Clinical Study of Tiaozhong Granule on the Treatment Effect on Reflux Esophagitis
|School||Hubei College of Traditional Chinese Medicine|
|Course||Traditional Chinese Medicine|
|Keywords||@ tiaozhong granule / TCM therapy reflux esophagitis clinical research|
Objective:To observe tiaozhong granule on effect of the treatment and anti-recurrence on reflux esophagitis(RE).Methods:84 RE patients of the First Hospital of Wuhan City conformed with the inclusive criteria from 2006-03 to 2007-05 were elected,according to numeration table patients randomized into the treatment group(44 cases)and the control group(40 cases).The treatment group take tiao zhong granule orally,6g each time half an hour befor meal,tid;The control group was treated orally with motilium 10mg,tid,both groups take omeprazole,20mg,qm at the same time,the course of treatment was 8 weeks.Blood、urine、faeces,liver and renal function、blood sugar、blood lipids、electrocardiogram and other conventional index were detected before and after treatment to all cases;refer reflux diagnostic questionnaire(RDQ)to score the frequency and severity of heartburn、regurgitate、un-cardiogenic chest pain and sour regurgitation to give a curative effect valuation of clinical symptoms before and after treatment; score the TCM symptoms and compared two groups of Chinese medicine card type curative effect;all the cases were arranged gastroscopy to carry out endoscopic classification and integral evaluation before and after treatment;fasting venous blood was taken to determine levels of gastrin before and after treatment;16 weeks after drug withdrawal to follow up changes in symptoms of recovery cases with clinical symptom and curative effect,observing recurrence situation. Results:(1)The number of participants:follow-up telephone links,and other methods,84 patients were all entered the final analysis.(2)Differences between two groups of patients with general information of comparison:Ridit analysis of the two groups in the number of cases,gender,age and course of disease showing the two groups were comparable(P>0.05).(3)Clinical curative effect comparison post-treatment:the treatment group of 44 cases,cured 18 cases,15 cases markedly effective, effective in 8 cases,3 cases invalid,and the total efficiency is 93.18 percent;the control group of 40 cases,cured 12 cases,14 cases markedly effective,effective in 8 cases,3 case of invalid,and the total efficiency is 85.00 percent.By X~2 test,the total efficiency of comparison after treatment showing there were significant(P<0.05).(4)Symptom score comparison before and after treatment:the two groups after treatment symptom score was significantly lower than prior treatment,by t-test the difference was significant(P<0.01);after treatment between the two groups the symptom score comparison showing the difference was significant(P<0.05).(5)TCM Symptom score comparison before and after treatment:the two groups after treatment TCM symptom score was significantly lower than prior treatment,by t-test the difference was significant(P<0.01); after treatment between the two groups the TCM symptom score comparison showing the difference was significant(P<0.05).(6)Two groups of Chinese medicine card type curative effect comparison:Tiaozhong granule is superior to splenic asthenia and pneuma stagnant type、incoordination between the liver and stomach type、coldheat complex type(P<0.05),short of stagnation of liver-QI heat-transmission type、fluid in stomach asthenic(P>0.05)。 (7)The effects and classification of endoscopy before and after treatment:two groups before treatment RE grading and the severity extent by Ridit analysis showing the difference was not significant(P＞0.05); after treatment 0 grade cases were significantly increased,Ⅲgrade cases were 0;see table 9.The treatment group of 44 cases cured 26 cases(59.09 percent),effective in 15 cases(34.09%),invalid 3 cases(6.82%),the total efficiency of 93.18 percent while the control group of 40 patients cured 23 cases(57.5%),effective in 25 cases(32.5%),invalid 4 cases (10%)and the total efficiency was 90 percent.Gastroscopy effect comparison in groups inside after treatment by Ridit analysis showing the differences were significant(P＞0.01).(8)Levels of blood gastrin(GhS)comparison before and after treatment:GAS levels increased after treatment in two groups,the treatment group compared with the control group the difference was significant(P＜0.05).(9)Recurrence situation comparisionbetween two groups:16 weeks after drug withdrawal the treatment group of 18 patients with cured therapeutic effect recurred 1 cases,the recurrence rate was 5.6 percent; the control group 12 cases in 4 cases of recurrence,the recurrence rate was 33.33 percent.By x~2 test,the difference was very significant(P＜0.01).(10)Security observation:two groups of patients with no apparent adverse effects,patients can tolerate to complete testing,there were no cases because of serious adverse reactions interrupted treatment. Blood、Urine、faeces,liver and renal function、blood sugar、blood lipids、electrocardiogram and other conventional index were detected before and after treatment,the results showed that the checks were in the normal range and found no abnormal changes. Conclusion:Tiaozhong granule can reduce reflux esophagitis in patients with symptoms of integration,improve the clinical symptoms,has a significant effect;can significantly improve the esophageal mucosal inflammation and promote healing of esophagitis;increase blood GAS levels;and has no significant adverse reactions and poison-side effects,having better security.Tiaozhong granule combined with omeprazole has a better role to motilium combined with omeprazole,having a lasting effects of treatment and obviously anti-recurrence which is better than western medicine treatment.