Family processes and structure: Longitudinal influences on adolescent disruptive and internalizing behaviors.

Objective: The present study revisits the assumption in American culture, based in "family privilege," that children fare better in two-parent households by longitudinally examining associations between family structure, process, and adolescent behavior. Background: Societal assumptions and cross-sectional research suggest that there is a difference in child adjustment across varying family structures. Relatedly, the family process literature emphasizes the importance of parent-child relationship quality in addition to family structure on child adjustment. Method: We utilized a longitudinal, prospective design that assessed family structures on nine occasions covering a 12-year period beginning when the target child was 2 years of age for a large (N = 714), ethnically and racially diverse sample of low-income families. We examined the relation between self-reported, teacher-reported, and primary caregiver-reported adolescent disruptive and internalizing problem behavior across family structures and parent-child relationship quality. Results: Across seven identified family structures, adolescent behavior did not differ after accounting for middle-childhood adjustment and relevant contextual factors. However, consistent with family process models of child adjustment, positive parent-child relationship quality predicted lower rates of adolescent maladaptive behavior. Conclusion: These findings serve to combat stigma related to family structures that deviate from married parents raising their children and highlight the need for interventions designed to foster positive parent-child relationships. Implications: Policy makers and practitioners should aim to support efforts to foster positive parent-child relationships across types of family structures and refrain from promoting or discouraging the formations of specific family structure types.

Current Status of Phytoseiid Mites as Biological Control Agents in Latin America and Experiences from Argentina Using Neoseiulus californicus.

Phytoseiidae is a large family of Mesostigmata mites. Members of this family are important biological control agents across the world since they are well-known natural enemies of phytophagous arthropods on cultivated and non-cultivated plants, mainly used to control pest spider mites. However, some can control thrips in greenhouses and fields. Several studies reporting on species in Latin America have been published. The most extensive studies were conducted in Brazil. Phytoseiid mites have been used in different biological control approaches, with two successful classical biological control programs: the biocontrol of the cassava green mite using Typhlodromalus aripo (Deleon) in Africa and the citrus and avocado mites by Euseius stipulatus (Athias-Henriot) in California. Efforts in using phytoseiid mites to enforce biological control of different phytophagous mites are being made in Latin America. Till now, only a few successful examples are available on this topic. This fact highlights the need to continue the investigations on the ability of other unknown species to be used in biological control through close collaboration between researchers and biocontrol companies. Various challenges remain, such as developing better rearing systems to provide a large number of predators to farmers in various crop systems, training farmers to improve their understanding of the use of predators, and chemical control aimed at conservation biological control, looking forward to increasing the use of the phytoseiid mites as biological control agents in Latin America and the Caribbean.

Perceived Stress, Religiosity, and Substance Use Among African American and Latinx College Students with Asthma in the USA.

This study examined associations among perceived stress, religiosity, and substance use in African American and Latinx college students with asthma. Participants included 194 college students with asthma (18-20 years, 63.4% African American, 21.1% Latinx). Eligible students completed an online questionnaire that included measures of asthma control, perceived stress, religiosity, alcohol misuse, and last 30-day tobacco use and marijuana use. Over one-quarter (25.3%) of participants reported using tobacco and 31.9% reported using marijuana in the past 30 days. Perceived stress and religiosity were each independently associated with multiple indicators of substance use. Asthma control moderated associations between religiosity and tobacco use in the past 30 days (b = - .014, p = .002), such that the association between religiosity and tobacco use was stronger among those with better asthma control. Participant gender significantly moderated the association between perceived stress and alcohol misuse (b = - .099, p = .029); a stronger, positive association between stress and alcohol misuse was found among men. Students' perceived stress levels were associated with marijuana use in the past 30 days and high alcohol misuse. Religiosity was inversely linked to substance use. There is a need for healthcare providers to recognize and focus on substance use prevention specifically among African American and Latinx college students with asthma.

The COVID-19 pandemic: asthma control, tobacco use, and mental health among African American and Latinx college students.

OBJECTIVE: This study investigated the impact of COVID-19 on tobacco use and mental health in US African American and Latinx college students with asthma. Associations among asthma control, tobacco use, and mental health were also examined. METHODS: 105 African American and Latinx college students with asthma (18-23 years) completed two online questionnaires (June 2019-March 2020 for Time 1; August 2020-October 2020 for Time 2). Participants completed the Epidemic-Pandemic Impacts Inventory (measure of COVID-19 impact), Asthma Control Test, Generalized Anxiety Disorder scale, Patient Health Questionnaire (measure of depression), Perceived Stress Scale, and items related to tobacco use. RESULTS: Asthma control improved (t = -3.326, p = 0.001) from Time 1 to 2, and e-vapor product use decreased (χ2104 = 6.572, p = 0.010). COVID-19 impact was positively associated with students' symptoms of anxiety, depression, and perceived stress (B = 0.201, p < 0.001; B = 0.179, p < 0.001; and B = 0.199, p = 0.001, respectively) at Time 2. These results remained significant with the Benjamini-Hochberg correction. Asthma control at Time 1 was negatively associated with anxiety symptoms at Time 2 (B = -0.418, p = 0.023); however, associations with perceived stress (B = -0.514, p = 0.019) and all other tobacco product use (B = -0.233, p = 0.030) did not remain significant with the Benjamini-Hochberg correction. CONCLUSIONS: As hypothesized, a higher COVID-19 impact score was associated with students endorsing more mental health symptoms. Better control of asthma symptoms before the pandemic predicted fewer anxiety symptoms during the pandemic.

Culturally enhancing a group-based motivational interviewing substance use prevention program for Latine youth.

Background: Group Motivational Interviewing for Teens (GMIT) has been effective in reducing youth substance use in diverse communities, yet more research is needed to determine its efficacy in reducing tobacco and alternative tobacco products (ATP) use among Latine adolescents. This study modified GMIT to include a focus on ATPs (GMIT-ATP). GMIT was also linguistically translated so it could be offered in English and Spanish, culturally enhanced, and parent sessions were added (GMIT-ATP + P). Methods: The study's aims were to 1) Develop a model of how cultural context, family relationships, and adolescent tobacco-related skills/beliefs are associated with smoking and ATP use; 2) Examine the impact of the GMIT-ATP intervention on adolescent tobacco use; 3) Examine whether the GMIT-ATP + P intervention improves family/parenting factors associated with reduced adolescent tobacco use; 4) Examine whether GMIT-ATP + P is more effective than GMIT-ATP in improving adolescent tobacco use; 5) Explore whether essential components of our behavior change model mediate the impact on tobacco use, and 6) Explore whether cultural factors influence the impacts of our intervention. Latine adolescents (ages 10-16) and their parents/guardians were recruited throughout Virginia. Parents and adolescents completed three surveys: before and immediately after the program ends and at 3-months post-intervention. Families attended 3 GMIT-ATP or GMIT-ATP + P sessions. Conclusion: Findings from this study will be disseminated in Latine communities and with providers working with Latine youth and can serve as a community-based model to reduce substance and tobacco use (e.g., ATP) in these Latine communities.

Immune, inflammatory and prothrombotic parameters in COVID-19 patients treated with an anti EGFR antibody.

SARS-CoV-2 infection causes a range of clinical presentations and induces changes in both innate and adaptive branches of the immune system. Furthermore, direct viral action to the cells of the lung promotes over-expression of the epidermal growth factor receptor (EGFR) which triggers pro-inflammatory response, contributes to coagulopathy and intravascular thrombi as well as lung fibrosis. Based on the role of this signaling pathway in the pathophysiology of the disease, nimotuzumab, an anti-EGFR monoclonal antibody, was used to treat patients with COVID-19. The aim of this study was to determine IL-6 and PAI-1 concentrations and lymphocyte subpopulations profiles in moderately and severely ill COVID-19 patients diagnosed during the B.1.617.2 variant wave in Cuba and included in a phase I/II trial to evaluate the safety and preliminary effect of nimotuzumab in COVID-19 disease. We observed high serum levels of IL-6, elevated plasma concentration of PAI-1, mean values of neutrophils to lymphocytes ratio (NLR) above three and CD4+ lymphopenia in both groups of patients. PAI-1 and IL-6 circulating levels decreased in patients treated with nimotuzumab. More than 95% of patients in which IL-6 decreased or increased slightly, were alive within 14 days after the monoclonal antibody administration. Patients with moderate and severe disease, were no different regarding the studied parameters, addressing the idea that several immune alterations could be present before the infection becomes clinically relevant. These findings suggest that nimotuzumab could be an attractive therapeutic option to interfere with the negative relationship between cytokines and procoagulant mediators in the inflammatory and prothrombotic phases of the disease.

Nimotuzumab Increases the Recovery Rate of Severe and Critical COVID-19 Patients: Evaluation in the Real-World Scenario.

EGFR signaling is an important regulator of SARS-CoV induced lung damage, inflammation and fibrosis. Nimotuzumab is a humanized anti-EGFR antibody registered for several cancer indications. An expanded access study was conducted to evaluate the safety and recovery rate of severe and critical patients with confirmed SARS-CoV-2 infection, treated with nimotuzumab in combination with the standard of care in the real-world scenario. The antibody was administered as an intravenous infusions every 72 h, up to 5 doses. In order to assess the impact of nimotuzumab, the recovery rate was compared with a paired retrospective cohort. Control patients received standard treatment according the national protocol but not nimotuzumab. Overall, 1,151 severe or critical patients received nimotuzumab in 21 hospitals of Cuba. Median age was 65 and 773 patients had at least one comorbidity. Nimotuzumab was very well-tolerated and mild or moderate adverse events were detected in 19 patients. 1,009 controls matching with the nimotuzumab patients, were selected using a "propensity score" method. The 14-day recovery rate of the nimotuzumab cohort was 72 vs. 42% in the control group. Controls had a higher mortality risk (RR 2.08, 95% CI: 1.79, 2.38) than the nimotuzumab treated patients. The attributable fraction was 0.52 (95% CI: 0.44%; 0.58), and indicates the proportion of deaths that were prevented with nimotuzumab. Our preliminary results suggest that nimotuzumab is a safe antibody that can reduce the mortality of severe and critical COVID-19 patients.

Comorbilidades en pacientes con enfermedad hepática alcohólica / Comorbidities in patients with alcoholic hepatic disease

Introducción: El consumo excesivo y prolongado de alcohol se asocia a una morbilidad elevada por afecciones hepáticas y de otros órganos. Objetivo: Precisar las lesiones hepáticas y su relación con otras enfermedades asociadas al alcohol y el estado nutricional en pacientes con enfermedad hepática alcohólica. Métodos: Se efectuó un estudio observacional, descriptivo y transversal de 270 pacientes con enfermedad hepática alcohólica, atendidos en el Servicio de Medicina Interna y la consulta especializada de Hepatología del Hospital Provincial Docente Clinicoquirúrgico Saturnino Lora de Santiago de Cuba, quienes fueron examinados clínicamente para detectar síntomas y signos de enfermedades hepática y asociadas al alcohol en diferentes sistemas, durante el decenio 2010-2019. Resultados: Predominaron los hombres (234), de los cuales 117 estuvieron en el grupo de 25 - 44 años de edad. La forma clínica preponderante fue la cirrosis hepática en 109 pacie2ntes, de ellos una proporción importante eran bebedores con más de 20 años de exposición al hábito. La enfermedad por reflujo gastroesofágico junto a las formas de gastropatía y la polineuropatía en 89 y 96 afectados, respectivamente, fueron las comorbilidades más asociadas a la lesión hepática. Se observaron diferentes grados de desnutrición en 167 afectados (61,8 %), de los cuales primaron aquellos con cirrosis hepática, de estos 51 (49,0 %) presentaron desnutrición moderada y 31 (49,2 %) grave. Conclusiones: Resulta elevada la presencia de comorbilidades en pacientes con enfermedad hepática alcohólica, lo cual se asocia al deterioro nutricional y a una exposición prolongada al hábito nocivo.

Introduction: The excessive and prolonged consumption of alcohol is associated with a high morbidity due to hepatic disorders and affections of other organs. Objective: To specify the hepatic lesions and their relationship with other diseases associated with alcohol and the nutritional state in patients with alcoholic hepatic disease. Methods: An observational, descriptive and cross-sectional study of 270 patients with alcoholic hepatic disease was carried out. They were assisted in the Internal Medicine Service and in the specialized visit of Hepatology from Saturnino Lora Teaching Clinical Surgical Provincial Hospital in Santiago de Cuba who were clinically examined to detect symptoms and signs of hepatic disease and those associated with alcohol in different systems, during the decade 2010-2019. Results: There was a prevalence of men (234), of which 117 were in the group of 25 - 44 years of age. The preponderant clinical form was the hepatic cirrhosis in 109 patients, an important proportion of them were drinkers with more than 20 years of exhibition to the habit. The disease due to gastroesophagic reflux along with the forms of gastropathy and polyneuropathy in 89 and 96 affected patients, respectively, were the comorbidities more associated with the hepatic lesion. Different degrees of malnutrition were observed in 167 affected patients (61.8 %), of which those with hepatic cirrhosis prevailed, of these 51 (49.0 %) presented moderate malnutrition and 31 (49.2 %) a serious one. Conclusions: The presence of comorbidities in patients with alcoholic hepatic disease is high, which is associated to the nutritional deterioration and a prolong exposure to the harmful habit.

An anti-CD6 antibody for the treatment of COVID-19 patients with cytokine-release syndrome: report of three cases.

In COVID-19, the inflammatory cytokine-release syndrome is associated with the progression of the disease. Itolizumab is a monoclonal antibody that recognizes human CD6 expressed in activated T cells. The antibody has shown to be safe and efficacious in the treatment of moderate to severe psoriasis. Its effect is associated with the reduction of pro-inflammatory cytokines release, including IFN-γ, IL-6 and TNF-α. Here, we report the outcome of three severe and critically ill COVID-19 patients treated with itolizumab as part of an expanded access protocol. Itolizumab was able to reduce IL-6 concentrations in all the patients. Two of the three patients showed respiratory and radiological improvement and were fully recovered. We hypothesize this anti-inflammatory therapy in addition to antiviral and anticoagulant therapy could reduce COVID-19 associated morbidity and mortality.

An anti-CD6 monoclonal antibody (itolizumab) reduces circulating IL-6 in severe COVID-19 elderly patients.

BACKGROUND: Since the COVID-19 outbreak an unprecedented challenge for healthcare systems around the world has been placed. In Cuba, the first case of COVID-19 was reported on March 11. Elderly with multiple comorbidities have been the most risky population. Although most patients present a mild to moderate disease, some have developed severe symptoms. One of the possible mechanisms underlying rapid disease progression is a cytokine storm, in which interleukin (IL) -6 seems to be a major mediator. Itolizumab is a humanized recombinant anti-CD6 monoclonal antibody (MAb), with the ability of reducing serum interferon gamma (INF-γ), tumour necrosis factor alpha (TNFα) and IL-6. Based on these previous results in patients with psoriasis and rheumatoid arthritis, an expanded access clinical trial was approved by the Cuban regulatory agency for COVID-19 critically, severely and moderately ill patients. RESULTS: We show here a short kinetic of IL-6 serum concentration in the first 24 COVID-19 patients treated with itolizumab. Most of patients were elderly with multiple comorbidities. We found that with one itolizumab dose, the circulating IL-6 decreased in critically and severely ill patients, whereas in moderately ill patients the values didn't rise as compared to their low baseline levels. CONCLUSION: These findings suggest that itolizumab could be an attractive therapeutic option to decrease the negative outcome of the cytokine storm in COVID-19 patients. TRIAL REGISTRATION: CECMED IIC RD-EC 179, RPCEC00000311. Registered 4 May 2020 - Retrospectively registered, http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp or http://rpcec.sld.cu/trials/RPCEC00000311-En.

Treatment of COVID-19 patients with the anti-CD6 antibody itolizumab.

OBJECTIVES: COVID-19 can lead to a hyperinflammatory state. CD6 is a glycoprotein expressed on mature T lymphocytes which is a crucial regulator of the T-cell activation. Itolizumab is a humanised antibody targeting CD6. Nonclinical and clinical data in autoimmune diseases indicate that it lowers multiple cytokines primarily involving the Th1/Th17 pathway. The primary objective of this study was to assess the impact of itolizumab in arresting the lung function deterioration of COVID-19 patients. Secondary objectives included safety, duration of ventilation, 14-day mortality and evaluation of interleukin 6 concentration. METHODS: Patients with confirmed SARS-CoV-2 received itolizumab in combination with other therapies included in the national protocol for COVID-19. RESULTS: Seventy critical, severe or moderate patients were treated with itolizumab in 10 Cuban hospitals. Median age was 68, and 94% had comorbidities. After 72 h, most patients improved the PO2/FiO2 ratio and reduced FiO2 requirements. Ventilation time was 8 days for critical and 1 day for severe cases. Ten patients had related adverse events while 3 subjects developed related serious events. In 30 patients, interleukin 6 decreased in individuals with high level and did not change in those with lower concentration. Fourteen-day lethality rate was 4% and 18% for moderate and severe patients, respectively. The proportion of moderate or severe patients with ventilation or death at day 14 was 9.8%. Time to treatment, neurological manifestations and biomarkers such as NLR were significantly associated with higher lethality. CONCLUSIONS: The opportune administration of itolizumab might interrupt the hyperinflammatory cascade and prevent COVID-19 morbidity and mortality.

Nimotuzumab: beyond the EGFR signaling cascade inhibition.

One of the most known oncogenes is the epidermal growth factor receptor (EGFR) family. It activates multiple signaling cascades that promote carcinogenesis and immune evasion. Therefore, these molecules have been extensively targeted in cancer immunotherapy. Beyond EGFR signaling cascade inhibition, some of these agents are able to induce T-cell activation, transforming a passive therapy into a vaccine-like effect. Nimotuzumab is an IgG1 humanized monoclonal antibody directed against the extracellular domain of the EGFR blocking the binding to its ligands. It possesses unique pharmacodynamic properties, which allow treating patients for long-term periods and with very low toxicity. Based on its clinical effect, nimotuzumab has been approved in Cuba and abroad for the treatment of different epithelial tumors. Recently, new potential mechanisms of action of nimotuzumab involving the activation of the innate and adaptive immune response have been reported. This review summarizes the main properties of nimotuzumab in comparison with other EGFR-specific monoclonal antibodies, highlighting its capacity to activate an effective immune response. In addition, differential clinical effects of this antibody and ongoing clinical trials to deeply characterize the biomarkers of clinical benefit are shown.

A pilot study of nimotuzumab plus single agent chemotherapy as second- or third-line treatment or more in patients with recurrent, persistent or metastatic cervical cancer.

Nimotuzumab is a humanized IgG1 monoclonal antibody against the EGFR extracellular domain that has been evaluated in solid tumors as a single agent or in combination with chemotherapy and radiation. Cervical cancer patients who are refractory or progressive to first-line chemotherapy have a dismal prognosis, and no second- or third-line chemotherapy is considered standard. This pilot trial aimed to evaluate the efficacy and safety of nimotuzumab in 17 patients with pre-treated advanced refractory or progressive cervical cancer. Nimotuzumab was administered weekly at 200 mg/m(2) as single agent for 4 weeks (induction phase), then concurrent with 6 21-day cycles of gemcitabine (800 mg/m(2)) or cisplatin (50 mg/m(2)) for 18 weeks (concurrent phase) and then once every 2 weeks (maintenance phase). Nimotuzumab could be continued beyond disease progression. Seventeen patients were accrued and evaluated for safety and efficacy. The median number of nimotuzumab applications was 20 (5-96). The median number of chemotherapy cycles administered was 6 (1-6). No toxicity occurred during induction and maintenance phases (single agent nimotuzumab). In the concurrent phase, grade 3 toxicity events observed were leucopenia, anemia and diarrhea in 11.7%, 5.8% and 11.7% respectively. No complete or partial responses were observed. The stable disease (SD) rate was 35%. The median PFS and OS rates were 163 days (95% CI, 104 to 222), and 299 days (95% IC, 177 to 421) respectively. Nimotuzumab is well tolerated and may have a role in the treatment of advanced cervical cancer.

A clinical exploratory study with itolizumab, an anti-CD6 monoclonal antibody, in patients with rheumatoid arthritis.

T cells are involved in the pathogenesis of rheumatoid arthritis (RA). CD6 is a co-stimulatory molecule, predominantly expressed on lymphocytes, that has been linked to autoreactive responses. The purpose of this study was to evaluate the safety, immunogenicity and preliminary efficacy of itolizumab, a humanized anti-CD6 monoclonal antibody, in patients with active rheumatoid arthritis. Fifteen patients were enrolled in a phase I, open-label, dose-finding study. Five cohorts of patients received a weekly antibody monotherapy with a dose-range from 0.1 to 0.8 mg/kg. Itolizumab showed a good safety profile, with no severe or serious adverse events reported so far. No signs or symptoms associated with immunosuppression were observed in the study. Objective clinical responses were achieved in more than 80% of patients after treatment completion, and these responses tend to be sustained afterwards. This clinical study constitutes the first evidence of the safety and positive clinical effect of a monotherapy using an anti-CD6 antibody in patients with rheumatoid arthritis.

Phase I single-dose study of intracavitary-administered Nimotuzumab labeled with 188 Re in adult recurrent high-grade glioma.

Radioimmunotherapy (RIT) may improve the management of malignant gliomas. A Phase I clinical trial was performed to evaluate, for the first time, the toxicity and clinical effect of an intracavitary administration of a single dose of Nimotuzumab (h-R3) labeled wit (188)Re. Nimotuzumab is a humanized monoclonal antibody directed against epidermal growth factor receptors. Three patients with anaplastic astrocytoma (AA) and 8 with glioblastoma multiforme (GBM) were intended to be treated with 3 mg of mAb labelled with 10 or 15 mCi of (188)Re. In patients treated with 10 mCi (n=6) transitory worsening of pre-existing neurological symptoms were observed. Two patients treated with 15 mCi (n=4) developed early severe neurological symptoms and one also developed late severe toxicity (radionecrosis). In the group treated with 10 mCi, 1 GBM patient died in progression 6 months after the treatment, 2 patients (1 GBM and 1 AA) developed stable disease during 3 months. One GBM patient had partial response for more than 1 year and 2 patients (1 GBM and 1 AA) were asymptomatic and in complete response after 3 years of treatment. Maximal tolerated dose of the radioimmunoconjugate (188)Re-Nimotuzumab was 3 mg of the h-R3 labelled with 10 mCi of (188)Re. The radioimmunoconjugate showed a high retention in the surgical created resection cavity and the brain adjacent tissues with a mean value of 85.5 % of the injected dose one hour post-administration. This radioimmunoconjugate may be relatively safe and a promising therapeutic approach for treating high grade gliomas.

Eficacia del extracto de Vimang en la estomatitis subprótesica Grado I / Efficacy of Vimang extract in Grade I Subprosthetic Stomatitis

Se realizó un ensayo clínico terapéutico (fase III) en la consulta de Prótesis de la Clínica Estomatológica Provincial Docente de Santiago de Cuba, con el objetivo de evaluar la eficiencia de la terapia antiinflamatoria con extracto de Vimang, sobre la mucosa afectada por estomatitis subprótesis grado I en portadores de prótesis con bases acrílicas. Se seleccionaron 100 pacientes, de los cuales 80 cumplieron los requisitos y recibieron nuestros servicios de octubre del 2005 a marzo del 2006. Se dividieron aleatoriamente en 2 grupos, uno estudio y otro control, con 40 cada uno. Los pacientes mostraron preocupaciones estéticas. Al primer grupo se le indicaron enjuagatorios del extracto de infusión de Vimang hasta su curación; al segundo grupo la regresión espontánea; se retiró la prótesis en el horario nocturno. Se evaluaron a los 3, 5 y 7 días para ver su curación y reacciones adversas, tiempo que correspondió con el concebido para la investigación. Para la validación estadística de los datos, se utilizó el test Chi cuadrado con el 95 por ciento de confiabilidad. Se obtuvo como resultado la curación de la lesión a los 5 días en la mayoría de los pacientes y manifestaciones astringentes. Se evidenció la eficacia de la terapia con Vimang en forma de infusión, por lo que se recomienda su uso a largo plazo(AU)

A therapeutic clinical trial (phase III) was conducted in the Prosthesis Department of the Provincial Dental Clinic of Santiago de Cuba aimed at evaluating the efficacy of the antiinflammatory therapy with Vimang extract on the mucosa affected by grade I subprosthesis stomatitis in individuals wearing prostheses with acrylic bases. 100 patients were selected. 80 of them met our requirements and received our services from October 2005 to March 2006. They were divided at random into 2 groups of 40 patients each: a control group and a study group. The patients were worried about aesthetics. The first group was indicated mouthwashes with Vimang infusion extract until they cured. In the second group, spontaneous regression, the prosthesis was removed at night. They were evaluated at 3, 5 and 7 days to check their cure and adverse reactions. This time corresponded to the time devoted to the investigation. Chi square test with 95 percent of confidence was used for the statistical validation of data. Most of the patients cured on the 5th day and astringent manifestations were observed. As the efficacy of the therapy with Vimang infusion was proved, its use on the long term was recommended(AU)

Eficacia del extracto de Vimang en la estomatitis subprótesica Grado I / Efficacy of Vimang extract in Grade I Subprosthetic Stomatitis

Se realizó un ensayo clínico terapéutico (fase III) en la consulta de Prótesis de la Clínica Estomatológica Provincial Docente de Santiago de Cuba, con el objetivo de evaluar la eficiencia de la terapia antiinflamatoria con extracto de Vimang, sobre la mucosa afectada por estomatitis subprótesis grado I en portadores de prótesis con bases acrílicas. Se seleccionaron 100 pacientes, de los cuales 80 cumplieron los requisitos y recibieron nuestros servicios de octubre del 2005 a marzo del 2006. Se dividieron aleatoriamente en 2 grupos, uno estudio y otro control, con 40 cada uno. Los pacientes mostraron preocupaciones estéticas. Al primer grupo se le indicaron enjuagatorios del extracto de infusión de Vimang hasta su curación; al segundo grupo la regresión espontánea; se retiró la prótesis en el horario nocturno. Se evaluaron a los 3, 5 y 7 días para ver su curación y reacciones adversas, tiempo que correspondió con el concebido para la investigación. Para la validación estadística de los datos, se utilizó el test Chi cuadrado con el 95 por ciento de confiabilidad. Se obtuvo como resultado la curación de la lesión a los 5 días en la mayoría de los pacientes y manifestaciones astringentes. Se evidenció la eficacia de la terapia con Vimang en forma de infusión, por lo que se recomienda su uso a largo plazo(AU)

A therapeutic clinical trial (phase III) was conducted in the Prosthesis Department of the Provincial Dental Clinic of Santiago de Cuba aimed at evaluating the efficacy of the antiinflammatory therapy with Vimang extract on the mucosa affected by grade I subprosthesis stomatitis in individuals wearing prostheses with acrylic bases. 100 patients were selected. 80 of them met our requirements and received our services from October 2005 to March 2006. They were divided at random into 2 groups of 40 patients each: a control group and a study group. The patients were worried about aesthetics. The first group was indicated mouthwashes with Vimang infusion extract until they cured. In the second group, spontaneous regression, the prosthesis was removed at night. They were evaluated at 3, 5 and 7 days to check their cure and adverse reactions. This time corresponded to the time devoted to the investigation. Chi square test with 95 percent of confidence was used for the statistical validation of data. Most of the patients cured on the 5th day and astringent manifestations were observed. As the efficacy of the therapy with Vimang infusion was proved, its use on the long term was recommended(AU)

Systemic and skin toxicity in Cercopithecus aethiops sabaeus monkeys treated during 26 weeks with a high intravenous dose of the anti- epidermal growth factor receptor monoclonal antibody Nimotuzumab.

Nimotuzumab (h-R3) is a humanized anti-epidermal growth factor receptor monoclonal antibody (mAb) registered for treating head and neck tumours. The present study was designed to evaluate the systemic and skin toxicity of chronic intravenous administration of the h-R3 in a relevant species demonstrated by comparing the h-R3 binding affinity constants (Kd) in microsomal placental fractions from Homo sapiens and Cercopithecus aethiops monkeys using an EGF-Receptor radioligand competition assay. The Kd obtained for Nimotuzumab were 9.1 x 10(-8) M for monkeys and 4.5 x 10(-8) M for humans. Monkeys (n = 18) were distributed into 3 groups with 3 animals of each sex in each group. Group I received saline; group II received 2.85 mg/kg of h-R3; and group III received 28.57 mg/kg of the h-R3, which represent 1 and 10 times the human dose, and they were weekly intravenously treated during 26 weeks. During the study there were no deaths. Electroneurophysiological, sanguine chemistry and haematological results did not evidence alterations. Areas of haematomas, probably related with the administration procedure, were observed at the administration zones of all animals. The electrocardiography study showed at the end of the study a slight increase in the cardiac frequency of four treated animals without other signs. Unexpectedly, skin biopsies and a detailed clinical inspection of the animals did not detect the presence of cutaneous rash or any other skin toxicity sign reported for the majority of the anti-EGF-R monoclonal antibodies. It is concluded that doses up to 28.5 mg/kg of h-R3, intravenously administered during 26 weeks to Cercopithecus aethiops monkeys, do not produce considerable toxic effects.