Current Usage Of Perftoran

Since its approval in 1997, Perftoran has been used for many clinical indications (Table 26.3). According to an All-Russian questionnaire (performed

100 n

8 10 12

Time (min)

100 n

8 10 12

Time (min)

8 10 12

Time (min)

8 10 12

Time (min)

Figure 26.3 Reperfusion restoration of mechanical activity of rabbit heart with different perfusion medium after 40 minutes of total ischemia: (a) Tirode salt solution; (b) Perftoran supplemented with 2.5 mM calcium chloride. Continuous lines with dark marks show the level of diastolic tension; broken lines with open marks show the level of systolic tension; crosshatched regions show amplitudes of heart contractilities. F,% = isometric tension relative of the initial level.

Table 26.2 Patient distribution according to indications, doses of Perftoran and frequency of side effects during clinical trials (n = 964*)

Indications

Doses (ml/kg

Summary

Patient

Frequency of

body weight)

doses (l)

distribution (%)

side reactions (%)

1. Acute blood loss,

6-30

1-5

22

2

hemorrhagic shock

2. Polytrauma, shock

4-12

0.4-1.2

20

0

3. Toxic shock

4-8

0.4-1.0

12.7

0

4. Limb ischemia

4-6

0.4-0.8

20.7

20

5. Cardiosurgery

-

1.0-2.0

11.1

0

6. Kidney transplantation

30

1.0-2.0

4.8

0

7. Burns, oncology and others

2-8

0.1-1.0

8.2

27

Total frequency of side effects

10**

*According to the original reports submitted in Russian Pharmaceutical Committee. ** Excluding cardioplegia and kidney transplantation patients.

*According to the original reports submitted in Russian Pharmaceutical Committee. ** Excluding cardioplegia and kidney transplantation patients.

by Evgeny Giburt at the Blood Center of the Russian Ministry of Health in 2002), positive effects of Perftoran were reported in 88.3 per cent of cases, negative effects in 3.3 per cent, the absence of any effect in 8.3 per cent, and side effects in 4 per cent of cases. The most frequent indication was bleeding (37 per cent), so the main Perftoran consumers were regional blood transfusion stations.

Perftoran was initially developed as a blood substitute to be used instead of allogeneic blood following massive blood losses, with simultaneous breathing of oxygen. In practice, Perftoran turned out to be useful even if the falling level of hematocrit and hemoglobin did not reach the transfusion trigger. As demonstrated byTikanadze (1997), Perftoran administration (n = 32) in doses of 900 ml (100-120 drops/min) together

Table 26.3 The percentage of patients treated with Perftoran, by indication. Total number of patients = 3528, including 1921 Perftoran-treated patients in comparative studies (according to Russian Scientific literature 1997-2004)

Indications Distribution of patients with Perftoran (%)

1.

Blood losses, multiple

37

organ dysfunction

2.

Limb ischemia

14

3.

Dysfunction of

8

inflammatory response

4.

Detoxication

4

5.

Lung function damage

6

6.

Cranial-cerebral trauma

7

7.

Burns, thermal shock

3

8.

Kidney transplantation

2

9.

Cardiosurgery

3

10.

Oncology

2

11.

Local application: wound

14

and ulcer healing, lavage

of lungs, spinal cord

and peritoneum

with crystalloids and colloids at F|O2 = 0.4 after the cessation of gastroduodenal bleeding of 1500-2500 ml provided the following: higher cardiac output due to an increase of the heart stroke volume to 60-68 ml (as opposed to 46-52 ml in the control group; P< 0.05); an increase in arterial and central venous blood pressure; and enhancement of arterial and venous PO2, which were also more sustainable than those in the control group of 30 patients. According to Lasarenko et al. (2002), Perftoran was infused at the beginning of gastroduodenal and colon operations in doses of 400 ml (25 patients) or 800 ml (14 patients) after blood losses of 1000 or 2000 ml, respectively. Perftoran administration augmented microcirculation by 15-30 per cent (P < 0.05) in the liver, intestine, skeletal muscle and peritoneum; increased erythrocyte elasticity from 36 to 78 per cent of the normal level (P < 0.05); and decreased the blood viscosity from 87 to 54cPs at 1/c (P < 0.05) when the normal level was 32 cPs at 1/c. In all these cases, Perftoran infusions were accompanied by acceleration of platelet aggregation and disaggregation, diminution of acidosis, and inhibition of peroxidative waste production in the blood by 1.5-2.0 times (Sofronov et al., 1999; Sofronov and Selivanov, 2003).

During lung resection with artificial ventilation (FIO2 = 0.5) when intraoperative blood losses were 400 ml (after hemodilution, hematocrit was 32-35), Perftoran administration (6 ml/kg) augmented saturation of HbO2 in arterial blood to a significantly higher level than that in the control group treated with crystalloids (Biryukov and Petrova, 2001). As shown by Zakharov et al. (2001), inclusion of Perftoran in doses of 4-6 ml/kg in conventional transfusion therapy 1, 2 and 3 days after a hemorrhagic shock and additional operation bleeding increased the efficiency of reanimation treatment, and shortened the reanimation period and duration of artificial ventilation.

Usenko et al. (2002) gained much clinical experience in Perftoran application when treating bleeding, cranial-cerebral traumas, and burn shock. They adjusted Perftoran doses to the volume of blood losses (VBL) in the following ratios: 2-4 ml/kg for 20 per cent VBL, 4-7 ml/kg for 20-40 per cent VBL, 7-10 ml/kg for 42-70 VBL, and 10-15 ml/kg if VBL exceeded 70 per cent. On Perftoran administration they noted a decrease in arterial-venous shunting in the lungs, and an increase in PaO2 and O2 extraction from blood. As a result, sequelae dropped by 12.5 per cent and morbidity by 5-8.5 per cent. Usage of donor blood was reduced by 1.5 times. In most cases a positive effect was achieved after Perftoran application in doses of 4-6 ml/kg when the supplementary oxygen capacity of PFC emulsion was insignificant. These doses of Perftoran accelerated patients' resuscitation after cranial-cerebral traumas, and also the restoration of their mental activities. Side effects occurred in about 1 per cent of cases.

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