The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda.
The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda.
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DOI：
10.1186/s12879-015-1082-x
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发表时间：
2015-08-19
影响因子：
3.7
通讯作者：
Fawzi WW
中科院分区：
文献类型：
--
作者：
Guwatudde D;Wang M;Ezeamama AE;Bagenda D;Kyeyune R;Wamani H;Manabe YC;Fawzi WW
在患者中补充多种维生素(MV)对高效抗逆转录病毒疗法(HAART)的影响的有效性试验到目前为止还没有定论。我们进行了一项随机、双盲、安慰剂对照试验，以确定一种推荐的每日MV补充量(RDA)对启动HAART患者的疾病进展的影响。符合条件的受试者随机接受安慰剂或MV补充剂，包括复合维生素B、C和E，并对参与者进行了长达18个月的跟踪调查。主要终点是：CD4细胞计数、体重和生活质量(QOL)的变化。次要终点是：i)出现新的或复发的艾滋病毒疾病进展事件，包括全因死亡；ii)从一线抗逆转录病毒疗法转向二线抗逆转录病毒疗法(ART)；iii)发生不良事件。意向治疗分析，使用线性回归混合效应模型来比较研究组之间主要终点随时间的变化。使用Kaplan-Meier事件发生时间分析和对数等级检验来比较HIV疾病进展事件和全因死亡率。400名参与者被随机分为两组，其中200人服用MV，200人服用安慰剂。到18个月时，MV组的CD_4细胞数平均变化为141个/ul，而安慰剂组为147个/ul，平均相差−6 · 17[95%CI−29 · 3，16 · 9]。平均体重变化MV组为3 · 9 kg，安慰剂组为3 · 3 kg，平均相差0 · 54[95%CI−0 · 40，1 · 48]；MV组生活质量平均变化6 · 8，安慰剂组8 · 8，−2.16[95%CI−4 · 59，0 · 27]。在这些主要终点或试验组之间不良事件的发生方面没有观察到显著差异。一次MV补充的RDA是安全的，但对启动HAART的HIV感染成年人的疾病进展指标没有影响。临床试验NCT01228578,2010年10月15日注册。
Efficacy trials investigating the effect of multivitamin (MV) supplementations among patients on Highly Active Antiretroviral Therapy (HAART) have so far been inconclusive. We conducted a randomized, double blind, placebo controlled trial to determine the effect of one recommended daily allowance (RDA) of MV supplementation on disease progression in patients initiating HAART. Eligible subjects were randomized to receive placebo or MV supplementation including vitamins B-complex, C and E. Participants were followed for up to 18 months. Primary endpoints were: change in CD4 cell count, weight and quality of life (QoL). Secondary endpoints were: i) development of a new or recurrent HIV disease progression event, including all-cause mortality; ii) switching from first- to second-line antiretroviral therapy (ART); and iii) occurrence of an adverse event. Intent-to-treat analysis, using linear regression mixed effects models were used to compare changes over time in the primary endpoints between the study arms. Kaplan-Meier time-to-event analysis and the log-rank test was used to compare HIV disease progression events and all-cause mortality. Four hundred participants were randomized, 200 onto MV and 200 onto placebo. By month 18, the average change in CD4 cell count in the MV arm was 141 cells/uL compared to 147 cells/uL in the placebo arm, a mean difference of −6 · 17 [95 % CI −29 · 3, 16 · 9]. The average change in weight in the MV arm was 3 · 9 kg compared to 3 · 3 kg in the placebo arm, a mean difference of 0 · 54 [95 % CI −0 · 40, 1 · 48]; whereas average change in QoL scores in the MV arm was 6 · 8 compared to 8 · 8 in the placebo arm, a mean difference of −2.16 [95 % CI −4 · 59,0 · 27]. No significant differences were observed in these primary endpoints, or in occurrence of adverse events between the trial arms. One RDA of MV supplementation was safe but did not have an effect on indicators of disease progression among HIV infected adults initiating HAART. Clinical trials NCT01228578, registered on 15th October 2010.