Effects of Tongxinluo Capsule on sepsis and microcirculation parameters
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维普
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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ICU0、6、24、48、72 h检测大循环参数(MAP、CVP及 ScvO2)、微循环参数(Pcv-aCO2、Pcv-aCO2/Ca-cvO2、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%,x2=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ScvO2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-aCO2组内比较差异具有统计学意义(P=0.006),Pcv-aCO2/Ca-cvO2组内比较无统计学意义(P=0.261);观察组Pcv-aCO2及Pcv-aCO2/Ca-cvO2组内比较差异均具有统计学意义(P均<0.05);2组Pcv-aCO2及Pcv-aCO2/Ca-cvO2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 ScvO2),micro circulation parameters(Pcv-aCO2,Pcv-aCO2/Ca-cvO2,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 con-ventional 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 admis-sion respectively,and relevant research indexes were detected.Results The total effective rate of treatment group was sig-nificantly higher than that of control group(100.0%vs.66.7%,x=8.857,P=0.003).The intra-group comparisons of large cycle parameters MAP,CVP and ScvO2 at different time points of 0h,6h,24h,48h and 72 h in the both groups were all sta-tistically significant(all P<0.001),and no significance between the two groups(all P>0.05).In the control group,Pcv-aCO2 was significantly different in the above 5 different time points(P=0.006),but no significance in Pcv-aCO2/Ca-cvO2(P=0261).The intra-group comparisons of Pcv-aCO2 and Pcv-aCO2/Ca-cvO2 in treatment group were all statistically significant(all P<0.05).There were no significances in Pcv-aCO2 and Pcv-aCO2/Ca-cvO2 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-Ⅱ and 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-Ⅱ scores 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 be-tween the two groups(all P>0.05).Conclusion Tongxinluo Capsule can improve the microcirculation disorder of sepsis pa-tients,relieve the condition and improve the clinical efficacy of TCM syndromes,but it cannot shorten the mechanical venti-lation time,ICU admission time and 28-day mortality.
SepsisMicrocirculation disorderTongxinluo CapsuleCombined therapy of Chinese and Western medicine