半夏调中颗粒治疗寒热错杂型非糜烂性反流病的临床疗效观察.pdf

2023年7 月第43卷第7 期Jul.2023Vol.43No.7临床研究本文引用：刘婉琪，舒磊，刘凡，刘嵩，张书，郭洁，时昭红。半夏调中颗粒治疗寒热错杂型非糜烂性反流病的临床疗效观察，湖南中医药大学学报，2 0 2 3，43(7)：12 7 3-12 7 7.半夏调中颗粒治疗寒热错杂型非糜烂性反流病的临床疗效观察湖南中医药大学学报Journal of Hunan University of Chinese Medicine1273刘婉琪 1,舒磊2*,刘凡,刘嵩,张书,郭洁,时昭红1.21.湖北中医药大学，湖北武汉430 0 6 5；2.武汉市中西医结合医院消化内科，湖北武汉42 0 0 2 0【摘要】目的观察半夏调中颗粒在寒热错杂型非糜烂性反流病（non-erosive refluxdisease,NERD)治疗中的临床疗效及其对高分辨率食管测压相关指标的改善情况。方法选取2 0 2 1年1月至2 0 2 2 年5月在武汉市中西医结合医院就诊的寒热错杂型NERD患者8 0 例，随机分为治疗组（半夏调中颗粒）及对照组（奥美拉唑联合伊托必利），治疗4周后，比较两组患者治疗前后中医症状积分、临床疗效及高分辨率食管测压相关数据包括食管下括约肌长度(lower esophageal sphincter length,LESL)、下食管括约肌静息压(loweresophageal sphincterpressure,LESP)、上食管括约肌静息压（upperesophageal sphincterpressure，U E S P)、远端收缩延迟时间(distal latency，D L)、收缩前沿速度（contractilefrontvelocity，CFV)和远端收缩积分(distal contractileintegral，D CI)的变化差异。结果治疗后，治疗组中主症胸骨后烧灼、反酸和次症食欲不振、神疲乏力、手足不温的中医症状积分较治疗前降低(P0.05),对照组中主症反酸、次症食欲不振的中医症状积分较治疗前降低(P0.05)。治疗组的总有效率与对照组比较,差异无统计学意义(P0.05)。治疗组治疗后高分辨率食管测压指标LESP、D CI、CFV较治疗前升高，差异有统计学意义(P0.05)；对照组治疗后LESP、D C I 较治疗前升高,差异有统计学意义(P0.05),治疗后组间比较显示，治疗组的CFV较对照组明显升高，差异有统计学意义(P0.05)。结论半夏调中颗粒在寒热错杂型NERD治疗中可有效改善患者的临床症状，同时调节食管体部运动功能，且安全性高，无明显不良反应。【关键词】半夏调中颗粒；非糜烂性反流病；寒热错杂证；高分辨率食管测压；食管动力；食管体部运动【中图分类号】R259文献标志码 B【文章编号 doi:10.3969/j.issn.1674-070X.2023.07.019Clinical efficacy observation of Banxia Tiaozhong Granule in treatingnon-erosive reflux disease with cold-heat complex patternLIU Wanqi,SHU lei?*,LIU Fan,LIU Song,ZHANG Shu,GUO Jie,SHI Zhaohong?1.Hubei University of Chinese Medicine,Wuhan,Hubei 430065,China;2.Department of Gastroenterology,Wuhan Hospital of Integrated Chinese and Western Medicine,Wuhan,Hubei 420020,ChinaAbstract Objective To observe the clinical efficacy of Banxia Tiaozhong Granule(BXTZG)in treating non-erosivereflux disease(NERD)with cold-heat complex pattern and its improvement of related indexes of high-resolution esophagealmanometry.Methods A total of 80 patients of NERD with cold-heat complex pattern in Wuhan Hospital of Integrated Chineseand Western Medicine from January 2021 to May 2022 were selected and randomly divided into treatment group(treated withBXTZG)and control group(treated with Omeprazole combined with Itopride).After 4 weeks of treatment,the changes of TCMsymptom scores,clinical eficacy and high-resolution esophageal manometry data including lower esophageal sphincter length(LESL),lower esophageal sphincter pressure(LESP),upper esophageal sphincter pressure(UESP),distal latency(DL),contractile收稿日期 2 0 2 3-0 2-15【基金项目】国家重点研发计划中医药现代化研究专项（2 0 19 YFC1709604）；武汉市卫生健康委员会科研项目（WZ20C03）。【第一作者 刘婉琪,女，硕士研究生,研究方向：中西医结合治疗消化系统疾病。【通信作者*舒磊，男，硕士，副主任医师，E-mail：w h y _s h u l e i 16 3.c o m。1274front velocity(CFV),and distal contractile integral(DCD)before and after treatment were compared between two groups.Results For treatment group,TCM symptom scores of the primary symptoms(poststernal burning and acid reflux)and thesecondary symptoms(loss of appetite,fatigue,and lack of warmth in the extremeties)after treatment were lower than thosebefore treatment(P0.05).For control group,TCM symptom scores of the primary symptom(acid reflux)and the secondarysymptom(loss of appetite)after treatment were lower than those before treatment(P0.05).Moreover,no significant difference was found inthe total effective rate between two groups(P0.05).For treatment group,the post-treatment high-resolution esophageal manometryindexes of LESP,DCI,and CFV were significantly higher than those before treatment(P0.05);for control group,LESP and DCIafter treatment were significantly higher than those before treatment(P0.05);however,the comparison of them between groups after treatment showedthat CFV of treatment group was significantly higher than that of control group(P0.05)。后期随访过程中，治疗组有2 例脱落,对照组有3例脱落。1.2诊断标准1.2.1西医诊断标准参照2 0 2 0 年中国胃食管反流病专家共识9：具有典型症状如烧心、反流等，或不典型症状如胸痛、暖气等；1个月内的内镜检查排除了食管黏膜损伤、巴雷特食管和恶性肿瘤等情况。1.2.2中医诊断标准参照胃食管反流病中西医结合诊疗共识意见（2 0 17 年）10 I中NERD寒热错杂证的中医辨证。主症：(1)胸骨后烧灼；(2)反酸；(3)胃皖隐痛;次症：(1)食欲不振；(2)神疲乏力；(3)肠鸣便糖；（4)手足不温。舌脉为舌红、苔白、脉弱。至少包括上述2 项主症和1或2 项次症。1.3纳入及排除标准1.3.1纳人标准（1)符合西医NERD诊断标准和中医NERD寒热错杂证诊断标准；(2)年龄18 6 5岁；(3)签署知情同意书并能遵循规定的服药及检查；(4)约2 周内未口服相关治疗药物,约1个月内存在相关症状。1.3.2排除标准（1)人选时近2 周内服用过促胃肠动力剂、抑酸剂等药物或曾行抗反流相关手术者；(2)有严重的全身疾病、不能配合者；(3)妊娠及哺乳期妇女。2023年第43卷1.4方法两组均予以健康宣教，不可进食如高脂、辛辣等食物，限酒,戒烟，控制体重。睡前3h避免进食，睡时枕头可抬高10 2 0 cm。1.4.1治疗组半夏调中颗粒（批号：鄂药制字2 0 0 5第Bz01-112号），组方如下：姜半夏10 g，黄连6 g，黄芩8 g,炮姜3g,太子参15g,甘草6 g,大枣10 g，杏仁10 g,厚朴10 g。冲服，1袋/次,3次/d,疗程为4周。1.4.2对照组奥美拉唑（规格：每片2 0 mg，批准文号：国药准字H20056577，悦康药业集团股份有限公司）,2 0 mg/次，2 次/d;伊托必利（规格：每片50 mg，批准文号：国药准字J20160075，上海雅培制药有限公司）,50 mg/次,3次/d。疗程为4周。1.5观察指标1.5.1中医症状积分及疗效评价于治疗前后,参照胃食管反流病中西医结合诊疗共识意见（2 0 17年）10 1中NERD寒热错杂证的主症与次症的评分标准。主症：(1)胸骨后烧灼；(2)反酸；(3)胃皖隐痛；次症：(1)食欲不振；(2)神疲乏力；(3)肠鸣便糖；(4)手足不温。主症记为0、2、4、6 分，次症记为0、1、2、3分，各症状积分进行组内及组间比较。于治疗后，参照其中的中医症状疗效评价指数计算方法，界定痊愈、显效、有效及无效。总有效率=(痊愈例数+显效例数+有效例数）/总例数10 0%。1.5.2高分辨率食管测压于治疗前后，采用高分辨率胃肠测压系统ManoScan360TM(Given Imaging公司,美国)测定，患者检查前禁食8 h,取坐位,将测压导管插人一侧鼻腔，视情况调整插入深度，显示屏上调整可显示食管近端和远端2 个高压带图像，确定胃腔内有1 3个压力通道,固定导管于鼻腔处。使用相应分析软件记录数值，10 min后记录食管基础压力水平，嘱患者吞咽5mL水10 次，固体食物（大小约为2 cmx2cmx2cm)10次，吞咽间隔应30 s，操作过程中与患者沟通配合。观察指标：(1)食