title: [Administration of the generic prostaglandin E1 VAP 20® in patients with lower limb critical ischaemia: a prospective study].
abstract: OBJECTIVE
  The study was aimed at assessing efficacy and safety of administering the generic alprostadil VAP in patients presenting with lower limb critical ischaemia.
  
  
  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).
  
  
  CONCLUSIONS
  VAP 20® demonstrated good efficacy and tolerability comparable to those of the original preparations.
authors.forename: A V
authors.initials: AV
authors.lastname: Pokrovskiĭ
authors.forename: A V
authors.initials: AV
authors.lastname: Chupin
authors.forename: P Iu
authors.initials: PIu
authors.lastname: Parshin
authors.forename: I P
authors.initials: IP
authors.lastname: Mikhaĭlov
authors.forename: V N
authors.initials: VN
authors.lastname: Lavrenov
authors.forename: A F
authors.initials: AF
authors.lastname: Kharazov
authors.forename: O E
authors.initials: OE
authors.lastname: Kutyrev
mesh_terms: D000368:Aged; D000527:Alprostadil / Q000008:administration & dosage* / Q000627:therapeutic use; D055109:Ankle Brachial Index; D004305:Dose-Response Relationship, Drug; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D007866:Leg / Q000098:blood supply*; D008297:Male; D058729:Peripheral Arterial Disease / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014654:Vascular Patency / Q000187:drug effects; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D016568:Drugs, Generic; D014665:Vasodilator Agents; D000527:Alprostadil