scholarly journals Addendum to Iwai and Hoberman (2014)—Reassessment of Developmental Toxicity of PFHxA in Mice

2019 ◽  
Vol 38 (3) ◽  
pp. 183-191 ◽  
Author(s):  
Hiroyuki Iwai ◽  
Alan M. Hoberman ◽  
Philip E. Goodrum ◽  
Emma Mendelsohn ◽  
Janet K. Anderson
Keyword(s):  
Adverse Effects ◽  
Developmental Toxicity ◽  
Statistical Significance ◽  
Incidence Rates ◽  
Original Study ◽  
Control Group ◽  
Analysis And Evaluation ◽  
Developmental Effects ◽  
Group Information ◽  
Low Incidence

This article presents a supplemental data analysis and evaluation of the findings from an oral (gavage) combined developmental and perinatal/postnatal reproduction toxicity study of the ammonium salt of perfluorohexanoic acid (CASRN: 21615-47-4) in Crl: CD-1(ICR) mice. The original study has been cited as supporting a lowest-observed-adverse-effects level of 175 mg/kg/d and no-observed-adverse-effects level of 35 mg/kg/d for developmental effects from perfluorohexanoic acid (PFHxA, CASRN: 307-24-4) in mice. The statistical analysis reported in 2014 was accurate in terms of quantifying statistical significance within phase 2 of the study. However, given the low incidence of findings, the purpose of this article is to extend the analysis and interpretation of findings by pooling the control group information from both phases of the same study, comparing the study findings to the incidence rates for stillbirths and postpartum viability for this species and strain of mouse observed for similar studies conducted by the same laboratory, and evaluating data on the incidence and range of spontaneous eye abnormalities reported in the literature. Based on this supplemental evaluation, the original study supports a NOAEL of 175 mg/kg/d for PFHxA in mice, which is a factor of 5-fold higher than previously reported. Furthermore, to the extent that this study may be considered in the selection of a point of departure for PFHxA in mice, it is noted that 175 mg/kg/d for maternal exposure is an unbounded NOAEL for developmental effects, meaning that the study did not establish a dose at which developmental effects may occur.

Escitalopram in Treatment of Sleep Disturbances in Major Depressive Disorder

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
N. Zivkovic ◽  
G. Djokic ◽  
D. Pavicevic ◽  
V. Ilic
Keyword(s):  
Major Depressive Disorder ◽  
Adverse Effects ◽  
Depressive Disorder ◽  
Sleep Disturbances ◽  
Rating Scale ◽  
Statistical Significance ◽  
Control Group ◽  
Major Depressive ◽  
High Statistical Significance ◽  
Experimental Group

Major depressive disorder (MDD) is common and severe affective disorder with sleep disturbances and non-bizarre delusions which are organized in permanent and unshakeable delusional system. Neurobiological basis of MDD is still completely unknown, but significant role has serotoninergic and noradrenergic neuronal systems. Escitalopram is highly potent and highly selective serotonin re-uptake inhibitor.Purpose of this study was to estimate efficacy of the escitalopram in treatment of sleep disturbances in MDD.Methods:This prospective clinical study included 95 patients diagnosed by ICD-10 criteria for MDD, who are randomly divided into control (30 patients) and experimental group (65 patients). Patients were observed for 6 months in hospital and outpatients conditions, according to specially designed protocol, which included Hamilton Depression Rating Scale (HAMD) and Leeds Sleeping Evaluation Questionnaire (LSEQ). Control group was treated with maprotiline (75-150 mg/24h) and experimental group with escitalopram (10-20 mg/24h).Results:Escitalopram therapy influenced on HAMD score with high statistical significance vs. maprotiline, p=0.000. Escitalopram therapy improves LSEQ score after 6 months in comparison to maprotiline therapy with high statistical significance p=0.000. Percentage of adverse effects is significantly lower in escitalopram (10.76%) than in maprotiline (26.67%) group.Conclusion:Escitalopram has significantly better efficacy and lower adverse effects rate in treatment of depressive symptoms and sleep disturbances in MDD patients comparing to maprotiline.

Effect of Salvia Miltiorrhiza Polyphenolic Acid Combined with Salvia Miltiorrhiza Ligustrazine Injection on Cognitive Function in Patients with Cerebral Infarction

2021 ◽  
Vol 7 (5) ◽  
pp. 2998-3002
Author(s):  
Hua Wei ◽  
Qi Tang ◽  
MinHua Kuang ◽  
HaiRong Cai ◽  
Jiajian Peng ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Cerebral Infarction ◽  
Salvia Miltiorrhiza ◽  
Statistical Significance ◽  
Incidence Rates ◽  
Plasma Viscosity ◽  
Control Group ◽  
Observation Group ◽  
Group 2 ◽  
Blood Pressure Fluctuation

Objective: To investigate the effect of salvia miltiorrhiza polyphenolic acid combined with salvia miltiorrhiza ligustrazine injection on cognitive function in patients with cerebral infarction. Methods: 60 patients with cerebral infarction from December 2017 to December 2019 were randomly divided into control group (n = 30) and observation group (n = 30) by random number table method. The control group was treated with salvia miltiorrhiza ligustrazine injection, and the observation group was treated with salvia miltiorrhiza polyphenolic acid on the basis of the control group. After 4-week treatment, the effect of the patients was evaluated, and the hemorheological level, cognitive function and drug safety of the two groups were compared. Results: The levels of high blood and low shear viscosity, high whole blood and plasma viscosity in the observation group were lower than those in the control group 4 weeks after treatment (P<0.05); the cognitive function scores in the observation group were higher than those in the control group 2 and 4 weeks after treatment (P<0.05); the incidence rates of liver and kidney function damage, mild diarrhea, dizziness and somnolence, nausea and vomiting, and blood pressure fluctuation in the treatment of the two groups had no statistical significance (P>0.05). Conclusion: The combination of salvia miltiorrhiza polyphenolic acid and salvia miltiorrhiza ligustrazine injection can improve the hemorheology of patients with cerebral infarction. It is helpful to improve the cognitive function of patients. The drug is safe and worthy of being popularized.

Visual hallucinations in Gentington's disease: ophthalmic validation of ‘North-East Visual Hallucinations Interview

2021 ◽  
pp. 26-31
Author(s):  
S. N. Svetozarsky ◽  
S. V. Kopishinskaya ◽  
M. A. Korotysh ◽  
I. A. Velichko ◽  
D. A. Smirnova
Keyword(s):  
Statistical Significance ◽  
Control Group ◽  
Type Ii ◽  
Type Ii Error ◽  
Visual Hallucinations ◽  
North East ◽  
The North ◽  
Small Group Size ◽  
Low Incidence ◽  
Adequate Method

Huntington's disease (HD) is a steadily progressive neurodegenerative disease caused by a mutation in the huntingtin gene, with progressive motor, cognitive and mental impairments.The aim of the study is to determine the validity of the North‑East Visual Hallucinations Interview (NEVHI) in a Russian sample of patients.Materials and methods. 78 subjects were examined: 26 patients at the manifest stage of HD, 21 pre‑manifest carriers of the HD gene and 31 volunteers of the control group.Results. The low incidence of visual hallucinations according to the NEVHI does not allow us to conclude about their specificity for HD. Failure to achieve the level of statistical significance in this case suggests a high risk of type II error associated with the low occurrence of the symptom and the relatively small group size.Conclusion. The study showed that the NEVHI questionnaire can serve as an adequate method for the diagnosis of visual hallucinations in HD.

Risperidone and olanzapine in treatment of delusional disorders

2011 ◽  
Vol 26 (S2) ◽  
pp. 1301-1301 ◽  
Author(s):  
N. Zivkovic ◽  
B. Bajovic ◽  
G. Djokic ◽  
D. Pavicevic ◽  
M. Nenadovic
Keyword(s):  
Adverse Effects ◽  
Statistical Difference ◽  
Psychotic Disorders ◽  
Statistical Significance ◽  
Control Group ◽  
High Statistical Significance ◽  
Delusional System ◽  
Scale Control

Delusional disorders are severe psychotic disorders with characteristic non-bizarre delusions often organized in permanent delusional system.AimTo estimate efficacy of risperidone and olanzapine in treatment of DD.Methods135 patients with DD were divided into Haloperidol-control (41), Risperidone (49) and Olanzapine group (45 patients). Patients were observed for 6 months according to protocol, which included PANSS Scale and CGI1-4 Scale. Control group was treated with haloperidol 5–30 mg/24 h. Experimental groups were treated with risperidone 2–6 mg/24 h and olanzapine 10–20 mg/24 h.ResultsPretrial PANSS score was 57.28 in risperidone(R), 60.47 in olanzapine(O) and 58.45 in control(H) group. PANSS score after 180 days was 34.32 in R, 35.58 in O and 37.97 in H group. There was no statistical difference in pretrial scores for PANSS (p = 0.691), CGI1 (p = 0.733), CGI2 (p = 1.000), and CGI3 (p = 1.000) scores. There was statistical significance in PANSS and CGI1-4 score reduction after 180 days in all groups (p = 0.000). There was no statistical difference in PANSS score reduction between R and H (p = 0.114) and O and H group (p = 0.136). CGI1-4 scores reduction: CGI1, Rvs.H, p = 0.019 and Ovs.H, p = 0.032 with high statistical significance; CGI2, Rvs.H, p = 0.153 and Ovs.H, p = 0.179 with no statistical significance; CGI3, Rvs.H, p = 0.183 and Ovs.H, p = 0.161 with no statistical significance; CGI4, Rvs.H, p = 0.000 and Ovs.H, p = 0.000 with high statistical significance. Adverse effects were significantly lower in Risperidone (21.42%) and Olanzapine (21.81%) than in Haloperidol (57.5%) group.ConclusionRisperidone and Olanzapine have slightly better efficacy in treatment of DD comparing to haloperidol, with statisticaly significant lower adverse effects rate.

TBE in Italy

2020 ◽  
Keyword(s):  
Surveillance System ◽  
Ad Hoc ◽  
National Level ◽  
Case Series ◽  
Incidence Rates ◽  
Mountainous Regions ◽  
North East ◽  
The North ◽  
Tick Borne Encephalitis ◽  
Low Incidence

Italy is considered a low-incidence country for tick-borne encephalitis (TBE) in Europe.1 Areas at higher risk for TBE in Italy are geographically clustered in the forested and mountainous regions and provinces in the north east part of the country, as suggested by TBE case series published over the last decade.2-5 A national enhanced surveillance system for TBE has been established since 2017.6 Before this, information on the occurrence of TBE cases at the national level in Italy was lacking. Both incidence rates and the geographical distribution of the disease were mostly inferred from endemic areas where surveillance was already in place, ad hoc studies and international literature.1

Correlation of Metabolic Risk Factors with Sessile Serrated Lesions

2020 ◽  
Vol 29 (2) ◽  
pp. 175-179
Author(s):  
Melania Macarie ◽  
Simona Bataga ◽  
Simona Mocan ◽  
Monica Pantea ◽  
Razvan Opaschi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Statistical Significance ◽  
Interval Cancer ◽  
Metabolic Risk Factors ◽  
Control Group ◽  
Anatomical Site ◽  
Metabolic Risk ◽  
Right Colon ◽  
Serrated Lesions ◽  
The Right

Background and Aims: The importance of sessile serrated lesions (SSLs) in the pathogenesis of colorectal carcinoma has been recently established. These are supposed to cause the so-called “interval cancer”, having a rapidly progressive growth and being difficult to detect and to obtain an endoscopic complete resection. We aimed to establish the most important metabolic risk factors for sessile serrated lesions. Methods: We performed a retrospective case-control study, on a series of 2918 consecutive patients who underwent colonoscopy in Gastroenterology and Endoscopy Unit, County Clinical Emergency Hospital, Târgu-Mureș, Romania between 1 st of January 2015-31 th of December 2017. In order to evaluate the metabolic risk factors for polyps’ development, enrolled participants were stratified in two groups, a study group, 33 patients with SSLs lesions, and a control group, 138 patients with adenomatous polyps, selected by systematic sampling for age and anatomical site. Independent variables investigated were: gender, smoking, alcohol consumption, obesity, arterial hypertension, diabetes, hypercholesterolemia, hypertriglyceridemia, hyperuricemia, nonalcoholic liver disease. Results: For SSLs the most common encountered localization was the right colon in 30.55% of cases. By comparative bivariate analysis between SSLs group and control group, it was observed that hypertension (p=0.03, OR 2.33, 95 %CI 1.03-5.24), obesity (p=0.03, OR 2.61, 95 %CI 1.08-6.30), hyperuricemia (p=0.04, OR 2.72, 95 %CI 1.28-7.55), high cholesterol (p=0.002, OR 3.42; 95 %CI 1.48-7.87), and high triglycerides level (p=0.0006, OR 5.75; 95 %CI 1.92-17.2) were statistically associated with SSLs development. By multivariate analysis hypertension and hypertriglyceridemia retained statistical significance. Conclusions: Our study showed that the highest prevalence of SSLs was in the right colon and hypertension and increased triglycerides levels were associated with the risk of SSLs development. These risk factors are easy to detect in clinical practice and may help identifying groups with high risk for colorectal cancer, where screening is recommended.

Сочетанные генотипы генов, кодирующих белки холецистокининергической системы и ферменты фолатного цикла в значительной степени связаны с мигренью

2020 ◽  
Author(s):  
J.E. Azimova ◽  
E.A. Klimov ◽  
E.A. Naumova ◽  
Z.G. Kokaeva ◽  
A.I. Zaitseva ◽  
...  
Keyword(s):  
Population Control ◽  
Statistical Significance ◽  
Episodic Migraine ◽  
Protective Role ◽  
Control Group ◽  
Maoa Gene ◽  
Specific Pcr ◽  
Genotype Frequencies ◽  
Biochemical Systems ◽  
Combined Genotypes

Перспективным в изучении биомаркеров мигрени может быть многолокусный анализ, в частности, анализ частот сочетанных генотипов. Цель исследования - поиск составных генетических биомаркеров индивидуальной предрасположенности к мигрени, полученных на основе полиморфизмов генов, уже показавших статистическую значимость при однолокусном ассоциативном анализе. Методика. Обследовано 155 пациентов с мигренью (104 пациента с эпизодической мигренью, 51 - с хронической мигренью), наблюдавшихся в Университетской клинике головной боли (Москва). Все пациенты - представители белой расы, жители Московского региона. Возраст пациентов - 30-50 лет. Контроль составили 365 необследованных лиц (популяционный контроль). Выявление исследуемых 22 генов (всего 31 SNP) осуществляли методом ПЦР, ПЦР-ПДРФ, аллель-специфичной ПЦР и ПЦР в реальном времени. Выявление ассоциированных с мигренью сочетанных генотипов проводили с использованием программы анализа полигенных данных APSampler v3.6. Результаты. Выявлено 8 сочетанных генотипов с высокой статистически значимой ассоциацией с мигренью (ОШ>20,0). В состав сочетанных генотипов вошли гены: CCKAR, CCKBR, COMT, MTHFR, MTR, MTRR. Так же выявлено 4 защитных сочетанных генотипа (ОШ<0,02), основным в которых является ген MAOA. Заключение. Полученные данные об ассоциированных с мигренью сочетанных генотипах указывают на значимую роль в патогенезе заболевания 2 биохимических систем: 1) холецистокининергической системы, регулирующей выброс и обратный захват дофамина, и 2) фолатного цикла, в ходе работы которого гомоцистеин метаболизируется в метионин. Результаты, полученные в данном исследовании, позволяют говорить о защитной роли аллеля VNT:R4 гена MAOA.Multilocus analysis, specifically, analysis of combined genotype frequencies may be promising in studying migraine biomarkers. The aim of the study was to search for composite genetic biomarkers, which would predict individual predisposition to migraine, obtained on the basis of gene polymorphisms that have already shown a statistical significance in a single-locus associative analysis. Methods. 155 patients with migraine aging 41.7 ± 12.5 who had been followed up at the University Clinic of Headache, Moscow, were evaluated (104 patients with episodic migraine and 51 with chronic migraine). All patients were white and residents of the Moscow region. The control group included 365 unexamined individuals (population control). Identification of The 22 genes under study (total, 31 SNPs) were identified by PCR, PCR-RFLP, allele-specific PCR, and real-time PCR. Combined genotypes associated with migraine were identified using the APSampler v3.6 software for polygenic data analysis. Results. Eight combined genotypes were identified with a highly significant association with migraine (OR> 20.0). The combined genotypes included the CCKAR, CCKBR, COMT, MTHFR, MTR, and MTRR genes. Four protective combined genotypes were also identified (OS <0.02) with the MAOA gene as the major one. Conclusion. Our data on migraine-associated combined genotypes indicate a significant role in the migraine pathogenesis of two biochemical systems, i) the cholecystokininergic system that regulates the release and reuptake of dopamine, and ii) the folate cycle, where homocysteine is metabolized to methionine. The results obtained in this study suggest a protective role of the VNT: R4 allele of the MAOA gene.

Risk of Depression in Adolescents and Young Adults with Rheumatic Diseases

2020 ◽  
Vol 62 (1) ◽  
pp. 38-42
Author(s):  
Anna Kostiukow ◽  
Wojciech Strzelecki ◽  
Mateusz W. Romanowski ◽  
Marta Rosołek ◽  
Ewa Mojs ◽  
...  
Keyword(s):  
Young Adults ◽  
Young People ◽  
Rheumatic Diseases ◽  
Disease Risk ◽  
Statistical Significance ◽  
Energy Levels ◽  
Young Patients ◽  
Depression Scale ◽  
Adolescents And Young Adults ◽  
Control Group

Introduction: The study is aimed at drawing the attention of the medical environment to the mental health aspects of young patients as a factor that significantly influences the efficiency of their rheumatic disease treatment. Aim: This paper is to check the risk of depression among a group of adolescents and young adults with rheumatic diseases. Material and Methods: The study was conducted among a group of 68 late adolescents and young adults (18-22 years old) with rheumatic diseases. The control group consisted of 102 young people (18-22 years old) without a diagnosed chronic disease. Risk of depression was measured using a screening tool – the Kutcher Adolescent Depression Scale (KADS). Results: The analysis showed that the probability of depression in the study group was 35.3%. In the control group, this rate was 19.6%. The results were statistical significance (p=0.028). Conclusions: The results of this study prove that the risk of depression among adolescents and young adults with rheumatic diseases is significantly higher than in healthy young people. The highest risk of depression is related to feeling tired, fatigue, low energy levels and lack of motivation as well as feeling worried, nervous, panicky, tense, keyed-up and anxious.

Clinical Study of Qingpeng Ointment Treatment of Shoulder-Hand Syndrome After Cerebral Hemorrhage During the Rehabilitation Period

2020 ◽  
Vol 23 ◽  
Author(s):  
Ruihuan Pan ◽  
Shanshan Ling ◽  
Haodong Yang ◽  
Yan Huang ◽  
Lechang Zhan ◽  
...  
Keyword(s):  
Treatment Group ◽  
Cerebral Hemorrhage ◽  
Clinical Medicine ◽  
External Rotation ◽  
Statistical Significance ◽  
Hand Function ◽  
Tibetan Medicine ◽  
Controlled Study ◽  
Control Group ◽  
The Difference

Background: Shoulder-hand syndrome (SHS) refers to a syndrome causing sudden edema, shoulder pain and limited hand function. Qingpeng ointment, a kind of Tibetan medicine, can reduce swelling, relieve pain, tonify stagnation and clear the meridians, which is consistent with the pathological mechanism of SHS after stroke. Therefore, if clinical trials can be used to explore the effectiveness of Qingpeng ointment for treatment of poststroke SHS and promote its application in clinical medicine, this is of specific significance for the treatment of poststroke SHS. Objective: To investigate the clinical efficacy and safety of Qingpeng ointment in the treatment of poststroke SHS. To provide an objective basis for a better therapeutic treatment for poststroke SHS． Method: A prospective, randomized, controlled study was conducted. This study recruited 120 patients with poststroke SHS who met the inclusion criteria. They were randomized into the treatment group and the control group, with 60 patients allocated to each group. The treatment group received routine medical treatment and rehabilitative care after using the Qingpeng ointment, while the patients in the control group received only routine treatment without the ointment. All patients received clinical assessment with the Visual Analogue Scale (VAS), measurement of the range of motion (ROM) of the upper-limb joints, the Fugl-Meyer Assessment of Upper Extremity (FMA-U) and the Modified Barthel Index Score (MBI) before and after the whole treatment. Results: After 4 weeks of treatment, the VAS scores of both groups were decreased significantly (P＜0.05), and the difference between the two groups was statistically significant (P < 0.05). There is no statistical significance for the difference between the treatment group and control group in terms of the FMA-U and MBI scores and the forward bend, backward, outstretch, external rotation and pronation angles after treatment. The increases in the values of VAS, FMA-M and MBI in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). The increases in the values of the forward bend, outreach and external rotation angles in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). Conclusion: The treatment group showed better results than the control group in terms of the relief of pain symptoms, the improvement of motor function and the improvement of the activities of daily living for patients with shoulder-hand syndrome after cerebral hemorrhage. Qingpeng ointment is effective and safe in treating poststroke SHS.

P0203EARLY DETECTION OF BREAST ARTERIAL CALCIFICATION IN DIFFERENT STAGES OF CHRONIC KIDNEY DISEASE PATIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Basma Sultan ◽  
Hamdy Omar ◽  
Housseini Ahmed ◽  
Mahmoud Elprince ◽  
Osama Anter adly ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Lipid Profile ◽  
Statistical Significance ◽  
University Hospital ◽  
Arterial Calcification ◽  
Control Group ◽  
Inpatient Ward ◽  
Stage 4 ◽  
Ckd Stage

Abstract Background and Aims Vascular calcification (VC) plays a major role in cardiovascular disease (CVD), which is one of the main causes of mortality in patients with chronic kidney disease (CKD). The study aims at early detection of breast arterial calcification (BAC) in different stages of CKD (stage 2, 3& 4) patients as an indicator of systemic VC. Method A case control study was conducted targeting CKD women, aged 18- 60 years old. The sample was divided into 3 groups; A,B,C (representing stage 2, 3 & 4 of CKD) from women who attended nephrology and Internal medicine clinics and admitted in inpatient ward in Suez Canal University Hospital. A 4th group (D) was formed as a control group and included women with normal kidney functions (each group (A, B, C, D) include 22 women). The selected participants were subjected to history taking, mammogram to detect BAC and biochemical assessment of lipid profile, Serum creatinine (Cr), Mg, P, Ca, PTH and FGF23. Results Our study detected presence of BAC in about 81.8% of hypertensive stage 4 CKD patients compared with 50% in stage 3 CKD, also in the majority of stage 4 CKD patients who had abnormal lipid profile parameters and electrolyte disturbance. Most of the variables had statistical significance regarding the presence of BAC. Conclusion Although it is difficult to determine the definite stage at which the risk of VC begins but in our study, it began late in stage 2 CKD, gradually increased prevalence through stage 3 and became significantly higher in stage 4. These results suggest that preventive strategies may need to begin as early as stage 2 CKD.

Sign in / Sign up

Export Citation Format

Share Document