PDF(Pubmed)
Abstract：
BACKGROUND: Acetazolamide is recommended for the prevention of acute mountain sickness (AMS); however, its use is limited in some areas because of side effects. Previous studies report ibuprofen to be similar to or slightly inferior to acetazolamide. This randomized, triple-blinded, parallel-group, placebo-controlled trial was designed to compare ibuprofen with acetazolamide for the prevention of AMS.
METHODS: Four hundred forty-three healthy Asian Indian men with a mean age of 29 (range: 20-49) years were randomized into three groups A, B, and P at 350m (SL). Acetazolamide (A): 85 mg; ibuprofen (B): 600 mg; or placebo (P): calcium carbonate was administered thrice daily, starting one day prior and continuing for three days after arrival at 3500m (HA). Participants were evaluated for AMS using the Lake Louise Questionnaire and for pulse, BP, SpO2, and respiratory rate twice daily for the first two days during rest and once a day for days three to six at HA.
RESULTS: Of the 443 participants recruited at SL, 139 could not be airlifted due to logistical limitations, and 304 were available for follow-up at HA. Among these, 254 had ascended as per protocol. By intent to treat (IT) (N = 304; A = 99, B = 102, P = 103), the incidence of AMS (LLQS>/=3) was 12%, 5%, and 13%, and the incidence of severe AMS was 1%, 2%, and 6%, in groups A, B, and P, respectively. Using per protocol analysis (PP) (N = 254; A = 83, B = 87, P = 84), the incidence of AMS was 12%, 6%, and 13% in groups A, B, and P, respectively. The relative risk for developing AMS vs. placebo was A-0.96 (CI:0.46-2.0, p=0.91), B-0.39 (CI:0.14-1.04, p=0.06), A-0.94 (CI:0.42-2.1, p=0.88), and B-0.45 (0.16-1.24, p=0.12) by IT and PP, respectively.
CONCLUSIONS: Ibuprofen is effective in males for the prevention of AMS with rapid ascent to 3500 m-rest for the first two days. Acetazolamide was superior to ibuprofen in the prevention of moderate-to-severe AMS.
METHODS: Four hundred forty-three healthy Asian Indian men with a mean age of 29 (range: 20-49) years were randomized into three groups A, B, and P at 350m (SL). Acetazolamide (A): 85 mg; ibuprofen (B): 600 mg; or placebo (P): calcium carbonate was administered thrice daily, starting one day prior and continuing for three days after arrival at 3500m (HA). Participants were evaluated for AMS using the Lake Louise Questionnaire and for pulse, BP, SpO2, and respiratory rate twice daily for the first two days during rest and once a day for days three to six at HA.
RESULTS: Of the 443 participants recruited at SL, 139 could not be airlifted due to logistical limitations, and 304 were available for follow-up at HA. Among these, 254 had ascended as per protocol. By intent to treat (IT) (N = 304; A = 99, B = 102, P = 103), the incidence of AMS (LLQS>/=3) was 12%, 5%, and 13%, and the incidence of severe AMS was 1%, 2%, and 6%, in groups A, B, and P, respectively. Using per protocol analysis (PP) (N = 254; A = 83, B = 87, P = 84), the incidence of AMS was 12%, 6%, and 13% in groups A, B, and P, respectively. The relative risk for developing AMS vs. placebo was A-0.96 (CI:0.46-2.0, p=0.91), B-0.39 (CI:0.14-1.04, p=0.06), A-0.94 (CI:0.42-2.1, p=0.88), and B-0.45 (0.16-1.24, p=0.12) by IT and PP, respectively.
CONCLUSIONS: Ibuprofen is effective in males for the prevention of AMS with rapid ascent to 3500 m-rest for the first two days. Acetazolamide was superior to ibuprofen in the prevention of moderate-to-severe AMS.
摘要：
背景：乙酰唑胺被推荐用于预防急性高山病（AMS）；然而，由于副作用，它的使用在某些领域受到限制。先前的研究报告布洛芬与乙酰唑胺相似或略逊。这个随机的，三盲，平行组，安慰剂对照试验旨在比较布洛芬与乙酰唑胺预防AMS的作用.
方法：将443名平均年龄为29岁（范围：20-49岁）的健康亚裔印度男性随机分为三组A，B,和P在350m（SL）。乙酰唑胺（A）：85毫克;布洛芬（B）：600毫克;或安慰剂（P）：碳酸钙每天给药三次，从前一天开始，并在到达3500米（HA）后持续三天。使用路易斯湖问卷和脉搏对参与者进行AMS评估，BP,在休息期间的头两天，SpO2和呼吸频率每天两次，在HA的第3至6天每天一次。
结果：在SL招募的443名参与者中，由于后勤限制，139无法空运，和304可在HA进行随访。其中,254人按照协议上升。通过意图治疗(IT)(N=304；A=99，B=102，P=103)，AMS(LLQS>/=3)的发生率为12%，5%,13%,严重AMS的发生率为1%，2%,6%,在A组中,B,P,分别。使用符合方案分析（PP）（N=254；A=83，B=87，P=84），AMS的发生率为12%，6%,A组13%,B,P,分别。开发AMS的相对风险与安慰剂为A-0.96（CI：0.46-2.0，p=0.91），B-0.39（CI：0.14-1.04，p=0.06），A-0.94（CI：0.42-2.1，p=0.88），由IT和PP得出B-0.45(0.16-1.24，p=0.12)，分别。
结论：布洛芬对男性AMS的预防有效，前两天快速上升至3500m-休息。乙酰唑胺在预防中重度AMS方面优于布洛芬。
方法：将443名平均年龄为29岁（范围：20-49岁）的健康亚裔印度男性随机分为三组A，B,和P在350m（SL）。乙酰唑胺（A）：85毫克;布洛芬（B）：600毫克;或安慰剂（P）：碳酸钙每天给药三次，从前一天开始，并在到达3500米（HA）后持续三天。使用路易斯湖问卷和脉搏对参与者进行AMS评估，BP,在休息期间的头两天，SpO2和呼吸频率每天两次，在HA的第3至6天每天一次。
结果：在SL招募的443名参与者中，由于后勤限制，139无法空运，和304可在HA进行随访。其中,254人按照协议上升。通过意图治疗(IT)(N=304；A=99，B=102，P=103)，AMS(LLQS>/=3)的发生率为12%，5%,13%,严重AMS的发生率为1%，2%,6%,在A组中,B,P,分别。使用符合方案分析（PP）（N=254；A=83，B=87，P=84），AMS的发生率为12%，6%,A组13%,B,P,分别。开发AMS的相对风险与安慰剂为A-0.96（CI：0.46-2.0，p=0.91），B-0.39（CI：0.14-1.04，p=0.06），A-0.94（CI：0.42-2.1，p=0.88），由IT和PP得出B-0.45(0.16-1.24，p=0.12)，分别。
结论：布洛芬对男性AMS的预防有效，前两天快速上升至3500m-休息。乙酰唑胺在预防中重度AMS方面优于布洛芬。
