Irritable bowel syndrome with predominant diarrhea (IBS-D), characterized by chronic and recurrent diarrhea and abdominal pain associated with defecation, is a common subtype of irritable bowel syndrome (IBS) in China, which seriously affects the quality of patient life.Previous investigation showed that Xingpi capsule is effective in the treatment of IBS but lacks clinical research evidence to provide reference for rational drug use.This study adopted a patient-centered prospective design, and systematically collected and analyzed population characteristics, disease improvement after taking Xingpi capsule in a real clinical diagnosis and treatment environment, as well as patient satisfaction and other information.The aim is to provide realworld evidence for rational drug use by clinicians and to provide reference for the design of clinical research elements for validation study of Xingpi capsule for IBS-D treatment in the absence of clinical evidence.This study observed and analyzed 28 symptom scores, major symptom group scores, gastrointestinal symptom rating scale(GSRS) scores and adverse events of 326 patients treated with Xipi capsule from Oct 2021 to Oct 2022.The results were as follows.Patients with IBS-D were more female than male (about 1.35 times), the proportion of young patients was relatively high (52.76%), and 90.80% of the patients were treated with Xingpi capsule alone.On the first day of treatment, the total symptom score, the major symptom cluster score and the insomnia symptom score were significantly improved (P<0.001), the GSRS score was significantly improved on the third day (P<0.001).Among the 326 patients, 99.08% were satisfied with the therapeutic effect of Xingpi capsule, and 6 (1.84%) had adverse events, including 1 case of nausea, 2 cases of stomach discomfort, 1 case of constipation, 1 case of dry mouth, and 1 case of upper abdominal discomfort.All six patients experienced discomfort within three days of taking the capsule, and discomfort disappeared after two to three days of continuing taking the pill.After 14 days of observation, Xingpi capsule could be used to treat young, middle-aged and elderly IBS-D; and clinical single drug effect was good.It could improve gastrointestinal symptoms such as diarrhea, abdominal pain, esophageal reflux and abnormal stool in patients with IBS-D, and treat the main symptoms of IBS-D within 2 days, with good safety and high patient satisfaction.
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