| Functional Constipation(FC) is one of the most common and multiple digestive system diseases. Because of the aging of social and changes of lifestyle and diet habit, the incidence of constipation among the population increases gradually. The etiology and the mechanism of the disease are complex and remain unclear. It may be related to several factors such as diet, exercise, lifestyle, heredity, psychology, intestinal neuroendocrine abnormalities and pelvic floor dysfunction. For the longer duration of illness, intractable functional constipation influences patients' quality of life and psychological state negatively and increases the financial burden to societies. A great number of drugs are used to treat this disease in clinical practice, but many patients with intractable functional constipation do not response well to these drugs. Long-time use of stimulant laxative has made many patients dependent on drugs severely and even leads to melanosis coli or carcinogenesis. Therefore, it is of great importance to find a new safe and effective intervention to intractable functional constipation.ObjectiveThe aim of this study is to evaluate the clinical efficacy of a combination of fecal microbiota transplantation(FMT) and polyethylene glycol electrolyte powder(PEG) for patients with intractable functional constipation. Bristol stool form scale(BSFS) and self-rating KESS clinical constipation symptoms scale are measured for therapeutic efficacy evaluation; PAC-QOL is scored for life quality assessment; SAS and SDS are used for indicators of mental health. Through analysis of the above-mentioned scales before and after the treatment, it provides the evaluation of clinical efficacy and safety of the combination of FMT and PEG for treatment of intractable functional constipation.Method Patients who met inclusion criteria were randomly assigned to groups that either underwent FMT after receiving polyethylene glycol electrolyte or were given only polyethylene glycol electrolyte(control). The control group was given polyethylene glycol electrolyte powder(2 bags of A and 2 bags of B were dissolved in 250 ml warm water, take for 2 times per day). The treatment group underwent FMT after receiving the same polyethylene glycol electrolyte treatment, and 300 ml liquid of fecal microbiota was delivered via gastroscopy every three days(three times in total). During this process, on the day when FMT was performed, PEG was forbidden to use. The course of the treatment for the two groups lasted 4 weeks respectively. In addition, during the experiment period, two groups of the patients were not allowed to take other medicines that may have therapeutic effects for constipation or increase gastrointestinal motility. If the patients do not defecate more than three days, glycerine enema was recommended as auxiliary for defecation. Finally, the scores of BSFS, KESS, PAC-QOL, SAS and SDS were used to evaluate the improvements of symptoms, life quality and mental conditions of both groups before the treatment and after the treatment, which should be followed with a careful analysis of the statistics for the final judgment.Result 1. There was no significant difference between the scores of BSFS, KESS, PAC-QOL, SAS and SDS of the FMT group and control group before treatment(P>0.05).2. 60 cases of functional constipation were enrolled. There were 23 cases of mixed constipation, 3 cases of slow transit constipation, 4 cases of outlet obstructive constipation in the treatment group. And there were 24 cases of mixed constipation, 1 case of slow transit constipation, 5 cases of outlet obstructive constipation in the control group. There was no significant difference between the treatment group and control group before treatment(P>0.05).3. There was a significant improvement(P<0.05) of the BSFS, KESS, PAC-QOL, SAS and SDS scores for both groups after the treatment, which indicated that both the treatment group and the control group can improve the situation of patients' excrement, abate patients' constipation symptoms, make patients' live better and comfort patients' psychological state.4. In four weeks' treatment, compared with the control group, the treatment group has a significant difference statistically in terms of scores of BSFS, KESS, PAC-QOL, SAS and SDS, whose value of P was 0.035, 0.021, 0.01, 0.001 and 0.045 respectively, which indicated that the treatment group takes an advantage in improving patients' excrement and constipation, as well as their quality of life and psychological state.5. After the treatment, the analysis of the comprehensive curative efficacy of the two groups shows: total effective rate of the treatment group was 83.3%, while the control group was 53.3%. The discrepancies between the two groups have a statistical meaning(c2 =6.873, P=0.031).6. Adverse reactions: in the process of the treatment, two groups of patients did not have adverse reactions. In the treatment group, one patient had abdominal bloating, diarrhea, nausea, and increasing exhaust, but on the second day these symptoms disappeared immediately without fever and stomachache. In the control group, two of the patients had endurable abdominal bloating, thus there were no special treatment. Until the second week, these symptoms fundamentally vanished and had no influence on the experiment process.Conclusion Combination of Fecal microbiota transplantation and polyethylene glycol electrolyte powder can improve the symptoms of the patients with intractable functional constipation,alleviate the constipation-related symptoms, improve the patients' quality of life, and relieve their mental problems such as anxiety and depression. FMT combined with polyethylene glycol should be a reasonable choice to treat intractable functional constipation for its efficacy and safety. |
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