positive end-expiratory pressure during general anesthesia for cesarean section: a prospective, randomized trial.

INTRODUCTION: During cesarean section, the supine position reduces functional residual capacity and worsens lung compliance. We tested the hypothesis that alveolar recruitment maneuvers and positive end-expiratory pressure improve lung compliance in women undergoing general anesthesia for cesarean section. METHODS: Ninety women undergoing cesarean section were randomly assigned to one of two groups in a prospective, double-blind trial. In the alveolar recruitment maneuver group, pressure-control ventilation was used and inspiratory time was increased to 50% after delivery; positive end-expiratory pressure was increased to 20cmH2O and peak airway inspiratory pressure gradually increased to 45-50cmH2O. Volume-control ventilation was then used with low tidal volumes (6mL/kg) and positive end-expiratory pressure was reduced stepwise to 8cmH2O. In the control group, alveolar recruitment maneuvers were not used. Data were collected before and 3, 10 and 20min after the alveolar recruitment maneuver, before extubation and postoperatively at 10 and 20min. RESULTS: Dynamic compliance, peak airway inspiratory pressure, PaO2 and PaO2/FiO2 were significantly different in the alveolar recruitment maneuver group compared to controls at all time points during surgery except at baseline. Oxygen saturation was significantly greater in the alveolar recruitment maneuver group at 10 and 20min and before extubation. Dynamic compliance was 29.7-42.5% higher and peak airway inspiratory pressure 3.6-10.2% lower in the alveolar recruitment maneuver group compared to controls. The PaO2, PaO2/FiO2 and oxygen saturation were higher (9.4-12%, 10.3-11.9% and 0.4-1.3%, respectively) in the alveolar recruitment maneuver group. Postoperatively, PaO2 and oxygen saturation were significantly higher in the alveolar recruitment maneuver group compared to controls (PaO2 9.2% at 10min and 8.4% at 20min, oxygen saturation 0.8% at 10min and 1.1% at 20min). There were no significant differences in hemodynamic stability or adverse events between groups. CONCLUSION: Compared to standard care, the alveolar recruitment maneuver with positive end-expiratory pressure and low tidal volumes appears safe and effective in improving lung compliance and both intraoperative and postoperative oxygenation in women undergoing general anesthesia for elective cesarean section.

A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.

WHAT IS KNOWN AND OBJECTIVE: The relative effectiveness and safety profile of the treatments with marketing authorization for relapsing multiple sclerosis (MS) are not well known because randomized controlled trials with head-to-head comparisons between these treatments do not exist. Thus, a network of multiple-treatments meta-analysis was performed using four clinical outcomes: 'patients free of relapse', 'patients without disease progression', 'patients without MRI progression' and 'patients with adverse events'. METHODS: Randomized controlled trials (RCTs) on MS were systematically searched in PubMed and Cochrane Central Register of Controlled Trial. The network analysis performed pairwise comparisons between the marketed treatments (Betaferon 250mcg, Avonex 30mcg, Rebif 44mcg, Rebif 22mcg, Aubagio 7 mg, Aubagio 14 mg, Copaxone 20 mg, Tysabri 300 mg, Gilenya 0·5 mg and Novantrone 12 mg/m(2)) using direct and indirect analyses. RESULTS AND DISCUSSION: The analysis included 48 articles, involving 20 455 patients with MS. The direct analysis showed better response for more than one outcome for Gilenya compared with Avonex ('patients free of relapse' and 'patients without MRI progression') and for Betaferon compared with Avonex ('patients without disease progression' and 'patients without MRI progression'). The indirect analysis indicated that Tysabri may have better relative effectiveness compared with the other treatments for two outcomes: 'patients free of relapse' and 'patients without MRI progression'. Regarding 'patients with adverse events', no data were available for all comparisons to make fair inferences. WHAT IS NEW AND CONCLUSION: This was an attempt, for the first time, to compare the efficacy and safety profile of existing approved treatments for relapsing MS. Although some treatments have shown better response, the results of the network analysis should be interpreted with caution because of the lack of RCTs with head-to-head comparisons between treatments.

Polymorphisms and haplotypes in MyD88 are associated with the development of sarcoidosis: a candidate-gene association study.

Sarcoidosis is considered as a disorder of protracted immune response to an as yet unidentified causative agent that leads to granuloma formation. Material from M. tuberculosis and P. acne has been repeatedly detected in the sarcoidosis lesions, implying the involvement of the Toll-like receptor2 (TLR2) gene that responds to these intracellular pathogens. Since TLR2 association studies have produced controversial results, we sought to investigate whether the downstream signalling molecule MyD88 could be linked to disease susceptibility. We analyzed a total of 93 cases with sarcoidosis and of 89 controls for the most common MyD88 SNPs: -938C>A (rs4988453) and 1944C>G (rs4988457). There is evidence that the genotype distributions of both variants are associated with the development of sarcoidosis (p = 0.038 for -938C>A and p = 0.026 for 1944C>G). In particular, -938A and 1944G carriers were associated with risk of sarcoidosis [OR = 2.48 (1.23-5.02) and OR = 0.33 (0.14-0.76)], respectively, indicating dominance of the mutant alleles; however, the adjustment of the effect size for age and sex diminished the significance. The haplotype analysis showed association for the -938A/1944G haplotype (p < 0.001). Since genetic association studies have linked MyD88 to Hodgkin's lymphoma it is tempting to speculate that MyD88 may contribute to the granuloma formation that characterizes sarcoidosis.

Intermittent recruitment with high-frequency oscillation/tracheal gas insufflation in acute respiratory distress syndrome.

In acute respiratory distress syndrome (ARDS), recruitment sessions of high-frequency oscillation (HFO) and tracheal gas insufflation (TGI) with short-lasting recruitment manoeuvres (RMs) may improve oxygenation and enable reduction of subsequent conventional mechanical ventilation (CMV) pressures. We determined the effect of adding HFO-TGI sessions to lung-protective CMV on early/severe ARDS outcome. We conducted a prospective clinical trial, subdivided into a first single-centre period and a second two-centre period. We enrolled 125 (first period, n = 54) patients with arterial oxygen tension (P(a,O(2)))/inspiratory oxygen fraction (F(I,O(2))) of <150 mmHg for >12 consecutive hours at an end-expiratory pressure of ≥ 8 cmH(2)O. Patients were randomly assigned to an HFO-TGI group (receiving HFO-TGI sessions with RMs, interspersed with lung-protective CMV; n = 61) or CMV group (receiving lung-protective CMV and RMs; n = 64). The primary outcome was survival to hospital discharge. Pre-enrolment ventilation duration was variable. During days 1-10 post-randomisation, P(a,O(2))/F(I,O(2))), oxygenation index, plateau pressure and respiratory compliance were improved in the HFO-TGI group versus the CMV group (p < 0.001 for group × time). Within days 1-60, the HFO-TGI group had more ventilator-free days versus the CMV group (median (interquartile range) 31.0 (0.0-42.0) versus 0.0 (0.0-23.0) days; p < 0.001), and more days without respiratory, circulatory, renal, coagulation and liver failure (p ≤ 0.003). Survival to hospital discharge was higher in the HFO-TGI group versus the CMV group (38 (62.3%) out of 61 versus 23 (35.9%) out of 64 subjects; p = 0.004). Intermittent recruitment with HFO-TGI and RMs may improve survival in early/severe ARDS.

Impact of dietary shift to higher-antioxidant foods in COPD: a randomised trial.

Chronic obstructive pulmonary disease (COPD) is characterised by increased oxidative stress. Dietary factors, such as ample consumption of foods rich in antioxidants, such as fruit and vegetables, might have beneficial effects in COPD patients. The association between dietary shift to foods rich in antioxidants and lung function in COPD was investigated in a 3-yr prospective study. A total of 120 COPD patients were randomised to follow either a diet based on increased consumption of fresh fruit and vegetables (intervention group (IG)) or a free diet (control group (CG)). The mean consumption of foods containing antioxidants was higher in the IG than in the CG throughout the study period (p<0.05). The relationship between consumption of foods rich in antioxidants and percentage predicted forced expiratory volume in 1 s was assessed using a general linear model for repeated measures; the two groups overall were different in time (p = 0.03), with the IG showing a better outcome. In investigating the effect of several confounders (sex, age, smoking status, comorbid conditions and exacerbation) of group response over time, nonsignificant interactions were found between confounders, group and time. These findings suggest that a dietary shift to higher-antioxidant food intake may be associated with improvement in lung function, and, in this respect, dietary interventions might be considered in COPD management.

Mesothelioma mortality in Greece from 1983 to 2003.

OBJECTIVE: To present summary statistics of the Greek mesothelioma epidemic including summaries by occupation and geographical area. METHODS: The National Statistics Service provides our data, which contain all deaths from 1983 to 2003 where mesothelioma was mentioned on the death certificate. RESULTS: The annual number of mesothelioma deaths has increased from 9 in the 3-year period of time 1983-1985 to 53 in 2001-2003. Current deaths in males account for about 72% of the cases. The area of Epirus in Greece has the highest cause-specific mortality rate over the period 1983-2003. The occupational group which is related to the higher number of mesothelioma deaths was clerks and those occupied in business; following farmers, workers-technicians and drivers. CONCLUSION: Our data suggest a change in the balance of risk away from traditional asbestos exposure industries to industries where one could describe the exposure as secondary such as plumbers, technicians, drivers, farmers. Also, we found out that the higher cause-specific mortality rate was 0.38/100,000 population in Epirus, the lower was 0.025/100,000 in Thessalia and the national average rate was 0.10/100,000 population.

Alpha-1 antichymotrypsin gene signal peptide a/t polymorphism and primary intracerebral hemorrhage.

BACKGROUND/AIMS: Alpha-1 antichymotrypsin (ACT), a serine proteinase inhibitor, has been implicated in vascular pathology. The TT genotype of the ACT signal peptide A/T polymorphism has been reported to confer susceptibility to primary intracerebral hemorrhage (PICH). We conducted a prospective study to test possible association of ACT signal peptide A/T polymorphism with PICH in a Greek cohort with enough power (80%) to detect a twofold increase in the odds ratio. METHODS: We prospectively recruited 147 patients with PICH. ACT signal peptide A/T genotypes were determined in patients and 206 healthy, age- and sex-matched control subjects from the neurology outpatient clinic using the polymerase chain reaction restriction fragment length polymorphism method. RESULTS: Our study did not show an association between ACT signal peptide A/T polymorphism and PICH. We also failed to find any influence on age at onset, the location and volume of PICH as well as on clinical severity at admission or 6-month outcome. CONCLUSION: Our data failed to confirm an association between ACT signal peptide A/T polymorphism and PICH. However, we cannot exclude the possibility that the TT genotype confers susceptibility at less than a twofold increase.

Low RLS prevalence and awareness in central Greece: an epidemiological survey.

Restless legs syndrome (RLS) is a sensorimotor disorder with a general population prevalence of 3-10%. A single, previous epidemiological study performed in south-east Europe reported the lowest prevalence rate amongst European countries. We conducted a population-based survey of RLS in central Greece. A total of 4200 subjects were randomly recruited. We used the international RLS study group criteria for diagnosis and the severity scale for severity assessment in subjects with RLS. We also included questions to assess the level of awareness of RLS in our region. A total of 3033 subjects were screened. The overall lifetime prevalence was 3.9% with a female-to-male ratio of 2.6:1. Nearly half of RLS patients reported moderate to severe intensity of symptoms. After adjustment for multiple comparisons we found no association of RLS with education level, smoking, alcohol intake, caffeine consumption, shift work, professional pesticide use or comorbid illness. Our study revealed a low level of awareness amongst the population and physicians in our region and sub-optimal management. We provide further evidence for low prevalence of RLS in south-east Europe and a low level of awareness of RLS in our region.

Discrimination of exudative pleural effusions based on multiple biological parameters.

Pleural effusion is a common complication of various diseases. Conventional methods are not always capable of establishing the cause of pleural effusion, so alternative tests are needed. The aim of this study was to explore means of discriminating between different pleural effusion groups, malignant, parapneumonic and tuberculous, based on the combined function of seven biological markers. Adenosine deaminase (ADA), interferon-gamma, C-reactive protein (CRP), carcinoembryonic antigen, interleukin-6, tumour necrosis factor-alpha and vascular endothelial growth factor concentration levels were measured in pleural fluid from 45 patients with malignant, 15 with parapneumonic and 12 with tuberculous pleural effusion. Receiver operating characteristic curve analysis, multinomial logit modelling and canonical variate analysis were applied to discriminate the pleural effusion groups. The three groups could be discriminated successfully using the measured markers. The most important parameters for discrimination were ADA and CRP concentration levels. An individual with an ADA concentration level of >45 U.L(-1) and a CRP concentration of <4 mg.dL(-1) was more likely to belong to the tuberculous pleural effusion group, whereas one with an ADA concentration level of <40 U.L(-1) and a CRP concentration of >6 mg.dL(-1) was more likely to belong to the parapneumonic pleural effusion group, and one with a CRP concentration of <4 mg.dL(-1) to the malignant pleural effusion group. The combination of adenosine deaminase and C-reactive protein levels might be sufficient for discriminating between the three different groups of exudative pleural effusion: malignant, tuberculous and parapneumonic.

Methylenetetrahydrofolate reductase gene and susceptibility to breast cancer: a meta-analysis.

The methylenetetrahydrofolate reductase (MTHFR) gene polymorphisms have been linked to the risk of developing breast cancer. A meta-analysis of 18 case-control studies investigating the association between the C677T and the A1298C polymorphisms of the MTHFR gene and breast cancer (BC) was carried out. The meta-analysis included genotype data on 5467/7336 and 3768/5276 cases/controls for C677T and A1298C, respectively. In the meta-analysis, the consistency of genetic effects across different ethnicities and the effect of menopausal status for various genetic contrasts were investigated. The overall analysis for investigating the association between the C677T allele T and the risk of developing BC showed significant heterogeneity (p = 0.08, I2 = 34%) and non-significant association [odds ratio (OR) 1.02; 95% confidence interval (0.95-1.10)]. The allele contrast was not significant in Caucasians (nine studies) and in East Asians (four studies) [OR 1.03 (0.93-1.14) and OR 0.96 (0.81-1.15), respectively] or in pre-menopausal (five studies) and post-menopausal (four studies) groups [OR 1.10 (0.94-1.29) and OR 1.06 (0.95-1.18), respectively]. The genotype contrast of the homozygotes (TT vs CC) produced significant results only for pre-menopausal cases [OR 1.46 (1.05-2.03)]. The recessive model for allele T produced significant association only in pre-menopausal cases [OR 1.49 (1.09-2.03)]. The dominant model for the effect of allele T produced no significant results, overall and in each subgroup. For the A1298C polymorphism, all genotype contrasts showed lack of association, overall and in Caucasians. In summary, the accumulated evidence supports an association in pre-menopausal women. BC is a complex disease with multifactorial etiology, and therefore, case-control studies that investigate gene-environment interaction might elucidate further the genetics of the disease.

Correlation of estrogen receptor beta gene polymorphisms with spinal bone mineral density in peri- and post-menopausal Greek women.

Estrogens play a significant role in bone physiology. Their action is mainly exerted through their receptors. Estrogen receptor alpha (ERalpha) plays a major role in bone homeostasis and there is evidence suggesting that estrogen receptor beta (ERbeta) has also an effect on BMD. We investigated the possible effect of two ERbeta gene polymorphisms on spinal bone mineral density (BMD) and metabolic bone markers in Greek women. Spine BMD as well as biochemical bone markers were measured in 147 healthy peri- and post-menopausal women [mean age (S.D.) 54 (7.9) years]. Genotyping was performed for two restriction fragment length polymorphisms (RFLPs) of ERbeta gene, RsaI in exon 5 and AluI in exon 8. For each polymorphism studied the cohort was divided into two groups: the "wild-type" group (RR and AA, respectively) and the "carrier" group including subjects with at least one allele with the restriction site (Rr&rr and Aa&aa, respectively). The distribution of RsaI genotypes was RR: 91.2% (n = 134), Rr: 8.2% (n = 12), and rr: 0.6% (n = 1) and of AluI genotypes AA: 36.7% (n = 54), Aa: 57.2% (n = 84), and aa: 6.1% (n = 9). No linkage disequilibrium was found between the two polymorphic sites studied. Spine BMD did not differ significantly in the two groups of either polymorphism, after adjusting for age, weight, height, and years since menopause [mean BMD (S.D.) for RR 0.841 (0.17) g/cm(2) versus Rr&rr 0.798 (0.13) g/cm(2), p = 0.25, and mean BMD (S.D.) for AA 0.828 (0.16)g/cm(2) versus Aa&aa 0.848 (0.17) g/cm(2), p = 0.32]. No significant differences were noted in metabolic bone markers except for a marginal difference of RR versus Rr/rr in urinary hydroxyproline/creatinine ratio [median (IQR) 3.88 (6.04) micromol/mmol in RR versus 8.2 (4.32) micromol/mmol in Rr/rr, p = 0.05]. Furthermore, no interaction between the two polymorphisms on BMD was found. In conclusion, in a Greek female post-menopausal population, the two ERbeta gene polymorphisms were not associated with BMD, or metabolic bone markers.

The value of a single combined measurement of VEGF, glycodelin, progesterone, PAPP-A, HPL and LIF for differentiating between ectopic and abnormal intrauterine pregnancy.

BACKGROUND: To evaluate whether serum concentrations of the non-placental markers vascular endothelial growth factor (VEGF), glycodelin (GLY) and progesterone (P) and the novel placental markers pregnancy-associated plasmaprotein A (PAPP-A), human placental lactogen (HPL) and leukaemia inhibiting factor (LIF) differ in ectopic pregnancy (EP) when compared with abnormal intrauterine pregnancy (aIUP). METHODS: A prospective clinical study was conducted at the University Hospital of Larissa, Greece. The study included 50 patients admitted with failed pregnancy and suspected ectopic pregnancy that were treated with curettage or laparoscopy and classified as histologically confirmed EPs (n = 27) or histologically confirmed aIUPs (n = 21) (mean gestational age of 7.15 and 7.3 weeks, respectively). Two suspected EPs proved to be normal IUPs and were excluded. VEGF, GLY, P, beta-HCG, PAPP-A, HPL and LIF were measured by enxyme-linked immunosorbent assay (ELISA) methods in a single pre-operative blood sample. RESULTS: The median VEGF concentration was 227.2 pg/ml in the EP group versus 107.2 pg/ml in the aIUP group (P < 0.001), with a suggested threshold value of 174 pg/ml for their differential diagnosis. LIF, P, PAPP-A, HPL and GLY serum measurements did not differ significantly between EP and aIUP. CONCLUSION: VEGF serum levels might be a useful marker in differentiating between EPs and aIUPs.

Impaired elastic properties of ascending aorta in patients with giant cell arteritis.

OBJECTIVE: To investigate the elastic properties of the ascending aorta in untreated patients with giant cell arteritis compared with age and sex matched normal controls. METHODS: Distensibility of the ascending aorta and aortic strain were measured in 22 patients with a recent diagnosis of giant cell arteritis (documented by a positive temporal artery biopsy) before initiation corticosteroid treatment, and in 44 age and sex matched healthy subjects. Aortic distensibility was calculated as 2x[pulsatile change in aortic diameter]/[(diastolic aortic diameter)x(aortic pulse pressure)], and aortic strain as [pulsatile change in aortic diameter]/[diastolic aortic diameter]. Aortic diameters were measured by echocardiography. Aortic pressures were obtained by external sphygmomanometry. RESULTS: Distensibility of the ascending aorta and aortic strain were both lower in patients with giant cell arteritis than in the controls (p<0.01). In the patients with giant cell arteritis, aortic distensibility was inversely correlated with white blood cell count (p<0.05), but not with erythrocyte sedimentation rate or C reactive protein. CONCLUSIONS: Compared with healthy subjects, aortic distensibility and aortic strain are decreased in patients with giant cell arteritis before initiation of corticosteroid treatment. There was an association between the degree of reduction of aortic distensibility and the white blood cell count in the patient group.

Changes in pituitary sensitivity to GnRH in estrogen-treated post-menopausal women: evidence that gonadotrophin surge attenuating factor plays a physiological role.

BACKGROUND: The purpose of this study was to investigate changes in pituitary response to GnRH in post-menopausal women during substitution treatment with exogenous estrogen and progesterone. METHODS: Seven healthy post-menopausal women (group 1) were treated with various doses of E2 valerate for 43 days, so as the serum concentrations of E2 mimicked those of a follicular (FP-1), a luteal (LP) and a second follicular (FP-2) phase. During the LP, progesterone was also administered. The 30 min response of LH (DeltaLH) and FSH (DeltaFSH) to GnRH (10 microg i.v.) (pituitary sensitivity) was investigated every 24 h in group 1 and also in seven normally cycling women (group 2) during a spontaneous (control) follicular phase (FP). Based on the hormone profiles, day 32 in group 1 (FP-2) corresponded to day 2 in the spontaneous FP of group 2. RESULTS: Basal FSH concentrations were significantly higher in FP-2 than in the control FP (P < 0.05), while basal LH concentrations were similar in the two phases with higher values in FP-2 towards the end of the experiment (corresponding to days 10 and 11, P < 0.05). However, an LH surge was seen only in the control FP. DeltaFSH values remained stable in both phases and increased only in the control FP on days 12 and 13. DeltaLH values remained stable in the control FP and only increased on days 12 (P < 0.05) and 13 (P < 0.05), but in FP-2, DeltaLH values increased earlier (corresponding to day 7, P < 0.05). CONCLUSIONS: The present study demonstrates for the first time that in the absence of ovarian function, follicular phase E2 concentrations sensitize the pituitary to GnRH at an earlier stage (corresponding to the midfollicular phase) than in the normal menstrual cycle (late follicular phase). It is suggested that during the early to midfollicular phase the ovaries produce a gonadotrophin surge attenuating factor (GnSAF) that antagonizes the pituitary-sensitizing effect of E2 to GnRH.

Autoimmune phenomena in myelodysplastic syndromes: a 4-yr prospective study.

OBJECTIVE: To determine the clinical aspects and evolution of autoimmune inflammatory manifestations (AIMs) in patients with myelodysplastic syndrome (MDS) and ascertain the prognostic implications of these manifestations in MDS. METHODS: Seventy patients diagnosed for MDS were enrolled in a prospective cohort study of 4-yr duration. Thirteen patients with AIMs were identified (group A). The remaining 57 MDS patients without AIMs constituted the control group (group B). Demographic, clinical features, laboratory data, treatment and outcome of all these cases were recorded. RESULTS: On comparing features between the two groups we were unable to identify any particular difference (P > or = 0.05) concerning bone marrow blast count [odds ratio (OR) = 0.68], international prognostic scoring system (IPSS) (OR = 1.36), favourable cytogenetic abnormalities (OR = 0.52), leukaemic transformation (OR = 1.30) and survival (P = 0.76). Furthermore there was a significant difference in survival between low vs non-low IPSS patients for both groups (P<0.01). CONCLUSION: In a 4-yr prospective study the prognosis of MDS patients with AIMs appeared to be closely related to the IPSS subcategory of the underlying haematological malignancy and not to the autoimmune process.

Infliximab Therapy for Patients With Active and Refractory Spondyloarthropathies at the Dose of 3 mg/kg: A 20-Month Open Treatment.

BACKGROUND: : Infliximab at the dose of 5 mg/kg per infusion has been shown effective for the treatment of active spondyloarthropathies. It is not clear if the 5 mg/kg is required in most patients. OBJECTIVE: : To evaluate the long-term efficacy and safety of infliximab at the lower dose of 3 mg/kg in patients with active and refractory ankylosing spondylitis (AS) and psoriatic arthritis (PsA). METHODS: : Thirty patients were enrolled in a 78-week, single-center, prospective, open-label pilot study, including 16 patients with severe and active AS and 14 patients with active and refractory PsA. Infliximab (3 mg/kg, in combination with a stable dose of methotrexate was administered intravenously at 0, 2 and 6 weeks, and q8 weeks thereafter (schedule-A) and the improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; for AS patients) and Patient Global Assessment of Disease Activity (PDA; for PsA patients) was monitored at baseline and at every visit (primary variables). Patients who did not respond sufficiently at 14 weeks, as well as patients who relapsed at any time during follow-up, received infliximab every 4 weeks (treatment schedule-B). Three different statistical approaches (per-protocol, last observation carried forward and by intention-to-treat) were applied. RESULTS: : Ten patients discontinued treatment for various reasons, including 3 (10.0%) because of allergic reactions. Twenty patients (66.7%, 9 with AS and 11 with PsA) had completed 78 weeks of treatment (schedule-A, 11 patients; schedule-B, 9 patients). Of these patients, 18 (90.0%) showed optimal response (improvement >/=50%), including 13 (65.0%) with improvement >/=70%. ASsessments in AS (ASAS) 50% was attained by 7/9 AS patients (77.8%). At 78 weeks of treatment, statistically significant improvement of indices of disease activity, function and quality of life was observed by all statistical approaches applied. CONCLUSIONS: : Infliximab at 3 mg/kg every 8 weeks or, if needed, every 4 weeks appears to be an effective and rather safe treatment of patients with active and refractory AS and PsA after 78 weeks of treatment.

Incidence and prognostic value of positive peritoneal cytology in colorectal cancer.

PURPOSE: This study was conducted to investigate the incidence of free cancer cells in the peritoneal washings of patients who had undergone surgery for colorectal cancer and to evaluate its influence as a prognostic factor of the disease. METHODS: From 1990 to 1996, intraoperative washing cytology was performed in 110 patients who underwent surgery for colorectal cancer. All patients had curative resections. Immediately after the abdomen was opened and before exploration and mobilization of the tumor, 100 ml of saline was injected over the tumor site. Washings were then aspirated and taken for cytologic examination. RESULTS: Twenty-two (20 percent) of 110 patients examined were found to have positive cytology for intraperitoneal free malignant cells. The site of tumor in the colon or rectum, tumor size, nodal status, degree of differentiation, mucinous characteristics, and vascular or neural invasion were found not to affect the incidence of free cancer cells. Conversely, tumor penetration was found to affect the incidence of positive cytology. The degree of association among the stages of tumor penetration was indicated by the contingency coefficient, which was 0.42. Patients with positive cytology had a significantly higher rate of local recurrence and peritoneal carcinomatosis (22.8 vs. 8 percent, P = 0.05) than patients with negative cytology. Mortality rate was not found to be related to the presence of free cancer cells. CONCLUSION: Cytologic examination of peritoneal lavage at the time of surgery could be a useful prognostic indicator for local and peritoneal recurrence rate. However, it was not found to be a predictor of survival.