PDF(Pubmed)
Abstract：
BACKGROUND: Existing therapies of systemic lupus erythematosus (SLE) are efficacious only in certain patients. Developing new treatment methods is urgent. This meta-analysis aimed to evaluate the efficacy and safety of low-dose IL-2 (LD-IL-2).
METHODS: According to published data from PubMed, Web of Science, Embase, ClinicalTrials.gov, MEDLINE, MEDLINE, Web of Knowledge, Cochrane Library, and FDA.gov, eight trials were included.
RESULTS: After the LD-IL-2 treatment, 54.8% of patients had distinct clinical remission. The SRI-4 response rates were 0.819 (95% confidence interval [CI]: 0.745-0.894), and the SELENA-SLEDAI scores were significantly decreased (SMD = -2.109, 95% CI: [-3.271, -0.947], p < .001). Besides, the proportions of CD4+ T (SMD = 0.614, 95% CI: [0.250, 0.979], p = .001) and Treg cells (SMD = 1.096, 95% CI: [0.544, 1.649], p < .001) were increased dramatically after LD-IL-2 treatment, while there were no statistical differences in the proportions of CD8+ T cells, Th1 cells, Th2 cells, and Th17 cells (p > .05). Besides, the proportions of Th17 (SMD = 1.121, 95% CI: [0.709, 1.533], p < .001) and Treg (SMD = 0.655, 95% CI: [0.273, 1.038], p = .001) were significantly increased after receiving subcutaneously 0.5 million IU of LD-IL-2 treatment per day for 5 days, but there were no statistical differences in the proportions of Treg after receiving 1 million IU every other day subcutaneously of LD-IL-2 treatment. Injection site reaction and fever were common side effects of IL-2, which occurred in 33.1% and 14.4% of patients. No serious adverse events were reported.
CONCLUSIONS: LD-IL-2 was promising and well-tolerated in treating SLE, which could promote Treg\'s proliferation and functional recovery. Injecting 0.5 million IU of IL-2 daily can better induce the differentiation of Treg cells and maintain immune homeostasis than injecting 1 million IU every other day.
METHODS: According to published data from PubMed, Web of Science, Embase, ClinicalTrials.gov, MEDLINE, MEDLINE, Web of Knowledge, Cochrane Library, and FDA.gov, eight trials were included.
RESULTS: After the LD-IL-2 treatment, 54.8% of patients had distinct clinical remission. The SRI-4 response rates were 0.819 (95% confidence interval [CI]: 0.745-0.894), and the SELENA-SLEDAI scores were significantly decreased (SMD = -2.109, 95% CI: [-3.271, -0.947], p < .001). Besides, the proportions of CD4+ T (SMD = 0.614, 95% CI: [0.250, 0.979], p = .001) and Treg cells (SMD = 1.096, 95% CI: [0.544, 1.649], p < .001) were increased dramatically after LD-IL-2 treatment, while there were no statistical differences in the proportions of CD8+ T cells, Th1 cells, Th2 cells, and Th17 cells (p > .05). Besides, the proportions of Th17 (SMD = 1.121, 95% CI: [0.709, 1.533], p < .001) and Treg (SMD = 0.655, 95% CI: [0.273, 1.038], p = .001) were significantly increased after receiving subcutaneously 0.5 million IU of LD-IL-2 treatment per day for 5 days, but there were no statistical differences in the proportions of Treg after receiving 1 million IU every other day subcutaneously of LD-IL-2 treatment. Injection site reaction and fever were common side effects of IL-2, which occurred in 33.1% and 14.4% of patients. No serious adverse events were reported.
CONCLUSIONS: LD-IL-2 was promising and well-tolerated in treating SLE, which could promote Treg\'s proliferation and functional recovery. Injecting 0.5 million IU of IL-2 daily can better induce the differentiation of Treg cells and maintain immune homeostasis than injecting 1 million IU every other day.
摘要：
背景：现有的系统性红斑狼疮（SLE）疗法仅对某些患者有效。开发新的治疗方法迫在眉睫。本荟萃分析旨在评估低剂量IL-2（LD-IL-2）的疗效和安全性。
方法：根据PubMed发布的数据，WebofScience,Embase,ClinicalTrials.gov,MEDLINE,MEDLINE,WebofKnowledge,科克伦图书馆,和FDA.gov,纳入了8项试验.
结果：LD-IL-2治疗后，54.8%的患者有明显的临床缓解。SRI-4反应率为0.819（95％置信区间[CI]：0.745-0.894），SELENA-SLEDAI评分显著降低(SMD=-2.109,95%CI:[-3.271,-0.947],p<.001)。此外,CD4+T的比例（SMD=0.614，95%CI：[0.250，0.979]，p=.001）和Treg细胞（SMD=1.096，95%CI：[0.544，1.649]，p<.001)在LD-IL-2治疗后显著增加，虽然CD8+T细胞的比例没有统计学差异，Th1细胞，Th2细胞，和Th17细胞(p>0.05)。此外,Th17的比例（SMD=1.121，95%CI：[0.709，1.533]，p<.001）和Treg（SMD=0.655，95%CI：[0.273，1.038]，p=.001）在每天皮下接受0.5百万IU的LD-IL-2治疗5天后显着增加，但是每隔一天皮下接受1百万IU的LD-IL-2治疗后Treg的比例没有统计学差异。注射部位反应和发热是IL-2常见的不良反应，分别占33.1%和14.4%。未报告严重不良事件。
结论：LD-IL-2在治疗SLE方面是有希望的且耐受性良好，可以促进Treg的增殖和功能恢复。每天注射50万IU的IL-2比每隔一天注射100万IU可以更好地诱导Treg细胞的分化并维持免疫稳态。
方法：根据PubMed发布的数据，WebofScience,Embase,ClinicalTrials.gov,MEDLINE,MEDLINE,WebofKnowledge,科克伦图书馆,和FDA.gov,纳入了8项试验.
结果：LD-IL-2治疗后，54.8%的患者有明显的临床缓解。SRI-4反应率为0.819（95％置信区间[CI]：0.745-0.894），SELENA-SLEDAI评分显著降低(SMD=-2.109,95%CI:[-3.271,-0.947],p<.001)。此外,CD4+T的比例（SMD=0.614，95%CI：[0.250，0.979]，p=.001）和Treg细胞（SMD=1.096，95%CI：[0.544，1.649]，p<.001)在LD-IL-2治疗后显著增加，虽然CD8+T细胞的比例没有统计学差异，Th1细胞，Th2细胞，和Th17细胞(p>0.05)。此外,Th17的比例（SMD=1.121，95%CI：[0.709，1.533]，p<.001）和Treg（SMD=0.655，95%CI：[0.273，1.038]，p=.001）在每天皮下接受0.5百万IU的LD-IL-2治疗5天后显着增加，但是每隔一天皮下接受1百万IU的LD-IL-2治疗后Treg的比例没有统计学差异。注射部位反应和发热是IL-2常见的不良反应，分别占33.1%和14.4%。未报告严重不良事件。
结论：LD-IL-2在治疗SLE方面是有希望的且耐受性良好，可以促进Treg的增殖和功能恢复。每天注射50万IU的IL-2比每隔一天注射100万IU可以更好地诱导Treg细胞的分化并维持免疫稳态。
