Moshfeghi Kamran, Nazemzadeh Neda, Mehrzad Valiollah, Hajiannejad Alireza, Esmaili Farah
Department of Hematology and Oncology, Arak University of Medical Sciences, Iran.
Adv Biomed Res. 2013 Mar 6;2:17. doi: 10.4103/2277-9175.108000. Print 2013.
Currently, imatinib is the drug of choice for initiation of medical treatment of chronic myeloid leukemia (CML) in the chronic phase. The current study was carried out to compare effectiveness and safety of Iranian vs. Indian imatinib.
The clinical study was performed on newly diagnosed CML patients in Seyyed-oShohada Hospital (Isfahan) and Khansari Hospital (Arak) from January to June 2011. The control group consisted of CML patients who received Indian imatinib previously. The drug was initiated with the dose of 400 mg daily. The patients were followed for six months, and the treatment outcomes (WBC <10(4)) and molecular response. Finally, the two groups were compared in these respects.
We evaluated 43 patients in each group. The hematological and molecular responses for the Iranian Imatinib were respectively 86.0% and 46.5%, while the rates were respectively 86.0 and 44.2% for the Indian imatinib. The two groups were similar with regard to the treatment outcome. The two groups were not significantly different with regard to the drug adverse effects.
According to the findings, the Iranian imatinib is not different from the Indian drug in the hematological and molecular responses in treatment of the chronic phase of CML patients. Furthermore, the adverse effects of the two kinds were not significantly different. Compared with the results of other studies, the effectiveness of Iranian imatinib is equivalent to the Indian drug can be employed for treatment of CML patients in the chronic phase.
目前，伊马替尼是慢性期慢性髓性白血病（CML）初始药物治疗的首选药物。本研究旨在比较伊朗产与印度产伊马替尼的有效性和安全性。
2011年1月至6月，在伊斯法罕的赛义德 - 奥 - 肖哈达医院和阿拉克的汗萨里医院对新诊断的CML患者进行了临床研究。对照组由先前接受印度产伊马替尼治疗的CML患者组成。药物起始剂量为每日400毫克。对患者进行了六个月的随访，并观察治疗结果（白细胞<10⁴）和分子反应。最后，在这些方面对两组进行了比较。
我们对每组43例患者进行了评估。伊朗产伊马替尼的血液学和分子反应率分别为86.0%和46.5%，而印度产伊马替尼的相应比率分别为86.0%和44.2%。两组在治疗结果方面相似。两组在药物不良反应方面无显著差异。
根据研究结果，伊朗产伊马替尼在治疗CML患者慢性期的血液学和分子反应方面与印度产药物无异。此外，两种药物的不良反应无显著差异。与其他研究结果相比，伊朗产伊马替尼的有效性等同于印度产药物，可用于治疗CML患者慢性期。
