越南青少年及成人细菌性脑膜炎患者使用地塞米松的情况

Dexamethasone in Vietnamese adolescents and adults with bacterial meningitis.

作者信息

Nguyen Thi Hoang Mai, Tran Thi Hong Chau, Thwaites Guy, Ly Van Chuong, Dinh Xuan Sinh, Ho Dang Trung Nghia, Dang Quoc Tuan, Nguyen Duy Phong, Nguyen Hoan Phu, To Song Diep, Nguyen van Vinh Chau, Nguyen Minh Duong, Campbell James, Schultsz Constance, Parry Chris, Torok M Estee, White Nicholas, Nguyen Tran Chinh, Tran Tinh Hien, Stepniewska Kasia, Farrar Jeremy J

机构信息

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

出版信息

N Engl J Med. 2007 Dec 13;357(24):2431-40. doi: 10.1056/NEJMoa070852.

DOI:10.1056/NEJMoa070852

PMID:18077808

Abstract

BACKGROUND

It is uncertain whether all adults with bacterial meningitis benefit from treatment with adjunctive dexamethasone.

METHODS

We conducted a randomized, double-blind, placebo-controlled trial of dexamethasone in 435 patients over the age of 14 years who had suspected bacterial meningitis. The goal was to determine whether dexamethasone reduced the risk of death at 1 month and the risk of death or disability at 6 months.

RESULTS

A total of 217 patients were assigned to the dexamethasone group, and 218 to the placebo group. Bacterial meningitis was confirmed in 300 patients (69.0%), probable meningitis was diagnosed in 123 patients (28.3%), and an alternative diagnosis was made in 12 patients (2.8%). An intention-to-treat analysis of all the patients showed that dexamethasone was not associated with a significant reduction in the risk of death at 1 month (relative risk, 0.79; 95% confidence interval [CI], 0.45 to 1.39) or the risk of death or disability at 6 months (odds ratio, 0.74; 95% CI, 0.47 to 1.17). In patients with confirmed bacterial meningitis, however, there was a significant reduction in the risk of death at 1 month (relative risk, 0.43; 95% CI, 0.20 to 0.94) and in the risk of death or disability at 6 months (odds ratio, 0.56; 95% CI, 0.32 to 0.98). These effects were not found in patients with probable bacterial meningitis. Results of multivariate analysis indicated that dexamethasone treatment for patients with probable bacterial meningitis was significantly associated with an increased risk of death at 1 month, an observation that may be explained by cases of tuberculous meningitis in the treatment group.

CONCLUSIONS

Dexamethasone does not improve the outcome in all adolescents and adults with suspected bacterial meningitis; a beneficial effect appears to be confined to patients with microbiologically proven disease, including those who have received prior treatment with antibiotics. (Current Controlled Trials number, ISRCTN42986828 [controlled-trials.com] .).

摘要

背景

对于所有患有细菌性脑膜炎的成年人，辅助使用地塞米松进行治疗是否有益尚不确定。

方法

我们对435名14岁以上疑似细菌性脑膜炎的患者进行了一项关于地塞米松的随机、双盲、安慰剂对照试验。目的是确定地塞米松是否能降低1个月时的死亡风险以及6个月时的死亡或残疾风险。

结果

总共217名患者被分配到地塞米松组，218名患者被分配到安慰剂组。300名患者（69.0%）确诊为细菌性脑膜炎，123名患者（28.3%）被诊断为可能的脑膜炎，12名患者（2.8%）被做出其他诊断。对所有患者进行的意向性分析表明，地塞米松与1个月时死亡风险的显著降低（相对风险，0.79；95%置信区间[CI]，0.45至1.39）或6个月时死亡或残疾风险的显著降低（比值比，0.74；95%CI，0.47至1.17）无关。然而，在确诊为细菌性脑膜炎的患者中，1个月时的死亡风险（相对风险，0.43；95%CI，0.20至0.94）和6个月时的死亡或残疾风险（比值比，0.56；95%CI，0.32至0.98）有显著降低。在可能患有细菌性脑膜炎的患者中未发现这些效果。多变量分析结果表明，对可能患有细菌性脑膜炎的患者进行地塞米松治疗与1个月时死亡风险的增加显著相关，这一观察结果可能是由治疗组中的结核性脑膜炎病例所解释。