دورية أكاديمية
[Administration of the generic prostaglandin E1 VAP 20® in patients with lower limb critical ischaemia: a prospective study].
| العنوان: | [Administration of the generic prostaglandin E1 VAP 20® in patients with lower limb critical ischaemia: a prospective study]. |
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| المؤلفون: | Pokrovskiĭ AV, Chupin AV, Parshin PIu, Mikhaĭlov IP, Lavrenov VN, Kharazov AF, Kutyrev OE |
| المصدر: | Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery [Angiol Sosud Khir] 2013; Vol. 19 (2), pp. 17-20, 22-4. |
| نوع المنشور: | Comparative Study; English Abstract; Journal Article |
| اللغة: | Russian |
| بيانات الدورية: | Publisher: Izd-vo Info-Media Country of Publication: Russia (Federation) NLM ID: 9604504 Publication Model: Print Cited Medium: Print ISSN: 1027-6661 (Print) Linking ISSN: 10276661 NLM ISO Abbreviation: Angiol Sosud Khir Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [Moskva] : Izd-vo Info-Media, c1995- |
| مواضيع طبية MeSH: | Alprostadil/*administration & dosage , Drugs, Generic/*administration & dosage , Ischemia/*drug therapy , Leg/*blood supply , Peripheral Arterial Disease/*drug therapy, Aged ; Alprostadil/therapeutic use ; Ankle Brachial Index ; Dose-Response Relationship, Drug ; Drugs, Generic/therapeutic use ; Female ; Follow-Up Studies ; Humans ; Ischemia/diagnosis ; Ischemia/etiology ; Male ; Peripheral Arterial Disease/complications ; Peripheral Arterial Disease/diagnosis ; Prospective Studies ; Severity of Illness Index ; Treatment Outcome ; Vascular Patency/drug effects ; Vasodilator Agents/administration & dosage ; Vasodilator Agents/therapeutic use |
| مستخلص: | Objective: The study was aimed at assessing efficacy and safety of administering the generic alprostadil VAP in patients presenting with lower limb critical ischaemia. Material and Methods: We carried out a prospective study including a total of 30 patients with lower limb critical ischaemia. The patients' mean age was 67.7±7.8 years, with men predominating - 60%. Trophic ulcers were observed in 40% of patients. The proximal level of the lesion was localized in the arteries below the inguinal ligament in 19 (63.3%) patients, in the aortofemoral segment - in 9 (30%) patients, and in the popliteal-crural-plantar segment - in 2 (6.6%) subjects. The average ankle-brachial index amounted to 0.49±0.4. The studied agent was used at a dose of 40 mcg once a day in patients with stage III ischaemia and a dose of 40 mcg twice daily in patients with stage IV ischaemia. The drug was administered for 14 days followed by a 14-day follow-up period. Results: The pain syndrome score over the 14 days of treatment decreased twofold from 6.1±2.5 to 3.5±2.6 and within the subsequent 14 days it did not increase - 2.4±3.1 (p< 0.05). The number of patients in whom the pain syndrome decreased by 50% amounted to 19 (63.3%). The consumption of analgesic agents decreased from 60% (at the beginning of treatment) to 12 (40%) (14 days after treatment) and to 8 (26.6%) (at the end of the follow-up period). In patients with trophic ulcers, the average size of the ulcers during treatment decreased from 3.3±3.7 cm to 2.8±3.8 after 14 days, and at the end of the follow-up period the size of the ulcers amounted to 2.1±2.8 cm (p >0.05). The number of patients responding to treatment amounted to 22 (77.3%). The ABI during treatment did not change, being 0.49 ± 0.4 at the beginning of treatment, 0.53±0.4 after 14 days of treatment, and 0.47±0.3 at the end of the follow-up period. There were no amputations either during treatment or within the follow-up period. Only one lethal outcome occurred which was related to acute coronary insufficiency. The "response to treatment" was significantly influenced only by the level of the proximal lesion and age (p<0.05). Conclusion: VAP 20® demonstrated good efficacy and tolerability comparable to those of the original preparations. |
| المشرفين على المادة: | 0 (Drugs, Generic) 0 (Vasodilator Agents) F5TD010360 (Alprostadil) |
| تواريخ الأحداث: | Date Created: 20130719 Date Completed: 20130924 Latest Revision: 20131121 |
| رمز التحديث: | 20221213 |
| PMID: | 23863787 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1027-6661 |
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