Journal of clinical apheresis · 1997
Pentastarch instead of albumin as replacement fluid for therapeutic plasma exchange. The Canadian Apheresis Group.
Клиническое исследованиеСравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Rock G, Sutton D M, Freedman J, Nair R C
Аннотация
BACKGROUND: Human albumin is commonly used as a replacement fluid in therapeutic plasma exchange (PE). In order to determine whether Pentaspan (PES), a synthetic low molecular weight starch solution, might be an effective substitute, we compared albumin with PES in 12 patients with myasthenia gravis or Guillain-Barré syndrome.
STUDY DESIGN AND METHODS: Six patients were randomly assigned to receive PES and six to receive albumin as replacement fluid during their course of PE, which consisted of two to five treatments delivered over a maximum of 10 days. All patients were hospitalized and observed closely. Blood pressures were recorded every 4 hours and daily measurements were made of hematologic, coagulation, and immunoglobulin parameters.
RESULTS: Individual exchange volumes were similar in each group (37 ml/kg--range 6-62--in patients receiving albumin vs. 41 ml/kg--range 6-41--in those receiving PES). Changes in immunoglobulin levels and coagulation parameters were similar but mild, transient thrombocytopenia was observed in three subjects given PES. Total serum protein and albumin levels decreased significantly in patients replaced with PES. Clinically, PES was well tolerated. Hypotension occurred in one patient who developed septic shock due to an infected femoral catheter; in another patient, a pre-existing pleural effusion was thought to increase slightly.
CONCLUSIONS: PES appears to be a safe replacement fluid for PE, but larger clinical studies are required to confirm these findings.
STUDY DESIGN AND METHODS: Six patients were randomly assigned to receive PES and six to receive albumin as replacement fluid during their course of PE, which consisted of two to five treatments delivered over a maximum of 10 days. All patients were hospitalized and observed closely. Blood pressures were recorded every 4 hours and daily measurements were made of hematologic, coagulation, and immunoglobulin parameters.
RESULTS: Individual exchange volumes were similar in each group (37 ml/kg--range 6-62--in patients receiving albumin vs. 41 ml/kg--range 6-41--in those receiving PES). Changes in immunoglobulin levels and coagulation parameters were similar but mild, transient thrombocytopenia was observed in three subjects given PES. Total serum protein and albumin levels decreased significantly in patients replaced with PES. Clinically, PES was well tolerated. Hypotension occurred in one patient who developed septic shock due to an infected femoral catheter; in another patient, a pre-existing pleural effusion was thought to increase slightly.
CONCLUSIONS: PES appears to be a safe replacement fluid for PE, but larger clinical studies are required to confirm these findings.