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目的观察血必净注射液联合乌司他丁注射液治疗重症脓毒症休克的临床疗效及安全性。方法将68例重症脓毒症休克患者随机分为对照组34例和试验组34例。对照组予以静脉滴注血必净50 mL,bid;试验组在对照组治疗的基础上,联合静脉滴注乌司他丁60万U,bid。2组患者均治疗2周。比较2组患者的临床疗效、临床指标、生化指标、死亡率及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为91.18%(31/34例)和88.24%(30/34例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组的C反应蛋白分别为(24.56±4.21)和(48.21±5.22)mg·L~(-1),降钙素原分别为(1.04±0.21)和(2.88±0.45)ng·mL~(-1),白细胞分别为(8.75±2.12)×109和(13.48±3.45)×109/L,脑钠肽分别为(0.54±0.05)和(0.87±0.15)ng·mL~(-1),肌钙蛋白T分别为(0.35±0.03)和(0.76±0.18)ng·mL~(-1),肌钙蛋白Ⅰ分别为(0.42±0.07)和(0.87±0.24)ng·mL~(-1),肌酸激酶同工酶分别为(14.57±2.41)和(18.79±3.52)U·L~(-1),乳酸分别为(2.65±0.46)和(5.21±1.04)nmol·L~(-1),机械通气时间分别为(10.21±1.56)和(18.22±3.87)d,住院时间分别为(16.09±2.45)和(24.33±4.53)d,差异均有统计学意义(均P<0.05)。试验组和对照组各发生皮疹1例,差异无统计学意义(P>0.05)。试验组和对照组的死亡率分别为5.88%和26.47%,差异有统计学意义(P<0.05)。结论血必净注射液联合乌司他丁注射液治疗重症脓毒症休克的临床疗效与单用血必净注射液相当,但前者能明显改善患者的生化指标,缩短住院时间,降低死亡率,且不增加药物不良反应发生率。
Objective To observe the clinical efficacy and safety of Xuebijing injection combined with ulinastatin injection in the treatment of severe septic shock. Methods Sixty-eight patients with severe septic shock were randomly divided into control group (34 cases) and experimental group (34 cases). The control group was given intravenous drip Xuebijing 50 mL, bid; experimental group in the control group based on the treatment, combined with intravenous ulinastatin 600,000 U, bid. Two groups of patients were treated for 2 weeks. The clinical efficacy, clinical indicators, biochemical indicators, mortality and adverse drug reactions in two groups were compared. Results After treatment, the total effective rates of the experimental group and the control group were 91.18% (31/34 cases) and 88.24% (30/34 cases), respectively, with no significant difference (P> 0.05). After treatment, the C-reactive protein in the experimental group and the control group were (24.56 ± 4.21) and (48.21 ± 5.22) mg · L -1, respectively. The procalcitonin were (1.04 ± 0.21) and (2.88 ± 0.45 ), ng · mL ~ (-1) and (8.75 ± 2.12) × 109 and (13.48 ± 3.45) × 109 / L, respectively. The levels of brain natriuretic peptide were (0.54 ± 0.05) and (0.87 ± 0.15) ng · mL ~ (-1), Troponin T were (0.35 ± 0.03) and (0.76 ± 0.18) ng · mL -1, Troponin Ⅰ were (0.42 ± 0.07) and (0.87 ± 0.24) ng · ML -1 and creatine kinase isozymes were (14.57 ± 2.41) and (18.79 ± 3.52) U · L -1, (2.65 ± 0.46) and (5.21 ± 1.04) (10.21 ± 1.56) and (18.22 ± 3.87) d, respectively. The length of hospital stay was (16.09 ± 2.45) and (24.33 ± 4.53) d, respectively, and the differences were statistically significant (All P <0.05). One case of rash occurred in each experimental group and control group, with no significant difference (P> 0.05). The mortality rates in the experimental and control groups were 5.88% and 26.47%, respectively, with significant differences (P <0.05). Conclusion The clinical efficacy of Xuebijing injection combined with ulinastatin injection in treating severe septic shock is comparable to that of Xuebijing Injection alone. However, the former can significantly improve the biochemical indexes, shorten the length of hospital stay, reduce the mortality, And does not increase the incidence of adverse drug reactions.