PDF(Pubmed)
Abstract：
Midazolam nasal spray (MDZ-NS) is a new emerging rescue medication that suppresses epileptic seizures. Until now, few studies, pharmacokinetic (PK) and pharmacodynamic (PD) profiles, and clinical trials have shown that midazolam nasal spray could become an effective and promising alternative to conventional routes (intravenous {IV}/rectal). Therefore, we thought of conducting a systematic review and meta-analysis of midazolam (MDZ) to assess its potential outcomes. The analysis was also evaluated based on the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of midazolam nasal spray. A systematic literature search was carried out through various databases to identify studies of accounted outcomes of midazolam nasal spray (MDZ-NS). Randomized and other studies of patients (12 years or older) with seizure clusters (SCs) were included. A total of three full-text articles were considered for systematic review and meta-analysis as per the inclusion and exclusion criteria. The 5 mg MDZ-NS was observed to be equally safe as a placebo, and the risk ratio (RR) was 1.01 (95% confidence interval (CI): 0.67-1.53). After the administration of MDZ-NS, either the patients remained seizure-free for six hours or more or the seizure was terminated within 10 minutes and had no recurrence between 10 minutes and six hours. The risk ratio (RR) obtained was 1.54 (95% CI: 1.25-1.91). The result was statistically significant as a higher success rate was observed with the use of 5 mg midazolam nasal spray compared to placebo (p < 0.0001). Heterogeneity was not observed in the results of the included studies (inconsistency index {I2}: 0%). The present systematic review and meta-analysis demonstrated that 5 mg midazolam nasal spray was efficacious in treating patients with seizure clusters and is well-tolerated. Also, its use is relatively safe.
摘要：
咪达唑仑鼻喷雾剂（MDZ-NS）是一种新兴的挽救药物，可抑制癫痫发作。直到现在,很少有研究，药代动力学（PK）和药效学（PD）概况，临床试验表明，咪达唑仑鼻喷雾剂可以成为常规途径（静脉{IV}/直肠）的有效且有希望的替代品。因此,我们考虑对咪达唑仑(MDZ)进行系统评价和荟萃分析,以评估其潜在结局.还基于咪达唑仑鼻喷雾剂的药代动力学(PK)和药效学(PD)谱评价分析。通过各种数据库进行了系统的文献检索，以确定咪达唑仑鼻喷雾剂（MDZ-NS）的预后研究。包括癫痫发作簇（SC）患者（12岁或以上）的随机和其他研究。根据纳入和排除标准，总共考虑了三篇全文文章进行系统评价和荟萃分析。观察到5mgMDZ-NS与安慰剂一样安全，风险比（RR）为1.01（95％置信区间（CI）：0.67-1.53）。MDZ-NS给药后，患者在6小时或更长时间内保持无癫痫发作,或者在10分钟内终止癫痫发作,并且在10分钟至6小时内没有复发.获得的风险比（RR）为1.54（95％CI：1.25-1.91）。结果具有统计学显著性,因为与安慰剂相比,使用5mg咪达唑仑鼻喷雾剂观察到更高的成功率(p<0.0001)。在纳入研究的结果中未观察到异质性(不一致指数{I2}:0%)。目前的系统评价和荟萃分析表明，5mg咪达唑仑鼻喷雾剂可有效治疗癫痫患者，并具有良好的耐受性。此外，它的使用相对安全。
