Novel growth reference ImaGrow differed from existing charts for preterm children aged 0-2 years.

AIM: This study aimed to address the critical need for more accurate growth reference charts for preterm infants, with a particular focus on low- and very low-birth-weight infants. METHODS: The subjects were recruited at a single tertiary centre. The cohort comprised singleton and twin infants born before 37 weeks of gestation, with data collected from 2000 to 2016. Standardised measurements of body parameters were recorded in this mixed longitudinal survey. LMS method was utilised for data analysis. Statistical analysis was performed using SPSS Statistics Version 21. The validation with another new cohort was executed. RESULTS: A total of 1781 infants (52.5% boys) met the inclusion criteria. The median gestational age at birth was 30 weeks, with a median birth weight of 1350 grams. The main findings included the construction of ImaGrow charts for low- and very low-birth-weight infants and significant differences in growth trajectories compared to Fenton+WHO charts. CONCLUSION: Our comprehensive growth references, ImaGrow, are based on a long-term auxological assessment of preterm infants and differ from charts derived from size-at-birth standards or charts for term babies. These charts have significant implications for clinical practice in monitoring and assessing the growth of preterm infants.

Symptomatic preterm infants suffer from lung function deficits, regardless of bronchopulmonary dysplasia.

BACKGROUND: The long-term respiratory consequences for children with bronchopulmonary dysplasia (BPD) are well known. However, there is little emphasis on monitoring preterm infants without BPD. Few studies have explored the lung function status of infants with the symptoms of chronic lung disease of prematurity (CLD). OBJECTIVE: To evaluate functional lung deficits in preterm infants with CLD, and to assess the perinatal determinants of diminished lung function. METHODS: In our cross-sectional study, 132 preterm infants with symptomatic CLD underwent infant pulmonary function testing (iPFT) at a median post-term age of 0.9 years. The iPFT included bodypletysmography, compliance measurement, tidal breath analysis, and rapid thoracoabdominal compression. The relationships between the respective z scores of the iPFT parameters and perinatal characteristics, postnatal treatment, and BPD status were investigated. RESULTS: Seventy-three patients (55.3%) were born before the 28th week of gestation, and 92 (69.7%) met the BPD criteria. Functional deficits were detected in 85.8%. The obstructive ventilatory pattern was more prevalent than restrictive (36.3 vs. 12.4%, p < 0.001). Infants with restriction had lower birth weight (BW) and required a longer duration of oxygenotherapy. In a univariate model, the lung function correlated with the duration of invasive mechanical ventilation, gestational week, and BW. In a general linear model, BPD status was not an additional determinant of the iPFT results. CONCLUSION: IPFT may reveal significant functional deficits in preterm infants with CLD even without BPD. The current symptoms and perinatal factors may be more important determinants of functional deficits than the BPD status itself.

Kava (Piper methysticum) Extract for the Treatment of Nervous Anxiety, Tension and Restlessness.

AIM: Prior to the kava ban of 2002, the indication for kava (Piper methysticum) extracts defined by the German Commission E was "nervous anxiety, tension and restlessness". In 2000, an observational trial was started in Germany with the aim of defining symptoms of these indications best treated with kava extract. The trial was interrupted and archived "unevaluated" in 2001 due to the upcoming safety debate on kava. The data from this study has now been analyzed in order to identify symptoms best treated with kava. METHODS: Documentation was available from 156 patients. Twelve typical symptoms of nervous anxiety, tension and restlessness were assessed on a five-item rating scale, together with the therapeutic context, the perceived time of onset of effects and the safety of application. RESULTS: The median duration of treatment was 28 days. All individual symptoms showed significant and clinically relevant improvements. The most effective results were seen for nervous tension and restlessness, with better effects in patients with acute versus chronic complaints. The safety of the treatment was found to be excellent, which included the assessment of laboratory data. CONCLUSIONS: Overall, the study confirms the effective and safe short-term use of kava in the Commission E-defined indication of "nervous anxiety, tension and restlessness", especially in other than chronic cases. The clinical use of kava might be translated into context-related phobias according to ICD-10 F40, or to nervous tension (ICD10 R45.0) or restlessness and excitation (ICD-10 R45.1).

Lip creams with propolis special extract GH 2002 0.5% versus aciclovir 5.0% for herpes labialis (vesicular stage) : Randomized, controlled double-blind study.

A lip cream with special propolis extract GH 2002 at a concentration of 0.5% (199 patients) was tested against aciclovir 5% (198 patients) in the treatment of episodes of herpes labialis under double-blind conditions. Upon inclusion, all patients were in the vesicular phase. Application was five times daily of approximately 0.2 g of cream to the entire upper and lower lip. The primary parameter was the difference in time between groups to complete encrustation or epithelization of the lesions. Secondary endpoints were the course of typical herpes symptoms (pain, burning and itching, tension and swelling), the global assessment of efficacy and the safety of application. The predefined clinical situation was reached after a (median) 3 days with propolis and 4 days with aciclovir (p < 0.0001). Significant differences in favor of propolis were also found for all secondary parameters. No allergic reactions, local irritations or other adverse events occurred.

Tolerability and effectiveness of an antitrauma cream with comfrey herb extract in pediatric use with application on intact and on broken skin.

OBJECTIVE: The safety of comfrey herbal cream application to broken skin is still a matter of regulatory debate. It was therefore examined in children with intact and with broken skin treated for blunt traumas and sports injuries, with the aim of collecting data for pharmacovigilance and clinical safety assessments. METHODS: A total of 712 children (386 children with intact skin and 326 children with abrasions and superficial wounds) were openly treated for up to 2 weeks with 1-5 applications daily of comfrey herb cream after presenting for blunt traumas and sports accidents. The incidence rate of adverse events was calculated, next to a global assessment of treatment effects. RESULTS: No adverse events occurred in the group of children with intact skin, and one intolerability reaction (burning and reddening) was observed after application to broken skin. The overall incidence rate of intolerability reactions per patient was calculated as 0.14% (95% CI 0.00-0.78%) and that of systemic adverse effects as 0.00% (95% CI 0.00-0.42%). Accordingly, the probability of the occurrence of local reactions and systemic adverse events is well below, which is one in 100 treated patients. The global assessment of effects corresponded to previously published experience. CONCLUSION: These studies confirm an excellent benefit-to-risk ratio for the application of comfrey herb cream in the treatment of blunt traumas and sports injuries in children with intact and with broken skin.

Comparative Study with a Lip Balm Containing 0.5% Propolis Special Extract GH 2002 versus 5% Aciclovir Cream in Patients with Herpes Labialis in the Papular/Erythematous Stage: A Single-blind, Randomized, Two-arm Study.

BACKGROUND AND OBJECTIVES: This controlled single-blind trial compared the efficacy of a lip balm with propolis special extract GH 2002 at a concentration of 0.5% in the treatment of episodes of herpes labialis with that of 5% aciclovir cream. METHODS: Patients in the erythematous/papular stage were randomized: 189 patients were treated with propolis cream, 190 patients were treated with aciclovir cream (intention-to-treat population). Application was 5 times daily. The primary parameter was the difference in median time to complete encrustation or epithelialization of lesions. Secondary parameters were the development of typical herpes symptoms (eg, pain, burning and itching, tension, and swelling), the global assessment of efficacy, and the safety of application. RESULTS: The predefined clinical situation was reached after a median of 4 days with propolis and after 5 days with aciclovir (P < 0.0001). Significant differences in favor of the study preparation were found with all secondary parameters and symptoms. No allergic reactions, local irritations, or other adverse events were observed. CONCLUSIONS: A formulation of 0.5% propolis GH 2002 extract lip balm was found to be superior in the treatment of episodes of herpes labialis over 5% aciclovir cream in patients in the papular/erythematous phase upon inclusion. EudraCT Registration No. 2006-001971-38.

Treatment of mild and moderate type-2 diabetes: open prospective trial with Hintonia latiflora extract.

BACKGROUND: Extracts from the bark of Hintonia latiflora are used as dietetic measures to support the regulation of glucose metabolism and the stabilization of blood glucose values. METHODS: A dry concentrated extract from the bark of Hintonia latiflora in capsule form was tested in an open, prospective clinical study in 41 dietetically stabilized subjects with type 2 diabetes. The effects on parameters of blood glucose control were documented over a period of six months. RESULTS: Fasting and postprandial glucose and the HbA1c value declined significantly. In the case of HbA1c, this meant a reduction of the absolute value from 7.49 ± 0.72% to 6.82 ± 0.67% (from 58.4 to 51.0 mmol/mol Hb; intention to treat (ITT) population). Furthermore, cholesterol and triglycerides were slightly reduced and no negative effect on other laboratory parameters and no change of the liver values were observed. Tolerance was very good. In particular, no side effects and no hypoglycemic episodes or worsening of diabetic symptoms occurred. CONCLUSIONS: The study confirms the positive effect of extracts from the bark of Hintonia latiflora on blood glucose values suggesting a potential benefit in the management of glucose metabolism in cases of type 2 diabetes. TRIAL REGISTRATION: Reg.-No. ISRCTN83308122.

High positive predictive value of PAPP-A for acute coronary syndrome diagnosis in heparin-naïve patients.

Pregnancy-associated plasma protein-A (PAPP-A) was studied as a marker of acute coronary syndrome (ACS). It has been shown that its levels are increased by heparin administration. Therefore, the aim of our study was to ascertain the diagnostic significance of PAPP-A in heparin-naïve patients and compare it with (TnI). We prospectively studied 67 heparin-naïve patients with acute chest pain. The patients were independently grouped according to the presence or absence of ACS. PAPP-A levels were significantly increased in ACS patients (8.6 vs. 7.3 mIU/l; P = 0.006) with high positive (95.7%) and lower negative predictive values (47.7%). In multivariate analysis, its levels were strongly predictive of a final diagnosis of ACS (OR 41.8; 95th CI 2.64-662.6; P = 0.008). The diagnostic significance of PAPP-A was not higher than TnI even within 6 h after the onset of chest pain [the area under the ROC curve (AUC) was 0.69 for PAPP-A and 0.91 for TnI, respectively; P = 0.08]. We observed no difference in the AUC in NSTE-ACS patients (0.73 for PAPP-A and 0.79 for TnI (P = 0.5)). PAPP-A levels were an independent predictor of ACS diagnosis in heparin-naïve patients. Its diagnostic significance was not higher than TnI even within a short period after the onset of chest pain. In troponin-negative NSTE-ACS patients, PAPP-A helped make the correct final diagnosis.

Arnica/Hydroxyethyl salicylate combination spray for ankle distortion: a four-arm randomised double-blind study.

570 patients with acute ankle joint distortion were randomized to four treatment groups: a combination spray of arnica tincture and hydroxyethyl salicylate (HES; group A, n = 228), arnica (B, n = 57), HES (C, n = 228), and placebo (D, n = 57). The medication was applied 4-5 times daily for 10 days. Efficacy was assessed on day 3-4 by evaluating pain on motion on a visual analogue scale (VAS). Pain improvement in group A was significantly superior over groups B-D (t-test with unadjusted baseline values, P < 4 × 10(-7) and ANCOVA after adjustment, P < 5 × 10(-11)) and approximately corresponded to the cumulative effect of the single constituents (12.1, 7.5, and 18.7 mm VAS for A versus B, A versus C, and A versus D; 95% CI 8.0-16.2, 4.7-10.4, and 14.8-22.5 mm). The combination is justified by the additive effects of the single active constituents.

Influence of concomitant heparin administration on pregnancy-associated plasma protein-A levels in acute coronary syndrome with ST segment elevation.

INTRODUCTION: The time course of pregnancy-associated plasma protein-A (PAPP-A) levels was studied at admission, immediately after percutaneous coronary intervention (PCI) and 1, 2, 4, 6, 12, 24 and 48 h after PCI in acute coronary syndrome with ST segment elevation (ACS-STE) to determine the impact of PCI, concomitant clinical complications and heparin administration. MATERIAL AND METHODS: Pregnancy-associated plasma protein-A serum levels, examined by the Kryptor(TM) system, were studied in 30 heparinized PCI ACS-STE patients, in 10 elective PCIs and 12 coronary angiographies with heparin, and in 5 patients with normal coronary angiogram without heparin. RESULTS: Heparin caused a high PAPP-A increase in ACS-STE patients, in all patients with heparin without ACS and angiographic signs of significant atherosclerosis. This increase was directly associated with heparin dosage and activated clotting time (ACT) (r = 0.71, p = 0.0001) and inversely with the interval between heparin applications and time of serum sampling. It was followed by a rapid decrease within 1 to 2 h and return to normal levels in 10 to 12 h. In ACS-STE patients the decrease was significantly slower than in heparinized elective PCI and angiography patients. The PAPP-A increase was not significantly dependent on the length of PCI. Persistent increase after 24 h was associated in 4/7 patients with concomitant clinical complications. CONCLUSIONS: The diagnostic validity of PAPP-A can be verified only within the 1(st) h after clinical onset of ACS before heparin administration, the prognostic value in heparinized patients not earlier than 12 h after the last heparin application, if ACT is normal and serious clinical concomitant complications are eliminated.

The occurrence and features of the atypical birefringence pattern in scanning laser polarimetry using GD × VCC in healthy children and its impact on the retinal nerve fiber layer thickness values.

PURPOSE: To investigate the occurrence and features of the atypical birefringence pattern (ABP) images in scanning laser polarimetry with variable corneal compensation (GD×VCC) in healthy children and to assess their impact on the values of the retinal nerve fiber layer (RNFL) thickness. METHODS: GD×VCC scans in 120 healthy white school-aged children with mean age ± standard deviation (SD) 12.85 ± 3.0 years were evaluated using typical scan score (TSS) calculation and by subjective grading of the scans. Statistical analysis including the impact of ABP on the RNFL thickness in GD × VCC Temporal-Superior-Nasal-Inferior-Temporal (TSNIT) parameters was done. RESULTS: The ABP was found in 18 out of 120 patients (15%) at cut-off value of TSS <80. Subjective evaluation of the scans raised the frequency of ABP to 20% of patients. The mean ± SD values of TSNIT Average, Superior Average, and Inferior Average in 26 eyes with ABP versus 214 eyes with normal birefringence pattern were 66.99 ± 7.29 µm versus 58.00 ± 6.22 µm (P = 7.2E to -11), 78.43 ± 9.27 µm versus 72.33 ± 8.72 µm (P = 0.001) and 80.87 ± 12.01 µm versus 70.00 ± 10.20 µm (P = 0.000001), respectively. The same comparison in TSNIT SD showed minimal difference and was 25.42 ± 5.84 µm versus 26.41 ± 4.81 µm (P = 0.41). CONCLUSIONS: The occurrence of ABP in children is not rare and may significantly distort the measured values of the RNFL thickness in TSNIT parameters using GD × VCC.

Regulatory T cells and their prognostic value for patients with squamous cell carcinoma of the head and neck.

Regulatory T cells (Treg) are important regulators of anti-cancer immune responses, and an increase in Treg frequency was observed in the blood of cancer patients. Blood samples from 112 patients with head and neck squamous cell carcinoma antigen (HNSCC) were obtained at the time of tumour diagnosis, and lymphocyte subpopulations (CD3(+); CD3(-)CD16(+)CD56(+); CD4(+); CD8(+); CD19(+); CD4(+)CD45RA(+)) with emphasis on Treg counts (CD3(+)CD4(+)CD25(+)), complete blood count and tumour markers (squamous cell carcinoma [SCC]; CEA; alpha-1-antitrypsin [AAT]; Cyfra 21-1; C-reactive protein [CRP]) were analysed. The data were grouped according to TNM classification, and their significance for the course of the disease at an interval of 1 year after the end of the therapy was determined. The percentage of CD8(+) cells increased and the CD/D8 ratio decreased with tumour grade. The ratio of B lymphocytes decreased in patients with locoregional metastases (11.25%versus 9.22%). Treg (15.2%) and CD4(+) cells (45.3%) increased, while NK cells (11.8%) decreased in HNSCC patients compared to controls (9.0%, 38.1% and 15.8%, respectively). The data obtained at time of diagnosis were used to assess the significance of tumour markers (SCC, Cyfra 21-1 and AAT) for evaluation of prognosis. The erythrocyte counts (4.64 x 10(12)/l versus 4.45 x 10(12)/l) and haemoglobin levels (14.58 g/dl versus 14.05 g/dl) decreased, while Treg counts (8.91%versus 15.70%) increased in patients with early recurrence. Our results show that examination of these parameters could be helpful for prognostication in HNSCC patients and aid improvement of treatment strategy.

Is allogeneic blood transfusion a risk factor for sternal dehiscence following cardiac surgery? A prospective observational study.

Sternal dehiscence following cardiac surgery has a multifactorial etiology. Significant risk factors contributing to sternal dehiscence include chronic obstructive pulmonary disease (COPD), obesity, or re-exploration due to bleeding or pericardial tamponade. We have focused on the role of allogeneic blood transfusion as a factor leading to the poor healing of surgical wounds. A prospective observational study of 1553 elective and emergency cardiac surgery patients was performed between January 2003 and June 2007. All of the patients enrolled in this study underwent median sternotomy. We studied the relationship between sternal dehiscence following cardiac surgery and the total number of packed red blood cells transfused. The incidence of sternal dehiscence in the study group was 3.4%. Diabetic patients did not have a higher incidence of wound dehiscence. Although COPD, obesity, and re-exploration contributed to sternal dehiscence, the number of allogeneic blood transfusions during the perioperative period was an important independent risk factor for sternal dehiscence. Patients with sternal dehiscence received an average of 7.6 transfusion units (TU) of allogeneic blood versus 1.6 TU of allogeneic blood in the group without sternal dehiscence (P < 0.00005). The dehiscence affected patients without any other significant risk factor who received 6 or more TU, or patients with at least one significant risk factor who received 4 or more TU of allogeneic blood. According to our results, the total amount of allogeneic blood transfused is an important risk factor contributing to sternal dehiscence. Regardless of other risk preconditions, the transfusion of 6 or more TU could result in sternal dehiscence following cardiac surgery.

Suicidal behavior in children and adolescents: does a history of trauma predict less severe suicidal attempts?

OBJECTIVES: The aim of this study was to identify risk factors and possible predictors of severity of suicidal behavior of children and adolescents. METHODS: Seventy-seven patients (15 boys and 62 girls) aged 15.5+/-1.6 years on average, hospitalized due to a suicidal attempt in the department of pediatric psychiatry, were examined. Structured interviews with patients and their parents were used to clinically assess circumstances of suicidal behavior, relevant risk factors and severity of suicidal behavior. RESULTS: The results indicated that patients with any previous traumatic experience tended to have somatically less severe suicidal attempts (p=0.050). Intensity of suicidal intent was associated with a history of depression (p=0.014) and anxiety disorders (p=0.004), and the current stress from a mental disorder (p=0.014). Somatic severity of suicidal behavior was significantly associated with intensity of suicidal intent (p=0.014). A history of any trauma (previous traumatic experience predicted less severe suicidal behavior, p=0.053) and the current stress from sexual problems (p=0.067) were identified as predictors of somatic severity of suicidality. These two predictors showed only a trend level of significance. The only significant predictor of intensity of suicidal intent was the current stress from a mental illness (p=0.017). CONCLUSIONS: Several risk factors of somatic severity of suicidal behavior and intensity of suicidal intent were described. The most important finding of the study was the association between a history of psychological trauma and a tendency to have less somatically severe suicidal behavior.

Retinal nerve fiber layer assessment in healthy children using scanning laser polarimetry with variable corneal compensation.

PURPOSE: To assess the normative data of the retinal nerve fiber layer (RNFL) thickness in healthy children using the scanning laser polarimeter with variable corneal compensation (GDxVCC). METHODS: Of the 186 enrolled white school-aged children, 120 subjects of the mean 12.85 +/- 3.0 years (age +/- SD) fulfilled inclusion criteria. After complete ophthalmic examination, including GDxVCC, 240 normal eyes were analyzed. Evaluation of RNFL thickness in GDxVCC temporal-superior-nasal-inferior-temporal (TSNIT) parameters was performed, and probability of normality was calculated. The influence of sex and age was investigated. RESULTS: The mean +/- SD values in TSNIT Average, Superior Average, Inferior Average, and TSNIT SD were 58.98 +/- 6.92 microm, 72.99 +/- 8.97 microm, 71.18 +/- 10.92 microm, and 26.30 +/- 4.92 microm. The values of 5% probability of normality in the same order were 47.6 microm, 58.2 microm, 53.2 microm, and 18.2 microm. The mean values of Inferior Average and TSNIT SD were greater in left eyes by 1.84 +/- 6.6 microm (p = 0.003) and by 3.04 +/- 3.8 microm (p < 0.00005), respectively. No correlation to sex and age was found. CONCLUSIONS: RNFL thickness assessed using GDxVCC was greater in children compared with previous published data in healthy adults. The values of Inferior Average and TSNIT SD were significantly greater in left eyes.

Area under the maximum expiratory flow-volume curve--a sensitive parameter in the evaluation of airway patency.

BACKGROUND: The most frequently used parameters for assessing bronchoconstriction and bronchodilation are forced expiratory volume in 1 s (FEV(1)) and peak expiratory flow (PEF). OBJECTIVES: To assess the sensitivity of other parameters after induced bronchoconstriction and bronchodilation. METHODS: From maximum expiratory flow-volume (MEFV) curves, forced vital capacity, FEV(1), PEF, maximum expiratory flows (MEF) at 25, 50 and 75% of vital capacity and the area under the MEFV curve (A(ex)) were measured in two groups of asthmatic children after induced bronchoconstriction and bronchodilation, and in children with cystic fibrosis (CF) after bronchodilation. RESULTS: In 142 asthmatics without airway obstruction, bronchoconstriction was induced by inhalation of 1% histamine aerosol. The 20% fall in A(ex) compared to baseline was found in all asthmatics, while the 20 and 15% falls in FEV(1) were noted in 36 and 65% of the patients, respectively. Other parameters were less sensitive or interpretation was problematic. Another 110 asthmatics with mild-moderate airway obstruction were treated with various bronchodilators. The 20% increase in A(ex) was observed in all asthmatics, while the 20% increase in FEV(1) was found in only 33% of the patients and the 15% increase in FEV(1) in 51%. In 9 CF children, the pattern of changes in A(ex) and FEV(1) after bronchodilation was similar to that in asthmatics. CONCLUSIONS: A(ex) was a sensitive and less problematic parameter in the evaluation of airway patency in comparison with FEV(1) and other parameters measured from the MEFV curve in our study patients.

Regression of left-ventricular hypertrophy in children and adolescents with hypertension during ramipril monotherapy.

BACKGROUND: Left-ventricular hypertrophy (LVH) is a risk factor for cardiovascular morbidity. Antihypertensive treatment with angiotensin-converting enzyme inhibitors (ACEI) is able to induce the regression of LVH in adults. However, there has been no study of the ability of ACEI to induce the regression of LVH in children. Our aim was to investigate the effect of ramipril on left-ventricular mass and blood pressure (BP) in hypertensive children. METHODS: Twenty-one children (median age, 15 years) with renal (76%) or primary (24%) hypertension were prospectively treated with ramipril monotherapy for 6 months. Blood pressure was evaluated using ambulatory BP monitoring, with hypertension defined as mean BP >or=95th percentile. Left-ventricular hypertrophy was defined either as left-ventricular mass index (LVMI) >38.6 g/m(2.7) (pediatric definition) or as LVMI >51.0 g/m(2.7) (adult definition). RESULTS: Nineteen children completed the study. The median LVMI decreased from 36.8 g/m(2.7) (range, 18.9 to 55.8 g/m(2.7)) to 32.6 g/m(2.7) (range, 19.0 to 52.1 g/m(2.7); P < .05) after 6 months. The prevalence of LVH decreased from 42% to 11% using the pediatric definition (P < .05) and did not change using the adult definition (ie, it remained at 5%). The median ambulatory BP decreased by 11, 7, 8, and 7 mm Hg for daytime systolic, daytime diastolic, nighttime systolic, and nighttime diastolic BP (P < .05), respectively. A positive correlation was found between LVMI and nighttime systolic BP at the start of the study (r = 0.46, P < .05). CONCLUSIONS: Ramipril is an effective drug in children with hypertension, for its ability to reduce not only BP but also left-ventricular mass and induce regression of LVH.

Protein microarray analysis as a tool for monitoring cellular autoreactivity in type 1 diabetes patients and their relatives.

BACKGROUND: Autoreactive T cells have a crucial role in type 1 diabetes (T1D) pathogenesis. OBJECTIVES: The aim of our study was to monitor the in vitro production of cytokines by peripheral blood mononuclear cells (PBMCs) after stimulation with diabetogenic autoantigens. SUBJECTS: Ten T1D patients (tested at the time of diagnosis and 6 and 12 months later), 10 first-degree relatives of the T1D patients, and 10 controls underwent the study. METHODS: PBMCs were stimulated with glutamic acid decarboxylase 65 (GAD65) amino acids (a.a.) 247-279, 509-528, and 524-543; proinsulin a.a. 9-23; and tyrosine phosphatase (islet antigen-2)/R2 a.a. 853-872. Interleukin (IL)-2, IL-4, IL-5, IL-6, IL-10, IL-13, interferon (IFN)-gamma, tumor necrosis factor beta, transforming growth factor beta1, and granulocyte colony-stimulating factor (GCSF) were analyzed by protein microarray. RESULTS: Differences in cytokine(s) poststimulatory and mainly in basal production were observed in all groups. The most prominent findings were in controls, the higher basal levels of IL-2, IL-4, IL-5, IL-13, and GCSF were observed when compared with relatives (p < 0.05, for all). After stimulation in controls, there was a significant decrease in IL-2, IL-13, GCSF, and IFN-gamma (p < 0.05, for all). The group of relatives was the most variable in poststimulatory production. A strong correlation between cytokines production was found but groups differed in this aspect. CONCLUSION: By multiplex analysis, it may be possible, for example, to define the risk immunological response pattern among relatives or to monitor the immune response in patients on immune modulation therapy.

Comparison of 18F-FDG-PET and standard procedures for the pretreatment staging of children and adolescents with Hodgkin's disease.

PURPOSE: The aim of this study was to perform a prospective, blinded comparison of( 18)F-fluorodeoxyglucose positron emission tomography (FDG-PET) and conventional staging methods (CSMs) for initial staging of children and adolescents with Hodgkin's disease (HD). METHODS: Over a period of 4 years, 55 children and adolescents with HD (mean age 15.5 years, range 3.9-18.9 years) were prospectively recruited into the study. They underwent 61 FDG-PET studies using a dedicated whole-body PET scanner as a part of their initial staging work-up. PET findings were correlated with the results of CSMs, including computed tomography (CT), ultrasound, bone scanning and bone marrow examination. Discordant findings were resolved by magnetic resonance imaging or clinical follow-up (range 2-47 months). RESULTS: PET correctly changed the staging in 15% of patients (seven upstagings, two downstagings). Only two out of 61 patients (3%) were not accurately staged by PET; in these children, PET missed small lymphoma nodules detected on lung CT. The sensitivity of PET and CSMs for pretreatment staging was 96.5% and 87.5%, respectively; specificity was 100% and 60%, and accuracy, 96.7% and 85.2%, respectively. Upon combination of FDG-PET and lung CT, the diagnostic accuracy reached 100% in our series. CONCLUSION: Our study showed that whole-body FDG-PET is an efficient and useful method for the initial staging of children with HD. FDG-PET in combination with lung CT should be recommended as a screening method prior to other conventional imaging modalities to plan a rational staging protocol. Large multicentre prospective studies are necessary to verify this conclusion.

Topical symphytum herb concentrate cream against myalgia: a randomized controlled double-blind clinical study.

The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (P<5 x 10 -9 ), pain at rest (P<.001), and pain on palpation (P=5 x 10 -5 ) was significantly more pronounced than that attained with the reference product and was clinically highly relevant. A number needed to treat of 3.2 was calculated from the study results. Global efficacy was significantly better (P=1 x 10 -8 ) and onset of effects was faster (P=4 x 10 -7 ) with the high-concentration product. Tolerability of the highly concentrated study product was good to excellent in all patients. Study results confirm the known anti-inflammatory and analgesic effects of topical (Symphytum cream. As a new finding, applicability in certain forms of back pain can be concluded.