Jin Gu1, Shen-Jie Tang2, Shou-Yong Tan3, Qi Wu4, Xia Zhang5, Cun-Xu Liu6, Xu-Sheng Gao7, Bao-Dong Yuan8, Li-Jun Han9, Ai-Ping Gao10, Mei-Ying Wu11, Li-Hua Huang12, Jun Ma13, He-Ping Xiao1. 1. Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine China. 2. Beijing Chest Hospital, Capital Medical University China. 3. Guangzhou Chest Hospital China. 4. Tianjin Haihe Hospital China. 5. Nanjing Chest Hospital China. 6. Guangxi Longtan Hospital China. 7. Shandong Provincial Chest Hospital China. 8. Tuberculosis Institute of Wuhan City China. 9. Infectious Disease Hospital of Changchun City China. 10. Anhui Chest Hospital China. 11. The Fifth People's Hospital of Suzhou China. 12. Wuxi Infectious Disease Hospital China. 13. Tianjin Medical University China.
Abstract
UNLABELLED: 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). METHOD: 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%). CONCLUSION:Preventive hepatoprotective therapy in the general population may reduce drug discontinuation rate, improve patient's compliance and outcomes of anti-TB treatment.
RCT Entities:
UNLABELLED: 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). METHOD: 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%). CONCLUSION: Preventive hepatoprotective therapy in the general population may reduce drug discontinuation rate, improve patient's compliance and outcomes of anti-TB treatment.
Authors: C Padmapriyadarsini; P K Bhavani; Alice Tang; Hemanth Kumar; C Ponnuraja; G Narendran; Elizabeth Hannah; C Ramesh; C Chandrasekar; Christine Wanke; Soumya Swaminathan Journal: Int J Infect Dis Date: 2013-09-13 Impact factor: 3.623
Authors: Rohit Singla; Surendra K Sharma; Alladi Mohan; Govind Makharia; V Sreenivas; Brajesh Jha; Sanjeev Kumar; Pawan Sarda; Sarman Singh Journal: Indian J Med Res Date: 2010-07 Impact factor: 2.375
Authors: Pawan Sarda; S K Sharma; Alladi Mohan; Govind Makharia; Arvind Jayaswal; R M Pandey; Sarman Singh Journal: Indian J Med Res Date: 2009-01 Impact factor: 2.375