The Research Of Clinical Effect Evaluation About Helicobacter Pylori Associated Gastritis By Hua Zhuo Jie Du Traditional Chinese Medicine Combined With Standard Triple Therapy

Objective: Helicobacter pylori(Hp)is a clear pathogenic factor of chronic gastritis,peptic ulcer and cancer of stomach.Eradication of Hp can improve the cure rate of Hp related diseases and reduce the recurrence.This research selects the quadruple therapy with bismuth,the standard triple therapy with Jing Hua Wei Kang and the standard triple therapy with Hua Zhuo Jie Du Traditional Chinese Medicine.By making observation on Hp eradication rate,symptoms,drug adverse reactions,we aim at exploring an effective HPAG treatment.Methods: 150 cases of eligible subjects were randomly divided into three groups,accroding to the inclusion criteria,50 per group.Group A(the quadruple therapy with bismuth)was given the standard triple therapy with Bismuth Potassium Citrate Granules 220 mg Bid,and the course was 14 days.Group B(the standard triple therapy with Jing Hua Wei Kang)was given the standard triple therapy with Jing Hua Wei Kang 2 pills Tid,and the course was 14 days.Group C(the standard triple therapy with Hua Zhuo Jie Du Traditional Chinese Medicine)was given the standard triple therapy with Hua Zhuo Jie Du Traditional Chinese Medicine one dose twice a day,and the course was 14 days.Before and after treatment,routine laboratory tests(blood,urine,stool routine examination,liver and kidney function,ECG)should be performed for security.During the treatment,we should observe the general situation(Heart rate,Breathing,Blood pressure,etc),clinical symptoms,compliance,adverse reactions in patients.In order to observe the Hp eradication rate,14C-Urea breath test(14-UBT)should be reviewed in 4 weeks after the drug was stopped.To evaluate the therapeutic effect,we observed clinical symptom score changes with the method of filling in the questionnaire and telephone follow-up before and after treatment.Finally,adverse reactions should be compared among the three groups.Results:1 In the eradication of Hp aspects: Hp eradication rates by intention-totreat(ITT)analysis in three groups were 78.0%,76.0%,80.0%,respectively;by per-protocol(PP)analysis were 81.3%,76.0%,81.6%,respectively.There was no statistically significant difference between three groups by above two methods of analysis(P(29)0.05).2 The clinical curative effect: The total effective rate of Group C was 95.9%,Group B was 86.0% and Group A was 66.7%.The difference between three groups is statistical significant(P(27)0.05),and each of two is statistical significant(P<0.0167).3 The improvement of clinical symptoms: The difference between three groups is statistical significant in improving the stomach bloating,pain,nausea/vomiting,belching,acid reflux/heartburn,etc(P(27)0.05);Group C is significantly greater than Group B and A(P(27)0.05),there is no statistically significance between Group A and B(P(29)0.05).4 The adverse reactions: During the treatment,the incidence of adverse reactions of group A,B and C were respectively 25.0%,20.0% and 4.1%.The difference between three groups is statistical significant(P(27)0.05).Incidence of group A is higher than that of Group B,but no statistical difference(P>0.0167);incidence of group A is significantly higher than that of Group C,the difference is statistically(P<0.0167);incidence of group B is significantly higher than that of Group C,the difference is statistically(P<0.0167).Conclusions:1 Three kinds of treatment are effective in respect of Hp eradication,and quite effective.2 Compared with the quadruple therapy with bismuth and standard triple therapy with Jing Hua Wei Kang,standard triple therapy with Hua Zhuo Jie Du Traditional Chinese Medicine showed obvious advantages in improving clinical curative effect and clinical symptoms.3 The method of standard triple therapy with Hua Zhuo Jie Du Traditional Chinese Medicine can significantly reduce the incidence of adverse reactions.4 Compared with the quadruple therapy with bismuth,standard triple therapy with Jing Hua Wei Kang showed obvious advantages in improving clinical curative.5 Recommended to use the method of standard triple therapy with Hua Zhuo Jie Du Traditional Chinese Medicine,for it has an advantage on treating HPAG.