Hematopoiesis reconstitution and anti-tumor effectiveness of Pai-Neng-Da capsule in acute leukemia patients with haploidentical hematopoietic stem cell transplantation

Table 1 Characteristics of the participants

Characteristics	Non-PND group (n = 31)	PND group (n = 29)	P value
Age (yr)			0.441
Median	33	37
Range	3–63	2–62
Males, n (%)	17 (54.8)	18 (62.1)	0.609
Diagnosis, n (%)			0.793
Acute myeloid leukemia	19 (61.3)	19 (65.5)
Acute lymphocytic leukemia	12 (38.7)	10 (34.5)
High cytogenetic risk, n (%)	11 (35.5)	12 (41.4)	0.791
Courses of chemotherapy before transplantation			0.819
Median	3	3
Range	2–7	2–8
Disease status at transplantation, n (%)			0.758
First complete remission	25 (80.6)	22 (75.9)
Second complete remission	6 (19.4)	7 (24.1)
Peripheral blood cell counts (pre-transplantation)
Neutrophil count (109/L)			0.824
Median	1.5	1.25
Range	0.45-6.21	0.42-6.77
Hemoglobin concentration (g/L)			0.773
Median	92	86
Range	68-130	72-142
Platelet count (109/L)			0.636
Median	87	83
Range	34-310	45-275
Donor’s age (yr)			0.668
Median	34	39
Range	9–62	10–63
Female donor–male recipient pairs, n (%)	7 (22.6)	8 (27.5)	0.769
Cytomegalovirus IgG-positive recipients, n (%)	16 (51.6)	13 (44.8)	0.617
Infused mononuclear cells (× 108/kg)			0.270
Median	12.42	14.67
Range	8.39–44.41	7.93–39.44
Infused CD34 + cells (× 106/kg)			0.243
Median	4.32	3.72
Range	1.20–7.47	1.03–10.80

PND: Pai-Neng-Da.

Table 2 The mean peripheral blood cell counts after haploidentical hematopoietic stem cell transplantation according to treatment group (mean ± SD)

Group	Case	Days after transplantation	Neutrophil count (109/L)	Hemoglobin concentration (g/L)	Platelet count (109/L)
Non-PND	31	6	0.12 ± 0.05	93.35 ± 15.23	21.55 ± 13.27
		12	1.61 ± 1.15	73.97 ± 7.67	27.65 ± 11.96
		18	2.78 ± 2.29	84.90 ± 12.17	45.03 ± 31.40
		24	3.01 ± 1.15	86.65 ± 11.70	68.39 ± 49.61
		30	3.21 ± 1.60	93.81 ± 16.94	76.65 ± 52.66
PND	29	6	0.10 ± 0.04	95.55 ± 14.13	19.55 ± 8.47
		12	1.87 ± 1.18	78.41 ± 10.01	28.07 ± 12.49
		18	2.86 ± 1.37	92.83 ± 14.58a	67.55 ± 35.63a
		24	3.28 ± 1.47	99.55 ± 17.83a	81.90 ± 38.37a
		30	3.36 ± 1.15	103.66 ± 19.22 a	82.31 ± 37.70

^aP < 0.05 vs non-PND group.

PND: Pai-Neng-Da.

Table 3 Comparison of therapeutic efficacy according to western medical evaluation indexes

Variates	Non-PND group(n = 31)	PND group(n = 29)	P value
Neutrophil engraftment time			0.454
Median	12	12
Range	10–15	10–14
Platelet engraftment time			0.039
Median	13	12
Range	9–145	8–152
RBC transfusion frequency			0.033
Median	1	0
Range	0–22	0–3
Platelet transfusion frequency			0.035
Median	3	2
Range	1–46	1–49
Poor graft function, n (%)	8 (25.8)	1 (3.4)	0.027
Infections within 100 d, n (%)	27 (87.1)	23 (79.3)	0.500
Cytomegaloviremia	15 (48.4)	11 (37.9)
Pneumonia	7 (22.6)	7 (24.1)
Sepsis	2 (6.5)	3 (10.3)
Other infections	3 (9.7)	2 (6.9)
aGVHD, n (%)	14 (45.2)	17 (58.6)	0.316
Ⅰ-Ⅱ	11 (35.5)	14 (48.3)
Ⅲ-Ⅳ	3 (9.7)	3 (10.3)
Relapse, n (%)	9 (29.0)	2 (6.9)	0.043

PND: Pai-Neng-Da; RBC: Red blood cells; aGVHD: Acute graft-versus-host disease.

Table 4 Comparison of therapeutic efficacy according to Chinese medical symptom scores [n (%)]

Group	Case	Basically cured	Favorably effective	Effective	Ineffective	Total effective
PND	29	2 (6.90%)	9 (31.03%)	16 (55.17%)	2 (6.90%)	27 (93.10%)a
Non-PND	31	0 (0)	6 (19.35%)	15 (48.39%)	10 (32.26%)	21 (67.74%)

^aP = 0.022 vs non-PND group.

PND: Pai-Neng-Da.