CAJ | 학술논문

目的：探讨血必净注射液对脓毒症患者的肾脏保护作用及其可能机制。方法采用前瞻性随机对照临床研究（RCT）方法，选取2013年6月至12月江苏省中医院重症医学科收治的严重脓毒症和脓毒性休克患者为研究对象，按简单随机法将患者分为对照组（31例）和血必净组（31例）。对照组给予脓毒症基础治疗；血必净组在对照组基础上加用血必净注射液100 mL静脉滴注，每日1次，疗程为7 d。观察两组患者治疗前和治疗后1、3、7 d急性生理学与慢性健康状况评分系统Ⅱ（APACHEⅡ）评分；检测两组治疗前及治疗后1 d和3 d血中胱抑素C（Cys C）、血肌酐（SCr）、白细胞介素（IL-6、IL-10）水平以及凝血酶原时间（PT）、纤维蛋白原（Fib）、活化部分凝血活酶时间（APTT）等。结果两组治疗前APACHEⅡ评分比较差异均无统计学意义；治疗后3 d、7 d均较治疗前明显降低，且治疗7 d时血必净组较对照组下降更为显著（分：13.61±7.62比16.34±8.70，P＜0.05）。两组治疗前Cys C、 SCr、 IL-6、 IL-10、 PT、 APTT、 Fib水平比较差异均无统计学意义；血必净组治疗后上述指标的改善程度均明显优于对照组，以治疗3 d时改善更为显著〔Cys C（mg/L）：1.12±0.11比1.35±0.14，SCr（μmol/L）：115.0±31.0比135.0±24.0，IL-6（ng/L）：54.27±28.79比73.35±31.01，PT（s）：13.50±0.11比15.71±0.11，APTT（s）：43.66±0.31比48.03±0.55，Fib（g/L）：1.91±0.51比1.51±0.52，P＜0.05或P＜0.01〕。两组间各时间点IL-10水平比较差异均无统计学意义。结论血必净注射液对脓毒症患者肾脏损伤具有一定的保护作用，其机制可能与血必净注射液可以调节并改善脓毒症时失控的炎症反应和凝血功能有关。
목적：탐토혈필정주사액대농독증환자적신장보호작용급기가능궤제。방법채용전첨성수궤대조림상연구（RCT）방법，선취2013년6월지12월강소성중의원중증의학과수치적엄중농독증화농독성휴극환자위연구대상，안간단수궤법장환자분위대조조（31례）화혈필정조（31례）。대조조급여농독증기출치료；혈필정조재대조조기출상가용혈필정주사액100 mL정맥적주，매일1차，료정위7 d。관찰량조환자치료전화치료후1、3、7 d급성생이학여만성건강상황평분계통Ⅱ（APACHEⅡ）평분；검측량조치료전급치료후1 d화3 d혈중광억소C（Cys C）、혈기항（SCr）、백세포개소（IL-6、IL-10）수평이급응혈매원시간（PT）、섬유단백원（Fib）、활화부분응혈활매시간（APTT）등。결과량조치료전APACHEⅡ평분비교차이균무통계학의의；치료후3 d、7 d균교치료전명현강저，차치료7 d시혈필정조교대조조하강경위현저（분：13.61±7.62비16.34±8.70，P＜0.05）。량조치료전Cys C、 SCr、 IL-6、 IL-10、 PT、 APTT、 Fib수평비교차이균무통계학의의；혈필정조치료후상술지표적개선정도균명현우우대조조，이치료3 d시개선경위현저〔Cys C（mg/L）：1.12±0.11비1.35±0.14，SCr（μmol/L）：115.0±31.0비135.0±24.0，IL-6（ng/L）：54.27±28.79비73.35±31.01，PT（s）：13.50±0.11비15.71±0.11，APTT（s）：43.66±0.31비48.03±0.55，Fib（g/L）：1.91±0.51비1.51±0.52，P＜0.05혹P＜0.01〕。량조간각시간점IL-10수평비교차이균무통계학의의。결론혈필정주사액대농독증환자신장손상구유일정적보호작용，기궤제가능여혈필정주사액가이조절병개선농독증시실공적염증반응화응혈공능유관。
ObjectiveTo evaluate the protective effect of Xuebijing injection against renal injury in patients with sepsis, and to explore its possible mechanism.Methods A prospective randomized controlled trial (RCT) was conducted in which 62 severe patients with sepsis and septic shock admitted in Department of Critical Care Medicine of Jiangsu Province Traditional Chinese Medicine Hospital from June 2013 to December 2013 were randomly divided into control group and Xuebijing group, with 31 patients in each group. The patients in both groups received basic treatment for sepsis, and the patients in Xuebijing group were additionally given intravenous injection of Xuebijing 100 mL once a day for 7 days. In both groups, the changes in acute physiology and chronic health evaluationⅡ (APACHEⅡ) score were observed before treatment and 1, 3, 7 days after treatment, and the changes in the levels of interleukins (IL-6, IL-10), prothrombin time (PT), fibrinogen (Fib), activated partial thromboplastin time (APTT), serum creatinine (SCr), and Cystain C (Cys C) were determined before treatment and 1 day and 3 days after treatment.Results There was no statistically significant difference in APACHEⅡ score before treatment between two groups, however, the APACHEⅡ scores were significantly decreased in both groups 3 days and 7 days after treatment compared with those before treatment, and the degree of decrease in Xuebijing group was more obvious 7 days after treatment (13.61±7.62 vs. 16.34±8.70,P< 0.05). Serum concentrations of Cys C, SCr, IL-6, IL-10, PT, APTT, and Fib showed no difference between two groups before treatment (allP> 0.05), while after treatment the degrees of improvement of above indexes in Xuebijing group were obviously superior to those in control group, especially 3 days after treatment[Cys C (mg/L):1.12±0.11 vs. 1.35±0.14, SCr (μmol/L): 115.0±31.0 vs. 135.0±24.0, IL-6 (ng/L): 54.27±28.79 vs. 73.35±31.01,PT (s): 13.50±0.11 vs. 15.71±0.11, APTT (s): 43.66±0.31 vs. 48.03±0.55, Fib (g/L): 1.91±0.51 vs. 1.51±0.52, P< 0.05 orP< 0.01].ConclusionXuebijing injection has certain renal protective effect in patients with sepsis, and its mechanism is possibly related to the regulation and improvement of uncontrolled inflammatory response and coagulation function in sepsis.