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急诊科静脉注射劳拉西泮与茶苯海明治疗眩晕的随机临床试验

Intravenous Lorazepam versus dimenhydrinate for treatment of vertigo in the emergency department: a randomized clinical trial.

作者信息

Marill K A, Walsh M J, Nelson B K

机构信息

Department of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso, TX, USA.

出版信息

Ann Emerg Med. 2000 Oct;36(4):310-9. doi: 10.1067/mem.2000.110580.

DOI:10.1067/mem.2000.110580
PMID:11020677
Abstract

STUDY OBJECTIVE

To determine whether lorazepam is more effective than dimenhydrinate in relieving the symptom of vertigo in the emergency department setting.

METHODS

A prospective, randomized, double-blind trial of intravenous lorazepam versus dimenhydrinate therapy was conducted in the ED of a county-owned, university-affiliated hospital. All adult patients who presented between January 24, 1998, and May 23, 1999, with the symptom of vertigo were eligible for inclusion. The intervention was varying the intravenous treatment between lorazepam, 2 mg, and dimenhydrinate, 50 mg. All patients received intravenous infusion of Ringer's lactate solution at a rate of 100 mL/h. Adequacy of randomization to the 2 treatment groups was assessed by comparing the patients' relevant baseline history, physical examination, and symptoms. The predetermined primary outcome measurement was the patient's sensation of "vertigo with ambulation" 1 and 2 hours after treatment. Secondary outcome measurements included vertigo while lying, sitting, and turning the head, ability to ambulate as judged by the enrolling physician, and sensation of nausea and drowsiness 1 and 2 hours after treatment, and whether the patient was "ready to go home" per patient report or physician assessment 2 hours after treatment. All patient symptoms were reported on 10-point scales. Outcome measurements were compared between the 2 treatment groups with a 2-way repeated-measures analysis of variance, Student's t test, Mann-Whitney U, and chi(2) test as appropriate.

RESULTS

Ten patients refused entry into the study, 16 were excluded, and 74 were enrolled, treated, and included in the analysis. One enrolled patient had evidence of vertigo of central origin. The pretreatment values of vertigo with ambulation were strongly correlated with the patient's ability to ambulate (P <.001), suggesting good internal validity. The patients randomly assigned to the lorazepam group were sicker based on their pretreatment symptoms and ability to ambulate, and this may have biased the study results. The patients' symptom of "vertigo with ambulation" decreased 1.5 units more (95% confidence interval [CI] 0 to 3.0) on average on a 10-point scale 2 hours after treatment in the dimenhydrinate group. All other measures of vertigo also decreased more in the dimenhydrinate group, although the differences were not statistically significant. At 2 hours after treatment, the patients' ability to ambulate was better in the dimenhydrinate group (P <.001), and 17% (95% CI -2 to 36) more patients in this group were "ready to go home." Patients in the lorazepam group experienced a 1.8-unit (95% CI 0.2 to 3.4) greater increase in drowsiness 2 hours after treatment.

CONCLUSION

Our results suggest that dimenhydrinate was more effective in relieving vertigo and less sedating than lorazepam at the intravenous doses administered in this study. Dimenhydrinate appears to be the preferred medicine for patients who present to the ED with vertigo likely to be of peripheral origin.

摘要

研究目的

确定在急诊科环境中,劳拉西泮在缓解眩晕症状方面是否比茶苯海明更有效。

方法

在一家县属大学附属医院的急诊科进行了一项前瞻性、随机、双盲试验,比较静脉注射劳拉西泮与茶苯海明治疗的效果。所有在1998年1月24日至1999年5月23日期间出现眩晕症状的成年患者均符合纳入标准。干预措施为在2毫克劳拉西泮和50毫克茶苯海明之间交替进行静脉治疗。所有患者均以100毫升/小时的速度静脉输注乳酸林格氏液。通过比较患者的相关基线病史、体格检查和症状,评估随机分配到两个治疗组的合理性。预定的主要结局指标是治疗后1小时和2小时患者“行走时眩晕”的感觉。次要结局指标包括躺着、坐着和转头时的眩晕、接诊医生判断的行走能力、治疗后1小时和2小时的恶心和嗜睡感,以及根据患者报告或医生评估,治疗后2小时患者是否“准备好回家”。所有患者症状均采用10分制报告。采用双向重复测量方差分析、学生t检验、曼-惠特尼U检验和卡方检验,对两个治疗组的结局指标进行比较。

结果

10名患者拒绝参加研究,16名被排除,74名患者被纳入研究、接受治疗并纳入分析。一名纳入研究的患者有中枢性眩晕的证据。行走时眩晕的治疗前值与患者的行走能力密切相关(P<.001),表明内部效度良好。根据治疗前症状和行走能力,随机分配到劳拉西泮组的患者病情更严重,这可能使研究结果产生偏差。在茶苯海明组,治疗后2小时,患者“行走时眩晕”症状在10分制量表上平均下降幅度多1.5个单位(95%置信区间[CI]0至3.0)。茶苯海明组眩晕的所有其他指标下降幅度也更大,尽管差异无统计学意义。治疗后2小时,茶苯海明组患者的行走能力更好(P<.001),该组“准备好回家”的患者多17%(95%CI -2至36)。劳拉西泮组患者在治疗后2小时嗜睡增加1.8个单位(95%CI 0.2至3.4)。

结论

我们的结果表明,在本研究中静脉给药剂量下,茶苯海明在缓解眩晕方面比劳拉西泮更有效,且镇静作用更小。对于到急诊科就诊且眩晕可能为外周性起源的患者,茶苯海明似乎是首选药物。

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