Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated With Pulmonary Infection: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Serum inflammatory factors：C-reactive protein (CRP) level
研究概览
简要总结
The goal of this prospective randomized controlled study is to explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. The intervention group and control group were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. To evaluate the clinical efficacy of both groups.
详细描述
To explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. Using a prospective randomized controlled study, 72 patients with pulmonary infection after stroke admitted to our hospital from May 2020 to May 2021 were randomly divided into the intervention group and control group, with 36 patients in each group. Both groups were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. The traditional Chinese medicine (TCM) syndrome score and clinical pulmonary infection score (CPIS) before and after treatment, time of fever relieving, time for the disappearance of cough, expectoration and moist rales in the lung, white blood cell count (WBC), serum C-reactive protein (CRP) level, calcitonin (PCT) level and pulmonary indexes were compared between the 2 groups, respectively, to evaluate clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 28 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria of Western medicine for stroke complicated with pneumonia
- •conforming to the TCM syndrome of vital qi deficiency and phlegm-heat obstructing the lung
- •confirmed as the initial onset of stroke through CT or magnetic resonance imaging (MRI)
- •clear consciousness, no cognitive impairment, and ability to cooperate with pulmonary function assessment and rehabilitation training
- •willingness to participate in this study and sign the informed consent
排除标准
- •Patients with systemic multi-organ failure such as the heart, brain, kidney, etc
- •patients with a coronary metal stent or pacemaker implantation
- •patients with malignant tumors
- •patients with severe cognitive impairment, depression or mental disorders
- •patients with pulmonary infections before stroke or caused by other causes
- •patients in the acute phase of infection
研究组 & 干预措施
the intervention group
TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training
干预措施: TCM acupuncture therapy (Device)
the intervention group
TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training
干预措施: Conventional drug therapy (Drug)
the intervention group
TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training
干预措施: Rehabilitation therapy (Behavioral)
the intervention group
TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training
干预措施: Breathing training (Behavioral)
the control group
Conventional drug therapy Rehabilitation therapy Breathing training
干预措施: Conventional drug therapy (Drug)
the control group
Conventional drug therapy Rehabilitation therapy Breathing training
干预措施: Rehabilitation therapy (Behavioral)
the control group
Conventional drug therapy Rehabilitation therapy Breathing training
干预措施: Breathing training (Behavioral)
结局指标
主要结局
Serum inflammatory factors：C-reactive protein (CRP) level
时间窗: 2 Weeks
C-reactive protein (CRP) level(mg/L)
Serum inflammatory factors：Calcitonin (PCT) level
时间窗: 2 Weeks
Calcitonin (PCT) level(ng/mL)
Serum inflammatory factors：WBC
时间窗: 2 Weeks
WBC (x 109/L)
Improvement time for symptoms and signs of pulmonary infection：Time of fever relieving
时间窗: 2 Weeks
the time for body temperature to return to normal (d)
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of cough
时间窗: 2 Weeks
the time for the disappearance of cough (d)
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of expectoration
时间窗: 2 Weeks
the time for the disappearance of expectoration (d)
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of moist rales
时间窗: 2 Weeks
the time for the disappearance of moist rales (d)
TCM syndrome score
时间窗: 2 Weeks
Before and after treatment, TCM syndrome scores were counted in the two groups. The main and secondary symptoms were classified into 4 levels, with scores of 0, 1, 2 and 3 based on the severity of the symptoms. The tongue coating and pulse pattern were scored into 2 levels, with no scored as 0 and yes as 1. The sum of various scores was calculated as the total score, with a score range of 0-36. The higher the score, the severer the condition.
Clinical pulmonary infection score (CPIS)
时间窗: 2 Weeks
Before and after treatment, the 2 groups were scored comprehensively based on the average range of 12-h body temperature, WBC range, amount and character of tracheal secretions, index of gas exchange, pulmonary infiltration shadow of X-ray chest film, and pathogenic bacteria in sputum culture. According to the severity, they were divided into 3 levels, with a score of 0, 1 and 2. The maximum score was 12. The higher the score, the severer the infection.
Pulmonary indexes:forced vital capacity (FVC)
时间窗: 2 Weeks
To measure the forced vital capacity (FVC)(L) before and after treatment
Pulmonary indexes:forced expiratory volume in the first second (FEV1)
时间窗: 2 Weeks
To measure the forced expiratory volume in the first second (FEV1)(L/S) before and after treatment
Pulmonary indexes: peak expiratory flow (PEF)
时间窗: 2 Weeks
To measure the peak expiratory flow (PEF)(L/S) before and after treatment
Efficacy evaluation:Number of patients with clinical efficacy（Cured，Effective，Remarkably effective，Invalid）
时间窗: 2 Weeks
Efficacy was evaluated according to the Criteria of Diagnosis and Therapeutic Effect of Diseases and Symptoms in Traditional Chinese Medicine . Cured: Clinical adverse symptoms such as cough, expectoration and chest tightness disappeared, inflammation was absorbed on X-ray or CT, and routine blood indexes were normal. Remarkably effective: Adverse symptoms such as cough, expectoration and chest tightness were improved significantly, and X-ray or CT and routine blood test results basically returned to normal. Effective: Clinical adverse symptoms such as cough, expectoration and chest tightness were relieved, and X-ray or CT and routine blood test results were improved partially. Invalid: Clinical adverse symptoms such as cough, expectoration and chest tightness had no changes or aggravated.
次要结局
未报告次要终点
研究者
WangHonglian
Principal Investigator
The Second Hospital of Hebei Medical University