1.
Intravenous magnesium sulfate for the management of severe hand, foot, and mouth disease with autonomic nervous system dysregulation in Vietnamese children: study protocol for a randomized controlled trial.
Qui, PT, Khanh, TH, Trieu, HT, Giang, PT, Bich, NN, Thoa, le PK, Nhan, le NT, Sabanathan, S, Van Doorn, R, Toan, ND, et al
Trials. 2016;:98
Abstract
BACKGROUND Over the last 15 years, hand, foot, and mouth disease (HFMD) has emerged as a major public health burden across the Asia-Pacific region. A small proportion of HFMD patients, typically those infected with enterovirus 71 (EV71), develop brainstem encephalitis with autonomic nervous system (ANS) dysregulation and may progress rapidly to cardiopulmonary failure and death. Although milrinone has been reported to control hypertension and support myocardial function in two small studies, in practice, a number of children still deteriorate despite this treatment. Magnesium sulfate (MgSO4) is a cheap, safe, and readily available medication that is effective in managing tetanus-associated ANS dysregulation and has shown promise when used empirically in EV71-confirmed severe HFMD cases. METHODS/DESIGN We describe the protocol for a randomized, placebo-controlled, double-blind trial of intravenous MgSO4 in Vietnamese children diagnosed clinically with HFMD plus ANS dysregulation with systemic hypertension. A loading dose of MgSO4 or identical placebo is given over 20 min followed by a maintenance infusion for 72 h according to response, aiming for Mg levels two to three times the normal level in the treatment arm. The primary endpoint is a composite of disease progression within 72 h defined as follows: development of pre-specified blood pressure criteria necessitating the addition of milrinone, the need for ventilation, shock, or death. Secondary endpoints comprise these parameters singly, plus other clinical endpoints including the following: requirement for other inotropic agents; duration of hospitalization; presence of neurological sequelae at discharge in survivors; and neurodevelopmental status assessed 6 months after discharge. The number and severity of adverse events observed in the two treatment arms will also be compared. Based on preliminary data from a case series, and allowing for some losses, 190 patients (95 in each arm) will allow detection of a 50 % reduction in disease progression with 90 % power at a two-sided 5 % significance level. DISCUSSION Given the large numbers of HFMD cases currently being seen in hospitals in Asia, if MgSO4 is shown to be effective in controlling ANS dysregulation and preventing severe HFMD complications, this finding would be important to pediatric care throughout the region. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01940250 (Registered 22 August 2013).
2.
New onset vasomotor symptoms but not musculoskeletal symptoms associate with clinical outcomes on extended adjuvant letrozole - Analyses from NCIC CTG MA.17.
Liedke, PE, Tu, D, Shepherd, L, Chavarri-Guerra, Y, Pritchard, KI, Stearns, V, Goss, PE
Breast (Edinburgh, Scotland). 2016;:99-104
Abstract
PURPOSE New onset symptoms on adjuvant aromatase inhibitors for hormone receptor positive early breast cancer may associate with clinical outcomes. We performed this exploratory analysis of the association of new onset musculoskeletal (MSK) and vasomotor (VM) symptoms with clinical outcomes in the NCIC CTG MA.17 trial 5 years of extended adjuvant endocrine therapy with letrozole after tamoxifen. METHODS Symptoms were collected at baseline, 1, 6, and every 12 months on study. Multivariate Cox Models adjusting for age, nodal status, duration of tamoxifen and prior chemotherapy were used to compare disease-free survival (DFS), distant disease-free survival (DDFS), and overall survival (OS) based on data collected before, and after, the unblinding between women with VM or MSK symptoms and those without. RESULTS Data post-unblinding showed new VM symptoms on extended letrozole significantly improved DFS and DDFS when occurring 1 month (DFS HR 0.52, 95% CI, 0.28-0.96; p = 0.04; DDFS HR 0.49, 95% CI, 0.24-0.99; p = 0.046) and 6 months (DFS HR 0.43, 95% CI, 0.24-0.78; p = 0.006; DDFS HR 0.44, 95% CI, 0.22-0.85; p = 0.02) after treatment initiation. Those with new VM symptoms at 12 months also had a significantly better DFS (HR 0.47, 95% CI 0.26, 0.84; P = 0.01) and a trend in improved DDFS. Only a trend to improved OS was found for those with VM symptoms 6 month after treatment. No significant improvement was found for those with new MSK symptoms at any time point or for any endpoint. CONCLUSIONS New onset VM symptoms with extended letrozole may be useful in predicting treatment benefit.
3.
[Differential approach to the combined correction of adaptive capabilities in patients with psychovegetative syndrome].
El'chininov, NV
Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury. 2008;(5):14-7
Abstract
Differential approach to the correction of functional state in young subjects with psychovegetative syndrome, simpatico-tonic vegetative tone, and hypersympatico-tonic vascular reactivity is described. It involves the use of combined treatment including physical factors (a constant magnetic field and negatively polarized phytoaeroions), soft-tissue manual therapy, and dosed physical exercises. This approach made it possible to influence different aspects of adaptive functional self-regulation of the organism, energo-informative homeostasis, sympatic-parasympatic balance, and mechanisms controlling cerebral circulation, cardiovascular, psycho-emotional, cognitive and physical activities.
4.
Real-time sonography for screening of gallbladder motility in diabetic patients: relation to autonomic and peripheral neuropathy.
Kayacetin, E, Kisakol, G, Kaya, A, Akpinar, Z
Neuro endocrinology letters. 2003;(1-2):73-6
Abstract
OBJECTIVES Diabetes mellitus is known as one of the factors causing the cholesterol gallstone. Gallstone incidence is about 30% in diabetic patients over 20 years of age. Pathophysiology is still not clear. The aim of the present study was to investigate gallbladder (GB) functions in diabetic patients and determine its relationship with peripheral and autonomic neuropathy. DESIGN Study was performed between October 2001 and may 2002 in fifty-one diabetic patients of similar age and weight. Diabetic patients (n=51) were chosen randomly among diabetic patients, who were being followed in Diabetes Out-patient clinics of Selcuk University, Meram Medical Faculty. Twenty-eight control subjects were chosen from healthy volunteers. We measured fasting and post-prandial gallbladder volumes and ejection fractions by real-time ultrasonography. The patients were divided into three groups; group A (n=18) had no diabetic autonomic and peripheral neuropathy, group B (n=13) had diabetic peripheral neuropathy, group C (n=13) had diabetic autonomic neuropathy. RESULTS No significant difference in any biochemical parameters between diabetic and control group could be found. Fasting gallbladder volume was significantly higher in the diabetic group (5.31 +/- 0.28 cm(3)) compared to control group (4.19 +/- 0.25 cm(3), p<0.01). But there was no difference within diabetic subgroups. Gallbladder ejection fraction was significantly reduced in diabetic patients in groups B and C (29.7 +/- 1.43%, 28.7 +/- 1.28%) compared to group A (44.8 +/- 2.4%; p<0.05, p<0.025 respectively). CONCLUSIONS Cholesterol crystal formation as a result of increased gallbladder volume and decreased ejection fraction in diabetic patients may result from hypotonicity and stasis and thus this may lead to gallstones.