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▎Editor of WuXi AppTec content team
In recent years, fecal flora transplantation has attracted much attention, and there have been many research reports
Recently, The Lancet Gastroenterology & Hepatology published the team of Professor Qin Huanlong, Professor Li Ning, Professor Chen Qiyi of the Colorectal Specialty/Intestinal Microecology Diagnosis and Treatment Center of Shanghai Tenth People's Hospital, as well as a follow-up study of a large sample of fecal flora transplantation by the Shanghai Tongji FMT Working Group, which confirmed the long-term safety of fecal flora transplantation in the treatment of a variety of intestinal diseases in China, and innovatively proposed.
Screenshot credit: The Lancet Gastroenterology & Hepatology
In the study, 8547 patients who had received fecal flora transplantation in Shanghai Tenth People's Hospital for gastrointestinal diseases were selected and followed up
Adverse reactions are generally unserious and transient
Most patients develop adverse reactions about 2 weeks after treatment, and the incidence varies from route of administration to patients
Most of these adverse effects are mild to moderate, occur briefly, and then disappear
▲Figure 1: Incidence of adverse reactions after 2 weeks of treatment with different routes of administration (screenshot source: reference [1])
There was no increase in new symptoms and disease
In the 5th year of follow-up, 1034 patients were found to have new symptoms or confirmed new diseases, mainly digestive tract diseases and respiratory diseases
Safety standards escort
At the same time, the research team also proposed the "Tongji fecal microbiota transplantation safety specification", through informed consent, strict donor screening management, transplant bacteria liquid safety management, patient transplantation suitability assessment, transplantation route safety, transplant process emergency handling plan, from 6 dimensions to improve the safety
▲Figure 2: Tongji fecal flora transplantation safety specifications (screenshot source: reference [1])
The researchers said that since 2015, fecal flora transplantation treatment began to be widely used in clinical practice, for the sake of operational technology implementation safety and other factors, a sound national clinical and patient safety data collection system may be a long-term work