Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach

Abstract: BACKGROUND: The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), designed to evaluate the effectiveness of a six-months regimen, assessed the adverse effects caused by the drugs. OBJECTIVE: Describe adverse effects due to MDT in U-MDT/CT-BR, comparing the uniform regimen (U-MDT) to the current WHO regimen (R-MDT). Patients and methods: After operational classification, patients were randomly allocated to the study groups. U-MDT PB and U-MDT MB groups, received the U-MDT regimen, six doses of MB-MDT (rifampicin, dapsone and clofazimine). R-MDT PB and R-MDT MB groups, received the WHO regimens: six doses (rifampicin and dapsone) for PB and 12 doses (rifampicin, dapsone and clofazimine) for MB. During treatment, patients returned monthly for clinical and laboratorial evaluation. Patients with single lesion were not included in this trial. RESULTS: Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints among 753 patients. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3% of the patients, glutamic oxaloacetic transaminase (GOT) above 40U/L in 29.5% and glutamic pyruvic transaminase (GPT) above 40U/L in 28.5%. Twenty-four patients (3.2%) stopped dapsone intake due to adverse effects, of whom 16.6% due to severe anemia. One case of sulfone syndrome was reported. STUDY LIMITATIONS: Loss of some monthly laboratory sample collection. CONCLUSIONS: There was no statistical difference regarding adverse effects in the R-MDT and U-MDT groups but anemia was greater in patients from R-MDT/MB group, therefore adverse effects do not represent a constraint to recommend the six-month uniform regimen of treatment for all leprosy patients.

Laboratory evidence for the hematopoietic potential of Beta vulgaris leaf and stalk extract in a phenylhydrazine model of anemia

This study was designed to provide laboratory evidence supporting the hematopoietic effect of Beta vulgaris (beet) leaf aqueous extract in phenylhydrazine-induced anemia model in albino rats. Extraction of the leaves/stalks was done by maceration in 30% hydro-ethanol for 48 h. An intraperitoneal injection of 20 mg/kg phenylhydrazine was applied for two consecutive days to develop hemolytic anemia on the 4th day after the 1st injection in 24 of 30 male albino rats. The animals were divided into 5 groups and received the following treatments: standard (ferrous ascorbate + folic acid; 13.5 + 0.135 mg/kg), B. vulgaris extract (100 and 200 mg/kg), or left untreated (normal and diseased controls). Blood samples were taken at 0, 4, 8, and 12 days of the experiment for hematological and clinico-chemical analysis. Beet leaf extract significantly restored the levels of red blood cells, white blood cells, hemoglobin, and hematocrit in dose- and time-dependent manners. Blood indices have been significantly corrected. Erythropoietin level was maintained at higher levels. Erythrocytic membrane oxidation biomarker (malondialdehyde) level was significantly reduced compared to the anemic untreated group. The extract exhibited potent, concentration (4-512 μg/mL)-dependent antioxidant activity indicated by the 2,2-diphenyl-1-picryl-hydrazyl (DPPH) assay, with IC50 value of 37.91 μg/mL. Beet leaf extract resulted in detection of flavonoid and phenolic compounds that may underlie its hematinic properties. These findings may indicate B. vulgaris as a good natural source for pharmaceutical preparations with hematopoietic effects and treatment of anemia and/or associated conditions.

Prevalência e fatores associados à presença de anemia em idosos do município de Viçosa (MG), Brasil / Prevalence and factors associated with the presence of anemia in the elderly of the municipality of Viçosa, State of Minas Gerais, Brazil

Resumo A anemia é o problema hematológico mais comum encontrado na população idosa. Com objetivo de avaliar a prevalência e os fatores associados à anemia em idosos no município de Viçosa (MG), foi realizado um estudo transversal, de base populacional. Os dados foram coletados de junho a dezembro de 2009, mediante inquérito domiciliar e realização de exames bioquímicos em 349 idosos. A prevalência de anemia foi de 11,7% (IC95% 8,3%-15,1%) e mostrou-se mais elevada entre os homens (15,4%), entre idosos com 80 anos e mais (30,0%) e naqueles que praticavam polifarmácia (16,8%). Os resultados evidenciaram determinantes de anemia semelhantes ao observado em países desenvolvidos. A real necessidade da polifarmácia deve ser avaliada na atenção à saúde dos idosos, com vistas a prevenir iatrogenias, dentre as quais a anemia está incluída.

Abstract Anemia is the most common hematological problem encountered in the elderly population. A cross-sectional, population-based survey was conducted to evaluate the prevalence and factors associated with anemia in the elderly in Viçosa (State of Minas Gerais). Data were collected by means of a household survey and conducting biochemical tests on 349 elderly between June and December 2009. The prevalence of anemia was 11.7% (95% CI 8.3% -15.1%) and was found to be higher among men (15.4%) among those aged 80 years and older (30%) and those who practiced polypharmacy (16.8%). The results obtained indicate anemia determinants similar to those observed in developed countries. The real need of polypharmacy should be evaluated in health care for the elderly, in order to prevent iatrogenic complications, of which anemia is one such complication.

Inosine triphosphatase allele frequency and association with ribavirin-induced anaemia in Brazilian patients receiving antiviral therapy for chronic hepatitis C

Inosine triphosphatase (ITPA) single nucleotide polymorphisms (SNPs) are strongly associated with protection against ribavirin (RBV)-induced anaemia in European, American and Asian patients; however, there is a paucity of data for Brazilian patients. The aim of this study was to evaluate the ITPA SNP (rs7270101/rs1127354) frequency in healthy and hepatitis C virus (HCV)-infected patients from Brazil and the association with the development of severe anaemia during antiviral therapy. ITPA SNPs were determined in 200 HCV infected patients and 100 healthy individuals by sequencing. Biochemical parameters and haemoglobin (Hb) levels were analysed in 97 patients who underwent antiviral therapy. A combination of AArs7270101+CCrs1127354 (100% ITPase activity) was observed in 236/300 individuals. Anaemia was observed in 87.5% and 86.2% of treated patients with AA (rs7270101) and CC genotypes (rs1127354), respectively. Men with AA (rs7270101) showed a considerable reduction in Hb at week 12 compared to those with AC/CC (p = 0.1475). In women, there was no influence of genotype (p = 0.5295). For rs1127354, men with the CC genotype also showed a sudden reduction in Hb compared to those with AC. Allelic distribution of rs7270101 and rs1127354 shows high rates of the genotypes AA and CC, respectively, suggesting that the study population had a great propensity for developing RBV-induced anaemia. A progressive Hb reduction during treatment was observed; however, this reduction was greater in men at week 12 than in women.

Association between IPTA Gene Polymorphisms and Hematological Abnormalities in Hepatitis C Virus-Infected Patients Receiving Combination Therapy

BACKGROUND/AIMS: Hematological abnormalities during hepatitis C virus (HCV) combination therapy with pegylated interferon alpha and ribavirin often necessitate dose reduction. Variants of the ITPA gene have been reported to protect against anemia during the early stages of HCV combination treatments but have also been associated with larger decreases in platelet counts. We aimed to identify the association between specific ITPA gene polymorphisms and hematological abnormalities in patients undergoing HCV combination therapy. METHODS: In this retrospective study, 175 patients treated with HCV combination therapy were enrolled at St. Martin De Porres Hospital in Taiwan between 2006 and 2012. Two single nucleotide polymorphisms (SNP) within or adjacent to the ITPA gene (rs1127354, rs6051702) were genotyped. We investigated the effect of ITPA gene variants on hematological abnormalities during the therapy. RESULTS: The ITPA rs1127354 minor variants were significantly associated with protection against anemia at week 4 (p=1.86 x 10(-6)) and with more severe decreases in platelet counts during HCV combination therapy. SNP rs6051702 was not associated with the hemoglobin decline to >3 g/dL at week 4 in our study (p=0.055). CONCLUSIONS: The ITPA SNP rs1127354 is a useful predictor of ribavirin-induced anemia in Taiwanese patients and may be related to more severe decreases in platelet counts during the early stage of HCV combination therapy.

Association between IPTA Gene Polymorphisms and Hematological Abnormalities in Hepatitis C Virus-Infected Patients Receiving Combination Therapy

BACKGROUND/AIMS: Hematological abnormalities during hepatitis C virus (HCV) combination therapy with pegylated interferon alpha and ribavirin often necessitate dose reduction. Variants of the ITPA gene have been reported to protect against anemia during the early stages of HCV combination treatments but have also been associated with larger decreases in platelet counts. We aimed to identify the association between specific ITPA gene polymorphisms and hematological abnormalities in patients undergoing HCV combination therapy. METHODS: In this retrospective study, 175 patients treated with HCV combination therapy were enrolled at St. Martin De Porres Hospital in Taiwan between 2006 and 2012. Two single nucleotide polymorphisms (SNP) within or adjacent to the ITPA gene (rs1127354, rs6051702) were genotyped. We investigated the effect of ITPA gene variants on hematological abnormalities during the therapy. RESULTS: The ITPA rs1127354 minor variants were significantly associated with protection against anemia at week 4 (p=1.86 x 10(-6)) and with more severe decreases in platelet counts during HCV combination therapy. SNP rs6051702 was not associated with the hemoglobin decline to >3 g/dL at week 4 in our study (p=0.055). CONCLUSIONS: The ITPA SNP rs1127354 is a useful predictor of ribavirin-induced anemia in Taiwanese patients and may be related to more severe decreases in platelet counts during the early stage of HCV combination therapy.

High incidence of zidovudine induced anaemia in HIV infected patients in eastern India.

Background & objectives: Zidovudine (ZDV) is the preferred nucleoside reverse transcriptase inhibitor in the first line antiretroviral regimen in India. It is known to be associated with life threatening toxicity like anaemia. This study was aimed at determining the prevalence of ZDV induced anaemia in HIV infected patients initiated on ZDV containing antiretroviral therapy regimen and also to find out the correlates, if any, for causing ZDV induced anaemia. Methods: This retrospective study was carried in ART Centre, Sir Sunderlal Hospital, Banaras Hindu University, Varanasi between March 2005 to December 2007. HIV infected patients registered at ART Centre were treated according to guidelines of National AIDS Control Organization (NACO). Patients (n=1256) with haemoglobin (Hb) >8 g/dl were prescribed ZDV based antiretroviral therapy regimens. Patients developing anaemia (<8 g/dl) with other causes of anaemia excluded were recorded. Correlation of baseline characteristics (age, gender, haemoglobin levels, weight, CD4 counts and WHO clinical stage) with risk of developing anaemia was also calculated. Results: Two hundred three (16.2%) patients on ZDV regimen developed anaemia (<8 g%); 7.9 per cent (n=100) of these developed severe anaemia (<6.5 g%). Females were more prone to develop anaemia (P=0.026). Age, weight, WHO clinical stage and CD4 counts had no relation to development of anaemia. Interpretation & conclusion: High incidence of ZDV induced anaemia seen in this study indicates regular monitoring of patients, particularly women on ZDV based antiretroviral regimens.

Pathology in children of HIV women.

Objective. To assess the frequency of perinatal pathology in children exposed to antiretrovirals in perinatal period. Methods. Retrospective observational cohort study. Data collected among uninfected children born to HIV-infected women followed up from 1994 to 2006 in a tertiary Hospital. 220 uninfected children were studied. Factors studied included maternal, obstetrical and pediatric variables. Results. The most common disorder found among children exposed to antiretroviral drugs was anemia (84%); 6,4% of children had neutropenia and more than 24% had thrombocytosis, a finding never described before. Prematurity (24%) and low birth weight (23.6%) rates were high. Several congenital malformations were found: Poland syndrome, angiomas, hypospadias, Pierre-Robin sequence, trisomy 8, craniostosis and others. Long-term follow-up revealed neurological, cardiological and ophthalmological pathologies. Conclusion. Some pathologies are frequent among children exposed to antiretroviral agents during perinatal life. It is crucial to carry out long-term studies to assess the safety of this therapy.

Cost-utility analysis of recombinant human erythropoietin in anemic cancer patients induced by chemotherapy in Thailand.

OBJECTIVE: To conduct a cost-utility analysis on recombinant human erythropoietin (rHuEPO) for treating anemic cancer patients induced by chemotherapy compared to blood transfusion alone under the Thai health care setting. MATERIALS AND METHODS: A health care provider's perspective was used to examine relevant costs and outcomes using the Markov model. Cost data were estimated based on the reference price set by the Ministry of Public Health. The effectiveness data were obtained from a systematic review of published literature. The results were presented in terms of incremental cost-effectiveness ratio (ICER) in Thai Baht per Quality Adjusted Life Years (QALYs) gained. A probabilistic sensitivity analysis method was performed. RESULTS: The ICERs of rHuEPO compared to blood transfusion alone were 3.7 and 2.7 millions Baht per QALY for patients with hemoglobin less than 8 g/dl and 8-9 g/dl, respectively. The rHuEPO required additional resources (more costly) with less benefit compared to blood transfusion for patients with hemoglobin 9-10 g/dl. CONCLUSIONS: The rHuEPO may be cost-ineffective for the treatment of anemia caused by chemotherapy in cancer patients in Thailand.

Adverse effects of antiretroviral treatment.

BACKGROUND: The introduction of highly active antiretroviral therapy (HAART) has led to significant reduction in acquired immune deficiency syndrome (AIDS)-related morbidity and mortality. Adverse drug reactions (ADRs) to antiretroviral treatment (ART) are however, major obstacles in its success. AIMS: We sought to study the adverse effects of ART in a resource-restricted setting in India. METHODS: Hundred patients on ART were studied prospectively over a period of two years. All patients were asked to visit the clinic if they developed any symptoms or on a monthly basis. They were screened clinically and investigated suitably for any ADRs. RESULT: Out of the 100 patients, ten patients did not come for follow-up; only 90 cases were available for evaluation. ADRs were observed in 64 cases (71.1%) - the maximal frequency of ADRs was seen with zidovudine (AZT) (50%) followed by stavudine (d4T) (47.9%), efavirenz (EFV) (45.4%) and finally, Nevirapine (NVP) (18.4%). Most common ADRs were cutaneous (44.4%) followed by hematological (32.2%), neurological (31.1%), metabolic (22.2%) and gastrointestinal (20%). Most common cutaneous ADRs observed were nail hyperpigmentation (14.4%) and rash (13.3%). Immune reconstitution inflammatory syndrome (IRIS) was observed as a paradoxical reaction to ART in 20 (22.2%) cases. CONCLUSION: To optimize adherence and thus, efficacy of ART, clinicians must focus on preventing adverse effects whenever possible, and distinguish those that are self-limited from those that are potentially serious.

Antianemic effect of once weekly regimen of epoetin alfa 40,000 units in anemic cancer patients receiving chemotherapy.

BACKGROUND: Anemia is a common problem in the cancer population that is the result of clinical consequences. It also has adverse effects on patients' perceived quality of life. Good management of anemia in the cancer population is therefore essential. A recent published clinical trial has demonstrated statistically significant increases in hemoglobin levels and significantly increased QOL assessment following the administration of recombinant erythropoietin. OBJECTIVE: To evaluate the effectiveness, the safety, and the quality of life by using once weekly dosing of Epoetin alfa (Eprex, Janssen-cilag) 40,000 units in the treatment of anemia in cancer patients receiving chemotherapy. SETTING: Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Chulalongkorn University Bangkok, Thailand. MATERIAL AND METHOD: This was an open label, non-randomized study, in 41 adult male and female anemic cancer patients who had non-myeloid malignancies in the upper area of the body part and hemoglobin ranging from 9-11 g/dL receiving chemotherapy at least 8 weeks with or without concurrent radiotherapy. The subjects were treated with Epoetin alfa 40,000 units once a week subcutaneously. If, the hemoglobin did not increase by > 1.0 g/dl after 4 weeks of treatment, the dose of Epoetin alfa was then increased to 60,000 units per dose subcutaneously at week 5. The Epoetin alfa treatment would continue for a total of 16 weeks. Clinical outcome was evaluated based on quality of life by using the linear analog scale assessment (LASA) and the functional assessment of cancer therapy-anemia (CU-QOL) instrument. Analyses were performed to determine the incremental change in QOL associated with hemoglobin increases. RESULTS: Seventy six percent of patients receiving Epoetin alfa subcutaneously showed good response with hemoglobin increases of > or = 1 g/dL (Hb level before and after = 9.82 +/- 0.78 g/dL and 12.56 +/- 1.49 g/dL, respectively; p < 0. 001). Improvement of all primary cancer- and anemia-specific QOL domains, including energy level and ability to do daily activities evaluated from LASA and fatigue assessed from CU-QOL, were significantly greater (p < 0.01) for week 16 (233.94 +/- 56.01 and 18.45 +/- 13.07) compared to the baseline (202.58 +/- 36.74 and 25.09 +/- 11.00). Epoetin alfa was well tolerated in all patients. CONCLUSION: Once weekly dosing of Epoetin alfa 40,000 units therapy is safe and effective in remodeling anemia and significantly improves the quality of life in cancer patients receiving chemotherapy. Therefore, the physician should maintain hemoglobin concentration of cancer patients in normal level to improve their quality of life through the chemotherapy period.

Effect of antiviral therapy on hematological parameters in patients with chronic hepatitis

To find out the effect of antiviral therapy on hematological parameters in patients of chronic hepatitis. Interventional descriptive study. Military hospital [MH] Rawalpindi Pakistan from May to Oct 2004. 31 patients admitted to M.H Rawalpindi for treatment of chronic hepatitis were studied. Their hematological parameters including Total Leucocyte count [TLC], Haemoglobin [Hb] and Platelet count [Plt] were recorded before starting antiviral therapy and then at 3 monthly intervals. All the patients were given Inj Alpha-Interferon [INF] and Tab Ribavirin as antiviral therapy. Data was collected over a period of 6 months. Descriptive statistics were applied to the recorded data using SPSS ver-10.0 for analysis. 31 patients with mean age +/- SD 38.58 +/- 8.85 years [range 16-49 years] were studied. There was mean hemoglobin [Hb] fall of 0.87g/dl at 3 months and 2g/dl at 6 months of antiviral therapy. Mean Total leukocyte count [TLC] fall of 1.30x10[9]/L at 3 months and 1.87x109/L was noted at 6 months. Similar downward trend was noted in Platelet [Plt] values with mean fall of 23.19x10[9]/mm[3] and 28.29/ mm[3] at 3 and 6 months of antiviral therapy respectively. 10% of the cases developed clinically significant anemia as evidenced by hemoglobin 11g/dl after 6 months of antiviral therapy. Clinically significant leucopenia [< 2.5x10[9]/l] was noted in 7% of the cases. This fall was noted only in first three months of treatment. There is significant decrimental response of hematological parameters to antiviral therapy

Protective role of Spirulina feed in a freshwater fish (Poecilia reticulata Peters) exposed to an azo dye-methyl red.

Acute toxicity of an azo dye-methyl red (5-40 ppm) was examined under starving conditions, on two groups of Poecilia reticulata--a freshwater fish, fed on different diets prior to their exposure to dye. Besides natural feed, fish of group-1 also received Spirulina feed for one month (feed population), whereas those of group-2 received only natural feed (non-feed population). The mortality data revealed non-feed population to be more tolerant to feed stress during acute toxicity study, whereas feed population exhibited better tolerance to the combined stress of both feed and methyl red; especially at higher concentrations of the latter. RBCs in methyl red treatments acquired different shapes (poikilocytosis) and an increase in their size (anisocytosis) was also noticed. Percentage of such abnormal RBCs was almost equal in both feed and non-feed populations, except at a lower concentration (5 ppm), at which percentage of poikilocytic RBCs was lesser in the feed population. RBC counts in the control non-feed fish (34.5 x 10(4)/mm3) were significantly lower than control feed population (50.0 x 10(4) /mm3). Their number decreased with an increase in methyl red concentrations in non-feed population (9-26%), but percent reduction in RBC counts was almost similar (20-26%) at various concentrations of methyl red (5-30 ppm) in the feed population. Despite reduction in RBC counts, feed population did not suffer from anemia in methyl red treatments, as evident by their RBC counts which were almost equal to control fish of non-feed population. The results suggest that Spirulina feed improves tolerance of test organism towards methyl red manifested by noticeable reduction in the cytotoxic effects on RBCs and a lower mortality rate at higher concentrations of dye.

Clinical benefits of epoetin alfa (Eprex) 10,000 units subcutaneously thrice weekly in Thai cancer patients with anemia receiving chemotherapy.

BACKGROUND: Recently the American society of clinical oncology and the American society of hematology have jointly launched the clinical practice guideline of epoetin usage in cancer related anemia patients The recommended starting dose is 150-300 unit/kg thrice weekly. The clinical outcome of epoetin alfa 10,000 units subcutaneously thrice weekly regimen has not been evaluated in Thai cancer patients with anemia yet. OBJECTIVES: To determine the clinical benefits and safety of epoetin alfa (Eprex) 10,000 units subcutaneously thrice weekly in anemic cancer patients receiving chemotherapy PATIENTS: The present study was an open label, non-randomized study. Adult patients were eligible for inclusion aged >18 years with a confirmed diagnosis of non-myeloid malignancy in the upper area of the body and scheduled to receive chemotherapy regardless of the concurrent radiotherapy. All patients had hemoglobin (Hb) level less than 11 g/dL, serum ferritin more than 100 ng/dL and had a life expectancy of at least 6 months. MATERIAL AND METHOD: All patients were initially treated with Epoetin alfa 10,000 units subcutaneously thrice weekly. The dose was up to 20,000 units after 4 weeks of therapy, if Hb level did not increase by > 1.0 g/dL. Treatment time was 16 weeks. Target Hb was 12 g/dL Blood transfusion and iron supplement was permitted. Efficacy Assessments: The primary efficacy end point was the proportion of responders (patients with an increase in Hb > or =1 g/dL). Secondary efficacy evaluation was change in Quality of life (QOL) scores by the Linear Analog Scale Assessment (LASA) and Quality of life-Chula (QOL-CU) scale. Statistical Analysis was t-tests, P < 0.05 was considered significant. RESULTS: Forty patients (21 men and 19 women) were enrolled. Twenty five patients (62.5%) had stage of disease in grade III or IV The mean Hb levels at baseline were 8.46 +/- 1.28 g/dL. Eight patients (20%) refused to complete the course during the study. Reasons for refusing to participate included lack of time, changing the resident area or disease progression. Twenty three of 32 patients (71.8%) were responders. These patients completed the study course and showed good response. Their mean Hb levels increased gradually and reach approximately 11 g/dl by week 4 and were maintained through week 16. The significant difference in mean Hb level of baseline was initially found at week 4 of the study (10.26 +/- 1.95 g/dl; p = 0.001 vs baseline). The LASA score increased in all of three items including level of energy, ability to do daily activities, and overall QOL but not statistical significance. However, the improvement of quality of life of cancer patients, evaluated by QOL-CU, was significantly apparent after treatment, (p < 0.05). The most common adverse events were grade I flu like symptoms (17.5%) and recovered the next day. CONCLUSION: Epoetin alfa (Eprex) 10,000 units thrice weekly significantly increased the hemoglobin levels, achieving the target hemoglobin and sustained the level in cancer patients with anemia receiving chemotherapy. Clinical benefits on functional status and quality of life were also improved. The treatment was well tolerated.

Bi-weekly Chemotherapy of Paclitaxel and Cisplatin in Patients with Metastatic or Recurrent Esophageal Cancer

Although various combinations of chemotherapy regimens have been tried for patients with esophageal cancer, their duration of survival is extremely poor. In this study, we investigated the safety and clinical efficacy of paclitaxel and cisplatin chemotherapy in metastatic or recurrent esophageal cancer. 32 patients enrolled in this study and the median age was 60 yr. Of all the 32, 28 patients (88%) had been treated previously, 22 of them with chemotherapy or radiation therapy. All patients in the study received biweekly paclitaxel (90 mg/m2) followed by cisplatin (50 mg/m2). One patient (3%) responded completely, and 12 patients (38%) showed a partial response; in 9 patients (28%) the disease remained stable, and in 10 patients (31%) it progressed. The objective response rate was 41%. The median duration of response was 4.8 months, and the median overall survival in all patients was 7 months. The 1-yr and 2-yr survival rates were 28.1% and 7.1%, respectively. Grade 3 or 4 of neutropenia and anemia were observed in 6 (19%) and 5 (16%) patients, respectively. The major non-hematologic toxicity was fatigue, but most of them could manageable. In conclusion, biweekly paclitaxel and cisplatin is effective in patients with metastatic or recurrent esophageal cancer.

Pharmacological and haematological study of shol fish (Channa striatus) skin extract on experimental animal.

Snake head fish Channa striatus (locally called 'shol') skin extract (SFSE) was examined for certain pharmacological and haematological effects on experimental animals. LD50 of SFSE was found to be 6 mg/20gm (iv) in male albino mice. SFSE potentiated pentobarbitone induced sleeping time in male albino mice and produced hypothermia. Low dose of SFSE decreased respiratory rate in rat and guineapig and high dose produced apnoea leading to death. On isolated toad and guineapig heart, SFSE significantly decreased rate and amplitude of contraction leading to temporary blockade, which returned after repeated wash. On isolated nerve muscle preparations, SFSE produced irreversible blockade of twitch response. SFSE induced quick contraction on isolated guineapig ileum, which was antagonised by atropine and cyproheptadine. SFSE did not possess haemolytic and haemorrhagic activity but produced anaemia in male albino mice. A neurotoxic compound (fluoroscent and ninhydrin positive) was isolated from SFSE by thin layer chromatography. This compound (CS-NT) was lethal in male albino mice, produced death by apnoea in rat and produced irreversible blockade of isolated nerve-muscle preparation. This study confirms that the skin of Channa striatus possesses toxic, and lethal components, which needs further detailed study.

Effect of dimecron on the blood parameters of Heteropneustes fossilis.

The effects of an organophosphate insecticide. dimecron. has been studied on certain haematological parameters, viz., haemoglobin concentration, RBC number, haematocrit, O2 carrying capacity of blood, etc. of Heteropneustes fossilis following exposures to the LC50 for 24 h and 96 h and 1/10 and 1/50 parts of 96 h LC50 for 90 days. There was a significant decrease in the Hb%, RBC number, HCt% and O2 carrying capcity of blood. But, there was significant increase in the MCH and MCV values following both acute and chronic exposures. The results indicate possible induction of anaemia in the exposed fish.

Hepatic and haematological adverse reactions associated with the use of multidrug therapy in leprosy--a five year retrospective study.

This study analyses retrospectively some of the risks associated with the use of WHO-multidrug therapy (MDT) in Sri Lanka. Case records of 3,333 new cases of leprosy attending the Central Leprosy Clinic in Colombo during 1991-1995, were analysed for adverse drug reactions involving the liver and blood. There were 81 reports of suspected hepatic or haematological adverse reactions associated with the use of MDT, of which 39 were classified as haemolytic anaemia, 25 as toxic hepatitis, 2 as methaemoglobinaemia and 15 as anaemia. Dapsone, was incriminated in the majority of adverse reactions (72%). Adverse drug reactions were more common in female than male subjects (55% vs 45%; P < 0.5), but there was no significant differences between the age groups. Majority of adverse reactions was seen within the first three months of initiation of MDT. This study in no way undermines the benefits of MDT but highlights the risks and suggests measures to minimize these risks.