1.Clinical data collection
1.1 General data
All 60 cases were inpatients and outpatients with UC in Yueyang Traditional Chinese Medicine Hospital, Hunan, China, from February 2011 to October 2012, and were randomly divided into 2 groups using the random number method. Single-blind method was observed. In the treatment group, there were 30 cases, including 18 males and 12 females; age ranged from 21 to 62 years, with a mean of (34.72±10.22) years; the shortest duration of disease was 3 months and the longest was 12 years, with a mean of (5.3±4.25) years. In the control group, there were 30 patients, including 17 males and 13 females, aged 18-66 years, with the shortest duration of 10 months and the longest duration of 11 years, with a mean of (5.26±3.78) years. the differences in gender, age, duration of disease and degree of disease between the two groups were not statistically significant (P>0.05) and were comparable.
1.2 Diagnostic criteria
The diagnostic criteria were referred to the Clinical Research Guidelines for the Treatment of Chronic Non-specific Ulcerative Colitis with New Chinese Medicines formulated by the Ministry of Health in 1993 [3] and the diagnostic criteria formulated by the National Academic Conference on Digestive Diseases of the Chinese Medical Association in Hangzhou in 1978.
1.3 Inclusion criteria
(i) Diagnosis was confirmed by colonoscopy and pathological biopsy;
②The clinical type belonged to patients with chronic recurrent type of UC in active stage;
③Diarrhea less than 6 times a day, abdominal pain, mucus stool, pus and blood stool, urgency, abdominal distension, bowel sounds, no obvious fever and water and electrolyte disorders;
④There is a damp-heat type in the large intestine according to Chinese medicine;
⑤ Age 18-68 years;
⑥Sign the informed consent form.
1.4 Exclusion criteria
①People under 18 years of age or over 68 years of age, women during pregnancy or lactation;
②Heavy ulcerative colitis or those with moderate fever and water and electrolyte disorders;
③Patients with serious primary diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic system, and psychiatric patients;
(4) Those who did not meet the inclusion criteria, did not follow the prescribed treatment, could not judge the efficacy or had incomplete data, etc., which affected the judgment of efficacy.
2. Methods
2.1 Experimental drug preparation.
120g of Huanglian, 240g of Huangqi, 60g of rhubarb, 120g of red peony, 120g of cinnamon were pounded and then decocted with Huangdan and condensed into medicinal flesh, and then the flesh was spread on the dressing sheet with bamboo sticks. It is supervised by the Department of Pharmacy of Yueyang City Hospital of Traditional Chinese Medicine.
During the treatment period of the above 2 groups, stop using all Chinese and Western medicines related to this disease, pay attention to rest, regulate the mood, low fiber and high nutrition diet, avoid smoking, alcohol, spicy and cold food.
2.2 Treatment methods.
2.1 Treatment group.
Select foot San Li, Shen Que and Spleen Yu as the first group of acupuncture points, and Zhong Gu, Tian Shu and Large Intestine Yu as the second group of acupuncture points, one group at a time, alternating between the two groups of acupuncture points, and apply intestinal healing cream to the acupuncture points once a day, removing after 6 hours, 30 days as a course of treatment.
2.2 Control group.
Oral administration of salazosulfapyridine, 3 times daily, from 0.5g each time in increments of 0.25g to 2g in the first week, 2g each time in the second week, and decreasing 0.25g to 1g each time in the third week, for a course of 30 consecutive days.
2.3 Observation indexes
2.3.1 Clinical symptoms in Chinese medicine
Main symptoms.
①Prolonged diarrhea, stool with pus and blood or mucus stool;
(ii) post-acute weight;
(iii) abdominal pain;
④Red tongue, yellowish coating and slippery pulse.
Secondary symptoms.
①Anal burning, foul-smelling stools;
② abdominal distension and intestinal tinnitus;
(iii) body heat;
④ short and red urine.
The symptoms were scored before and after treatment, and the main symptoms were scored as 0, 2, 4 and 6 for asymptomatic, mild, moderate and severe respectively, while the secondary symptoms were scored as 0, 1, 2, 3 and 4 for asymptomatic, mild, moderate and severe respectively.
2.3.2 Electronic colonoscopy
The examination was performed once before and after treatment, and recorded according to the modified Baron endoscopic UC activity grading standard: Grade 0 is no congestion, edema, erosion and ulceration of colonic mucosa; Grade I is mild congestion, edema, no or mild erosion, no or scattered distribution of ulcers, the number of less than 3; Grade II is moderate congestion, edema, moderate erosion or with bleeding, scattered distribution of ulcers greater than or equal to 3; Grade III is severe The grade III is severe congestion, edema, severe erosion, obvious bleeding when touched, more ulcers distribution, surface covered with pus moss, according to its degree, counted 0, 1, 2, 3 points respectively.
2.3.3 Pathological examination
The examination was performed once before and after treatment, and recorded with reference to the grading method: Grade 0 is no obvious inflammation, no crypt abscess or destruction of mucosal epithelium; Grade Ⅰ is mild inflammation with congestion and edema; Grade Ⅱ is moderate inflammation with congestion and edema, disorganized vascular texture, increased inflammatory cells, but intact mucosal epithelium; Grade Ⅲ is severe inflammation with acute and chronic inflammatory cell infiltration, abscess crypt and superficial mucosal ulcer formation. According to its severity grade Ⅰ, grade Ⅱ and grade Ⅲ were scored 0, 1, 2 and 3 respectively.
2.3.4 Safety indicators
Routine blood, urine and stool examinations, liver and kidney functions were checked regularly before and after treatment.