目的 以仁丹為對照評價龍虎人丹治療中暑（暑熱證）的有效性和安全性。方法 采用區(qū)組隨機、雙盲、陽性藥平行對照、多中心臨床研究的方法，隨機納入中暑（暑熱證）受試者176例，其中試驗組132例、對照組44例。兩組均接受物理降溫和對癥處理，試驗組口服或含服龍虎人丹8粒/次，對照組含化或用溫開水送服仁丹20粒/次，兩組均3次/d，連續(xù)服藥1 d。結(jié)果 用藥后2 h，試驗組和對照組的愈顯率分別為37.12%和22.73%，兩組比較差異有統(tǒng)計學(xué)意義（P<0.05）；2組中醫(yī)主癥積分比較差異有統(tǒng)計學(xué)意義（P<0.05）；總有效率、痊愈率、其他單項癥狀兩組比較差異無統(tǒng)計學(xué)意義，不良事件與不良反應(yīng)發(fā)生率組間比較差異均無統(tǒng)計學(xué)意義（P>0.05）。結(jié)論 龍虎人丹治療中暑（暑熱證）可縮短中暑主要癥狀如頭痛、頭暈、惡心嘔吐、口渴的緩解時間。

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 and 44 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.