Abstract:
Reference values are very important in clinical management of patients, screening participants for enrolment into clinical trials and for monitoring the onset of adverse events during these trials. The aim of the study was to establish reference ranges for biochemical and hematological parameters for the population of Bangladesh.
A total of 758 adults between 18 and 65 years apparently healthy members of the Bangladeshi population included Dhaka, Chittagong, Rajshahi and Khulna were selected and enrolled in this Prospective study as reference individuals who fulfill the CLSI selection criteria. Out of the 758 participants recruited for the study, only 730 were involved in the study, 436(59.726%) males and 295(40.274%) females.
Reference ranges for twenty biochemical and fifteen hematological analyses were constructed by using the non parametric methods to estimate 2.5 and 97.5 percentiles of distribution. Partitioning of the data were performed for two sex groups (males and females) and two age groups (less than forty years and more than forty years) when applicable.
The reference ranges for the biochemical analyses were found for Fasting blood glucose [ 4.0 -6.1 mmol/L]; Creatinine [ males 0.76 - 1.37 mg/dl, females 0.52 - 1.08 mg/dl]; Urea [the males 13 -38.3 mg/dl, the females 10.5 - 34 mg/dl, ];Uric acid [ males 3.48 - 7.5 mg/dl, females 2.5 - 6.41mg/dl];Serum sodium [ males 134.8 - 145 mmol/L, females 134.8 - 142mmol/L];Serum potassium 3.4 - 5.0mmol/L]; Serum chloride[ 99 - 108 mmol/L]; Serum calcium [ 2.2 - 2.65 mmol/L]; Serum magnesium [ 0.75 - 1.05 mmol/L]; Serum Inorganic phosphate[combined(0.85 - 1.59 mmol/L]; Serum Cholesterol [ 122 - 249 mg/dl, less than 40 years old subjects 131.4 - 240 mg/dl and more than 40 years old subjects 117 - 270 mg/dl]; Serum HDL. Cholesterol [males 24 - 52 mg/dl, females 27 - 59mg/dl,];Serum LDL. Cholesterol [ 69 - 167 mg/dl, less than 40 years old subjects is 71.5 - 162 mg/dl and more than 40 years old subjects 54.59 - 176mg/dl]; Serum triglyceride[males 62.5 - 297 mg/dl, females 45 - 237 mg/dl, less than 40 years old subjects is 60 - 253 mg/dl and more than 40 years old subjects 45 - 282 mg/dl]; Serum total protein [ 64 - 82 g/L,]; Serum albumin [ 33 - 50 g/L]; Serum bilirubin- total[males 0.35 - 1.35 mg/dl, females 0.33 - 0.97mg/dl,]; Serum Alanine aminotransferase [males 10 - 57 U/L, females 9 to 48 U/L];Serum aspartate aminotransferase [males 12 - 39 U/L, females 12 - 34 U/L,]and Serum alkaline phosphatase [males 45.03 -125 U/L, females 41.47 - 118 U/L,].
Reference ranges for hematological parameters were observed for, RBC [males 4.4 - 5.6 ×106/µl, the females 3.9 - 5.2 ×106/µl];hemoglobin [males 12.4 - 16.55 gm/dl, females 10.3 - 13.6 gm/dl]; hematocrite [males 36.5 - 48.8 %, females 32.1 - 41.7%]; MCV [males 74.5 - 94 fl, females 70.6 - 94.3 fl]; MCH [males 24.6 - 32.3 pg, females 23.0 - 31.6 pg];MCHC [males 31.9 -35.9gm/dl, females 30.2 - 35.2 gm/dl];RDW-CV [ 12.2 - 15.1 %];Platelets [males 151 - 331× 103/µl, the females 175 - 420×103/µl];MPV [ 9.2 - 12.7 fl]; WBC [ 4.5 - 11 ×103/µl];Neutrophil [ combined (M&F) 45.6 - 72.1 %];Lymphocyte [ 21.6 - 47.7 %];Monocyte [ 2.2 - 6.7 %]; Eosinophil [ 0.7 - 6.9 %] and Basophil [ 0.0 - 0.3 %]
This study established the importance of sex and age specific reference intervals. The data was broadly divided into two sex groups (males and females) and two age groups (based on less than forty years and more than 40 years) . Significance between two groups were carried out by p value with 90% confidence intervals values and clinical consideration.
Reference ranges for Creatinine, Urea, Uric acid, Sodium, HDL. cholesterol, Triglyceride, Total Bilirubin, Alanine amino Transferase (ALT), Aspartate amino Transferase (AST) and Alkaline phosphatase (ALP) and hematological parameters RBC, hemoglobin , HCT, MCH, MCHC, MCV and platelets are finally significant for sex difference. The study also showed reference ranges for all hematology parameters are finally not significant for age difference only urea, creatinine and lipid profile are finally significant for age difference in biochemistry parameters.
In conclusion, the findings of this study provide sex and age specific reference range values for healthy adults population in Bangladesh. Reference ranges in the study some of which were different from those reported in literature. Reference values established by this study could have paramount importance for quality of health care in the clinical management of patients. Further nationwide study where included large sample volume should be carried out to establish the biochemical and hematological reference values of the Bangladeshi population as a whole.
Description:
This thesis is Submitted to the Department of Biochemistry and Molecular Biology, University of Rajshahi, Rajshahi, Bangladesh for The Degree of Master of Philosophy (MPhil)