Clinical Study on Acupoint Application Based on the Theory of "State-target Syndrome Differentiation" in Relieving qi Deficiency and Constipation in Patients With Colorectal Cancer Undergoing Postoperative Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- The Nimodipine method was used to calculate the total symptom score of patients
研究概览
简要总结
4.1 Research Content
- Clarifying the acupoint application scheme for deficiency and constipation in CRC patients undergoing chemotherapy: the preliminary acupoint application scheme for deficiency and constipation in CRC patients was formulated according to the systematic literature search, analysis of acupoint and traditional Chinese medicine prescription, analysis of meridian tropism of acupoints, Chinese herbal medicine taste and meridian tropism, etc., and multidisciplinary expert consultation. Through two rounds of Delphi expert letter consultation, the acupoint application scheme for deficiency and secret of CRC patients undergoing chemotherapy was determined.
- Randomized controlled trials were conducted to compare the effect of acupoint application scheme and conventional treatment in improving constipation symptoms, total clinical efficacy, and improving patient comfort rate in CRC patients undergoing chemotherapy.
4.2 Key problems to be solved Based on the theory of "state-target dialectics", the analysis of acupoints and traditional Chinese medicine prescriptions, the analysis of meridian tropism of acupoints, the flavor and meridian tropism of Chinese herbs are used to select Chinese herbs that moisten the intestine and relieve defecation, strengthen the central and qi, and explore the acupoint application to provide a basis for more effective application of acupoint application in the treatment of qi deficiency and constipation in patients with CRC chemotherapy, form a generalized integrated Chinese and western medicine diagnosis and treatment plan, and promote the development of integrated Chinese and western medicine.
4.3 Expected Goals
- Clarify the diagnosis and treatment plan of acupoint application in the treatment of qi deficiency and constipation in patients with colorectal cancer.
- The flexible application of classic formula and scientific acupoint selection and sticking can effectively relieve qi deficiency and constipation in CRC patients undergoing chemotherapy, improve the total clinical efficacy and comfort of patients. It has been used in clinical practice and promoted to other medical institutions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of colorectal cancer
- •Chemotherapy was performed after surgery
- •Diagnosis of qi deficiency and constipation
- •Age ≥18 years old
排除标准
- •Clinical diagnosis of other digestive tract or anal organic diseases
- •Observed with severe cardiac, hepatic, renal insufficiency or other complications
- •Allergic constitution or allergy to a drug in constipation paste
研究组 & 干预措施
Acupoint application + conventional treatment and nursing program
干预措施: Acupoint application (Drug)
Acupoint application + conventional treatment and nursing program
干预措施: Routine treatment and nursing of constipation (Behavioral)
Routine treatment and nursing of constipation
干预措施: Routine treatment and nursing of constipation (Behavioral)
结局指标
主要结局
The Nimodipine method was used to calculate the total symptom score of patients
时间窗: Five days after the intervention
Efficacy index =\[(pre-treatment score - post-treatment score)/pre-treatment score\]× 100%, which was divided into 4 grades: clinical cure, marked effect, effective and ineffective. Clinical recovery: the main symptoms and signs disappeared or basically disappeared, and the efficacy index was ≥ 95%. Marked efficacy: the main symptoms and signs were significantly improved, 70% ≤ efficacy index \< 95%; Effective: the main symptoms and signs were significantly improved, 30% ≤ efficacy index \< 70%; Ineffective: the main symptoms and signs were not significantly improved, or even aggravated, and the efficacy index was less than 30%.
Constipation symptom assessment form
时间窗: Before and after 5 days of intervention
It was formulated by the Anorectal Surgery Group of Chinese Society of Surgery of Chinese Medical Association, and included six dimensions: defecation frequency, defecation time, defecation difficulty, stool character, abdominal distension, falling, incomplete and fullness. A 4-point scale was used to evaluate the severity of symptoms.The higher the score, the more severe the constipation symptoms.The minimum score was 0 and the maximum score was 18.
次要结局
- Chinese version of Symptom Checklist for Constipation (PAC-SYM)(Before and after 5 days of intervention)
- TCM syndrome rating scale of qi deficiency and constipation(Before the intervention and 5 days after the intervention)
- Constipation quality of life self-rating scale (PAC-QOL)(Before the intervention and 5 days after the intervention)