糖尿病肾病越南东医文献研究及261例临床病案回顾分析
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摘要
糖尿病肾病(Diabetic Nephropathy,DN)是糖尿病(Diabetes Mellitus,DM)常见而难治的微血管并发症,已成为糖尿病患者的主要死因之一。在西方国家糖尿病肾病是引起终末期肾脏疾病(end-stage renal disease,ESRD)的主要原因,大约30%-40%的糖尿病患者会发展为糖尿病肾病,进而发展为ESRD,且ESRD的发病率在逐年上升。西医治疗主要是控制血糖、控制血压、纠正脂质代谢紊乱和其他影响肾功能的各种疾病和因素,一旦进入肾功能衰竭阶段,只能透析或肾移植。而传统医药治疗DN,不仅改善了临床症状,保护肾功能,延缓和阻止肾脏损害的病程进展,提高DN患者生存质量,而且毒副作用小,受到国内外医学界的关注。越南传统医药受中医药影响殊深。故研究传统东医药诊治糖尿病肾病必然会涉及中医药。由于传统东医药的特殊历史和地域关系,故从传统东医药及中医药中寻求防治DN的有效措施和治疗药物,是人们关注的课题。
     研究目的
     本文通过文献研究与现代统计学分析相结合的方法,探求糖尿病肾病的演变轨迹及证治规律,期望能够为有效防治糖尿病肾病提供更多借鉴和新的思路。首先,运用文献学的方法,收集整理古代文献,从历史发展的角度,对历代医家关于糖尿病肾病的论述进行了全面总结和回顾。系统分析糖尿病肾病的病名沿革、病因、病机、辨证、治则、方药等诸多方面,力求从整体上认识糖尿病肾病辨证论治的发展规律,为今后的研究奠定文献基础。
     其次,结合观察大样本的DN病例,对各种证型的症状、检查指标运用科学的统计学方法进行分析。在DN中医诊疗的规范化、客观化上提供较为可靠的临床依据,并为临床探索更有效的治疗方法提供依据,使其更具可比性、科学性。
     研究方法
     研究方案:设计回顾性调查研究方法。
     研究原则:严格按照入选标准,确诊为糖尿病肾病的患者。收集包括一般情况、个人既往病史、自主症状、实验室检查、治疗方法等资料进行统计学分析。
     研究对象与病例来源:为合理地选择资料来源,增加临床研究可信度,我们拟定所在越南地区等医院为研究单位;以糖尿病肾病患者为研究对象;确定越南东医采用中医治疗进行临床资料回顾性调查研究。
     记录内容与方法:研究者对病例均需填写《糖尿病肾病患者回顾性研究调查表》,记录所用东医治疗方案(包括疗程完成情况)以及治疗疗效。参加临床研究者需经过一定的培训,充分了解临床研究方案和各项检查指标。在填写表格时,如有填写错误不得涂改,可用横线划去并在旁边写上正确内容,并签署修改日期及修改者姓名。
     统计分析方法:①检验水准:所有的统计检验均采用双侧检验,P值小于或等于0.05将被认为所检验的差别有统计意义,若检验差别有意义,则做两两比较。②统计描述:数值变量将采用均数士标准差进行统计描述;分类变量采用频数(出现率)进行统计描述。③结果分析:多组计量资料用方差分析,两两比较采用t检验;样本率比较采用χ~2检验,等级资料采用秩和检验。
     研究结果
     1.研究对象的一般资料:本文261例糖尿病肾病,来源干越南中医院三年的住院病人,均符合DN的临床诊断标准。其中男121例,女140例;男女患者之比为1:1.16;年龄最小为34岁,最大为76岁,男性患者平均年龄高于女性患者(各为59.45±7.41、56.11±7.79),平均年龄57.66±7.78岁。早期12例,临床期224例,晚期25例;治疗效果:显效63例(24.1%),有效115例(44.1%),无效83例(31.8%),有统计学意义(P<0.01)。
     2.证型分析
     2.1按五脏虚证标准研究:糖尿病肾病五脏虚证中以肾虚证(47.5%)为多见,其次为脾虚证(35.6%),肺虚证(3%)及肝虚证(5%)较少见,有统计学意义(P<0.01)。糖尿病肾病Ⅱ期肾虚证的发生率最高(41.6%),但无统计学意义(P>0.05);Ⅲ期、Ⅳ期肾虚证的发生率均为最高(各为48.6%、51.3%),Ⅴ期则以脾虚证发生率最高(52%),有统计学意义(P<0.01)。
     2.2按阴阳气血虚证标准研究:糖尿病肾病气血阴阳虚证中以阴虚证(46%)为多见,其次为气虚证(27.2%),血虚证(18.4%)及阳虚证(8.4%)则较少见,有统计学意义(P<0.001)。糖尿病肾病Ⅱ期阴虚证的发生率最高(41.7%),Ⅴ期则以气虚证的发生率最高(32%),但均无统计学意义(P>0 05);Ⅲ期、Ⅳ期阴虚证的发生率均为最高(各占56.7%、46.5%),有统计学意义(P<0.001)。
     2.3按各种复合证型标准研究:糖尿病肾病复合虚证中以气阴两虚证(41%)为多见,其次为脾肾气虚证(31.4%),阴阳两虚证(4.2%)及肺肾气虚证(3.4%)则较少见,且有统计学意义(P<0.001)。糖尿病肾病Ⅱ期、Ⅲ期、Ⅳ期气阴两虚证的发生率均为最高(各为58.3%、32.4%、43.8%),且均有统计学意义(P<0.001);Ⅴ期则以脾肾气虚证发生率最高(32%),但无统计学意义(P>0.05)。
     2.4按实证标准研究:糖尿病肾病实证中以血瘀证(39.8%)为多见,其次为水湿证及湿热证(各为17.2%、16.5%),气滞证(7.2%)则较少见,有统计学意义(P<0.05)。糖尿病肾病Ⅱ期、Ⅲ期、Ⅳ期、Ⅴ期实证的血瘀证发生率均为最高(各为58.3%、43.2%、38.5%、36%),且均有统计学意义(P<0.05)。
     3.各证型治疗前后实验室查测值的比较:各型在治疗后血糖水平指标均较治疗前明显降低,差异有显著性(P<0.01)。各型在治疗后肾功能指标均较治疗前明显改善,具有显著性差异(P<0.01或P<0.05)。各型在治疗后CHOL、TG、HDL—C、LDL—C改善明显,与治疗前比较,具有显著性差异(P<0.01)。各型在治疗后ApoA、ApoB改善明显,与治疗前比较,具有显著性差异(P<0.01或P<0.05);治疗后各型血压均明显下降,与治疗前比较,有显著性差异(P<0.01)。
     研究结论
     糖尿病肾病是现阶段国际医药界研究的热门。其影响较大,病死率高,是当今亟待解决的重大疑难病症。现代医学尚无理想的治疗药物和方法。人们寄希望于传统医学。本文从越南传统的东医学角度,通过文献资料研究及对东医药临床糖尿病肾病案例的回顾性分析研究,探讨了东医治疗DN的方药及其相关证治规律,希望能为本病临床和科研提供一些新的思路和方法。本研究主要包括以下几个方面:
     1、运用文献学方法,收集、归纳、整理古今文献资料,系统探讨了糖尿病肾病(消渴病肾病)相关病名、病因病机、治疗用药等。由于越南传统东医学与中医药的密切关系和历史渊源,两者之间相互交流,贯穿古今。其理论体系一脉相承。故本文在研究传统东医药诊治糖尿病肾病必然会论及历史悠久的中医药。我们发现传统的东医和中医药学在糖尿病肾病的临床和研究方面有很多共同特征。但二者各有特色,具有不可替代性。特别是越南传统东医学具有明显的地域特色,与中医药学有很强的优势互补性:双方治疗糖尿病肾病的经验和研究成果,能进行迅速而有效的交流。两地所产的大量地道药材亦可通过边贸采用。研究表明,东医治疗糖尿病肾病所用的大量带有中国烙印的“北药”就很好地体现了这一点。
     2、本文运用统计学方法,对东医药临床糖尿病肾病261例病案进行回顾性分析研究,发现DN患者中以肾虚证表现为主(47.5%),其次为脾虚证(35.6%)。肾虚证始终贯穿DN分期;Ⅴ期则以脾虚证发生率最高(52%),脾肾虚可能是导致DN病情发展的重要因素。肾脏功能的虚损始终影响着DN病程的发展,脾脏功能的虚损过程与DN病程发展密切相关。这对糖尿病肾病关键时期的救治有重要提示作用。此外研究发现DN患者以气阴两虚证(41%)为多见,其次为脾肾气虚证(31.4%),血瘀证(39.8%)。糖尿病肾病Ⅱ期、Ⅲ期、Ⅳ期、Ⅴ期实证的血瘀证发生率均较高(各为58.3%、43.2%、38.5%、36%),可见血瘀证贯穿整个DN病程,随着正气的虚损,水湿证、湿热证、湿浊证逐渐增多,水液代谢失常逐渐加重。这些对糖尿病肾病各期的治疗有重要参考价值。
     3、本研究通过文献和临床病案回顾性分析研究,对越南传统东医诊治糖尿病肾病的方药证治规律有了一定的了解。发现了不少传统东医治疗糖尿病肾病较为有效的方法和方药。特别是一些具有越南地域特色的“南药”,对糖尿病肾病的临床应用和研究都有较大的价值和潜力。本文还介绍了导师临床辨治糖尿病肾病行之有效的一些独特经验和方法。这对共同探讨糖尿病肾病的辨治有良好借鉴意义。
The Diabetic Nephropathy(DN) is a frequent chronic capillaries complications of Diabetes Mellitus(DM) and difficult to be cured,having become one of the main cause of deaths of the diabetic.The Diabetic Nephropathy is the main reason that causes eventually in last phase the kidney disease (the end-stage renal disease,ESRD) in developed countries,about 30%- 40% diabetic will develop into the diabetes kidney disease,then developed into the ESRD,and the ESRD outbreak rate is year by year rising.The modern medical treatment mainly is various disease and factor that controls the blood sugar, controls the blood pressure and rectifies the fat metabolism mess with other influence kidney function,once entering the kidney function to crock up the stage,an ability is dialysis or kidney transplantation.But the Chinese medicine cures the DN,not only improved the clinical symptoms,the protection of renal function,slow down and stop the disease progression of renal damage and improve quality of life in patients with DN,and the poisonous side effect is very small,by the international medical attention.Vietnamese traditional medicine by the influence of Chinese medicine it is.Therefore the Vietnamese tradition of medical research and treatment of diabetic nephropathy in Chinese medicine inevitably involves.Vietnamese traditional medicine as a result of special historical and geographical relations,the Vietnam Traditional Medicine and Chinese Medicine to seek effective measures to control the DN and the therapeutic drug,is a topic of concern.
     Objective
     Through literature research and analysis of modern statistical methods, and explore the evolution of diabetic nephropathy and the treatment of the laws of the track,hoping to be able to provide effective prevention and treatment of diabetic nephropathy and learn more new ideas.First of all,learn the methods of use of literature,organize the collection of ancient literature, from the perspective of historical development of ancient medicine on diabetic nephropathy about a comprehensive summary and review.Analysis of the disease evolution of diabetic nephropathy,etiology,pathogenesis,differentiation, in principle,treatment,prescriptions and many other aspects to the overall understanding of the development of diabetic nephropathy syndrome differentiation rules of literature to lay the future of basic research.
     Secondly,the combination of the DN observed large sample of cases, evidence of various types of symptoms,examination of the target to use scientific statistical methods for analysis.DN at the standardization of Chinese medicine clinics,the objective of providing more reliable on the basis of clinical and clinical exploration of more effective treatment methods to provide a basis to make it more comparable and scientific.
     Method
     Research program:A retrospective survey design research methods.
     Research principles:Strict accordance with the selected criteria, diagnosed in patients with diabetic nephropathy.Collection,including the general situation,personal past history,their own symptoms,laboratory tests, treatment modalities,such as statistical analysis of data.
     Sources and case study:In order to select a reasonable source of information,increase the credibility of clinical research,the development of our region such as Vietnam,where the research unit for the hospital;to patients with diabetic nephropathy were studied;to determine the use of Vietnamese traditional medicine for the treatment of Chinese traditional medicine Retrospective clinical investigation and research information.
     Record Content and Methods:The researchers need to fill in for cases "in patients with diabetic nephropathy questionnaire retrospective study",Record of Vietnamese traditional medicine used in treatment programs(including the completion of treatment),as well as treatment.Clinical researchers take part in the training must go through a full understanding of clinical research programs and the inspection target.In completing the form,fill in error shall not be altered if there can be designated line and go right up next to the content of written and signed amendment to amend the date and name.
     Statistical Analysis Methods:①Test standards:All statistical tests are used both tests,P values less than or equal to 0.05 by the test will be considered statistically significant difference,if the test meaningful differences,the two make the comparison.②Statistics Description:Variable will use the average value±standard deviation for descriptive statistics; classification using variable frequency(rate) for statistical description.③Analysis:Multiple analysis of variance with measurement data,compare the two using the t test;sample rateχ~2 test data using Level rank sum test.
     Results
     1.General information on the study:In this study,261 cases of diabetic nephropathy,the source of three years,do the Vietnamese hospital in-patients, are consistent with the clinical diagnostic criteria for DN.Man one of 121 cases,140 cases of female;the ratio of male and female patients 1:1.16;the youngest was 34 years old,maximum 76 years old,the average age of male patients than female patients(59.45±7.41,56.11±7.79),with an average age of 57.66 years old±7.78.12 cases of early,224 cases of clinical stage, 25 cases of late;Treatment:63 cases markedly effective(24.1%),115 cases of effective(44.1%),83 cases of invalid(31.8%),there is statistical significance(P<0.01).
     2.Evidence-based analysis
     2.1 Deficiency organs according to five criteria for research:Five organs of diabetic nephropathy Kidney Deficiency in evidence(47.5%) were much, followed by spleen deficiency(35.6%),lung deficiency(3%) and liver deficiency(5%) is less common,there is statistical Significance of study (P<0.01).PhaseⅡDiabetic Nephropathy Kidney permit the highest incidence (41.6%),but no statistical significance(P>0.05);ⅢPhase,Ⅳcertification period the incidence of kidney deficiency are the highest(48.6 percent each, 51.3%),Ⅴa view to spleen deficiency with the highest incidence(52%),there is statistical significance(P<0.01).
     2.2 According to yin and yang,qi and blood deficiency Standards: Deficiency of yin and yang qi and blood of diabetic nephropathy in Yin-deficiency(46%) as much,followed by Qi(27.2%),blood deficiency Standards(18.4%) and Yang(8.4%) were less common,there is statistical Significance of study(P<0.001).PhaseⅡDiabetic Nephropathy deficiency permits the highest incidence(41.7%),PhaseⅤ:Qi highest incidence(32%), but no statistical significance(P>0.05);ⅢPhase,ⅣPhase permit the incidence of deficiency are the highest(56.7%,46.5%),there is statistical significance(P<0.001).
     2.3 According to a variety of complex research evidence standard:Diabetic nephropathy with compound deficiency of Qi-Yin Deficiency card(41%) as much, followed by spleen and kidney Qi deficiency(31.4%),deficiency of yin and yang of two(4.2%) kidney and lung deficiency(3.4%) than rare,and there is statistical significance(P<0.001).PhaseⅡdiabetic nephropathy,ⅢPhase,Ⅳcertification period the incidence of both Qi and Yin deficiency are the highest(58.3 percent each,32.4%,43.8%),and were statistically significant (P<0.001);Ⅴperiod Spleen and Kidney Qi deficiency in the highest incidence (32%),but no statistical significance(P>0.05).
     2.4 According to the standard empirical research:Evidence of diabetic nephropathy with blood stasis syndrome(39.8%) were much,followed by wet and humid certification card(all for 17.2%,16.5%),gas stagnation(7.2%) were less common,there is statistical significance(P<0.05).PhaseⅡdiabetic nephropathy,ⅢPhase,Ⅳphase,Ⅴphase evidence of the incidence of blood stasis are the highest(58.3 percent each,43.2%,38.5%,36%),and were statistically significant(P<0.05).
     3.The evidence-based laboratory investigations before and after treatment comparison of measured values:The type in the target blood glucose levels after treatment were significantly lower before treatment,there was a significant difference(P<0.01).Various types of renal function after treatment than before treatment target a marked improvement,with significant difference(P<0.01 or P<0.05).After treatment at various types of CHOL,TG, HDL-C,LDL-C to improve significantly,compared with before treatment,with significant difference(P<0.01).After treatment at various types of ApoA, ApoB improve significantly,compared with before treatment,with significant difference(P<0.01 or P<0.05);various types of blood pressure after treatment were significantly decreased,compared with before treatment,there is significant difference(P<0.01).
     Conclusion
     Diabetic nephropathy is the international medical research at this stage the most popular.The impact of larger,high mortality,is in urgent need of solution in today's major illnesses.Modern medicine has not yet ideal and methods of treatment.We all hope that the treatment with traditional medicine. This article from the perspective of the Vietnamese traditional medicine, through research and documentation of the Vietnamese traditional medicine clinical diabetic nephropathy in a retrospective analysis of case study to examine the treatment of the Vietnamese traditional medicine prescriptions DN of the certificate and its associated governance principles and we hope for the clinical and DN scientific research to provide some new ideas and methods.The purpose of this study include the following:
     1.The use of literature methods to collect,summarize,collate information on ancient and modern literature,the system of diabetic nephropathy(DN)-related disease,pathogenesis,treatment,medication.v.v. As a result of the Vietnamese traditional medicine and the close relationship between Chinese medicine and the history of mutual exchanges between the two countries,through the ancient and modern.The same theoretical system. Therefore,this article on Vietnamese traditional medicine in the diagnosis and treatment of diabetic nephropathy is bound to deal with a long history of Chinese medicine.We found that the Vietnamese and Chinese traditional medicine in diabetic nephropathy and the clinical research there are many common features.Vietnam and China but also has characteristics with irreplaceability.Vietnamese traditional medicine in particular,has obvious geographical characteristics,and Chinese medicine has a strong complementary advantages;the treatment of diabetic nephropathy both experience and research results can be rapid and effective communication.Both produced a large number of authentic ingredients can also be used through the border trade.Studies have shown that the Vietnamese traditional medicine used in the treatment of diabetic nephropathy with Chinese brand of a large number of "Northern medicine" on a good reflection of this.
     2.In this paper,the use of statistical methods,traditional medicine of Vietnam 261 cases of clinical diabetic nephropathy cases were retrospectively analyzed the findings of a study of patients with DN in the performance of Kidney evidence-based(47.5%),followed by spleen deficiency (35.6%).Kidney Deficiency DN stages throughout;Ⅴphase with the highest incidence of Spleen Deficiency Syndrome(52%),spleen and kidney may lead to false DN an important factor in the progression of the disease.Poor kidney function always affects the course of the development of DN,spleen function of poor course of the development process and is closely related to DN.This is a critical period of diabetic nephropathy where the role of important tips. The study found that patients with DN to Qi Yin deficiency(41%) for many, followed by spleen and kidney Qi deficiency(31.4%),blood stasis syndrome (39.8%).PhaseⅡdiabetic nephropathy,ⅢPhase,Ⅳphase,Ⅴphase evidence of the incidence of blood stasis were higher(58.3 percent each,43.2%,38.5%, 36%),blood stasis can be seen throughout the course of DN,With the health of poor,wet card,damp-heat syndrome;wetlands permit a gradual increase in turbidity,water gradually increase metabolism disorders.These stages of diabetic nephropathy treatment has an important reference value.
     3.In this study,through literature and clinical analysis of a retrospective study of cases of Vietnamese traditional medicine diagnosis and treatment of diabetic nephropathy Treatment prescriptions a certain understanding of the law.Found a lot of Vietnamese traditional medicine is more effective treatment of diabetic nephropathy in the methods and prescriptions.In particular,a number of geographical features of Vietnam's "Southern medicine",diabetic nephropathy on clinical applications and research have greater value and potential.This article also describes a professor of clinical syndrome differentiation of diabetic nephropathy identified a number of well-established unique experience and methods.This is to discuss the Diagnosis and Treatment of diabetic nephropathy have a good reference.
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