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目的粪便移植已被证明在治疗难治性艰难梭菌感染方面有效,但是实际应用中面临的困难和安全性的顾虑阻碍了其在临床中的广泛应用。本研究目的是评价粪便移植的安全性及其对复发性艰难梭菌感染相关性腹泻的缓解效果。用于粪便移植的可以口服的冰冻粪便胶囊由经过筛选的健康志愿者捐赠粪便制成。方法 2013年8月到2014年6月期间美国波士顿麻省总医院开展一项非双盲、单组、初步可行性研究。纳入20例患者,一种是有3次或以上的轻度到中度艰难梭菌感染表现,且经过6~8周的万古霉素治疗无效,另一种是有2次或以上的因重度艰难梭菌感染住院,年龄介于11~89岁,中位年龄64.5岁。捐献粪便的志愿者要经过筛选。用于移植的胶囊储存在-80℃条件下。患者在连续2天内服用15颗胶囊,然后追踪症状缓解情况和6个月内不良反应情况。主要结局指标包括安全性(通过2级或以上的不良反应来评价)和临床症状缓解且8周内不复发。次要指标包括患者主观感觉良好程度和每天排便次数。结果没有观察到由粪便移植引起的严重不良反应。粪便移植1个疗程后,14例(70%)症状缓解(95%CI:47%~85%)。6例无明显缓解,但是经过第2疗程后,4例缓解。总共18例(90%)患者腹泻明显缓解(95%CI:68%~98%)。患者治疗前排便次数平均5次/天,治疗3天后减少到2次/天(P=0.001),8周后减少到1次/天(P<0.001)。结论本研究利用经筛选的志愿者粪便制成的胶囊进行粪便移植治疗复发性艰难梭菌感染,粪便移植安全有效,但只是初步研究,仍需要更大的研究来评价粪便移植的安全性和有效性。
The purpose of faecal transplantation has been shown to be effective in the treatment of refractory C. difficile infections, but the practical difficulties and safety concerns hindered its widespread use in the clinic. The purpose of this study was to evaluate the safety of faecal transplants and their efficacy in alleviating recurrent C. difficile infection-associated diarrhea. Oral ice manure capsules for fecal transplants are made by donating faeces from selected healthy volunteers. Methods From August 2013 to June 2014, a non-double-blind, single-group, preliminary feasibility study was conducted at the Massachusetts General Hospital in Boston, Mass. 20 patients were enrolled, one with mild-to-moderate C. difficile infection with 3 or more episodes and ineffective with vancomycin 6 to 8 weeks and the other with 2 or more severe Clostridium difficile infection hospitalized, aged between 11 to 89 years old, the median age of 64.5 years old. Volunteers who donate their feces should be screened. Capsules for transplantation were stored at -80 ° C. The patient took 15 capsules for two consecutive days and then tracked for symptom relief and adverse events within 6 months. The primary outcome measures included safety (assessed by grade 2 or higher adverse reactions) and clinical symptoms were relieved and no recurrence occurred within 8 weeks. Secondary indicators include the patient’s subjective feeling of well-being and the number of bowel movements per day. As a result, no serious adverse reactions caused by fecal transplants were observed. Fourteen patients (70%) had symptom relief (95% CI: 47% -85%) after a course of excretion. No significant relief was seen in 6 cases, but after the second course of treatment, 4 cases were relieved. In a total of 18 patients (90%), diarrhea was significantly relieved (95% CI: 68% -98%). The average number of bowel movements was 5 times / day before treatment, 2 times / day after 3 days of treatment (P = 0.001) and once / 8 weeks (P <0.001). CONCLUSIONS: This study, using screened volunteers’ capsules for fecal transurethral resection of recurrent Clostridium difficile infections and faecal transplants, is safe and effective but only preliminary studies are still needed to evaluate the safety and effectiveness of faecal transplants Sex.