Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial
Table 2
Baseline characteristics of the patients.
Characteristic
Total (n=49)
ZPO ( n=23)
Control ( n=26)
Age (years), median and range
44 (24-60)
45 (24-60)
44 (29-60)
Gender
Male
30 (61.2%)
12 (52.2%)
18 (69.2%)
Female
19 (38.8%)
11 (47.8%)
8 (30.8%)
Diagnosis
Essential thrombocythemia
35 (71.4%)
16 (69.6%)
19 (73.1%)
Polycythemia vera
9 (18.4%)
5 (21.7%)
4 (15.4%)
Myelofibrosis
5 (10.2%)
2 (8.7%)
3 (11.5%)
Duration of ulcer at enrolment (months), median and range
10 (2-36)
9 (2-18)
11 (2-36)
BMI (kg/m2)
<18.5
12 (24.5%)
4 (17.4%)
8 (30.8%)
18.5-24.9
29 (59.2%)
16 (69.6%)
13 (50.0%)
≥25
8 (16.3%)
3 (13.0%)
5 (19.2%)
Treatment after withdrawal of HU
Recombined human interferon α
37 (75.5%)
16 (69.6%)
21 (80.8%)
Watchful waiting
12 (24.5%)
7 (30.4%)
5 (19.2%)
Routine blood test
Leukocyte (×109/L)
7.6±5.2
8.8±5.4
6.6±4.8
Hemoglobin (g/L)
115±36.3
116±36.9
114±37
Platelet (×109/L)
303±179
298±167
308±183
Ulcer area (cm2)
3.5±1.0
3.3±1.0
3.6±1.0
Wagner’s classification of the ulcers
Grade 1
13 (26.5%)
5 (21.7%)
8 (30.8%)
Grade 2
21 (42.9%)
9 (39.1%)
12 (46.1%)
Grade 3
15 (30.6%)
9 (39.1%)
6 (23.1%)
Germiculture of the ulcers
Positive
9 (18.4%)
6 (26.1%)
3 (11.5%)
Negative
40 (81.6%)
17 (73.9%)
23 (88.5%)
Pain evaluation (NRS classification)
0-3
7 (14.3%)
3 (13.0%)
4 (15.4%)
4-6
28 (57.1%)
15 (65.3%)
13 (50.0%)
7-10
14 (28.6%)
5 (21.7%)
9 (34.6%)
Abbreviations: ZPO, Zhangpi Ointment; BMI, Body Mass Index; HU, hydroxyurea; NRS, Numerical Rating Scale.
