Development of standard operating procedure [SOP] of a unani pharmacopoeial formulation

In various Unani pharmacopoeias thousands of formulations are present which have been formulated by eminent physicians of Unani System of Medicine. The majority of these formulations are based on plant origin drugs and their efficacy may get altered as a result of seasonal variation, use of different drying methods, their storage conditions and microbiai contamination. To avoid these alterations, standardization of drugs is necessary especially in case of compound formulations the use of Standard Operating Procedures [SOPs] for their manufacturing is essential. It will help to prepare a formulation repeatedly with the same quality. The present study was designed to develop the SOP of a Unani pharmacopoeial formulation i.e., Habbc Gule Aak [HG]. Total eight batches of HG were prepared with different conditions i.e., binder, particle size, time of drying and temperature of drying'. All the eight batches of HG were evaluated thrice for the hardness, friability and disintegration time. The batch with minimum friability, hardness nearest to standard value and minimum disintegration time as per pharmacopoeias was selected as final batch and all conditions regarding powder size, binder, temperature of drying and time of drying used in the preparation of frnal batch were fixed as its Standard Operating Procedure. Out of eight batches the Batch No. 2 with 150 micron particle size [100 mesh sieve], mucilage of 30% w/w samaghe arabi [binder], dried at 80°C for 150 minutes was selected as final batch. The final batch showed minimum friability [0.05 +/- 0.01], hardness nearest to the standard value [4.59 +/- 0.30] and considerable disintegration time [33.67 +/- 0.33]. The resulting SOP will be helpful in setting the pharmacopoeial standards of HG and the methodology of the work will help in the development of SOPs for other Unani formulations too

Oxidative stress and total antioxidant status in acute leukemia at diagnosis and post remission induction phase

This study evaluated the activity of superoxide dismutase [SOD1], glutathione reductase [GR] and total antioxidant status [TAS] in the hemolysate and sera of patients with acute leukemia [AL] at diagnosis, post remission induction phase and in healthy controls. However, total antioxidant status and glutathione reductase activities normalized after remission induction phase in acute myeloid leukemia [AML] only whereas levels of SOD were reduced but not achieved the normal level in acute lymphoblastic leukemia [ALL]. TAS activity showed no difference in either sex among any subtype of acute leukemia but glutathione reductase level was significantly higher in female ALL patients. Activity of SOD was elevated in T-cell ALL and acute myelomonocytic leukemia however; no significant difference in the activity of GR and TAS was noted. Levels of antioxidant were reduced insignificantly in patients who achieved complete remission

Vitamin D levels in patients of acute leukemia before and after remission-induction therapy

To determine the levels of 25-hydroxyvitamin [25[OH]D3] in patients with acute leukemia and the effect of remission-induction chemotherapy. This study was case control, all newly diagnosed patients of acute leukemia between the age of one to sixty years and residents of Pakistan were enrolled and evaluated. Those who were unwilling or unable to provide written informed consent were excluded. All selected patients [n=86] were grouped in to acute myeloid leukemia [AML] and acute lymphoblastic leukemia [ALL]. AML was further categorized as A1 before remission-induction [n=17] and B1 after remission induction [n=13], ALL was further categorized as A2 before remission-induction [n=31] and B2 after remission induction [n=25]. The 25-hydroxyvitamin [25[OH]D3] levels were measured in the sera of all patients [before and after remission-induction] by one step delayed chemiluminescent micro particle immunoassay [CMIA].We compared 25[OH]D3 levels in all patients before and after the remission-induction chemotherapy. A total of 86 patients were analyzed, in which 60 patients were male. Mean age was 24.39 years [range, 1 to 60 years]; the mean levels of 25[OH]D in group A1 [n=17] was 17.70 +/- 3.2 ng/ml, in group B1 [n=13] 14.06 +/- 2.4 ng/ml, 19.07 +/- 7.08 ng/ml in group A2 [n=31], while 10.59 +/- 3.9 ng/ml found in group B2 [n=25]. 25[OH]D3 insufficiency was evident subnormal in majority of patients with acute leukemia and 25[OH]D3 were further reduced after remission-induction as compared to untreated group, difference was statistically significant when compared with each group

Seropositivity of hepatitis C, hepatitis B and HIV in chronically transfused beta -thalassaemia major patients

The purpose of this study was to determine the frequency and trend of transfusion transmitted infections [TTI] in chronically transfused beta-thalassaemia major [TM] patients with reference to the duration of transfusions. A cross-sectional study was done on 160 beta-TM patients and 5517 healthy blood donors to find out the prevalence of HCV, HBV and HIV infections. Out of 160 patients, 21 cases [13.1%] were anti-HCV positive, 2 [1.25%] were HBsAg positive. HIV antibodies were not detected in any sample. However, 109 [1.9%] and 104 [1.8%] of 5517 blood donors were positive for HCV and HBV respectively. No donor showed HIV antibodies. Anti-HCV was positive in 9/111[8.4%] thalassaemics [< 10 years of age] while 11/49 [22%] [> 10 years of age] showing significant difference [p = 0.005] among the two groups. For the past 10 - 12 years the screening of blood has reduced the magnitude of the disease significantly as shown by the trend in two age groups. Further improvements need to be done to implement uniform screening throughout the country

JAK2V617F mutation in chronic myeloid leukemia predicts early disease progression

To determine the association of JAK2V617F mutation along with BCR-ABL translocation or Philadelphia chromosome in chronic myeloid leukemia with early disease progression to advanced stages [accelerated phase or blast crisis] and poor outcome. Case series. National Institute of Blood Diseases and Bone Marrow Transplantation, Karachi, from February 2008 to August 2009. All the newly diagnosed cases of BCR-ABL or Philadelphia positive CML were tested for JAK2V617F mutation by Nested PCR. Demographic data, spleen size, hemoglobin levels, white blood cell and platelet counts were recorded. Independent sample t-test was used for age, haemoglobin level and spleen size. Fisher's exact test was applied to compare disease progression in JAK2V617F mutation positive and negative cases. Out of 45 newly diagnosed cases of CML, 40 were in chronic phase, 01 in accelerated phase and 04 in blast crisis. JAK2V617F mutation was detected in 12 [26.7%] patients; 09 [22.5%] in chronic phase, none in accelerated phase and 03 [75%] in blast crisis. During a mean follow-up of 8 months, 03 patients in chronic phase transformed in blast crisis and 02 into accelerated phase. Overall 08 out 0f 11 [73%] JAK2V617F positive patients either had advanced disease or showed disease progression. Only 2 of 20 [10%] available patients, negative for the mutation, showed disease progression by transforming into blast crisis [p < 0.001]. No statistically significant difference was seen in the age, spleen size, haemoglobin levels, white blood cells and platelets counts in JAK2V617F positive patients. JAK2V617F mutation was detected in 26.7% cases of chronic myeloid leukemia. A significant proportion of them showed early disease progression

[Frequency of diabetes mellitus in skin tag patients in comparison with control group]

Background and Aims: Diabetes mellitus is one of the most common types of chronic disease leading to serious complications such as blindness, end stage renal disease [ESRD], neuropathy and cardiac disorders. Skin tag is a common benign skin tumor that its association with impaired carbohydrate metabolism has been reported in some studies. The aim of this study was to compare the frequency of diabetes and other carbohydrate metabolism disorders in patients with and without skin tag

Methods: In a case- control study on 200 individuals over 30 years old referring to Dermatology Clinic of Afzalipour Hospital, 100 individuals with at least 3 skin tags as case group and 100 individuals without skin tag as control group underwent FBS and standard GTT tests

Results: There was no significant difference between case and control groups in the frequency of diabetes [19% vs. 10%], IGTT [11%vs.13%] and IFG [19% vs. 15%]. Mean FBS and GTT were significantly higher in the case group compared to the control group. There was a positive correlation between the total number of skin tags and mean FBS [r= 0.33, P= 0.001] and GTT [r= 0.37, P= 0.000]. The frequency of diabetes in patients with at least 20 skin tags was 45.8%. Positive predictive value, negative predictive value, sensitivity and specificity of skin tag for the diagnosis of diabetes were 19%, 90%, 52% and 65% respectively

Conclusion: This study revealed that patients with skin tags are at a higher risk of carbohydrate metabolism disorders. Therefore, screening of patients with skin tag for carbohydrate metabolism disorders is recommended

histopathological changes and immunohistochemical findings of acute, chronic nonlupoid and chronic lupoid types of cutaneous leishmaniasis

Dry type localized cutaneous Leishmaniasis due to Leishmania tropica is one of the most prevalent cutaneous parasitic infections in Kerman province. It seems that cellular immune response and the nature of immune inflammatory cells comprising the inflammatory background play a determinant role in this infection. Skin biopsies of 53 patients with acute [<2 years duration], nonlupoid chronic [>/= 2 years duration] and lupoid chronic [new lesions around old scar] types of cutaneous leishmaniasis due to Leishmania tropica were studied by hematoxylin-eosin staining for evaluation of inflammatory cells and epidermal and dermal changes. Immunohistochemical staining was used to determine immunophenotypic patterns [CD1a, CD68, CD3, CD8, CD4, CD20] and to evaluate host immune response at tissue level, the correlation between the presence and concentration of certain cell types, and the clinical presentation and duration of disease. Mean percentages of epidermal and dermal Langerhans cells CD1a+ were higher in lupoid than in acute lesions. Also, the predominant T lymphocyte in acute, chronic and lupoid leishmaniasis was T CD8+. It seems that Langerhans cells CD1a+ are responsible for the suppression of the inflammatory response against L.tropica infection and by providing Leishmania antigens in a steady state induce tolerance to the Leishmania antigens and consequently cause cutaneous chronic lupoid leishmaniasis. This study also suggests that T CD8+ play an effective role in parasite elimination and in the process of healing of cutaneous leishmaniasis due to Leishmania tropica

Infection with Dactylogyrus spp. among introduced cyprinid fishes and their geographical distribution in Iran

In the present study, we reported infection with eighteen species of the genus Dactylogyrus, belong to the family Dactylogyridae from five breeder fish species, including common carp [Cyprinus carpio], grass carp [Ctenopharyngodon idella], silver carp [Hypophthalmichthys molitrix], big head carp [Hypophthalmichthys nobilis] and black carp [Myelopharyngodon piceus] which introduced and imported to iranian freshwaters from Russia, Romania, Hungary and China over the last 40 years. The infection was also found in Carassius auratus gibelio, it is not known when this fish species was introduced into the country. The Dactylogyrus spp. were as follows: Daclylogyrus achmerovi, D. anchoratus, D. aristichthys, D. baueri, D. dulikeity, D. cienopharyngodonis, D. extensus, D. hypophthalmichthys, D intermedius, D. intermedioides, D lamellotus, D. magnihamotus, D nobilis, D. sahuensis, D. suchengtaii, D taihuensis, D. vastator and D wegeneri. Among these, D. vastator and D. anchoratus infecting common carp and D. lamelIatus infecting grass carp are very harmful and were responsible for high mortalities observed in fry and fingerling production in Iran. Uncontrolled import of live fish into the country can lead to transmission of pathogenic monogeneans or other group of parasites to native fishes, causing a great economical and ecological threat to valuable native fishes. For example, transmission of D. anchoratus from common carp to Barbus sharpeyi, an important native fish species, despite of the high host-specificity of monogeneans, indicates the possibility of transmission of exotic monogenean parasites to native hosts. It is strongly suggested that the risk of introducing exotic pathogens along with importing fish or any other living organism to the country, should be assessed well in advance, in order to protect native species and the ecosystem

Arteriovenous thrombosis in chronic renal failure patients receiving renal replacement therapy

To determine the frequency of thrombotic complications and to identify factors associated with arteriovenous thrombosis in patients of chronic renal failure receiving renal replacement therapy. A descriptive study. The study was carried out at Sindh Institute of Urology and Transplantation [SIUT], Karachi, from May 2003 to December 2003. Of the 3000 patients evaluated, 61 End Stage Renal Disease [ESRD] patients on regular dialysis, having recent renal transplant, were selected for the study after informed consent. These patients had arteriovenous thrombosis with temporary central lines thrombosis and vascular access problems. Cases of congenital or acquired thrombotic disorders, e.g. with malignancy, DIG, liver disease, systemic lupus erythematosus or other immunologic diseases, pregnancy or women using oral contraceptives, were excluded. Similarly, patients taking any type of anticoagulant therapy during the preceding one week were not included in the study. Findings were recorded in a structured questionnaire. Laboratory analysis was done after clinical and radiological evaluation. Thrombophilia screening included antithrombin, protein C, protein S deficiencies and lupus anticoagulant. Forty-seven out of 61 patients selected were positive for thrombophilia screening with protein C deficiency in 26.2%, protein S deficiency in 16.3%, antithrombin in 5%, lupus anticoagulant in 13.1% and combined deficiency was observed in 16.3%. Of the 3000 patients, 61 with frequency of 2% were found to be deficient in one or had combined deficiency of these. Thus, the study of ESRD patients presenting with arteriovenous thromboembolism emphasizes the need to reconsider the perception that this clinical entity is rare and requires further studies

Triglyceride profile in dyslipidemia of type 2 diabetes mellitus

To evaluate ratios of serum triglycerides and cholesterol levels which may indicate postprandial lipid handling and to assess their role as prospective markers of dyslipidaemia in type 2 diabetes mellitus. Comparative, observational study. Bismillah Taqee Hospital, Karachi from July 2002 till December 2003. The study comprised 160 subjects, including 83 known type 2 diabetics [45 males, 38 females] and 77 age-matched controls [45 males, 32 females]. Fasting blood samples were analysed for serum triglycerides and total cholesterol, using automated chemistry analyzer. HDL-C was determined by precipitation method and LDL-C and VLDL-C were estimated by Friedewalds formula. LDL/HDL ratio and TG/HDL ratios were also calculated. The mean values for male and female diabetics were compared with that for the male and female non-diabetics respectively and tested for significance by paired t-test. Serum triglycerides and VLDL were raised in both male and female diabetics. No significant differences were observed in levels of serum total cholesterol, LDL, HDL and the LDL/HDL ratio. The mean value of the TG/HDL ratio for male diabetics was higher than that for the male non-diabetics [p=0.39]. A statistically significant difference was found in the TG/HDL ratios for the female diabetics and non-diabetics [p < 0.05]. In this study, type 2 diabetics showed marked hypertriglyceridaemia and raised TG/HDL ratio. The dyslipidaemia of diabetes predisposes to development of coronary heart disease and, therefore, evaluation of the TG:HDL ratio may provide a good tool to monitor and manage the lipid abnormalities in diabetics

[Frequency of contact dermatitis in patients with chronic dermatitis referring to dermatology clinics in Kerman]

Allergic and irritant compounds are frequent in nature, and the environmental allergic factors which can induce or exacerbate eczema are different and often unknown in different areas. The aim of this study was to determine the frequency of contact dermatitis in patients with chronic dermatitis referring to dermatology clinics in Kerman. In this descriptive study, standard patch test containing 24 allergens was done for 156 cases [56 males and 69 females] with confirmed chronic dermatitis who had been referred to Afzalipoor Hospital Dermatology Clinics. Evaluation of the results was done for every case 24, 48 and 72 hours after application of the patch test. In whole, 153 positive patch tests were seen in 66 [52.8%] cases of 125 patients who had been examined. The most common allergic agent was nickel sulfate detected in 20 [13.1%] patients [17 females and 3 males]. The hypersensitivity reaction to this agent was significantly more common in females than males [P<0.05]. Potassium dichromate with frequency of 11.1% [12 males and 5 females] was the second common allergic agent and males showed significantly more positive reaction to this agent than females [p<0.05]. There was no statistically significant difference according to the age and sex between groups with positive and negative patch test results [P>0.05]. As the causative agents of contact dermatitis are different in various areas, by doing patch test in each area the allergic agents can be detected for more appropriate preventive measures and treatment strategies. In this study, the first and second common allergens were respectively Nickel and Chrome compounds. Thiorum, Cobalt, benzocaine and theazolin compounds were in the third rank

[Effects of problem solving training on coping skills of suicidal clients]

Suicide is a primary health problem, requiring evidence-based information for prevention. Suicidal clients have difficulty in coping skills. Coping skills have important role in mental health. Cognitive therapies such as problem solving can improve coping skills and may be useful in the prevention of suicide. The Purpose of this study was to assess the effects of problem solving training on coping skills of suicidal clients. In this quasi-experimental study, subjects consisted of 80 suicidal clients selected by purposive sampling and randomly divided into two equal case and control groups. A demographic questionnaire and Coping Skills Scale [Blinghs and Mous] were used for data collection. Reliability and validity of the questionnaire were obtained by Cronbach's alpha, stability reliability and content methods. Both groups were first assessed in terms of their coping skills. 7-10 training sessions in the case group were hold 4 times a week for each client individually each lasted 30-45 minutes. Gholdfried and Davidson's method in problem solving training was provided for them. 2 weeks after completion of the training, coping skill test was carried out in both groups. Findings showed no significant difference in coping skill variables [emotion and problem focused] before the intervention [P>0.05] but the difference became significant after the intervention [P=0.000] in the case group. Problem solving training has significant effects on coping skills and, therefore, can be applied in the treatment of behavioral disorders. It may also prevent suicidal attempts in clients and promote their health condition

Allogeneic peripheral blood stem cell transplantation in patients with haematological malignancies

To report the initial data on allogeneic peripheral blood stem cell transplantation for haematological malignancies in Pakistan. Design: A single centre descriptive study. Place and Duration of Study: Bismillah Taqee Institute of Health Sciences and Blood Diseases Centre from September 1999 to June 2004. Patients and Patients with haematological malignancies were included who had received allogeneic PBSC transplantation of Filgrastim [rhG-CSF] mobilized peripheral blood stem cells from HLA-identical siblings [except one 5/6 antigen sibling] with Busulphan and Cyclophosphamide standard conditioning therapy in all patients. No patient received antibiotics for gut decontamination. Empirical antibiotics included Ceftriaxone and Amikacin for febrile neutropenia, oral Itraconazole for antifungal prophylaxis while oral acyclovir was used for antiviral prophylaxis. All donors and recipients were CMV IgG positive Cyclosporin A / Methotrexate were given for graft versus host disease [GvHD] prophylaxis. Stem cells were harvested using Haemonetics MCS+ cell separator. All patients received G-CSF starting from day +4 until their neutrophil count rose to normal. There were 21 patients with age range of 8-38 years and male to female ratio of 2:1. Engraftment was achieved in all patients; median time to absolute neutrophil count of > 0.5 x 109 /l was 10 days [range 8 ' 12 days] and platelet count of > 20 x 109 /l was 14 days [12'17 days]. Acute graft versus host disease [aGvHD] was seen in 7 patients; one patient had grade IV skin and hepatic GvHD; another patient had grade III gut GvHD, grade II GvHD was seen in 3 patients while grade I skin aGvHD was seen in 2 patients. Median hospital stay was 34 days. Treatment related mortality was seen in 3 patients [18%]. Chronic GvHD was seen in 5 patients. Four more patients died during the follow-up period. Malaria was seen in 2 while tuberculosis developed in one case. Relapse was seen in 2 patients. The estimated probability of survival at one hundred day, at one year and five years was 82, 47 and 40% respectively. Haematopoietic stem cell transplant programme can be developed in a developed country setting. Post transplant complications are similar to what have been reported in the developed countries. In endemic areas malaria could prove to be fatal if not recognised and treated early

Application of fibrin glue in maintaining post operative haemostasis in a thrombocytopenic patient: a novel approach case report

Here we report a case of chronic refractory autoimmune thrombocytopenic purpura [ITP] who presented with severe persistent thrombocytopenia, 3 months history of incisional hernia with aggravating symptoms. Considering the potential danger of acute obstruction, with its disastrous consequences, surgery was performed under cover of fibrin glue and hernia was repaired without any excess post operative bleeding

Peripheral blood stem cell transplantation in children with B-thalassemia major

To share the preliminary data on stem cell transplantation in Pakistan. Design: This is a single center retrospective analysis of the outcome of allogeneic peripheral blood stem cell [PBSC] transplantation in b-thalassemia major patients. Place and Duration of Study: Bismillah Taqee Blood Diseases Centre, Karachi; a tertiary care hematology center from September 1999 to September 2002. Patients and Twelve patients with b-thalassemia major received allogeneic PBSC transplantation from HLA identical sibling donors except in one case where mother was the donor. All patients received busulphan and cyclophosphamide conditioning therapy and cyclosporin A / methotrexate for graft versus host disease [GVHD] prophylaxis. Donors were primed with G-CSF for 4 days and stem cells were harvested using Haemonetics MCS + cell separator on 5th day. All patients received G-CSF starting from day + 4 until their neutrophil count rose to normal. Engraftment was achieved in all patients except one who required a second dose of bone marrow graft on day +21. Median time to achieve absolute neutrophil count of > 0.5 x 109 /l was 9.0 days [range 8 ' 31 days] and platelet count of > 20 x 109 /l was 14 days [12 ' 35 days]. Acute GVHD was seen in 3 patients, one patient had grade IV gut GVHD; another patient had grade III gut GVHD while third patient had grade II skin GVHD. Median hospital stay was 29 days. Six patients were well and transfusion independent 3 to 36 months posttransplant. One episode of primary graft failure required a second dose of bone marrow harvest. Another episode of graft rejection received two doses of donor lymphocytes infusion. There were 4 deaths due to grade IV gut GVHD because of uncontrolled systemic Candida infection and one due to hepatic veno-occlusive [VOD] disease. Allogeneic peripheral blood stem cell transplantation can be safely and economically carried out in Pakistan. Although there had been 4 deaths during 36 months follow-up, with increasing understanding and experience the outcome is expected to improve

Predictive value of MCV/RBC count ratio to discriminate between iron deficiency anaemia and beta thalassemia trait

Two forms of hypochromic microcytic anaemia i.e. iron deficiency and beta-thalassaemia trait are common in our society. This study reports the prevalence of iron deficiency anaemia and beta-thalassaemia trait and predictive value of MCV/RBC count ratio to discriminate between two. Venous blood was taken from 299 students of Karachi Medical and Dental College and Ziauddin Medical University in Na2 EDTA and analyzed by semi-automated Sysmex K-1000 haematology analyzer. MCV/RBC count ratio was used to discriminate between iron deficiency and beta-thalassaemia trait and > 14% was marked as iron deficiency. Hb electrophoresis was used as gold standard test for confirmation. Serum iron and TIBC was performed to confirm iron deficiency anaemia. Iron deficiency was found in 9% while beta-thalassaemia was seen in 3% students. MCV/RBC count ratio showed a positive predictive value of 91%. In areas where iron deficiency anaemia and beta-thalassaemia trait are common, MCV/RBC count ratio can be used to screen out beta-thalassaemia trait