Effect of phospholipid curcumin Meriva on liver histology and kidney disease in nonalcoholic steatohepatitis: A randomized, double-blind, placebo-controlled trial.

Phospholipid curcumin (Meriva) is a phospholipid formulation with ameliorated systemic curcumin absorption and delivery.

磷脂姜黄素（Meriva）是一种磷脂配方，具有改善的全身姜黄素吸收和输送。

We assessed the safety and efficacy of Meriva in NASH.

我们评估了Meriva在非酒精性脂肪性肝炎(NASH)中的安全性和有效性。

approach_and_results

In this double-blindtrial, 52 patients with biopsy-proven NASH (71% with stage ≥F2 fibrosis, 58% with stage A2-G2/A2-G3a chronic kidney disease) were randomized 1:1 to receive Meriva 2 g/d or placebo for 72 weeks.

在这项双盲试验中，52名经活检证实为非酒精性脂肪性肝炎(NASH)的患者（71%的患者纤维化程度≥F2期，58%的患者患有A2-G2/A2-G3a期慢性肾脏病）被随机分为1:1接受Meriva 2克/天或安慰剂治疗，持续72周。

The primary endpoint was NASH resolution with no worsening of fibrosis.

主要终点是NASH的缓解且纤维化无恶化。

The secondary endpoints included a ≥1 stage liver fibrosis improvement with no NASH worsening; regression of significant (ie, stage ≥F2) fibrosis and CKD; and improvement in renal, glucose, lipid, and inflammatory parameters.

次要终点包括纤维化改善≥1级且NASH无恶化；显著（即F2级或以上）纤维化和慢性肾脏病（CKD）的逆转；以及肾脏、血糖、血脂和炎症指标的改善。

We also explored the treatment effect on hepatic activation of NF-kB, a key proinflammatory transcription factor and a major target of curcumin.

我们还探讨了治疗对肝内NF-kB活化的影响，NF-kB是关键的促炎转录因子，也是姜黄素的主要靶点。

Fifty-one patients (26 on Meriva and 25 on placebo) completed the trial. Sixteen (62%) patients on Meriva versus 3 (12%) patients on placebo had NASH resolution (RR = 5.33 [95% CI = 1.76-12.13]; p = 0.003).

共有51名患者（26名接受Meriva治疗，25名接受安慰剂）完成了试验。在接受Meriva治疗的患者中，有16名（62%）患者的非酒精性脂肪性肝炎（NASH）得到缓解，而在接受安慰剂的患者中，有3名（12%）患者的NASH得到缓解（相对风险=5.33 [95% 置信区间=1.76-12.13]；p=0.003）。

Thirteen (50%) patients on Meriva versus 2 (8%) patients on placebo had ≥1 stage fibrosis improvement (RR = 6.50 [1.63-21.20]; p = 0.008).

在 Meriva 组中，有 13 名（50%）患者与在安慰剂组中 2 名（8%）患者相比，纤维化程度改善了 ≥1 期（相对风险 RR = 6.50 [1.63-21.20]；p = 0.008）。

Eleven (42%) patients on Meriva versus 0 (0%) on placebo had regression of significant liver fibrosis (RR = 18.01 [1.43-36.07]; p = 0.02).

在 Meriva 组中，有 11 名（42%）患者与在安慰剂组中 0 名（0%）患者相比，显著的肝纤维化有所逆转（相对风险 RR = 18.01 [1.43-36.07]；p = 0.02）。

Hepatic NF-kB inhibition predicted NASH resolution (AUC = 0.90, 95% CI = 0.84-0.95) and fibrosis improvement (AUC = 0.89, 95% CI = 0.82-0.96).

肝脏NF-kB抑制预测了NASH的缓解（AUC = 0.90, 95% 置信区间 = 0.84-0.95）和纤维化的改善（AUC = 0.89, 95% 置信区间 = 0.82-0.96）。

Thirteen (50%) patients on Meriva versus 0 (0%) on placebo had chronic kidney disease regression (RR = 10.71 [1.94-17.99)]; p = 0.004).

在Meriva治疗的患者中，有13名（50%）患者的慢性肾脏病出现了逆转，而在安慰剂组中，0名（0%）患者出现了逆转（RR = 10.71 [1.94-17.99]）；p = 0.004）。

Compared with placebo, Meriva improved eGFR (difference in adjusted eGFR change: +3.59 [2.96-4.11] mL/min/1.73 m 2 /y, p = 0.009), fasting glucose(-17 mg/dL; 95% CI = -22, -12), HbA1c (-0.62%; 95% CI = -0.87%, -0.37%), LDL-C (-39 mg/dL; 95% CI = -45, -33), triglycerides (-36 mg/dL, 95% CI = -46, -26), HDL-C (+10 mg/dL; 95% CI = +8, +11), and inflammatory markers.

与安慰剂相比，Meriva改善了估算肾小球滤过率（eGFR）（调整后eGFR变化的差异：+3.59 [2.96-4.11] mL/min/1.73 m2/年，p = 0.009），空腹血糖（-17 mg/dL；95% 置信区间= -22, -12），糖化血红蛋白（HbA1c）（-0.62%；95% 置信区间= -0.87%, -0.37%），低密度脂蛋白胆固醇（LDL-C）（-39 mg/dL；95% 置信区间= -45, -33），甘油三酯（-36 mg/dL，95% 置信区间= -46, -26），高密度脂蛋白胆固醇（HDL-C）（+10 mg/dL；95% 置信区间= +8, +11）以及炎症标志物。

Adverse events were rare, mild, and evenly distributed.

不良事件罕见，轻微，并且分布均匀。

Conclusions

In patients with NASH, Meriva administration for 72 weeks was safe, well-tolerated, and improved liver histology, possibly through NF-kB inhibition, kidney disease, and metabolic profile.

在非酒精性脂肪性肝炎(NASH)患者中，Meriva治疗72周是安全的、耐受性良好的，并且可能通过抑制NF-kB、改善肾脏疾病和代谢状况来改善肝脏组织学。