[Clinical comparison of incidence of side effects of cilostazol analogs in treatment of diabetic foot syndrome].

K A Koreiba, K N Syuzev, O A Serebryakova, E Sh Makarimov
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Abstract

The purpose of our study was to test the assumptions about possible side effects of two brand names of cilostazol. It included a total of 165 patients presenting with neuroischemic form of diabetic foot syndrome, stage IIA-IIB lower-limb chronic ischemia, moderate-to-severe distal sensorimotor neuropathy, as well as tissue damage according to the W (W1-W3) scale, with no urgent indications for limb amputation. The patients were willing to comply with the requirements for examination and treatment performed according to the algorithm at the 'Diabetic Foot' Center of Kazan after obtaining written informed consent. Two trade names of cilostazol analogs, i. e., 'Aducyl' and 'Pletax', were compared. The patients were divided into 2 groups, representative by the baseline data, in accordance with the received analog. The frequency of side effects, as well as the frequency of favorable and unfavorable outcomes were compared. The side effects encountered in both groups were as follows: headache, edematous syndrome in the lower extremities, destabilization of blood pressure, dermatitis in the lower extremities, tachycardia, shortness of breath, nausea, and general malaise. Also, the frequency of complications and the frequency of refusal to take the drug were compared. When analyzing the data obtained, it was found that the group of patients receiving Aducyl® included in the complex therapy regimen had significantly more favorable outcomes. Taking Pletax® was associated with a higher level of clinically verified complications. The chance of an unfavorable outcome during treatment with Pletax® was 2.43 times higher than that with Aducyl®.

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西洛他唑类似物治疗糖尿病足综合征副反应发生率的临床比较
本研究的目的是检验两种品牌西洛他唑可能产生的副作用。根据W (W1-W3)分级,共纳入165例表现为神经缺血型糖尿病足综合征、IIA-IIB期下肢慢性缺血、中重度远端感觉运动神经病变以及组织损伤的患者,无紧急截肢指征。患者在获得书面知情同意后,愿意遵守喀山“糖尿病足”中心根据算法进行检查和治疗的要求。比较了西洛他唑类似物的两个商品名,即“Aducyl”和“Pletax”。根据接受的模拟物将患者分为2组,以基线数据为代表。比较两组不良反应发生的频率,以及良好和不良结果发生的频率。两组患者的副作用如下:头痛、下肢水肿综合征、血压不稳定、下肢皮炎、心动过速、呼吸短促、恶心和全身不适。比较两组患者并发症发生频率和拒绝服药频率。在分析获得的数据时,发现接受Aducyl®的患者组包括在复杂治疗方案中具有明显更有利的结果。服用Pletax®与更高水平的临床验证并发症相关。Pletax®治疗期间出现不良结果的几率是Aducyl®治疗期间的2.43倍。
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