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    "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">Dear Editor&#44;</span></p><p class="elsevierStylePara">We present a case of kidney transplant recipient who developed a rare&#44; life threatening&#44; lower GI bleeding six months after the transplantation&#44; possibly associated with MMF treatment&#46;</p><p class="elsevierStylePara">The most common side effects of MMF are gastrointestinal &#40;GI&#41; disturbances &#40;nausea&#44; vomiting&#44; abdominal discomfort&#44; diarrhea or constipation&#41;&#44; hematological disorders&#44; hepatic dysfunction etc&#46;<span class="elsevierStyleSup">1&#44;2</span> GI bleeding requiring hospitalization has been observed in approximately 3&#37; of renal transplant patients&#44; GI perforations have rarely been observed&#46;<span class="elsevierStyleSup">1</span></p><p class="elsevierStylePara">A 73-year-old Caucasian male kidney transplant patient was hospitalized due to profuse haematochezia&#46;</p><p class="elsevierStylePara">Six months prior to admission the patient received a renal transplant from a deceased donor due to an end stage renal disease&#46; For induction therapy the patient received mycophenolate mofetil 1g and daclizumab 75mg preoperatively&#46; Prednisone in a dose of 500mg was administrated intraoperatively&#46; On the second post transplant day tacrolimus was introduced&#46; The patient was discharged from the hospital with immunosuppressive regimen consisting of mycophenolate mofetil 750mg bid&#44; tacrolimus 3mg bid and prednisone 20mg plus pantoprazole 40mg&#46;</p><p class="elsevierStylePara">At admission&#44; laboratory findings showed severe posthemoragic anemia &#40;hemoglobin level 62g&#47;L&#41;&#44; slightly elevated kidney function parameters &#40;BUN 13&#44;9mmol&#47;L&#44; creatinine 137&#181;mol&#47;L&#41; and clinical signs of hipovolemic shock&#46; Coagulation parameters were within normal ranges&#46;</p><p class="elsevierStylePara">Because of severe haematochezia the patient was admitted to gastroenterology intensive care unit where erythrocyte transfusions and crystalloid infusions were given for initial stabilization&#46; His immunosuppressive therapy was continued and consisted of mycophenolate mofetil 750mg bid&#44; tacrolimus 3mg bid and prednisone 20mg plus pantoprazole 20mg qd&#46;</p><p class="elsevierStylePara">Two days upon admission a new episode of profuse haematochezia occurred and after basic bowel preparation&#44; urgent colonoscopy was performed&#46; Diverticular disease of left colon was found with intense bleeding in several diverticules which disabled local haemostatic therapy &#40;Figure 1&#41;&#46; After rinsing left colon with saline and epinephrine solution an octreotide therapy was administered &#40;500mL saline with 0&#46;6&#181;g octreotide&#44; 40mL&#47;hour&#41;&#46; Repeated erythrocyte transfusions were given&#46; In total&#44; the patient received eight erythrocyte units during a period of three days&#46; In consultation with nephrologists&#44; MMF dose was reduced to 250mg bid&#44; and prednisone to 8mg while the dose of tacrolimus remained unchanged&#44; 3mg bid&#46;</p><p class="elsevierStylePara">The following day the bleeding had stopped with slow recovery in hemoglobin level&#46; An ultrasound of kidney graft revealed normal kidney parenchyma with slightly increased arterial resistance index of 0&#46;75 at the level of interlobar arteries&#46;</p><p class="elsevierStylePara">At a discharge&#44; on the 9<span class="elsevierStyleSup">th</span> day the laboratory findings were satisfactory &#40;hemoglobin level 133g&#47;L&#44; BUN 7&#44;9mmol&#47;L and creatinine 126&#181;mol&#47;L&#41;&#46; Suggested maintenance immunosuppressive therapy consisted of mycophenolate mofetil 250mg bid&#44; tacrolimus 2mg bid and prednisone 8mg daily&#46; The patient is well without symptoms of GI toxicity or rejection for 5 months&#46;</p><p class="elsevierStylePara">MMF is used in treatment regimens as an immunosuppressive agent in both solid organ and bone marrow&#47;peripheral blood stem cell transplantation&#44; as well as in treatment of autoimmune disorders&#44; such as lupus&#46;<span class="elsevierStyleSup">3</span> Drug effects are mediated via the active metabolite&#44; MPA which seems to be responsible for GI toxic effects&#46; GI adverse events are common following renal transplantation and all immunosuppressive regimens have been associated with such events&#46; They are the most frequent problems associated with MMF therapy occurring in up to 20&#37;<span class="elsevierStyleSup">4</span> or&#44; in some studies up to 40&#37;<span class="elsevierStyleSup">5</span> of renal transplant recipients&#46; Such adverse events can extend along the entire GI tract&#44; and can vary in severity from those which are mild &#40;nausea&#44; discomfort&#44; appetite loss&#41; and do not require altering immunosuppressive regimen to those which are more severe or even life threatening &#40;severe diarrhea&#44; GI tract ulcerations&#44; hemorrhage and perforations&#41;&#46;<span class="elsevierStyleSup">4&#44;6</span></p><p class="elsevierStylePara">The etiology of GI disorders following transplantation is not well understood&#46; Because of enterocyte dependency for <span class="elsevierStyleItalic">de novo</span> purine synthesis MMF exposure could thus restrict the ability of intestinal epithelial cells to maintain normal barrier function&#44; or decrease their capacity to recover from damage&#46;<span class="elsevierStyleSup">7</span></p><p class="elsevierStylePara">Our patient has experienced a life threatening&#44; severe lower GI bleeding which reoccurred within 2 days upon initial stabilization while on a stable immunosuppressive regimen&#46; Upon dose reduction&#44; the bleeding had stopped&#44; indicating the possible adverse effect of MMF&#46;</p><p class="elsevierStylePara">A database from the United States Food and Drug Administration&#8217;s &#40;US FDA&#41; Adverse Event Reporting System &#40;AERS&#41;&#44; containing more than 4&#44;000&#44;000 adverse events reported between 2004 and 2011&#44; has a record of 9 cases of haematochezia &#40;0&#46;02&#37;&#41; associated with MMF treatment &#40;<a href="http&#58;&#47;&#47;www&#46;drugcite&#46;com&#47;" class="elsevierStyleCrossRefs">www&#46;drugcite&#46;com</a>&#59; accessed Feb 1&#44; 2012&#41;&#46;</p><p class="elsevierStylePara">We have reported this case to the Croatian National Drug Agency and in feedback letter have been informed that it is a serious&#44; unexpected adverse drug reaction&#44; possibly associated with MMF treatment&#46; A total of 16 cases have been reported to the WHO Adverse Drug Reaction Monitoring Center with two fatal outcomes &#40;WHO&#44; UMC VigiBase&#44; 29<span class="elsevierStyleSup">th</span> November 2011&#41;&#46;</p><p class="elsevierStylePara">Clinicians should be aware of possible&#44; rare&#44; but life threatening&#44; lower GI bleeding associated with MMF treatment in renal transplant patients&#46; Special caution should be given to patients with digestive system disease even if asymptomatic&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Conflict of interest<br></br>&#160;<br></br><br></br></span></p><p class="elsevierStylePara">The authors declare that there is no conflict of interest associated with this manuscript&#46;</p><p class="elsevierStylePara"><a href="grande&#47;11512&#95;16025&#95;30726&#95;en&#95;f111512&#46;jpg" class="elsevierStyleCrossRefs"><img src="11512_16025_30726_en_f111512.jpg"></img></a></p><p class="elsevierStylePara">Figure 1&#46; 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Mycophenolate mofetil induced severe, life threatening lower gastrointestinal bleeding - Case report
Goran Hausera, Ivan Bubicb, Vera Vlahovic-Palcevskic, Josip Spanjold, Davor Stimaca
a Department of Gastroenterology, Clinical Hospital Centre, Rijeka, Croatia,
b Nefrology Department, Clinical Hospital Centre, Rijeka, Croatia,
c Department of Clinical Pharmacology, Clinical Hospital Centre, Rijeka, Croatia,
d Department of Urology, Clinical Hospital Centre, Rijeka, Croatia,
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For induction therapy the patient received mycophenolate mofetil 1g and daclizumab 75mg preoperatively&#46; Prednisone in a dose of 500mg was administrated intraoperatively&#46; On the second post transplant day tacrolimus was introduced&#46; The patient was discharged from the hospital with immunosuppressive regimen consisting of mycophenolate mofetil 750mg bid&#44; tacrolimus 3mg bid and prednisone 20mg plus pantoprazole 40mg&#46;</p><p class="elsevierStylePara">At admission&#44; laboratory findings showed severe posthemoragic anemia &#40;hemoglobin level 62g&#47;L&#41;&#44; slightly elevated kidney function parameters &#40;BUN 13&#44;9mmol&#47;L&#44; creatinine 137&#181;mol&#47;L&#41; and clinical signs of hipovolemic shock&#46; Coagulation parameters were within normal ranges&#46;</p><p class="elsevierStylePara">Because of severe haematochezia the patient was admitted to gastroenterology intensive care unit where erythrocyte transfusions and crystalloid infusions were given for initial stabilization&#46; His immunosuppressive therapy was continued and consisted of mycophenolate mofetil 750mg bid&#44; tacrolimus 3mg bid and prednisone 20mg plus pantoprazole 20mg qd&#46;</p><p class="elsevierStylePara">Two days upon admission a new episode of profuse haematochezia occurred and after basic bowel preparation&#44; urgent colonoscopy was performed&#46; Diverticular disease of left colon was found with intense bleeding in several diverticules which disabled local haemostatic therapy &#40;Figure 1&#41;&#46; After rinsing left colon with saline and epinephrine solution an octreotide therapy was administered &#40;500mL saline with 0&#46;6&#181;g octreotide&#44; 40mL&#47;hour&#41;&#46; Repeated erythrocyte transfusions were given&#46; In total&#44; the patient received eight erythrocyte units during a period of three days&#46; In consultation with nephrologists&#44; MMF dose was reduced to 250mg bid&#44; and prednisone to 8mg while the dose of tacrolimus remained unchanged&#44; 3mg bid&#46;</p><p class="elsevierStylePara">The following day the bleeding had stopped with slow recovery in hemoglobin level&#46; An ultrasound of kidney graft revealed normal kidney parenchyma with slightly increased arterial resistance index of 0&#46;75 at the level of interlobar arteries&#46;</p><p class="elsevierStylePara">At a discharge&#44; on the 9<span class="elsevierStyleSup">th</span> day the laboratory findings were satisfactory &#40;hemoglobin level 133g&#47;L&#44; BUN 7&#44;9mmol&#47;L and creatinine 126&#181;mol&#47;L&#41;&#46; Suggested maintenance immunosuppressive therapy consisted of mycophenolate mofetil 250mg bid&#44; tacrolimus 2mg bid and prednisone 8mg daily&#46; The patient is well without symptoms of GI toxicity or rejection for 5 months&#46;</p><p class="elsevierStylePara">MMF is used in treatment regimens as an immunosuppressive agent in both solid organ and bone marrow&#47;peripheral blood stem cell transplantation&#44; as well as in treatment of autoimmune disorders&#44; such as lupus&#46;<span class="elsevierStyleSup">3</span> Drug effects are mediated via the active metabolite&#44; MPA which seems to be responsible for GI toxic effects&#46; GI adverse events are common following renal transplantation and all immunosuppressive regimens have been associated with such events&#46; They are the most frequent problems associated with MMF therapy occurring in up to 20&#37;<span class="elsevierStyleSup">4</span> or&#44; in some studies up to 40&#37;<span class="elsevierStyleSup">5</span> of renal transplant recipients&#46; Such adverse events can extend along the entire GI tract&#44; and can vary in severity from those which are mild &#40;nausea&#44; discomfort&#44; appetite loss&#41; and do not require altering immunosuppressive regimen to those which are more severe or even life threatening &#40;severe diarrhea&#44; GI tract ulcerations&#44; hemorrhage and perforations&#41;&#46;<span class="elsevierStyleSup">4&#44;6</span></p><p class="elsevierStylePara">The etiology of GI disorders following transplantation is not well understood&#46; Because of enterocyte dependency for <span class="elsevierStyleItalic">de novo</span> purine synthesis MMF exposure could thus restrict the ability of intestinal epithelial cells to maintain normal barrier function&#44; or decrease their capacity to recover from damage&#46;<span class="elsevierStyleSup">7</span></p><p class="elsevierStylePara">Our patient has experienced a life threatening&#44; severe lower GI bleeding which reoccurred within 2 days upon initial stabilization while on a stable immunosuppressive regimen&#46; Upon dose reduction&#44; the bleeding had stopped&#44; indicating the possible adverse effect of MMF&#46;</p><p class="elsevierStylePara">A database from the United States Food and Drug Administration&#8217;s &#40;US FDA&#41; Adverse Event Reporting System &#40;AERS&#41;&#44; containing more than 4&#44;000&#44;000 adverse events reported between 2004 and 2011&#44; has a record of 9 cases of haematochezia &#40;0&#46;02&#37;&#41; associated with MMF treatment &#40;<a href="http&#58;&#47;&#47;www&#46;drugcite&#46;com&#47;" class="elsevierStyleCrossRefs">www&#46;drugcite&#46;com</a>&#59; accessed Feb 1&#44; 2012&#41;&#46;</p><p class="elsevierStylePara">We have reported this case to the Croatian National Drug Agency and in feedback letter have been informed that it is a serious&#44; unexpected adverse drug reaction&#44; possibly associated with MMF treatment&#46; A total of 16 cases have been reported to the WHO Adverse Drug Reaction Monitoring Center with two fatal outcomes &#40;WHO&#44; UMC VigiBase&#44; 29<span class="elsevierStyleSup">th</span> November 2011&#41;&#46;</p><p class="elsevierStylePara">Clinicians should be aware of possible&#44; rare&#44; but life threatening&#44; lower GI bleeding associated with MMF treatment in renal transplant patients&#46; Special caution should be given to patients with digestive system disease even if asymptomatic&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Conflict of interest<br></br>&#160;<br></br><br></br></span></p><p class="elsevierStylePara">The authors declare that there is no conflict of interest associated with this manuscript&#46;</p><p class="elsevierStylePara"><a href="grande&#47;11512&#95;16025&#95;30726&#95;en&#95;f111512&#46;jpg" class="elsevierStyleCrossRefs"><img src="11512_16025_30726_en_f111512.jpg"></img></a></p><p class="elsevierStylePara">Figure 1&#46; 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2020 June 23 14 37
2020 May 34 16 50
2020 April 32 14 46
2020 March 33 20 53
2020 February 35 17 52
2020 January 35 26 61
2019 December 55 31 86
2019 November 30 19 49
2019 October 22 10 32
2019 September 44 26 70
2019 August 30 8 38
2019 July 35 28 63
2019 June 40 19 59
2019 May 50 17 67
2019 April 61 50 111
2019 March 32 17 49
2019 February 23 17 40
2019 January 26 19 45
2018 December 88 35 123
2018 November 161 28 189
2018 October 116 15 131
2018 September 79 14 93
2018 August 88 21 109
2018 July 56 17 73
2018 June 76 16 92
2018 May 61 20 81
2018 April 104 11 115
2018 March 83 14 97
2018 February 73 11 84
2018 January 76 10 86
2017 December 74 12 86
2017 November 51 9 60
2017 October 30 6 36
2017 September 40 11 51
2017 August 27 5 32
2017 July 22 10 32
2017 June 29 6 35
2017 May 47 13 60
2017 April 31 8 39
2017 March 20 4 24
2017 February 22 8 30
2017 January 24 15 39
2016 December 42 4 46
2016 November 63 11 74
2016 October 76 11 87
2016 September 70 5 75
2016 August 160 5 165
2016 July 163 13 176
2016 June 141 0 141
2016 May 121 0 121
2016 April 86 0 86
2016 March 65 0 65
2016 February 88 0 88
2016 January 91 0 91
2015 December 108 0 108
2015 November 108 0 108
2015 October 93 0 93
2015 September 56 0 56
2015 August 65 0 65
2015 July 63 0 63
2015 June 38 0 38
2015 May 46 0 46
2015 April 5 0 5
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Idiomas
Nefrología (English Edition)