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Table 1 Characteristics of the included studies

From: The clinical efficacy and adverse effects of Entecavir plus Thymosin alpha-1 combination therapy versus Entecavir Monotherapy in HBV-related cirrhosis: a systematic review and meta-analysis

Author [year]

Region

Study design

Enrollment period

Type of disease

Number of patients included

Diagnostic criteria of HBV

Groups

Number of patients in control/ETV plus Tα1 (n)

Intervention method

Shi TM [2013] [25]

Gansu Province, Jiayuguan

RCT

2009–2012

HBC

30

Diagnostic

Criteria of HBV revised by Xian National Viral Hepatitis

Conference in 2000

CG

VS.

EG

15

15

ETV 0.5 mg, once per day, treated for 48 weeks.

ETV 0.5 mg, once per day, combined with Tα1 injection 1.6 mg, twice per week, treated for 24 weeks, and then single ETV 0.5 mg, once per day, treated until 48 weeks.

Diao YH [2017] [22]

Henan Province,

Nanyang

RCT

2013.4-2014.4

CHBC

80

Guidelines for prevention and treatment of chronic hepatitis B in 2010

CG

VS.

EG

40

40

ETV 0.5 mg, once per day, treated for 24 weeks.

ETV 0.5 mg, once per day, combined with Tα1 injection 1.6 mg, twice per week, treated for 24 weeks.

Wu XN [2018] [23]

China

RCT

2013.01-2015.09

CHBC

690

NA

CG

VS.

EG

339

351

After 26 weeks of ETV treatment (0.5 mg per day), patients were randomly assigned to receive ETV (0.5 mg per day) or combination with Tα1 injection (1.6 mg twice per week) for 52 weeks.

Wang XR [2016] [26]

Hei

longjiang Province,

Jiamusi

RCT

2013.4- 2016.4

HBC

50

NA

CG

VS.

EG

25

25

ETV 0.5 mg, once per day, treated for 12 weeks.

ETV 0.5 mg, once per day, combined with Tα1 injection 1.6 mg, twice per week, treated for 12 weeks.

Xu YQ [2017] [21]

Sichuan Province,

Leshan

RCT

2014.1- 2016.12

DHBC

60

NA

CG

VS.

EG

30

30

ETV 0.5 mg, once per day, treated for 48 weeks.

ETV 0.5 mg, once per day, combined with Tα1 injection 1.6 mg, twice per week, treated for 48 weeks.

Zhang XX [2018] [24]

Liaoling Province,

Shenyang

RCT

2014..5- 2017.5

CHBC

104

Guidelines for prevention and treatment of chronic hepatitis B in 2010

CG

VS.

EG

52

52

ETV 0.5 mg, once per day, treated for 24 weeks.

ETV 0.5 mg, once per day, combined with Tα1 injection 1.6 mg, twice per week, treated for 24 weeks.

Jia P [2017] [20]

Heilong

jiang Province,

Jiamusi

RCT

2016.5- 2017.5

CHBC

130

Guidelines for prevention and treatment of chronic hepatitis B in 2015

CG

VS.

EG

65

65

ETV 0.5 mg, once per day, treated for 6 months.

ETV 0.5 mg, once per day, combined with Tα1 injection 1.6 mg, twice per week, treated for 6 months.

  1. CG control group, the group with ETV monotherapy, EG experimental group, the group with ETV plus Tα1 combination therapy, RCT randomized controlled trials, HBC HBV-related cirrhosis, CHBC compensated HBV-related cirrhosis; DHBC, decompensated HBV-related cirrhosis; NA, not available