From: Real-world safety of ulinastatin: a post-marketing surveillance of 11,252 patients in China
Total | ICU | General ward | |
---|---|---|---|
Total use, times, n | 12,719 | 7993 | 4726 |
Single dose consistent with the indications, times, n (%) | 2878 (22.63) | 991 (12.40) | 1887 (39.93) |
Single dose of 300 thousand U, times, n (%) | 2751 (21.63) | 1852 (23.17) | 899 (19.02) |
Single dose > 10,000 U, times, n (%) | 9736 (76.55) | 6938 (87.46) | 2798 (59.19) |
Single dose < 10,000 U, times, n (%) | 45 (0.35) | 4 (0.05) | 41 (0.87) |
Consecutive treatment time, day, median (range) | 5 (1–141) | 2 (1–138) | 3 (1–141) |
Usage times, day, mean ± SD (range) | 3.83 ± 5.52 (1–196) | 3.38 ± 5.20 (1–138) | 4.59 ± 5.94 (1–196) |
Average continuous single dose, million U, mean ± SD | 145.70 ± 262.23 | 146.58 ± 271.30 | 144.22 ± 246.16 |
Average cumulative total dosage/patient, million U, mean ± SD | 163.94 ± 302.96 | 165.90 ± 307.98 | 160.64 ± 294.27 |
Solvent use, times, n (%) | |||
Sodium chloride | 8626 (67.82) | 4784 (60.31) | 3842 (81.29) |
5% glucose | 2066 (16.24) | 1236 (15.58) | 830 (17.56) |
Others* | 1928 (15.16) | 1885 (23.76) | 43 (0.91) |
Unknown | 39 (0.31) | 28 (0.35) | 11 (0.23) |
Solvent volume, times, n (%) | |||
10 ml | 2927 (23.01) | 1447 (18.10) | 1480 (31.32) |
20 ml | 3573 (28.09) | 2669 (33.64) | 904 (19.12) |
100 ml | 3102 (24.39) | 1779 (22.43) | 1323 (27.99) |
250 ml | 2397 (18.84) | 1848 (23.30) | 549 (11.62) |
500 ml | 720 (5.66) | 250 (21.23) | 470 (9.94) |
Administration route, n (%) | |||
Intravenous drip | 6480 (50.95) | 4246 (53.52) | 2234 (47.27) |
Intravenous pump | 2068 (16.26) | 1913 (24.11) | 155 (3.28) |
Intravenous injection | 4030 (31.68) | 1774 (22.36) | 2256 (47.74) |
Prefilling | 141 (1.11) | 60 (0.75) | 81 (1.71) |
Dosing frequency, n (%) | |||
once daily | 4837 (38.03) | 2519 (31.75) | 2318 (49.05) |
twice daily | 3523 (27.70) | 1978 (24.93) | 1545 (32.69) |
3 time/day | 2305 (18.12) | 1562 (19.69) | 743 (15.72) |
4 time/day (off-label) | 71 (0.55) | 66 (0.83) | 5 (0.11) |
6 time/day (off-label) | 7 (0.0055) | 7 (0.09) | 0 (0) |
8 time/day (off-label) | 4 (0.03) | 1 (0.01) | 3 (0.06) |
Treatment just once, n (%) | 404 (3.18) | 386 (4.87) | 18 (0.38) |
Treatment immediately, n (%) | 1507 (11.85) | 1414 (17.82) | 93 (1.97) |
Mixed with other drugs, times, n (%) | 2058 (16.18) | 2015 (25.20) | 43 (0.91) |
Combined with other drugs, times, n (%) | 12,719 (100.00) | 7993 (100.00) | 4726 (100.00) |