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Pu Yuan clinical research and treatment of gastric ulcer capsules


[Abstract] Objective To determine the daily 3.0g Pu Yuan and stomach capsule treatment of duodenal ulcer efficacy and safety. Methods A randomized, double-blind, double dummy, positive drug parallel controlled design, enrolled patients in a 2: 1 randomized to Pu Yuan and stomach capsule group (1.0g tid, 40 patients) or a control group rabeprazole (10mg / d, 40 Example) for 4 weeks. Results Pu Yuan and stomach capsules and rabeprazole patients can quickly relieve pain, acid reflux, nausea, vomiting, belching, bloating and other symptoms. Pu Yuan and stomach capsule group and rabeprazole group two weeks ulcer healing rates were 89.88% and 80.55%; 4 weeks healing rates were 95.67% and 90.11%, respectively, no statistically significant difference between the two groups. Conclusion daily 3.0g Pu Yuan and stomach capsule safe and effective treatment of duodenal ulcer, superior efficacy Bileibeila azole.

[Key words] duodenal ulcer; Pu Yuan and stomach capsule; treatment; security;

 

Duodenal ulcer (DU) is a common disease of Gastroenterology, drug therapy is still the preferred method currently used, Pu Yuan and stomach capsule Qingdao Huaren Pharmaceutical Co., Ltd. The new imperial pure Chinese medicine, according to the incidence of ulcer disease Features, Pu yuan and stomach capsule to liver and stomach, gas pain, remove saprophytic new for the law, on the one hand can inhibit gastric acid secretion, inhibiting and killing Helicobacter pylori; the other hand, can protect the gastric mucosa, improve the body's immunization, promote ulcers repair and regeneration. At the same time, reducing the development of drug resistance, effectively prevent recurrence. To observe Pu Yuan and stomach capsule treat DU efficacy and safety, and with Japan's Eisai rabeprazole compared the efficacy of enteric-coated tablets. Our hospital in May 2008 to December 2009 for the treatment of DU conducted clinical research, will now report the results as follows.

Materials and Methods

First, patient selection

1. Inclusion criteria: (1) 18-65 years of age, male or female; front (2) medication within 72h confirmed by endoscopy in patients with active duodenal ulcer; (3) the number of ulcer no more than two, maximum diameter ≤2.0cm, at least one ulcer diameter ≥0.3cm; (4) not to use other drugs to inhibit gastric acid within a week; (5) signed informed consent.

 

2. Exclusion criteria: (1) failure to rule out cancer, ulcers and cancer may ulcers (mild dysplasia were not excluded); (2) complex ulcer; gastrointestinal surgery (3) previous (excluding repair) ; (4) or esophageal varices; (5) Zhuo - Ellison syndrome (6) serious complications, such as pyloric obstruction, endoscopic bleeding events; (7) endoscopic pyloric stenosis hampered by; (8 ) esophageal erosion or ulceration; (9) severe gastrointestinal disease, such as Crohn's disease, ulcerative colitis; (10) has a serious heart, liver, lung, kidney, blood, endocrine system diseases; (11) pregnant or lactating women; (12) suffering from cancer and gastrin garnet (13) has a history of drug allergy research.

 

3. Exclusion criteria: (1) the failure to require medication; application (2) during the test other therapeutic drugs for acid-related symptoms (such as prokinetic agents, antacids, mucosal protective agents) and may affect the clinical drug drug or treatment observation.

 

Second, the test method

 

1. Experimental design: The test is a randomized, double blind simulation, positive drug parallel controlled design, enrolled patients in a 2: 1 ratio, divided into segments randomly divided experimental group and control group.

2. The method of administration and duration of treatment:; each group taking Japan Eisai rabeprazole enteric-coated tablets 10mg, test postprandial 30 minutes with warm water delivery service Pu Yuan and stomach 1.0g capsules three times a day, treatment 28d once a day, treatment 28d ..

 

Third, the clinical data

In this study, 80 cases of DU were enrolled, of which the test group of 40 patients in the control group of 40 patients, the test group of 25 males and 15 females; aged 18-65 years, mean (40.94 ± 10.64) years, the control group 32 males and females 8 patients aged 18-70 years, mean (41.44 ± 12.84) years old. When the two groups smoking and drinking situations and demographic data were not statistically significant. Course of the study, both groups were not taking medication combined impact test observations.

Fourth, the observed indicators and results recording

1. Basic situation of patients: patients before treatment should be recorded sex, age, height, weight, medical history, history and history of ulcer drugs, smoking and drinking habits.

2. OUTCOME MEASURES: (1) clinical symptoms: before treatment and medication after 2 and 4 weeks of follow-up record-related symptoms (including pain, burning, acid reflux, nausea, vomiting, belching and bloating) and score. Grading: asymptomatic 0; 1 minute with mild symptoms; symptoms (partially affected the daily life and work) 2 points; severe symptoms (affecting the daily life and work) 3 points. (2) endoscopy Rating: 3 days before the treatment, taking the first two weeks, four weeks into the endoscopy, a detailed record of ulcer locations, quantity, shape, size, and staged according Sakita and Miwa ulcers division method. First when endoscopy Rapid urease test; ulcer healing medication two weeks after the end of treatment no longer gastroscopy; check before and after the implementation of the same physician. (3) Laboratory tests: before treatment and 4 weeks of blood, urine, stool, and liver and kidney function tests.

3. adverse drug events: a detailed record of the entire course of the experiment and divided into adverse events, mild, moderate, and severe.

 

Fifth, the clinical criteria

1. Symptoms efficacy evalsuation criteria: (1) recovery: the symptoms score of 0; (2) markedly: by 2 points, but did not disappear; (3) Effective: 1 point reduction, but did not disappear; (4) is invalid: no score improvement or worsening. Healing rate = [(cured + number of cases markedly effective) / total cases] × 100%

2. gastroscopy evalsuation criteria: cured (S2): ulcers and inflammation around the disappeared; healing (S1): ulcer disappearance, there is still inflammation; Effective: ulcer size reduced by 50% or more; invalid: reduced ulcer size less than 50%. Healing rate = [(number of patients cured + number of cases healed) / total number of cases] × 100% (statistics two weeks, four weeks of healing and the healing rate). Check the first two weeks of healing in the first four weeks efficacy evalsuation, according to the assessment of recovery.

Sixth, drug safety assessment

  Adjusted downward between the adverse event associated with study drug related assessment is affirmative, it is possible, which may be irrelevant, certainly irrelevant. Certainly related, probably related, possibly related classified as adverse reactions.

Seven, statistically

Efficacy indicators using protocol analysis and intention to treat analysis. Before the test was used to compare two sets of data comparable Fisher exact test, t test and non-parametric statistical analysis and other methods. Experimental and control groups themselves using paired t test, ANOVA and non-parametric statistical methods. Comparison of experimental and control groups, measurement data using analysis of variance, classification and grading information considered CMH test method. Two-sided test, with a = 0.05 level of significance.

result

I. evalsuation

1. Comparison of the treatment groups changes in clinical symptoms: (1) improve the efficacy syndrome: two weeks Pu Yuan and stomach capsule syndrome significantly improve the efficiency of 90.11%, 94.58% efficiency, rabeprazole significant efficiency 82.44%, efficiency 94.27%; 4 weeks Pu yuan and stomach capsule syndrome significantly improve the efficiency of 90.6%, efficiency 97.68%, 90.72% rabeprazole significant efficiency, efficiency 95.82%; the two groups showed no significant difference (P> 0.05) . (2) a single symptom improvement effect: the two groups could improve pain, acid reflux, nausea, vomiting, belching, bloating and other symptoms; improvement of 2 weeks Pu Yuan bloating and stomach capsule group is better than rabeprazole group (P < 0.05) (Table 1).

2. After two endoscopic treatment efficacy evalsuation of comparison: taking 2 weeks and 4 weeks between the two groups no ulcer healing rate and the cure rate significant difference (P> 0.05), Table 2.

Second, safety evalsuation

  A total of 28 cases of drug-related adverse reactions. 13 cases of treatment group, 6.64% incidence of adverse reactions, 15 cases in the control group, 10.52% incidence of adverse reactions. Two groups, the correlation between the number of cases occurred, the type, degree of response, study drug adverse events, no significant difference. Pu Yuan common adverse reactions were diarrhea and stomach capsules 2.12% (2 cases), headache, dizziness, 2.12% (2 cases), rare adverse reactions are rash 0.80% (2 cases), abdominal distension 0.40% (1 case), dry mouth 0.40% (1 case), renal dysfunction 0.40% (one case of elevated blood urea nitrogen), palpitations 0.40% (1 case), prolonged menstrual 0.40% (1 case). Adverse events were mild to moderate, returned to normal after treatment, serious adverse events occurred.

                                  discuss

Peptic ulcer especially DU final formation is due to gastric acid / pepsin digestion of the mucosa itself caused by pepsin activity is dependent PH in PH> 4 loses activity, therefore investigate the pathogenesis of peptic ulcer when the acid treatment and the primary consideration, and to achieve the appropriate level of acid suppression time is the basis for the treatment of acid-related disease treatment. Clinical studies have shown Pu Yuan and stomach acid-suppressing effect of the capsule strong, 3 times a day, each 1.0g Pu Yuan and stomach capsule can quickly relieve pain associated with duodenal ulcers, acid reflux, nausea, vomiting, belching, bloating and other digestive symptoms, medication two weeks ulcer healing rate was 89.88%, four weeks ulcer healing rate was 95.67%, the cure rate was 91.42%. Pu Yuan and bad stomach capsule group reaction rate was 6.64%, the main adverse reactions include diarrhea, headache, dizziness, mild to moderate degree, without treatment can restore itself. In short Pu Yuan and stomach capsule Bileibeila azole has superior acid control and was well tolerated, with higher efficacy in the treatment of DU and acid-related diseases.

Table 12 Week is to improve the efficiency of the two groups of symptoms and the symptoms disappeared median time (d) Comparison

 

 

Group pain acid reflux, nausea and vomiting, abdominal distension and belching

The number of cases efficiency (%) number of cases of disappearance time efficiency (%) number of cases of disappearance time efficiency (%) number of cases rate (%) number of cases rate (%)

Pu Yuan and stomach capsule 32 90.27 430 91.56 318 90.36 25 96.6 29 85.8

Rabeprazole 30 90.11 316 85.9 424 97.1 26 84.3 23 70.9

Note: The number of patients each group the number of cases when the presence of the symptoms; a: two groups, p = 0.0344

 

 

Table 2 groups ulcer healing rate, recovery rate comparison

 

2 weeks 4 weeks

Group Cases healing rate (%) recovery rate (%) healing rate (%) recovery rate (%)

Pu Yuan and stomach 40 capsules 89.88 35.76 95.67 91.42

Rabeprazole 40 80.55 32.24 90.11 84.36


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