首页|优化炎调方治疗脓毒性休克随机、对照、多中心研究

优化炎调方治疗脓毒性休克随机、对照、多中心研究

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目的 观察优化炎调方治疗脓毒性休克患者的临床疗效及安全性。方法 纳入2021年7月—2023年10月上海中医药大学附属曙光医院、上海市宝山区中西医结合医院、上海中医药大学附属曙光医院安徽医院急诊病房、急诊ICU收治的124例脓毒性休克患者,按随机数表法将其随机分为治疗组62例和对照组62例。对照组给予西医基础治疗,治疗组给予西医基础治疗+优化炎调方颗粒剂鼻饲或口服,2组疗程均为14 d。比较2组患者28 d生存率及治疗前后急性生理与慢性健康评分(APACHEⅡ评分)、序贯器官衰竭评分(SOFA评分)、中医证候评分、实验室指标[白细胞计数(WBC)、中性粒细胞比例(N%)、C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)、白细胞介素-8(IL-8)、降钙素原(PCT)、乳酸、肝素结合蛋白(HBP)]和治疗14 d后中医证候疗效。结果 试验过程中,对照组脱落3例、治疗组脱落2例,最终治疗组60例、对照组59例完成研究。治疗组28 d生存率明显高于对照组[78。3%(47/60)比42。4%(25/59),P<0。05]。2组治疗后APACHEⅡ评分、SOFA评分、中医证候评分及WBC、N%、CRP、TNF-α、IL-6、IL-8、PCT、乳酸、HBP水平均明显低于治疗前(P均<0。05),且治疗组治疗后APACHEⅡ评分、SOFA评分、中医证候评分及CRP、IL-6、PCT、HBP水平均明显低于对照组(P均<0。05)。治疗14 d后治疗组中医证候总有效率明显高于对照组[81。7%(49/60)比62。7%(37/59),P<0。05]。结论 优化炎调方能够显著提高脓毒性休克患者28 d生存率,可明显减轻患者症状,改善患者预后。
Optimized inflammation regulating decoction in the treatment of septic shock:A randomized,controlled,multi-center clinical trial
Objective It is to observe the clinical efficacy and safety of optimized inflammation regulating decoction in the treatment of patients with septic shock.Methods A total of 124 patients with septic shock treated in the emergency ward and emergency ICU of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai Baos-han Hospital of Integrated Traditional Chinese and Western Medicine,and Anhui Hospital of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from July 2021 to October 2023 were enrolled in this study.They were randomly divided into treatment group (62 cases) and control group (62 cases).The control group was given basic therapy of western medicine,and the treatment group was given basic therapy of western medicine+optimized inflammation regulating decoction by nasal feeding or oral administration.Both groups were treated for 14 days.The 28-day survival rate,APACHE Ⅱ score,Sequential Organ Failure Assessment ( SOFA) score,traditional Chinese medicine ( TCM) syndrome scores,laboratory parameters[white blood cell count ( WBC),neutrophil percentage ( N%),C-reactive protein ( CRP),tumor necrosis factor-α(TNF-α),interleukin-6 (IL-6),interleukin-8 (IL-8),procalcitonin (PCT),lactic acid,heparin-binding protein ( HBP)]before and after treatment,and the efficacy of TCM syndrome after treatment for 14 days were compared between the two groups.Results During the trial,3 cases in the control group and 2 cases in the treatment group were dropped,and finally 60 cases in the treatment group and 59 cases in the control group completed the study.The 28-day survival rate of the treatment group was significantly higher than that of the control group[78.3% (47/60) VS.42.4% (25/59),P<0.05].The APACHEⅡscore,SOFA score,TCM syndrome score,and the levels of WBC,N%,CRP,TNF-α,IL-6,IL-8,PCT,lactic acid,and HBP were significantly lower after treatment than those before treatment in the two groups (all P<0.05),and the APACHE Ⅱ score,SOFA score,TCM syndrome score and levels of CRP,IL-6,PCT,HBP of the treatment group were significantly lower than those of the control group after treatment (all P<0.05).The total effective rate of TCM syndrome in the treatment group was significantly higher than that in the control group after 14 days of treatment[81.7% (49/60) VS.62.7% (37/59),P<0.05].Conclusion Optimized inflammation regulating decoction can significantly raise 28-day survival rate of patients with septic shock,and can obviously alleviate their symp-toms and improve their prognosis.

optimized inflammation regulating decoctionseptic shocksurvival ratetraditional Chinese medicine syndrome

陈天阳、严佳、徐童、郑佳萍、诸炳骅、姜春雷、韩丹、欧阳洋、方荣、王倩

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上海中医药大学附属曙光医院,上海201203

优化炎调方 脓毒性休克 生存率 中医证候

2024

现代中西医结合杂志
中国中西医结合学会河北分会,中华中医药学会

现代中西医结合杂志

CSTPCD
影响因子:1.775
ISSN:1008-8849
年,卷(期):2024.33(22)