Hp相关性慢性胃炎证素研究及中医药治疗的疗效评价研究
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摘要
慢性胃炎(chronic gastritis, CG)是临床的常见病和多发病,可分为慢性浅表性、萎缩性和特殊类型胃炎三大类。其发病率高,在各种胃病中居于首位,约占接受胃镜检查患者的90%以上。幽门螺杆菌(Helicobacter pylori, Hp)是慢性胃炎的主要致病因素,长期感染后,部分患者可发生胃黏膜萎缩和肠化,根除Hp可使胃黏膜炎症消退,慢性炎症程度减轻,成为治疗慢性胃炎的关键环节之一。随着抗生素耐药性的增加,中医药有望为Hp感染治疗开辟一条新的途径。诸多中药实验证实,很多中药具有很强的抗Hp作用,临床研究亦表明,中西医结合治疗能显著提高幽门螺杆菌的根除率,并且临床症状改善明显,还可以降低西药治疗中的副作用,本研究在文献研究的基础上,对中医药治疗Hp相关性慢性胃炎的疗效和安全性进行系统地评价；并采用流行病学的调查方法,运用因子分析法研究该病的的中医证候分布及证素分布特点,为该病中医证素辨证提供理论依据；对中医药治疗Hp相关性慢性胃炎进行疗效评价研究。
本文主要包括四个部分：
第一部分：文献综述,第一篇介绍了祖国医学对Hp相关性慢性胃炎病因病机的认识、证候的研究进展、中医的治则治法及部分中药的Hp体外抑菌实验研究的概况,并详述了导师魏玮教授运用辛开苦降法治疗Hp相关性慢性胃炎的经验体会。第二篇从Hp生物学特征、对慢性胃炎的影响、致病机制、诊断、治疗、耐药性等方面探讨了西医对该病的研究现状。第三篇对近年来研究热点证素辨证作了概述,从证素的历史沿革、证素特征、证素辨证的优势、证素辨证的思维过程等方面予以介绍。第四篇介绍了导师魏玮教授治疗幽门螺杆菌相关性慢性胃炎的经验体会。
第二部分：中医药治疗Hp相关性慢性胃炎随机对照临床试验的Meta分析
目的：对中医药治疗Hp相关性慢性胃炎的疗效和安全性进行系统地评价。
方法：采用计算机检索中文和外文文献数据库,中文检索词包括中医药、经方、验方、中医、中药、草药、中成药、幽门螺旋杆菌、慢性胃炎等,英文检索词为"traditional Chinese medicine, herbal-medicine, Chinese patent medicine, helicobacter pylori, chronic gastritis",进行文献筛选、质量评价、提取资料、采用Cochrane协作网提供的RevMan5.2软件(Cochrane Collaboration)进行数据分析。
结果：共检索到文献506篇,其中中文文献490篇,英文文献16篇。运用NoteEx-press软件排除重复的题录共192条,通过阅读文章题目和摘要排除明显无关的文献,初步纳入148篇。下载并阅读文献全文,排除重复发表的文章2篇,非随机对照临床研究36篇及试验组干预措施为中西医结合的研究92篇,最终纳入中文文献18篇。偏倚风险评估显示纳入文献的方法学质量和报告质量普遍较低,具有高度的偏倚风险。Meta分析结果显示,在Hp根除率方面,单纯中药治疗与西医二联疗法、三联疗法、四联疗法比较均无统计学差异,提示中药治疗具有与西医抗Hp治疗相同的功效,在复发率方面,18篇文献中仅1项研究对患者进行了跟踪随访,报告了Hp阴转后的复发率。在治愈率方面,中医疗法较西医或者中医非特异性治疗有更高的治愈率。在好转率方面。中药与二联疗法、三联疗法、四联疗法及非特异性治疗比较好转率均无统计学差异。中医证候的改善方面,中医在胃痛、痞满、嘈杂、暖气、纳差方面疗效明显,与西医治疗组比较有统计学差异。不良反应方面,仅4篇文献报告了不良反应结局,大多数研究报道的不良反应经对症处理后症状减轻或消失,未报道患者是否因不良反应退出研究。倒漏斗图结果显示中药与二联疗法、三联疗法以及四联疗法的比较发表的文献较对称,发表偏倚较小,而中药与非特异治疗比较发表的文献呈不对称,提示存在发表偏倚。
结论：中医药治疗Hp相关性慢性胃炎的文献研究的方法学质量和报告质量总体较低,尚不能对中医药治疗Hp相关性慢性胃炎的疗效做出肯定的结论,仍需要通过实施规范的RCTs研究进一步证实中医药的疗效。
第三部分：Hp相关性慢性胃炎证候及证素分布特点的临床研究
目的：明确Hp相关性慢性胃炎中医证候、证素分布特点,为该病中医证素辨证提供理论依据。
方法：临床收集经胃镜及病理检查确诊为Hp相关性慢性胃炎患者,采用流行病学调查方法,客观认真的填写临床观察表,建立数据库,运用因子分析提取证型和证素,结合专业知识归纳总结Hp相关性慢性胃炎的证候及证素分布规律。
结果：915慢性胃炎患者中,共纳入375例Hp相关性慢性胃炎患者,CSG患者307例,CAG患者68例,通过因子分析得出证候分布为：脾胃湿热证(34.1%)、肝胃郁热证(24.3%)、脾胃虚弱证(28%)、胃阴不足证(6.4%)、胃络瘀阻证(7.2%)。本研究所提取的证素包括病位类证素3个,病性类证素7个,病位证素为脾、胃、肝,病性证素有虚实之分,实证为湿、热、气滞、血瘀,虚证以气虚、阳虚、阴虚为主。
结论：①脾胃湿热证、肝胃郁热证、脾胃虚弱证、胃阴不足证、胃络瘀阻证是Hp相关性慢性胃炎常见的证型,病位证素为脾、胃、肝,病性证素为湿、热、气滞、血瘀、气虚、阳虚、阴虚。②Hp相关性慢性胃炎中,湿、热、气虚为发病较高的证素,CSG与CAG证素分布在阴虚、血瘀之间有差异。③Hp相关性慢性胃炎中医证型发病与性别无关,与年龄相关,CSG患者年龄分布以50一59岁年龄组所占比例最大,CAG患者则60岁以上年龄组患病率最高。④Hp相关性慢性胃炎饮食结构与发病有密切关系。⑤证素分布与胃镜下炎症分布部位、病理分级之间无相关性。
第四部分：辨证论治联合“标准三联”治疗幽门螺杆菌的疗效评价研究
目的：对中医药治疗Hp相关性慢性胃炎进行疗效评价研究。
方法：采用随机对照临床试验方法,将92例Hp相关性慢性胃炎随机分为3组,对照组A组为西药标准三联疗法10天；试验组B组为西药配合汤药2周；C组为西药配合汤药4周。主要疗效指标：Hp根除率。次要疗效指标：①中医证候疗效；②单项中医证候疗效；③治疗前后SF-36量表比较。
结果：①A组根除率为70%,B组根除率为81.25%,C组为78%,三组Hp根除率差异有统计学意义(p<0.05)。②三组治疗前后中医证候差异有统计学意义(p<0.05)；三组治疗后症状积分较治疗前均有明显改善(p<0.05),但B组与C组治疗后症状积分比较差异无统计学意义(p>0.05)。③B组、C组治疗后患者的生理职能RP、躯体疼痛BP、总体健康GH、生命活力VT、社交功能SF和心理健康MH六个维度的积分提高有统计学意义(p<0.05),而生理功能PF和情感职能RE维度积分提高无统计学意义(p>0.05)、A组患者治疗后,只有躯体疼痛BP维度的积分提高有统计学意义(p<0.05)而躯体功能PF、躯体职能RP、总体健康GH、生命活力VT、社交功能SF、情感职能RE和心理健康MH七个维度积分提高均无统计学意义(p>0.05)
结论：①中医辨证联合西医标准三联治疗Hp相关性慢性胃炎可提高Hp的根除率,优于单纯西药组,②中西医结合可明显改善患者临床症状,优于单纯西药组,但B组、C组差异无统计学意义(p<0.05),尚不能认为中药疗程28天优于14天；③临床治疗中,SF-36量表对中医药疗效进行评价,可克服中医辨证的模糊性和不确定性,生活质量应作为疗效评价的效果指标。
Chronic gastritis is a common disease with high incidence rate. It can be classified as non-atrophic gastritis, atrophic gastritis, special gastritis. It is found in over90%of patient performed gastro scope. The incidence rate is highest among digestive diseases. Helicobacter pylori (Hp) infection is the major etiology. After infection, the mucous membrane of the stomach will shrink. Therefore, the elimination of antibiotic can relieve inflammation and it is the essential step of treatment. As the drug tolerance of Hp increases, Chinese Medicine may provide another way to treat chronic gastritis. A lot of Chinese herbs have been proved to have strong effect on Hp in several experimental studies. In addition, clinical studies also indicate the combined of Chinese and Western medicine can raise the elimination rate of Hp, improve clinical symptoms and reduce side effects. Based on literature review, this study try to evaluate the efficacy and safety of Chinese Medicine in treating chronic gastritis. Also, the study apply factor analysis to investigate Chinese Medicine syndrome distribution. It can provide evidence basic for Chinese Medicine syndrome classification. The study evaluates the efficacy of Chinese Medicine on the treatment of Hp related chronic gastritis.
The manuscript composes of four parts: The first part:Literature Review, The first chapter introduces the view of Chinese Medicine on the etiology of chronic gastritis, the research progress of syndrome, the treatment principle and method of Chinese Medicine, some experimental research on in vivo effect of Chinese herbal medicine and the experience of Prof. Wei on the treatment of Hp related chronic gastritis. The second chapter investigate the current research situation of Western Medicine from characteristic of Hp, disease etiology, diagnosis, treatment and drug tolerance. The third chapter concludes researches on factor analysis from historical perspective, factor characteristic, and advantage of factor analysisd logic of factor analysis. The forth chapter introduces the experiences.of Professor Wei Wei in the treatment of Helicobacter pylori-related chronic gastritis.
The second part:Meta analysis of randomized control clinical study of Chinese Medicine on Hp related chronic gastritis
Objective:Systematically evaluate the efficacy and safety of Chinese Medicine on Hp related chronic gastritis
Methods:Search the data base with Chinese and English key word, traditional Chinese medicine, herbal-medicine, Chinese patent medicine, helicobacter pylori, chronic gastritis. Afterwards, perform selection, quality evaluation, data extraction and use RevMan5.2software (Cochrane Collaboration) for data analysis.
Results:506manuscripts are identified,490manuscripts are Chinese and16manuscripts are English. NoteEx-press software is used to eliminate192repeated manuscripts.148manuscripts was primarily included through title and abstract. The148manuscripts are downloaded and read.2repeat manuscripts are excluded. There are36non-randomized control clinical studies and92combined Western and Chinese medicine treatment groups.18Chinese manuscripts are finally included. The risk of bias indicates the included manuscripts have poor method and report quality and high risk of bias. The result of meta-analysis indicates that simple Chinese herbal medicine treatment has similar effect on Hp elimination rate as western medicine. There is only1manuscript performed follow-up and report the recurrence rate of Hp. Specific Chinese medicine therapy has a higher recovery rate than western or non-specific Chinese medicine therapy. The improvement rate do not show statistical significant between Chinese herbal medicine, western medicine and non-specific therapy. The improvement of Chinese medicine symptoms including stomachache, swelling of stomach, eructation, decrease appetite is statistically significant compared with western medicine. Only4manuscripts report side effects and the side effects reported are relieved or disappeared after treatment. There is no report of patient quit the study because of side effects. The result of funnel plot indicates Chinese medicine and western medicine study are more symmetrical with little report bias while Chinese medicine and non-specific therapy present non-symmetrical funnel plot.
Conclusion:The literature review shows that the manuscripts have poor method and report quality so definite conclusion about the effect of Chinese Medicine on Hp related chronic gastritis cannot be made. More RCTs should be performed to prove the effect of Chinese Medicine on chronic gastritis.
The third part:Factor analysis and syndrome distribution of Hp related chronic gastritis
Objective:Identify Chinese Medicine syndrome, syndrome distribution characteristic of Hp related chronic gastritis to establish theoretical basic for Chinese syndrome differential diagnosis
Methods:Gather Hp related chronic gastritis patients through gastroscope and pathological session and apply epidemiology method to perform investigation. The clinical observation form is filled objectively and data base is build. Factor analysis is applied to extract syndrome and syndrome properties and the result is analyzed with professional knowledge.
Results:375Hp related chronic gastritis patients are selected from915chronic gastritis patient. There is307cases of CSG patients and68cases of CAG patients. Through factor analysis, the syndrome distribution is34.1%spleen and stomach wet heat syndrome,24.3%liver and stomach heat stagnation syndrome,28%deficiency of spleen and stomach,6.4%deficiency of stomach yin,7.2%stagnation of stomach meridian. The syndrome factor extracted in the study include3disease position, spleen, stomach and liver and7disease properties, the excessive properties include wet, heat, qi stagnation and blood stagnation; deficiency properties include qi deficiency, yang deficiency and yin deficiency.
Conclusion:Spleen and stomach wet heat syndrome, liver and stomach heat stagnation syndrome, deficiency of spleen and stomach, deficiency of stomach yin, stagnation of stomach meridian are the common syndromes of chronic gastritis. The disease positions are spleen, stomach and liver. The disease properties are wet, heat, qi stagnation, blood stagnation, qi deficiency, yang deficiency and yin deficiency.
The forth part:Investigate the efficacy of Syndrome differentiation and treatment combined with standard western medicine treatment of Hp
Objective:To evaluate the efficacy of Chinese herbal medicine on Hp related chronic gastritis
Methods:92patients of Hp related chronic gastritis are randomized into three group. Group A is the control group which used standardize western medicine treatment; Group B is the combination of Western medicine and2weeks herbal medicine; Group C is the combination of Western medicine and4weeks herbal medicine. The major therapeutic index is the elimination rate of Hp. The secondary therapeutic index is (1)Therapeutic efficacy of Chinese herbal medicine with syndrome differentiation;(2)Therapeutic efficacy of each syndrome;(3)Comparison of SF-36before and after treatment.
Results:①The elimination rate of group A is70%, group B is81.25%, group C is78%, the difference between three groups is statistical significant (P<0.05)②The difference between treatment and after treatment is statistical significant (P<0.05) and the symptoms score before and after treatment also have significant improved for all the three groups③The RP, BP, GH, VT,SF and MH of group B and C have significant improved (P<0.05) while PF and RE score has not significant improved. The BP score of A group has significant improved (P<0.05) while PF, RP, GH, VT, SF, RE and MH score has not significant improved.
Conclusion:①Chinese syndrome differentiation with western medicine can raise the elimination rate of Hp compare with western medicine group,②The combination of Chinese and Western medicine can improve clinical symptoms. The effect is significant while compared with western medicine group but group B and C has no statistical significant (p<0.05). Therefore, the effect of28days of Chinese Medicine treatment may not be better than14days,③In clinical study, SF-36is used to evaluate the effect of Chinese Medicine on chronic gastritis. The use of quality of life as the tool of efficacy evaluation can overcome the instability of Chinese Medicine syndrome differentiation.
本文主要包括四个部分：
第一部分：文献综述,第一篇介绍了祖国医学对Hp相关性慢性胃炎病因病机的认识、证候的研究进展、中医的治则治法及部分中药的Hp体外抑菌实验研究的概况,并详述了导师魏玮教授运用辛开苦降法治疗Hp相关性慢性胃炎的经验体会。第二篇从Hp生物学特征、对慢性胃炎的影响、致病机制、诊断、治疗、耐药性等方面探讨了西医对该病的研究现状。第三篇对近年来研究热点证素辨证作了概述,从证素的历史沿革、证素特征、证素辨证的优势、证素辨证的思维过程等方面予以介绍。第四篇介绍了导师魏玮教授治疗幽门螺杆菌相关性慢性胃炎的经验体会。
第二部分：中医药治疗Hp相关性慢性胃炎随机对照临床试验的Meta分析
目的：对中医药治疗Hp相关性慢性胃炎的疗效和安全性进行系统地评价。
方法：采用计算机检索中文和外文文献数据库,中文检索词包括中医药、经方、验方、中医、中药、草药、中成药、幽门螺旋杆菌、慢性胃炎等,英文检索词为"traditional Chinese medicine, herbal-medicine, Chinese patent medicine, helicobacter pylori, chronic gastritis",进行文献筛选、质量评价、提取资料、采用Cochrane协作网提供的RevMan5.2软件(Cochrane Collaboration)进行数据分析。
结果：共检索到文献506篇,其中中文文献490篇,英文文献16篇。运用NoteEx-press软件排除重复的题录共192条,通过阅读文章题目和摘要排除明显无关的文献,初步纳入148篇。下载并阅读文献全文,排除重复发表的文章2篇,非随机对照临床研究36篇及试验组干预措施为中西医结合的研究92篇,最终纳入中文文献18篇。偏倚风险评估显示纳入文献的方法学质量和报告质量普遍较低,具有高度的偏倚风险。Meta分析结果显示,在Hp根除率方面,单纯中药治疗与西医二联疗法、三联疗法、四联疗法比较均无统计学差异,提示中药治疗具有与西医抗Hp治疗相同的功效,在复发率方面,18篇文献中仅1项研究对患者进行了跟踪随访,报告了Hp阴转后的复发率。在治愈率方面,中医疗法较西医或者中医非特异性治疗有更高的治愈率。在好转率方面。中药与二联疗法、三联疗法、四联疗法及非特异性治疗比较好转率均无统计学差异。中医证候的改善方面,中医在胃痛、痞满、嘈杂、暖气、纳差方面疗效明显,与西医治疗组比较有统计学差异。不良反应方面,仅4篇文献报告了不良反应结局,大多数研究报道的不良反应经对症处理后症状减轻或消失,未报道患者是否因不良反应退出研究。倒漏斗图结果显示中药与二联疗法、三联疗法以及四联疗法的比较发表的文献较对称,发表偏倚较小,而中药与非特异治疗比较发表的文献呈不对称,提示存在发表偏倚。
结论：中医药治疗Hp相关性慢性胃炎的文献研究的方法学质量和报告质量总体较低,尚不能对中医药治疗Hp相关性慢性胃炎的疗效做出肯定的结论,仍需要通过实施规范的RCTs研究进一步证实中医药的疗效。
第三部分：Hp相关性慢性胃炎证候及证素分布特点的临床研究
目的：明确Hp相关性慢性胃炎中医证候、证素分布特点,为该病中医证素辨证提供理论依据。
方法：临床收集经胃镜及病理检查确诊为Hp相关性慢性胃炎患者,采用流行病学调查方法,客观认真的填写临床观察表,建立数据库,运用因子分析提取证型和证素,结合专业知识归纳总结Hp相关性慢性胃炎的证候及证素分布规律。
结果：915慢性胃炎患者中,共纳入375例Hp相关性慢性胃炎患者,CSG患者307例,CAG患者68例,通过因子分析得出证候分布为：脾胃湿热证(34.1%)、肝胃郁热证(24.3%)、脾胃虚弱证(28%)、胃阴不足证(6.4%)、胃络瘀阻证(7.2%)。本研究所提取的证素包括病位类证素3个,病性类证素7个,病位证素为脾、胃、肝,病性证素有虚实之分,实证为湿、热、气滞、血瘀,虚证以气虚、阳虚、阴虚为主。
结论：①脾胃湿热证、肝胃郁热证、脾胃虚弱证、胃阴不足证、胃络瘀阻证是Hp相关性慢性胃炎常见的证型,病位证素为脾、胃、肝,病性证素为湿、热、气滞、血瘀、气虚、阳虚、阴虚。②Hp相关性慢性胃炎中,湿、热、气虚为发病较高的证素,CSG与CAG证素分布在阴虚、血瘀之间有差异。③Hp相关性慢性胃炎中医证型发病与性别无关,与年龄相关,CSG患者年龄分布以50一59岁年龄组所占比例最大,CAG患者则60岁以上年龄组患病率最高。④Hp相关性慢性胃炎饮食结构与发病有密切关系。⑤证素分布与胃镜下炎症分布部位、病理分级之间无相关性。
第四部分：辨证论治联合“标准三联”治疗幽门螺杆菌的疗效评价研究
目的：对中医药治疗Hp相关性慢性胃炎进行疗效评价研究。
方法：采用随机对照临床试验方法,将92例Hp相关性慢性胃炎随机分为3组,对照组A组为西药标准三联疗法10天；试验组B组为西药配合汤药2周；C组为西药配合汤药4周。主要疗效指标：Hp根除率。次要疗效指标：①中医证候疗效；②单项中医证候疗效；③治疗前后SF-36量表比较。
结果：①A组根除率为70%,B组根除率为81.25%,C组为78%,三组Hp根除率差异有统计学意义(p<0.05)。②三组治疗前后中医证候差异有统计学意义(p<0.05)；三组治疗后症状积分较治疗前均有明显改善(p<0.05),但B组与C组治疗后症状积分比较差异无统计学意义(p>0.05)。③B组、C组治疗后患者的生理职能RP、躯体疼痛BP、总体健康GH、生命活力VT、社交功能SF和心理健康MH六个维度的积分提高有统计学意义(p<0.05),而生理功能PF和情感职能RE维度积分提高无统计学意义(p>0.05)、A组患者治疗后,只有躯体疼痛BP维度的积分提高有统计学意义(p<0.05)而躯体功能PF、躯体职能RP、总体健康GH、生命活力VT、社交功能SF、情感职能RE和心理健康MH七个维度积分提高均无统计学意义(p>0.05)
结论：①中医辨证联合西医标准三联治疗Hp相关性慢性胃炎可提高Hp的根除率,优于单纯西药组,②中西医结合可明显改善患者临床症状,优于单纯西药组,但B组、C组差异无统计学意义(p<0.05),尚不能认为中药疗程28天优于14天；③临床治疗中,SF-36量表对中医药疗效进行评价,可克服中医辨证的模糊性和不确定性,生活质量应作为疗效评价的效果指标。
Chronic gastritis is a common disease with high incidence rate. It can be classified as non-atrophic gastritis, atrophic gastritis, special gastritis. It is found in over90%of patient performed gastro scope. The incidence rate is highest among digestive diseases. Helicobacter pylori (Hp) infection is the major etiology. After infection, the mucous membrane of the stomach will shrink. Therefore, the elimination of antibiotic can relieve inflammation and it is the essential step of treatment. As the drug tolerance of Hp increases, Chinese Medicine may provide another way to treat chronic gastritis. A lot of Chinese herbs have been proved to have strong effect on Hp in several experimental studies. In addition, clinical studies also indicate the combined of Chinese and Western medicine can raise the elimination rate of Hp, improve clinical symptoms and reduce side effects. Based on literature review, this study try to evaluate the efficacy and safety of Chinese Medicine in treating chronic gastritis. Also, the study apply factor analysis to investigate Chinese Medicine syndrome distribution. It can provide evidence basic for Chinese Medicine syndrome classification. The study evaluates the efficacy of Chinese Medicine on the treatment of Hp related chronic gastritis.
The manuscript composes of four parts: The first part:Literature Review, The first chapter introduces the view of Chinese Medicine on the etiology of chronic gastritis, the research progress of syndrome, the treatment principle and method of Chinese Medicine, some experimental research on in vivo effect of Chinese herbal medicine and the experience of Prof. Wei on the treatment of Hp related chronic gastritis. The second chapter investigate the current research situation of Western Medicine from characteristic of Hp, disease etiology, diagnosis, treatment and drug tolerance. The third chapter concludes researches on factor analysis from historical perspective, factor characteristic, and advantage of factor analysisd logic of factor analysis. The forth chapter introduces the experiences.of Professor Wei Wei in the treatment of Helicobacter pylori-related chronic gastritis.
The second part:Meta analysis of randomized control clinical study of Chinese Medicine on Hp related chronic gastritis
Objective:Systematically evaluate the efficacy and safety of Chinese Medicine on Hp related chronic gastritis
Methods:Search the data base with Chinese and English key word, traditional Chinese medicine, herbal-medicine, Chinese patent medicine, helicobacter pylori, chronic gastritis. Afterwards, perform selection, quality evaluation, data extraction and use RevMan5.2software (Cochrane Collaboration) for data analysis.
Results:506manuscripts are identified,490manuscripts are Chinese and16manuscripts are English. NoteEx-press software is used to eliminate192repeated manuscripts.148manuscripts was primarily included through title and abstract. The148manuscripts are downloaded and read.2repeat manuscripts are excluded. There are36non-randomized control clinical studies and92combined Western and Chinese medicine treatment groups.18Chinese manuscripts are finally included. The risk of bias indicates the included manuscripts have poor method and report quality and high risk of bias. The result of meta-analysis indicates that simple Chinese herbal medicine treatment has similar effect on Hp elimination rate as western medicine. There is only1manuscript performed follow-up and report the recurrence rate of Hp. Specific Chinese medicine therapy has a higher recovery rate than western or non-specific Chinese medicine therapy. The improvement rate do not show statistical significant between Chinese herbal medicine, western medicine and non-specific therapy. The improvement of Chinese medicine symptoms including stomachache, swelling of stomach, eructation, decrease appetite is statistically significant compared with western medicine. Only4manuscripts report side effects and the side effects reported are relieved or disappeared after treatment. There is no report of patient quit the study because of side effects. The result of funnel plot indicates Chinese medicine and western medicine study are more symmetrical with little report bias while Chinese medicine and non-specific therapy present non-symmetrical funnel plot.
Conclusion:The literature review shows that the manuscripts have poor method and report quality so definite conclusion about the effect of Chinese Medicine on Hp related chronic gastritis cannot be made. More RCTs should be performed to prove the effect of Chinese Medicine on chronic gastritis.
The third part:Factor analysis and syndrome distribution of Hp related chronic gastritis
Objective:Identify Chinese Medicine syndrome, syndrome distribution characteristic of Hp related chronic gastritis to establish theoretical basic for Chinese syndrome differential diagnosis
Methods:Gather Hp related chronic gastritis patients through gastroscope and pathological session and apply epidemiology method to perform investigation. The clinical observation form is filled objectively and data base is build. Factor analysis is applied to extract syndrome and syndrome properties and the result is analyzed with professional knowledge.
Results:375Hp related chronic gastritis patients are selected from915chronic gastritis patient. There is307cases of CSG patients and68cases of CAG patients. Through factor analysis, the syndrome distribution is34.1%spleen and stomach wet heat syndrome,24.3%liver and stomach heat stagnation syndrome,28%deficiency of spleen and stomach,6.4%deficiency of stomach yin,7.2%stagnation of stomach meridian. The syndrome factor extracted in the study include3disease position, spleen, stomach and liver and7disease properties, the excessive properties include wet, heat, qi stagnation and blood stagnation; deficiency properties include qi deficiency, yang deficiency and yin deficiency.
Conclusion:Spleen and stomach wet heat syndrome, liver and stomach heat stagnation syndrome, deficiency of spleen and stomach, deficiency of stomach yin, stagnation of stomach meridian are the common syndromes of chronic gastritis. The disease positions are spleen, stomach and liver. The disease properties are wet, heat, qi stagnation, blood stagnation, qi deficiency, yang deficiency and yin deficiency.
The forth part:Investigate the efficacy of Syndrome differentiation and treatment combined with standard western medicine treatment of Hp
Objective:To evaluate the efficacy of Chinese herbal medicine on Hp related chronic gastritis
Methods:92patients of Hp related chronic gastritis are randomized into three group. Group A is the control group which used standardize western medicine treatment; Group B is the combination of Western medicine and2weeks herbal medicine; Group C is the combination of Western medicine and4weeks herbal medicine. The major therapeutic index is the elimination rate of Hp. The secondary therapeutic index is (1)Therapeutic efficacy of Chinese herbal medicine with syndrome differentiation;(2)Therapeutic efficacy of each syndrome;(3)Comparison of SF-36before and after treatment.
Results:①The elimination rate of group A is70%, group B is81.25%, group C is78%, the difference between three groups is statistical significant (P<0.05)②The difference between treatment and after treatment is statistical significant (P<0.05) and the symptoms score before and after treatment also have significant improved for all the three groups③The RP, BP, GH, VT,SF and MH of group B and C have significant improved (P<0.05) while PF and RE score has not significant improved. The BP score of A group has significant improved (P<0.05) while PF, RP, GH, VT, SF, RE and MH score has not significant improved.
Conclusion:①Chinese syndrome differentiation with western medicine can raise the elimination rate of Hp compare with western medicine group,②The combination of Chinese and Western medicine can improve clinical symptoms. The effect is significant while compared with western medicine group but group B and C has no statistical significant (p<0.05). Therefore, the effect of28days of Chinese Medicine treatment may not be better than14days,③In clinical study, SF-36is used to evaluate the effect of Chinese Medicine on chronic gastritis. The use of quality of life as the tool of efficacy evaluation can overcome the instability of Chinese Medicine syndrome differentiation.
引文
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