Human thrombin plus 5 per cent ethanolamine oleate injected to sclerose oesophageal varices: a prospective randomized trial.
Fifty cirrhotic Japanese patients with oesophageal varices underwent sclerotherapy in a prospective randomized trial carried out to examine the effects of human thrombin given concomitantly with the sclerosant 5 per cent ethanolamine oleate. The two groups (25 patients each) were comparable with regard to size of the oesophageal varices, and the aetiology and severity of the liver disease. Twenty-five patients, 13 and 12 in the thrombin + and - groups, respectively, had at least one episode of variceal bleeding. The remaining 25 were given prophylactic injections. There was a significantly lower rate of occurrence of bleeding from injection sites when the injection needle was removed at the initial session of sclerotherapy in the thrombin + group, where human thrombin was injected (0.2-0.3 ml, 100-150 units per injection) just before removal of the injection needle. Endoscopy at 1 week after the initial session showed a significantly (P less than 0.05) higher rate of disappearance of red colour signs on varices in the thrombin + group (96 per cent) than in the thrombin - group (72 per cent). Fibrin degradation product E-fraction (FDP-E) values increased 1 h, 1 day and 6 days after the initial session of sclerotherapy in the two groups. The rate of increase in FDP-E values 1 h after sclerotherapy was significantly larger (P less than 0.001) in the thrombin + than in the thrombin - group. There was no clinical sign of disseminated intravascular coagulation. Administration of human thrombin plus a sclerosant seems to be useful and efficacious, especially for patients with huge oesophageal varices.
Department of Surgery II, Kyushu University, Faculty of Medicine, Japan.
S
S
Kitano
M
M
Hashizume
H
H
Yamaga
H
H
Wada
Y
Y
Iso
T
T
Iwanaga
K
K
Sugimachi
D004724:Endoscopy; D004932:Esophageal and Gastric Varices / Q000473:pathology / Q000628:therapy*; D004947:Esophagus / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009829:Oleic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011897:Random Allocation; D012597:Sclerosing Solutions / Q000009:adverse effects / Q000627:therapeutic use*; D013917:Thrombin / Q000009:adverse effects / Q000627:therapeutic use*
D009829:Oleic Acids; D012597:Sclerosing Solutions; D013917:Thrombin; C033343:ethanolamine oleate