Cognitive and emotional empathy in individuals at clinical high risk of psychosis.

BACKGROUND: Impairments of social cognition are considered core features of schizophrenia and are established predictors of social functioning. However, affective aspects of social cognition including empathy have far less been studied than its cognitive dimensions. The role of empathy in the development of schizophrenia remains largely elusive. METHODS: Emotional and cognitive empathy were investigated in large sample of 120 individuals at Clinical High Risk of Psychosis (CHR-P) and compared with 50 patients with schizophrenia and 50 healthy controls. A behavioral empathy assessment, the Multifaceted Empathy Test, was implemented, and associations of empathy with cognition, social functioning, and symptoms were determined. RESULTS: Our findings demonstrated significant reductions of emotional empathy in individuals at CHR-P, while cognitive empathy appeared intact. Only individuals with schizophrenia showed significantly reduced scores of cognitive empathy compared to healthy controls and individuals at CHR-P. Individuals at CHR-P were characterized by significantly lower scores of emotional empathy and unspecific arousal for both positive and negative affective valences compared to matched healthy controls and patients with schizophrenia. Results also indicated a correlation of lower scores of emotional empathy and arousal with higher scores of prodromal symptoms. CONCLUSION: Findings suggest that the tendency to 'feel with' an interaction partner is reduced in individuals at CHR-P. Altered emotional reactivity may represent an additional, early vulnerability marker, even if cognitive mentalizing is grossly unimpaired in the prodromal stage. Different mechanisms might contribute to reductions of cognitive and emotional empathy in different stages of non-affective psychotic disorders and should be further explored.

[Quality of life and job performance resulting from operatively treated tibial plateau fractures]. / Lebensqualität und Arbeitsfähigkeit nach operativer Behandlung von Tibiakopffrakturen.

BACKGROUND: The aim of this article is to present the functional results and the effect on quality of life of surgically treated tibial plateau fractures in physically active and working patients with multiple and serious injuries. In addition, the relationships between functional and radiological outcome were evaluated and compared with activity in daily and professional life. PATIENTS AND METHODS: In all, 41 injured patients were followed up a mean of 47 months after surgical treatment and examined with radiological, functional, as well as quality of life score. RESULTS: In the radiological scoring, a mean value of 72 points (max 100 points) was achieved. In the activity score, there was an average of 63.5 points (max 100 points). When evaluating the health-related quality of life, an average score of 69.6 points was achieved. There was a significant relationship between radiological and activity scores and the radiological and life quality scores. Furthermore, the relationship between activity and quality of life scores was considered significant. Surgeon's influence on the functional outcome could be confirmed. CONCLUSION: The functional and the radiological results were moderate. Quality of life was permanently affected by the consequences of tibial plateau fracture in 12 patients; 11 patients were not re-employed. However, the quality of life was assessed as good or very good and 28 patients had returned to work. The quality of life was firmly linked to the radiological and functional parameters, which tended to be influenced by the quality of the primary surgical treatment when looking at the overall population.

Does the use of a visualised decision board by undergraduate students during shared decision-making enhance patients' knowledge and satisfaction? - A randomised controlled trial.

OBJECTIVES: Aim of this RCT was to evaluate whether the added use of a decision board (DB) during shared decision-making improves patients' knowledge as for different treatment options and overall satisfaction with the consultation. METHODS: Forty-nine undergraduate students were trained in shared decision-making (SDM) and evaluated by an Objective Structured Clinical Examination (OSCE). According to their test results, all participants were randomly allocated to either the test- (DB) or the control-group (Non-DB). Both groups performed SDM with patients showing a defect in a posterior tooth (Class-II defect). Prior to the interview, patients of the DB group were given the decision aid for review. In the Non-DB group, patients were consulted without additional aids. After treatment decision, a questionnaire was completed by all patients to measure knowledge (costs, survival rate, characteristics and treatment time) and overall satisfaction with the consultation. Fifty DB patients and 31 Non-DB patients completed the questionnaire. RESULTS: DB patients (n = 50) demonstrated a statistically significant increase in knowledge compared to the Non-DB group (n = 31) (Mann-Whitney U-test; DB group = 10.04; Non-DB group = 4.16; P = 0.004). There was no significant difference between groups regarding satisfaction with the consultation (t-test; P > 0.05). CONCLUSIONS: During the shared decision-making process, the use of a decision board yielding information about Class-II treatment options leads to a significantly higher patient knowledge compared to knowledge gained through consultation alone. It is therefore desirable to provide DBs for dental diagnoses with several treatment options to increase transparency for the patient.

The flexion withdrawal reflex reveals an increasing threshold during the first year of life and is influenced by the infant's state of consciousness.

BACKGROUND: The idea that preterm and term infants are capable of experiencing pain is now widely accepted. However, there is still insufficient knowledge how pain perception develops throughout infancy. A promising approach to quantify the level of spinal excitability in infants is to measure cutaneous sensitivity by the flexion withdrawal reflex (WR). In our study we wanted to test how the threshold of the WR develops in healthy infants during the first year of life. Furthermore, we aimed to analyse the impact of the state of consciousness on the reflex threshold. PATIENTS AND METHOD: In 44 healthy infants we tested the threshold of the WR with calibrated von-Frey-Filaments at the age of 3 days as well as with 4, 12, 26 and 52 weeks. To analyse the influence of the state of consciousness on the reflex threshold, we documented at 12, 26 and 52 weeks whether the infants were quietly awake or lightly asleep during testing. RESULTS: The median threshold of the WR increased during the first year of life from 1.2 g up to 4.6 g at the age of 1 year. At 12, 26 and 52 weeks we found significantly lower thresholds in sleeping infants compared to infants being awake (p=0.004, p<0.001 and p=0.086, respectively). CONCLUSION: The threshold of the flexion withdrawal reflex increases during infancy, probably reflecting neuronal maturation processes in the first year of life. Besides postnatal age, the threshold of the WR also depends on the state of consciousness. Therefore, future studies about the WR should consider postnatal age as well as the state of consciousness.

Comparison of sufentanil versus fentanyl in ventilated term neonates.

BACKGROUND: Increasingly frequent applications of opioid analgesics in neonatal intensive care require the evaluation of efficacy and side effects. PATIENTS: Mechanically ventilated term neonates were consecutively enrolled. METHODS: In a double-blind randomized trial 20 newborns received a continuous intravenous infusion of fentanyl (n=10) or sufentanil (n=10) in an assumed equipotent dose of 7:1. The analgesic dose was individually adjusted according to sedation scores. The period between cessation of analgesic medication and successful extubation (weaning time), adverse drug effects and urinary cortisol concentrations were evaluated. RESULTS: No significant difference of weaning time was seen between fentanyl and sufentanil group (mean weaning time (+/-SD) of fentanyl group 520+/-381 min, median 380 min; sufentanil group 585+/-531 min, median 405 min, p=0.78, 2-tailed U-Test, Mann and Whitney). The mean opioid dose resulted in a 10:1 ratio (fentanyl 4.11 microg/(kg x h) vs sufentanil 0.41 microg/(kg x h)). We found no marked differences in sedation levels, blood pressure, heart rate, oxygenation index, co-medication or urinary cortisol levels. In both groups similar adverse effects were assessed including respiratory depression, mild withdrawal symptoms or decrease of gastrointestinal motility. CONCLUSION: In our study sufentanil did not reduce the weaning period in ventilated term neonates when compared to fentanyl. The equipotent dose ratio for fentanyl/sufentanil was 10:1. According to sedation scores both substances provided effective pain and stress protection.

How does spinal canal decompression and dorsal stabilization affect segmental mobility? A biomechanical study.

INTRODUCTION: When decompression of the lumbar spinal canal is performed, segmental stability might be affected. Exactly which anatomical structures can thereby be resected without interfering with stability, and when, respectively how, additional stabilization is essential, has not been adequately investigated so far. The present investigation describes kinetic changes in a surgically treated motion segment as well as in its adjacent segments. MATERIAL AND METHODS: Segmental biomechanical examination of nine human lumbar cadaver spines (L1 to L5) was performed without preload in a spine-testing apparatus by means of a precise, ultrasound-guided measuring system. Thus, samples consisting of four free motion segments were made available. Besides measurements in the native (untreated) spine specimen further measurements were done after progressive resection of dorsal elements like lig. flavum, hemilaminectomy, laminectomy and facetectomy. The segment was then stabilised by means of a rigid system (ART((R))) and by means of a dynamic, transpedicularly fixed system (Dynesys((R))). RESULTS: For the analysis, range of motion (ROM) values and separately viewed data of the respective direction of motion were considered in equal measure. A very high reproducibility of the individual measurements could be verified. In the sagittal and frontal plane, flavectomy and hemilaminectomy did not achieve any relevant change in the ROM in both directions. This applies to the segment operated on as well as to the adjacent segments examined. Resection of the facet likewise does not lead to any distinct increase of mobility in the operated segment as far as flexion and right/left bending is concerned. In extension a striking increase in mobility of more than 1degree compared to the native value can be perceived in the operated segment. Stabilization with the rigid and dynamic system effect an almost equal reduction of flexion/extension and right/left bending. In the adjacent segments, a slightly higher mobility is to be noted for rigid stabilization than for dynamic stabilisation. A linear regression analysis shows that in flexion/extension monosegmental rigid stabilisation is compensated predominantly in the first cranial adjacent segment. In case of a dynamic stabilisation the compensation is distributed among the first and second cranial, and by 20% in the caudal adjacent segment. SUMMARY: Monosegmental decompression of the lumbar spinal canal does not essentially destabilise the motion segment during in vitro conditions. Regarding rigid or dynamic stabilisation, the ROM does not differ within the operated segment, but the distribution of the compensatory movement is different.

[Digital X-ray mammography: comparison of the image quality achievable with a wet laser imager, a dry infrared laser imager and a dry laser imager using direct thermography]. / Digitale Röntgenmammographie: Bildqualitativer Vergleich eines Nasslaserdruckers, eines infrarotbasierten Trockenlaserdruckers und eines thermographiebasierten Trockendruckers.

PURPOSE: To compare the image quality of digital X-ray mammographies obtained with wet imagers with that of standard dry imaging technology. MATERIAL AND METHODS: Beginning 03/08/2003, 200 X-ray mammographies with a digital fullfield mammography system (Lorad Selenia, Lorad/Hologic) were prospectively and consecutively documented with a wet laser imager (Scopix LR 5200, Agfa), a dry infrared laser imager (DryView 8610, Kodak) and a dry imager using the principle of direct thermography (Drystar 4500M, Agfa, N = 166). One X-ray exposure was systematically chosen from each examination and was presented in an anonymous and randomized form to three radiologists who evaluated the films using a structured questionnaire. RESULTS: The visualization of normal anatomic structures was considered being good to excellent for all imagers with the mean assessments 1.0 - 2.4 for the Drystar 4500M, 1.0 - 2.1 for the DryView 8610 and 1.1 - 2.0 for the Scopix LR 5200. The mean assessments were 0.1 - 0.6 points lower in dense than in normal parenchyma, thus, the parenchymal density is the predominant factor for image quality. CONCLUSION: In view of the comparable image quality obtained with the different imagers used in the study, individual decisions to purchase a specific imager will be based on economics rather than on diagnostic points of view.

A randomized, placebo-controlled study of the use of filgrastim in non neutropenic patients with nosocomial pneumonia.

Pneumonia remains the number one cause of death from infectious diseases in Western Europe and the United States despite the introduction of potent broad-spectrum antibiotics. Granulocyte colony-stimulating factor is considered to improve host defense during infection and may be an effective adjunctive in the treatment of severe infections. We examined the efficacy of granulocyte colony-stimulating factor (r-metHUG-CSF, filgrastim) with regard to clinical response in non-neutropenic ICU patients with nosocomial pneumonia in a prospective, randomized, placebo-controlled trial. 28 patients with newly diagnosed nosocomial pneumonia were randomly assigned to receive 300-480 microg filgrastim or placebo subcutaneously for up to seven days. Study endpoints were death within 15 days, duration of antibiotic therapy and occurrence of serious adverse events (SAE). No significant differences were observed in respect of 15-day (filgrastim1/12 vs. placebo 2/16) or 30-day mortality (1/12 vs.4/16, p=0.355), and length of antibiotic treatment (13.5 vs.11.5 days, p=0.985). Sepsis developed in 1/12 patients in the filgrastim and 6/16 patients in the placebo group (p=0.184). None of the patients developed ARDS or any other SAE related to the study medication. Filgrastim is safe in non-neutropenic ICU patients with nosocomial pneumonia. A benefit of filgrastim with regard to clinical endpoints could not be observed, while there was a trend toward reduced sepsis rate.

Clinical risk factors for malnutrition in HIV-1-infected patients.

OBJECTIVE: To estimate the influence of fever, diarrhoea, stage of HIV disease, opportunistic infection and anorexia on malnutrition in HIV-infected patients we analysed data of patients undergoing a nutritional counselling programme from November 1989 to April 1992. PATIENTS AND METHODS: Our study group comprised 104 HIV-infected patients (98 homosexual men, 15 asymptomatics, 30 AIDS-related complex patients, 59 AIDS patients). Nutritional status was measured by previous weight loss, bioelectrical impedance analysis and prospective intake protocol. RESULTS: Patients had lost 10 +/- 8.7% of body weight. Compared with controls, body mass index was lower (P < 0.001), and extracellular/body cell mass ratio (ECM/BCM) was higher (P < 0.001). BCM was reduced proportionately to weight loss, percentage of body fat was lower compared with controls (P < 0.001), even in patients with stable weight. Clinical risk factors for malnutrition were identified as fever in 31, diarrhoea in 26, acute infections in 42 and anorexia in 73 out of 104 patients. One single risk factor was predominant in 63 patients: fever in five, diarrhoea in 14, acute infections in 17 and anorexia in 27 patients. Weight loss was not linearly correlated to CD4 count or to time since AIDS diagnosis. Food intake was highly variable (39-165% of calculated needs) without correlation to weight loss. CONCLUSIONS: Loss of body fat was found even in the earlier stages of HIV infection and was more severe than loss of BCM. Important risk factors for malnutrition are anorexia (most frequent), diarrhoea and fever (most severe). Most patients have combined risk factors. Treatment strategies and pathophysiologic studies should consider the heterogeneity of HIV-associated malnutrition.

Coamplification of the hst and bcl-1 oncogenes in advanced squamous cell carcinomas of the head and neck.

Squamous cell carcinomas of the head and neck from 40 untreated patients were analysed for rearranged or amplified proto-oncogenes by Southern blot hybridisation. The bcl-1 and the hst genes were coamplified 8-32-fold in 5 patients (12.5%). Only males with stage III and IV disease showed coamplification of these oncogenes. Northern blot analysis of the positive samples did not show expression of bcl-1 or hst genes. In contrast, a third oncogene located on chromosome 11 (Ha-ras-1) was not amplified in these tumours. Disease development was observed in all cases over a minimum period of 3 years. Survival of the patients with coamplification of hst/bcl-1 seemed to be shorter than of those with stage III and IV disease without amplification. This difference was not significant probably due to the small number of investigated patients.

Radiotherapy of esthesioneuroblastoma.

PURPOSE: Only 3% of all malignant intranasal tumors are esthesioneuroblastomas (ENB). As the tumor is very rare, the number of ENB treated in individual departments is small. In order to evaluate the efficacy of radiotherapy (RT), patients' data of 2 centres were analysed with reference to new reports in literature. METHODS AND MATERIALS: From 1981 to 1998, 17 patients with ENB, 8 men and 9 women aged between 6 and 81 years, were treated in the departments of radiotherapy of the universities of Cologne and Muenster. The tumors were Kadish Stage B in 4/17 patients and Stage C in 13/17 patients. Treatment included incomplete surgery and irradiation in 2/17 patients, adjuvant RT postoperatively in 6/17 patients, definitive RT in 7/17 patients and RT after incomplete surgery of recurrent tumors in 2/17 patients. Postoperatively, the median target dose of EBRT was 56 (range 50-60) Gy; for definitive RT it was 58 (range 40-70) Gy. RESULTS: After a median follow-up period of 86 (range 2-208) months 10/17 patients showed no evidence of disease (NED). There were 6 patients treated with radical complete surgery plus postoperative irradiation and 5 of them were NED. There were 7 patients treated with only irradiation and 3 of those patients were NED. Of 2 patients with incomplete surgery and irradiation there was one patient NED. Of 2 patients with incomplete resection of recurrent tumor who received irradiation, there was one patient NED. 2 of the patients with NED died after 22 and 94 months respectively. 4/17 patients died as a result of local recurrence and 2/17 patients as a result of distant metastases (liver, brain). One patient with a recurrent tumor is alive. Median survival of all 17 patients was 94 months. Progressive disease after definitive RT occurred after a median of 11 months. CONCLUSION: Esthesioneuroblastomas are radiocurable tumors. In correlation to literature a primarily complete tumor resection followed by adjuvant RT (50-60 Gy) offers the best disease free survival.

Analysis of protooncogenes in squamous-cell carcinomas of the head and neck (scchn).

We have analysed DNA and RNA from 40 untreated head and neck cancers for amplified and overexpressed proto-oncogenes by Southern and Northern blot hybridisation. Coamplification but no expression of the bcl-1 and the hst genes was found in 12.5% of the patients. Furthermore, amplifications of c-myc were found in 10%, of Ha-ras and c-erbB-2 in 5%. c-erbB-2 amplification was accompanied by gene expression but no overexpression. Correlating our results with clinicopathological data of the patients amplifications were only found in stage III and IV disease (p=0.0164). No correlation was found between amplification and primary tumour site, histopathological differentiation of the tumours, response to induction chemotherapy, or survival. Our results indicate that oncogene amplification in advanced SCCHN reflects more the general genomic instability of advanced tumours than be a reason for tumour growth.

Lymph node staging in 872 patients with carcinoma of the stomach and the presumed benefit of lymphadenectomy. German Stomach Cancer TNM Study Group.

The incidence of surgically suspected and microscopically proved lymph nodes from adenocarcinoma of the stomach and the results of systematic lymphadenectomy have been studied and correlated to survival rate of 99.4 percent at a follow-up period of five years in 872 patients who underwent resection as a part of a prospective observational study in carcinoma of the proximal and distal parts of the stomach. Surgeons believe that, in the median, only one-fifth of the patients with and without systematic lymphadenectomy had positive nodes, whereas pathologists found almost three-fourths of positive lymph nodes (72.7 percent) in patients with proximal carcinoma of the stomach as compared with those without systematic lymphadenectomy (30.8 percent). The figures for middle and lower third carcinomas were even higher (63.5 versus 13.9 percent and 75.9 versus 27.1 percent). Positive nodes were most common in the perigastric area and their distribution was clearly related to the site of the tumor. Frequently, however, lymph node groups were involved, far from the primary, that is, along the hepatoduodenal ligament in 9 to 19 percent of patients with carcinoma of the proximal part of the stomach and in 7 to 16 percent of patients with carcinoma of the distal part of the stomach. There were some hints of a better survival rate for patients with systematic lymphadenectomy as compared with those without, only for low stage carcinoma of the stomach (TNM stage IA-IB, p = 0.1157, Breslow). We suggest a more extensive operation with gastric resection, always combined with systematic lymphadenectomy if no distant metastases are found.

Colorectal cancer--a multivariate analysis of prognostic factors.

The data from 1050 patients who had undergone colorectal carcinoma resection at the University of Cologne between 1976 and 1990 were studied. The aim of the study was to determine the concomitant effects on survival of several patient characteristics (sex, age, tumour localization, blood transfusion) and histopathological variables (Dukes' staging). We first calculated survival rates, both including and excluding post-operative mortality. We set up a hierarchical log-linear model for the detection of relationships between selected crossclassified categorial variables. We then used Cox's proportional hazard regression method to study the relationship between survival and different prognostic patterns. Dukes' staging was shown to be a highly discriminating factor in survival (P<0.001). Survival rates were better in women (P<0.001), and better for younger patients (<70 years; P<0.001). Tumour site (colon; P = 0.0362) and blood transfusion (P = 0.0857) also correlated with survival.

Evaluation of nutritional counselling in HIV-associated malnutrition.

In HIV-infected patients, the outcome of counselling as the first step of a nutritional intervention programme was evaluated, in order to identify clinical and nutritional predictors for its efficacy. 75 HIV-infected patients were investigated, most with advanced disease. Nutritional status was determined by body weight, bioelectrical impedance and 7-day food intake record. Prior mean weight loss was 10% (range = +4% to -31%). Counselling facilitated weight gain in 40 75 patients (1-4 months later, overall mean difference +1.4 +/- 6.2%) and in 14 34 patients (8-11 months later, overall mean difference -1.4 +/- 9.0%). Weight changes correlated with changes in body cell mass (r(2) = .69, p < .001) and in body fat (r(2) = .29, p < 0.05), but not extracellular mass. Underlying conditions such as AIDS definition, fever, and diarrhoea correlated to prior weight loss (p < .001) but not to the outcome of counselling. Low energy intake (before counselling, < 31.5 kcal/kg) did not correlate to prior weight loss but it predicted further weight loss (p < 0.05 towards normal intake). High energy intake (> 38.5 kcal/kg) correlated (p < 0.05) with more prior weight loss but not with further weight changes. Nutritional counselling may be an effective first-line intervention for malnourished HIV infected patients. More than half of patients gain weight without other nutritional treatment. Whereas the severity of malnutrition is influenced by the underlying disease, fever, and diarrhoea, the course of weight change after nutritional intervention is not. Counselling may reduce the nutritional impact of these risk factors. In patients with low spontaneous intake, efficacy of counselling alone is limited, but it may help to identify those who require more invasive nutritional treatment.

Bronchoalveolar inflammation following airway infection in preterm infants with chronic lung disease.

Chronic lung disease (CLD) of the newborn is associated with pulmonary inflammation. However, the origin of this inflammation is not known. We evaluated the impact of airway infection on bronchoalveolar inflammation in mechanically ventilated preterm infant at risk for CLD (n = 68). Mean and maximum concentrations of the inflammatory mediators (IM) interleukin-1 and interleukin-8 were assayed in the tracheobronchial aspirate fluid (TAF) of neonates with perinatal airway infection (Ureaplasma urealyticum, or bacteria), postnatal nosocomial airway infection, or respiratory disease without airway infection from days 1-10 of postnatal age. Patients with CLD (n = 23;) exhibited increased levels of IM in TAF compared to neonates without CLD. Within the three subgroups, concentrations of IM were increased in CLD patients with perinatal infection and in CLD patients with respiratory disease without airway infection, but not in CLD patients with nosocomial airway infection. Although airway colonization with Gram-negative bacteria was more frequently found in CLD patients within the first month of life, there were no differences between levels of IM in patients colonized with Gram-negative bacteria or coagulase-negative staphyloccoci. We conclude that perinatal infections with Ureaplasma urealyticum or bacteria and respiratory disease without infection, but not nosocomial airway infection, contribute to the bronchopulmonary inflammatory response in neonates with CLD.

Gender related survival in colorectal cancer.

The importance of patient characteristics to long term survival in colorectal carcinoma is the subject of much debate. The importance of female gender as an advantagous factor in prognosis is difficult to determine. A retrospective study based on data from 1050 patients resected for colorectal carcinoma was carried out. A complete follow-up and survival data were available. Categorical variables such as age, sex, tumor stage and location, perioperative blood transfusions, and postoperative complications were used. Standard univariate and multivariate descriptive analysis was applied. In addition to tumor staging patients' sex was a strong significant factor on prognosis. When analysed independently of tumor location, blood transfusions, and severe complications, sex was revealed to be a statistically significant independent prognostic factor in longterm survival. The 5-year survival rate for men was 43.5 % and 54.7 % for women. When the observed survival was compared with sex related life expectancy of a representive population, similar differences of survival were seen for both sexes.

Colorectal carcinoma--aspects of surgery in the elderly.

In accordance with the aging of the German population an increasing number of surgical procedures are performed on patients of advanced age. Perioperative data from 441 patients (223 women, 218 men, mean age 64.1 +/- 11.7 years) undergoing colorectal carcinoma resection 133 were aged 70 years and older, 308 were younger than 70 years-were prospectively recorded. Risk factors were found more frequently in the elderly (hypertonus 49% vs. 34%; coronary artery disease 18% vs. 8%; pulmonary disease 39% vs. 31%, gastrointestinal disease 30% vs. 23%). No differences were found in operative (loss of blood, duration of operation, ventilation) and postoperative parameters (intensive care, hospitalization) neither age dependent nor between elective and emergency surgery. Postoperative complications in electively treated patients, such as pneumonia, wound infection, urinary tract infection, pulmonary complications, and anastomotic leakages were not age dependent. Although cardial complications were recorded five times as often in electively treated elderly patients perioperative mortality was unchanged (0.8% vs. 0.9%). After emergency operations the rate of anastomotic leakage after perforating peritonitis was increased in the elderly (5.5%). In particular, cardial complications during emergency surgery in 50% of the elderly had a causal connection with perioperative mortality that was substantially increased by up to 28.6%.

Liver lectin blocking with D-galactose to prevent hepatic metastases in colorectal carcinoma patients.

Animal experiments in BALB/c-mice and in DBA/2-mice confirmed that lectin blockade with D-galactose containing receptor analogues can inhibit metastatic spread into the liver. The number of liver colonies of inoculated tumor cells was significantly reduced after D-galactose treatment as compared to animals of control group. Based on experimental investigations 193 colorectal carcinoma patients (UICC stages I-III) were enrolled in a prospectively randomized clinical trial. 93 patients were treated perioperatively with D-galactose- (treatment group: 1.5 g/kg body weight and per day) or D-glucose containing electrolyte infusions (control group: n = 100). Significant side effects were not observed. There were no cases of perioperative mortality. The overall complication rate was 7.3%. Since tumor stages were unequally distributed, analysis was performed in strata. Patients were observed for a total of 6237 months. Differences in overall survival and survival free of recurrence and hepatic metastases were negligible for stages I and II. For stage III carcinoma patients (n = 75) analysis of survival free of hepatic metastases revealed a shift to delayed events (i.e. hepatic metastases or death) after D-galactose treatment within 24 months following surgery. In patients with stage III carcinoma there was an indication for an overall benefit in survival after D-galactose treatment (p = 0.102).