Journal of Iranian Blood Transfusion
فصلنامه پژوهشی خون
bloodj
Medical Sciences
http://bloodjournal.ir
91
journal91
1027-9520
1735-8248
10.61882/bloodj
fa
jalali
1402
4
1
gregorian
2023
7
1
20
2
online
1
fulltext
fa
ارزیابی میزان آنتیبادیها بر علیه ویروسهای هپاتیت در فرآورده ایمونوگلوبین تزریق وریدی تهیه شده از پلاسمای ایرانی
Evaluation of anti-hepatitis antibodies in intravenous immunoglobulin products from Iranian plasma
ويروس شناسي
Virology
پژوهشي
Research
<div style="text-align: justify;"><span style="font-size:10pt"><span style="text-justify:inter-ideograph"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><span style="font-weight:bold"><span lang="FA" style="line-height:80%"><span style="font-family:Jadid"><span style="font-weight:normal">چکید</span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:Jadid"><span style="font-weight:normal">ه</span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:Jadid"><span style="font-weight:normal"></span></span></span></span></span></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:inter-ideograph"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><i><span lang="FA" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:Titr">سابقه و هدف </span></span></span></i></b></span></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:inter-ideograph"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus"">ایمونوگلوبولین تزریق وریدی ، یک محصول بیولوژیکی حاوی </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">IgG</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> است که برای محافظت از بیماریهای خاص در برابر پاتوژن­های میکروبی استفاده می­شود. به دلیل کاهش شیوع هپاتیت­های ویروسی سراسر جهان، اثر محافظتی ایمونوگلوبولین­ها در درمان نیاز به بررسی مجدد دارد. لذا آنتی­بادی­های</span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HAV</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> و </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HBs</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> ، </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HGV</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> ، </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HDV</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> و </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HEV</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> در </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">IVIG</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> های ساخته شده از پلاسمای ایرانی مورد بررسی قرار گرفت.</span></span></span></b></span></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:inter-ideograph"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><i><span lang="FA" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:Titr">مواد و روشها</span></span></span></i></b></span></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:inter-ideograph"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus"">در این مطالعه مقطعی توصیفی ، حضور و یا عدم حضور آنتی­بادی علیه هپاتیت</span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">A</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> ، </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">E</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> ، </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">D</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> ، </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">G</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> و آنتی­بادی­های ضد آنتی­ژن سطحی هپاتیت </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">B</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> و آنتی­ژن هسته هپاتیت </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">B</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> در 38 سری ساخت مختلف محصول </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">IVIG</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> از پلاسمای بازیافتی و یا پلاسمای منبع با روش الایزا تعیین و آنتی­بادی ضد </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">HAV</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> و ضد </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">HBs</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> تیتر گردید. یافتهها توسط آزمون </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">t</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> مستقل و 23 </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">SPSS</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> تجزیه و تحلیل شدند.</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""></span></span></span></b></span></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><i><span lang="FA" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:Titr">یافتهها</span></span></span></i></b></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus"">تیتر </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HAV</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> در محصول </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">IVIG</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> برابر با </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">mIU/mL</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> 17735 ± 38304 بود و این تیتر در </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">IVIG</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus"">های تولید شده از پلاسمای بازیافتی به طور قابل توجهی بالاتر بود. تیتر </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HBs</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> در محصول </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">IVIG</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> برابر با </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">mIU/mL</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> 965 ± 2487 بود که تفاوت معنا­داری بین دو نوع پلاسمای منبع و بازیافتی مشاهده نگردید. آنتی­بادی </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HBc</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> ، </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HEV</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> و</span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">anti-HGV</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> در همه محصولات مورد مطالعه شناسایی شد، و هیچ آنتی­بادی ضد </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">HDV</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> یافت نشد.</span></span></span></b></span></span></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:inter-ideograph"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><i><span lang="FA" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:Titr">نتیجه گیری</span></span></span></i></b></span></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:inter-ideograph"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus"">با وجود کاهش شیوع هپاتیت­های ویروسی و گزارشهای کاهش تیترآنتی</span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">HAV</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> و </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">HBs</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> در محصولات </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">IVIG</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> تولید شده در دنیا، محصولات </span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">IVIG</span></span></span></b><b><span lang="FA" style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> پلاسمای ایرانی دارای تیتر قابل قبول آنتی</span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">HAV</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> و آنتی</span></span></span></b><b><span dir="LTR" style="font-size:9.0pt"><span style="line-height:80%"><span style="font-family:"Times New Roman Bold","serif"">HBs</span></span></span></b><b><span style="font-size:11.0pt"><span style="line-height:80%"><span style="font-family:"2 Lotus""> طبق فارماکوپه اروپا بوده و برای درمان جایگزینی مناسب می­باشد.</span></span></span></b></span></span></span></span></span></span><br>
</div>
<div dir="rtl" style="text-align: left;"><span style="font-size:10pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><span style="font-size:12.0pt">Abstract</span></b><b><span style="font-size:12.0pt"></span></b></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><i>Background and Objectives</i></b></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif"">Intravenous immunoglobulin (IVIG) is a biological product containing a mixture of IgGs which is needed to protect special patients against various microbial pathogens. Due to worldwide decrease in the prevalence of viral hepatitis, the protective effect of immunoglobulins in treatment needs to be re-examined. For this reason the presence of, anti-HAV, anti-HBs, Anti HBc, anti-HGV, anti-HDV and anti-HEV antibodies in the IVIG products of Iranian plasma have been investigated.</span></span></span></span></span><br>
<br>
<span style="font-size:10pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><i>Materials and Methods</i></b></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif"">In this randomized descriptive cross-sectional study, the presence or absence of antibodies against hepatitis A, hepatitis E, hepatitis D, hepatitis G, antibodies against hepatitis B surface antigen and hepatitis B core antigen in 38 different lots of IVIG products from the Iranian recovered and source plasma was determined by ELISA method and anti-HAV and anti-HBs antibodies were titrated.</span></span></span></span></span><br>
<br>
<span style="font-size:10pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><i>Results</i></b></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif"">Total anti-HAV in IVIGs was 38304 ± 17735 mIU/mL and this titer was significantly higher in IVIGs from recovered plasma compared with source plasma. Total anti-HBs titer in IVIGs was equal to 2487 ± 965 mIU/mL, and no significant difference was observed between the two types of recovered and source plasma. Anti-HBc, Anti-HEV and Anti-HGV were detected in all products, while no anti-HDV was found.</span></span></span></span></span><br>
<br>
<span style="font-size:10pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><b><i>Conclusions </i></b></span></span></span></span></span><br>
<span style="font-size:10pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif"">Despite the worldwide decrease in the prevalence of viral hepatitis and reports of a decrease in anti-HAV and anti-HBs titers in IVIG products, IVIG products prepared from Iranian plasma have acceptable anti-HAV and anti-HBs titers according to the European Pharmacopeia and are suitable for replacement therapy.</span></span></span></span></span><br>
</div>
کلمات کلیدی: ایمونوگلوبولین تزریق وریدی (IVIG), هپاتیتها, ایران, پلاسما
Key words: Intravenous Immunoglobulin, Hepatitis, Iran, Plasma
81
89
http://bloodjournal.ir/browse.php?a_code=A-10-738-6&slc_lang=fa&sid=1
M.
Zadsar
مریم
زادسر
9100319475328460024113
9100319475328460024113
No
دانشیار مرکز تحقیقات انتقال خون ـ مؤسسه عالی آموزشی و پژوهشی طب انتقال خون
Z.
Sharifi
زهره
شریفی
9100319475328460024114
9100319475328460024114
No
استاد مرکز تحقیقات انتقال خون ـ مؤسسه عالی آموزشی و پژوهشی طب انتقال خون
A.
Aghai
افسانه
آقایی
aghaie.a@gmail.com
9100319475328460024115
9100319475328460024115
Yes
دانشیار مرکز تحقیقات انتقال خون ـ مؤسسه عالی آموزشی و پژوهشی طب انتقال خون