疏郁降逆汤联合奥美拉唑、多潘立酮治疗胃食管反流病的临床观察
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摘要
目的:
本研究旨在观察评价疏郁降逆汤联合奥美拉唑、多潘立酮治疗肝胃不和型胃食管反流病(GERD)的疗效,并与对照组(奥美拉唑、多潘立酮)作比较,进一步从理论和研究两方面探讨疏郁降逆汤的作用机制。
方法:
1.选取GERD患者64例,均为2007年5月-2008年4月在湖北省中医院消化内科门诊就诊的病例,全部病例均符合1999年8月25日全国反流性食管病/反流性食管炎研讨会制定的诊断标准。参照中华人民共和国卫生部1997年制定颁布的《中药新药临床研究指导原则第一辑》及《实用中医消化病学》,中医证型为肝胃不和证(含肝胃郁热证)。采用统计软件随机分为观察组32例和对照组32组。两组患者在年龄、性别、病程、病情方面的差异无统计学意义(P＞0.05),具有可比性。
2.观察组给与口服疏郁降逆汤:醋炙柴胡9g、枳壳10g、陈皮12g、香附12g、川芎10g、白芍15g、姜半夏10g、黄连6g、黄芩9g、白术9g、海螵蛸25g、炙甘草6g,随症加减。上述药物水煎服,每日一剂,早晚分服。在此基础上,服用西药奥美拉唑每次20mg,早晚各一次,多潘立酮每次10mg(餐前15分钟),一天3次。4周为一疗程,共服用两个疗程。对照组口服奥美拉唑、多潘立酮,服法同观察组。两组患者在治疗期间均戒烟禁酒、不进油腻及刺激性食物、抬高床头15-20cm,注意睡前不进食,不服用除上述药物外的其他与本病有关的治疗药物。期间密切观察患者临床症状,一周门诊复诊一次,记录症状,体征变化情况,治疗前后各检查胃镜1次,按照国内食管炎炎症程度分级标准判断级别。治疗期间分别进行安全性检查(一般体检项目,三大常规化验,心电图,肝肾功能检查,可能出现的不良反应)和疗效性观察。治疗结束后,随访6个月,观察远期疗效。
3、统计学分析方法:数据应用SPSS17.0统计软件进行分析。等级资料采用Ridit分析,计数资料采用x~2检验,计量资料采用t检验。
结果:
1.观察组:治愈率为25.00%,总有效率为90.63%;对照组:治愈率为15.63%,总有效率为84.38%。两组疗效差异有统计学意义(P＜0.05),观察组综合疗效优于对照组。
2.治疗后两组患者中医症状总积分与治疗前比较差异均有统计学意义(P＜0.01),观察组和对照组均能改善中医症状;治疗后两组患者中医症状总积分差异有统计学意义(P＜0.01),观察组中医症状总积分的改善优于对照组。
3.治疗结束后,随访6个月,观察组复发率为21.88%,对照组复发率为46.88%,两组复发率差异有统计学意义(P＜0.05),观察组远期疗效优于对照组。
结论:
本课题研究提示疏郁降逆汤是治疗胃食管反流病安全有效的方药,联合西药奥美拉唑、多潘立酮治疗该病的综合疗效、远期疗效优于单纯西药组。其机理可能与以下几个方面有关:1.增加胃肠蠕动,促进胃肠排空,抗反流;2.抑制胃酸、镇痛作用;3.抗炎抑菌作用。按中医辨证论治的治疗原则,应用中医药联合西药治疗本病,确实取得显著的效果,值得我们进一步深入的探讨和总结。
Objective:
This study was designed to observe and evaluate the curative effect of the treatment of Shuyu Jiangni Tang United omeprazole and domperidone treat gastroesophageal reflux disease(GERD) which was the type of Gan Wei Bu He.To compared with the control group(omeprazole,domperidone ),was to explore further the mechanism of Shuyu Jiangni Tang in the aspect of theory and research.
Methods:
1.Selected 64 cases of patients with GERD,both in May 2007—2008 year in April in Chinese medicine hospital in Hubei Province to digest the case of internal medicine out-patient clinic,all cases are in line with August 25,1999 National esophageal reflux disease / reflux esophagitis workshop developed diagnostic criteria.Reference to the Ministry of Health People's Republic of China in 1997 by enacting the "traditional Chinese medicine clinical research of new drugs the first series of guiding principles" and "practical study of Chinese medicine of digestive diseases,"The type of TCM is Gan Wei Bu He (including the type of Gan Wei Yu Re ).In accordance with the statistical software,all cases were randomly divided,into observer group and control group which were 32 cases.Two groups in age,gender,disease duration and disease aspects of the difference was not significant(P＞0.05),and comparable.
2.Observer Group to be given orally Shuyu Jiangni Tang:Cuzhichaihu 9g,Zhike 10g,Chenpi 12g,Xiangfu 12g,Chuanxiong 10g,Baichao 15g,Jiangban xia 10g,Huanglian 6g,Huangqin 9g,Baizhu 9g,Haipiaoxiao 25g,Zhigancao 6g, addition and subtraction with the disease.Taking traditional herb,a daily, morning and evening service hours.On this basis,taking western medicine omeprazole 20mg,two times a day,and Domperidone 10mg(fasting for 15 minutes),three times a day.One course of treatment for four weeks,a total of two courses taken.Control group,oral omeprazole,domperidone,guilty with the observation group.Two groups of patients to quit smoking during treatment were temperance,not into the greasy and irritating food,raise the bed 15—20cm,the attention of not eating before going to bed,In addition to the above do not take other drugs with the disease-related drugs.Close observation during the clinical symptoms,one week out-patient referral, recording symptoms,signs Change,the treatment of endoscopic inspection before and after one meeting,in accordance with the domestic esophagitis grading criteria to determine the degree of inflammation level.During treatment were carried out security checks(general physical examination items,the three conventional laboratory tests,electrocardiogram,Liver and kidney function tests,possible adverse reactions) and efficacy of observation.After the treatment,6 months follow-up to observe the long-term effect.
3.statistical analysis methods:statistical software SPSS17.0 data for analysis.Information on the use of Level Ridit analysis,count data using x~2 test,measurement data using t test.
Results:
1.Observer Group:the cure rate was 25.00%,total effective rate was 90.63%;control group:the cure rate was 15.63%,total effective rate was 84.38%.Differences between the two groups was statistically significant effect(P＜0.05),the integrated effect of the observation group than the control group.
2.The two groups of patients with total score of symptoms of TCM difference were statistically significant(P＜0.01) between pre-treatment and after treatment,the observation group and control group can improve symptoms of TCM;Chinese medicine treatment in patients with symptoms of two groups of total score differences were significant(P＜0.01),the observation group of Chinese medicine to improve the symptoms of the total score is better than the control group.
3.Observer Group recurrence rate was 21.88%,control group,the recurrence rate of 46.88%,relapse rates were significantly(P＜0.05),long-term effect of the observation group than the control group.
Conclusion:
Prompted this research Shuyu Jiangni Tang is safe and effective treatment of gastroesophageal reflux disease of the prescription,the Joint Western medicine omeprazole,domperidone integrated effect of the treatment of the disease,long-term effect is better than western medicine group.Its mechanism may be related to some aspects of the following:1.Increase the gastric peristalsis,and promote gastrointestinal emptying,anti-reflux, 2.Inhibit gastric acid,analgesic effect,3.Anti-inflammatory and antibacterial effects,the application of Traditional Chinese Medicine and Western Medicine United this disease,has achieved significant results,it is worthy of our further in-depth and summary.
本研究旨在观察评价疏郁降逆汤联合奥美拉唑、多潘立酮治疗肝胃不和型胃食管反流病(GERD)的疗效,并与对照组(奥美拉唑、多潘立酮)作比较,进一步从理论和研究两方面探讨疏郁降逆汤的作用机制。
方法:
1.选取GERD患者64例,均为2007年5月-2008年4月在湖北省中医院消化内科门诊就诊的病例,全部病例均符合1999年8月25日全国反流性食管病/反流性食管炎研讨会制定的诊断标准。参照中华人民共和国卫生部1997年制定颁布的《中药新药临床研究指导原则第一辑》及《实用中医消化病学》,中医证型为肝胃不和证(含肝胃郁热证)。采用统计软件随机分为观察组32例和对照组32组。两组患者在年龄、性别、病程、病情方面的差异无统计学意义(P＞0.05),具有可比性。
2.观察组给与口服疏郁降逆汤:醋炙柴胡9g、枳壳10g、陈皮12g、香附12g、川芎10g、白芍15g、姜半夏10g、黄连6g、黄芩9g、白术9g、海螵蛸25g、炙甘草6g,随症加减。上述药物水煎服,每日一剂,早晚分服。在此基础上,服用西药奥美拉唑每次20mg,早晚各一次,多潘立酮每次10mg(餐前15分钟),一天3次。4周为一疗程,共服用两个疗程。对照组口服奥美拉唑、多潘立酮,服法同观察组。两组患者在治疗期间均戒烟禁酒、不进油腻及刺激性食物、抬高床头15-20cm,注意睡前不进食,不服用除上述药物外的其他与本病有关的治疗药物。期间密切观察患者临床症状,一周门诊复诊一次,记录症状,体征变化情况,治疗前后各检查胃镜1次,按照国内食管炎炎症程度分级标准判断级别。治疗期间分别进行安全性检查(一般体检项目,三大常规化验,心电图,肝肾功能检查,可能出现的不良反应)和疗效性观察。治疗结束后,随访6个月,观察远期疗效。
3、统计学分析方法:数据应用SPSS17.0统计软件进行分析。等级资料采用Ridit分析,计数资料采用x~2检验,计量资料采用t检验。
结果:
1.观察组:治愈率为25.00%,总有效率为90.63%;对照组:治愈率为15.63%,总有效率为84.38%。两组疗效差异有统计学意义(P＜0.05),观察组综合疗效优于对照组。
2.治疗后两组患者中医症状总积分与治疗前比较差异均有统计学意义(P＜0.01),观察组和对照组均能改善中医症状;治疗后两组患者中医症状总积分差异有统计学意义(P＜0.01),观察组中医症状总积分的改善优于对照组。
3.治疗结束后,随访6个月,观察组复发率为21.88%,对照组复发率为46.88%,两组复发率差异有统计学意义(P＜0.05),观察组远期疗效优于对照组。
结论:
本课题研究提示疏郁降逆汤是治疗胃食管反流病安全有效的方药,联合西药奥美拉唑、多潘立酮治疗该病的综合疗效、远期疗效优于单纯西药组。其机理可能与以下几个方面有关:1.增加胃肠蠕动,促进胃肠排空,抗反流;2.抑制胃酸、镇痛作用;3.抗炎抑菌作用。按中医辨证论治的治疗原则,应用中医药联合西药治疗本病,确实取得显著的效果,值得我们进一步深入的探讨和总结。
Objective:
This study was designed to observe and evaluate the curative effect of the treatment of Shuyu Jiangni Tang United omeprazole and domperidone treat gastroesophageal reflux disease(GERD) which was the type of Gan Wei Bu He.To compared with the control group(omeprazole,domperidone ),was to explore further the mechanism of Shuyu Jiangni Tang in the aspect of theory and research.
Methods:
1.Selected 64 cases of patients with GERD,both in May 2007—2008 year in April in Chinese medicine hospital in Hubei Province to digest the case of internal medicine out-patient clinic,all cases are in line with August 25,1999 National esophageal reflux disease / reflux esophagitis workshop developed diagnostic criteria.Reference to the Ministry of Health People's Republic of China in 1997 by enacting the "traditional Chinese medicine clinical research of new drugs the first series of guiding principles" and "practical study of Chinese medicine of digestive diseases,"The type of TCM is Gan Wei Bu He (including the type of Gan Wei Yu Re ).In accordance with the statistical software,all cases were randomly divided,into observer group and control group which were 32 cases.Two groups in age,gender,disease duration and disease aspects of the difference was not significant(P＞0.05),and comparable.
2.Observer Group to be given orally Shuyu Jiangni Tang:Cuzhichaihu 9g,Zhike 10g,Chenpi 12g,Xiangfu 12g,Chuanxiong 10g,Baichao 15g,Jiangban xia 10g,Huanglian 6g,Huangqin 9g,Baizhu 9g,Haipiaoxiao 25g,Zhigancao 6g, addition and subtraction with the disease.Taking traditional herb,a daily, morning and evening service hours.On this basis,taking western medicine omeprazole 20mg,two times a day,and Domperidone 10mg(fasting for 15 minutes),three times a day.One course of treatment for four weeks,a total of two courses taken.Control group,oral omeprazole,domperidone,guilty with the observation group.Two groups of patients to quit smoking during treatment were temperance,not into the greasy and irritating food,raise the bed 15—20cm,the attention of not eating before going to bed,In addition to the above do not take other drugs with the disease-related drugs.Close observation during the clinical symptoms,one week out-patient referral, recording symptoms,signs Change,the treatment of endoscopic inspection before and after one meeting,in accordance with the domestic esophagitis grading criteria to determine the degree of inflammation level.During treatment were carried out security checks(general physical examination items,the three conventional laboratory tests,electrocardiogram,Liver and kidney function tests,possible adverse reactions) and efficacy of observation.After the treatment,6 months follow-up to observe the long-term effect.
3.statistical analysis methods:statistical software SPSS17.0 data for analysis.Information on the use of Level Ridit analysis,count data using x~2 test,measurement data using t test.
Results:
1.Observer Group:the cure rate was 25.00%,total effective rate was 90.63%;control group:the cure rate was 15.63%,total effective rate was 84.38%.Differences between the two groups was statistically significant effect(P＜0.05),the integrated effect of the observation group than the control group.
2.The two groups of patients with total score of symptoms of TCM difference were statistically significant(P＜0.01) between pre-treatment and after treatment,the observation group and control group can improve symptoms of TCM;Chinese medicine treatment in patients with symptoms of two groups of total score differences were significant(P＜0.01),the observation group of Chinese medicine to improve the symptoms of the total score is better than the control group.
3.Observer Group recurrence rate was 21.88%,control group,the recurrence rate of 46.88%,relapse rates were significantly(P＜0.05),long-term effect of the observation group than the control group.
Conclusion:
Prompted this research Shuyu Jiangni Tang is safe and effective treatment of gastroesophageal reflux disease of the prescription,the Joint Western medicine omeprazole,domperidone integrated effect of the treatment of the disease,long-term effect is better than western medicine group.Its mechanism may be related to some aspects of the following:1.Increase the gastric peristalsis,and promote gastrointestinal emptying,anti-reflux, 2.Inhibit gastric acid,analgesic effect,3.Anti-inflammatory and antibacterial effects,the application of Traditional Chinese Medicine and Western Medicine United this disease,has achieved significant results,it is worthy of our further in-depth and summary.
引文
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