Institute of Digestive Disease, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.
Department of Social Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
Evid Based Complement Alternat Med. 2013;2013:965723. doi: 10.1155/2013/965723. Epub 2013 Dec 4.
Objective. To evaluate the efficacy and safety of Jiang Zhi Granule (JZG), a Chinese herbal formula, in patients with nonalcoholic fatty liver (NAFL). Methods. A multicenter, randomized, double-blind, placebo-controlled, parallel clinical trial was conducted for 24 weeks in 224 patients with NAFL at 6 university-affiliated hospitals. Patients were randomized 1 : 1 to receive JZG and placebo, respectively. Primary outcome was the change of liver to spleen ratio (L/S ratio) over computed tomography (CT). Secondary outcomes included body mass index (BMI), serum triglyceride (TG), and total cholesterol (TC) levels. Results. Of all the 224 eligible patients, 221 patients were analyzed in the full analysis set (FAS), 205 in the per protocol set (PPS), and 3 patients were withdrawn prematurely. For FAS, JZG significantly increased L/S ratio from 0.74 ± 0.21 to 0.99 ± 0.24 compared to that from 0.79 ± 0.18 to 0.85 ± 0.27 in placebo group (P = 0.0011). For PPS, it showed an increase of 0.26 ± 0.23 of L/S ratio in the patients on JZG versus 0.07 ± 0.22 in those on placebo (P = 0.0003). Superiority of JZG over placebo was also observed with greater reduction in BMI (P < 0.05) in both FAS and PPS. No observable difference in decrease of serum TC and TG was recorded (P > 0.05). There were no serious adverse events (AEs) in the study process and safety indices were normal in both groups. Conclusions. The Chinese herbal formula JZG was found to be superior to placebo in increasing L/S ratio and reducing BMI in NAFL patients. It was also well tolerated in patients and might be a safe and effective medicine for NAFL.
目的。评价姜之颗粒（JZG）一种中药配方在非酒精性脂肪肝（NAFL）患者中的疗效和安全性。方法。在 6 家大学附属医院进行了一项为期 24 周的多中心、随机、双盲、安慰剂对照、平行临床试验，共纳入 224 名 NAFL 患者。患者以 1:1 的比例随机接受 JZG 和安慰剂治疗。主要终点是 CT 计算的肝脾比值（L/S 比值）变化。次要终点包括体重指数（BMI）、血清甘油三酯（TG）和总胆固醇（TC）水平。结果。在所有 224 名合格患者中，221 名患者在全分析集（FAS）中进行了分析，205 名患者在符合方案集（PPS）中进行了分析，3 名患者提前退出。对于 FAS，与安慰剂组（0.79 ± 0.18 至 0.85 ± 0.27）相比，JZG 组的 L/S 比值从 0.74 ± 0.21 显著增加到 0.99 ± 0.24（P = 0.0011）。对于 PPS，JZG 组 L/S 比值增加 0.26 ± 0.23，安慰剂组增加 0.07 ± 0.22（P = 0.0003）。FAS 和 PPS 中 BMI 降低也显示 JZG 优于安慰剂（P < 0.05）。TC 和 TG 血清水平降低无显著差异（P > 0.05）。研究过程中未观察到严重不良事件（AE），两组安全性指标均正常。结论。中药配方 JZG 可提高 NAFL 患者的 L/S 比值和降低 BMI，且耐受性良好，可能是治疗 NAFL 的一种安全有效的药物。
