الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
ESRD patients experience UP at a frequent and disturbing rate, which significantly affects their quality life and mortality. Although the pathogenesis of UP remains obscure, most of the studies attribute the pathophysiology of UP to inflammatory states. Sertraline hydrochloride is a selective serotonin reuptake inhibitor is one of the drugs that can modulate the inflammatory markers and cytokines. It has established improvement in pruritus in patients with cholestatic pruritus. Few studies in the literature suggested the role of sertraline in relieving UP. Our study was constructed to verify this role.
We conducted a double-blinded, placebo-controlled, multicentre randomized clinical trial which enrolled sixty patients from the dialysis units in Alexandria. We included ESRD patients with mild, moderate or severe pruritus who had been assigned to regular long-term HD (thrice-weekly, four-hour HD sessions for more than 30 days), aged 18–80 years. Patients were randomly assigned using block randomization method to receive sertraline 50 mg twice daily or placebo for 8 weeks. We excluded patients with primary skin diseases including eczema, psoriasis, allergic dermatitis or any drug rash and those with peripheral neuropathy, thyroid disease, leukemia, lymphoma, liver disease, systemic lupus erythematosus or pregnancy were excluded. Another criteria of exclusion were emollients cream, antihistamine, opioid antagonist, immunosuppressants, cholestyramine, corticosteroids or UVB phototherapy use within 1 month of the study. Also patients with calcium X phosphorus (Ca X P) >55.0 mg2/dl2, P >5.5 mg/dl, parathyroid hormone (PTH) >450 pg/ml or selective serotonin reuptake inhibitors intolerance were excluded as well.
All patients were subjected to full history taking with emphases on demographic data, the cause of ESRD, comorbid conditions, the vintage of HD and drug history. Thorough physical examination with a special focus on cutaneous examination was done. Laboratory investigations included complete blood count, serum phosphorus, serum calcium, serum PTH, serum sodium, serum potassium, serum creatinine, blood urea, serum albumin, serum triglycerides, ALT, AST, total bilirubin.
Assessment of pruritus was done before and after the course of treatment (8 weeks) through the VAS and the 5D itch scores.
The results of our study showed that:
• There was a statistically significant relation between VAS score and sex. Female patients reported a significantly higher VAS score compared to males.
• There was a statistically significant positive relation between blood urea and UP intensity in both VAS and 5D scores.
• There was also a statistically significant positive relation between both scores and serum ferritin.
• There was no statistically significant relation between UP intensity in both scores and ESRD etiology, HD vintage, pruritus duration or any other laboratory parameters.
• At the end of the study, in the sertraline group the VAS and 5D scores decreased significantly. In the placebo group after 8 weeks, the VAS score showed a very slight non-significant decrease and the 5-D score increased. Furthermore, the VAS and 5-D scores’ change (Δ) in sertraline group was significant.
• Also, at the end of the study, the percentage of patients with severe and very severe pruritus grade decreased significantly in both scores in the sertraline group compared to placebo.
• There was no significant difference in the reported adverse events between both groups.