| Background:Acid-related diseases are caused by hyperacidity, including gastroesophageal reflux disease (GERD), peptic ulcer, acute gastric mucosal lesions and functional dyspepsia, et al. Common clinical symptoms are acid regurgitation, epigastric pain, epigastric discomfort, upper abdominal burning or distension. With the accelerated pace of life, lifestyle changes and dietary adjustments, acid-related disease incidence increased year by year in the world. The purpose of the treatment of such diseases is to eliminate or alleviate the symptoms, and promote the growth and repair of mucosal injury. Clinicians pay more and more attention to the diagnosis, treatment, rational use of drugs of such diseases, and it has become a research hotspot in recent years. PPI is the most potent acid-suppressing drugs, which suppress the final part of acid secretion of parietal cells, has become the first choice in the treatment of acid-related diseases, with a wide range of clinical applications. With the development of society, patients need the rapid relief of symptoms, oral calcium carbonate suspension can quickly neutralize stomach acid, relieve abdominal pain, abdominal discomfort, acid regurgitation, heartburn and other symptoms caused by the hyperacidity, but the reports about oral calcium carbonate suspension in treatment of acid-related diseases is still small. So it is necessary to evaluate the efficacy and safety of oral calcium carbonate suspension in treatment of acid-related diseases.Objective To study the efficacy and safety of oral calcium carbonate suspension in rapid relief of symptoms with acid-related diseases compared to the PPI (omeprazole).Methods:A multi-center, randomized and controlled trial was designated for 400 patients with at least one of the moderate or severe symptoms (including acid regurgitation, epigastric pain, epigastric discomfort, upper abdominal burning or distension), aged from14 to 70 years. They were equally randomized into two groups and treated with oral calcium carbonate suspension (hereinafter referred to as the treatment group) and the omeprazole enteric-coated tablets (hereinafter referred to as the control group). The time of the efficeny appeared after therapy for each symptom, the ease rate of acid regurgitation, epigastric pain, epigastric discomfort, upper abdominal burning or distension on the third day and seventh day were recorded. And record adverse events in patients, and determine their degree of correlation with the test drugs.Results:The average onset time of each symptom for the treatment group was significantly faster than the control group (P<0.05); All symptoms (including acid regurgitation, epigastric pain, epigastric discomfort, upper abdominal burning or distension) were significant improved after 3 days and 7 days treatment (P<0.05), The symptoms of epigastric pain after 3 days and upper abdominal burning after 7 days of the treatment group were significant improved than the control group(P< 0.05), but for the other symptoms there were no significant difference(P>0.05).The improvement rate was 57.22% and the effective rate was 69.05% after 3 days treatment for the treatment group, and the improvement rate was 78.55% and the effective rate was 92% after 7 days treatment. The improvement rate was 59.73% and the effective rate was 72.5% after 3 days treatment for the control group, and the improvement rate was 78.82% and the effective rate was 96.5% after 7 days treatment.There was no significant difference between treatment group and control group on day 3 and day 7 in improvment rate (P>0.05). There were no significant differences in effective rate (P>0.05).14 cases of mild adverse reactions,2 cases with moderate adverse reactions and no severe adverse reactions occured in treatment group,10 cases of mild adverse reactions, no moderate adverse reactions and no severe adverse reactions occured in control group.There was no significant difference in safety between treatment group and control group (P>0.05).Conclusions:The onset time of the treatment group was significantly faster than the control group. Oral calcium carbonate suspension is a safe and effective medical reparation in treatment of symptoms in acid-related diseases. |
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