通心络胶囊治疗脓毒症疗效及对微循环的影响

Effects of Tongxinluo Capsule on sepsis and microcirculation parameters

目的观察通心络胶囊对脓毒症患者临床疗效和微循环指标的影响。方法选取2018年11月—2021年10月河北以岭医院ICU收治的脓毒症患者60例,按照随机数字表法分为观察组和对照组,各30例。2组均给予西医常规治疗,观察组加用通心络胶囊,疗程均7 d。分别于入ICU 0、6、24、48、72 h检测大循环参数(MAP、CVP及ScvO_(2))、微循环参数(Pcv-aCO_(2)、Pcv-aCO_(2)/Ca-cvO_(2)、Lac、CRT)及APACHE-Ⅱ、SOFA评分、机械通气时间、ICU住院时间及28 d病死率。结果观察组临床疗效总有效率显著高于对照组(100.0%vs.66.7%,χ^(2)=8.857,P=0.003);2组0、6、24、48及72 h不同时间点大循环参数MAP、CVP及ScvO_(2)组内比较均具有统计意义(P均<0.001);而组间比较皆无统计意义(P均>0.05)。对照组0、6、24、48及72 h不同时间点Pcv-aCO_(2)组内比较差异具有统计学意义(P=0.006),Pcv-aCO_(2)/Ca-cvO_(2)组内比较无统计学意义(P=0.261);观察组Pcv-aCO_(2)及Pcv-aCO_(2)/Ca-cvO_(2)组内比较差异均具有统计学意义(P均<0.05);2组Pcv-aCO_(2)及Pcv-aCO_(2)/Ca-cvO_(2)在0、6、24 h组间比较差异均无统计学意义(P>0.05),但48及72 h组间比较均具有统计学意义(P均<0.05),观察组均优于对照组。2组0、6、24、48及72 h不同时间点Lac、CRT组内比较均具有统计学意义(P均<0.001);2组0、6、24、48 h Lac组间比较均无统计学意义(P均>0.05),72 h Lac组间比较差异具有统计学意义(P=0.036),观察组优于对照组;2组0、6、24 h CRT组间比较均无统计学意义(P均>0.05),48及72 h CRT组间比较差异均具有统计学意义(P均<0.05),观察组均优于对照组。2组7 d与1 d组内比较APACHE-Ⅱ及SOFA评分差异均有统计学意义(P均<0.001);2组APACHE-Ⅱ与SOFA评分1 d组间比较差异均无统计学意义(P均>0.05);7 d时APACHE-Ⅱ评分组间比较差异无统计学意义(P>0.05),SOFA评分组间比较差异有统计学意义(P=0.010),观察组优于对照组。2组在机械通气时间、ICU住院时间及28 d病死率方面比较差异均无统计学意义(P均>0.05)。结论通心络胶囊能够改善脓毒症患者微循环障碍,缓解病情,改善中医证候临床疗效,但未能缩短机械通气时间、ICU住院时间及28 d病死率。

Objective To observe the effects of Tongxinluo Capsule on major circulation parameters(MAP,CVP and ScvO_(2)),micro circulation parameters(Pcv-aCO_(2),Pcv-aCO_(2)/Ca-cvO_(2),Lac,CRT),clinical efficacy,APACHE-Ⅱ,SOFA score,mechanical ventilation time,ICU admission time and 28-day mortality in septic patients.Methods Sixty patients with sepsis were randomly divided into treatment group and control group,30 cases in each group,both groups were given conventional western medicine,the treatment group plus Tongxinluo Capsule,the control group plus placebo,4 capsules,3 times a day,the course of treatment for 7 days.Blood samples were collected at 0,6,24,48 and 72 hours after ICU admission respectively,and relevant research indexes were detected.Results The total effective rate of treatment group was significantly higher than that of control group(100.0%vs.66.7%,χ^(2)=8.857,P=0.003).The intra-group comparisons of large cycle parameters MAP,CVP and ScvO_(2) at different time points of 0h,6h,24h,48h and 72 h in the both groups were all statistically significant(all P<0.001),and no significance between the two groups(all P>0.05).In the control group,Pcv-aCO_(2) was significantly different in the above 5 different time points(P=0.006),but no significance in Pcv-aCO_(2)/Ca-cvO_(2)(P=0.261).The intra-group comparisons of Pcv-aCO_(2) and Pcv-aCO_(2)/Ca-cvO_(2) in treatment group were all statistically significant(all P<0.05).There were no significances in Pcv-aCO_(2) and Pcv-aCO_(2)/Ca-cvO_(2) between the 2 groups at 0h,6h and 24h(all P>0.05),but there were significances between the 48h and 72h(all P<0.05),and the treatment group was superior to the control group.Lac and CRT were statistically significant in the above 5 different time points with intra-group comparisons of the both groups(all P<0.001).There were no significances in Lac levels between the 2 groups at 0h,6h,24h and 48 h(all P>0.05),but there was a statistically significant difference between the groups at 72 h(P=0.036),and the treatment group was better than the control group.No significances were found in CRT between groups at 0h,6h and 24h(all P>0.05),but there were significances between groups at 48h and 72 h(all P<0.05),and the treatment group was superior to the control group.There were no significant differences in APACHE-Ⅱand SOFA scores between the two groups before treatment(P all>0.05).There were significant differences before and after treatment with intra-group comparison of both groups(all P<0.001).After 7 days of treatment,there was no significant difference in APACHE-Ⅱscores among groups(P>0.05),while significant difference was found in SOFA scores among groups(P=0.010).The treatment group was better than the control group.But there were no significant differences in mechanical ventilation time,ICU admission time and 28-day mortality between the two groups(all P>0.05).Conclusion Tongxinluo Capsule can improve the microcirculation disorder of sepsis patients,relieve the condition and improve the clinical efficacy of TCM syndromes,but it cannot shorten the mechanical ventilation time,ICU admission time and 28-day mortality.