Social support and its association with depression, gender and socioeconomic indicators in individuals with spinal cord injury in Iran.

STUDY DESIGN: Descriptive cross-sectional study. OBJECTIVES: To investigate the relationship between perceived social support and depression and to evaluate the role of family, friends and other caregivers in the perception of social support in Iranian individuals with spinal cord injury (SCI). SETTING: Brain and Spinal Cord Injury Research Center, Tehran University of Medical Sciences, Tehran, Iran. METHODS: Social support was evaluated using the Multidimensional Scale of Perceived Social Support questionnaire, which gauges perceptions of support from family, friends and 'important persons'. The presence and severity of depression were assessed with the Beck Depression Inventory (BDI-II-PERSIAN)-a 21-item multiple-choice questionnaire. RESULTS: A total of 140 individuals with SCI were enrolled in the study. The average age of the participants was 29.4±7.9 years; the mean duration of injury was 46.3±46.5 months and most patients were male (72%). Social support and all subscales of social support were numerically greater in males; however, this difference was not statistically significant. The subcategory of friends' support in men was 17.9±7.9 compared to 14.6±8.0 in women (P=0.04). The self-reported social support score (r=-0.387, P<0.001) and subscales of social support, including family (r=-0.174, P=0.045), friends (r=-0.356, P<0.001) and important persons (r=-0.373, P<0.001), were all negatively correlated with depression. CONCLUSION: Higher self-reported perception of social support appears to be associated with lower levels of depression in individuals with SCI. SCI care providers should consider the relationship between social support and depression in their continuing care.

Association of pain, social support and socioeconomic indicators in patients with spinal cord injury in Iran.

STUDY DESIGN: Descriptive cross-sectional study. OBJECTIVES: Pain is a prevalent complication of individuals with spinal cord injury (SCI). Our objective was to examine the association between social support, socioeconomic factors and psychosocial factors and pain to develop more effective management strategies. SETTING: Brain and Spinal Cord Injury Research (BASIR) Center, Tehran University of Medical Sciences, Tehran, Iran. METHODS: The Persian version of the Brief Pain Inventory was used to measure the pain, and the Multidimensional Scale of Perceived Social Support was used to measure social support through structured face-to-face interviews in SCI individuals. RESULTS: The overall prevalence of pain was 50.7%; 79.3% of individuals had bilateral pain, with lower limbs and back being the most common location. The quality of pain was described as aching (41.4%), tingling (32.9%), pressure (15.7%), coldness (5.7%) and feeling electric shock sensations (4.3%). The frequency of pain in individuals with paraplegia (60.9% vs 45.7%) and incomplete (53.5% vs 52.5%) SCI was higher than with other types of neurological injuries. Patients with a medium level of education had the least pain and those with good economic situation reported higher frequency of having pain (P=0.034). There was no significant relationship between pain and social support. There was a positive correlation between pain and impairment of mood, normal work, relations with other people and lack of sleep (P<0.001). CONCLUSION: These novel findings will inform the development of strategies to manage pain by improving access to health-care facilities and supplies.

The effect of preexisting hypertension on early neurologic results of patients with an acute spinal cord injury.

STUDY DESIGN: Retrospective case-control. OBJECTIVES: To characterize changes in American Spinal Injury Association Motor Score (AMS) in patients treated with relative hypertension (HTN) (mean arterial pressure (MAP) > 85 mm Hg for 5 days) with and without preexisting HTN. SETTING: A regional spinal cord injury (SCI) center in Pennsylvania, United States. METHODS: All patients with an acute SCI who were treated with induced HTN (MAP goal above 85) in the intensive care unit (ICU) for at least 5 days were identified. Patients were stratified based on the presence of preexisting HTN, and the change in the AMS between admission and day 5 was determined. Predictors of outcome were identified using correlation analysis and multiple linear regression. RESULTS: Ninety-two patients met inclusion criteria of which 22 had a previous history of HTN. HTN was a predictor of poor early outcome. Patients with HTN had an average decline in their AMS of 7.6, compared with an average decrease of only 0.6 in the AMS of patients without HTN (P=0.04). HTN had no effect (P>0.05) on other in-hospital variables including length of stay, length of stay in the ICU, complications or mortality. Additionally, multiple linear regression analysis demonstrated that diabetes, coronary artery disease and pulmonary disease had no effect on the change in AMS. CONCLUSION: Chronic HTN is an independent risk factor for poor early neurologic recovery in patients treated with relative HTN for an acute SCI. This is independent of age and other comorbidities.

International Spinal Cord Injury: Spinal Interventions and Surgical Procedures Basic Data set.

STUDY DESIGN: Survey of expert opinion, feedback and final consensus. OBJECTIVE: To describe the development and the variables included in the International Spinal Cord Injury (SCI) Spinal Interventions and Surgical Procedures Basic Data set. SETTING: International working group. METHODS: A committee of experts was established to select and define data elements. The data set was then disseminated to the appropriate committees and organizations for comments. All suggested revisions were considered and both the International Spinal Cord Society and the American Spinal Injury Association endorsed the final version. RESULTS: The data set consists of nine variables: (1) Intervention/Procedure Date and start time (2) Non-surgical bed rest and external immobilization, (3) Spinal intervention-closed manipulation and/or reduction of spinal elements, (4) Surgical procedure-approach, (5) Date and time of the completion of the intervention or surgical closure; (6) Surgical procedure-open reduction, (7) Surgical procedure-direct decompression of neural elements, and (8 and 9) Surgical procedure-stabilization and fusion (spinal segment number and level). All variables are coded using numbers or characters. Each spinal intervention and procedure is coded (variables 1 through 7) and the spinal segment level is described (variables 8 and 9). Sample clinical cases were developed to illustrate how to complete it. CONCLUSION: The International SCI Spinal Interventions and Surgical Procedures Basic Data Set was developed to facilitate comparisons of spinal interventions and surgical procedures among studies, centers and countries.

Mesenteric root pseudocyst: finding in an asymptomatic patient-a case report.

BACKGROUND: Mesenteric cysts are one of the rarest abdominal tumor masses, representing a little-studied pathology. In turn, the variability and non-specificity of clinical manifestations make diagnosis difficult, as it can be reached by imaging findings due to another cause or by non-specific abdominal pain. CASE PRESENTATION: This article describes the case report of an asymptomatic 28-year-old patient who presented a 6-cm abdominal cystic mass with mixed density, which was found incidentally by computed tomography. Exploratory laparoscopy was performed followed by conversion to conventional surgery to extract the tumor mass. The anatomical pathology diagnosis was pseudocyst of the mesentery root. Mesenteric cysts are one of the rarest abdominal tumor masses, representing a little-studied pathology. In turn, the variability and non-specificity of clinical manifestations make diagnosis difficult, as it can be reached by imaging findings due to another cause or by non-specific abdominal pain. CONCLUSIONS: Mesenteric cysts are rare, and their nonspecific symptoms often lead to diagnosis based on imaging findings. Complete laparoscopic enucleation is the standard treatment.

Pharmacology of levosimendan: inotropic, vasodilatory and cardioprotective effects.

WHAT IS KNOWN AND OBJECTIVE: Positive inotropic agents are frequently used in acute decompensated heart failure (ADHF) due to left ventricular systolic dysfunction. These agents are known to improve cardiac performance and peripheral perfusion in the short-term treatment. However, several preclinical and clinical studies emphasized detrimental effects of these drugs on myocardial oxygen demand and on sympathetic tone entailing arrhythmogenesis. Levosimendan is an inotropic agent with an original mechanism of action. This review focuses on major data available for levosimendan. METHODS: A literature search was conducted in the PubMed database by including studies published in English using combinations of the following key words, levosimendan, inotropic drugs and acute heart failure. Furthermore, bibliographies of selected references were also evaluated for relevant articles. The collection for this review was limited to the most recently available human and animal data. RESULTS AND DISCUSSION: Levosimendan's vasodilatory and cardioprotective effects are mediated by calcium sensitization of contractile proteins and opening of adenosine triphosphate (ATP)-dependent K+ channels in vascular smooth muscle cells and on mitochondrial ATP-sensitive potassium [mito.K(ATP)] channels. This inotropic agent has mild PDE inhibitory action. Unlike other inotropic agents, levosimendan improves cardiac performance without activating the sympathetic nervous system. Moreover, there are evidences that levosimendan has additional anti-inflammatory and anti-apoptotic properties that prevent cardiac toxicity and contributes to positive hemodynamic response of the drug. Four randomized trials evaluated the effects of levosimendan on mortality in patients with acute decompensated chronic heart failure; nevertheless, a clear benefit has not been demonstrated so far. Although levosimendan is indicated for the treatment of ADHF (class of recommendation IIa, level of evidence B), it is has not been approved in all countries. WHAT IS NEW AND CONCLUSION: This review summarizes the characteristics and the current knowledge of the literature on levosimendan and its active metabolite OR-1896.

Perceived stress and self-rated health of Haitian and African Americans with and without Type 2 diabetes.

BACKGROUND: Blacks have a higher incidence of diabetes and its related complications. Self-rated health (SRH) and perceived stress indicators are associated with chronic diseases. The aim of this study was to examine the associations between SRH, perceived stress and diabetes status among two Black ethnicities. MATERIALS AND METHODS: The cross-sectional study included 258 Haitian Americans and 249 African Americans with (n = 240) and without type 2 diabetes (n = 267) (n = 507). Recruitment was performed by community outreach. RESULTS: Haitian-Americans were less likely to report 'fair to poor' health as compared to African Americans [OR = 0.58 (95% CI: 0.35, 0.95), P = 0.032]; yet, Haitian Americans had greater perceived stress than African Americans (P = 0.002). Having diabetes was associated with 'fair to poor' SRH [OR = 3.14 (95% CI: 2.09, 4.72), P < 0.001] but not perceived stress (P = 0.072). Haitian-Americans (P = 0.023), females (P = 0.003) and those participants having 'poor or fair' SRH (P < 0.001) were positively associated with perceived stress (Nagelkerke R(2) = 0.151). CONCLUSION: Perceived stress associated with 'poor or fair' SRH suggests that screening for perceived stress should be considered part of routine medical care; albeit, further studies are required to confirm our results. The findings support the need for treatment plans that are patient-centered and culturally relevant and that address psychosocial issues.

SARS-CoV-2 infection in adult liver transplantation recipients: a systematic review of risk factors for mortality and immunosuppression role.

OBJECTIVE: Data on mortality, immunosuppression, and vaccination role regarding liver transplant (LT) recipients affected by COVID-19 are still under debate. This study aims to identify risk factors for mortality and the role of immunosuppression in COVID-19 LT recipients. MATERIALS AND METHODS: A systematic review of SARS-CoV-2 infection in LT recipients was performed. The primary outcomes were risk factors for mortality, the role of immunosuppression and vaccination. A meta-analysis was not performed as there was a different metric of the same outcome (mortality) and a lack of a control group in most studies. RESULTS: Overall, 1,343 LT recipients of 1,810 SOT were included, and data on mortality were available for 1,110 liver transplant recipients with SARS-CoV-2 infection. Mortality ranged between 0-37%. Risk factors of mortality were age >60 years, Mofetil (MMF) use, extra-hepatic solid tumour, Charlson Comorbidity Index, male sex, dyspnoea at diagnosis, higher baseline serum creatinine, congestive heart failure, chronic lung disease, chronic kidney disease, diabetes, BMI >30. Only 51% of 233 LT patients presented a positive response after vaccination, and older age (>65y) and MMF use were associated with lower antibodies. Tacrolimus (TAC) was identified as a protective factor for mortality. CONCLUSIONS: Liver transplant patients present additional risk factors of mortality related to immunosuppression. Immunosuppression role in the progression to severe infection and mortality may correlate with different drugs. Moreover, fully vaccinated patients have a lower risk of developing severe COVID-19. The present research suggests safely using TAC and reducing MMF use during the COVID-19 pandemic.

Factors associated with the development of pressure ulcers after spinal cord injury.

STUDY DESIGN: Cross-sectional observational study. OBJECTIVES: To examine variables associated with the development of pressure ulcers in subjects with spinal cord injury (SCI). SETTING: SCI patients under coverage of the State Welfare Organization of Iran. METHODS: Mobile rehabilitation teams gathered data from 20 of the 30 provinces in Iran. There were 8104 SCI patients registered in the database; 7489 patients were included in the analysis. The prevalence of PU in patients aged <10 years was lower than those aged >10; therefore, we used different logistic models for these groups. Likewise, separate models were created for patients who had experienced SCI during the past year versus patients injured >1 year before the evaluation. RESULTS: PU was present in 34.6% of the patients. The variables associated with PU in patients aged <10 years were female gender and the time passed since SCI. In patients aged >11 years, male gender, the time passed since SCI, lower level of education, lack of an intimate partner, quadriplegia and older age presented a significant association with PU. Patients for whom <1 year has passed since SCI, male gender, quadriplegia and older age were associated with PU. And patients for whom >1 year had passed since SCI, male gender, quadriplegia, older age, lower level of education and lack of an intimate partner were associated with PU. CONCLUSION: SCI patients are a heterogeneous group and the risk factors associated with PU may vary in specific subgroups. Different models are needed to describe PU in SCI patients depending on the patient's age and the time passed since SCI.

International spinal cord injury spinal column injury basic data set.

STUDY DESIGN: Survey of expert opinion, feedback and final consensus. OBJECTIVES: To describe the development of the International Spinal Cord Injury (SCI) Spinal Column Injury Basic Data Set. SETTING: International working group. METHODS: A committee of experts was established to select and define data elements. The data set was then disseminated to the appropriate committees and organizations for comment. All suggested revisions were considered and the final version was endorsed by both the International Spinal Cord Society (ISCoS) and the American Spinal Injury Association (ASIA). RESULTS: The data set consists of seven variables: (1) penetrating or blunt injury, (2) spinal column injury(ies), (3) single or multiple level spinal column injury(ies), (4) spinal column injury level number, (5) spinal column injury level, (6) disc and/or posterior ligamentous complex injury and (7) traumatic translation. All variables are coded using numbers or characters. For variables 1, 2, 3, 4, 6 and 7, response categories are assigned a numeric point score. Variable 5 assigns both characters and numbers to identify level(s) of spinal injured vertebra(e). When there are several distinct and separate levels of injury, then each one is described using variables 4 through 7. CONCLUSION: The International SCI Spinal Column Injury Basic Data Set was developed to facilitate comparisons of spinal column injury data among studies, centres and countries. This data set is part of the National Institute of Neurological Disorders and Stroke Common Data Element project, and tools are now available to assist investigators in collecting this data in their SCI clinical studies.

A systematic review of the evidence supporting a role for vasopressor support in acute SCI.

STUDY DESIGN: A systematic review of clinical and preclinical literature. OBJECTIVE: To critically evaluate the evidence supporting a role for vasopressor support in the management of acute spinal cord injury and to provide updated recommendations regarding the appropriate clinical application of this therapeutic modality. BACKGROUND: Only few clinical studies exist examining the role of arterial pressure and vasopressors in the context of spinal cord trauma. METHODS: Medical literature was searched from the earlier available date to July 2009 and 32 articles (animal and human literature) answering the following four questions were studied: what patient groups benefit from vasopressor support, which is the optimal hypertensive drug regimen, which is the optimal duration of the treatment and which is the optimal arterial blood pressure. Outcome measures used were the incidence of patients needing vasopressors, the increase of arterial blood pressure and neurologic improvement. RESULTS: Patients with complete cervical cord injuries required vasopressors more frequently than either incomplete injuries or thoracic/lumbar cord injuries (P<0.001). There was no statistical difference in neurologic improvement between patients on vasopressor support with a mean arterial pressure (MAP) of less than 85 mm Hg and those with MAP less than 90 mm Hg. Duration of treatment is often recommended between 5 and 7 days although this is not supported by high-level evidence and no single vasopressor appeared superior over the variety used in clinical treatment. CONCLUSION: There is currently no gold standard on vasopressor support. Based on non-randomized human studies, complete cervical cord injuries require vasopressors more frequently than other spinal cord injuries.

Burden of spinal cord injury in Tehran, Iran.

STUDY DESIGN: Investigation of burden of traumatic spinal cord injury (SCI) using disease modeling. OBJECTIVES: The present paper is intended to estimate the SCI burden for the year 2008. SETTING: Tehran, capital of Iran. METHODS: Epidemiological data needed to calculate Disability-Adjusted Life-Years (DALYs) for SCI, was estimated according to prevalence, duration and relative risk of mortality using DISMOD software. For DALY calculation, the years of life lost because of premature mortality (YLL) was added to the number of years lost because of disability (YLD). To calculate DALYs for SCI, first year DALY calculated separately and for the next years, the DALY was assessed for six different clinical presentations of traumatic SCI including quadriplegia, quadriparesis, paraplegia, paraparesis, hemiplegia and hemiparesis. RESULTS: In first year following SCI, the DALY was 3772 years, which has 0.5 DALY per 1000 people and YLL/DALY was 89.3%. Following the first year, the DALY was 435 for quadriplegia, 163 for quadriparesis, 868 for paraplegia, 164 for paraparesis, 26 for hemiplegia and 14 for hemiparesis. The total YLL for traumatic SCI was 4077 years and total YLD was 1364 years (total YLL/DALY was 74.9%) and total DALY was 5441 years, (M/F=2.0), which has 0.7 DALY per 1000 people in Tehran in 2008. CONCLUSIONS: This study showed a high burden for SCI. Identifying the risk factors of SCI, and performing cost-effective preventive interventions for reducing burden of SCI is recommended.

Biogenic habitat shifts under long-term ocean acidification show nonlinear community responses and unbalanced functions of associated invertebrates.

Experiments have shown that increasing dissolved CO2 concentrations (i.e. Ocean Acidification, OA) in marine ecosystems may act as nutrient for primary producers (e.g. fleshy algae) or a stressor for calcifying species (e.g., coralline algae, corals, molluscs). For the first time, rapid habitat dominance shifts and altered competitive replacement from a reef-forming to a non-reef-forming biogenic habitat were documented over one-year exposure to low pH/high CO2 through a transplant experiment off Vulcano Island CO2 seeps (NE Sicily, Italy). Ocean acidification decreased vermetid reefs complexity via a reduction in the reef-building species density, boosted canopy macroalgae and led to changes in composition, structure and functional diversity of the associated benthic assemblages. OA effects on invertebrate richness and abundance were nonlinear, being maximal at intermediate complexity levels of vermetid reefs and canopy forming algae. Abundance of higher order consumers (e.g. carnivores, suspension feeders) decreased under elevated CO2 levels. Herbivores were non-linearly related to OA conditions, with increasing competitive release only of minor intertidal grazers (e.g. amphipods) under elevated CO2 levels. Our results support the dual role of CO2 (as a stressor and as a resource) in disrupting the state of rocky shore communities, and raise specific concerns about the future of intertidal reef ecosystem under increasing CO2 emissions. We contribute to inform predictions of the complex and nonlinear community effects of OA on biogenic habitats, but at the same time encourage the use of multiple natural CO2 gradients in providing quantitative data on changing community responses to long-term CO2 exposure.

Spinal injuries after falls from hunting tree stands.

BACKGROUND CONTEXT: Spinal injuries are common sequelae of falls from hunting tree stands. Significant neurological injury is not uncommon and can result in significant morbidity as well as enormous expenditure of health care dollars. Recent literature on the subject is limited. PURPOSE: The purpose of this study was to identify precipitating causes, characterize the spectrum of spinal injury, and determine potential interventional safety and prevention recommendations. STUDY DESIGN: A retrospective study. METHODS: Medical record review of 22 patients admitted either directly or via referral to a level I spinal cord injury referral center over a 10-year period (1995-2005) after a fall from a hunting tree stand. RESULTS: All patients were men with a mean age of 46 years (range, 27-80 years). Initial acute care hospitalization averaged 10 days (range, 2-28 days). The average height of fall was 18 feet (range, 10-30 feet). Four of 19 falls (21%) occurred during the morning hours, 2 of 19 falls occurred during the afternoon, and 13 of 19 falls (68%) occurred during the evening hours. Time lapse from injury to presentation to an emergency department ranged from 30 minutes to 14 hours. Alcohol use was a factor in 2 of 20 falls (10%). Hypothermia complicated 3 of 21 cases (14%). Associated injuries were present in 12 of 21 patients (57%) and included fractures to the axial and appendicular skeleton, pneumothoraces, a retroperitoneal bleed, and a brachial plexopathy. Eight of 22 patients (37%) sustained injury to the cervical spine. Five of these 8 patients (63%) had neurological deficits (3 complete and 2 incomplete spinal cord injuries). Thirteen of 22 (59%) patients sustained injury to the thoracic or lumbar spine. Ten of these 13 (77%) had neurologic deficits (3 complete and 7 incomplete). Nine of 22 (41%) patients were treated nonoperatively; the remaining 13 (59%) underwent operative intervention. CONCLUSIONS: Falls from hunting tree stands remain a significant cause of spinal injury and subsequent disability. The best intervention for these injuries is prevention. There is a continued need for hunter safety education to reduce the incidence of these injuries with emphasis on safety harness usage, proper installation and annual inspection of tree stands, hunting in groups with periodic contact, the use of communication devices, and abstinence from alcohol consumption while hunting.

Surgeon equipoise as an inclusion criterion for the evaluation of nonoperative versus operative treatment of thoracolumbar spinal injuries.

BACKGROUND CONTEXT: Prospective studies have failed to demonstrate the superiority of either operative or nonoperative treatment of thoracolumbar fractures. Similar to other surgical fields, research has been limited by the variability in surgical interventions, difficult recruitment, infrequent pathology, and the urgency of interventions. PURPOSE: To outline factors precluding randomized controlled trials in spinal fractures research, and describe a novel methodology that seeks to improve on the design of observational studies. STUDY DESIGN/SETTING: A preliminary report describing an observational study design with clinical equipoise as an inclusion criterion. The proposed methodology is a cohort study with head-to-head comparison of operative and nonoperative treatment regimens in an expertise-based trial fashion. Patients are selected retrospectively by an expert panel and clinical outcomes are assessed to compare competing treatment regimens. Surgeon equipoise served as an inclusion criterion. PATIENT SAMPLE: Patients with closed or open thoracolumbar spinal fracture with or without neurological impairment, presenting to one of two different trauma centers between 1991 and 2005 (N = 760). OUTCOME MEASURES: Homogeneity of baseline clinical and demographic data and distribution of prognostic risk factors between the operative and the nonoperative cohort. METHODS: Patients treated for spine fractures at two University hospitals practicing opposing methods of fracture intervention were identified by medical diagnosis code searches (n = 760). A panel of spine treatment experts, blinded to the treatment received clinically has assessed each case retrospectively. Patients were included in the study when there was disagreement on the preferred treatment, that is, operative or nonoperative treatment of the injury. Baseline and initial data of a study evaluating nonoperative versus operative spinal fracture treatment are presented. RESULTS: One hundred and ninety patients were included in the study accounting for a panel discordance rate of 29%. The distribution of baseline characteristics and demographics of the study populations were equal across the parallel cohorts enrolled in the study, that is, no differences in prognostic factors were observed. CONCLUSIONS: The use of clinical equipoise as an inclusion criterion in comparative studies may be used to avoid selection bias. Using multivariate analysis of retrospectively assembled parallel cohorts, a valid comparison of operative and nonoperative spine fracture treatment strategies and their outcomes is possible.

Exophytic intramedullary meningioma of the cervical spinal cord.

Intramedullary spinal cord neoplasms are relatively uncommon. The most common intramedullary tumors are astrocytomas and ependymomas. Meningiomas can occur as an intradural tumor; however, they are typically in the extramedullary compartment. A 42-year-old male presented with progressive sensory loss in the upper extremities and lower extremity weakness. Pre-operative imaging suggested an intramedullary cervical lesion. To treat the progressive neurological abnormality, surgical resection was planned. At surgery, it was noted that the tumor originated in the cervical spinal cord and extended into the extramedullary region. Histology confirmed the lesion to be a meningioma. This meningioma variant has not previously been described. Spinal meningiomas may occur in locations other than intradural, extramedullary locations, and should be included in the differential diagnosis of intramedullary lesions. Intramedullary meningiomas can be successfully treated with surgery.

Effects on free radicals and inhibition of alpha-amylase of Cardamine battagliae (Cruciferae), an apoendemic Calabrian (southern Italy) plant.

The present study showed for the first time the biological properties of different fractions from Cardamine battagliae Cesca & Peruzzi, an apoendemic Calabrian (southern Italy) plant that belongs to the Cruciferae family. The antioxidant activities of the different fractions of C. battagliae were carried out using two different in vitro assays (beta-carotene bleaching test and lipid peroxidation of liposomes assay) while radical scavenging activity was carried out using DPPH test. AcOEt fraction showed the highest activity on DPPH inhibition (IC50 of 0.162 mg mL(-1)) while dichloromethane fraction showed the highest activity on beta-carotene bleaching (IC(50) of 0.004 mg mL(-1)). The assay for alpha-amylase inhibition showed that n-hexane fraction showed the highest activity with an IC50 of 0.055 mg mL(-1).

Clinical effects of erdosteine in the treatment of acute respiratory tract diseases in children.

Erdosteine has positive effects on mucus rheology and transport due to the active metabolite (Metabolite I) which contains a free thiol group. Erdosteine inhibits bacterial adhesiveness and has antioxidant properties. A synergistic effect of erdosteine with various antibiotics has been demonstrated in pharmacological and clinical studies. The present study was multicenter, randomized, double-blind and placebo-controlled. The aims of the study were to compare a combination of erdosteine with amoxicillin against an amoxicillin-placebo combination in pediatric patients with acute lower respiratory tract disease. A total of 158 patients (78 in the erdosteine group and 80 in the placebo group) were treated for 7 +/- 2 days. The efficacy parameters were cough (primary), polypnea, rhonchi, rales and body temperature (all measured at baseline, on Day 3 and at the end of treatment). Safety was assessed by strictly monitoring the occurrence of adverse events and using standard laboratory parameters. The results of the intention-to-treat analysis showed that the severity of cough was decreased by 47% at Day 3 in the erdosteine group with a statistically significant difference compared to placebo, the difference was still significant at the final visit. The decrease in the severity of rales was significantly greater at Day 3 in the erdosteine group than in the placebo group. The incidence of polypnea and rhonchi in the two groups showed similar decreases, an improvement mainly due to the antibiotic. No adverse events occurred and no adverse changes in laboratory parameters were observed. It is concluded that the combination of erdosteine and amoxicillin is a safe medication which is clinically superior to that of the antibiotic combined with placebo, especially in regard to the effects on cough.