Intradialytic Hypotension Clinical Trial
Official title:
The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients by Ear Pills Combined With Shengmai Capsule
This clinical study is to observe the improvement of MHD (maintenance hemodialysis) patients, quality of life,after applying therapy combining Auriculotherapy and Shengmai capsule. As a compliment to each other, Traditional Chinese Medicine and Modern Medicine form a joint and help improving life quality of MHD patients. Through the therapy, MHD patients, symptoms of thirst are improved, the incidence of intradialytic hypotension is reduced, the intake of water and sodium is lessen and the weight gain during dialysis is controlled, which consequently reduce cardiovascular and cerebrovascular complications and eventually reduce the mortality of MHD patients. Aiming to improve patients, thirst symptom and reduce the incidence of intradialytic hypotension, this study prospectively followed 144 MHD patients using multicenter prospective randomized crossover controlled clinical studies, using KT/V, URR, improvement of thirst, blood pressure and cognitive assessment as observational index. Multiple questionnaire surveys are conducted to understand patients, life quality from different angle. The use of Auriculotherapy is simple and effective and Shengmai capsule conforms to patients, syndrome, which is consistent with TCMs principle of "syndrome differentiation and treatment"and the theory of preventive treatment. The study not only expends the use of TMC in hemodialysis treatment, but also suggests a set of easy therapeutic schedules to improve the quality of life in patients receiving hemodialysis treatment.
3.1 research object 3.1.1 case: 3.1.1.1 Beijing University of Chinese Medicine Dongzhimen
hospital 48 cases 3.1.1.2 54 cases of Oriental Hospital of Beijing University of Chinese
Medicine 3.1.1.3 Chinese Academy of traditional Chinese medicine, Wangjing Hospital, 20
cases 3.1.1.4 28 case of Beijing Pinggu Hospital of Traditional Chinese Medicine 3.1.2
diagnostic criteria: 3.1.2.1: syndrome score standard: according to the traditional Chinese
medicine clinical research guiding principle (2002), chronic renal failure syndrome of
deficiency of both qi and Yin compiled score table and determine the inclusion criteria.
Diagnostic criteria of hypotension in 3.1.2.2:
Referring to the Ministry of health of the people's Republic of China promulgated the "blood
purification standard operating procedures (2010 Edition)" in the "blood dialysis
hypotension prevention and control standards for the prevention and control of standard
operating procedures", the diagnostic criteria are as follows: (1) can be diagnosed: (1)
systolic blood pressure reduction of more than 20mmHg; (2) the average arterial pressure
decreased more than 10mmHg.
3.1.2.3 mouth thirst intensity score The investigators will mouth thirst intensity score
table (XQ) eight problems in the translation into Chinese questionnaire, each question by
visual rating scale method and by the patients according to their own scoring. The higher
score indicated the mouth thirst more serious or mouth thirst caused discomfort heavier, and
the summation of the scores of each question and convert it to a range of 0 to 100 score,
resulting score higher mouth thirst more serious degree.
3.1.4.2 on the treatment of Chinese and Western medicine treatment of poor compliance.
3.1.4.3 infection, fever, acute heart failure or diabetes and blood glucose control is not
ideal.
3.1.4.4 for the preparation of the capsule and the skin allergic patients with adhesive
tape.
3.1.4.5 patients can not cooperate or not sign the informed consent. 3.1.5 removing and
dropping standard 3.1.5.1 all cases that are not included in the criteria for inclusion in
the inclusion criteria shall be excluded; 3.1.5.2 clinical information is not the whole case
to be removed. 3.2 case grouping method This research is to set up experimental group
(Western medicine routine + acupoint therapy combined with birth control group) and the
control group (Western medicine group). To meet the inclusion exclusion criteria of the
subjects, using random number table method to produce random sequence number, according to
the random sequence number to the subjects were assigned to different treatment groups.
3.3 treatment method and treatment The clinical design of this study was a randomized
crossover trial. This experiment research is divided into two stages, each stage is 8 weeks.
Experimental group on regular hemodialysis based on given auricular therapy selected export
sympathetic endocrine, God door, massage time for about 1 minute, 3 ~ 5 times / day, each
taking one side ear, 3 ~ 7 days take on the other side of the ear; Shengmai capsules and
Shengmai Capsules (ChiaTai Qingchunbao Pharmaceutical Co., Ltd., Chinese medicine quasi word
Z33021036, every grain of 0.3g. Ingredients: ginseng, ophiopogon root, Schisandra 3 capsules
/ time, 3 times / day. Control group received regular hemodialysis treatment, completed in
the treatment of the first stage. After 4 weeks after a washout period, two groups of cross
accept the next phase of treatment.
3.5 observation index 3.5.1 safety index: Into the group, crossover trial and the end of the
experiment were used to detect the blood routine hemodialysis patients, before and after
dialysis and renal ion, and serum albumin.
3.5.2 evaluation index:
1. and KT/V: and URR were measured in the clinical observation of the biochemical,
dialysis, and body weight at the end of the biochemical, dialysis, and weight gain of
hemodialysis and Improvement Center. URR = (BUN) /BUN (BUN = 100%) + (4 *) + (3.5 * R)
* KT/V (R = R) (BUN = 0.03) (LN = UF/W) (BUN =).
2. thirst improvement: combined with clinical experience, thirst was divided into eight
levels (combined with patients' self perception and thirst intensity score), making a
thirst scale, in the group, when the end of the experiment and the end of the
experiment, respectively, to observe the improvement of thirst before and after
treatment.
3. on the basis of the analysis of the improvement of the low blood pressure (first):
according to the diagnostic criteria of hypotension in hemodialysis patients, the
incidence of hypotension in the experimental group and the second stage was compared
with that of the experimental group and the control group.
4. the quality of life improvement in dialysis patients: in the clinical observation, the
patients were treated with in-depth interviews, the use of key data extraction methods,
to reflect the quality of life of patients with dialysis information; in the clinical
observation of the patients, the cross exchange and the end of the life quality of
SF-36 patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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