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目的观察参麦注射液对胸外科手术患者预后的临床疗效及安全性。方法将48例胸外科手术患者随机分为对照组24例和试验组24例。对照组于围手术期给予常规治疗;试验组在对照组治疗的基础上,于麻醉诱导后予以静脉滴注参麦注射液50 mL qd,连续给药5 d。比较2组患者术前和术后1,4,48,120 h血清白细胞介素-6(IL-6)、IL-8、补体C_3、C_4的变化、免疫功能,以及药物不良反应的发生情况。结果术后1,4,48,120 h,试验组的IL-6分别为(124.58±29.12),(90.26±15.83),(29.17±4.21)和(16.53±2.02)pg·mL~(-1),对照组的IL-6分别为(398.56±56.22),(239.68±34.23),(148.52±18.93)和(96.43±14.63)pg·mL~(-1);试验组的IL-8分别为(16.19±5.24),(9.26±3.13),(4.38±1.42)和(3.43±1.14)pg·mL~(-1),对照组的IL-8分别为(24.57±6.33),(19.79±3.17),(148.52±18.92)和(96.4±14.63)pg·mL~(-1),2组术后各时点的IL-6和IL-8比较,差异均有统计学意义(均P<0.05)。术前和术后1,4,48,120 h,试验组的补体C_3分别为(1.12±0.47)%,(0.85±0.22)%,(0.80±0.26)%,(0.78±0.19)%和(0.77±0.14)%,对照组的补体C_3分别为(1.10±0.47)%,(0.61±0.28)%,(0.76±0.24)%,(0.83±0.21)%和(0.81±0.16)%;试验组的补体C_4分别为(0.49±0.27)%,(0.31±0.16)%,(0.35±0.14)%,(0.36±0.17)%和(0.35±0.15)%,对照组的补体C_4分别为(0.51±0.28)%,(0.37±0.21)%,(0.32±0.18)%,(0.39±0.14)%和(0.37±0.16)%,且2组术后各时点的补体C_3和C_4水平与术前比较,差异均有统计学意义(均P<0.05)。术前和术后1,4,48,120 h,试验组的CD_3~+分别为(69.87±2.34)%,(60.49±2.18)%,(54.17±1.78)%,(52.46±1.79)%和(51.41±1.79)%,对照组的CD_3~+分别为(70.12±2.47)%,(53.18±2.19)%,(52.52±1.79)%,(50.79±2.09)%和(50.31±1.72)%;试验组的CD_4~+分别为(43.04±3.85)%,(35.46±2.56)%,(32.17±1.98)%,(29.59±2.14)%和(29.21±2.11)%,对照组的CD_4~+分别为(42.93±2.51)%,(32.73±2.28)%,(30.41±2.04)%,(31.14±1.89)%和(30.57±2.16)%;试验组的CD_4~+/CD_8~+分别为(1.57±0.39),(1.40±0.41),(1.39±0.37),(1.37±0.35)和(1.38±0.36),对照组的CD_4~+/CD_8~+分别为(1.56±0.43),(1.24±0.29),(1.33±0.25),(1.36±0.28)和(1.39±0.34),且2组患者术后各时点的CD_3~+、CD_4~+、CD_4~+/CD_8~+水平与术前比较,差异均有统计学意义(均P<0.05)。2组患者治疗过程中未出现严重药物不良反应。结论参麦注射液可明显提高胸外科患者术后的恢复效果,降低患者的炎症因子和补体C_3、C_4水平,改善患者的免疫功能,且安全性较高。
Objective To observe the clinical efficacy and safety of Shenmai injection on the prognosis of thoracic surgery patients. Methods Forty-eight patients undergoing thoracic surgery were randomly divided into control group (24 cases) and experimental group (24 cases). The control group was given routine treatment during perioperative period. On the basis of the treatment of the control group, the experimental group was given intravenous injection of Shenmai injection 50 mL qd after induction for 5 days. The changes of serum IL-6, IL-8, complement C_3 and C_4, immunologic function and adverse drug reactions were compared between the two groups before operation and at 1,4,48 and 120 h after operation. Results The levels of IL-6 in the experimental group were (124.58 ± 29.12), (90.26 ± 15.83), (29.17 ± 4.21) and (16.53 ± 2.02) pg · mL -1 at 1, The levels of IL-6 in the control group were (398.56 ± 56.22), (239.68 ± 34.23), (148.52 ± 18.93) and (96.43 ± 14.63) pg · mL -1, respectively; ± 5.24, 9.26 ± 3.13, 4.38 ± 1.42 and 3.43 ± 1.14 pg · mL -1, respectively. The levels of IL-8 in the control group were (24.57 ± 6.33) and (19.79 ± 3.17), respectively (148.52 ± 18.92) and (96.4 ± 14.63) pg · mL ~ (-1), respectively. There were significant differences in IL-6 and IL-8 between the two groups after operation (all P <0.05). Preoperative and postoperative 1,4,48,120 h, the experimental group of complement C_3 were (1.12 ± 0.47)%, (0.85 ± 0.22)%, (0.80 ± 0.26)%, (0.78 ± 0.19)% and 0.14 ± 0.24)%, (0.83 ± 0.21)% and (0.81 ± 0.16)%, respectively. The complement of the experimental group was (1.10 ± 0.47)%, (0.49 ± 0.27)%, (0.31 ± 0.16)%, (0.35 ± 0.14)%, (0.36 ± 0.17)% and (0.35 ± 0.15)% respectively in the control group and (0.51 ± 0.28) %, (0.37 ± 0.21)%, (0.32 ± 0.18)%, (0.39 ± 0.14)% and (0.37 ± 0.16)% respectively. The levels of complement C_3 and C_4 in the two groups were significantly different from those before operation All were statistically significant (P <0.05). The preoperative and postoperative 1,4,48,120 h, the experimental group of CD_3 ~ + were (69.87 ± 2.34)%, (60.49 ± 2.18)%, (54.17 ± 1.78)%, (52.46 ± 1.79)% and ± 1.79%, respectively. The CD_3 ~ + values in the control group were (70.12 ± 2.47)%, (53.18 ± 2.19)%, (52.52 ± 1.79)%, (50.79 ± 2.09)% and (50.31 ± 1.72) (43.04 ± 3.85)%, (35.46 ± 2.56)%, (32.17 ± 1.98)%, (29.59 ± 2.14)% and (29.21 ± 2.11)%, respectively. The CD_4 ~ (31.4 ± 2.04)%, (31.14 ± 1.89)%, and (30.57 ± 2.16)%, respectively; The levels of CD_4 ~ + / CD_8 ~ + in the experimental group were (1.57 ± 0.39), (32.73 ± 2.28)%, (1.40 ± 0.41), (1.39 ± 0.37), (1.37 ± 0.35) and (1.38 ± 0.36) respectively in the control group and (1.56 ± 0.43) and (1.24 ± 0.29) (1.33 ± 0.25), (1.36 ± 0.28) and (1.39 ± 0.34), respectively. The levels of CD_3 ~ +, CD_4 ~ + and CD_4 ~ + / CD_8 ~ + in the two groups were significantly different from those before operation All were statistically significant (P <0.05). Two groups of patients during treatment did not appear serious adverse drug reactions. Conclusion Shenmai injection can significantly improve postoperative recovery in patients with thoracic surgery, reduce the levels of inflammatory cytokines and complement C_3 and C_4 in patients, and improve the immune function of patients with high safety.