生物反馈与六磨汤联用治疗功能性便秘气秘证临床研究

Clinical study of biofeedback combined with oral Liumo Decoction in the treatment of functional constipation and qi constipation syndrome

目的评价生物反馈与六磨汤联用治疗功能性便秘(functional constipation,FC)气秘证疗效。方法将符合入选标准的2018年1月-2019年12月北京市肛肠医院120例FC气秘证患者采用随机数字表法分为2组,每组60例。对照组给予生物反馈治疗,观察组在对照组基础上口服六磨汤。2组均治疗4周。分别于治疗前后进行中医证候评分,于静息状态下测定肛管静息压(resting anal pressure,RAP),用力收缩肛门测定肛管最大自主收缩压(anal maximalcontraction pressure,AMCP),保持放松状态并向直肠气囊内注入气体记录直肠感觉阈值(rectal sensation threshold,RST)及直肠最大耐受量(rectal maximum tolerance,RMT);采用双抗体夹心ELISA法及免疫比浊法检测血清P物质、NO水平;记录不良事件,评价临床疗效。结果观察组总有效率为89.3%(50/56)、对照组为64.4%(38/59),2组比较差异有统计学意义(χ^(2)=9.90,P=0.002)。治疗后,观察组中医证候评分低于对照组(t=-15.36,P<0.01);RAP[(48.31±4.15)mmHg比(53.64±5.46)mmHg,t=-5.88]、RST[(30.14±3.17)ml比(35.42±3.12)ml,t=-9.00]、RMT[(154.21±15.27)ml比(160.61±16.38)ml,t=-2.16]低于对照组(P<0.05),AMCP[(156.67±15.62)mmHg比(132.26±13.21)mmHg,t=9.07]高于对照组(P<0.01);P物质高于对照组(t=9.08,P<0.01),NO低于对照组(t=-6.58,P<0.01)。2组治疗期间均未发生严重不良事件。结论生物反馈与六磨汤联用可有效缓解FC气秘证患者的临床症状,改善肛门直肠动力学指标,调节肠神经递质水平,疗效确切且安全性较好。

Objective To explore the curative effect of biofeedback combined with oral Liumo Decoction on functional constipation(FC)and qi constipation syndrome.Methods According to random number table method,120 patients with FC of qi constipation meeting inclusion criteria in BeijingRectumHospitalwere divided into two groups between January 2018 andDecember 2019,60 in each group.The control group was treated with biofeedback,while the observation group was additionally treatedwith oral LiumoDecoction.Allwere treated for 4weeks.Before and after treatment,TCM syndromes were scored and recorded.The resting anal pressure(RAP)was detected.The anal maximal contraction pressure(AMCP)was detected by forced systolic anus.In relaxation status,gas was injected into rectal balloon to record the rectal sensation threshold(RST)and rectal maximum tolerance(RMT).The levels of serum substance P and NO were detected by double-antibody sandwich ELISA and immunoturbidimetry.The adverse events were recorded,and clinical curative effect was evaluated.Results The differences in total response rate between the observation group and the control group was statistically significant[89.3%(50/56)vs.64.4%(38/59)](χ2=9.90,P=0.002).After treatment,scores of TCM syndromes in observation group was significantly lower than that of the control group(t=-15.36,P<0.01).After treatment,the RAP[(48.31±4.15)mmHg vs.(53.64±5.46)mmHg,t=-5.88],RST[(30.14±3.17)ml vs.(35.42±3.12)ml,t=-9.00]and RMT[(154.21±15.27)ml vs.(160.61±16.38)ml,t=-2.16]in observation group were significantly lower than those in the control group(P<0.05),while AMCP[(156.67±15.62)mmHg vs.(132.26±13.21)mmHg,t=9.07]was significantly higher than that of the control group(P<0.01).After treatment,the substance P in observation groupwas significantly higher than that of the control group(t=9.08,P<0.01),whileNOwas significantly lower than that of the control group(t=-6.58,P<0.01).There were no serious adverse events during treatment in either group.Conclusion Biofeedback combined with oral Liumo Decoction can alleviate clinical symptoms,improve anorectal dynamics indexes and regulate levels of entericneurotransmitters inpatientswithFCofqi constipationwithsafety.