A novel Chilean salmon fish backbone-based nanoHydroxyApatite functional biomaterial for potential use in bone tissue engineering.

Introduction: Given the ensuing increase in bone and periodontal diseases and defects, de novo bone repair and/or regeneration strategies are constantly undergoing-development alongside advances in orthopedic, oro-dental and cranio-maxillo-facial technologies and improvements in bio-/nano-materials. Indeed, there is a remarkably growing need for new oro-dental functional biomaterials that can help recreate soft and hard tissues and restore function and aesthetics of teeth/ dentition and surrounding tissues. In bone tissue engineering, HydroxyApatite minerals (HAp), the most stable CaP/Calcium Phosphate bioceramic and a widely-used material as a bone graft substitute, have been extensively studied for regenerative medicine and dentistry applications, including clinical use. Yet, limitations and challenges owing principally to its bio-mechanical strength, exist and therefore, research and innovation efforts continue to pursue enhancing its bio-effects, particularly at the nano-scale. Methods: Herein, we report on the physico-chemical properties of a novel nanoHydroxyApatite material obtained from the backbone of Salmon fish (patent-pending); an abundant and promising yet under-explored alternative HAp source. Briefly, our nanoS-HAp obtained via a modified and innovative alkaline hydrolysis-calcination process was characterized by X-ray diffraction, electron microscopy, spectroscopy, and a cell viability assay. Results and Discussion: When compared to control HAp (synthetic, human, bovine or porcine), our nanoS-HAp demonstrated attractive characteristics, a promising biomaterial candidate for use in bone tissue engineering, and beyond.

The chemical and sensory qualities of smoked blood sausage made with the edible by-products of goat slaughter.

The aim was to evaluate smoked blood sausage prepared using goat blood (50%), viscera (10%) and meat fragments (20%). Microbiological, chemical and sensory evaluations were conducted. The quality analyses showed that smoked goat blood sausage is rich in high biological value proteins, amino acids, essential fatty acids, and iron (26.65mg/100g). The smoked goat blood sausage was rated to have a sensory acceptance of greater than 80%. The use of edible by-products from the slaughter of goats in the formulation of smoked blood sausage is viable because it uses low-cost raw materials; furthermore, the utilisation of these by-products can generate income for producers, allowing them to offer a meat product of high nutritional and sensory quality.

Evaluation of the effect of intravenous lidocaine on propofol requirements during total intravenous anaesthesia as measured by bispectral index.

BACKGROUND: I.V. lidocaine is increasingly used as an adjuvant during general anaesthesia. The aim of this study was to evaluate the effect of i.v. lidocaine in reducing propofol anaesthetic requirements during total i.v. anaesthesia (TIVA) maintenance and to evaluate its effect on early recovery from anaesthesia. METHODS: Forty adult patients undergoing elective laparoscopic cholecystectomy under TIVA were randomly allocated into the lidocaine group (administered 1.5 mg kg(-1) i.v. lidocaine over 5 min followed by 2 mg kg(-1) h(-1)) and the control group (administered an equal volume of saline). Propofol was administered using a target-controlled infusion to maintain the bispectral index values between 40 and 60. After surgery, all infusions were discontinued and the time to extubation was recorded. Serial arterial blood samples were drawn to assess drug plasma levels. RESULTS: The maintenance dose of propofol was significantly lower in the lidocaine group [6.00 (0.97) mg kg(-1) h(-1)] vs the control group [7.25 (1.13) mg kg(-1) h(-1); P=0.01]. Propofol plasma levels measured at the end of the infusion were 3.71 (0.89) µg ml(-1) in the lidocaine group and 3.67 (1.28) µg ml(-1) in the control group (P=0.91). The median time to extubation was longer (11.0 min; range: 10.0-21.0) in the lidocaine group vs the control group (8.3 min; range: 5.5-12.5; P=0.02). CONCLUSIONS: I.V. lidocaine reduces propofol requirements during the maintenance phase of TIVA, particularly during surgical stimulation. This sparing effect is associated with an increased time to extubation. Owing to its effect on early recovery from anaesthesia, i.v. lidocaine should be taken into account when used as a component of i.v. anaesthesia.

Analysis of hepatitis C virus core encoding sequences in chronically infected patients reveals mutability, predominance, genetic history and potential impact on therapy of Cuban genotype 1b isolates.

BACKGROUND AND OBJECTIVES: Hepatitis C virus (HCV) genotypes are relevant to epidemiological questions, vaccine development, and clinical management of chronic HCV infection. In the present work, we aimed at investigating HCV genotype, variability and genetic history of HCV isolates in Cuba from a sample of chronically infected patients. MATERIAL AND METHODS: A prospective study, involving 73 Cuban anti-HCV positive patients, was carried out. RT-PCR and phylogenetic analysis was employed to determine HCV genotypes. Divergence dates and demographic parameters in a Bayesian coalescent framework were estimated, as implemented in BEAST v1.4.8. RESULTS: HCV RNA was undetectable in 15 patients that received antiviral therapy. All HCV RNA positive patients, 58, were infected with genotype 1, three of them with subtype 1a and 55 with subtype 1b. The analysis of the DNA sequence coding for a core fragment, spanning nt positions 435-816 (relative to strain H77), revealed high percent (96.7% +/- 0.8%) nucleotide identity within Cuban HCV subtype 1b sequences. However, 56.7% and 20% of 30 analyzed individuals had changes in the core region in a six-month interval, at the nucleotide and amino acid level, respectively. Mutations involving aa changes were mainly found in the region encompassed between aa 70 and 106 of the core protein, with only one isolate showing a point mutation at position 43. Interestingly, some of the observed changes seem to be reversions and might in fact contribute to reducing the variability of this region. The estimated date for the most recent common ancestor of HCV genotype 1b Cuban isolates is 1969 (CI, 1953 to 1977). DISCUSSION: Analysis of HCV core encoding sequences from chronic patients reveals mutability of genotype 1b isolates in Cuba, which seem to be predominant and rapidly multiplied during the eighty decade of last century, and might limit the benefits obtained from current antiviral therapy.

Performance evaluation of paediatric propofol pharmacokinetic models in healthy young children.

BACKGROUND: The performance of eight currently available paediatric propofol pharmacokinetic models in target-controlled infusions (TCIs) was assessed, in healthy children from 3 to 26 months of age. METHODS: Forty-one, ASA I-II children, aged 3-26 months were studied. After the induction of general anaesthesia with sevoflurane and remifentanil, a propofol bolus dose of 2.5 mg kg(-1) followed by an infusion of 8 mg kg(-1) h(-1) was given. Arterial blood samples were collected at 1, 2, 3, 5, 10, 20, 40, and 60 min post-bolus, at the end of surgery, and at 1, 3, 5, 30, 60, and 120 min after stopping the infusion. Model performance was visually inspected with measured/predicted plots. Median performance error (MDPE) and the median absolute performance error (MDAPE) were calculated to measure bias and accuracy of each model. RESULTS: Performance of the eight models tested differed markedly during the different stages of propofol administration. Most models underestimated propofol concentration 1 min after the bolus dose, suggesting an overestimation of the initial volume of distribution. Six of the eight models tested were within the accepted limits of performance (MDPE<20% and MDAPE<30%). The model derived by Short and colleagues performed best. CONCLUSIONS: Our results suggest that six of the eight models tested perform well in young children. Since most models overestimate the initial volume of distribution, the use for TCI might result in the administration of larger bolus doses than necessary.

Componentes ocupacionales a evaluar en el proceso de tratamiento y rehabilitación del consumo problemático de drogas / Assessment of occupational components in the treatment and rehabilitation process of problematic drug abuse

La recolección de datos se llevó a cabo a través de la revisión de la literatura existente sobre el tema y una entrevista semiestructurada a siete Terapeutas Ocupacionales, con experiencia en el área de estudio. La entrevista se centró en los siguientes temas: Componentes Ocupacionales evaluados por terapeutasocupacionales durante el proceso de Tratamiento y Rehabilitación, modelos y evaluaciones utilizadas por terapeutas ocupacionales y Componentes Ocupacionales que muestran mayor déficit. Los resultados de esta investigación revelaron que la mayoría de los terapeutas ocupacionales evalúan los componentes ocupacionales de rutina/hábitos, roles, volición, tiempo libre e historia laboral en la etapa de ingreso a Centros de Tratamiento y Rehabilitación. Los resultados también revelaron una carencia de modelos y evaluaciones adecuadas y específicas desde la Terapia Ocupacional en el tema de estudio. Este estudio concluye en que existe una carencia de homogeneidad en el lenguaje, instrumentos de evaluación y los modelos utilizados entre Terapeutas Ocupacionales en los distintos Centros de Tratamiento y Rehabilitación.

This research topic is framed within the field of occupational therapy and problematic drug abuse. The purpose of this qualitative study is to explore what occupational components occupational therapists assess in the process of treatment and rehabilitation of problematic drug abuse. The study also explores the models and assessments used during this process. The participants were selected out of the list of Treatment and Rehabilitation Centers, that provides Occupational Therapy intervention in an Intensive Outpatient Program. This list was obtained from thedatabase of the National Council for Narcotics Control (CONACE). Data was collected through literature review on the topic and semi-structured interviews with seven Occupational Therapists with experience in the field of Drug Addiction Treatment and Rehabilitation. Theinterviews focused on the following topics: occupational components that are assessed for occupational therapists during the process of Treatment and Rehabilitation, models or theoretical frameworks and assessments used during this process and occupational components most affected. The results revealed that the majority of occupational therapists evaluate the occupational components of routine / habits, roles, volition, leisure and work history at the stage of admission to Treatment and Rehabilitation Centers. In addition, the results reveal a lack of appropriate and specific models andassessments from the occupational therapy perspective within the field of drug abuse. This study concludes that there is a lack of homogeneity in language, assessment tools and models used between the Occupational Therapists working in the Treatment and Rehabilitation Centers.

Synthesis and anabolic/androgenic evaluation of novel 9alpha-fluorosteroids.

3Beta,11beta-dihydroxy-9alpha-fluor-5alpha-androstane-17-one (2), 3beta-acetoxy-9alpha-fluor-11beta-hydroxy-5alpha-androstane-17-one (3), 3beta-acetoxy-9alpha-fluor-11beta,17beta-dihydroxy-5alpha-androstane (4), 3beta,17beta-diacetoxy-9alpha-fluor-11beta-hydroxy-5alpha-androstane (5), 3beta-acetoxy-9alpha-fluor-11beta-hydroxy-5alpha-androstane 17beta-propionate (6), 3beta-acetoxy-9alpha-fluor-11beta-hydroxy-5alpha-androstane 17beta-enanthate (7), 3beta-acetoxy-9alpha-fluor-11beta-hydroxy-5alpha-androstane 17beta-isobutyrate (8) were synthesized in the present study. Compounds 2 and 8 exhibited higher anabolic activity than the rest of the synthesized compounds. The structure of all these newly synthesized compounds was confirmed by analytic spectral data (mass, (1)H NMR and (13)C NMR).

Immunogenicity of CIGB-230, a therapeutic DNA vaccine preparation, in HCV-chronically infected individuals in a Phase I clinical trial.

SUMMARY: Hepatitis C virus (HCV) is a worldwide health problem. No vaccine is available against this pathogen and therapeutic treatments currently in use are of limited efficacy. In the present study, the immunogenicity of the therapeutic vaccine candidate CIGB-230, based on the mixture of pIDKE2, a plasmid expressing HCV structural antigens, with a recombinant HCV core protein, Co.120, was evaluated. CIGB-230 was administered by intramuscular injection on weeks 0, 4, 8, 12, 16 and 20 to 15 HCV-chronically infected individuals, non-responders to previous treatment with interferon (IFN) plus ribavirin. Interestingly, following the final immunization, neutralizing antibody responses against heterologous viral pseudoparticles were modified in eight individuals, including six de novo responders. In addition, 73% of vaccinees exhibited specific T cell proliferative response and T cell IFN-gamma secretory response 24 weeks after primary immunization with CIGB-230. Furthermore, 33.3% of individuals developed de novo cellular immune response against HCV core and the number of patients (46.7% at the end of treatment) with cellular immune response against more than one HCV structural antigen increased during vaccination (P = 0.046). In addition, despite persistent detection of HCV RNA, more than 40% percent of vaccinated individuals improved or stabilized liver histology, particularly reducing fibrosis, which correlated with cellular immune response against more than one HCV antigen (P = 0.0053). In conclusion, CIGB-230 is a promising candidate for effective therapeutic interventions based on its ability for enhancing the immune response in HCV chronically infected individuals.

Group education on asthma for children and caregivers: a randomized, controlled trial addressing effects on morbidity and quality of life.

OBJECTIVE: To establish the efficacy in terms of morbidity and quality of life of a group education program on asthma aimed at children and caregivers. METHODS: An open, randomized, controlled trial was undertaken in 13 primary health care centers in Spain, Cuba, and Uruguay and involved 245 children with active asthma aged 9 to 13 years and their caregivers. The intervention consisted of 3 educational sessions lasting 45 to 60 minutes each and was performed with 3 intervention groups: children alone, caregivers alone, and both children and caregivers. The outcome measures were difference between intervention and control groups in the rate of asthma attacks and hospital admission, as well as the quality of life of children and caregivers in the 6 months following the intervention. RESULTS: The rate of asthma attacks per patient-year decreased when the intervention was given only to children (mean difference, -1.61; 95% confidence interval [CI], -2.87 to -0.34) or to both children and caregivers (-1.60; 95% CI, -2.88 to -0.31). Hospital admissions per patient-year decreased in the intervention groups children alone (-0.28; 95% CI, -0.51 to -0.05) and both children and caregivers (-0.25; 95% CI, -0.49 to -0.02). Education provided to caregivers alone was not associated with any changes in morbidity. No differences were observed in terms of quality of life between controls and any of the intervention groups. CONCLUSIONS: Group education on asthma reduces morbidity but does not improve quality of life. The benefits are apparent when education is aimed at children but no additional benefit is obtained if the intervention is also aimed at their caregivers. Finally, group education for adult caregivers alone is not effective.

Therapeutic drug monitoring of mycophenolic acid in kidney transplant patients: a abbreviated sampling strategy.

Mycophenolic acid (MPA) levels have demonstrated a good correlation with clinical outcomes, but with great pharmacokinetic variability between patients. Therapeutic drug monitoring (TDM) is recommended to include a 12-hour area under the concentration-time curve (AUC). Since full AUC estimates are not practical for routine monitoring, limited sampling strategies have been suggested. We evaluated MPA pharmacokinetics in 18 stable renal transplant patients receiving mycophenolate mofetil (MMF) as part of their immunosuppressive therapy. The correlation between measured and estimated AUC was assessed using 4 different sparse sampling algorithms. The mean values for C(0) and AUC(0-6h) were 1.8 +/- 1.2 mg/L and 31.1 +/- 14.8 mg*h/L, respectively. The dose-corrected AUC(0-6h) was 35.4 +/- 17.9 mg*h/L. Regarding the single time points, C(0) showed a low correlation with AUC(0-6h) (r(2) = .34); C(1.5), the best correlation (r(2) = .72); and C(3), the worst (r(2) = .07). Sparse sample algorithms used to estimate 12-hour AUC including C(0), C(1), C(2), C(3), C(4), and/or C(6) showed a good correlation with the calculated AUC(0-6) (r(2) = .81-.96). The algorithm that used C(0), C(1), C(2), and C(4) showed the best correlation, but we also found a good correlation (r(2) = .91) with C(0), C(1), and C(2). Based on these results, we have suggested using the 3-point algorithm (C(0), C(1), and C(2)) for MPA TDM in stable renal transplant patients due to the good correlation with drug exposure and better functionality than an algorithm using a 4-hour postdose measurement.

Comparative study of red blood cell method in rat and calves blood as alternatives of Draize eye irritation test.

INTRODUCTION: Red blood cell assay (RBC) is used to estimate potential irritation of tensioactive agents and detergents. Cell membrane lysis and cell protein denaturation are measured photometrically. This study was aimed to determine if rat blood cells can be used to predict eye potential irritation in the same way of calves blood cells in RBC assay. METHODS: We evaluated 20 cosmetic formulations using rat and calves blood according to INVITOX protocol No 37. Data of media hemolysis concentration, denaturation index and the ratio of both parameters were compared with in vivo data of eye irritancy. RESULTS: There was a significant difference (p<0.01) between H50 value when evaluated the standard SDS with red blood cell method in rat and calves blood. According to the exact probability of Fisher taking as approach the acceptance or rejection of the substance there are no significant differences between in vitro assay with calves blood and in vivo results. Not happening the same way for the RBC assay with rat blood where significant differences were obtained (p<0.01) among the classification of in vitro and in vivo test. DISCUSSION: The RBC assay using calves blood showed better results. Several test substances were false negatives with rat blood. This high false negative rate would be correctly identified by the animal test but it may also lead to increased animal consumption. For that RBC assay with calf blood cells is preferable to the employment of rat blood as screening method with a reduction and refinement strategy.

In vitro quantitative determination of ophthalmic irritancy by the chorioallantoic membrane test with trypan blue staining as alternative to eye irritation test.

The damage provoked by some substances on the chicken egg's chorioallantoic membrane (CAM) is used as an alternative assay to determine ocular irritation. There is good prediction of the eye irritation when compared to the in vivo Draize method. Nevertheless, this assay has some limitations, such as subjectivity. Hagino et al. developed an objective evaluation technique using the amount of trypan blue absorbed at the site of treatment as an indicator of injury to the CAM. The present work was aimed at the determination of ocular irritation of 21 substances (chemicals and cosmetics). We used the spectrophotometric quantification by trypan blue staining of the damage produced on CAM, of fertile chicken eggs. Results were compared with the values obtained by the traditional Draize assay. We observed a good correlation (r=0.835; p<0.0001) between the amount of dye absorbed by the CAM and the Draize eye irritation test score. The r values were 0.688; p<0.05 for cosmetics and 0.925; p<0.0001 for chemicals. Three chemicals turned as false positive and one cosmetic substance as false negative. The CAM-TBS assay is inexpensive, simple and provides an in vitro alternative method to predict the damage that chemical substances or cosmetics can cause to the ocular structures.

Envenenamiento por rayas de agua dulce / Poisoning by fresh water stingray

El envenenamiento por rayas de agua dulce ocurre en forma accidental, cuando estas se defienden al ser pisadas o estimuladas; el veneno inoculado tiene acción histolítica y anafiláctica, en raras ocasiones es fatal. Se presenta un estudio descriptivo de 20 casos atendidos entre enero de 2000 y diciembre de 2003 en el ambulatorio rural tipo II San Rafael de Atamaica, estado Apure, Venezuela. El 70 por ciento de los casos entre febrero y abril (época de sequía), con un predominio de pacientes masculinos (90 por ciento) en la tercera década de vida durante la realización de actividades recreacionales. La herida más frecuente fue en el dorso del pie derecho (43 por ciento). La mitad de los pacientes acudió a control, presentado curación a las dos semanas

Immunological evaluation of Escherichia coli-derived hepatitis C virus second envelope protein (E2) variants.

Two variants of the hepatitis C virus (HCV) E2 envelope protein, lacking the C-terminal domain and comprising amino acids 458-650 (E2A) and 382-605 (E2C), respectively, were efficiently produced in BL21 (DE3) Escherichia coli cells. E2A and E2C were used to immunize mice. The E2C variant induced the maximal mean antibody titer. Anti-E2C mouse sera reacted mainly with E2 synthetic peptides covering the 70 amino acid N-terminal region of the E2 protein. Moreover, a panel of anti-HCV positive human sera recognized only the E2C protein (28.2%) and the synthetic peptide covering the HVR-1 of the E2 protein (23.1%). These data indicate the existence of an immunologically relevant region in the HVR-1 of the HCV E2 protein.

Disseminated cutaneous histoplasmosis and AIDS: case report.

Histoplasmosis is caused by the dimorphic fungus Histoplasma capsulatum. It manifests by the presence of fever as the only symptom in most individuals. The disease may present as self-limited pneumonia, or as an hematogenous widespread fungal infection with a potentially fatal outcome in elderly individuals and people with compromised T-cell mediated immunity. Here, we report a case of disseminated cutaneous histoplasmosis in a patient with AIDS. The patient was a 33 year old male homosexual, intravenous drug user, who had been diagnosed with HIV infection 5 years earlier. He was in good health, but had erythematous papules and pustules in the skin of the scalp, face, back, thighs, abdomen, palms, and soles. He was placed on anti-retroviral therapy, fluconazole for mucosal candidiasis, trimethoprim/sulfamethoxazole for pneumocystis prophylaxis, and antibiotics for the skin pustules. The skin lesions improved remarkably within 14 days. He was discharged and soon lost to follow-up. After his discharge, skin biopsy and fungal culture results revealed H. capsulatum. He was seen again 1 year later. The interim history revealed that he had taken fluconazole 100 mg/day for 1 month and fluconazole 150 mg/week for 7 months. He had not continued anti-retroviral therapy, nor taken other antifungal drugs. The clinical evolution of the disease was exceptional in that there was disappearance of all the skin lesions attributed to histoplasmosis with fluconazole. Although itraconazole remains the drug of choice for histoplasmosis. Cutaneous histoplasmosis should be considered in the differential diagnosis of atypical cutaneous lesions in individuals infected with HIV.

Disseminated cutaneous histoplasmosis and AIDS: Case report

Histoplasmosis is caused by the dimorphic fungus Histoplasma capsulatum. It manifests by the presence of fever as the only symptom in most individuals. The disease may present as self-limited pneumonia, or as an hematogenous widespread fungal infection with a potentially fatal outcome in elderly individuals and people with compromised T-cell mediated immunity. Here, we report a case of disseminated cutaneous histoplasmosis in a patient with AIDS. The patient was a 33 year old male homosexual, intravenous drug user, who had been diagnosed with HIV infection 5 years earlier. He has in good health, but had erythematous papules and pustules in the skin of the scalp, face, back, thighs, abdomen, palms, and soles. He was placed on anti-retroviral therapy, fluconazole for mucosal candidiasis, trimethoprim/sulfamethoxazole for pneumocystis prophylaxis, and antibiotics for the skin pustules. The skin lesions improved remarkably within 14 days. He was discharged and soon lost to follow-up. After his discharge, skin biopsy and fungal culture results revealed H. capsulatum. He was seen again 1 year later. the interim history revealed that he had taken fluconazole 100 mg/day for 1 month and fluconazole 150 mg/week for 7 months. He had not continued anti-retroviral therapy, nor taken other antifungal drugs. The clinical evolution of the disease was exceptional in that there was disappearance of all the skin lesions attributed to histoplasmosis with fluconazole. Although itraconazole remains the drug of choice for histoplasmosis. Cutaneous histoplasmosis should be considered in the differential diagnosis of atypical cutaneous lesions in individuals infected with HIV.

Expression and immunological evaluation of the Escherichia coli-derived hepatitis C virus envelope E1 protein.

Immunological response against envelope protein E1 is very important in natural hepatitis C virus (HCV) infection, although it is insufficient to clear the viraemia. The HCV genomic region encoding the first 149 amino acids of the envelope E1 protein (E1(340), amino acids 192-340) was expressed in Escherichia coli (to a level of 30% of the whole cellular proteins) and purified to 85%. We measured the immune response in rabbits and mice as well as the reactivity against 37 human sera raised against the whole recombinant protein and E1-encoding peptides. From this, 51.1% of human sera were found to react with E1(340). High-level antibodies against E1(340) were obtained in rabbits and mice when immunized. These antibodies had a similar peptide-recognition pattern to that described previously for human sera. The most reactive region was located at the N-terminus of the E1 protein. Cellular immunity in mice was evaluated by delayed-type hypersensitivity assay. It revealed the induction of a CD4+ T-cell-mediated response by this protein. This E1(340) protein and the animal-derived anti-E1 sera are immunological tools that could aid in the monitoring and development of anti-HCV therapies.

Etiología microbiana de la enfermedad inflamatoria pélvica leve y moderada (EIP) / Microbial ethiology of mild and moderate pelvic inflammatory disease

La Enfermedad Inflamatoria Pélvica (EIP) es una de las complicaciones más severas de las Enfermedades de Transmisión Sexual (ETS) se puede deber entre otros eventos al ascenso de la microflora genital femenina o a la infección de gérmenes implicados en ETS como la Chlamydia trachomatis o Neisseria gonorrhoeae. Esto trae como consecuencia serias repercusiones desde el punto de vista gineco-obstétrico. Una de las principales limitaciones a la que se enfrenta el médico es el conocer su etiología. De tal manera que con el presente trabajo, se pretende establecer el tipo de microorganismos involucrados en esta patología a fin de que al identificarlos, mediante el cultivo de endocérvix, endometrio y líquido peritoneal; se otorgue a la paciente el tratamiento adecuado, oportuno y certero, logrando así una mayor eficacia terapéutica

Carcinogenicity of policosanol in mice: an 18-month study.

Policosanol (trade name Ateromixol) is a new cholesterol-lowering drug that has been isolated and purified from sugar cane wax. The effects of policosanol (50-500 mg/kg) administered orally for 18 months to male and female Swiss mice were investigated. No differences in daily clinical observations, weight gain, food consumption and mortality (survival analysis) between groups were found. Histopathological study showed that the frequency of neoplastic (benign and malignant) lesions was similar in the control and policosanol-treated groups. The lesions observed were similar to the spontaneous lesions in Swiss mice reported in previous studies. As no drug-related increase in the occurrence of malignant or benign neoplasm was found, nor acceleration in tumour growth in any specific group observed, this study shows no evidence of policosanol-induced carcinogenicity in Swiss mice.