目的 探讨右美托咪定对小儿七氟烷吸入麻醉苏醒期躁动的影响。 方法 选择2011年3月-2012年1月美国麻醉医师协会分级Ⅰ~Ⅱ级、年龄2~8岁、择期行疝囊高位结扎术和隐睾下降固定术患儿40例,随机分为2组,右美托咪定组(A组)和对照组(B组),两组患儿在年龄、体重、手术种类无明显差异。两组患儿均采用面罩8%七氟烷吸入麻醉诱导,开放静脉,给予盐酸戊乙奎醚0.1 mg/kg、顺式阿曲库铵0.15 mg/kg,插入喉罩,麻醉维持根据血压、心率及脑电双频指数调节吸入麻醉药浓度。A组静脉给予1 μg/kg右美托咪定,B组给予同等容量的生理盐水。入室至手术结束时连续观察收缩压、舒张压、心率、血氧饱和度,记录清醒时间、拔除喉罩时间,记录苏醒期并发症的发生数。记录入麻醉恢复室即刻(0 min)、15、30、60、90 min患儿疼痛和躁动评分。 结果 两组患儿在手术时间、清醒时间以及拔除喉罩时间差异无统计学意义(P>0.05),A组术后入恢复室0、15、30 min疼痛评分和躁动评分均低于B组(P<0.05),两组患儿围术期均未出现低血压和心动过缓。 结论 右美托咪定用于小儿七氟烷吸入麻醉能够增强术后镇痛,减少苏醒期躁动。
Objective To assess the effectiveness and safety of Shuangjie Capsule (Piece) in the treatment of acute upper respiratory tract infection. Methods The multiple center, double-blinded, double-dummy and randomized controlled method was adopted to observe 770 patients who were divided into the treatment group A (n=330, treated with Shuangjie Capsule 3 pieces tid), treatment group B (n=330, treated with Shuangjie Piece 3 pieces tid) and the control group (n=110, treated with Chaihuang Piece 3 pieces tid). The therapeutic course for three groups was 5 days. Results Among 770 included patients, 724 and 718 were screened for intention to treat (ITT) and per-protocol population set (PPS) analysis, respectively. For the effectiveness on upper respiratory tract infection, in treatment group A, the markedly effective rate were 83.60% (ITT) and 84.69% (PPS) respectively, and effective rate were 98.39% (ITT) and 99.02% (PPS) respectively; in treatment group B, the markedly effective rate were 83.28% (ITT) and 83.22% (PPS) respectively, and effective rate were 99.04% (ITT) and 99.03% (PPS) respectively; while in the control group the markedly effective rate were 68.62% and 69.30% respectively, and effective rate were 98.04% and 99.01% respectively. The effectiveness of treatment group were significantly better than that of control group (Plt;0.05). For effects on TCM syndrome, in treatment group A, the markedly effective rate were 83.92% (ITT) and 85.02% (PPS), and effective rate were 98.07% (ITT) and 98.70% (PPS); in treatment group B, the markedly effective rate were 83.92% (ITT) and 83.87% (PPS), and effective rate were 99.36% (ITT) and 99.35% (PPS); while in the control group the markedly effective rate were 74.51% (ITT) and 75.24% (PPS), and effective rate was 98.04% (ITT) and 98.02% (PPS). It also showed a statistical significance between treatment and control group (Plt;0.05). ITT and PP analysis have the same results. No major adverse effect was found in the observation.Conclusion Shuangjie Capsule (Piece) shows a definite effect with no obvious toxic-adverse effects.