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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 12
First page : ( 5757) Last page : ( 5764)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00997.1

Clinical adverse effects of Chemotherapy protocolusing 6-Mercaptopurine in Iraqi patients with Acute Lymphocytic Leukemia during Maintenance Phase

Hasan Mohammed Khudair1,*, Ghareeb Mowafaq Mohammed2, Mate Bassam Francis3, Aga Qutaiba Ahmed Ibrahim Al Khames4

1Department of Clinical Pharmacy, College of Pharmacy, University of Baghdad, Iraq

2Pharmaceutics Department, College of Pharmacy, University of Baghdad, Iraq

3Department of Hematology, Baghdad Teaching Hospital, Medical City Complex, Iraq

4Faculty of pharmacy, Philadelphia University, Jordan, qutaiba975@gmail.com

*Corresponding Author E-mail: mopharmacy@gmail.com, msc.phclinc@yahoo.com

Online published on 24 February, 2020.

Abstract

Objective

The study was aimed to find out the main clinical adverse effect of acute lymphocytic leukemia chemotherapy protocol. Acute lymphoblastic leukemia patients require long time continuation therapy to reduce the duration of moderately intensive chemotherapy to 12 to 18 months or less have given poor results in both children and adults. Thus, patients treated for two years or more. The most frequent adverse reaction to chemotherapy protocolis myelosuppression, hepatotoxicity, Hyperuricemia and hyperuricosuria, and immunosuppressive effect.

Material and Methods

Sixty ALL patients and sixty healthy subjects selected to participate in this study. The subjects involved two groups; group A Includes 60 patients with acute lymphoblastic leukemia on maintenance (continuation) phase receiving 6-mercaptopurine at least for a twomonth duration on daily doses based on body surface area. The total number of patients was 60 (40 male and 20 Female); among them, 44 were less than 18 years old (mean ± SD was 9.348 ± 5.131), and 16 were more than 18 years old (mean ± SD was 29.058 ± 7.9173); and, group B Includes 60 healthy subjects ’adults and children without any medical illnesses. Of this group there were (40 male and 20 Female), among them, 42 were less than 18 years old (mean ± SD was 8.926 ± 5.326), and 18 were more than 18 years old (mean ± SD was 28.645 ± 7.482). The mean ± SD of months using 6-MP was 13.94 ± 9.49 months, the mean ± SD of 6-MP dose for patients less than 18 years old was 43.77 ± 16.01 and for patients more than 18 years old was 88.23 ± 30.76. The mean ± SD of weight of patients less than 18 years old was 35.45 ± 9.66 and for patients more than 18 years old was 65.423 ± 13.654. Patients characteristics (such as age, weight, gender, B.S.A, date of the beginning maintenance phase, date of blood sampling, adverse effects of 6-mp and presence of other diseases obtained through patient interview. Complete blood count (Hb, W.B.C count, R.B.C count, platelets count, absolute neutrophils count), liver function tests (AST, ALT, ALP and total serum bilirubin T.S.B), renal function tests (serum creatinine and blood urea) and blood sugar concentration obtained at the same day of blood sampling for patient and control subjects were done.

Results

There was no significant change between the male and female in patient and control subjects (p= 0.8675) in regard to age and gender. The main adverse effect of the protocol was seen with higher incidence of jaundice, fever, decreased appetite, unusual tiredness or weakness, headache, stomach pain, dark urine and pale skin. Whereas, the fewer incidences among the common adverse effect are hemoptysis, painful or difficult urination, diarrhea, nausea and vomiting, chest pain and sore throat. The mean serum creatinine and BUN increased significantly in patients ² 18 year (mean ± SD 0.97 ± 0.13) (mean ± SD 24.44 ± 6.92) and > 18 year (mean ± SD 0.98 ± 0.12) compared to the control subjects (0.64 ± 0.19 and 0.64 ± 0.22) (14.87 ± 3.64 and 15.21 ± 0.22) consequently. The mean serum ALT, AST, ALP and T.S. bilirubin increased significantly in the patients compared to the control subjects (60.66 ± 14.26 vs. 31.52 ± 5.51), (45.71 ± 23.04 vs. 11.48 ± 7.05), ALP (99.63 ± 38.21 vs. 60.61 ± 19.52) and (1.61 ± 0.58 vs. 0.40 ± 0.14 mg/dl) consequently. The mean RBS increased significantly in the patients compared to the control subjects (166.93 ±87.56 vs.104.45 ± 16.74). The mean RBC and WBC count decreased significantly in the patients compared to the control subjects (3.68 ± 0.66 vs. 4.37 ± 0.94) and (3.48 ± 1.62 vs. 7.26 ± 1.70). The absolute neutrophil and absolute Lymphocyte count/μm3 were significantly less for patients than for control (1.36 ± 1.12 vs. 4.43 ± 1.27) and (0.81 ± 0.37 vs. 2.18 ± 0.64). The platelets counts *103 were significantly decreased in patients comparing to the control subjects(213.81 ± 83.78 vs. 344.07 ± 46.34). Hemoglobin mean were significantly less in patients comparing to the control subjects (11.43 ±1.51 vs. 14.55 ± 1.17).

Conclusions

In this study, our patients were higher in children and young study population with a male: female 2: 1. In addition to the leukopenia, the adverse effect was recorded from the patients was jaundice, fever, decreased appetite, and weakness. The less commonly documented adverse effects of 6-MPhave reported from our study was joint pain, heartburn, sores, and ulcer. There is an importance of long-term follow-up, especially for those diagnosed at a young age. Renal involvement is not uncommon in ALL. Renal involvement can present as an elevation in renal function test (creatinine and BUN). Although hematological malignancies commonly involve the liver, they rarely cause clinically significant hepatic disease. Metabolic disorders are common in ALL. Insulin resistance is emerging as a concern for long-term ALL survivors, as is diabetes. Diabetes, hypertension and cardiovascular events must evaluate.

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Keywords

Acute lymphocytic leukemia ALL, 6-Mercaptopurine, Renal toxicity, Hepatic toxicity, Hematological malignancies, Metabolic disorders, Insulin resistance.

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