Table 1.
Characteristics of the patients between the two groups.
| Characteristic | Full analysis set (N = 93) |
Per-protocol population (N = 80) |
||||
|---|---|---|---|---|---|---|
| Butylphthalide Group (n = 62) | Placebo Group (n = 31) | P | Butylphthalide Group (n = 52) | Placebo Group (n = 28) | P | |
| Age, mean (SD), year | 57.1 ± 12.0 | 57.5 ± 11.0 | 0.886 | 55.73 ± 11.69 | 57.29 ± 10.97 | 0.564 |
| Sex, male, n (%) | 53 (85.5) | 25 (80.6) | 0.550 | 45 (86.5) | 22 (78.6) | 0.357 |
| Clinical history, n (%) | ||||||
| Smoking | 34 (54.8) | 17 (54.8) | >0.999 | 30 (57.7) | 14 (50.0) | 0.509 |
| Hypertension | 30 (48.4) | 13 (41.9) | 0.556 | 26 (50.0) | 11 (39.3) | 0.359 |
| Diabetes | 12 (19.4) | 3 (9.7) | 0.232 | 9 (17.3) | 2 (7.1) | 0.181 |
| Dyslipidemia | 3 (4.8) | 4 (12.9) | 0.165 | 3 (5.8) | 2 (7.1) | 0.577 |
| Cerebrovascular disease a | 6 (9.7) | 6 (19.4) | 0.189 | 6 (11.5) | 6 (21.4) | 0.195 |
| Concomitant medication, n (%) | ||||||
| Anti-hypertensive drugs | 21 (33.9) | 9 (29.0) | 0.638 | 20 (36.4) | 8 (28.6) | 0.478 |
| Anti-hyperlipidemic drugs | 54 (87.1) | 27 (87.1) | >0.999 | 50 (90.9) | 24 (85.7) | 0.472 |
| Anti-diabetic drugs | 10 (16.1) | 6 (19.4) | 0.698 | 10 (18.2) | 5 (17.9) | 0.971 |
| Anti-platelet drugs | 55 (88.7) | 26 (83.9) | 0.512 | 51 (92.7) | 23 (82.1) | 0.143 |
| Admission blood pressure, median (IQR), mmHg | ||||||
| SBP | 148 (132–162) | 143 (134–164) | 0.791 | 148 (132–161) | 144 (135–162) | 0.908 |
| DBP | 85 (75–99) | 84 (80–92) | 0.660 | 86 (78–100) | 85 (80–97) | 0.747 |
| Admission HR, median (IQR), times/minute | 76 (66–80) | 78 (70–84) | 0.313 | 76 (68–80) | 78 (71–84) | 0.511 |
| NIHSS score, median (IQR) | 7 (6–10) | 10 (6–13) | 0.057 | 7 (5–10) | 10 (6–13) | 0.080 |
| Baseline monitor | ||||||
| SBP, median (IQR), mmHg | 143 (124–164) | 142 (142–156) | 0.512 | 143 (123–160) | 141 (131–154) | 0.617 |
| DBP, median (IQR), mmHg | 78 (67–90) | 81 (75–92) | 0.117 | 78 (67–89) | 81 (75–91) | 0.060 |
| HR, median (IQR), times/minute | 70 (65–76) | 71 (65–78) | 0.562 | 71 (65–77) | 71 (66–79) | 0.422 |
| End-tidal CO2, median (IQR), mmHg | 40 (34–45) | 37 (34–44) | 0.511 | 41 (35–46) | 37 (35–44) | 0.330 |
| Baseline phase difference, median (IQR), degree | ||||||
| Affected side | 25.20 (8.37–37.81) | 25.05 (15.98–37.86) | 0.788 | 28.71 (9.54–40.61) | 26.60 (16.36–38.46) | 0.904 |
| Unaffected side | 32.83 (18.81–48.11) | 29.89 (19.95–41.71) | 0.453 | 32.83 (17.02–48.22) | 29.39 (20.54–41.75) | 0.579 |
| Baseline gain, median (IQR), %/mmHg | ||||||
| Affected side | 0.81 (0.60–1.14) | 1.01 (0.75–1.36) | 0.093 | 0.81 (0.60–1.13) | 1.04 (0.75–1.36) | 0.050 |
| Unaffected side | 1.05 (0.76–1.42) | 1.12 (0.91–1.53) | 0.246 | 1.00 (0.70–1.42) | 1.13 (0.92–1.63) | 0.125 |
| 14 days/discharge monitor | ||||||
| SBP, median (IQR), mmHg | 136 (125–148) | 130 (124–140) | 0.426 | 135 (124–142) | 131 (125–140) | 0.828 |
| DBP, median (IQR), mmHg | 80 (76–84) | 82 (76–85) | 0.527 | 80 (76–83) | 82 (76–86) | 0.413 |
| HR, median (IQR), times/minute | 76 (70–80) | 75 (64–82) | 0.287 | 76 (70–80) | 74 (64–82) | 0.332 |
| End-tidal CO2, median (IQR), mmHg | 39 (34–44) | 42 (37–47) | 0.164 | 39 (33–45) | 43 (37–47) | 0.078 |
| 90 days monitorb | ||||||
| SBP, median (IQR), mmHg | 130 (125–140) | 130 (123–137) | 0.601 | 130 (123–137) | 130 (122–137) | 0.933 |
| DBP, median (IQR), mmHg | 82 (75–87) | 81 (71–84) | 0.437 | 81 (76–86) | 81 (72–84) | 0.357 |
| HR, median (IQR), times/minute | 77 (71–82) | 76 (70–84) | 0.667 | 76 (71–82) | 77 (70–86) | 0.720 |
| End-tidal CO2, median (IQR), mmHg | 40 (34–45) | 43 (37–46) | 0.258 | 39 (35–45) | 44 (38–46) | 0.209 |
SD: standard deviation; IQR: interquartile range; SBP: systolic blood pressure; DBP: diastolic blood pressure; HR: heart rate.
aCerebrovascular disease was defined as all diseases involving cerebral blood vessels with an onset of more than 3 months, including ischemic stroke, hemorrhagic stroke, transient ischemic attack or subarachnoid hemorrhage.
bData on monitor at 90 days were available for 71 patients (butylphthalide group, n = 45; placebo group, n = 26).