JAMANO:补锌与安慰剂对酗酒的HIV阳性成人死亡风险和HIV疾病进展的影响

2021-09-25 从医路漫漫 MedSci原创

补锌可以减少酒精相关的微生物感染和炎症发生。本研究的目的是评价补锌是否能降低酗酒的HIV/AIDS患者的死亡率和心血管疾病风险,降低炎症和微生物感染水平,减缓HIV疾病进展。

目的:补锌可以减少酒精相关的微生物感染和炎症发生。本研究的目的是评价补锌是否能降低酗酒的HIV/AIDS患者的死亡率和心血管疾病风险,降低炎症和微生物感染水平,减缓HIV疾病进展。

设计、设置和配对:本研究是一项在2013年至2015年招募的受试者中进行的双盲、随机对照试验。招募HIV和酒精成瘾的患者。他们在基线时未接受抗逆转录病毒治疗,并且过去30天大量饮酒。数据分析时间为2017年2月至2020年2月。

干预:将药物级葡萄糖酸锌补充剂(男性15毫克,女性12毫克,连续18个月每日口服)与安慰剂进行比较。

主要结果和测量:主要结果是死亡风险,以(VACS指数评分在基线和18个月之间的变化来衡量。VACS指数得分从0到164,得分越高,死亡风险越高。次要结果是基线和18个月之间CD4细胞计数的变化,心血管疾病风险的评估(Reynolds风险评分,范围从0%到100%,分数越高表明风险越高),以及18个月时炎症或微生物易感染生物标志物的变化。进行调整后的线性回归分析。

结果:共254名受试者(男性184人[72%];平均[SD]年龄,34[6]岁)纳入试验。126名接受锌治疗,128名接受安慰剂治疗。参与者有较高的CD4细胞计数(平均[SD], 521[292]细胞/mm3), 188人(74%)在过去一周大量饮酒。在主要分析中,补充锌没有影响18个月时VACS指数评分的变化(锌的变化,平均值[SD], 0.49 [14.6];中位数[四分位数范围],0.0[−7.0到6.0];安慰剂的变化,平均[SD], 5.5 [17.2];中位数[四分位数范围],6.0[−6.0至14.0];调整平均差[AMD],−4.68;95% CI,- 9.62 - 0.25;P=0 .06)或任何次要结果,包括CD4细胞计数的变化(AMD, 41.8细胞/mm3;95% CI,−20.3至103.8细胞/mm3;P=0.19),Reynolds风险评分(AMD,−0.014;95% CI,−0.167 - 0.139;P= 0.85),白细胞介素-6水平(AMD,−0.13 pg/mL;95% CI,−0.38 ~ 0.11 pg/mL;P= 0.30),D-二聚体水平(AMD,−0.21μg/mL;95% CI,−0.48 ~ 0.07μg/mL;P=0 .14),可溶性CD14水平(AMD,−38.01 ng/mL;95% CI,−166.90 ~ 90.88 ng/mL;P= .56),肠道脂肪酸结合蛋白水平(AMD, 0.08 pg/mL;95% CI,−0.07 ~ 0.22 pg/mL;P= .32)和脂多糖结合蛋白水平(AMD,−0.09 ng/mL;95% CI,−0.23至0.06 ng/mL;P= .24)。在单个方案分析中,补充锌在统计学上显著影响18个月时VACS指数评分的变化(AMD, - 7.49;95% CI,−13.74至−1.23,P= .02);然而,补充锌的依从率为51%。

表1 主要和关键的次要结果:锌与安慰剂对死亡率、HIV进展、心血管疾病风险和炎症标志物的影响

表2 单个方案结果:锌与安慰剂对死亡率、HIV进展、心血管疾病风险和炎症标志物的影响

结论和相关性:补充锌没有降低HIV/AIDS患者的死亡风险、CD4细胞计数、心血管疾病风险以及炎症或微生物易位的水平。补锌没有改变VACS指数评分,但可能受到低依从性的限制。

原文出处:

Freiberg MS,  Cheng DM,  Gnatienko N,et al,Effect of Zinc Supplementation vs Placebo on Mortality Risk and HIV Disease Progression Among HIV-Positive Adults With Heavy Alcohol Use: A Randomized Clinical Trial.JAMA Netw Open 2020 05 01;3(5)

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