A Randomized, Placebo-Controlled Trial of Hydroxychloroquine in Incomplete Lupus.

This condition includes individuals with a high risk of progression to SLE.

这种情况包括那些进展为SLE风险较高的个体。

Treatment of ILE may reduce symptoms, severity, and incidenceof SLE.

ILE的治疗可能减轻症状、降低严重程度和减少SLE的发病率。

Methods

Hydroxychloroquine (HCQ) was chosen as an ILE intervention for a randomized, double-blindtrial to determine whether the rate of accumulation of SLE features defined by the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria could be reduced.

羟氯喹（HCQ）被选为ILE干预措施，用于一项随机、双盲试验，以确定是否可以降低根据2012年系统性红斑狼疮国际协作组（SLICC）标准定义的SLE特征的累积率。

ILE was defined as antinuclear antibody positivity with one to two additional criteria.

ILE 被定义为抗核抗体阳性且具备一到两项其他标准。

Patients 15 to 49 years old were eligible.

年龄在15至49岁之间的患者符合入选条件。

Randomization was 1:1 HCQ to placebo.

随机分配比例为1:1，羟氯喹与安慰剂对照。

Evaluations were at 3-month intervals over 24 months.

评估在24个月内每3个月进行一次。

Meeting SLICC classification sooner required exit.

更早达到SLICC分类标准的参与者需要退出。

Results

Participants (N = 187) were randomized at seven sites.

参与者（N=187）在七个地点被随机分配。

After excluding 7 patients who met SLE classification at baseline when screening laboratory data were completed, 180 patients were analyzed: 92 receiving HCQ and 88 receiving placebo.

在完成筛查实验室数据的基线时，排除了7名符合系统性红斑狼疮分类标准的患者后，对180名患者进行了分析：其中92名接受羟氯喹治疗，88名接受安慰剂治疗。

Considering all these enrollees, 55 developed additional criteria.

考虑到所有这些入组者，有55人发展出额外的标准。

Of the 118 participants who exited early with SLE or who completed 24 months of evaluation, SLE classification developed in 24 (13.3%); another 24 developed additional criteria but did not meet classification.

在118名提前退出或完成24个月评估的参与者中，有24人（13.3%）发展为系统性红斑狼疮（SLE）分类；另外24人发展了额外的标准但未达到分类。

The rates of acquisition of SLICC criteria and progression to SLE were similar in the two groups (P = 0.72 and P = 0.98, respectively).

两组中获得SLICC标准和进展为SLE的比率相似（P = 0.72和P = 0.98，分别）。

Development of SLE was associated with new malar rash, oral ulcers, joint tenderness, or pleurisy (P < 0.04).

系统性红斑狼疮（SLE）的发展与新出现的蝶形红斑、口腔溃疡、关节压痛或胸膜炎有关（P < 0.04）。

Conclusions

Although the Study of Antimalarials in Incomplete Lupus Erythematosus (SMILE) did not show effects of HCQ on ILE progression, the results offer insights into SLE risk in the ILE population.

尽管在不完全性红斑狼疮（ILE）患者中使用抗疟药的研究（SMILE）未显示羟氯喹（HCQ）对ILE进展的影响，但研究结果为ILE人群中的系统性红斑狼疮（SLE）风险提供了见解。