医学翻译学习-抗CD4抗体UB-421对治疗中断后HIV-1反弹的效应

关于“抗CD4抗体UB-421对治疗中断后HIV-1反弹的效应”一文医学翻译摘要学习情况，记录于此。

Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption

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背景

BACKGROUND

在人类免疫缺陷病毒（HIV）感染者未接受抗逆转录病毒治疗（ART）的情况下，单独给予广泛中和HIV特异性抗体会导致耐抗体病毒的产生。

Administration of a single broadly neutralizing human immunodeficiency virus (HIV)–specific antibody to HIV-infected persons leads to the development of antibody-resistant virus in the absence of antiretroviral therapy (ART).

笔记：

• development vs 产生
• In the absense of

在实施分析性治疗中断（analytic treatment interruption）的HIV感染者中，UB-421（阻断人CD4+ T细胞上病毒结合位点的抗体）有可能诱导持续的病毒学抑制，且不会诱导耐药。

It is possible that monotherapy with UB-421, an antibody that blocks the virus-binding site on human CD4+ T cells, could induce sustained virologic suppression without induction of resistance in HIV-infected persons after analytic treatment interruption.

笔记：

• virus-binding site 病毒结合位点
• analytic treatment interruption 分析性治疗中断
• without induction of resistance 不会诱导耐药
• monotherapy 省略了....可惜我没有这个魄力

方法

Methods

我们开展了一项非随机、开放标签、2期临床研究，在实施分析性治疗中断的HIV感染者中评价了UB-421单药治疗的安全性、药代动力学和抗病毒活性。

We conducted a nonrandomized, open-label, phase 2 clinical study evaluating the safety, pharmacokinetics, and antiviral activity of UB-421 monotherapy in HIV-infected persons undergoing analytic treatment interruption.

笔记：

• 虽然有人用open-labelled，但实际上，open-label最常用
• 整体结构属于套路

筛选访视时，所有参与者的血浆病毒均不可测（＜20 copies HIV RNA/mL）。

All the participants had undetectable plasma viremia (<20 copies of HIV RNA per milliliter) at the screening visit.

笔记：

• the screening visit 筛选访视

停用ART后，参与者接受了8次UB-421静脉输入，剂量为每周1次，每次10 mg/kg（队列1），或者每2周1次，每次25 mg/kg（队列2）。

After discontinuation of ART, participants received eight intravenous infusions of UB-421, at a dose of either 10 mg per kilogram of body weight every week (Cohort 1) or 25 mg per kilogram every 2 weeks (Cohort 2).

笔记：

• kilogram of body weight 翻译到英文时，常常会漏掉
• either or 这个结构其实也挺有意思的

主要结局是至病毒反弹（≥400 copies/mL）的时间。

The primary outcome was the time to viral rebound (≥400 copies per milliliter).

结果

RESULTS

本研究共纳入29例参与者，队列1中14例，队列2中15例。

A total of 29 participants were enrolled, 14 in Cohort 1 and 15 in Cohort 2.

在分析性治疗中断期间，UB-421对于所有参与者（研究访视2～9中94.5%的测定值）均维持了病毒学抑制（＜20 copies/mL），在8例参与者（28%）中观察到间歇性病毒载量一过性小幅反弹（viral blip）（范围，21～142 copies/mL）。

Administration of UB-421 maintained virologic suppression (<20 copies per milliliter) in all the participants (94.5% of measurements at study visits 2 through 9) during analytic treatment interruption, with intermittent viral blips (range, 21 to 142 copies per milliliter) observed in 8 participants (28%).

笔记：

• 维持病毒学抑制 maintain virologic suppression

没有任何参与者的血浆病毒反弹至超过400 copies/mL。

No study participants had plasma viral rebound to more than 400 copies per milliliter.

CD4+ T细胞计数在整个研究期间保持稳定。

CD4+ T-cell counts remained stable throughout the duration of the study.

笔记：

• the duration of the study

皮疹（大部分为1级）是常见的一过性不良事件；1例参与者因皮疹停用研究药物。

Rash, mostly of grade 1, was a common and transient adverse event; one participant discontinued the study drug owing to a rash.

笔记：

• transient 和上文的 intermittent 都处理未一过性

在UB-421单药治疗期间观察到CD4+调节T细胞群减少。

A decrease in the population of CD4+ regulatory T cells was observed during UB-421 monotherapy.

结论

Conclusions

在参与者未接受ART的情况下，UB-421（在研究的8～16周）维持了病毒学抑制。

UB-421 maintained virologic suppression (during the 8 to 16 weeks of study) in participants in the absence of ART.

1例参与者因皮疹停止治疗（由United Biomedical等资助；在ClinicalTrials.gov注册号为NCT02369146）。

One participant discontinued therapy owing to a rash. (Funded by United Biomedical and others; ClinicalTrials.gov number, NCT02369146 .)