Boonyavorakul C, Thakkinstian A, Charoenpan P
Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Respirology. 2000 Sep;5(3):221-5. doi: 10.1046/j.1440-1843.2000.00252.x.
Intravenous magnesium sulfate (MgSO4), as an adjunctive medication to the standard treatment of acute asthma, improves admission rate or severity score in acute severe asthma patients.
We conducted a randomized double-blind placebo controlled trial with subjects from the emergency room, Ramathibodi Hospital, Bangkok, Thailand. Patients, aged 15-65 years with acute severe asthma attack, whose severity scores were greater than 4 and who were willing to be enrolled in a study during March to November 1997 participated in the study. Randomly allocated patients received either 2 g intravenous MgSO4 or placebo, sterile water, as an adjunctive medication to standard therapy for acute asthma. The medication was diluted in 50 mL of 0.9% normal saline.
Severity scores were measured by two investigators using Fischl's indices. The times interval of measurements were at the initial (0), 60, 120, 180, and 240 min from receipt of treatment. Patients were hospitalized if the severity scores at 240 min exceeded 1. Risk ratio (RR) and 95% confidence interval (CI) of RR were applied to estimate the risk of admission. Analysis of variance with repeated measurement on time was used to determine the severity score between two groups.
Thirty-four patients with acute severe asthma were enrolled in the present study. One patient from the placebo group was excluded because he did not consent to undergoing peak expiratory flow rate. Seventeen patients received MgSO4 and 16 patients received placebo. The general characteristics between the two groups were not significantly different, which reflected the quality of randomization. The admission rates of the placebo and MgSO4 group were 25.00% and 17.65%, respectively. Patients who received MgSO4 had preventive risk to be hospitalized 0.71 times relative to patients who received placebo. However, this preventive risk did not reach statistical significance (95% CI of RR = 0.19-2.67). The severity score at any time between the two groups was also not statistically significantly different (P = 0.366).
With the present evidence, the hypothesis was not confirmed. Magnesium sulphate as an adjunct to standard therapy did not improve either admission rate or severity score in patients with acute severe asthma.
静脉注射硫酸镁(MgSO4)作为急性哮喘标准治疗的辅助药物,可提高急性重症哮喘患者的入院率或严重程度评分。
我们在泰国曼谷拉玛蒂博迪医院急诊科进行了一项随机双盲安慰剂对照试验。年龄在15 - 65岁、患有急性重症哮喘发作、严重程度评分大于4且愿意在1997年3月至11月期间参加研究的患者参与了该研究。随机分配的患者接受2 g静脉注射硫酸镁或安慰剂(无菌水),作为急性哮喘标准治疗的辅助药物。药物用50 mL 0.9%的生理盐水稀释。
由两名研究人员使用菲施尔指数测量严重程度评分。测量的时间间隔为接受治疗后的初始(0)、60、120、180和240分钟。如果240分钟时的严重程度评分超过1分,则患者住院。应用风险比(RR)和RR的95%置信区间(CI)来估计入院风险。采用时间重复测量的方差分析来确定两组之间的严重程度评分。
本研究纳入了34例急性重症哮喘患者。安慰剂组有1例患者被排除,因为他不同意进行呼气峰值流速检测。17例患者接受硫酸镁治疗,16例患者接受安慰剂治疗。两组之间的一般特征无显著差异,这反映了随机化的质量。安慰剂组和硫酸镁组的入院率分别为25.00%和17.65%。接受硫酸镁治疗的患者相对于接受安慰剂治疗的患者,住院预防风险为0.71倍。然而,这种预防风险未达到统计学意义(RR的95% CI = 0.19 - 2.67)。两组在任何时间的严重程度评分也无统计学显著差异(P = 0.366)。
根据目前的证据,该假设未得到证实。硫酸镁作为标准治疗的辅助药物,并未改善急性重症哮喘患者的入院率或严重程度评分。