Lee Chia-Jung, Cheng Chen-Hung, Li Yu-Hsien, Liu Chia-Yu, Hsu Chung-Hua
1 Institute of Traditional Medicine, National Yang-Ming University , Taipei, Taiwan .
J Altern Complement Med. 2013 Dec;19(12):964-9. doi: 10.1089/acm.2013.0136. Epub 2013 Jul 17.
To examine the effects of a Chinese medical herb complex formula, Kuan-Sin-Yin (KSY) decoction, on hepatitis B virus (HBV) carriers.
Of 86 HBV carriers, 57 who met the inclusion criteria completed this study from February 2011 to December 2011 in Taipei City Hospital, Taiwan. The participants were randomly assigned to one of two groups: the KSY group (n=29) and a control group (n=28) that received KSY diluted 16 times. The participants took one packet of decoction per day after dinner for 6 weeks. The major outcome measurements were the percentage reduction in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and the log of the HBV DNA level. The other measurements included seroconversion of hepatitis B e antigen and responses to the World Health Organization Quality of Life-Brief Version (WHOQOL-BREF) and Short-Form-12. The measurements were collected before the first treatment and 6 weeks later.
In the KSY group, AST and ALT levels decreased significantly and the score on the physical component of WHOQOL-BREF increased significantly. However, in the control group, there was no significant change after 6 weeks of treatment. Only the KSY group had a significant percentage reduction in ALT (change, -25.2% versus -0.74% in the control group) after 6 weeks of treatment. No major adverse effects occurred after 6 weeks of treatment.
KSY significantly improved ALT levels. The study suggests that a longer-term study testing the efficacy of KSY in a larger sample is warranted.
探讨中药复方宽心饮(KSY)汤剂对乙肝病毒(HBV)携带者的影响。
2011年2月至2011年12月,在台湾台北市立医院,86名HBV携带者中57名符合纳入标准的完成了本研究。参与者被随机分为两组:KSY组(n = 29)和对照组(n = 28),对照组接受16倍稀释的KSY。参与者每天晚餐后服用一包汤剂,共6周。主要观察指标为谷丙转氨酶(ALT)、谷草转氨酶(AST)降低的百分比以及HBV DNA水平的对数。其他测量指标包括乙肝e抗原血清学转换以及对世界卫生组织生活质量简表(WHOQOL - BREF)和简明健康状况调查量表(Short - Form - 12)的反应。在首次治疗前和6周后收集测量数据。
KSY组中,AST和ALT水平显著降低,WHOQOL - BREF身体维度得分显著升高。然而,对照组在治疗6周后无显著变化。治疗6周后,只有KSY组的ALT有显著降低百分比(变化为 - 25.2%,而对照组为 - 0.74%)。治疗6周后未出现重大不良反应。
KSY显著改善了ALT水平。该研究表明,有必要进行一项更大样本的长期研究来测试KSY的疗效。