title: An open-label, randomized and multi-center clinical trial to evaluate the efficacy of Silibinin in preventing drug-induced liver injury.
abstract: To assess the clinical efficacy and safety of Silibinin in preventing drug-induced liver injury (DILI) in the general population (high-risk patients with non-drug induced liver injury).
  
  
  METHODS
  A prospective, multi-center, randomized, open-label and controlled trial was conducted with 568 patients undergoing primary treatment of pulmonary tuberculosis. The study included 277 patients in experimental group and 291 patients in control group. The patients in the two group were treated with conventional 2HREZ (S)/4HR for tuberculosis (TB), and additional Silibinin capsules (oral administration of 70 mg/time, 3 times/day for 8 weeks in experimental group. Outcomes of liver function, interruption of anti-TB treatment and therapeutic results, as well as adverse reactions were observed and analyzed.
  
  
  RESULTS
  At 2, 4 and 8 weeks of treatment, the incidences of liver injury in experimental group were 3.97%, 1.44% and 2.17%, respectively; the incidences in control group were 4.12%, 4.12% and 2.41%, respectively. Statistical analysis showed that there was no difference in the incidence between the two groups at each treatment period (P>0.05). At 8 weeks, the numbers of patients diagnosed of DILI were 18 (7.22%) and 27 (9.28%) in experimental and control groups, respectively (P>0.05). 34.30% and 27.49% of the patients in experimental and control groups had transient abnormal liver function or symptoms, respectively; similar percentages (3.25% and 6.19%) of the patients in two groups have liver function injury and symptoms, and were suspended for anti-TB treatment (P>0.05). The incidence of anorexia and nausea symptoms was lower in experimental group than in control group, and the differences were significant at 4 and 8 weeks (P<0.05). 8 weeks after the treatment, 98.30% of the sputum smear culture were negative in experimental group, which was significantly higher (P<0.01) than that in control group (92.98%).
  
  
  CONCLUSIONS
  Preventive hepatoprotective therapy in the general population may reduce drug discontinuation rate, improve patient's compliance and outcomes of anti-TB treatment.
authors.affiliation: Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine China.
authors.forename: Jin
authors.initials: J
authors.lastname: Gu
authors.affiliation: Beijing Chest Hospital, Capital Medical University China.
authors.forename: Shen-Jie
authors.initials: SJ
authors.lastname: Tang
authors.affiliation: Guangzhou Chest Hospital China.
authors.forename: Shou-Yong
authors.initials: SY
authors.lastname: Tan
authors.affiliation: Tianjin Haihe Hospital China.
authors.forename: Qi
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Nanjing Chest Hospital China.
authors.forename: Xia
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Guangxi Longtan Hospital China.
authors.forename: Cun-Xu
authors.initials: CX
authors.lastname: Liu
authors.affiliation: Shandong Provincial Chest Hospital China.
authors.forename: Xu-Sheng
authors.initials: XS
authors.lastname: Gao
authors.affiliation: Tuberculosis Institute of Wuhan City China.
authors.forename: Bao-Dong
authors.initials: BD
authors.lastname: Yuan
authors.affiliation: Infectious Disease Hospital of Changchun City China.
authors.forename: Li-Jun
authors.initials: LJ
authors.lastname: Han
authors.affiliation: Anhui Chest Hospital China.
authors.forename: Ai-Ping
authors.initials: AP
authors.lastname: Gao
authors.affiliation: The Fifth People's Hospital of Suzhou China.
authors.forename: Mei-Ying
authors.initials: MY
authors.lastname: Wu
authors.affiliation: Wuxi Infectious Disease Hospital China.
authors.forename: Li-Hua
authors.initials: LH
authors.lastname: Huang
authors.affiliation: Tianjin Medical University China.
authors.forename: Jun
authors.initials: J
authors.lastname: Ma
authors.affiliation: Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine China.
authors.forename: He-Ping
authors.initials: HP
authors.lastname: Xiao
keywords: Pulmonary tuberculosis; Silibinin; drug-induced liver injury