Effect of sertraline on complications and survivalafter Hematopoietic Stem Cell Transplantation

سال انتشار: 1397
نوع سند: مقاله کنفرانسی
زبان: انگلیسی
مشاهده: 475

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شناسه ملی سند علمی:

AMSMED19_036

تاریخ نمایه سازی: 1 دی 1397

چکیده مقاله:

Introduction and background: Previous studies have found a connection between psychiatric problems and post-hematopoietic stem cell transplantation (HSCT) complications including acute GVHD, infection and sepsis. We sought to evaluate the effect of sertraline on engraftment time, hospitalization period, mortality, and post-transplantation complications in HSCT recipients with depression and/or anxiety. Methods: This was a double-blind, randomized, placebo-controlled trial. The trial has been registered in Iranian Registry of Clinical Trials (IRCT 201310083210N4). The study was performed from July 2013 until August 2014 in the HSCT center of Taleghani Hospital, affiliated with Shahid Beheshti University of Medical Sciences, Tehran, Iran. The study protocol was approved by Taleghani Hospital Ethics committee. Informed consent was obtained from all individual participants included in the study. We recruited 47 adults aged 18–60, who were candidates for autologous or allogeneic HSCT with major depression and/or anxiety disorder diagnosed by an expert psychiatrist and the severity of depression, was evaluated via the Hospital Anxiety and Depression Scale (HADS) questionnaire. Patients who met the criteria were allocated into either placebo or sertraline group by simple randomization method. They were trained to take 50 mg of oral tablet of sertraline or placebo daily for the first week and then 100 mg for the following 7 weeks. Both placebo and sertraline tablets were prepared and packaged by the same manufacturer (Sobhan™ Pharmaceutical Company, Rasht, Iran), were visually identical and labelled with a code number from the random list. Occurrence of early post-HSCT complications and adverse effects including infection (viral, bacterial, and fungal), mucositis, nausea and vomiting, diarrhea, pain (post- and pre-transplantation), renal toxicities and liver complications (cholestatic and hepatocellular) were recorded. Severity of these complications was evaluated using National Cancer Institution (NCI) Toxicity Criteria. Occurrence of acute graft-versus-host disease (aGVHD) in the first 100 days post transplantation, and veno-occlusive disease (VOD) were recorded and their grading was done according to International Bone Marrow Transplantation (IBMTR) grading system Registry and modified Seattle clinical criteria, respectively. Neutrophil and platelet recovery time were documented, too. Time to engraftment was defined as absolute neutrophil count (ANC) > 500/μL for three consecutive days and platelet count > 20,000/μL for seven) consecutive days without requiring transfusions. All of the mentioned factors were evaluated during the hospitalization period and until six months after transplantation, in regular patients’ appointment every two weeks or sooner (when needed). Hospitalization length and mortality (until 6 months post-transplantation) were documented for all patients, too. We documented occurrence and severity of early post-HSCT complications, including infection, mucositis, nausea and vomiting, diarrhea, pain, renal toxicities and liver complications, acute graft-versus host disease, and veno-occlusive disease, as well as time to engraftment time, length of hospitalization and 6-month mortality. Results: Overall 56 patients participated in the study (sertraline group n = 30, placebo group n = 26). Of the complications, only mortality and readmission up to 6 months post transplantation were significantly higher in the placebo group compared to sertraline group (P values = 0.040, 0.028, respectively). There were no significant differences for other complications between the groups. Mean engraftment time was significantly lower in the sertraline group (P value = 0.048). This study provides evidence that sertraline positively influences engraftment time, readmission, and mortality after HSCT. Discussion and conclusion: Animal studies showed that bone marrow stem cells have different receptors for some neurotransmitters such as norepinephrine and glucocorticoids, which regulate their proliferation and differentiation. On the other hand, depression and anxiety can accompany dysregulation of secretion of these neurohormonal mediators. As a result, psychological problems can affect engraftment time by dysregulation of the mediators. So, it seems reasonable that the use of antidepressants (like sertraline) could decrease engraftment time in HSCT patients, by decreasing depression and anxiety, and therefore, by regulation of the neurohormonal mediators in these patients.

نویسندگان

Maryam Mehrpooya

Department of Clinical Pharmacy, School of Pharmacy, Hamedan University of Medical Sciences, Hamedan, Iran

Zahra Ganjirad

Student Research Committee, School of pharmacy, Hamedan University of medical sciences, Hamedan, Iran