| Objective: By observing the clinical curative effect and safety of Chaishao tiaogan Decoction in the treatment of liver stagnation and spleen deficiency type diarrhea type irritable bowel syndrome, and exploring the mechanisms of Chaishao tiaogan Decoction from two aspects of theory and clinic, the purpose of the study was to provide new ideas for clinical treatment of the disease, basis of diagnosis and treatment as well as support.Methods:1 64 outpatient and inpatient at Hebei Province hospital gastroenterology departmentn from March 2013 to September 2014,who were diagnosed with irritable bowel syndrome by western medicine and liver stagnation and spleen deficiency type diarrhea in traditional Chinese medicine were divided into treatment group and control group by the principle of random and control, according to the doctor order and random number table method. There were 32 cases in the treatment group and 30 cases in control group.All patients had no obvious abnormality by electronic colonoscopy examination.The blood, urine, stool and occult blood test were normal, conforming to the study of the inclusion criteria, diarrhea type of IBS in western Roman Ⅲstandard diagnostic criteria.There were no significant statistical difference of the patients in the gender, age, course of the disease, illness and symptoms integral(P>0.05).2 Treatment: The treatment group were given Chinese medicine Chaishao tiaogan Decoction, which was fried in hebei traditional Chinese hospital. Control group were given western medicine Trimebutine Maleate Dispersible Tablets three times a day, and 200 mg at a time. Treatment for 2 months. The treatment course was 8 weeks.Patients were asked to stop taking other drugs during treatment, low fat, rich in protein and vitamins to the diet, avoid eating spicy cold stimulation and greasy food. Evaluated the effect after treatment. Observed and recorded the general condition, general physical examination project, routine tests of blood, urine and dung, heart, liver, kidney, and possible adverse reactions.3 Statistical analysis: Recorded the observation data before and after the treatment. Measurement data used mean and standard deviation(x—±s) for statistical description, count data used frequency, rate and so on for statistical description. Carried on the statistical analysis using SPSS13.0 software. Measurement data used t test or rank sum test, count data used chi-square test or rank sum test. For repeated measurement data, the first test of sphericity were to meet spherically symmetric, the repeated measures analysis of variance design information.Data that dissatisfied football symmetry, used multivariate analysis of variance. Pvalues taked on both sides, with P < 0.05 showing significant difference.Results:1 IBS-SSS total integral comparison in treatment group and control group before and after the treatment: IBS-SSS score in treatment group was 248.06±61.21 before the treatment, 153.28±51.02, 129.13±61.66, after the treatment one month, and end of the treatment, 104.75±47.18, 90.44±40.12 followed up for one month and two months. While data were 263.83±62.25, 204.90±42.4, 187.23±64.05, 171.83±62.37, 161.47±58.26 in control group. By comparison, two groups were statistically significant different(P<0.01). The curative effect in treatment group was better than the control group.2 IBS-SSS levels to improve evaluation in treatment group and control group before and after the treatment:11 cases in the treatment group were cured and 4 cases markedly effective, 14 cases effective, 3 cases invalid. The total effective rate was 90.62%; 4 cases in the control group were cured and 3 cases markedly effective, 14 cases effective, 9 cases invalid. The total effective rate was 70%. By rank-sum test, the difference was statistically significant between the two groups(P<0.05), the efficacy of the treatment group was better than that of the control group.3 Abdominal pain degree in the two group of each time point were compared. There were no statistically significant difference in 1 month of treatment, P>0.05. At the three points in the end of the treatment, follow-up1 month and 2 months, there was statistically significant difference in the aspect of improving the abdominal pain.4 The frequency of abdominal pain at each time point in two groups were compared. There was no statistically significant difference between one month of the treatment and end of the treatment. While there was statistically significant difference betweens the follow-up 1 month and the follow-up 2 months with P<0.05.5 Degree of two groups of abdominal distention integral at each point was compared, P<0.05, which indicated that, the treatment group was superior to the control group in the improvement of the degree of abdominal distention in the four time points.6 Defecation satisfaction of two groups at each point was compared, P<0.05, which showed that, the treatment group was superior to the control group in the improvement of the defecation satisfaction in the four time points.7 Impact on the life of the integral of two groups at each point was compared, P<0.05, which showed that, the treatment group was superior to the control group in the improvement of impact on the life of the integral at the four time points.8 Safety observation: There was no adverse reaction and laboratory abnormalities associated with the drug.Conclusion:1 Chaishao tiaogan Decoction can significantly decrease the IBS-SSS total score, the degree of abdominal pain in IBS symptoms severity scale, frequency of abdominal pain, abdominal distension, defecation satisfaction and the influence of the entry points of life in the treatment of liver stagnation and spleen deficiency type diarrhea type irritable bowel syndrome. It can significantly improve the abdominal pain, abdominal distension, bowel movement, the impact of life and other symptoms, and can improve curative effect.2 Chaishao tiaogan Decoction is better than Trimebutine Maleate in improving the total efficiency.3 There were no specific adverse events and laboratory test happened, showing that it is effective and safe. |
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