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PubMed1995

Background factors and scoring systems in relation to pregnancy outcome after fertility surgery.

BACKGROUND: A study was initiated to identify background factors, clinical features and pre-operative scoring systems of importance for future selection of patients suitable for fertility surgery. METHODS: Surgical procedures, background factors and scoring systems for tubal lesions and adnexal adhesions and risk factors for ectopic pregnancy were analyzed with respect to possible correlation to subsequent fertility in a retrospective study of 246 patients undergoing fertility surgery (adhesiolysis, salpingostomy, tubal anastomoses, implantation and myomectomy) between 1986 and 1990. Follow-up periods varied between one to six years. RESULTS: In 94% of cases a second look laparoscopy was performed. Adhesiolysis was done in 62%. The conception rate was 41.1%, the ectopic pregnancy rate was 14.6% and the delivery rate was 22.0%. Myomectomy procedures were most successful, with a delivery rate of 44.0% and no ectopic pregnancy. Previous ectopic pregnancy indicated a higher risk for recurrence, as did a high risk score for ectopic pregnancy. The extent of tubal damage was most relevant to subsequent fertility. Salpingostomies in women with mild or moderate tubal damage resulted in a delivery rate of 25.4% compared with those with severe damage (5.6%). No deliveries were seen after lysis of extensive adnexal adhesions. CONCLUSION: Adhesion formation is not negligible and a second look laparoscopy is recommended. Women with fibroids should always be considered for fertility surgery, not only because of high success rates, but also as an adjuvant to subsequent in vitro fertilization. Patients with previous ectopic pregnancy, extensive adhesions and unfavorable tubal scores should not be considered for surgery but referred for in vitro fertilization.

Abortion, Spontaneous↗
PubMed2003

Weekly, high-dose paclitaxel in advanced lung carcinoma: a phase II study with pharmacokinetics by the Cancer and Leukemia Group B.

BACKGROUND: The Cancer and Leukemia Group B conducted a Phase II trial to evaluate the efficacy, toxicity, and pharmacokinetics of paclitaxel administered at a maximum dose density for patients with chemotherapy-naïve, advanced-stage non-small cell lung carcinoma (NSCLC). METHODS: Patients with Stage IIIB/IV or recurrent NSCLC, a performance status (PS) score of 0-1, and no history of chemotherapy exposure were eligible. Paclitaxel, 150 mg/m(2), was administered over 3 hours during Weeks 1-6 of an 8-week cycle. Doses were modified for ANC < 1500/microL or for >or= Grade 2 neuropathy on the day of therapy. Treatment continued until toxicity or disease progression. Pharmacokinetics were assessed at Weeks 1, 3, and 5 of Cycle 1. RESULTS: Thirty-eight patients (median age, 64 years; range, 31-81 years) were treated. There were 21 males (PS = 0 for 17). Eleven patients had received previous radiation, 2 had brain metastases, 25 had adenocarcinoma, 23 had Stage IV disease, 6 had StageIIIB disease, and 9 had recurrent disease. Grade 3-4 granulocytopenia occurred in 39% of patients. There were no deaths due to toxicity. Grade 2 or 3 neuropathy occurred in 29% and 24% of patients, respectively. Ten (27%) patients had Grade 3 hyperglycemia (glucose concentration > 250 mg/dL). There were 16 partial responses (42%; 95% confidence interval [CI], 26-59%). The median survival period was 12.3 months (95% CI, 7.9-19.6%), and the 1-year and 2-year survival rates were 52% (95% CI, 39-71%) and 26% (95% CI, 15-45%), respectively. Paclitaxel pharmacokinetics were consistent with published values and clearance was not induced. Older age and hyperglycemia were associated with greater neurotoxicity. CONCLUSIONS: Paclitaxel at 150 mg/m(2) per week x 6 every 8 weeks can be administered safely in the cooperative group setting. These Phase II data are comparable to those associated with combination therapy. The weekly dose-dense schedule may be more active than conventional schedules.

Adult↗
PubMed1989

A placebo-controlled comparison of nortriptyline and phenelzine in maintenance therapy of elderly depressed patients.

Fifty-one elderly depressed outpatients who had responded to antidepressants and completed continuation therapy were observed under double-blind conditions for 1 year. Twenty-three had been switched to placebo, while 13 and 15 took nortriptyline hydrochloride and phenelzine sulfate, respectively. Patients administered phenelzine did significantly better with 13.3% recurrences than patients administered either nortriptyline (53.8% recurrences) or placebo (65.2% recurrences). In addition, patients who had higher Hamilton scores and who had an earlier age of onset of the first depressive episode were significantly more likely to have recurrences.

Aged↗
PubMedDate not supplied

[Safety and efficacy of oral escitalopram as continuation treatment of intravenous citalopram, in patients with major depressive disorder--the navigade switch study].

Intravenous (iv) administration of an antidepressant is a common practice in some European countries, particularly in France, Spain, and Italy in the initial treatment phase of hospitalised, severe depressed patients. After a beneficial response is observed, patients are switched to an oral formulation. The approved treatment period of the iv form of citalopram is limited to 8-10 days. The high bioavailability of citalopram permits the use of identical iv and oral doses. Citalopram is a racemate, consisting of a 1:1 mixture of the S- and R-enantiomers. The therapeutically active component is the S-enantiomer (escitalopram). Pharmacokinetic single dose administration studies in healthy subjects have demonstrated that daily oral administration of 20 mg of escitalopram or 40 mg citalopram results in similar plasma concentrations of the S-enantiomer of citalopram. This open-label multicentre French prospective study investigated the tolerability and efficacy of oral escitalopram 10 and 20 mg/day, administered for a 6-week period as continuation treatment of citalopram (20 mg or 40 mg daily) intravenous (iv), in patients with Major Depressive Disorder. A total of 171 patients were enrolled, of whom 147 (85%) completed the study. The mean MADRS score at inclusion (last citalopram dose) was 31.6 +/- 9.9. The total MADRS score decreased after 3 days of oral treatment with escitalopram. Escitalopram demonstrated a continuous effect in treating depressive symptoms throughout the study. The decrease in MADRS mean total score from baseline was statistically significant to each visit (day 3, 15; p < 0.0001). At final visit (J42), the decrease was - 18.9 +/- 11.7 (p < 0.0001) and the MADRS mean total score was 12.7 +/- 9.3. There were no differences seen in the patient response comparing gender, age, and the single or recurrent episodes. The changes of Clinical Global Impression scores (CGI-S, CGI-I, PGE-Patient Global Evaluation) were also indicative of an improvement of the patients' depression. The CGI-I and PGE scores were significantly correlated indicating good agreement between investigator and patient in rating the degree of improvement. At the end of the study, 67% of patients were classified as responders (decrease of MADRS score from baseline > or = 50%), and the majority of them were considered remitters (final MADRS score < or = 12). Overall, the switch from intravenous citalopram to oral escitalopram was well tolerated in the study population. In all, 57 patients (33%) reported at least one adverse event (AE) during the study (21 patients in the 10 mg group and 36 patients in the 20 mg group); of these, 7 patients (4%) withdrew from the study. The most frequently reported AEs were suggestive of residual symptoms of depression (anxiety, 9%; insomnia, 5% of patients). In conclusion, in this study oral escitalopram (10 mg or 20 mg) was well tolerated as continuation treatment after switching from intravenous citalopram (20 mg or 40 mg). From the efficacy and safety data of this study, it can be concluded that the switch from citalopram iv to oral escitalopram (10 and 20 mg/day) is effective in decreasing depressive symptoms, and could be safely proposed in patients with major depressive disorder.

Administration, Oral↗
PubMed1994

Prognostic significance of right ventricular hypokinesis and perfusion lung scan defects in pulmonary embolism.

We studied the relation between right ventricular (RV) hypokinesis on echocardiography and defects on the initial perfusion lung scan among 90 hemodynamically stable patients with pulmonary embolism (PE). Of the 90, 38 had qualitative evidence of RV hypokinesis, with a mean RV end-diastolic area significantly larger than those with normal RV wall motion (40.0 +/- 10.2 cm2 vs 20.1 +/- 6.4 cm2; p < 0.001). The degree of the perfusion defect was greater in those patients with baseline RV hypokinesis (54% +/- 16% of the lung nonperfused) than in those patients with normal RV wall motion at baseline (30% +/- 18% nonperfused lung; p < 0.001). Receiver operating characteristic curve analysis showed that a perfusion lung scan defect score of 0.3 (i.e., 30% of the lung nonperfused) had a 92% sensitivity for predicting RV hypokinesis and carried a relative risk for observing RV hypokinesis of 6.8 times greater than among those patients with a perfusion scan score of < 0.3. Considering that all patients with recurrent symptomatic PE were in the subgroup with RV hypokinesis (13% vs 0% for those with normal RV wall motion; p = 0.01), a strategy of performing echocardiography in those patients with a perfusion scan defect score of > or = 0.3 appears to identify patients at increased risk for recurrent PE.

Chi-Square Distribution↗
PubMed1995

Surgery with adjuvant irradiation in patients with pathologic stage C adenocarcinoma of the prostate.

BACKGROUND: In recent years, the routine use of prostate-specific antigen (PSA) to detect cancer of the prostate (CaP) early has renewed the controversy regarding radiotherapy versus radical prostatectomy as the superior definitive treatment. Radiotherapy alone has been reported to result in a high incidence of local recurrence, whereas on the other hand surgical treatment has resulted in a high incidence of microscopic residual tumor. The purpose of this study was to review our treatment results with radical prostatectomy followed by planned courses of postoperative irradiation in patients with pathologic Stage (PS) C disease. METHODS: From 1972 to 1989, 95 patients with CaP with PS C tumors were treated with radical prostatectomy and bilateral pelvic lymphadenectomy. Pathologic stage distribution was: C1 in 26 (27%), C2 in 37 (39%), and C3 in 32 (34%) patients. The median follow-up was 6 years. All 95 study patients received postoperative pelvic irradiation as the only adjuvant treatment. Radiotherapy treated volume included the prostatic fossa and its immediate vicinity. The RT dose ranged from 33 Gy to 61.8 Gy (median, 45 Gy). RESULTS: The overall 5- and 10-year actuarial survival rates were 94% and 73%, respectively, with the 5 and 10 year disease specific survival of 98% and 91%, respectively. Clinical and/or prostate specific antigen recurrence was 31% at 5 years and 44% at 10 years. Prostate specific antigen elevation without clinical evidence of recurrent disease was recorded in 26 (27%) patients. Seminal vesicle involvement (C3) and high Gleason's score (8-10) were the most important factors predicting recurrence. Of the 95 patients treated, 2 had pelvic recurrence alone and 1 had local and distant metastatic disease. Radiotherapy was well tolerated with no clinically important morbidity. CONCLUSION: Based on this experience, moderate dose adjuvant radiotherapy after radical prostatectomy in patients with PS C CaP is recommended.

Adenocarcinoma↗
PubMed1998

Accuracy of whole-body fluorine-18-FDG PET for the detection of recurrent or metastatic breast carcinoma.

UNLABELLED: This study assessed the diagnostic accuracy of whole-body PET on a patient and lesion basis using 18F-fluorodeoxyglucose (FDG) for the detection of tumor foci in patients with suspected recurrent or metastatic lesions of breast carcinoma. METHODS: Whole-body FDG-PET imaging was performed on 57 patients with a previous history of breast carcinoma who were referred for a clinical suspicion of disease recurrence. Whole-body PET images were scored from 1 (definitely negative) to 5 (definitely positive) by three independent observers, and discrepancies were resolved by a fourth observer. Patients were clinically followed for up to 24 mo to assess the accuracy of PET diagnosis by biopsy, follow-up imaging and other diagnostic tests. RESULTS: PET scans showed that there were 41 sites indicating recurrent or metastatic disease in 29 patients. There were 38 sites in 28 patients that showed no evidence for malignant disease. On a patient basis, with scores 4 or 5 considered to be positive, sensitivity and specificity were 93% and 79%, respectively. The corresponding positive and negative predictive values were 82% and 92%. On a lesion basis, with scores 4 or 5 considered to be positive, the sensitivity was 85% and specificity 79%. The area index in receiver operating characteristic analysis was 0.91 for patient-based analysis and 0.88 for lesion-based analysis. To determine the cause for false-negative and false-positive findings more precisely, false-negative lesions with scores of 3 or lower and false-positive lesions with scores of 4 or higher were analyzed. Bone metastases had a significantly larger proportion of false-negative lesions than other nonosseous malignant sites (p < 0.05). False-positive lesions were due to muscle uptake (n = 5), inflammation (n = 4), blood pool activity in the great vessels (n = 2), bowel uptake (n = 1) and unknown causes (n = 6). CONCLUSION: The whole-body FDG-PET scan is a useful diagnostic test for detecting recurrent or metastatic lesions of breast carcinoma. However, the sensitivity for metastases to bone appears to be lower than that to other organs. Specificity may be improved by more strict attention to patient preparation and better recognition of physiologic skeletal muscle or artifactual uptakes.

Bone Neoplasms↗
PubMed1994

Recurrently situational (reactive) depression: a study of course, phenomenology and familial psychopathology.

Probands with non-bipolar major depressive disorder (MDD) were grouped according to the consistency across episodes with which depression appeared to arise from situational factors. Situational depression showed significant diagnostic stability across the second and third recurrences in a 10-year follow-up. The relatives of recurrently situational probands had higher neuroticism scores, higher lifetime rates of MDD and, when depressed, fewer endogenous symptoms than did the relatives of non-situational probands. This study joins two others in finding an association between stress-related depression and high familial loadings for MDD. It also illustrates the value of diagnostic consistency across episodes as a means of refining groups for the study of diagnostic subtypes.

Adjustment Disorders↗
PubMed2001

[Clinical behavior of thyroid papillary cancer in pregnancy: optimal time for its treatment].

OBJECTIVE: To analyze the clinical characteristic and evolution of papillary thyroid cancer with pregnancy and know the optimal time to treatment. MATERIAL AND METHODS: Cohort analytic study with two groups: One with 6 papillary cancer and pregnancy and group 2 with 24 papillary cancer and the same age, prognostic score AMES and MACIS, treatment, time of follow up and mortality. The variables analyzed was clinical presentation, local, regional, distant recurrence, and mortality. The statistical analyzed by Chi Square and t test. RESULTS: There were no statistical differentiation between the two groups in age, prognostic score, rates of recurrence and mortality with a time of follow up for G1 83 (33 to 240) months and 88 (12 to 288) months for G2. There were differences only in clinical presentation with positive cervical nodes in 100% of patients in G1 vs. 12.5% in G2. This condition does not alter the final evolution. CONCLUSION: A pregnant patient with papillary thyroid cancer can wait the end of the pregnancy and then receive the appropriated cancer treatment.

Adolescent↗
PubMed2000

Local recurrence after laparoscopic radiofrequency thermal ablation of hepatic tumors.

BACKGROUND: Since we first described laparoscopic radiofrequency ablation (LRFA) of liver tumors, several reports have documented technical and safety aspects of this procedure. Little is known, however, about the long-term follow-up of such patients. METHODS: From January 1996 to February 1999, we performed LRFA on 250 liver tumors in 66 patients. Triphasic spiral computed tomographic scanning was obtained preoperatively and at 1 week, and every 3 months postoperatively. Lesion diameter was measured in the x- and y-axes and the volume estimated; 181 lesions in 43 patients for whom computed tomographic scans available were included in the study. The tumor types were as follows: 64 metastatic adenocarcinomas, 79 neuroendocrine metastases, 27 other metastases, and 11 primary liver tumors. RESULTS: One week postoperatively, the ablated zone was larger than the original tumor in 178 of 181 lesions, which suggests ablation of the tumor and a margin of normal liver tissue. A progressive decline in lesion size was seen in 156 (88%) of 178 lesions, followed for at least 3 months (mean, 13.9 months; range, 4.9-37.8 months), which suggests resorption of the ablated tissue. Fourteen definite local treatment failures were apparent by increase in size and change in computed tomographic scan appearance, and eight lesions were scored as failures because of multifocal recurrence that encroached on ablated foci (22 total recurrences). Predictors of failure include lack of increased lesion size at 1 week (2 of 3 such lesions failed), adenocarcinoma or sarcoma (18 of 22 failures; P < .05), larger tumors (failures, M = 18 cm3 vs. successes, M = 7 cm3; P < .005) and vascular invasion on laparoscopic ultrasonography. By size criteria, 17 of 22 failures were apparent by 6 months. Energy delivered per gram of tissue was not significantly different (P = .45). CONCLUSIONS: LRFA has a 12% local failure rate, with larger adenocarcinomas and sarcomas at greatest risk. Failures occur early in follow-up, with most occurring by 6 months. LRFA seems to be a safe and effective treatment technique for patients with primary and metastatic liver malignancies.

Adenocarcinoma↗
PubMed2003

Accelerated rehabilitation after arthroscopic Bankart repair for selected cases: a prospective randomized clinical study.

PURPOSE: Increased stress within a certain limit enhances ligament healing and improves joint function. In this prospective randomized clinical trial, we compared the clinical results of early motion versus conventional immobilization after arthroscopic Bankart repair in a selected patient population. TYPE OF STUDY: Prospective randomized clinical trial. METHODS: We performed an arthroscopic Bankart repair using suture anchors in 62 patients with traumatic recurrent anterior instability of the shoulder. Patients were randomized into 2 groups; group 1 (28 patients; mean age, 28 years) was managed with 3 weeks of immobilization using an abduction sling and conventional rehabilitation program, and group 2 (34 patients; mean age, 29 years) was managed with an accelerated rehabilitation program that consisted of staged range of motion and strengthening exercises from the immediate postoperative day. Selection criteria were nonathletes with recurrent anterior shoulder dislocation and a classic Bankart lesion with a robust labrum limited to 1 cm from the midglenoid notch. The patients were followed up for a mean of 31 months (range, 27 to 45 months; standard deviation, 9 months). Analysis of outcome included pain scores at 6 weeks and at final follow-up evaluation, range of motion, return to activity, recurrence rate, patient satisfaction with each rehabilitation program, and shoulder scores assessed by the American Shoulder and Elbow Surgeons Shoulder Index, the rating system of the University of California at Los Angeles, and another scoring system. RESULTS: The recurrence rate was not different between the 2 groups (P =.842). None of the groups developed recurrent dislocation. Two patients from each group were positive for anterior apprehension signs. Patients who underwent accelerated rehabilitation resumed functional range of motion faster (P <.001) and returned earlier to the functional level of activity (P <.001). Accelerated rehabilitation decreased postoperative pain (P =.013), and more patients were satisfied with this program (P <.001). Shoulder scores, return to activity, pain score, and range of motion were not different between the 2 groups at the final follow-up evaluation (P >.05). CONCLUSIONS: Early mobilization of the operated shoulder after arthroscopic Bankart repair does not increase the recurrence rate in a selected group of patients. Although the final outcomes are approximately the same for both groups, the accelerated rehabilitation program promotes functional recovery and reduces postoperative pain, which allows patients an early return to desired activities.

Adolescent↗
PubMed2000

Plasma endothelin-1 levels neither increase nor correlate with neurological scores, stroke risk factors, or outcome in patients with ischemic stroke.

BACKGROUND AND PURPOSE: Endothelins (ETs) are potent vasoconstrictors and may play a role in the pathophysiology of several diseases. Limited and controversial data exist on their role in human ischemic stroke. We planned a prospective, observational, and longitudinal clinical study to test whether ET-1 levels increase in various phases of ischemic stroke and whether the ET-1 levels correlate with neurological scores, stroke etiology, stroke risk factors, or final outcome. METHODS: We measured plasma ET-1 levels with a sandwich-enzyme immunoassay method in 101 consecutive patients with ischemic stroke on admission and 1 week, 1 month, and 3 months after stroke and in 101 sex- and age-matched control subjects. At each sampling, the patients underwent a complete neurological evaluation. All stroke risk factors were recorded, an array of laboratory tests were performed, and the subtype of ischemic stroke was determined. The patients were contacted 3 years later for prognostic determination. RESULTS: ET-1 levels in patients (2.4+/-1.3 pg/mL on admission, 2.2+/-1.4 pg/mL at 1 week, 2.1+/-1.4 pg/mL at 1 month, and 2.1+/-1.2 pg/mL at 3 months) were not different from those of the control subjects (2.2+/-0.9 pg/mL) at any time point. No correlation was found between the ET-1 levels and stroke etiology, stroke risk factors, stroke recurrence risk, age, sex, or neurological scores, except that ET-1 levels correlated with the use of warfarin and with body mass index. CONCLUSIONS: Plasma ET-1 levels were normal in patients with ischemic stroke. Our findings cannot exclude a role of ETs in the pathophysiology of ischemic stroke because plasma levels might not accurately reflect intracerebral concentrations, but they also do not support the occurrence of a major plasma ET-1 level increase at any phase of stroke. Our patient population is the largest ever reported in whom ET-1 levels were measured, but it consisted of mild and moderately ill patients with stroke due to the study design, of which the aim was long-term observation, which excludes severely ill patients.

Adult↗
PubMed2003

The prolyl isomerase Pin1 is a novel prognostic marker in human prostate cancer.

Prostate cancer (PCa) is the most common male cancer in the United States. A major challenge that remains is to predict the clinical outcome in managing PCa patients. The prolyl isomerase Pin1 has been shown to be overexpressed in some human cancer tissues and thought to be an important player in several oncogenic pathways. However, the relationship between Pin1 expression and clinical outcome of cancer patients has not been explored. In this study, we investigated the role of Pin1 in human PCa progression and its clinicopathological significance. Immunohistochemical assessment with affinity-purified polyclonal Pin1-specific antibodies was performed on formalin-fixed paraffin sections of tissue microarray composed of 580 radical prostatectomy specimens. As determined by visual semiquantitation and confirmed by automated image analysis quantitation, Pin1 expression was positively correlated with clinical stage. Furthermore, Cox survival analysis results indicated that patients with a higher Pin1 expression had a significantly higher probability of recurrence than their counterparts with low Pin1 expression, as defined by a serum prostate-specific antigen level of > or =0.4 ng/ml on two consecutive occasions after radical prostatectomy. In addition, patients with high Pin1 expression had almost 4 times the risk of having earlier recurrence than those with low Pin1 expression; patients with a very high level had 8.1 times the risk of an earlier recurrence than a low Pin1 expresser. Pin1 was also an excellent predictor of recurrence in the subset of patients with Gleason score 6 or 7 when analyzed separately: a patient with high Pin1 expression had 8.6 times the risk of having earlier recurrence than one with low Pin1 expression. Pin1 expression is as good as or better than currently used postoperatively available clinicopathological parameters and potentially could be used in the preoperative setting to assist in choice of treatment. Thus, this study suggests a role for Pin1 expression as a potentially excellent prognostic marker in PCa and suggests that Pin1 may also serve as a novel therapeutic target for PCa.

Adult↗
PubMed2005

Identifying methodologies in the assessment of treatment effects on the repeated occurrences of hot flashes in postmenopausal women.

BACKGROUND: Two methods that are commonly used in most clinical trials for evaluating the effect of treatment on hot flashes are frequency only and severity score methods. However, in these crude methods, composite recurrent hot flash data on a patient are reduced to a one-dimensional summary measure, an approach which may not be optimal. In addition, the duration of a hot flash event provides additional information, which is not accounted for in the two methods mentioned above. PURPOSE: We propose two new methods in the analysis of hot flash data in this paper. METHODS: The first method utilizes a generalization of the continuation ratio model to model the severity of a hot flash event. The model accounts for individual random effects and dependence of recurrent events within an individual. The other method that accounts for the duration of a hot flash event is a 3-Dimensional (3D) score method, which incorporates hot flash information on frequency, severity, and duration. RESULTS: Simulation studies were conducted to evaluate the properties of our proposed methods. The results indicate that our proposed generalized continuation ratio model has appreciably high power in detecting small treatment effects on severity compared with the two commonly used methods. The proposed 3D score, on the other hand, is sensitive in detecting treatment effects on both frequency and duration, but has low power in detecting treatment effects on severity alone. CONCLUSIONS: Our proposed generalized continuation ratio model approach provides a valuable and powerful alternative to the two commonly used methods in the analysis of treatment effects on hot flash severity. Our proposed 3D score method incorporates the additional information hot flash duration provides, and is another analysis option for the practitioners to employ.

Analysis of Variance↗
PubMed1998

Evaluation of staging lymphadenectomy in prostate cancer.

OBJECTIVES: To prospectively evaluate a clinical algorithm that predicts nodal status in patients with prostate cancer and to assess the impact on the outcome. METHODS: Between September 1988 and December 1994, 192 patients with organ-confined prostate cancer and considered surgical candidates for radical perineal prostatectomy (RPP) were stratified using the algorithm: prostate-specific antigen (PSA) 20 ng/mL or less, Gleason score 7 or lower, and clinical Stage T2a or lower. Patients failing any of these criteria were placed in the high-risk group and underwent a pelvic lymphadenectomy. Patients who satisfied all the criteria were placed in the low-risk group and underwent RPP without evaluation of the pelvic lymph nodes. Another contemporaneous cohort of patients (n = 65) underwent pelvic lymphadenectomy and radical retropubic prostatectomy (RRP) without use of the algorithm and were used as a control group. Patients were monitored for at least 24 months. RESULTS: In the RPP group, 177 patients were considered low risk according to the algorithm and were not offered staging lymphadenectomy before surgery, whereas 15 patients were categorized as high risk for metastasis and underwent staging lymphadenectomy. In the RRP and lymphadenectomy group, 41 patients were considered at low risk and 24 at high risk of disease spread according to the algorithm. In the RPP group, low-risk patients (no lymphadenectomy) had a PSA recurrence rate (27%) similar to that of low-risk patients in the RRP group with negative lymph nodes (29%), P = 0.8. Similarly, high-risk patients with negative lymph nodes in both groups had a similar recurrence rate (53% for RPP and 50% for RRP). Univariate logistic regression analysis showed that PSA was the most significant predictor for disease recurrence (P = 0.0004) followed by preoperative Gleason scores (P = 0.02) and clinical stages (P = 0.03). Multivariate stepwise analysis demonstrated that Gleason score and clinical stage did not add to the prediction of recurrence over PSA alone. CONCLUSIONS: Staging lymphadenectomy can be omitted in low-risk patients without deleterious effects on the outcome as measured by PSA recurrence.

Aged↗
PubMed2006

Generalized joint laxity and contralateral patellar hypermobility in unilateral recurrent patellar dislocators.

PURPOSE: The purpose of this study was to assess the relation between generalized joint laxity and patellar hypermobility in unilateral recurrent patellar dislocators. TYPE OF STUDY: Case series. METHODS: A total of 82 patients (23 male and 59 female patients) with unilateral recurrent patellar dislocation were studied compared with an age- and sex-matched control group. The modified Carter and Wilkinson criteria for generalized joint laxity and lateral patellar hypermobility test were examined. RESULTS: Generalized joint laxity (score of 4 or 5) was present in 20 patients (24%) with recurrent patellar dislocation in 8 subjects (10%) of the control group. The mean total score was 2.5 (SD, 1.4) in the recurrent patellar dislocators and 1.7 (SD, 1.3) in the control group. The incidence of generalized joint laxity (P = .013) and the mean total score (P = .00004) were statistically significant between the two groups. A hypermobile patella was present in 42 patients (51%) and in 5 subjects (6%) of the control group. There was a large statistically significant difference between the two groups (P < .00001). CONCLUSIONS: Although a hypermobile patella and generalized joint laxity were significant between the recurrent patellar dislocators and the control group, a hypermobile patella was more significant than generalized joint laxity as the predisposing factors of patellar dislocation. LEVEL OF EVIDENCE: Level IV, prognostic case series.

Adolescent↗
PubMed2001

Pediatric Crohn's disease: risk factors for postoperative recurrence.

OBJECTIVE: Postoperative recurrence of Crohn's disease in adults has been extensively studied; however, the course of Crohn's disease after surgery in children has not been well defined. The aim of this study was to examine the postoperative course of pediatric Crohn's disease and the factors that may predict early postoperative recurrence. METHODS: We identified 100 resective surgeries in 79 children with Crohn's disease seen at the Children's Hospital of Philadelphia between 1978 and 1996. A retrospective, multivariable analysis of factors potentially influencing postoperative clinical recurrence was performed. Preoperative and postoperative height measurements were compared, and z scores were computed for height-for-age. Two-tailed t test was used for the analysis. RESULTS: Clinical recurrence rates were 17% at 1 yr, 38% at 3 yr, and 60% at 5 yr. Patients with colonic Crohn's disease had a significantly shorter postoperative recurrence-free interval (median 1.2 yr) than patients with ileocecal (median 4.4 yr) or diffuse disease (median 3.0 yr) (p = 0.01). On multivariable analysis, a high Pediatric Crohn's Disease Activity Index at the time of surgery (p = 0.01) and preoperative use of 6-mercaptopurine (6-MP) (p < 0.005) were also independently associated with higher postoperative recurrence rates. There was a significant improvement in z scores for height (p = 0.04) after surgery. CONCLUSIONS: In children undergoing resective surgery for Crohn's disease, high rates of postoperative Crohn's disease recurrence are associated with severe disease at the time of surgery, colonic Crohn's disease, and the preoperative use of 6-MP. Patients who require preoperative use of 6-MP are likely to suffer from a more aggressive disease and would benefit from postoperative 6-MP prophylaxis. Height growth was improved after intestinal resection for Crohn's disease.

Adolescent↗
PubMedDate not supplied

[Value of tianeptine in treating major recurrent unipolar depression. Study versus placebo for 16 1/2 months of treatment].

OBJECTIVES: The aim of this study was to assess the efficacy of tianeptine vs placebo in the long-term treatment of unipolar major recurrent depression. METHOD: 286 patients who met DSM-III-R criteria for major depression with a Hamilton Depression Rating Scale (HDRS-21 items) score > or = 17, and with a history of at least one previous episode within the last 5 years, were treated in an open trial with tianeptine for 6 weeks. 185 patients who responded to treatment at day 42 (intent-to-treat) were randomly assigned to tianeptine 37.5 mg/day (n = 111), or placebo (n = 74). Among these patients 173 were strict responders to tianeptine (per-protocol-population), as defined in the present study by a 50% reduction in the HDRS score, a global score lower than 15 and confirmation by clinical evaluation. Both groups were comparable except for the severity of the depressive episode (significantly more severe in the tianeptine group (33%) than in the placebo group (18%)) (p = 0.018). Relapses and recurrences were defined by a HDRS score > or = 15, and/or a CGI score > or = 4, the recurrences being confirmed by the clinician. Patients were subsequently evaluated at day 63, and the 3rd, 6th, 9th, 12th, 15th and 18th month. RESULTS: Special attention was given to the number of relapses and recurrences, and to the delay of onset (Kaplan Meier Method). Between day 42 and 18th month (intent-to-treat group), the rate of relapses and recurrences was significantly higher in the placebo group (36%), than in the tianeptine group (16%) (p = 0.002). Long term comparison of the rate of patients without recurrence or relapse, also showed a significant difference in favour of tianeptine (p < 0.001). The difference between teh 2 groups increased within time. Secondary analysis of relapses and recurrence in the intent-to-treat group showed a significantly higher rate of relapses for the placebo group (p = 0.002); the rate of patients without recurrences in the long term appeared to be at the limit in the intent-to-treat group (p = 0.067) but significant in the per-protocol-group, in favour of tianeptine (p = 0.36). Furthermore, no difference was observed between the 2 groups, in terms of tolerance. Secondary effects attributed to treatment by investigators were rare and benign in each group. CONCLUSIONS: These data support the use of tianeptine in the long term treatment of unipolar major recurrent depression. Relapses and recurrences were 2 to 3 times less frequent with tianeptine as compared to placebo. Furthermore, prolonged treatment with tianeptine appeared to be very well tolerated.

Adolescent↗