Dan Bai Xiao Formula combined with glucocorticoids and cyclophosphamide for pediatric lupus nephritis: A pilot prospective study

Table 1 Basic composition of the traditional Chinese herbal decoction Dan Bai Xiao Formula

DBXF meterial	Equivalent pharmaceutical name	Amount (g)
Feng Wei Cao	Herba Pteridis Multifidae	15
Ku Shen	Radix Sophorae Flavescentis	10
Shi Wei	Folium Pyrrosiae	12
Dao Kou Cao	Herba Achyranthis Asperae	15
Lian Xu	Stamen Nelumbinis	10
Dan Dou Chi	Semen Sojae Preperatum	12
Chi Xiao Dou	Semen Vignae Angularis	30
Yi Yi Ren	Semen Coicis	30

DBXF: Dan Bai Xiao Formula.

Table 2 Baseline clinical characteristics of all patients

Characteristic	Control group (n = 38)	TCM group (n = 40)	P value
Age (yr)	11.07 ± 2.28	11.51 ± 2.77	0.338
Female sex, n (%)	25 (65.8)	28 (70)	0.690
Weight (kg)	39.18 ± 11.55	41.61 ± 15.55	0.582
Duration of SLE (years)	0.65 ± 1.37	0.78 ± 1.21	0.607
Duration of LN (years)	0.15 ± 0.41	0.17 ± 0.28	0.559
Serum creatinine (μmol/L)	61.73 ± 46.68	51.46 ± 22.52	0.127
White blood cell count	5.03 ± 3.22	5.83 ± 3.20	0.201
NE (%)	53.85 ± 19.54	57.56 ± 15.33	0.489
HGB (g/L)	100.18 ± 16.93	105.85 ± 23.73	0.308
PT (s)	10.45 ± 0.93	11.23 ± 2.09	0.115
APTT (s)	35.48 ± 17.25	37.6 ± 16.17	0.577
D-D (mg/L)	1.08 ± 1.64	1.02 ± 1.32	0.161
Serum albumin (g/L)	29.23 ± 5.99	30.92 ± 4.61	0.167
Urine protein (g/24 h)	1.29 ± 1.81	1.32 ± 1.11	0.314
Urine RBC count/HPF	26.17 ± 37.92	25.65 ± 37.59	0.24
Serum C3 (g/L)	0.28 ± 0.18	0.39 ± 0.28	0.101
Serum C4 (g/L)	0.05 ± 0.04	0.06 ± 0.05	0.782
BUN (IU/mL)	6.94 ± 3.89	5.72 ± 2.31	0.057
ALT (mmol/L)	33.20 ± 28.04	32.88 ± 36.34	0.730
AST (mmol/L)	40.00 ± 41.21	39.61 ± 43.37	0.957
SLEDAI	15.57 ± 5.01	14.07 ± 3.49	0.315
ds-DNA postive, n (%)	28 (73.6)	33 (82.5)	0.345

Results are given as the mean ± SD. TCM: Traditional Chinese medicine; RBC: Red blood cell; SLEDAI: Systemic Lupus Erythematosus Disease Activity Index; LN: Lupus nephritis; BUN: Blood urea nitrogen.

Table 3 Comparison of clinical indexes between the two groups

Characteristic	Follow up (wk)	Control group (n = 38)	TCM group (n = 40)	P value
Urine protein (g/24 h)	4	1.11 ± 1.54	0.73 ± 1.48	0.008
	12	0.67 ± 0.91	0.34 ± 0.82	0.0159
	24	0.30 ± 0.29	0.09 ± 0.14	< 0.0001
Urine RBC count/HPF	4	17.63 ± 15.48	9.02 ± 8.78	0.001
	12	10.55 ± 9.73	4.35 ± 8.54	0.0007
	24	10.47 ± 8.43	2.82 ± 5.11	< 0.0001
Serum albumin (g/L)	4	34.60 ± 6.57	36.36 ± 4.91	0.324
	8	37.27 ± 6.64	39.35 ± 3.82	0.428
	12	39.65 ± 6.73	41.16 ± 3.99	0.701
	16	40.26 ± 6.45	41.17 ± 5.02	0.879
	20	41.50 ± 5.16	41.08 ± 7.00	0.821
	24	40.30 ± 6.28	41.15 ± 5.14	0.808
Serum C3 (g/L)	4	0.61 ± 0.14	0.53 ± 0.19	0.112
	8	0.73 ± 0.16	0.69 ± 0.25	0.205
	12	0.80 ± 0.19	0.73 ± 0.0.21	0.143
	16	0.82 ± 0.15	0.77 ± 0.20	0.452
	20	0.82 ± 0.15	0.85 ± 0.14	0.874
	24	0.88 ± 0.17	0.86 ± 0.22	0.990
Serum C4 (g/L)	4	0.10 ± 0.04	0.08 ± 0.05	0.800
	8	0.12 ± 0.05	0.11 ± 0.05	0.730
	12	0.14 ± 0.07	0.10 ± 0.05	0.122
	16	0.15 ± 0.06	0.13 ± 0.05	0.235
	20	0.16 ± 0.06	0.14 ± 0.06	0.874
	24	0.18 ± 0.07	0.18 ± 0.23	0.624
SCR (μmol/L)	4	44.75 ± 19.10	42.65 ± 12.86	0.768
	8	44.18 ± 19.10	44.02 ± 13.08	0.794
	12	59.08 ± 76.32	45.17 ± 14.43	0.244
	16	46.53 ± 11.70	48.81 ± 14.68	0.922
	20	49.46 ± 12.47	49.38 ± 14.09	0.939
	24	50.11 ± 9.58	45.40 ± 10.32	0.060
BUN (IU/mL)	4	6.93 ± 2.60	6.08 ± 2.01	0.135
	8	6.24 ± 3.13	5.46 ± 2.04	0.492
	12	5.20 ± 1.86	5.39 ± 1.61	0.654
	16	5.04 ± 1.38	5.04 ± 1.60	0.975
	20	4.93 ± 1.42	4.67 ± 1.43	0.469
	24	4.88 ± 1.24	4.34 ± 1.38	0.051
Dosage of GCs	0	55.05 ± 7.44	52.70 ± 10.94	0.683
	4	52.94 ± 6.38	46.79 ± 12.72	0.098
	8	47.67 ± 6.44	40.78 ± 12.11	0.011
	12	43.58 ± 6.32	35.14 ± 12.77	< 0.0001
	16	39.14 ± 5.38	30.62 ± 9.87	0.0001
	20	34.64 ± 5.04	25.74 ± 8.84	0.060
	24	31.44 ± 4.85	17.61 ± 7.45	< 0.0001
ds-DNA positive, n (%)	24	10 (26.3)	9 (22.5)	0.694
SLEDAI	4	11.00 ± 5.21	9.02 ± 4.02	0.073
	12	7.16 ± 3.52	6.58 ± 3.64	0.625
	24	5.67 ± 4.27	5.12 ± 3.48	0.990

Results are given as the mean ± SD. Between-group P value were calculated using analysis of covariance, with adjustment for the baseline values. Unpaired t-test and Mann-Whitney U test were used as appropriate. RBC: Red blood cell; SLEDAI: Systemic Lupus Erythematosus Disease Activity Index; BUN: Blood urea nitrogen; GCs: Glucocorticoids; TCM: Traditional Chinese medicine.

Table 4 Comparison of adverse events between the two groups

Item	Control group		TCM group		P value
	n = 38	Percent (%)	n = 40	Percent (%)
Gastroenteritis	24	63.1	12	30.0	0.006
Anemia	5	13.1	2	5.0	0.970
Hepatic function damage	16	42.1	9	22.5	0.030
Leukopenia	3	7.8	0	0	0.060
Upper respiratory infection	5	13.1	7	17.5	0.590
Phlebothrombosis	2	5.3	0	0	0.140
Urinary infection	1	2.6	0	0	0.300
Hypothyroidism	3	7.9	1	2.5	0.280
Hypertension	10	26.3	3	7.5	0.020

Gastroenteritis included diarrhea, vomiting, and nausea. Alanine transaminase and aspartate transaminase above the normal range were considered as hepatic function damage. White blood cell count of less than 4 × 10⁹/L was considered as leukopenia. Hypertension was defined as a systolic or diastolic blood pressure > 90^th percentile. Chi-Square test and Fisher’s exact test were used as appropriate. A P value of < 0.05 was considered significant. TCM: Traditional Chinese medicine.