粪菌移植联合美沙拉嗪治疗大肠湿热型溃疡性结肠炎临床研究
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摘要
[目的]观察粪菌移植联合美沙拉嗪治疗大肠湿热型活动期溃疡性结肠炎的临床疗效。[方法]选择中医辨证为大肠湿热型的活动期溃疡性结肠炎患者30例,随机分为粪菌移植联合美沙拉嗪组(观察组)及安慰剂联合美沙拉嗪组(对照组)2组,在治疗前、治疗后2周、治疗后4个月观察2组改良Mayo评分、中医证候评分及C反应蛋白(CRP)、血沉(ESR)的变化情况,以减分值评定疗效,并对观察组和对照组的血常规、肝肾功能等指标进行观察,治疗中的不良反应进行记录。[结果]观察组治疗后2周、治疗后4个月Mayo评分及中医证候积分下降值均优于对照组(Z_2周_(Mayo)=-2.208,Z_4月_(Mayo)=-2.02,Z_2周中医=-2.029,Z_4月中医=-2.15,P<0.05),观察组治疗后2周CRP及ESR下降值均优于对照组(Z_(CRP)=-2.118,Z_(ESR)=-2.118,P<0.05),治疗后4个月观察组CRP下降值优于对照组(Z=-1.986,P<0.05),ESR下降值对比无差异(Z=-1.879,P>0.05)。2组天门冬氨酸氨基转移酶(ALT)、门冬氨酸转移酶(AST)、肌酐(CR)、尿素氮(BUN)、白细胞(WBC)、血红蛋白(HGB)前后比较差异无统计学意义(Z_(HGB)=-1.828,T_(WBC)=1.676,Z_(CR)=-0.442,Z_(BUN)=-0.965,ZALT=-1.416,Z_(AST)=-0.032,P>0.05)。[结论]粪菌移植联合美沙拉嗪可有效治疗大肠湿热型活动期溃疡性结肠炎,其疗效优于单药美沙拉嗪,且无明显不良反应,安全性高。
[Objective]To observe the clinical efficacy of fecal microbiota transplantation combined with mesalazine in treatment of active ulcerative colitis with intestinal moist heat syndrome type.[Methods]Thirty active ulcerative colitis patients with TCM syndrome type of intestinal moist heat are randomly divided into feces transplantation combined with mesalazine and placebo combined with mesalazine group.Before treatment,after 2 weeks of treatment and after 4 months of treatment,the changes of modified Mayo scores,TCM syndrome scores,C-reactive protein,and ESR were observed to evaluate the efficacy of score reduction,at the same time,we observe the blood routine,liver and kidney function in observation group and control group.[Results]The Mayo score and the decrease in TCM syndrome scores in the observation group after 2 weeks and 4 months of treatment were all better than those in the control group.The decrease in CRP and ESR in the observation group was better than that in the control group after 2 weeks of treatment(P<0.05).The decrease in CRP in the observation group was better than that in the control group after 4 months of treatment(P<0.05).But there was no difference in the ESR decrease between the two groups(P>0.05).There was no significant difference in liver and kidney function,white blood cells,red blood cells,and electrocardiogram between the two groups(P<0.05).[Conclusion]Fecal microbiota transplantation combined with mesalazine can effectively treat the active intestinal ulcerative colitis with intestinal moist heat syndrome type and reduce the index of inflammatory activity.The curative effect is better than that of the single drug mesalazine,and is relatively safe.
[Objective]To observe the clinical efficacy of fecal microbiota transplantation combined with mesalazine in treatment of active ulcerative colitis with intestinal moist heat syndrome type.[Methods]Thirty active ulcerative colitis patients with TCM syndrome type of intestinal moist heat are randomly divided into feces transplantation combined with mesalazine and placebo combined with mesalazine group.Before treatment,after 2 weeks of treatment and after 4 months of treatment,the changes of modified Mayo scores,TCM syndrome scores,C-reactive protein,and ESR were observed to evaluate the efficacy of score reduction,at the same time,we observe the blood routine,liver and kidney function in observation group and control group.[Results]The Mayo score and the decrease in TCM syndrome scores in the observation group after 2 weeks and 4 months of treatment were all better than those in the control group.The decrease in CRP and ESR in the observation group was better than that in the control group after 2 weeks of treatment(P<0.05).The decrease in CRP in the observation group was better than that in the control group after 4 months of treatment(P<0.05).But there was no difference in the ESR decrease between the two groups(P>0.05).There was no significant difference in liver and kidney function,white blood cells,red blood cells,and electrocardiogram between the two groups(P<0.05).[Conclusion]Fecal microbiota transplantation combined with mesalazine can effectively treat the active intestinal ulcerative colitis with intestinal moist heat syndrome type and reduce the index of inflammatory activity.The curative effect is better than that of the single drug mesalazine,and is relatively safe.
引文
[1]李明松,朱维铭,陈白莉.溃疡性结肠炎-基础研究与临床实践[M].北京:高等教育出版社,2015:17-17.
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[3] Nishida A,Inoue R,Inatomi R,et al.Gut microbiota in the pathogenesis of inflammatory bowel disease[J].Clin J Gastroenterol,2018,11(1):1-10.
[4] Alka Goyal,Andrew Yeh,Brian R,et al.Safety,Clinical Response,and Microbiome Findings Following Fecal Microbiota Transplant in Children With Inflammatory Bowel Disease[J].Inflamm Bowel Dis,2018,24(2):410-421.
[5](东晋)葛洪.肘后备急方(2卷)[M].天津:天津科技出版社,2000:36.
[6]陈立亚,袁柏思,韦成,等.粪便钙卫蛋白对溃疡性结肠炎镜下活动及严重程度的评估价值[J].医学研究生学报,2018,31(3):294-299.
[7]炎症性肠病诊断与治疗的共识意见(2012年·广州)[J].胃肠病学,2012,17(12):763-781.
[8]张声生,沈洪,郑凯,等.溃疡性结肠炎中医诊疗专家共识意见(2017)[J].中华中医药杂志,2017,32(8):3585-3589.
[9]郑筱萸.中药新药临床研究指导原则(试用)[M].北京:中国医药科技出版社,2002.
[10]张俊美,孙滨滨,张秀.肠道微生态重建与粪菌移植[J].现代医药卫生,2017,33(10):1472-1474.
[11]Sheehan D,Shanahan F.The gut microbiota in inflammatory bowel disease[J].Gastroenterol Clin North Am,2017,46(1):143-154.
[12]Van Nood E,Vrieze A,Nieuwdorp M,et al.Duodenal infusion of donor feces for recurrent Clostridium difficile[J].New England Medicine,2013,368(5):407-415.
[13]Narula N,Kassam Z,Yuan Y,et al.Systematic Review and Meta-analysis:Fecal Microbiota Transplantation for Treatment of Active Ulcerative Colitis[J].Inflamm Bowel Dis,2017,23(10):1702-1709.
[14]Kelly CR,KahnS,Kashyap P,et al.Update on fecal microbiota transplantation 2015:indications,methodologies,mechanisms,and outlook[J].Gastroenterology,2015,149(1):223-237.
[15]赵妍,李海波.基于古今文献金汁及人中黄考析[J].辽宁中医药大学学报,2015,17(4):92-93.
[16](清)汪昂.本草备要[M].北京:中国中医药出版社,1998:283-283.
[17]许建峰,王英絮,田彤,等.中药金汁与粪菌移植的异同[J].中华中医药杂志,2017,32(8):3414-3416.
[18]谢冠群,朱飞叶,侯晓丽,等.从粪便移植疗法话中医金汁[J].中华中医药杂志,2015,30(6):1907-1909.
[19]中华医学会消化病分会炎症性肠病学组.炎症性肠病诊断与治疗的共识意见[J].中华消化杂志,2018,38(5):292-311.
[20]Magro F,Gionchetti P,Eliakim R,et al.Third European Evidence-Based Consensus on Diagnosis and Management of Ulcerative Colitis.Part 1:Definitions,diagnosis,extra-intestinal manifestations,pregnancy,cancer surveillance,surgery,and ileo-anal pouch disorders[J].J Crohns Colitis,2017,11(6):649-670.
[21]Narula N,Kassam Z,Yuan Y,et al.Systematic Review and Meta-analysis:Fecal Microbiota Transplantation for Treatment of Active Ulcerative Colitis[J].Inflamm Bowel Dis,2017,23(10):1702-1709.
[22]Iqbal U,Anwar H,Karim M A.Safety and efficacy of encapsulated fecal microbiota transplantation for recurrent Clostridium difficile infection:a systematic review[J].Eur J Gastroenterol Hepatol,2018,30(7):730-734.
[23]Costello SP,Soo W,Bryant RV.et al.Systematic review with meta-analysis:faecal microbiota transplantation for the induction of remission for active ulcerative colitis[J].2017,46(3):213-224.
[24]Kump P K,Gr9chenig H P,Lackner S,et al.Alteration of intestinal Dysbiosis by Fecal MicrobiotaTransplantation Does not Induce Remission inPatients with Chronic Active Ulcerative Colitis[J].Inflamm Bowel Dis,2013,19(10):2155-2165.
[25]Paramsothy S,Kamm M A,Kaakoush N O,et al.Multidonor intensive faecal microbiota transplantation foractive ulcerative colitis:a randomised placebo-controlled trial[J].Lancet,2017,389(10075):1218-1228.
[26]Wang S,Xu M,Wang W,et al.Systematic Review:Adverse Events of Fecal Microbiota Transplantation[J].PLoS One,2016,11(8):e0161174.
[2] Sartor R B.Microbial influences in inflammatory bowel diseases[J].Gastroenterology,2008,134(2):577-594.
[3] Nishida A,Inoue R,Inatomi R,et al.Gut microbiota in the pathogenesis of inflammatory bowel disease[J].Clin J Gastroenterol,2018,11(1):1-10.
[4] Alka Goyal,Andrew Yeh,Brian R,et al.Safety,Clinical Response,and Microbiome Findings Following Fecal Microbiota Transplant in Children With Inflammatory Bowel Disease[J].Inflamm Bowel Dis,2018,24(2):410-421.
[5](东晋)葛洪.肘后备急方(2卷)[M].天津:天津科技出版社,2000:36.
[6]陈立亚,袁柏思,韦成,等.粪便钙卫蛋白对溃疡性结肠炎镜下活动及严重程度的评估价值[J].医学研究生学报,2018,31(3):294-299.
[7]炎症性肠病诊断与治疗的共识意见(2012年·广州)[J].胃肠病学,2012,17(12):763-781.
[8]张声生,沈洪,郑凯,等.溃疡性结肠炎中医诊疗专家共识意见(2017)[J].中华中医药杂志,2017,32(8):3585-3589.
[9]郑筱萸.中药新药临床研究指导原则(试用)[M].北京:中国医药科技出版社,2002.
[10]张俊美,孙滨滨,张秀.肠道微生态重建与粪菌移植[J].现代医药卫生,2017,33(10):1472-1474.
[11]Sheehan D,Shanahan F.The gut microbiota in inflammatory bowel disease[J].Gastroenterol Clin North Am,2017,46(1):143-154.
[12]Van Nood E,Vrieze A,Nieuwdorp M,et al.Duodenal infusion of donor feces for recurrent Clostridium difficile[J].New England Medicine,2013,368(5):407-415.
[13]Narula N,Kassam Z,Yuan Y,et al.Systematic Review and Meta-analysis:Fecal Microbiota Transplantation for Treatment of Active Ulcerative Colitis[J].Inflamm Bowel Dis,2017,23(10):1702-1709.
[14]Kelly CR,KahnS,Kashyap P,et al.Update on fecal microbiota transplantation 2015:indications,methodologies,mechanisms,and outlook[J].Gastroenterology,2015,149(1):223-237.
[15]赵妍,李海波.基于古今文献金汁及人中黄考析[J].辽宁中医药大学学报,2015,17(4):92-93.
[16](清)汪昂.本草备要[M].北京:中国中医药出版社,1998:283-283.
[17]许建峰,王英絮,田彤,等.中药金汁与粪菌移植的异同[J].中华中医药杂志,2017,32(8):3414-3416.
[18]谢冠群,朱飞叶,侯晓丽,等.从粪便移植疗法话中医金汁[J].中华中医药杂志,2015,30(6):1907-1909.
[19]中华医学会消化病分会炎症性肠病学组.炎症性肠病诊断与治疗的共识意见[J].中华消化杂志,2018,38(5):292-311.
[20]Magro F,Gionchetti P,Eliakim R,et al.Third European Evidence-Based Consensus on Diagnosis and Management of Ulcerative Colitis.Part 1:Definitions,diagnosis,extra-intestinal manifestations,pregnancy,cancer surveillance,surgery,and ileo-anal pouch disorders[J].J Crohns Colitis,2017,11(6):649-670.
[21]Narula N,Kassam Z,Yuan Y,et al.Systematic Review and Meta-analysis:Fecal Microbiota Transplantation for Treatment of Active Ulcerative Colitis[J].Inflamm Bowel Dis,2017,23(10):1702-1709.
[22]Iqbal U,Anwar H,Karim M A.Safety and efficacy of encapsulated fecal microbiota transplantation for recurrent Clostridium difficile infection:a systematic review[J].Eur J Gastroenterol Hepatol,2018,30(7):730-734.
[23]Costello SP,Soo W,Bryant RV.et al.Systematic review with meta-analysis:faecal microbiota transplantation for the induction of remission for active ulcerative colitis[J].2017,46(3):213-224.
[24]Kump P K,Gr9chenig H P,Lackner S,et al.Alteration of intestinal Dysbiosis by Fecal MicrobiotaTransplantation Does not Induce Remission inPatients with Chronic Active Ulcerative Colitis[J].Inflamm Bowel Dis,2013,19(10):2155-2165.
[25]Paramsothy S,Kamm M A,Kaakoush N O,et al.Multidonor intensive faecal microbiota transplantation foractive ulcerative colitis:a randomised placebo-controlled trial[J].Lancet,2017,389(10075):1218-1228.
[26]Wang S,Xu M,Wang W,et al.Systematic Review:Adverse Events of Fecal Microbiota Transplantation[J].PLoS One,2016,11(8):e0161174.