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血必净注射液对急性呼吸窘迫综合征患者预后影响的前瞻性随机对照临床研究 被引量:20

A prospective randomized control clinical study of the effect of Xuebijing injection (血必净注射液) on prognosis of acute respiratory distress syndrome patients
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摘要 目的研究血必净注射液对急性呼吸窘迫综合征(ARDS)患者预后、免疫调节、肾上腺皮质功能及全身炎症反应调控等方面的影响。方法采用前瞻性研究方法,将2008年1—12月重症监护病房(ICU)收治的ARDS患者随机分为血必净组(31例)和对照组(30例),两组均按照常规治疗,血必净组加用血必净注射液100ml,每日2次,治疗7d。记录机械通气时间、ICU住院时间、28d病死率,治疗前后进行急性生理学与慢性健康状况评分系统Ⅱ(APACHEI)评分、急性肺损伤Murray评分、器官功能障碍Marshall评分,并于治疗前及治疗结束时(第8日)静脉注射促肾上腺皮质激素250big,放射免疫法测定注射前(TO)及注射后30min(T30)、60min(T60)血浆皮质醇水平,计算T30或T60最大值与TO的差值(△Tmax),以△Tmax≤248.4nmol/L作为相对肾上腺皮质功能不全诊断标准统计肾上腺皮质功能不全发生率;分别检测治疗前后外周血人白细胞DR抗原(HLA—DR)和淋巴细胞亚群(CD4^+/CD8^+)、白细胞介素-6(IL-6)、IL-10水平变化。结果血必净组治疗后Murray评分[(1.5±1.5)分]、Marshall评分[(2.9+2.7)分]、外周血IL-6[(3.4±1.9)umol/L]、IL-10[(1.5±0.8)umol/L]均较对照组[分别为(4.3±3.1)分、(6.3±4.1)分、(8.9±10.2)umol/L、(4.2±4.8)umol/L]明显下降(P均〈0.01),HLA—DR(41.1±10.1)、CD4^+(58.0±10.7)、CD4^+/CD8^+比值(1.9±0.3)则均较对照组(分别为30.6±15.0、50.5±16.2、1.4±0.7)显著升高(P〈0.05或P〈0.01);血必净组肾上腺皮质功能不全发生率(45.2%)较对照组(83.3%)明显降低(P〈0.01),△Tmax明显升高((328.4±278.3)umol/L比(172.8±110.8)umol/L,P均〈0.01];血必净组机械通气时间[(4.0±3.3)d]及ICU住院时间[(8.4±4.2)d]较对照组明[分别为(5.9±3.8)d、(12.0±7.6)d]明显缩短(P均〈0.05);28d病死率血必净组较对照组降低11.2%(35.5%比46.7%),但差异无统计学意义(P〉0.05)。结论血必净注射液可以改善脏器功能状态,降低机械通气和ICU住院时间,其机制可能是调节ARDS患者免疫功能,降低ARDS肾上腺皮质功能不全发生率,调控炎症反应。 Objective To study the effect of Xuebijing injection (血必净注射液) on prognosis, immune function, adrenal function and inflammatory reaction during the treatment of acute respiratory distress syndrome (ARDS). Methods From January 2008 through December 2008, a clinical study was conducted on consecutive adult patients with ARDS in intensive care unit (ICU). The patients were divided into Xuebijing group (31 patients) and control group (30 patients). Both groups were treated with the routine therapy of ARDS, and in addition, Xuebijing injection was used in a dose of 100 ml twice a day for 7 days in Xuebijing group. Duration of mechanical ventilation (MV) and ICU length of stay, 28-day mortality, acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ), Murray and Marshall scores were recorded in both groups. Every patient was given one injection of corticotrophin 250 ug intravenously before and after treatment, and plasma contisol level was detected by radio-immunoassay before the injection (T0) and 30 minutes (T30) and 60 minutes (T60) after the injection. The ratio of adrenal insufficiency was evaluated according to diagnostic criteria of ralative adrenal insufficiency, which was defined as the diffenence between TO and the highest value of T30 or T60 (△Tmax)≤248. 4 nmol/L. Human leukocyte antigen-DR (HLA-DR), subpopulations of T lymphocyte (CD4^+/CD8^+), interleukin-6 (IL-6), IL-10 in peripheral blood was also determined. Results Murray (1.5 ± 1.5) and Marshall score (2.9±2.7) and the level of IL-6 [(3. 4±1. 9)umol/L], IL-10 [(1.5±0. 8) umol/L] in the Xuebijing group were decreased significantly after the use of Xuebijing compared with control group [4.3±3.1, 6.3±4.1, (8. 9±10. 2)umol/L, (4. 2±4.8)umol/L, respectively, all P〈0. 01], while the values of HLA-DR (41.1±10. 1), CD4^+(58.0±10. 7), CD4^+/CD8^+ (1.9±0.3) were increased compared with control group C30.6±15.0, 50.5±16.2, 1.4±0.7, respectively, P〈0.05 or P〈0.01]. The ratio of adrenal insufficiency in Xuebijing group (45.2%) was lower than that of control group (83.3 % ), while that of △Tmax [ (328.4 ± 278. 3)umol/L^3 was higher than that of control group [(172. 8±110. 8) umol/L, both P〈0. 01]. MV duration ((4. 0±3.3) days] and ICU length of stay ((8.4 ± 4.2) days] were less than those of control group [(5.9±3.8) days, (12. 0±7.6) days, both P〈0. 05], and 28-day mortality in Xuebijing group was 35.5%, which was 11.2% less than that of control group (46.7 %), but there was no statistically significant difference between two groups (P 〉 0. 05). Conclusion Xuebijing injection improves organ function, decreases MV duration and ICU length of stay in ARDS patients. The underlying mechanism may involve modulation of the immune function, decrease in the degree of adrenal insufficiency, and modulation of regulating inflammatory reaction.
出处 《中国危重病急救医学》 CAS CSCD 北大核心 2009年第7期405-408,共4页 Chinese Critical Care Medicine
基金 江苏省333高层次人才培养工程基金项目(2007-58)
关键词 血必净注射液 急性呼吸窘迫综合征 预后 Xuebijing injection acute respiratory distress syndrome prognosis
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