Clinical trials of the treatment of chronic cholecystitis YGLDG
|School||Hubei College of Traditional Chinese Medicine|
|Course||Chinese medical science|
|Keywords||Chronic cholecystitis / liver yin deficiency YGLDG Clinical trials|
Objective: To observe the changes of the clinical signs and symptoms before and after treatment of chronic cholecystitis and B-ultrasound, further observed YGLDG treatment of liver yin deficiency chronic cholecystitis validity by observing the three conventional, heart, liver and kidney function emergent adverse events, further evaluation of its security, and lay the foundation for its popularization and application in the clinical. Method: 1. Experimental design: Stratified random, parallel-group, double-blind, multi-center clinical trial methodology. 2. Study population: This study selected cases of 80 patients, all from the Hubei Province Traditional Chinese Medicine Hospital outpatient as well as inpatient, were confirmed by the diagnosis of patients with chronic cholecystitis and TCM liver and lack of permit, were randomly divided into two groups, the test group of 60 patients, the control group (20 cases). 3. Western diagnostic criteria: reference literature intended. (1) Continuing right upper quadrant dull pain or discomfort, or with the right shoulder and foot pain. (2) dyspeptic symptoms of nausea, Heating, pantothenic acid, bloating and stomach burning, aggravated after eating greasy food. (3) long course, the course of the disease after acute exacerbation and remission alternating characteristics. (4) gallbladder area with mild tenderness or percussion pain. (5) B visible gallbladder wall rough thickening or abnormalities associated with sound transmission, gall bladder narrow or deformed, or may have gallstones. Where have the item (5), plus (1) - (4) of the two, can be diagnosed. 4. TCM syndrome diagnostic criteria: according to the literature intended. (1) The main symptoms: Youxie pain or discomfort, or with shoulder radiating pain or worse after eating greasy food. (2) Secondary symptoms: dry mouth, bloating, fatigue. Tongue, little coating, in cracks or light stripping, pulse string or band number. 5. Case inclusion criteria: (1) meet the of chronic cholecystitis diagnostic criteria and TCM liver and insufficient syndrome Diagnostic Criteria. (2) between the ages of 18-65 years old, male or female. (3) is not a week since the use of Chinese and Western medicine treatment of chronic cholecystitis. (4) informed consent, voluntary subjects. Obtaining informed consent process should comply with GCP requirements. 6. Case exclusion criteria: (1) examination confirmed gallbladder polyps, acute uncomplicated cholecystitis, acute suppurative cholecystitis, acute gangrenous cholecystitis, acute obstructive suppurative cholecystitis, gallbladder perforation complicated by diffuse peritonitis. (2) chronic cholecystitis acute exacerbation. (3) The body temperature ≥ 37.5 ℃, WBC> 10 × 10 ~ 9 / L. (4) pregnant and lactating women. (5) has a serious primary darling lung and kidney blood or affect the survival of serious diseases, such as cancer or AIDS; renal dysfunction; urine protein>, microscopic urine red blood cells (urinary HB as a criterion): ALT> 2N (N is the upper limit of normal); clinically significant ECG abnormalities; blood leukocytes <3.0 × 10 9 / L. (6) patients with disability law (blind, deaf, dumb, mental retardation, mental disorders, physical disabilities). (7) suspect does have a history of alcohol and drug abuse. (8) According to the investigator's judgment, could easily lead to loss to follow to reduce the possibility of inclusion into the complex set of other lesions, such as working conditions change frequently. (9) allergies, such as two or more drugs or a history of food allergies; or known composition of the drug who are allergic to. (10) patients participate in clinical trials of other drugs. 7. Treatment options: test group: YGLDG, oral, 1 bag each time, 2 times a day. The anetholtrithione piece (simulation agent), oral, one at a time, three times a day. Control group: anetholtrithione tablets, orally, every one, three times a day. YGLDG (simulation agent), oral, 1 bag each time, twice a day. Continuous medication for four weeks for a course of treatment, one week, two weeks, four weeks of referral once. Observation time for a course of treatment. 8. Clinical criteria: (1) The main symptoms to improve the situation. (2) Consolidated efficacy index = [(treatment score - Treatment Score) ÷ treatment score] × 100% ① clinical cure: symptoms and signs disappeared after treatment, the integral value decrease ≥ 95%. The ② markedly: symptoms and signs improved after treatment, reduce the integral value ≥ 70% ③ progress: reduced symptoms and signs of improvement, the integral value ≥ 30% ④ invalid after treatment: after treatment, no significant improvement in symptoms, signs, or reduced integral value < 30% (3) imaging (B-) clinical criteria: ① healed: three returned to normal gallbladder or gallbladder wall thickness of the pipe wall, rough, transparent sound. ② markedly: the wall thickness of the gallbladder or gallbladder wall, rough, through the sound of two improvement. ③ effective: the wall thickness of the gallbladder or gallbladder wall, rough, transparent sound an improvement. ④ invalid: three no improvement of the wall thickness of the gallbladder or gallbladder wall, rough, transparent sound. 9. Observation of safety indicators: blood, urine, stool. ECG, liver function (AST, ALT, ALP, г-GT, TBiL, DBiL), renal (BuN, Scr). Type, degree and incidence of adverse events. 10. Records and statistical data: evaluation of efficacy and safety, the efficacy observation and security observation after the end of the trial data entry, statistical analysis of the final data. Results: (1) two groups of patients efficacy comparison: the experimental group the total effective rate of 93%, the control group, the total effective rate was 85%, statistically, the total effective rate between the two groups was no significant difference (P> 0.05) The test group and the control group, indicating that the same effect. TCM syndrome score in the two groups of patients (2) comparison: each TCM symptom scores in the two groups of patients were significantly reduced compared with before treatment a significant difference (P <0.05), the two groups can effectively improve the clinical symptoms. Between the two groups, the experimental group improved symptoms in addition to eating greasy food emphasis and the the abdominal distention two disorders (P> 0.05), and the rest are better than the control group (P <0.05). (3) The two groups of patients before and after TCM climate total score comparison: signs and symptoms before and after treatment were significantly improved (P> 0.05) between the two groups, within-group comparisons P <0.05, test and control groups showed no significant . (4) The two groups of patients the gallbladder B ultrasound imaging before and after comparison: the statistical analysis, p> 0.05, B-efficacy differences in the two groups of patients, the two groups of patients under the B-efficacy quite. (5) adverse reactions after administration of the two groups of patients comparison: 1 abdominal pain during the treatment, the experimental group, the control group during the medication three were nausea, rash 1, but the symptoms are mild, not addressed by the successful completion of the treatment, I not seen any adverse reactions. X ~ 2 test, the test group adverse reaction rate compared with the control group, a significant difference (P <0.05), the side effects of the experimental group was significantly less than the control group. Lower severity of the clinical symptoms of chronic cholecystitis Chinese medicine in patients with liver and lack of certificate and B YGLDG significantly reduced compared with the control group, total no significant differences in the efficiency of the treatment group with the control group the same efficacy . YGLDG during treatment had no significant effect on the electrocardiogram, and liver and kidney function, hematuria stool, only 1 abdominal pain, mild symptoms were not handling their own mitigation, the successful completion of treatment, indicating Liver choleretic particles suit the theory of traditional Chinese medicine, the treatment of liver yin deficiency with chronic cholecystitis is a safe and effective route of administration.