Oral Glutathione and Growth in Cystic Fibrosis: A Multicenter, Randomized, Placebo-controlled, Double-blind Trial.
Oral Glutathione and Growth in Cystic Fibrosis: A Multicenter, Randomized, Placebo-controlled, Double-blind Trial.
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DOI：
10.1097/mpg.0000000000002948
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发表时间：
2020-12
影响因子：
2.9
通讯作者：
GROW study group
中科院分区：
文献类型：
--
作者：
Bozic M;Goss CH;Tirouvanziam RM;Baines A;Kloster M;Antoine L;Borowitz D;Schwarzenberg SJ;GROW study group
囊性纤维化（CF）儿童的营养状况与死亡率和发病率相关。肠道炎症可能导致CF患者的消化、吸收和营养利用受损，口服谷胱甘肽可能减少炎症，促进CF患者营养状况的改善。GROW研究是一项在2-10岁的CF胰腺功能不全患者中进行的前瞻性、多中心、随机、安慰剂对照、双盲、II期临床试验。患者每天口服还原型谷胱甘肽或安慰剂24周。主要终点是治疗组之间从基线至第24周年龄别体重z评分变化的差异。次要终点包括其他人体测量学、血清和粪便炎症标志物以及其他临床结局。共有58名参与者完成了研究。谷胱甘肽组（n=30）和安慰剂组（n=28）在6个月年龄别体重z评分变化方面无显著差异（−0.08; 95% CI：−0.22，0.06; p=0.25）;体重绝对变化（kg）（−0.18; 95% CI：−0.55，0.20; p=0.35）;或BMI kg/m2的绝对变化（−0.06; 95% CI：−0.37，0.25; p=0.69）。其他次要终点无显著差异。总体而言，谷胱甘肽是安全的，耐受性良好。与安慰剂相比，口服谷胱甘肽补充剂并不影响CF胰腺功能不全儿童的生长或改变血清或粪便炎症标志物。在一项更大规模的多中心研究中评估口服谷胱甘肽的作用，可防止CF患者的药物负担不必要的增加。
The nutritional status of children with cystic fibrosis (CF) is associated with mortality and morbidity. Intestinal inflammation may contribute to impaired digestion, absorption and nutrient utilization in patients with CF and oral glutathione may reduce inflammation, promoting improved nutritional status in patients with CF. The GROW study was a prospective, multi-center, randomized, placebo-controlled, double-blind, Phase II clinical trial in pancreatic insufficient patients with CF between the ages of 2–10 years. Patients received reduced glutathione or placebo orally daily for 24 weeks. The primary endpoint was the difference in change in weight-for-age z-scores from baseline through week 24 between treatment groups. Secondary endpoints included other anthropometrics, serum and fecal inflammatory markers in addition to other clinical outcomes. 58 participants completed the study. No significant differences were seen between glutathione (n=30) and placebo (n=28) groups in the 6 month change in weight-for-age z-score (−0.08; 95% CI: −0.22, 0.06; p=0.25); absolute change in weight (kg) (−0.18; 95% CI: −0.55, 0.20; p=0.35); or absolute change in BMI kg/m2 (−0.06; 95% CI: −0.37, 0.25; p=0.69). There were no significant differences in other secondary endpoints. Overall, glutathione was safe and well tolerated. Oral glutathione supplementation did not impact growth or change serum or fecal inflammatory markers in pancreatic insufficient children with CF when compared to placebo. Evaluating the role of oral glutathione in a larger, multicenter study prevents unnecessary increase in the medication burden of people with CF.