加味左金丸合膈肌生物反馈法治疗胃食管反流病的作用研究
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摘要
胃食管反流病(gastroesophageal reflux disease,GERD),是指胃内容物反流入食管引起不适症状和(或)并发症的一种疾病。GERD是临床常见慢性病,全球不同地方的患病率不同。其发生机制主要是食管抗反流防御机制减弱和反流物对食管粘膜的攻击作用增强,具体病因不详。对患者生活质量影响明显。目前国内外GERD的治疗主要是采用抑酸药物治疗。中医药治疗GERD有着长期的经验,GERD在中医属于“反酸”、“噎醋”、“胸痹”、“咳嗽”等范畴。
研究目的:通过随机对照研究,评价中药加味左金丸(左金丸与半夏泻心汤合方)结合膈肌生物反馈训练治疗胃食管反流病的治疗作用。
将可纳入病例随机分为治疗组(加味左金丸结合膈肌生物反馈训练)和西药组,治疗结束后,统计二组在临床症状、胃肠动力学指标等的疗效差异。
方法:2007年3月至2008年3月广东省中医院消化专科门诊病人,连续入组首诊的原发性GERD患者,年龄18-65岁,一周内停服药物检查治疗。对照组PPI组给予泮托拉唑胶囊(40mg/日);治疗组PPI联合膈肌生物反馈治疗组在应用中药治疗同时进行膈肌反馈训练(2次/日,15-20min/次)。治疗组患者每周一次到医院在医生指导下进行反馈训练。观察反流症状、生活质量、抗反流药物使用情况、食管动力监测检查。
在基线期行电子胃镜、食管测压及24小时食管pH测定,治疗前后采用五分法使用GERD健康相关生活质量调查量表(GERD-HRQL)评估患者生活质量。在基线期、治疗第4、8周后进行。采用三分法评估患者治疗前后症状,包括4个主要症状,分别为烧心、反酸、反食和胸骨后疼痛,3个食管外症状,分别为咳嗽、气短、口中异味,在基线期、治疗第4、周8周后进行。食管动力检查参数:在基线、治疗第8周后进行。采用牵拉式,4方位测定LES压力、膈脚静息张力。所有数据用SPSS11.0统计软件进行统计分析。
结果:两组资料年龄、性别、病程、BMI、中医证型分布、主要症状分布等比较均无显著性差异(P＞0.05)。87例GERD患者中肝胃不和型13例(14.94%),肝胃郁热型60例(68.97%),痰气交阻型10例(11.49%),脾胃虚弱型4例(4.6%)。
1.对GERD患者临床症状的影响
基线期治疗组症状程度和频度积分为8.37±1.64,对照组为8.24±1.89,治疗8周后症状总积分治疗组为1.14±0.72,对照组为1.26±0.95,p＞0.05,从统计学讲两组患者在临床症状方面没有明显的差异。但两组患者都可明显改善患者的临床症状,且治疗组症状改善下降了86.38%,对照组下降了84.71%,治疗第4周、第8周和基线期比较均有显著性差异。
2.对GERD患者健康相关生活质量的影响
GERD对患者健康相关生活质量的影响较大,GERD-HRQL主要研究患者在烧心、反酸、胸痛、吞咽不适等食管内症状的变化,腹胀、饮食习惯的变化,及对治疗的依从性方面。在治疗四周后两组均可改善患者健康相关生活质量,但两者并无明显差异,治疗八周后,治疗组6.1±3.50,下降幅度更大,对照组10.4±5.94,p＜0.05,两组有明显统计学意义,可能与中药治疗组在对腹胀和吞咽不适感的改善更加明显有关。
3.对GERD患者食管动力及膈脚的影响
治疗八周后,两组的LESP分别为:治疗组2.13±0.34mmHg,对照组2.09±0.61,p＞0.05;在膈脚压力方面,治疗组吸气末为35.18±6.74mmHg,对照组为8.43±2.017mmHg,p＜0.01,两组有统计学差异中药加膈肌生物以馈训练综合治疗可明显提高患者治疗前后的膈脚压力,从而提高了EGJ抗反流的屏障功能。
4.对GERD患者临床总疗效的影响
治疗八周后治疗组显效26例(60.47%),有效14例(32.56%),无效3例(6.98%),总有效率为(显效+有效)93.02%;对照组显效23例(52.27%),有效16例(36.36%),无效5例(11.36%),总有效率为(显效+有效)88.64%;经ridit分析,p＞0.05,两组无统计学差异。
结论:
1.GERD的中医病因方面,肝胃郁热是主要发病因素,胃气上逆是其主要病机。
2.中药加味左金丸合膈肌生物反馈训练可显著改善GERD患者健康相关生活质量,提高EGJ处膈脚的吸气末基础压,两组在改善患者主要症状及临床总疗效的短期疗效方面(八周)无明显差异,加味左金丸合膈肌生物反馈训练能够治疗GERD患者。
Gastroesophageal reflux disease(GERD)refers to the reverse movement of gastric contents from the stomach or duodenum to the esophagus and produces symptoms and complications within esophagus or extra-esophagus.It's a common and chronic disease that can limit daily activities.
The pathophysiologieal mechanism closely linked to the lower esophageal sphincter and distal esophageal body motility disfunction.The cause of the abnomal mitility in reflux disease is unknown.Not only there are great regative impacts,but also it can lead in much economic affording to treat GERD.
AIM:
This study aimed to investigate therapeutic effect of jiaweizuojinwan and diaphragma biofeedback training on GERD.Following studies were carried out.(1)To observe the distribution of syndrome types of GERD,To explore and Investigate the basic types of syndromes and Certificate Type Law of Traditional Chinese Medicine of GERD.(2)To evaluate.the change of the main Symptoms noted by using a scoring system and the scores by using GERD-HRQL At 4 and 8 weeks after treatment.(3)To inquiry the esophageal motility including hESP(Pressure of lower esophageal sphincter,LESP)and Tension of diaphragmic crural at resting.(4)To evaluate the clinical effectiveness jiaweizuojinwan and diaphragma biofeedback training on GERD.
METHODS:
87 subacute patients with GERD cases undergoing gastroscopy and 24-h pH monitoring,ranging in age from 18 to 65,were classified randomly into observed group and control group,43 patients in the treatment group took jiaweizuojinwan and diaphragma biofeedback training while the control group treated by pantoprazole capsule 20 mg qd p.o,between March 2007 and March 2008,in the GI Endoscopy and Manometry Laboratory of the Guangdong Provincial TCM Hospital.main symptom scores and the scores by using GERD-HRQL of two groups were performed in baseline phase and at 4 and 8 weeks weeks after treatment,Esophageal motility in baseline phase and at 8 weeks weeks treatment. All data of esophageal manometry and pH monitoring were recorded using the MMS Solar GI and ORIONⅡPM Device(Medical Measurement System B.V,The Netherlands)and were analyzed with MMS software,the distal pHsensor of the monitoring catheter is positioned 5 cm above the proximal border of the lower esophageal sphincter(LES).TCM Diagnostic Criteria of GERD According to Luo yunjuan and Yu shanyan.SPSS 11.0 statistical software were used for statistics,analysis and evaluation.
RESULTS:
There was no significant difference on age,sex,BMIand cardinal symptoms distribution between two groups(p＞0.05).TCM patterns distribution of 87 patients with GERD:13 cases of liver-stomach disharmony syndrome between (14.94%),60 cases of liver-stomach heat syndrome(68.97%),10 cases of pleen-hypofunction and reverse qi syndrome(11.49%),4 cases of deficiency of spleen and stomach(4.6%).There were 39 cases of NERD,3 cases of RE,1 case of BE in the treatment group,and 40 cases of NERD,4 cases of RE,0 case of BE in the control group(p＞0.05)。
1.The effectiveness on the Clinical symptom scores:Clinical symptom scores reduced from 8.37±1.64.in the baselina to 1.14±0.72(86.38%)at 8 weeks after treatment(p＜0.05)in the treatment group,from 8.24±1.89 in the baselina to 1.26±0.95(84.71%)at 8 weeks after treatment in the control group (p＜0.05).but there were no significant difference in clinical symptom scores between the two groups at 8 weeks after treatmen(p＞0.05).
2.The effectiveness on the health-related quality of life:scores of HRQL in the the treatment group reduced from 39.4±10.1 in the baselina to 6.1±3.50at 8 weeks after treatment(p＜0.05),from 39.1±12.2 in the baselina to 10.4±5.94 at 8 weeks after treatment in the control group(p＜0.05).and there were significant difference in scores of HRQL between the two groups at 8 weeks after treatmen(p＜0.05).
3.The effectiveness on the LESP and Tension ofdiaphragmic crural at resting:LESP of two groups were similar in the baseline and at 8 weeks after treatmen.The tension of crural diaphragm at resting in the the treatment group was quite higher than in the control group(P＜0.05).
4.The clinical efficacy rate:According to the standardization Total effective rate in the treatment group and the control group was 93.02%and 88.64%,respectively.No significant difference was found between the two roups after Ridit analysis.
CONCLUSIONS:
1.The type of liver-stomach heat is main TCM syndrome of GERD.
2.Jiaweizuojinwan and diaphragma biofeedback training holds therapeutic effects on patients with GERD by strengthening the esophageal anti-reflux barrier and enhancing the quality of life.
研究目的:通过随机对照研究,评价中药加味左金丸(左金丸与半夏泻心汤合方)结合膈肌生物反馈训练治疗胃食管反流病的治疗作用。
将可纳入病例随机分为治疗组(加味左金丸结合膈肌生物反馈训练)和西药组,治疗结束后,统计二组在临床症状、胃肠动力学指标等的疗效差异。
方法:2007年3月至2008年3月广东省中医院消化专科门诊病人,连续入组首诊的原发性GERD患者,年龄18-65岁,一周内停服药物检查治疗。对照组PPI组给予泮托拉唑胶囊(40mg/日);治疗组PPI联合膈肌生物反馈治疗组在应用中药治疗同时进行膈肌反馈训练(2次/日,15-20min/次)。治疗组患者每周一次到医院在医生指导下进行反馈训练。观察反流症状、生活质量、抗反流药物使用情况、食管动力监测检查。
在基线期行电子胃镜、食管测压及24小时食管pH测定,治疗前后采用五分法使用GERD健康相关生活质量调查量表(GERD-HRQL)评估患者生活质量。在基线期、治疗第4、8周后进行。采用三分法评估患者治疗前后症状,包括4个主要症状,分别为烧心、反酸、反食和胸骨后疼痛,3个食管外症状,分别为咳嗽、气短、口中异味,在基线期、治疗第4、周8周后进行。食管动力检查参数:在基线、治疗第8周后进行。采用牵拉式,4方位测定LES压力、膈脚静息张力。所有数据用SPSS11.0统计软件进行统计分析。
结果:两组资料年龄、性别、病程、BMI、中医证型分布、主要症状分布等比较均无显著性差异(P＞0.05)。87例GERD患者中肝胃不和型13例(14.94%),肝胃郁热型60例(68.97%),痰气交阻型10例(11.49%),脾胃虚弱型4例(4.6%)。
1.对GERD患者临床症状的影响
基线期治疗组症状程度和频度积分为8.37±1.64,对照组为8.24±1.89,治疗8周后症状总积分治疗组为1.14±0.72,对照组为1.26±0.95,p＞0.05,从统计学讲两组患者在临床症状方面没有明显的差异。但两组患者都可明显改善患者的临床症状,且治疗组症状改善下降了86.38%,对照组下降了84.71%,治疗第4周、第8周和基线期比较均有显著性差异。
2.对GERD患者健康相关生活质量的影响
GERD对患者健康相关生活质量的影响较大,GERD-HRQL主要研究患者在烧心、反酸、胸痛、吞咽不适等食管内症状的变化,腹胀、饮食习惯的变化,及对治疗的依从性方面。在治疗四周后两组均可改善患者健康相关生活质量,但两者并无明显差异,治疗八周后,治疗组6.1±3.50,下降幅度更大,对照组10.4±5.94,p＜0.05,两组有明显统计学意义,可能与中药治疗组在对腹胀和吞咽不适感的改善更加明显有关。
3.对GERD患者食管动力及膈脚的影响
治疗八周后,两组的LESP分别为:治疗组2.13±0.34mmHg,对照组2.09±0.61,p＞0.05;在膈脚压力方面,治疗组吸气末为35.18±6.74mmHg,对照组为8.43±2.017mmHg,p＜0.01,两组有统计学差异中药加膈肌生物以馈训练综合治疗可明显提高患者治疗前后的膈脚压力,从而提高了EGJ抗反流的屏障功能。
4.对GERD患者临床总疗效的影响
治疗八周后治疗组显效26例(60.47%),有效14例(32.56%),无效3例(6.98%),总有效率为(显效+有效)93.02%;对照组显效23例(52.27%),有效16例(36.36%),无效5例(11.36%),总有效率为(显效+有效)88.64%;经ridit分析,p＞0.05,两组无统计学差异。
结论:
1.GERD的中医病因方面,肝胃郁热是主要发病因素,胃气上逆是其主要病机。
2.中药加味左金丸合膈肌生物反馈训练可显著改善GERD患者健康相关生活质量,提高EGJ处膈脚的吸气末基础压,两组在改善患者主要症状及临床总疗效的短期疗效方面(八周)无明显差异,加味左金丸合膈肌生物反馈训练能够治疗GERD患者。
Gastroesophageal reflux disease(GERD)refers to the reverse movement of gastric contents from the stomach or duodenum to the esophagus and produces symptoms and complications within esophagus or extra-esophagus.It's a common and chronic disease that can limit daily activities.
The pathophysiologieal mechanism closely linked to the lower esophageal sphincter and distal esophageal body motility disfunction.The cause of the abnomal mitility in reflux disease is unknown.Not only there are great regative impacts,but also it can lead in much economic affording to treat GERD.
AIM:
This study aimed to investigate therapeutic effect of jiaweizuojinwan and diaphragma biofeedback training on GERD.Following studies were carried out.(1)To observe the distribution of syndrome types of GERD,To explore and Investigate the basic types of syndromes and Certificate Type Law of Traditional Chinese Medicine of GERD.(2)To evaluate.the change of the main Symptoms noted by using a scoring system and the scores by using GERD-HRQL At 4 and 8 weeks after treatment.(3)To inquiry the esophageal motility including hESP(Pressure of lower esophageal sphincter,LESP)and Tension of diaphragmic crural at resting.(4)To evaluate the clinical effectiveness jiaweizuojinwan and diaphragma biofeedback training on GERD.
METHODS:
87 subacute patients with GERD cases undergoing gastroscopy and 24-h pH monitoring,ranging in age from 18 to 65,were classified randomly into observed group and control group,43 patients in the treatment group took jiaweizuojinwan and diaphragma biofeedback training while the control group treated by pantoprazole capsule 20 mg qd p.o,between March 2007 and March 2008,in the GI Endoscopy and Manometry Laboratory of the Guangdong Provincial TCM Hospital.main symptom scores and the scores by using GERD-HRQL of two groups were performed in baseline phase and at 4 and 8 weeks weeks after treatment,Esophageal motility in baseline phase and at 8 weeks weeks treatment. All data of esophageal manometry and pH monitoring were recorded using the MMS Solar GI and ORIONⅡPM Device(Medical Measurement System B.V,The Netherlands)and were analyzed with MMS software,the distal pHsensor of the monitoring catheter is positioned 5 cm above the proximal border of the lower esophageal sphincter(LES).TCM Diagnostic Criteria of GERD According to Luo yunjuan and Yu shanyan.SPSS 11.0 statistical software were used for statistics,analysis and evaluation.
RESULTS:
There was no significant difference on age,sex,BMIand cardinal symptoms distribution between two groups(p＞0.05).TCM patterns distribution of 87 patients with GERD:13 cases of liver-stomach disharmony syndrome between (14.94%),60 cases of liver-stomach heat syndrome(68.97%),10 cases of pleen-hypofunction and reverse qi syndrome(11.49%),4 cases of deficiency of spleen and stomach(4.6%).There were 39 cases of NERD,3 cases of RE,1 case of BE in the treatment group,and 40 cases of NERD,4 cases of RE,0 case of BE in the control group(p＞0.05)。
1.The effectiveness on the Clinical symptom scores:Clinical symptom scores reduced from 8.37±1.64.in the baselina to 1.14±0.72(86.38%)at 8 weeks after treatment(p＜0.05)in the treatment group,from 8.24±1.89 in the baselina to 1.26±0.95(84.71%)at 8 weeks after treatment in the control group (p＜0.05).but there were no significant difference in clinical symptom scores between the two groups at 8 weeks after treatmen(p＞0.05).
2.The effectiveness on the health-related quality of life:scores of HRQL in the the treatment group reduced from 39.4±10.1 in the baselina to 6.1±3.50at 8 weeks after treatment(p＜0.05),from 39.1±12.2 in the baselina to 10.4±5.94 at 8 weeks after treatment in the control group(p＜0.05).and there were significant difference in scores of HRQL between the two groups at 8 weeks after treatmen(p＜0.05).
3.The effectiveness on the LESP and Tension ofdiaphragmic crural at resting:LESP of two groups were similar in the baseline and at 8 weeks after treatmen.The tension of crural diaphragm at resting in the the treatment group was quite higher than in the control group(P＜0.05).
4.The clinical efficacy rate:According to the standardization Total effective rate in the treatment group and the control group was 93.02%and 88.64%,respectively.No significant difference was found between the two roups after Ridit analysis.
CONCLUSIONS:
1.The type of liver-stomach heat is main TCM syndrome of GERD.
2.Jiaweizuojinwan and diaphragma biofeedback training holds therapeutic effects on patients with GERD by strengthening the esophageal anti-reflux barrier and enhancing the quality of life.
引文
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[47]Stanghellini V.Relationship between upper gastrointestinal symptoms and lifestyle,psychosocial factors and comorbidity in the general population:results from the Domestic/International Gastroenterology Surveillance Study (DIGESTA).Scand J Gastroenterol Suppl,1999;231:29-37.
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[49]郭惠平,潘国宗,柯美云,等.北京成年人胃食管反流相关症状流行病学调查.胃肠病学和肝病学杂志,1997,6:122-126.
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[51]胡兆元,周丽雅,林三仁,等.十年间2088例反流性食炎临床分析.中华消化杂志,2005;25:31-318.
[52]鲁文珍.半夏泻心汤合左金丸治疗胃食管反流病30例.浙江中西医结合杂志,2007;17(1):48-49.
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