国医大师经验方清胃颗粒治疗难治性反流性食管炎的临床研究
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摘要
目的观察雷贝拉唑胶囊比较评价联合使用清胃颗粒治疗难治性反流性食管炎的疗效及其安全性。方法符合入组标准的难治性反流性食管炎的患者120例,随机进入治疗组与对照组,两组均服用雷贝拉唑胶囊1粒/次,2次/d,治疗组同时加用清胃颗粒1袋/次,2次/d,共8周,治疗结束评价疗效和安全性。结果治疗组在胃食管反流病症状频率表评价中总有效率为81.67%,中医症状、证候量表评价中总有效率为78.33%,对照组分别为58.33%、66.67%,两组比较差异有统计学意义(P<0.05);其中吐酸、烧心、心下烦治疗前后比较差异有统计学意义(P<0.01),疗效显著,但两组比较差异无统计学意义(P>0.05)。停药率两组分别为治疗组56.67%,对照组38.33%,两组比较差异有统计学意义(P<0.05);复发率显示治疗组44.12%,对照组73.91%,差异有统计学意义(P<0.05);不良反应发生率分别是6.67%,8.33%,差异无统计学意义(P>0.05)。结论(1)雷贝拉唑胶囊联合使用清胃颗粒可显著降低难治性反流性食管炎症状分级量表等各项评分;(2)雷贝拉唑胶囊联合使用清胃颗粒,停药率及复发率有显著下降;(3)清胃颗粒与雷贝拉唑胶囊均为临床使用安全的药物。
Objective To observe and comparably evaluate the effects and the safety of rabeprazole capsules in combination with qingwei granules in the treatment of refractory reflux esophagitis. Methods A total of 120 patients of refractory reflux esophagitis,in compliance with the inclusion criteria were randomized into a treatment group and a control group. The rabeprazole capsules were taken orally,1 capsule each time,twice a day in the two groups. Additionally,qingwei granules were taken,one bag each time,twice a day in the treatment group. Totally,the treatment lasted 8 weeks. At the end of treatment,the effects and safety were evaluated. Results In the treatment group,the total effective rate was 81. 67% in the evaluation of frequency scale for the symptoms of gastroesophageal reflux disease( FSSG); the total effective rate was78. 33% in the evaluation of TCM symptom and syndrome scale. They were 58. 33% and 66. 67% respectively in the control group. The differences were significant in comparison of the two groups( P < 0. 05). The differences were significant in terms of acid reflux,burning sensation in the stomach and discomfort in the stomach before and after treatment( P < 0. 01).The therapeutic effects were significant,but without statistical difference between the two groups( P > 0. 05). The drug withdrawal rate was 56. 67% in the treatment group and was 38. 33% in the control group,indicating the significant difference( P < 0. 05). The recurrence rate was 44. 12% in the treatment group and was 73. 91% in the control group,indicating the significant difference( P < 0. 05). The incidence rate of the adverse reaction was 6. 67% in the treatment group and was8. 33% in the control group,without significant difference( P > 0. 05). Conclusion 1. The combined medication of rabeprazole capsules and qingwei granules significantly reduces the score of each item in the symptom scale of refractory reflux esophagitis. 2. The combined medication significantly reduces the drug withdrawal rate and the recurrence rate. 3. Both qingwei granules and rabeprazole capsules are safe in the clinical treatment.
Objective To observe and comparably evaluate the effects and the safety of rabeprazole capsules in combination with qingwei granules in the treatment of refractory reflux esophagitis. Methods A total of 120 patients of refractory reflux esophagitis,in compliance with the inclusion criteria were randomized into a treatment group and a control group. The rabeprazole capsules were taken orally,1 capsule each time,twice a day in the two groups. Additionally,qingwei granules were taken,one bag each time,twice a day in the treatment group. Totally,the treatment lasted 8 weeks. At the end of treatment,the effects and safety were evaluated. Results In the treatment group,the total effective rate was 81. 67% in the evaluation of frequency scale for the symptoms of gastroesophageal reflux disease( FSSG); the total effective rate was78. 33% in the evaluation of TCM symptom and syndrome scale. They were 58. 33% and 66. 67% respectively in the control group. The differences were significant in comparison of the two groups( P < 0. 05). The differences were significant in terms of acid reflux,burning sensation in the stomach and discomfort in the stomach before and after treatment( P < 0. 01).The therapeutic effects were significant,but without statistical difference between the two groups( P > 0. 05). The drug withdrawal rate was 56. 67% in the treatment group and was 38. 33% in the control group,indicating the significant difference( P < 0. 05). The recurrence rate was 44. 12% in the treatment group and was 73. 91% in the control group,indicating the significant difference( P < 0. 05). The incidence rate of the adverse reaction was 6. 67% in the treatment group and was8. 33% in the control group,without significant difference( P > 0. 05). Conclusion 1. The combined medication of rabeprazole capsules and qingwei granules significantly reduces the score of each item in the symptom scale of refractory reflux esophagitis. 2. The combined medication significantly reduces the drug withdrawal rate and the recurrence rate. 3. Both qingwei granules and rabeprazole capsules are safe in the clinical treatment.
引文
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[8]刘芳,姚树坤,王慧芬,等.氟哌噻吨美利曲辛片联合常规方法治疗难治性反流性食管炎的临床研究[J].中日友好医院学报,2016,30(2):67-69.
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[10]袁增.埃索美拉唑、伊托必利与十六角蒙脱石联合治疗难治性反流性食管炎临床观察[J].中华临床医师杂志:电子版,2015,9(11):173-175.
[11]Salvatore Tolone,Giorgia Gualtieri,Edoardo Savarino,et al.Pre-operative clinical and instrumental factors as antireflux surgery outcome predictors[J].World J Gastrointest Surg,2016,8(11):719-728.
[12]朱生梁,李勇,朱晓燕,等.胃食管反流病证型研究[J].上海中医药杂志,2002,36(12):12-13.
[13]王代梅,曹泽伟.胃力康颗粒联合泮托拉唑治疗反流性食管炎的临床疗效观察[D].天津:天津中医药大学,2012.
[14]宋宏伟,朱凌云.和中健脾法治疗难治性反流性食管炎的临床疗效观察[J].上海:上海中医药大学,2012.
[15]苏林.血府逐瘀汤加减治疗难治性反流性食管炎37例[J].光明中医,2011,26(12):2477.
[16]王燕鸽.一贯煎加芍药甘草汤对慢性萎缩性胃炎患者胃黏膜影响研究[J].亚太传统医药,2016,12(12):132-133.
[17]陈艳,王盛丰,沈欢欢,等.元胡总碱对实验性大鼠胃黏膜损伤的保护作用[J].中国药理学与毒理学杂志,2015,29(5):825-830.
[2]刘文忠.2013年美国胃肠病学院胃食管反流病诊断和处理指南解读[J].胃肠病学,2013,18(4):193-199.
[3]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:124-128,134-138.
[4]张伯臾.中医内科学[M].5版.上海:上海科学技术出版社,1985:133-137.
[5]国家中医药管理局.ZY/T001.1-94中医病症诊断疗效标准[S].南京:南京大学出版社,1994:37.
[6]王亚洲,高会军,杨新民,等.抗焦虑抑郁药物对难治性胃食管反流病辅助治疗作用的临床研究[J].中国实用神经疾病杂志,2013,16(22):42-43.
[7]汤毓华.张作记行为医学量表手册[M].北京:中华医学电子音像出版社,2005:225-227.
[8]刘芳,姚树坤,王慧芬,等.氟哌噻吨美利曲辛片联合常规方法治疗难治性反流性食管炎的临床研究[J].中日友好医院学报,2016,30(2):67-69.
[9]杨健,陈高红,殷红霞,等.质子泵抑制剂加铝碳酸镁、百乐眠治疗难治性胃食管反流病的疗效观察[J].实用临床医药杂志,2014,18(24):133-134.
[10]袁增.埃索美拉唑、伊托必利与十六角蒙脱石联合治疗难治性反流性食管炎临床观察[J].中华临床医师杂志:电子版,2015,9(11):173-175.
[11]Salvatore Tolone,Giorgia Gualtieri,Edoardo Savarino,et al.Pre-operative clinical and instrumental factors as antireflux surgery outcome predictors[J].World J Gastrointest Surg,2016,8(11):719-728.
[12]朱生梁,李勇,朱晓燕,等.胃食管反流病证型研究[J].上海中医药杂志,2002,36(12):12-13.
[13]王代梅,曹泽伟.胃力康颗粒联合泮托拉唑治疗反流性食管炎的临床疗效观察[D].天津:天津中医药大学,2012.
[14]宋宏伟,朱凌云.和中健脾法治疗难治性反流性食管炎的临床疗效观察[J].上海:上海中医药大学,2012.
[15]苏林.血府逐瘀汤加减治疗难治性反流性食管炎37例[J].光明中医,2011,26(12):2477.
[16]王燕鸽.一贯煎加芍药甘草汤对慢性萎缩性胃炎患者胃黏膜影响研究[J].亚太传统医药,2016,12(12):132-133.
[17]陈艳,王盛丰,沈欢欢,等.元胡总碱对实验性大鼠胃黏膜损伤的保护作用[J].中国药理学与毒理学杂志,2015,29(5):825-830.