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Frontiers of Medicine

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ISSN 2095-0225(Online)

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Front. Med.    2021, Vol. 15 Issue (3) : 495-505    https://doi.org/10.1007/s11684-020-0790-9
RESEARCH ARTICLE
The “Traditional Chinese medicine regulating liver regeneration” treatment plan for reducing mortality of patients with hepatitis B-related liver failure based on real-world clinical data
Ling Dai, Xiang Gao, Zhihua Ye, Hanmin Li(), Xin Yao, Dingbo Lu, Na Wu
Institute of Liver Diseases, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China; Institute of Basic Theory of Chinese Medicine, Hubei Province Academy of Traditional Chinese Medicine, Wuhan 430074, China; Theory and Application Research of Liver and Kidney in Traditional Chinese Medicine, Hubei Provincial Key Laboratory, Wuhan 430074, China; Key Laboratory of Treating Chronic Liver Diseases from Liver and Kidney, State Administration of Traditional Chinese Medicine, Wuhan 430061, China
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Abstract

On the basis of real-world clinical data, the study aimed to explore the effect and mechanisms of the treatment plan of “traditional Chinese medicine (TCM) regulating liver regeneration.” A total of 457 patients with HBV-related liver failure were retrospectively collected. The patients were divided into three groups: the modern medicine control group (MMC group), patients treated with routine medical treatment; the control group combining traditional Chinese and Western medicine (CTW), patients treated with routine medical treatment plus the common TCM formula; and the treatment group of “TCM regulating liver regeneration” (RLR), patients treated with both routine medical treatment and the special TCM formula of RLR. After 8 weeks of treatment, the mortality of patients in the RLR group (12.31%) was significantly lower than those in the MMC (50%) and CTW (29.11%) groups. Total bilirubin level significantly decreased and albumin increased in the RLR group when compared with the MMC and CTW groups (P<0.05). In addition, there were significant differences in the expression of several cytokines related to liver regeneration in the RLR group compared with the MMC group. RLR treatment can decrease jaundice, improve liver function, and significantly reduce the mortality in patients with HBV-related liver failure. The mechanism may be related to the role of RLR treatment in influencing cytokines related to liver regeneration.
Keywords hepatitis B virus-related liver failure      traditional Chinese medicine      liver regeneration      liver regeneration microenvironment      cytokines     
Corresponding Author(s): Hanmin Li   
Just Accepted Date: 27 November 2020   Online First Date: 12 January 2021    Issue Date: 18 June 2021
 Cite this article:   
Ling Dai,Xiang Gao,Zhihua Ye, et al. The “Traditional Chinese medicine regulating liver regeneration” treatment plan for reducing mortality of patients with hepatitis B-related liver failure based on real-world clinical data[J]. Front. Med., 2021, 15(3): 495-505.
 URL:  
https://academic.hep.com.cn/fmd/EN/10.1007/s11684-020-0790-9
https://academic.hep.com.cn/fmd/EN/Y2021/V15/I3/495
Fig.1  Trial flow diagram. ACLF, acute-on-chronic liver failure; SACLF, subacute-on-chronic liver failure; and CLF, chronic liver failure.
Characteristic MMC
(n = 96)		 CTW
(n = 158)		 RLR
(n = 203)		 P value
Age (year, x ¯± s) 47.65±12.96 47.68±12.91 47.32±12.98 0.959
Male (n (%)) 79 (82.29) 128 (81.01) 168 (82.76) 0.91
Disease course (year, x¯±s) 11.84±11.98 11.16±10.52 12.24±9.76 0.63
Acute-on-chronic (subacute) liver failure (n (%)) 55 (57.29) 84 (53.16) 103 (50.74) 0.569
Chronic liver failure (n (%)) 41 (42.71) 74 (46.84) 100 (49.26) 0.569
Tab.1  Demographic and clinical diagnosis of the three groups
Antiviral drug MMC
(n = 96)		 CTW
(n = 158)		 RLR
(n = 203)
No antiviral drugs used 30 (31.25) 45 (28.48) 64 (31.53)
Lamivudine 23 (23.96) 40 (25.32) 32 (15.76)
Adefovir dipivoxil 0 (0.00) 11 (6.96) 17 (8.37)
Telbivudine 4 (4.16) 12 (7.59) 8 (3.94)
Entecavir 34 (35.42) 43 (27.22) 69 (33.99)
Lamivudine plus adefovir dipivoxil 3 (3.13) 4 (2.53) 7 (3.45)
Entecavir plus adefovir dipivoxil 2 (2.08) 3 (1.90) 6 (2.96)
Antiviral drugs used (total) 66 (68.75) 113 (71.52) 139 (68.47)
Tab.2  Antiviral drugs and percentages of patients receiving antiviral therapy in each group (n (%))
Fig.2  Mortality rates of patients with HBV-related liver failure in the three groups. (A) The fatality rate in the RLR group was significantly lower than those in the MMC group (12.31% vs. 50.00%, P = 0.000) and CTW group (12.31% vs. 29.11%, P = 0.005) after 8 weeks of treatment. (B) Survival rates were recorded and analyzed by log-rank (Mantel–Cox) test.
Group Time n PTA (%) n TBIL (mmol/L) n ALB (g/L) n ALT (IU/L)
MMC Before 93 30.62±12.89 95 299.95±185.45 93 31.32±6.46 95 299.34±393.30
After 54 41.73±21.82 57 224.96±198.61 57 32.44±5.90 57 77.98±186.39
CTW Before 154 33.72±14.20 158 291.78±165.72 158 30.45±5.27 158 304.56±475.07
After 129 44.35±22.80 137 233.25±226.16 137 33.11±5.43 137 67.29±123.70
RLR Before 203 36.56±15.90 203 273.13±177.27 202 32.86±16.90 203 356.51±532.83
After 181 47.71±22.39 181 155.42±176.17 181 35.09±6.42 181 49.87±73.39
Tab.3  Comparison of biochemical indexes among the three groups before and after treatment ( x¯ ±s)
Cytokine NC
(n = 10)		 MMC
(n = 10)		 CTW
(n = 10)		 RLR
(n = 5)
HGF 57.16±27.81 413.84±387.89▲ 1162.47±1264.03▲ 2634.29±3923.86□▲
TGF-β1 58 552.84±38 940.57 40 650.32±23 862.58 21 952.78±15 136.54?□ 9739.96±5811.91▲□
SCF 25.48±6.33 14.93±6.54▲ 33.31±13.65■ 28.76±13.32■
VEGF 26.14±19.59 6.26±8.86▲ 10.79±10.07 14.38±15.44□
IFN-γ 99.88±125.91 70.04±62.80 35.91±58.64 220.51±295.43●
TRAIL 27.24±18.14 18.32±5.27 12.11±16.16?□ 11.03±9.19
TNF-α 6.16±5.50 15.08±18.21 29.84±60.76 30.16±39.95
PDGFbb 587.51±687.94 445.66±470.39 212.08±264.77 92.18±39.78
FGF-basic 12.24±8.28 7.75±13.05 6.21±5.68 9.28±12.29
IL-12 192.80±119.08 56.05±96.54 97.70±92.18 22.68±42.88
IL-18 35.04±20.30 22.72±11.01 59.11±35.15 95.51±118.55
IL-6 18.22±26.95 12.84±12.93 106.19±145.82 44.58±44.65
IL-10 3.99±6.27 2.17±2.44 1.99±2.34 11.60±21.38
IL-13 4.89±6.34 6.10±4.67 11.82±16.62 8.89±13.67
GCSF 1.98±1.01 1.53±0.88 3.54±7.35 3.65±2.74
GMCSF 60.65±37.22 36.17±27.62 40.52±30.20 80.02±113.77
LIF 106.45±55.45 34.70±44.66 64.08±59.79 64.35±24.43
MIF 1424.54±1775.34 797.51±846.12 1952.77±2115.81 2343.00±2045.04
bNGF 1.26±0.43 1.56±0.45 1.01±0.73 1.20±0.55
Tab.4  Comparison of serum cytokine levels among the different groups
Fig.3  Serum cytokine levels in patients with CHBLF (pg/mL, mean±SD). *P<0.05, **P<0.01, vs. the normal control group; #P<0.05, ##P<0.01, vs. the MMC group; ※P<0.05, vs. the CTW group.
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