Clinical trial with traditional Chinese medicine intervention ''tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment'' for chronic hepatitis B-associated liver failure

Table 1 Baseline characteristics of the patients n (%)

Characteristic	MMC group (n = 31)	“TQD” group (n = 65)	“TTK” group (n = 36)	P value
Age, yr, mean ± SD	43.71 ± 9.85	44.94 ± 12.64	46.69 ± 11.86	0.580
Male	29 (93.55)	51 (78.46)	32 (88.89)	0.114
Course of disease, yr, mean ± SD	9.87 ± 10.93	8.74 ± 8.48	10.03 ± 9.21	0.753
Chronic liver failure	15 (48.39)	35 (53.85)	14 (38.89)	0.354

MMC group: Modern medicine control group; “TQD” group: “Tonifying qi and detoxification” group.

Table 2 Antiviral therapy in groups n (%)

Nucleoside drugs	MMC group (n = 31)	“TQD” group (n = 65)	“TTK” group (n = 36)
Not using nucleoside drugs	21 (67.74)	55 (84.62)	27 (75.00)
Using nucleoside drugs	10 (32.26)	10 (15.38)	9 (25.00)
Lamivudine	12 (38.71)	30 (46.15)	12 (33.33)
Adefovir	0 (0.00)	5 (7.69)	4 (11.11)
Telbivudine	2 (6.45)	6 (9.23)	1 (2.78)
Entecavi	6 (19.35)	12 (18.46)	5 (13.89)
Lamivudine combined with adefovir	1 (3.23)	1 (1.54)	5 (13.89)
Entecavir combined with adefovir	0 (0.00)	1 (1.54)	0 (0.00)

There was no difference among the three groups in using nucleoside drugs in the study (P = 0.153).

Table 3 Traditional Chinese medicine formula of “tonifying qi and detoxification”

English translation	Chinese pinyin	Dosage
Astmgali Radix Praeparata cum Melle	Zhihuangqi	30 g
Polygoni Cuspidati Rhizoma et Radix	Huzhang	30-60 g
Poria	Fuling	30 g
Salviae Miltiorrhizae Radix et Rhizoma	Danshen	30 g
Leonuri Herba	Yimucao	30 g
Polyporus	Zhuling	20 g
Stir-baked Atractylodis Macrocephalae Rhizoma	Chaobaizhu	30 g
Artemisiae ScopariaeHerba	Yinchen	30-60 g
Gardeniae Fructus	Zhizi	12 g
Scutellariae Radix	Huangqin	6 g
Rhei Radix et Rhizoma	Dahuang	10 g
Glycyrrhizae Radix et Rhizoma	Gancao	6 g

Table 4 Traditional Chinese medicine formula of “tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment”

English translation	Chinese Pinyin	Dosage
Rehmanniae Radix Praeparata	Shudihuang	15-30 g
Artemisiae Scopariae Herba	Yinchen	30-60 g
Schisandrae Chinensis Fructus	Wuweizi	10-15 g
Curcumae Longae Rhizoma	Jianghuang	3-6 g
Glycyrrhizae Radix et Rhizoma	Gancao	9-12 g
Rhizoma Dioscoreae	Shanyao	15 g
Fructus Lycii	Gouqizi	15 g
Fructus Corni	Shanzhuyu	15 g
Cuscutae Semen	Tusizi	10 g
Poria	Fulin	30 g
Moutan Cortex	Mudanpi	10 g
Alismatis Rhizoma	Zexie	10 g

Table 5 Hepatitis B virus DNA after 8-wk treatment n (%)

Group	n	Negative	Positive
MMC	6	3 (50.0)	3 (50.0)
“TQD”	17	4 (23.5)	13 (76.5)
“TTK”	6	2 (33.3)	4 (66.7)

Normal range of HBV DNA (FQ-PCR): < 1.0 × 10³ copies/mL. Positive result: HBV DNA was absent or had decreased by ≥ 2 logarithms. HBV: Hepatitis B virus.

Table 6 Biochemical indicators after 8-wk treatment (mean ± SD)

Group	Time	n	PTA (%)	n	TBIL (µmol/L)	n	ALB (g/L)	n	ALT (IU/L)
MMC	Before treatment	28	26.80 ± 10.91	30	326.29 ± 210.47	28	28.07 ± 4.56	30	202.00 ± 249.20
	After treatment	18	43.14 ± 18.60	21	176.13 ± 185.70	21	28.57 ± 4.56	21	39.90 ± 30.19
“TQD”	Before treatment	61	32.50 ± 12.15	65	314.04 ± 160.20	65	29.54 ± 4.75	65	254.80 ± 424.32
	After treatment	55	43.59 ± 22.08	63	242.54 ± 229.05	63	31.30 ± 4.77c	63	78.70 ± 161.80
“TTK”	Before treatment	36	28.63 ± 11.28	36	369.13 ± 198.06	36	27.82 ± 4.52	36	189.52 ± 241.97
	After treatment	30	32.55 ± 15.58	33	339.40 ± 270.09a	33	30.72 ± 2.89e	33	70.12 ± 82.23

Normal range: PTA: 80%-120%; TBIL: 3.4-20.5 μmol/L; ALB: 35-55 g/L; ALT: 0-46 IU/L.

^aP < 0.05 vs MMC group;

^cP < 0.05 vs MMC group,

^eP < 0.05 vs MMC group.