Racial disparities in prostate cancer outcome among prostate-specific antigen screening eligible populations in the United States.

Background: In 2012, the United States Preventive Services Task Force (USPSTF) recommended against prostate-specific antigen (PSA) screening, despite evidence that Black men are at a higher risk of prostate cancer-specific mortality (PCSM). We evaluated whether Black men of potentially screening-eligible age (55-69 years) are at a disproportionally high risk of poor outcomes. Patients and methods: The SEER database was used to study 390 259 men diagnosed with prostate cancer in the United States between 2004 and 2011. Multivariable logistic regression modeled the association between Black race and stage of presentation, while Fine-Gray competing risks regression modeled the association between Black race and PCSM, both as a function of screening eligibility (age 55-69 years versus not). Results: Black men were more likely to present with metastatic disease (adjusted odds ratio [AOR] 1.65; 1.58-1.72; P < 0.001) and were at a higher risk of PCSM (adjusted hazard ratio [AHR] 1.36; 1.27-1.46; P < 0.001) compared to non-Black men. There were significant interactions between race and PSA-screening eligibility such that Black patients experienced more disproportionate rates of metastatic disease (AOR 1.76; 1.65-1.87 versus 1.55; 1.47-1.65; Pinteraction < 0.001) and PCSM (AHR 1.53; 1.37-1.70 versus 1.25; 1.14-1.37; Pinteraction = 0.01) in the potentially PSA-screening eligible group than in the group not eligible for screening. Conclusions: Racial disparities in prostate cancer outcome among Black men are significantly worse in PSA-screening eligible populations. These results raise the possibility that Black men could be disproportionately impacted by recommendations to end PSA screening in the United States and suggest that Black race should be included in the updated USPSTF PSA screening guidelines.

Transoesophageal echocardiographic evaluation of central venous catheter positioning using Peres' formula or a radiological landmark-based approach: a prospective randomized single-centre study.

BACKGROUND: The lower superior vena cava (SVC), near its junction with the right atrium (RA), is considered the ideal location for the central venous catheter tip to ensure proper function and prevent injuries. We determined catheter insertion depth with a new formula using the sternoclavicular joint and the carina as radiological landmarks, with a 1.5 cm safety margin. The accuracy of tip positioning with the radiological landmark-based technique (R) and Peres' formula (P) was compared using transoesophageal echocardiography. METHODS: Real-time ultrasound-guided central venous catheter insertion was done through the right internal jugular or subclavian vein. Patients were randomly assigned to either the P group (n=93) or the R group (n=95). Optimal catheter tip position was considered to be within 2 cm above and 1 cm below the RA-SVC junction. Catheter tip position, abutment, angle to the vascular wall, and flow stream were evaluated on a bicaval view. RESULTS: The distance from the skin insertion point to the RA-SVC junction and determined depth of catheter insertion were more strongly correlated in the R group [17.4 (1.2) and 16.7 (1.5) cm; r=0.821, P<0.001] than in the P group [17.3 (1.2) and 16.4 (1.1) cm; r=0.517, P<0.001], with z=3.96 (P<0.001). More tips were correctly positioned in the R group than in the P group (74 vs 93%, P=0.001). Abutment, tip angle to the lateral wall >40°, and disrupted flow stream were comparable. CONCLUSIONS: Catheter tip position was more accurate with a radiological landmark-based technique than with Peres' formula. CLINICAL TRIAL REGISTRATION: Clinical Trial Registry of Korea: https://cris.nih.go.kr/cris/index.jsp KCT0001937.

Medical androgen deprivation therapy and increased non-cancer mortality in non-metastatic prostate cancer patients aged ≥66 years.

PURPOSE: To examine the potential relationship between androgen deprivation therapy and other-cause mortality (OCM) in patients with prostate cancer treated with medical primary-androgen deprivation therapy, prostatectomy, or radiation. METHODS: A total of 137,524 patients with non-metastatic PCa treated between 1995 and 2009 within the Surveillance Epidemiology and End Results Medicare-linked database were included. Cox-regression analysis tested the association of ADT with OCM. A 40-item comorbidity score was used for adjustment. RESULTS: Overall, 9.3% of patients harbored stage III-IV disease, and 57.7% of patients received ADT. The mean duration of ADT exposure was 22.9 months (median: 9.1; IQR: 2.8-31.5). Mean and median follow-up were 66.9, and 60.4 months, respectively. At 10 years, overall-OCM rate was 36.5%; it was 30.6% in patients treated without ADT vs. 40.1% in patients treated with ADT (p < 0.001). In multivariable-analysis, ADT was associated with an increased risk of OCM (Hazard-ratio [HR]: 1.11, 95% Confidence-interval [95% CI]: 1.08-1.13). Patients with no comorbidity (10-year OCM excess risk: 9%) were more subject to harm from ADT than patients with high comorbidity (10-year OCM excess risk: 4.7%). CONCLUSIONS: In patients with PCa, treatment with medical ADT may increase the risk of mortality due to causes other than PCa. Whether this is a simple association or a cause-effect relationship is unknown and warrants further study in prospective studies.

Perioperative outcomes and hospital reimbursement by type of radical prostatectomy: results from a privately insured patient population.

BACKGROUND: With the increasing use of robotic surgery in the United States, the comparative effectiveness and differences in reimbursement of minimally invasive radical prostatectomy (MIRP) and open prostatectomy (ORP) in privately insured patients are unknown. Therefore, we sought to assess the differences in perioperative outcomes and hospital reimbursement in a privately insured patient population who were surgically treated for prostate cancer. METHODS: Using a large private insurance database, we identified 17,610 prostate cancer patients who underwent either MIRP or ORP from 2003 to 2010. The primary outcomes were length of stay (LOS), perioperative complications, 90-day readmissions rates and hospital reimbursement. Multivariable regression analyses were used to evaluate for differences in primary outcomes across surgical approaches. RESULTS: Overall, 8981 (51.0%) and 8629 (49.0%) surgically treated prostate cancer patients underwent MIRP and ORP, respectively. The proportion of patients undergoing MIRP markedly rose from 11.9% in 2003 to 72.5% in 2010 (P<0.001 for trend). Relative to ORP, MIRP was associated with a shorter median LOS (1.0 day vs 3.0 days; P<0.001) and lower adjusted odds ratio of perioperative complications (OR: 0.82; P<0.001). However, the 90-day readmission rates of MIRP and ORP were similar (OR: 0.99; P=0.76). MIRP provided higher adjusted mean hospital reimbursement compared with ORP (US $19,292 vs. US $17,347; P<0.001). CONCLUSIONS: Among privately insured patients diagnosed with prostate cancer, robotic surgery rapidly disseminated with over 70% of patients undergoing MIRP by 2009-2010. Although MIRP was associated with shorter LOS and modestly better perioperative outcomes, hospitals received higher reimbursement for MIRP compared with ORP.

The effect of age at diagnosis on prostate cancer mortality: a grade-for-grade and stage-for-stage analysis.

OBJECTIVE: To evaluate the effect of advancing age on cancer-specific mortality (CSM) after radical prostatectomy (RP). MATERIALS AND METHODS: Overall, 205,551 patients with PCa diagnosed between 1988 and 2009 within the Surveillance Epidemiology and End Results (SEER) database were included in the study. Patients were stratified according to age at diagnosis: ≤ 50, 51-60, 61-70, and ≥ 71 years. The 15-year cumulative incidence CSM rates were computed. Competing-risks regression models were performed to test the effect of age on CSM in the entire cohort, and for each grade (Gleason score 2-4, 5-7, and 8-10) and stage (pT2, pT3a, and pT3b) sub-cohorts. RESULTS: Advancing age was associated with higher 15-year CSM rates (2.3 vs. 3.4 vs. 4.6 vs. 6.3% for patients aged ≤ 50 vs. 51-60 vs. 61-70 vs. ≥ 71 years, respectively; P < 0.001). In multivariable analyses, age at diagnosis was a significant predictor of CSM. This relationship was also observed in sub-analyses focusing on patients with Gleason score 5-7, and/or pT2 disease (all P ≤ 0.05). Conversely, age failed to reach the independent predictor status in men with Gleason score 2-4, 8-10, pT3a, and/or pT3b disease. CONCLUSIONS: Advancing age increases the risk of CSM. However, when considering patients affected by more aggressive disease, age was not significantly associated with higher risk of dying from PCa. In high-risk patients, tumor characteristics rather than age should be considered when making treatment decisions.

Intensity-modulated radiation therapy leads to survival benefit only in patients with high-risk prostate cancer: a population-based study.

BACKGROUND: During the last years, there has been a rapid adoption of intensity-modulated radiation therapy (IMRT) in patients with prostate cancer (PCa), despite the lack of randomized trials evaluating its effectiveness. The aim of our study was to evaluate the survival benefit associated with IMRT in patients with PCa. PATIENTS AND METHODS: Overall, 42 483 patients with PCa treated with IMRT or initial observation between 2001 and 2007 within the Surveillance, Epidemiology, and End Results (SEER)-Medicare were evaluated. Patients in both treatment arms were matched using propensity-score methodology. After propensity-score matching, 19 064 patients remained in our analyses. Eight-year cancer-specific mortality (CSM) rates were estimated, and the number needed to treat (NNT) was calculated. Competing risks regression analyses tested the relationship between treatment type and CSM. RESULTS: Overall, the 8-year CSM rates were 3.4% and 4.1% for patients treated with IMRT versus initial observation, respectively (P < 0.001). The corresponding 8-year NNT was 142. In patients with low/intermediate-risk disease, IMRT was not associated with lower CSM rates compared with observation (P = 0.7). In patients with high-risk disease, the 8-year CSM rates for IMRT versus observation were 5.8% versus 10.5%, respectively (P < 0.001). The corresponding NNT was 21. When high-risk patients were stratified according to age (<73 versus ≥73), and Charlson comorbidity index (≤1 versus >1) the 8-year CSM rates for IMRT versus observation were 4.3% versus 9.4% and 6.9% versus 11.9% and 5.3% versus 11.4% and 6.1% versus 10.1%, respectively (all Ps < 0.001). The corresponding NNTs were 19, 21, 16, and 25, respectively. In multivariate analyses, the protective effect of IMRT was more evident in high-risk patients with younger age and lower comorbidities. CONCLUSIONS: IMRT leads to a survival advantage only in patients with high-risk disease. Conversely, patients with low/intermediate-risk disease did not benefit from IMRT at 8-year follow-up.

Specialty bias in treatment recommendations and quality of life among radiation oncologists and urologists for localized prostate cancer.

BACKGROUND: Given the importance of physician attitudes about different treatments and the quality of life (QOL) in prostate cancer, we performed a national survey of specialists to assess treatment recommendations and perceptions of treatment-related survival and QOL. METHODS: We mailed a self-administered survey instrument to a random sample of 1366 specialists in the U.S. Respondents were asked for treatment recommendations and survival that varied by PSA levels and Gleason scores and estimate QOL outcomes. Pearson's chi-square and multivariable regression models were used to test for differences in each outcome. RESULTS: Response rates were similar for radiation oncologists (52.6%) and urologists (52.3%; P=0.92). Across all risk strata, urologists were more likely to recommend surgery than were radiation oncologists, for conditions ranging from PSA>20 and Gleason score 8-10 (35.2 vs. 0.2%; P<0.001) to PSA 4-10 and Gleason score 7 (87.5 vs. 20.9%; P<0.001). Radiation oncologists were also more likely to recommend radiation therapy relative to urologists (all P<0.001). From low- to high-risk prostate cancer, radiation oncologists and urologists perceived their treatment as being better for improving survival (all P<0.001). Each specialty also viewed their treatment as having less urinary incontinence (all P<0.001). CONCLUSIONS: Radiation oncologists and urologists both prefer the treatment modalities they offer, perceive them to be more effective and to lead to a better QOL. Patients may be receiving biased information, and a truly informed consent process with shared decision-making may be possible only if they are evaluated by both specialties before deciding upon a treatment course.

Continuous neuronal ensemble control of simulated arm reaching by a human with tetraplegia.

Functional electrical stimulation (FES), the coordinated electrical activation of multiple muscles, has been used to restore arm and hand function in people with paralysis. User interfaces for such systems typically derive commands from mechanically unrelated parts of the body with retained volitional control, and are unnatural and unable to simultaneously command the various joints of the arm. Neural interface systems, based on spiking intracortical signals recorded from the arm area of motor cortex, have shown the ability to control computer cursors, robotic arms and individual muscles in intact non-human primates. Such neural interface systems may thus offer a more natural source of commands for restoring dexterous movements via FES. However, the ability to use decoded neural signals to control the complex mechanical dynamics of a reanimated human limb, rather than the kinematics of a computer mouse, has not been demonstrated. This study demonstrates the ability of an individual with long-standing tetraplegia to use cortical neuron recordings to command the real-time movements of a simulated dynamic arm. This virtual arm replicates the dynamics associated with arm mass and muscle contractile properties, as well as those of an FES feedback controller that converts user commands into the required muscle activation patterns. An individual with long-standing tetraplegia was thus able to control a virtual, two-joint, dynamic arm in real time using commands derived from an existing human intracortical interface technology. These results show the feasibility of combining such an intracortical interface with existing FES systems to provide a high-performance, natural system for restoring arm and hand function in individuals with extensive paralysis.

Neural control of cursor trajectory and click by a human with tetraplegia 1000 days after implant of an intracortical microelectrode array.

The ongoing pilot clinical trial of the BrainGate neural interface system aims in part to assess the feasibility of using neural activity obtained from a small-scale, chronically implanted, intracortical microelectrode array to provide control signals for a neural prosthesis system. Critical questions include how long implanted microelectrodes will record useful neural signals, how reliably those signals can be acquired and decoded, and how effectively they can be used to control various assistive technologies such as computers and robotic assistive devices, or to enable functional electrical stimulation of paralyzed muscles. Here we examined these questions by assessing neural cursor control and BrainGate system characteristics on five consecutive days 1000 days after implant of a 4 × 4 mm array of 100 microelectrodes in the motor cortex of a human with longstanding tetraplegia subsequent to a brainstem stroke. On each of five prospectively-selected days we performed time-amplitude sorting of neuronal spiking activity, trained a population-based Kalman velocity decoding filter combined with a linear discriminant click state classifier, and then assessed closed-loop point-and-click cursor control. The participant performed both an eight-target center-out task and a random target Fitts metric task which was adapted from a human-computer interaction ISO standard used to quantify performance of computer input devices. The neural interface system was further characterized by daily measurement of electrode impedances, unit waveforms and local field potentials. Across the five days, spiking signals were obtained from 41 of 96 electrodes and were successfully decoded to provide neural cursor point-and-click control with a mean task performance of 91.3% ± 0.1% (mean ± s.d.) correct target acquisition. Results across five consecutive days demonstrate that a neural interface system based on an intracortical microelectrode array can provide repeatable, accurate point-and-click control of a computer interface to an individual with tetraplegia 1000 days after implantation of this sensor.

Predictors of idiopathic thrombocytopenic purpura in pregnant women presenting with thrombocytopenia.

OBJECTIVE: Idiopathic thrombocytopenic purpura (ITP) and gestational thrombocytopenia (GT) are common causes of thrombocytopenia during pregnancy. Despite an ever-increasing experience with these disorders, differentiation between the two entities still remains a diagnostic challenge. The current study attempted to identify the antenatal predictors of ITP for pregnant women. METHODS: Between January 1999 and June 2005, a total of 58 pregnant women with a presumptive diagnosis of either ITP or GT were recruited for the study. All of them had platelet counts of less than 100 x 10(9)/L. The predictors of ITP were evaluated by comparison between the two disorders. RESULTS: The detection of thrombocytopenia prior to 28 weeks of gestation and platelet counts <50 x 10(9)/L at its diagnosis remained independently predictive of ITP (P<0.001 and P=0.004, respectively). The combined analysis of these two factors provided a 96.0% sensitivity and a specificity of 75.8%. CONCLUSION: The onset time of thrombocytopenia and platelet count at its presentation remain the strongest predictors of ITP for pregnant women. The combination model using these factors may be useful for the early prediction of ITP.

Supportive management of pregnancy-associated aplastic anemia.

OBJECTIVE: To examine maternal and fetal outcomes of pregnancy-associated aplastic anemia treated with supportive care. METHODS: From January 1995 to December 2004, 14 women newly diagnosed as having pregnancy-associated aplastic anemia were recruited for the study. RESULTS: Diagnosis was made during the second or third trimester for 11 (78%) of the 14 patients, and 3 of the 8 severe cases of aplastic anemia were diagnosed at initial presentation. All patients had conservative management with transfusions but no specific immunologic or hormonal therapy during pregnancy. Of the 12 women eligible for follow-up, 1 achieved complete remission and 8 achieved partial remission after delivery. The pregnancies progressed uneventfully in most cases. CONCLUSIONS: This study demonstrated favorable maternal and neonatal outcomes with transfusion support alone for pregnancy-associated aplastic anemia.

A comparison of optimal MIMO linear and nonlinear models for brain-machine interfaces.

The field of brain-machine interfaces requires the estimation of a mapping from spike trains collected in motor cortex areas to the hand kinematics of the behaving animal. This paper presents a systematic investigation of several linear (Wiener filter, LMS adaptive filters, gamma filter, subspace Wiener filters) and nonlinear models (time-delay neural network and local linear switching models) applied to datasets from two experiments in monkeys performing motor tasks (reaching for food and target hitting). Ensembles of 100-200 cortical neurons were simultaneously recorded in these experiments, and even larger neuronal samples are anticipated in the future. Due to the large size of the models (thousands of parameters), the major issue studied was the generalization performance. Every parameter of the models (not only the weights) was selected optimally using signal processing and machine learning techniques. The models were also compared statistically with respect to the Wiener filter as the baseline. Each of the optimization procedures produced improvements over that baseline for either one of the two datasets or both.

Ultrastructural evaluation of the protective effect of nitroglycerin in preservation-reperfusion injury of rat lungs.

AIM OF STUDY: Nitric oxide (NO) has been reported as a favorable protective supplement in donor lung preservation, but related ultrastructural studies are rare in the literature. This study was performed to assess the ultrastructural changes and to evaluate the protective effect of NO as donor nitroglycerin (NTG) treatment of ischemia-reperfusion injury in rat lungs. MATERIALS AND METHODS: Fifteen Sprague-Dawley rats weighing 300 to 350 g were used in this study. The NTG group (n = 5) used intravenous administration followed by mixture in the University of Wisconsin (UW) solution. For the non-NTG group (n = 5), we injected the same amount of normal saline intravenously followed by admixture in the UW solution. The heart-lung blocks were removed, weighed, and kept in UW solution for 24 hours at 10 degrees C. Reperfusion using human blood diluted in Krebs-Hensleit solution was done for 60 minutes. For the control group (n = 5), we injected the same amount of normal saline intravenously, and removed the lungs with no preservation and reperfusion procedures. RESULTS: The non-NTG group showed multiple patchy areas of alveolar collapse with marked swelling and destruction of type I epithelial cells, loss of type II cell surfactant granules, endothelial swelling and papillary projection, interstitial edema, and alveolar macrophages with active phagocytosis of the destroyed materials. The NTG group showed similar ultrastructural changes, but in a lesser severity compared with the non-NTG group. CONCLUSION: Administration of the NTG reduced the ischemia-reperfusion injury in the rat donor lungs. Ultrastructural examination was an effective tool to evaluate the protective effect of NTG in ischemia-reperfusion procedures of donor lungs.

Effects of polyhemoglobin-antioxidant enzyme complex on ischemia-reperfusion in kidney.

INTRODUCTION: The kidney suffers ischemia-reperfusion (I/R) injury during transplantation. The purpose of the present study was to investigate the therapeutic effect of artificials cells on renal I/R injury through biochemical assays and histological examination. METHODS: We prepared artificial cells using cross-linked hemoglobin (Hb), superoxide dismutase (SOD), and catalase. Normal male Sprague-Dawley rats were divided into 6 groups: the sham-operated control group, the group treated with polyHb,and the group treated with polyHb-SOD-catalase (PSC) (per groups were subjected to ischemia for 1 hour or 2 hours). After reperfusion for 4 hours, kidney and blood samples were obtained. RESULTS: The levels of SOD and catalase in the PSC group were 15 and 50 times higher than those of the control group, respectively. In the polyHb group, the levels of blood urea nitrogen (BUN), serum creatinine, renal hydrogen peroxide, and renal malondialdehyde were increased. However, their levels were significantly decreased by PSC administration. Renal SOD activity did not show any significant changes in the polyHb group, but renal catalase activity was decreased by polyHb treatment in comparison with the control group. The activities of renal SOD and catalase were increased using PSC treatment. In the histological findings, the PSC group showed no evidence of acute tubular necrosis in proximal convoluted tubules; their microvilli and cytoplasmic microorganelles were relatively well preserved. CONCLUSIONS: These results show that PSC effectively reduces renal damage via diminished oxygen free radical-mediated injury after I/R.

Effect of artificial cells on hepatic function after ischemia-reperfusion injury in liver.

BACKGROUND: The liver suffers from ischemia/reperfusion injury during transplantation. Reactive oxygen species generated by xanthine oxidase during reperfusion of the ischemic liver may be partially responsible for the hepatic injury. Oxygen free radicals are removed by antioxidant enzymes such as superoxide dismutase (SOD), catalase, and glutathione peroxidase. Using glutaraldehyde and lysine we constructed crosslinked hemoglobin, containing SOD and catalase, and assessed its ability to protect against ischemia/reperfusion injury during transplantation. METHODS: In contrast to the sham-operated control groups, blood was exchanged using crosslinked hemoglobin (polyHb) a PolyHb-SOD-catalase (PSC) group. After ischemia/reperfusion injury, several parameters of hepatic damage and oxygen free radicals were measured as well as microscopic examination. RESULTS: Alanine aminotransferase, aspartate aminotransferase, superoxide production, hydrogen peroxide, and malondialdehyde levels were higher among the PolyHb group than sham-operated controls. The PolyHb group revealed a few apoptotic bodies, some acute inflammatory infiltrates in the sinusoids, nuclear fragmentations, cell shrinkage, and chromatin clumping with formation of apoptotic bodies in the apoptotic cells under microscopic examination. Alanine aminotransferase, aspartate aminotransferase, superoxide production, and hydrogen peroxide levels were lower in the PSC than the PolyHb group. Hepatic structures were well preserved in the PSC group. CONCLUSIONS: Reactive oxygen species contribute to hepatic dysfunction with morphologic changes. PSC is effective to reduce hepatic damage by lowering oxygen free radical-mediated injury after ischemia/reperfusion in the liver.

Elective vs. conservative management of ovarian tumors in pregnancy.

OBJECTIVES: To determine optimal management of the ovarian tumors in pregnancy. METHODS: This study included 89 cases of the ovarian tumor in pregnancy that required surgery at Holy Family hospital of the Catholic University from January, 1990 to December, 2001. Among 89 cases, 36 and 53 were emergency and elective surgery, respectively. Student's t-test and the chi(2)-test were used for statistical analysis and a P-value of <0.05 was considered statistically significant. RESULTS: The most common size of torsion of ovarian tumors during pregnancy was 6-10 cm and the incidence was the most frequent during the first trimester of pregnancy. The incidence of preterm delivery (<37 weeks) was higher in emergency surgery, but there was no difference in the gestational age at delivery, also no difference in the birth weight or the method of delivery. CONCLUSIONS: Although surgery for ovarian tumors in pregnancy is delayed until the onset of symptoms, adverse pregnancy outcome is not worsened when compared with that after elective surgery. We propose that conservative management would be used in optimal management of pregnant women with ovarian tumors.

Expression of insulin-like growth factor-II and insulin-like growth factor binding protein-1 in the placental basal plate from pre-eclamptic pregnancies.

OBJECTIVES: To determine whether expressions of insulin-like growth factor-II (IGF-II) and insulin-like growth factor binding protein-1 (IGFBP-1) are altered in pre-eclamptic placenta and to elucidate the possible relationship between their expressions and a mechanism for inadequate trophoblast invasion in pre-eclampsia. METHODS: Placental tissues were obtained at cesarean delivery from five normotensive, nine mild pre-eclamptic and five severe pre-eclamptic women at 33-39 completed weeks of gestation. After total ribonucleic acid was extracted, reverse transcriptase-polymerase chain reaction was performed to determine IGF-II and IGFBP-1 mRNA expression. Product bands were quantitated by scanning densitometry and results were expressed as ratio of cytokines/beta-actin. Western blot analysis was also done to determine IGF-II and IGFBP-1 protein expression. Statistical analysis was determined by Kruskal-Wallis analysis of variance with the Scheffe multiple post-hoc test. RESULTS: The IGF-II mRNA levels of mild and severe pre-eclamptic placenta were significantly lower than that of uncomplicated placenta (P<0.005, P<0.001, respectively), with the level of severe pre-eclamptic placenta being significantly lower than that of mild pre-eclamptic placenta (P<0.05). As for the IGF-II protein expression, a significant decrease was found among the three groups (P<0.001), correlating with the IGF-II mRNA results. However, the mean IGFBP-1 mRNA levels of mild and severe pre-eclamptic placenta were significantly higher than that of uncomplicated placenta (P<0.05, P<0.005, respectively), with the level of severe pre-eclamptic placenta being significantly raised compared with that of mild pre-eclamptic placenta (P<0.05). Finally, a significant increase of IGFBP-1 protein expression was noted among the three groups (P<0.001), correlating with the IGFBP-1 mRNA results. CONCLUSIONS: This study suggests that IGF-II and IGFBP-1 might be associated with the impaired trophoblastic invasion that may lead to pathogenesis of pre-eclampsia.