Zhao Heping, Hou Tianqing, Shao Dandan
J Tradit Chin Med. 2014 Dec;34(6):646-51. doi: 10.1016/s0254-6272(15)30077-7.
To observe the therapeutic effect of Chishaodanpi decoction (CSDPD) on chronic viral cholestatic hepatitis.
A total of 107 subjects with chronic viral cholestatic hepatitis were enrolled in our hospital from March 2007 to November 2012. Patients were randomly divided into treatment (54 cases) and control groups (53 cases). The control group was treated with potassium magnesium aspartate, diammonium glycyrrhizinate, glucurolactone, vitamin C, and lamivudine, once a day. The treatment group was treated with modified CSDPD, 100 mL a time, twice a day, in addition to the treatment given to the control group. The patients in both groups were treated for 8 weeks. The main symptoms and signs were recorded every day throughout the clinical trial. Before and after the trial, changes in liver function including total bilirubin (TBil), direct bilirubin (DBil), total bile acid (TBA), and the activities of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and γ-glutamyl transferase (γ-GT), were all detected. Adverse reactions were also recorded.
There were no differences in gender, age, disease duration, symptoms, signs, or laboratory findings between the two groups (P > 0.05). After an 8-week treatment, improvements in jaundice, weakness, poor appetite, abdominal distention, and skin itching were significantly better in the treatment group than in the control group (P < 0.05). In the treatment group, 43 patients had a significant response to the treatment, seven patients had a response, and four patients had no response, with 21, 12, and 20 patients in the control group, respectively. The total effective rate was 92.6% in the treatment group and 62.3% in the control group, which was a significant difference (P < 0.05). The levels of TBil, DBil, TBA, ALP, ALT, AST, and γ-GT in both groups were significantly lower after treatment, and were significantly different between the two groups (P < 0.05). A few patients in the treatment group had mild adverse effects such as increased bowel movement frequency and mild stomach-ache. No other adverse reactions were observed in either group.
观察赤芍丹芪汤（CSDPD）对慢性病毒性胆汁淤积性肝炎的治疗效果。
2007年3月至2012年11月我院共纳入107例慢性病毒性胆汁淤积性肝炎患者。将患者随机分为治疗组（54例）和对照组（53例）。对照组给予门冬氨酸钾镁、甘草酸二铵、葡醛内酯、维生素C及拉米夫定治疗，每日1次。治疗组在对照组治疗基础上，加用加味CSDPD治疗，每次100 mL，每日2次。两组患者均治疗8周。在整个临床试验过程中每天记录主要症状和体征。试验前后检测肝功能变化，包括总胆红素（TBil）、直接胆红素（DBil）、总胆汁酸（TBA）以及碱性磷酸酶（ALP）、丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）和γ-谷氨酰转移酶（γ-GT）的活性。同时记录不良反应。
两组患者在性别、年龄、病程、症状、体征或实验室检查结果方面均无差异（P>0.05）。经过8周治疗，治疗组在黄疸、乏力、食欲减退、腹胀和皮肤瘙痒等方面的改善明显优于对照组（P<0.05）。治疗组中，43例患者治疗反应显著，7例患者有反应，4例患者无反应，对照组分别为21例、12例和20例。治疗组总有效率为92.6%，对照组为62.3%，差异有统计学意义（P<0.05）。两组治疗后TBil、DBil、TBA、ALP、ALT、AST和γ-GT水平均显著降低，且两组间差异有统计学意义（P<0.05）。治疗组少数患者出现轻度不良反应，如排便次数增多和轻度胃痛。两组均未观察到其他不良反应。
