机构地区:[1]中国医科大学航空总医院神经内科,北京100012
出 处:《中华老年医学杂志》2021年第11期1376-1380,共5页Chinese Journal of Geriatrics
基 金:北京市自然科学基金资助项目(7202237);北京神经变性病学会基金资助项目(BNDS201901);航空总医院重点疾病研究室科研项目(JB2019-015)。
摘 要:目的研究醋甲唑胺(methazolamide,MTZ)治疗正常压力脑积水(NPH)患者的有效性及安全性.方法本研究为随机、双盲、安慰剂对照前瞻性临床研究.收集我院2019年9月至2021年3月35例NPH患者,其中包括29例特发性正常压力脑积水(iNPH)和6例继发性正常压力脑积水(sNPH)患者,上述患者因各种原因不适宜或拒绝手术治疗.随机分为药物组和安慰剂组,给予口服MTZ或安慰剂25 mg,2次/d,1周后无不适增加至50 mg,2次/d治疗.口服前、口服1月后分别进行10 m步态评分、认知功能评分、特发性正常压力脑积水分级量表(iNPHGS)评分、头MRI检查,口服3个月后进行iNPHGS评分.主要疗效终点为用药后3个月iNPHGS评分,次要疗效终点为用药后1个月上述各项评分.结果35例NPH患者中28例进入最终分析.药物组18例,安慰剂组10例.用药1月后药物组MOCA评分[(16.2±8.8)分和(14.8±8.7)分,t=-2.68,P=0.02]、10 m步态评分[(22.3±11.2)分和(25.6±12.9)分,t=2.76,P=0.02]、iNPHGS评分[(7.3±3.2)分和(8.1±3.5)分,t=4.08,P<0.01]均较基线改善;用药3个月后药物组iNPHGS评分(6.1±2.4)分较基线时(t=5.07,P<0.01)和1个月时改善(t=4.11,P<0.01);而对照组用药1个月和3个月后各项评分较基线均无明显改善(均P>0.05);用药1个月后药物组较对照组10 m步态评分、iNPHGS评分改善(均P<0.05);用药3个月后iNPHGS评分相对于基线水平较对照组改善(t=-4.41,P<0.05).上述35例患者未出现低钾、酸中毒等严重不良反应.两组间不良事件差异无统计学意义(x^(2)=0.01,P=1.00).结论醋甲唑胺可有效改善部分不能手术的NPH患者临床症状,且安全性良好.Objective To study the efficacy and safety of Methazolamide(MTZ)for the treatment of normal pressure hydrocephalus(NPH)patients.Methods A randomized.double-blind.placebo-controlled.prospective clinical study was conducted in Aviation(;eneral Hospital.A total of 35 NPH patie nts including 29 idiopathic normal pressure hydrocephalus(iNPH)and 6 sec on dary normal pressure hydrocephalus(sNPH)received drug treatment in our hospital from September 2019 to March 2021.All patienls were unsuitable for or refused surgical treatment for some reasons.The patients were divided into drug group(n=18)and control group(n=10).laking oral MTZ or placebo 25 mg twice daily,increasing to 50 mg twice daily after 1 week if there was no discomfort.The 10 m gait score,cognitive function score,brain MRI check were completed before and 1 month after oral administration.The assessment of idiopathic normal pressure hydrocephalus scale(iNPHGS)score were performed 1 month and 3 months after oral administration.The primary efficacy endpoint was iNPHGS score for 3 months treatment and the sec on dary efficacy endpoi nl was the assessment of above scales for 1 month treatment.Results As compared with baseline.the effect of 1 month treatment showed that MOCA scores](16.2±8.8)and(14.8±8.7)scores.t=-2.68,P=0.02],10 mgait scores](22.3+11.2)and(25.6+12.9).t=2.76,P=O.02],iNPHGS scores[7.3±3.2)and(8.1±3.5),t=4.08,P<0.01]were improved.The effect of 3 month treatment showed that the iNPHGS score(6.1+2.4)was improved compared with baselined=5.07,P<0.01)and 1 monih(t=4.ll,P<0.01).But the above scores of the control group were not significantly improved compared with the baseline(all P>0.05).After 1 month treatment.the 10 m gait score and iNPHGS score in the drug group were improved compared with those in the control group(all P<C0.05).After 3 months treatment.the iNPHGS score was improved compared with the baseline level in the control group(z=-4.41,P<0.05).The above 35 patients had no serious adverse reactions such as hypokalemia and acidosis.There was
分 类 号:R742.7[医药卫生—神经病学与精神病学]
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