研究疾病:
|
感染性休克
|
研究疾病代码:
|
|
Target disease:
|
Infectious shock
|
Target disease code:
|
研究类型:
Study type:
|
干预性研究
Interventional study
|
研究设计:
Study design:
|
随机平行对照
randomized controlled trial(parallel group design)
|
研究所处阶段:
Study phase:
|
其它
Others
|
研究目的:
|
本项目拟进行一个高质量临床研究,在分析感染性休克中医证候要素分布特点的基础上,观察参附注射液治疗感染性休克不同证候的中西医临床疗效,明确参附注射液治疗合适证候,完善中医疗效判断标准;并观察参附注射液对于脓毒症心肌病、高排低阻状态及血容量状态的影响,并使用血流动力学监测工具精准观察和指导参附注射液优化患者循环功能,为精准指导参附注射液应用提供中西医结合循证医学证据。
|
Objectives of Study:
|
This project intends to conduct a high-quality clinical study. On the basis of analyzing the distribution characteristics of TCM syndrome elements of septic shock, we will observe the clinical efficacy of Shenfu injection in treating different syndromes of septic shock in traditional Chinese and western medicine, clarify the appropriate syndromes of Shenfu injection and improve the criteria for judging the efficacy of traditional Chinese medicine. And observe the influence of Shenfu injection on sepsis cardiomyopathy, high discharge and low resistance state and blood volume state, and use hemodynamic monitoring tools to accurately observe and guide Shenfu injection to optimize patients' circulatory function, so as to provide evidence-based medicine of integrated traditional Chinese and western medicine for accurately guiding the application of Shenfu injection.
|
药物成份或治疗方案详述:
|
参附注射液为中药红参、附片的提取物,主要成分为人参皂苷和乌头类生物碱。该药的功能主治为回阳救逆、益气固脱,用于阳气暴脱所致的厥脱( 感染性、失血性及失液性休克等)。人参皂苷具有双重调节血压的作用,可有效抑制心肌细胞膜三磷酸腺苷酶的生物活性,提高心泵功能,降低心肌耗氧量,具有改善心功能的作用。同时乌头类生物碱对α肾上腺受体具有兴奋作用,可增加心肌收缩力,提高心肌搏动的频率及幅度,起到改善血液流变性、温和升血压的作用。
|
Description for medicine or protocol of treatment in detail:
|
Shenfu injection is the extract of ginseng radix rubri and radix aconiti lateralis preparata, and its main components are ginsenoside and aconite alkaloids. The main functions of this medicine are to restore yang, save the adverse reaction, and replenish qi to stop the stagnation. It is used for syncope (infectious, hemorrhagic and fluid-losing shock, etc.) caused by sudden loss of yang-qi. Ginsenoside has dual effects of regulating blood pressure, effectively inhibiting the biological activity of ATPase in myocardial cell membrane, improving cardiac pump function, reducing myocardial oxygen consumption and improving cardiac function. At the same time, Aconitum alkaloids can excite α adrenoceptor, increase myocardial contractility, increase the frequency and amplitude of myocardial pulsation, improve hemorheology, and moderately raise blood pressure.
|
纳入标准:
|
1.年龄在18至80周岁之间,男女不限。2.符合感染性休克诊断标准,在脓毒症的基础上,出现持续低血压,在充分容量复苏后仍需血管活性药来维持平均动脉压(MAP)≥65mmHg,以及血乳酸浓度>2mmol/L。3.发病24小时内入住ICU。4.入院时未使用任何的血管活性药。5.自愿签署知情同意书。
|
Inclusion criteria
|
1.the age is between 18 and 80 years old,male or female.2.Compliance with infectious shock diagnostic criteria, on the basis of sepsis, there is a continuous low blood pressure, and vascular active drugs are still needed after full capacity recovery to maintain average arterial pressure (MAP) ≥ 65mmHg, and blood lactate concentration>2mmol/L.3.Check at the ICU within 24 hours.4. No vascular active drugs are used when admission.5. voluntarily signed an informed consent.
|
排除标准:
|
1.急性脑血管疾病、恶性肿瘤者。2.妊娠或哺乳期妇女。3.用药期间对药物过敏者。4.未按规定用药,无法判断疗效,资料不全等影响疗效或安全性判断者。5.合并其他原因导致的心源性休克、失血性休克、梗阻性休克者。6.在过去三个月参加了其他临床试验。
|
Exclusion criteria:
|
1. acute cerebrovascular disease, malignant tumor.2.Pregnancy or lactating women.3.Drug allergies during medication.4.The efficacy or safety judgment is not judged by specified medication.5.Heartborne shock, blood loss shock, obstructive shock, caused by other reasons.6.Other clinical trials have participated in other clinical trials over the past three months
|
研究实施时间:
Study execute time:
|
从From
2022-02-01
至To
2023-12-31
|
征募观察对象时间:
Recruiting time:
|
从From
2022-02-01
至To
2022-06-01
|