3种中药复方制剂治疗高原脱适应症的随机安慰剂对照试验  

Three preparations of compound Chinese herbal medicines for de-adaptation to high altitude:a randomized,placebo-controlled trial

作　　者：石自福 周其全[2] 向路 马三丁 闫成军 罗涵[2] 

机构地区：[1]解放军68303部队医院 [2]第三军医大学高原军事医学系高原疾病学教研室教育部高原医学重点实验室和全军高原生理与高原病研究重点实验室

出　　处：《中西医结合学报》2011年第4期395-401,共7页Journal of Chinese Integrative Medicine

基　　金：国家科技支撑计划资助项目(No.2009BAI85B003)

摘　　要：背景:部队进入高原执行任务导致完成任务返回平原后出现高原脱适应的人数明显增加,但至今对高原脱适应症尚无有效的治疗方法。目的:探讨中药复方制剂对高原脱适应症的干预效果,为今后高原返回平原人群高原脱适应症的治疗提供科学依据。设计、场所、对象和干预措施:选择某部2010年4月14日～8月7日参加高原抗震救灾返回平原后出现高原脱适应症状的官兵作为观察对象,采用随机、单盲、安慰剂对照的试验设计方法,将高原返回平原出现高原脱适应反应的534名官兵按排建制分为三康胶囊组、红景天胶囊组、参芪花粉胶囊组和安慰剂组,分别给予相应药物治疗15d。主要结局指标:采用高原脱适应症状自评量表进行问卷调查。以治疗后症状改善的有效率和组间症状改善的差异评价治疗效果。结果:3种药物对高原脱适应症状均有一定改善作用,与安慰剂组比较,3组官兵的脱适应症状均明显减轻(P<0.05)。与安慰剂比较,三康胶囊主要对头晕、乏力、心慌、咳痰、咽痛、注意力不集中等症状有明显改善作用(P<0.05),红景天胶囊主要对乏力、嗜睡、胸闷、心慌、眩晕、注意力不集中、记忆力减退等症状有明显改善作用(P<0.05),参芪花粉胶囊主要对头晕、疲倦、乏力、胸闷、心慌、咳嗽、咯痰、咽痛、记忆力减退、反应迟钝、手足麻木等症状有明显改善作用(P<0.05)。参芪花粉胶囊症状改善率明显高于其他两种药物。结论:3种药物对高原脱适应反应均有明显的干预效果,参芪花粉胶囊的效果优于三康胶囊和三普红景天胶囊。Background：With the increase of troops entering the plateau for a variety of missions,the occurrence of de-adaptation increased significantly when the army returned to the plains,however,until now,there has been no effective treatment for de-adaptation to high altitude.Objective：To observe the interventional effects of compound Chinese herbal preparations（Sankang Capsule,Rhodiola Rosea Capsule and Shenqi Pollen Capsule） on de-adaptation to high altitude,and provide scientific evidence for appropriate treatment methods in the army health care for future missions.Design,setting,participants and interventions：A randomized,single-blind,placebo-controlled trial design was used.Soldiers of a returning army unit who exhibited de-adaptation response symptoms were selected for observation after participating in earthquake relief at high altitude.A total of 543 soldiers were divided into a Sankang Capsule group,a Rhodiola Rosea Capsule group,a Shenqi Pollen Capsule group and a placebo group for drug intervention and administered with corresponding drugs.The course of treatment was 15 days.A self-evaluation scale for de-adaptation to high altitude was used to measure the signs and symptoms exhibited by the soldiers.Main outcome measures：Effective rate of signs and symptoms of de-adaptation to high altitude was analyzed after a 15-day treatment and the differences of improvement rate of symptoms between groups were compared to evaluate the efficacy of the drugs.Results：All three drugs improved the symptoms of de-adaptation to high altitude.Compared with the placebo group,symptoms of de-adaptation to high altitude in the drug-treated groups were remitted（P0.05）.Compared with placebo,Sankang Capsule mainly had well-marked effects on dizziness,fatigue,palpitations,cough,sputum and sore throat（P0.05）;Rhodiola Rosea Capsule significantly reduced the symptoms of fatigue,drowsiness,chest tightness,palpitations,vertigo,lack of attention and memory loss（P0.05）;Shenqi Pollen Capsule significantly reduced the

关 键 词：高原病 高原脱适应症 中草药 单盲法 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]