Correspondence mail:
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia-Cipto
Mangunkusumo Hospital. Jl. Diponegoro no. 71, Jakarta 10430, Indonesia. email: arisyam91@yahoo.com.
ABSTRAK
Tujuan: untuk menilai keamanan dan efikasi dari injeksi lansoprazole (Prosogan) pada pasien dengan
perdarahan gastrointestinal atas (UGIB) akibat ulkus peptikum atau gastritis erosiva. Metode: suatu studi
observasional pasca-pemasaran lansoprazol injeksi. Pasien dengan UGIB akibat ulkus peptikum atau gastritis
erosiva diberi lansoprazol injeksi selama maksimal 7 hari atau sampai perdarahan berhenti dan pasien dapat
minum lansoprazol oral. Outcome primer studi ini adalah berhentinya perdarahan. Beberapa parameter
laboratorium juga diukur. Hasil: sejumlah 204 pasien dapat dinilai keamanannya, dan tidak ada kejadian tidak
diinginkan yang dilaporkan selama studi. Sejumlah 200 pasien dapat dinilai efikasinya, 125 pasien di antaranya
adalah pasien laki-laki. UGIB berhenti pada 20 pasien (10%) pada hari pertama, 71 pasien (35,5%) pada hari
ke-2, 75 pasien (37,5%) pada hari ke-3, 24 pasien (12,0%) pada hari ke-4, dan 7 pasien (3,5%) pada hari ke-5,
total 197 pasien (98,5%) pada hari ke-5. Efek hemostatik ini dinilai baik sekali jika perdarahan berhenti dalam
waktu 3 hari dan baik jika perdarahan berhenti dalam waktu 5 hari. Dengan demikian hasilnya baik sekali pada
166 pasien (83,0%) dan baik pada 31 pasien (15,5%). Hasil ini tidak berbeda antara laki-laki dan perempuan,
antara umur di bawah 60 tahun dan 60 tahun ke atas, dan antara Hb awal di bawah 10 g/dL dan 10 g/dL ke atas.
Kesimpulan: hasil studi observasional pasca pemasaran pada 200 pasien dengan UGIB akibat ulkus peptikum
atau gastritis erosiva ini menunjukkan bahwa lansoprazol intravena dua kali sehari aman dan sangat efektif.
Kata kunci: survei pasca-pemasaran, lansoprazole, perdarahan saluran cerna bagian atas.
ABSTRACT
Aim: to assess the safety and effectiveness of lansoprazole injection (Prosogan) in patients with upper
gastrointestinal bleeding due to peptic ulcers or erosive gastritis. Methods: this study was a multicenter observational
postmarketing study of lansoprazole (Prosogan) injection. Patients with upper gastrointestinal bleeding due
to peptic ulcers or erosive gastritis were given intravenous lansoprazole for a maximum of 7 days or until the
bleeding stopped and the patients were able to take oral doses of lansoprazole. Primary outcome of the study was
cessation of bleeding. Some laboratory parameters were also measured. Results: among a total of 204 patients
evaluable for safety, there was no adverse event reported during the study. A total of 200 patients were eligible
for efficacy evaluation, 125 patients (62.5%) were males. Among these patients, upper GI bleeding stopped in 20
patients (10.0%) on day 1, in 71 patients (35.5%) on day 2, 75 patients (37.5%) on day 3, 24 patients (12.0%)
on day 4, and 7 patients (3.5%) on day 5, making a cumulative of 197 patients (98.5%) on day 5. The hemostatic
Acta Medica Indonesiana - The Indonesian Journal of Internal Medicine
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Ari F. Syam
effect was rated as excellent if the bleeding stopped within 3 days, and good if the bleeding stopped within 5
days. Thus, the results were excellent in 166 patients (83.0%) and good in 31 patients (15.5%). These results
were not different between males and females, between age below 60 years and 60 years and above, and between
baseline Hb below 10 g/dL and 10 g/dL and above. Conclusion: the results of this observational postmarketing
study in 200 patients with upper gastrointestinal bleeding due to peptic ulcers or erosive gastritis demonstrated
that intravenous lansoprazole twice a day was well tolerated and highly effective.
Key words: postmarketing surveillance (PMS), lansoprazole, upper gastrointestinal bleeding (UGIB).
INTRODUCTION
124
Missing
52.1 (13.34)
Weight (kg)
60.8 (10.39)
BMI (kg/m2)
23.0 (3.54)
Variables
Mean (SD)
Male: n (%)
125 (62.5%)
Age (yrs)
Median
(Range)
Missing
123.1 (18.02)
120.0 (90180)
77.6 (9.77)
80.0 (50100)
Heart rate
(bpm)
89.5 (10.66)
88.0 (69124)
Respiratory
rate (per min)
20.0 (3.02)
20.0 (1431)
121.9 (12.89)
120.0 (90190)
78.4 (7.46)
80.0 (60100)
Heart rate
(bpm)
83.7 (8.01)
82.0 (68124)
Respiratory
rate (per min)
19.5 (3.10)
20.0 (1436)
Baseline
End of the
study (day 7)
125
Ari F. Syam
-- Erosive gastritis
81
40.5
-- Gastric ulcer
53
26.5
-- Duodenal ulcer
24
12.0
-- GERD
19
9.5
-- Hematemesis
13
6.5
-- Dyspepsia
4.5
-- Upper GI bleeding
1.5
-- Others
3.0
-- Diabetes mellitus
11
5.5
-- Hypertension
15
7.5
2.5
-- Dyslipidemia
1.0
-- Osteoarthritis
4.0
-- Rheumatoid arthritis
0.5
-- Others:
Other diseases:
-- Obesity
1.0
-- Others
20
10.0
Before
treatment
After
treatment
p value
Hb (g/dL)
9.9 (2.68)
10.9 (1.82)
< 0.001
Creatinine
(mg/dL)
1.2 (0.65)
1.1 (0.51)
0.01
BUN (mg/dL)
37.9 (17.22)
35.4 (14.19)
< 0.001
ALT (U/L)
33.5 (19.92)
32.5 (14.49)
0.31 (NS)
AST (U/L)
32.8 (28.64)
30.5 (10.78)
0.17 (NS)
3.5 (0.50)
3.5 (0.49)
0.05
Albumin (g/dL)
126
N (%)
Male (%)
Female
(%)
Excellent (bleeding
stopped within 3
days)
166 (83.0)
105 (84.0)
61 (81.3)
Good (bleeding
stopped within 5
days)
31 (15.5)
19 (15.0)
12 (16.0)
Fair (bleeding
stopped within 7
days)
2 (1.0)
1 (1.0)
1 (1.3)
Poor (bleeding
did not stopped
within 7 days)
1 (0.5)
1 (1.3)
125 (100.0)
75 (100.0)
Total
Table 6. Hemostatic effects based on age group and hemoglobin level at baseline
Hemostatic effect
Hb <10 (%)
Hb >10 (%)
Excellent
36 (80.0)
130 (83.9)
76 (79.2)
90 (86.5)
Good
8 (17.8)
23 (14.8)
19 (19.8)
12 (11.5)
Fair
2 (1.3)
1 (1.0)
1 (1.0)
Poor
1 (2.0)
1 (1.0)
Total
45 (100.0)
155 (100.0)
96 (100.0)
104 (100.0)
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Ari F. Syam
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