目的 探討右美托咪定對小兒七氟烷吸入麻醉蘇醒期躁動的影響。 方法 選擇2011年3月-2012年1月美國麻醉醫師協會分級Ⅰ~Ⅱ級、年齡2~8歲、擇期行疝囊高位結扎術和隱睪下降固定術患兒40例,隨機分為2組,右美托咪定組(A組)和對照組(B組),兩組患兒在年齡、體重、手術種類無明顯差異。兩組患兒均采用面罩8%七氟烷吸入麻醉誘導,開放靜脈,給予鹽酸戊乙奎醚0.1 mg/kg、順式阿曲庫銨0.15 mg/kg,插入喉罩,麻醉維持根據血壓、心率及腦電雙頻指數調節吸入麻醉藥濃度。A組靜脈給予1 μg/kg右美托咪定,B組給予同等容量的生理鹽水。入室至手術結束時連續觀察收縮壓、舒張壓、心率、血氧飽和度,記錄清醒時間、拔除喉罩時間,記錄蘇醒期并發癥的發生數。記錄入麻醉恢復室即刻(0 min)、15、30、60、90 min患兒疼痛和躁動評分。 結果 兩組患兒在手術時間、清醒時間以及拔除喉罩時間差異無統計學意義(P>0.05),A組術后入恢復室0、15、30 min疼痛評分和躁動評分均低于B組(P<0.05),兩組患兒圍術期均未出現低血壓和心動過緩。 結論 右美托咪定用于小兒七氟烷吸入麻醉能夠增強術后鎮痛,減少蘇醒期躁動。
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.