龙虎人丹治疗中暑（暑热证）随机、双盲、多中心临床研究

Randomized, double blind, multi-center clinical study of Longhurendan with insolation(summer-heat syndrome)

目的以仁丹为对照评价龙虎人丹治疗中暑(暑热证)的有效性和安全性。方法采用区组随机、双盲、阳性药平行对照、多中心临床研究的方法,随机纳入中暑(暑热证)受试者176例,其中试验组132例、对照组44例。两组均接受物理降温和对症处理,试验组口服或含服龙虎人丹8粒/次,对照组含化或用温开水送服仁丹20粒/次,两组均3次/d,连续服药1 d。结果用药后2 h,试验组和对照组的愈显率分别为37.12%和22.73%,两组比较差异有统计学意义(P<0.05);2组中医主症积分比较差异有统计学意义(P<0.05);总有效率、痊愈率、其他单项症状两组比较差异无统计学意义,不良事件与不良反应发生率组间比较差异均无统计学意义(P>0.05)。结论龙虎人丹治疗中暑(暑热证)可缩短中暑主要症状如头痛、头晕、恶心呕吐、口渴的缓解时间。

Objective To evaluate the efficacy and safety of Longhurendan in the treatment of insolation(summer-heat syndrome) by comparison with Rendan. Methods This study adopts randomized blocks, double-blind multi-center and parallel control study. A total of 176 subjects with insolation(summer-heat syndrome) were randomly included, including 132 in the experimental group and44 in the control group. Patients in both groups received physical cooling and symptomatic treatment. In the experimental group,eight tablets of Longhurendan were taken orally or sublingually. Control group received 20 tablets of Rendan sublingually or orally with warm water per time. Both groups received 3 times/d of continuous medication for 1 day. Results After 2 h of treatment, the markedly effective rate of disease in the treatment and control groups are 37.12% and 22.73%, respectively.There were significant intergroup differences regarding markedly effective rate and major syndromes’ scores(P < 0.05). There were no significant intergroup difference with regard to other outcomes. Conclusion Longhurendan can shorten the duration of clinical syndromes of insolation such as headache, dizziness, nausea, vomiting and thirst.