اثربخشي و عوارض يك ساله داروي ريتوكسيماب در بيماران مبتلا به مالتيپل اسكلروزيس در كرمانشاه

Evaluation of the one-year effectiveness and side effects of rituximab in patients with multiple sclerosis in Kermanshah

مالتيپل اسكلروزيس Multiple Sclerosis (MS) بيماري التهابي سيستم عصبي مركزي است. اين مطالعه اثربخشي و عوارض ريتوكسيماب را بررسي مي كند. روش بررسي اين كارآزمايي باليني نيمه تجربي از شهريور 1397 تا شهريور 1398 در بيمارستان امام رضا (ع) كرمانشاه انجام شد. 44 بيمار به روش در دسترس انتخاب و با داروي ريتوكسيماب به مدت يك سال تحت درمان بودند. نمره ناتواني (EDSS) و ضايعات فعال براساس MRI براي بيماران بررسي شده و در طول يك سال ازنظر عود و عوارض دارويي پيگيري گرديدند. مطالعه با حمايت دانشگاه علوم پزشكي كرمانشاه و با دريافت رضايت آگاهانه از همه شركت كنندگان انجام شد. يافته ها 29 نفر (65/9%) زن و 15 نفر (34/1%) مرد بررسي شدند. 22 نفر از بيماران RRMS و 22 نفر PRMS داشتند. در بيماراني كه ام اس نوع RR داشتند، نمره ناتواني در پايان مطالعه نسبت به ابتداي مطالعه به طور معناداري كاهش يافته بود (P=0.010) اما در بيماران نوع PRMS اين نمره افزايش غيرمعنادار يافته بود(P=0.148). هم در بيماران RR و هم در بيماران PRMS، تعداد ضايعات موجود در MRI در پايان مطالعه نسبت به ابتداي مطالعه كاهش غيرمعنادار داشت (P>0.05). عوارض زودرس بيشتر در بيماران RRMS رخ داد (13/6% در مقابل 4/5%) و عوارض تاخيري بيشتر در بيماران PRMS مشاهده شد (54/5% در مقابل 36/3%). نتيجه گيري ريتوكسيماب در درمان MS عود كننده، بهبود يابنده نسبت به MS پيشرونده، عود كننده باعث كاهش بيشتري در ميزان ناتواني شد و استفاده از آن با عوارض اندك همراه بود.

Multiple sclerosis (MS) is an inflammatory disease affecting the central nervous system. Rituximab (Zytux) is a type of monoclonal antibody against B cells with CD20 antigen that reduces B cells. The present study examined the one-year effectiveness and side effects of Rituximab. Methods: This quasi-experimental clinical trial was conducted from September 2018 to September 2019 in Imam Reza Hospital in Kermanshah. 44 eligible patients were selected by the available sampling method and entered the study after evaluation in terms of inclusion and exclusion criteria. Patients were treated with rituximab for one year. At the beginning of the study and at the end of the year, the disability score based on the Expanded Disability Status Scale (EDSS) and active lesions based on MRI for patients were evaluated. Also, the patients were followed up in terms of relapse and medication side effects throughout the year. This study was performed with the support of Kermanshah University of Medical Sciences. Informed consent was obtained from all participants. The data were analyzed by SPSS-25 software. Results: 44 patients with MS including 29 (65.9%) female and 15 (34.1%) male were studied. 22 patients had RRMS and 22 patients had progressive-relapsing MS (PRMS). In patients with RRMS, the EDSS score at the end of the study was significantly reduced compared to the beginning of the study (P=0.010) but in PRMS patients EDSS was increased but this increase was not significant (P=0.148). In both RRMS and PRMS patients, the number of MRI lesions at the end of the study was lower than the beginning of the study and this decrease was not significant (P>0.05). More Immediate side effects occurred in RRMS patients (13.6% vs. 4.5%) and more delayed side effects were observed in PRMS patients (54.5% vs. 36.3%). Conclusion: rituximab caused a greater reduction in EDSS in the treatment of RRMS than PRMS and its use had few side effects.