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目的：观察七厘散内服并外敷治疗外伤所致肿胀疼痛的疗效与不良反应。方法：将70例外伤患者按抽签方式随机分成治疗组和对照组，各35例。治疗组患者口服七厘散（1.5 g/次，2次/d），并外敷该药于患处（75％酒精调成糊状，1次/d）；对照组患者仅口服七厘散（1.5 g/次，2次/d）。两组均7 d为1个疗程。比较两组患者治疗前后疼痛程度评分及疼痛持续时间、肿胀程度评分及肿胀改善率、临床总有效率和不良反应。结果：治疗后两组患者疼痛程度评分、疼痛持续时间、肿胀程度评分与治疗前比较均有减少，差异有统计学意义（P＜0.01或P＜0.05），且治疗组的减少程度优于对照组，差异有统计学意义（P＜0.01或P＜0.05）。治疗后两组患者肿胀改善率和总有效率均明显优于对照组，差异有统计学意义（P＜0.01或P＜0.05）。两组患者治疗期间均未见明显不良反应。结论：七厘散内服并外敷治疗外伤所致肿胀疼痛安全、有效，其疗效优于仅口服用药。“,”OBJECTIVE:To observe therapeutic efficacy and ADR of oral administration and external application of Qili san in the treatment of trauma-induced swelling and pain. METHODS:70 traumatic patients were randomly divided into treatment group and control group with 35 patients in each group. Treatment group was given Qili san(1.5 g/time,2 times/d)orally,and ap-plied to affected area(blended with 75% alcohol to make paste,1 time/d);control group was only given Qili san(1.5 g/time,2 times/d) orally;a treatment course lasted for 7 d. Pain degree score,pain duration,swelling degree score and improvement rate, total effective rate and ADR were compared between 2 groups before and after treatment. RESULTS:Compared with before treat-ment,pain degree score,pain duration and swelling degree score of 2 groups were decreased after treatment;there was statistical significance(P<0.01 or P<0.05);clinical symptom of treatment group was better than that of control group;there was statistical significance(P<0.01 or P<0.05). There was statistically significant difference in the improvement rate of swelling and total effec-tive rate between 2 groups after treatment(P<0.01 or P<0.05). No obvious ADR was found during treatment. CONCLUSIONS:Oral administration and external application of Qili san is safe and effective for trauma-induced swelling and pain,and its therapeu-tic efficacy is better than only oral administration.