Terlipressin (Remestyp ) in the Treatment of Acute Oesophageal Variceal and/or Hyper-
tensive Gastropathy Bleeding: Double Blind Randomized, Comparative Multi-center Study of the
Effect of Dual Dose
Brůha R., Mareček Z., Špičák J. * , Hůlek P. ** , Lata J. *** , Petrtýl J., Urbánek P.,
I. interní klinika VFN a l. LF UK Praha 2 * Klinika hepatogastroenterologie IKEM, Praha 4 ** I. interní klinika FN Hradec Králové *** III. interní klinika, MU Brno |
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Summary:
Objective: 1.To test the effectiveness of Remestyp ® therapy in the treatment of oesophageal varices. 2. Com-
pare the effectiveness of two-day administration of Remestyp ® , 0.2 mg i.v after 4-hour intervals, with the
effectiveness of 5-day administration of 1 mg i.v. after 4-hour intervals. 3. Evaluate the incidence of adverse
reaction when applying the two patterns of administration.
Patients and methods: A total of 86 patients from four centres in the CR were included over a period of 2
years. 54 men and 32 women, mean age 51 years, with cirrhosis of the liver of different etiology and
haemorrhage into the GIT associated with portal hypertension were randomized into two groups to receive
treatment according to the above two therapeutic patterns (larger dose 45 patients, smaller dose 41 patients).
Haemorrhage was confirmed by diagnostic endoscopy within 24 hours after its development (42 patients had
haemorrhage from varices, 17 portal hypertensive gastropathy, the rest had haemorrhage from both sites),
sclerotization was not used. The two groups were statistically fully comparable. Failure of treatment was
evaluated according to „Baveno II“ criteria.
Results: The successfulness in the group with the larger doses (I) was on the second day 89 % and on the 5th
day 79 %, in the group with the smaller doses (II) 78 % and 75 % resp. The difference was not statistically
significant. The use of transfusion units on the second day was in the two groups 2.4 vs. 3.4 units which is statistically significant. By the fifth day of treatment three patients in group I died and two in group II,
between the 6th and 30st day in these groups 6 and 5 patients resp. died. A relapse of haemorrhage by the
fifth day occurred in group I in 16.3 %, in group II in 15 %. As to adverse reaction, there was no difference
between the two groups.
Conclusion: Administration of terlipressin (Remestype ® ) i.v. is a highly effective treatment of acute haemorr-
hage into the GIT in patients with portal hypertension. With a dosage of 1 mg i.v. at four-hour intervals the
successfulness by the second day was as high as 90% and the consumption of blood derivatives was signifi-
cantly lower as compared with the lower dosage. The higher dosage is not associated with a higher incidence
of undesirable phenomena.
Key words:
portal hypertension – cirrhosis of the liver – haemorrhage from oesophageal varices – haemorrha-
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