Abolghasemi, Hassan
(Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences)
,
Panahi, Yunes
(Pharmacotherapy Department, Faculty of Pharmacy, Baqiyatallah University of Medical Sciences)
,
Ahmadinejad, Minoo.
(High Institute of Research, Iranian Blood Transfusion Organization)
,
Toogeh, Gholamreza
,
Karimi, Mehran
(Hematology Research Centre, Shiraz University of Medical Sciences)
,
Eghbali, Aziz
(Department of Pediatric Hematology-Oncology, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences)
,
Mirbehbahani, Nargess Bigom
(Golestan University of Medical Sciences)
,
Dehdezi, Bighan Keikhaei
(Department of Thalassemia & Hemoglobinopathy Research Center, Ahvaz Jundishapur University of Medical Science)
,
Badiee, Zahra
(Sheikh Hospital, Mashhad University of Medical Sciences)
,
Hoorfar, Hamid
(Isfahan University of Medical Sciences)
,
Eshghi, Peyman
(Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences)
,
Maghsoudi, Nader
(Neuroscience Research Center (NRC), Shahid Beheshti University of Medical Sciences)
,
Sahebkar, Amirhossein
(Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University o)
,
Gholami-Fesharaki, Mohammad
Objective: This study compared the safety and efficacy of $Safacto^{(R)}$ versus $xyntha^{(R)}$ in patients with severe hemophilia A. Methods: Thirty-three male patients with severe hemophilia A were randomly divided into two groups. Seventeen patients received $Safacto^{(...
Objective: This study compared the safety and efficacy of $Safacto^{(R)}$ versus $xyntha^{(R)}$ in patients with severe hemophilia A. Methods: Thirty-three male patients with severe hemophilia A were randomly divided into two groups. Seventeen patients received $Safacto^{(R)}$ and 16 patients received $Xyntha^{(R)}$ for four consecutive times. The dosage of FVIII was 40-50 IU/kg for each injection. Plasma level of FVIII activity was evaluated before every injection, 15 minutes after the injection and one month after the start of the trial. The rate of factor VIII activity, pain and joint motion were also assessed before and after the treatment. Results: Plasma level of FVIII clotting activity in $Safacto^{(R)}$ and $Xyntha^{(R)}$ were $1.96{\pm}0.5IU/dl$ and $1.63{\pm}0.5IU/dl$ and increased to $88.84{\pm}25.2IU/dl$ and $100.09{\pm}17.8IU/dl$, respectively (P<0.001). Pain score and range of motion improvement were $9.3{\pm}0.9$ and $8.7{\pm}0.1$ in $Safacto^{(R)}$ (P=0.17); and $9.4{\pm}0.8$ and $8.8{\pm}0.3$ in $Xyntha^{(R)}$ (P=0.35), respectively. No allergic or other unfavorable reactions was observed with either of the preparations. Conclusion: This study showed that $Safacto^{(R)}$ has a favorable efficacy and safety profile.
Objective: This study compared the safety and efficacy of $Safacto^{(R)}$ versus $xyntha^{(R)}$ in patients with severe hemophilia A. Methods: Thirty-three male patients with severe hemophilia A were randomly divided into two groups. Seventeen patients received $Safacto^{(R)}$ and 16 patients received $Xyntha^{(R)}$ for four consecutive times. The dosage of FVIII was 40-50 IU/kg for each injection. Plasma level of FVIII activity was evaluated before every injection, 15 minutes after the injection and one month after the start of the trial. The rate of factor VIII activity, pain and joint motion were also assessed before and after the treatment. Results: Plasma level of FVIII clotting activity in $Safacto^{(R)}$ and $Xyntha^{(R)}$ were $1.96{\pm}0.5IU/dl$ and $1.63{\pm}0.5IU/dl$ and increased to $88.84{\pm}25.2IU/dl$ and $100.09{\pm}17.8IU/dl$, respectively (P<0.001). Pain score and range of motion improvement were $9.3{\pm}0.9$ and $8.7{\pm}0.1$ in $Safacto^{(R)}$ (P=0.17); and $9.4{\pm}0.8$ and $8.8{\pm}0.3$ in $Xyntha^{(R)}$ (P=0.35), respectively. No allergic or other unfavorable reactions was observed with either of the preparations. Conclusion: This study showed that $Safacto^{(R)}$ has a favorable efficacy and safety profile.
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제안 방법
This study was also registered in the Iranian Registry of Clinical Trials (IRCT) (registration number: IRCT2014101218870N2). This trial was designed as triple-blind and parallel.
대상 데이터
Survey of Inhibitors in Plasma-Product Exposed Toddlers (SIPPET) was performed by Peyvandi et al.A total of 303 patients were screened for inhibitors. Seventy-six patients developed inhibitors and fifty of them had high-titer inhibitors (more than 5 BU).
The authors are grateful to the Saman Darou 8 Pharmaceutical Company (Mashhad, Iran) that provided both drugs (Safacto® and Xyntha® ) for this study.
Thirty-three male patients with severe hemophilia A were enrolled in this study. No patient was excluded from the study.
데이터처리
, New York, NY, USA). Data were analyzed using a t-test for data with normal distribution, and Mann-Whitney U test for data without normal distribution. Independent categorical data were compared using Chi-square and Fishers’ exact tests, and dependent categorical data were compared using the McNemar test.
이론/모형
Independent categorical data were compared using Chi-square and Fishers’ exact tests, and dependent categorical data were compared using the McNemar test.
성능/효과
The results of this study showed that Safacto® has favorable safety and efficacy.
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