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比较不同糖皮质激素方案治疗抗中性粒细胞胞质抗体相关性血管炎患者的疗效和安全性:一项系统评价。

Comparative efficacy and safety of alternative glucocorticoids regimens in patients with ANCA-associated vasculitis: a systematic review.

机构信息

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada

West China School of Nursing/Department of Nursing, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

出版信息

BMJ Open. 2022 Feb 25;12(2):e050507. doi: 10.1136/bmjopen-2021-050507.

Abstract

OBJECTIVE

To compare the efficacy and safety of alternative glucocorticoids (GCs) regimens as induction therapy for patients with antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.

DESIGN

Systematic review of randomised controlled trials (RCTs).

DATA SOURCES

Medline, Embase, Clinicaltrials.gov and Cochrane Central Register of Controlled Trials up to 10 April 2020.

STUDY SELECTION AND REVIEW METHODS

RCTs comparing two (or more) different dose regimens of GC in ANCA-associated vasculitis during induction of remission, regardless of other therapies. Pairs of reviewers independently screened records, extracted data and assessed risk of bias. Two reviewers rated certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach.

RESULTS

Of 3912 records identified, the full texts of two records met the eligibility criteria. Due to the heterogeneity of population and dose regimen of GCs between the two trials, we descriptively presented the two trials and did not combine the results using meta-analysis. Compared with the standard-dose regimen, the reduced-dose regimen of GC may reduce death risk difference (RD): from -1.7% to -2.1%, low certainty), while not increasing end-stage kidney disease (ESKD) (RD: from -1.5% to 0.4%, moderate certainty). The reduced-dose regimen probably has an important reduction in serious infections at 1 year (RD: from -12.8% to -5.9%, moderate certainty). Reduced-dose regimen of GCs probably has trivial or no effect in disease remission, relapse or health-related quality of life (moderate to high certainty).

CONCLUSIONS

The reduced-dose regimen of GC may reduce death at the follow-up of 6 months to longer than 1 year and serious infections while not increasing ESKD.

PROSPERO REGISTRATION NUMBER

CRD42020179087.

摘要

目的

比较替代糖皮质激素(GC)方案作为抗中性粒细胞胞质抗体(ANCA)相关性血管炎患者诱导缓解治疗的疗效和安全性。

设计

系统评价随机对照试验(RCT)。

数据来源

截至 2020 年 4 月 10 日,在 Medline、Embase、Clinicaltrials.gov 和 Cochrane 对照试验中心注册库中进行检索。

研究选择和审查方法

RCT 比较了 ANCA 相关性血管炎诱导缓解期间两种(或更多)不同剂量 GC 方案的疗效,无论其他治疗方法如何。两名审查员独立筛选记录、提取数据并评估偏倚风险。两名审查员使用推荐评估、制定和评估方法(Grading of Recommendations Assessment, Development, and Evaluation approach)对证据的确定性进行评级。

结果

在 3912 条记录中,有 2 条记录的全文符合入选标准。由于两项试验中人群和 GC 剂量方案存在异质性,我们对两项试验进行了描述性呈现,并未使用荟萃分析对结果进行合并。与标准剂量方案相比,GC 的低剂量方案可能会降低死亡率差异(RD):从-1.7%降至-2.1%,证据质量低),而不会增加终末期肾病(ESKD)(RD:从-1.5%降至 0.4%,证据质量中等)。低剂量方案可能会在 1 年内显著降低严重感染(RD:从-12.8%降至-5.9%,证据质量中等)的风险。GC 的低剂量方案可能对疾病缓解、复发或健康相关生活质量几乎没有影响或没有影响(证据质量为中到高)。

结论

GC 的低剂量方案可能会降低 6 个月至 1 年以上随访期间的死亡率和严重感染的风险,同时不会增加 ESKD 的风险。

前瞻性注册号

CRD42020179087。

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