基于Meta分析法近20年经方治疗糖尿病及并发症临床文献整理
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摘要
目的:
     2型糖尿病及并发症是十分普遍的慢性疾病,香港约有七十万港人患糖尿病,数字亦有持续上升的趋势,而中国亦日加严重。经方在治疗糖尿病及其并发症方面,无论过去、还是现在均有卓效。本文运用Meta分析法,冀通过对近20年公开发表的临床资料进行系统回顾及分析,并结合名家临床经验,对经方治疗糖尿病及并发症的疗效及理法方药做出较完整的论述,为今后临床研究推广经方提供指引和借鉴。
     方法:
     选用符合一定科学研究标准之文献,运用Meta分析法,比较经方与西医治疗糖尿病及并发症的疗效;通过统计糖尿病及并发症常用方药与治则,总结糖尿病及并发症的治疗规律,为以后临床研究提供指引和借鉴。资料来源:在中国期刊网上搜索与经方及糖尿病有关的文献资料。搜索的关键词主要有:“糖尿病”,“消渴病”“伤寒论”、“经方”、伤寒论及金匮中的每个方名、及多位经方名家的名字。以“主题”、“作者”、“关键词”、“摘要”、“题目”进行搜寻。
     资料入选:按照研究目的对文献数据进行筛选处理。
     1.删去重复文献。
     2.将文献分为糖尿病和糖尿病各个并发症。
     3.选择有设立对照的临床文献,以作科学性的系统回顾。
     4.删去文献量不足的病,加强meta分析时的可信性。
     5.结合名家临床经验及meta分析提出结论。
     统计分析:使用RevMan5.2作疗效评估,以Odds Ratio, OR或RR统计,其95%CI表示,其他如证型,治则,药物,方剂之统计,使用Microsoft Office Excel软件作分析。
     结果:
     检索获得19527篇文献题录,通过阅读题目及摘要收集1762篇。根据纳入和排除标准共入选94篇。其中,2型糖尿病[16篇]、糖尿病周围神经[41篇]、糖尿病足[3篇]、糖尿病胃瘫[14篇]、糖尿病神经原性膀胱病变[2篇]、糖尿病肾病[13篇]、糖尿病脑梗死[3篇]、糖尿病高血脂症[2篇]。
     一、临床疗效比较
     经方治疗2型糖尿病,治疗组明显好转率为54.22%,对照组为34.12%。,16篇文献没有明显差异性,(R R)为0.2可信区为0.16-0.24,P<0.05,其疗效差异具有非常显着统计学意义。
     大柴胡汤治疗2型糖尿病,治疗组明显好转率为54.54%,对照组为18.05%。文献没有明显异质性,(R R)为0.37可信区为0.23-0.52,P<0.05,其疗效差异具有非常显着性统计学意义。
     金匮肾气丸治疗2型糖尿病,治疗组明显好转率为51.14%,对照组为31.76%。文献没有明显异质性。(R R)为0.19可信区为0.12-0.27,P<0.05,其疗效差异具有非常显着统计学意义。
     经方治疗2型糖尿病周围神经病变,治疗组明显好转率为55.30%,对照组为24.11%。文献没有明显异质性,(OR)为3.97可信区为2.70-5.84,P<0.05,其疗效差异具有非常显着统计学意义。
     经方治疗2型糖尿病足,治疗组明显好转率为41.67%,对照组为28.43%。文献没有明显异质性,(OR)为1.89可信区为1.04-3.41,P<0.05,其疗效差异具有非常显着统计学意义。
     经方治疗2型糖尿病胃轻瘫,治疗组明显好转率为51.63%,对照组为31.03%。(OR)为2.48可信区为1.9卜3.21,P<0.05,其疗效差异具有非常显着性意义。经方治疗2型糖尿病周围神经病变,治疗组明显好转率为51.64%,对照组为26.91%。(OR)为3.06可信区为2.63-3.55,而P<0.05,其疗效差异具有非常显着统计学意义。经方治疗2型糖尿病肾病周围神经病变,治疗组明显好转率为41,86%,对照组为20.22%。文献没有明显异质性,(OR)为3.07可信区为2.32-4.05,P<0.05,其疗效差异具有非常显着统计学意义。
     经方治疗2型糖尿病血脂异常,治疗组明显好转率为40.00%,对照组为26.53%。2篇文献没有明显异质性,(OR)为1.58可信区为0.85-2.95,P<0.05,其疗效差异具有非常显着统计学意义。
     二、中医病机、治法与方剂分析
     2型糖尿病最常见病机:包括气虚,阴虚,热,瘀,脾虚,气机不利,肾虚;常用治法:包括祛瘀,滋阴,温阳,清热,补气,补肾;常用经方:肾气丸,大柴胡汤,白虎汤。
     2型糖尿病周围神经病变最常见病机:包括瘀,阴虚,阳虚;最常用治法:补气,化瘀,温阳散寒;最常用经方:黄芪桂枝五物汤,当归四逆汤。
     2型糖尿病足最常见病机:瘀,热;最常用的治法:温阳,清热,化瘀,益肾,补气,养阴;最常用的方剂:金匮肾气丸。
     2型糖尿病胃瘫,最常见病机:寒热错杂或互结,阴虚,脾胃虚,痰湿饮;最常用的治法:健脾和胃,祛痰化饮,益气,降逆平胃;最常用经方:半夏泻心汤、麦门冬汤。
     2型糖尿病神经原性膀胱病变研究中,未见特别突出病机,与文献纳入量小有关。
     2型糖尿病肾病,最常见病机:阴虚,阳虚,肾虚;最常用的治法:祛水湿痰,祛瘀,温阳;最常用经方:金匮肾气丸,五苓散,真武汤。
     2型糖尿病脑梗死,常见病机:瘀,阴虚;常用治法:祛瘀,益气,滋阴,温阳;常用经方:金匮肾气汤。
     2型糖尿病高血脂症,常用治法有清热,化痰,益肾,调脾,温阳,养阴;主要病位在脾病。
     结论:
     经方治疗糖尿病及并发症效果佳。
     糖尿病中后期多有血瘀,而气机不利在不同阶段皆有出现。早期糖尿可见热症,中后期多见肾虚证。
     糖尿病中后期多用化瘀药。调畅气机、疏肝解郁能进一步提高疗效。
     2型糖尿病周围神经病变以血瘀为本,活血化瘀贯穿全程,补气法也是常用治法。
     2型糖尿病足,血瘀病机贯穿全程,虚证多见,由于血瘀跟正虚比重不同,用药比例亦不同。温阳亦为最多用的治法。
     2型糖尿病胃轻瘫,半夏在所有证型主方或加减药中多见,半夏泻心汤最为多用。健脾和胃是本病总法,但须助以其他治法。祛瘀法相对应用较少,在久病后间有运用者。
     2型糖尿病神经原性膀胱,设有对照组的临床研究资料较少。
     2型糖尿病肾病,病情严重亦较复杂,证型多有兼夹,邪实正虚互见,多以正虚为主,邪实为主的证型较少;正虚中必见邪实,邪实中必见正虚。虚证中以肾虚为主,血瘀症状贯穿本病全程。
     2型糖尿病脑梗死中,瘀血贯穿全程,而正虚亦必见,治疗宜把握邪实正虚的比例。
     2型糖尿病血脂异常,血脂、血糖互为影响,两者往往一同恶化,或一同好转,治疗亦须互相顾及。创新点
     首次运用Meta分析法对近20年运用经方治疗糖尿病及并发症相关文献进行整理,并对中医辨治规律进行了初步探讨。
     不足与展望
     1.部分并发症的文献量不足,即现时以经方治疗多没有设立对照组;
     2.部分文献对病因病机、治则、分型、方药运用记录不全;
     3.大部分文献资料显示,随证加减的药物比主方用药还多。
     基于文献整理中发现问题,对未来临床研究提出以下建议:
     1.增加以经方为主临床运用研究,并设立对照组,使研究结论更具说服力;
     2.文献中病因病机,分型用药的记录应系统而清晰;
     3.减少主方后加减药物数量,确保用方的专一度;
     4.增加经方与时方的临床运用对照研究。
Objective
     Diabetes and its Complications is very common chronic disease in Hong Kong, about700,000Hong Kong people suffering from it, this number is still increasing, and condition in China is more serious.
     No meter the past or now, theTreatment of Discussion of Treatise on Cold-Induced and Miscellaneous Diseases on Diabetes II and its complications is also good, but we still don't have a systematic study on it. In this thesis, we aim to use systematic review and evident base study together with the experience of those masters, to study the efficacy of theTreatment of Discussion of Treatise on Cold-Induced and Miscellaneous Diseases on Diabetes Ⅱ and its complications and summarize, investigate its recipe, treatment law, in order to guide the future clinical or research theTreatment of Discussion of Treatise on Cold-Induced and Miscellaneous Diseases on Diabetes II and its complications.
     Methods
     RevMan5.2will be used as the assessment of the efficacy, as OR or RR95%CI. Microsoft Office Excel is used as the study of calculation of syndrome type, treatment law and the prescriptions.
     By using different keyword such as the formula name, books name and diseases name, searching on the database:CNKI. Then1. Deleting repeated literature.2. Dividing the Literature is into two group diabetes II and diabetes complications.3. Select the literature have controlled clinical study for the systematic review.4. Combining and investigating the result of systematic review.
     Results
     X19527result is get in the first search, by reading the title and abstract collection1762. According to the inclusion and exclusion criteria were collected58:including Type2diabetes [16], diabetic peripheral neuropathy (5), diabetic foot (3), diabetic gastroparesis [14], diabetes, neurogenic bladder lesions (3), diabetic nephropathy [13], diabetes, cerebral infarction(3), diabetes hyperlipidemia (2).
     Treatment of type2diabetes, the treatment group was significantly improved to54.22%,34.12%in the control group.16literature there is no significant heterogeneity (RR)0.2confidence interval0.16-0.24, P<0.05, statistically there is a very significant meaning.
     The big bupleurum in the treatment the type2diabetes, treatment group was significantly improved to54.54%in the control group was18.05%. Literature there is no significant heterogeneity (RR)0.37confidence interval0.23-0.52, P<0.05, statistically there is a very significant meaning.
     Jinkuishenqiwan the treatment of type2diabetes treatment group was significantly improved to51.14%, and31.76%in the control group. Literature there is no significant heterogeneity.(RR)0.19confidence interval0.12-0.27, and P<0.05, statistically there is a very significant meaning.
     Treatment of type2diabetes and peripheral neuropathy treatment group was significantly improved to55.30%,24.11%in the control group. Literature there is no significant heterogeneity (OR)3.97confidence interval2.70-5.84, P<0.05, statistically there is a very significant meaning.
     Treatment of type II diabetic foot treatment group was significantly improved to41.67%,28.43%in the control group. Literature there is no significant heterogeneity (OR)1.89confidence interval1.04-3.41, and P <0.05, statistically there is a very significant meaning.
     Treatment of type2diabetic gastroparesis treatment group was significantly improved to51.63%,31.03%in the control group.(OR)2.48confidence interval1.91-3.21, P<0.05, statistically there is a very significant meaning.
     Treatment of type2diabetes and peripheral neuropathy treatment group was significantly improved to42.86%,23.91%in the control group. Literature can be combined.(OR)3.11confidence interval1.22-7.93, P<0.05, statistically there is a very significant meaning.
     Treatment of type2diabetic nephropathy peripheral neuropathy treatment group was significantly improved for41,86%of the control group was20.22%. Literature there is no significant heterogeneity (OR)3.07confidence interval2.32-4.05, P<0.05, statistically there is a very significant meaning
     Treatment of type2diabetes and peripheral neuropathy treatment group was significantly improved to76.77%,49.77%in the control group. Literature there is no significant heterogeneity (OR)3.33confidence interval2.19-5.05, P<0.05, statistically there is a very significant meaning.
     The treatment of type2diabetes and high cholesterol lesions and Western medicine Comparison of efficacy of the treatment group was40.00%,26.53%in the control group. After statistics, the two literature there is no significant heterogeneity (OR)1.58confidence interval0.85-2.95, and P<0.05, statistically there is a very significant meaning.
     The six most common symptom type of diabetes II:1. Deficiency of Qi, deficiency of Yin3. heat4. Stasis, spleen6. Inefficiency of qi, deficiency of kidney. Six most commonly used Therapeutic law:1. Eradicates stasis, Reinforcing Yin, Reinforcing yang, clear the heat, reinforcing qi, and Reinforcing kidney. The most commonly used prescription:1. Shen Qi Wan2. large Chai Hu soup3BHT.
     Type2diabetic peripheral neuropathy three most common symdrome type: stasis, Deficiency of yin, Deficiency ofyang. The three most commonly used treatment Law:clear the stasis, reinforcing qi, reinforceing yang and clear cold, the two most commonly used prescription:Astragalus Gui Zhi Wu Wu the soup, Dangguisini soup.
     The two most common syndrome type of the type2diabetic foot:stasis, heat, the most commonly used Therapeutic law:warming yang and, clear heat, clear the stasis reinforcing kidney, reinforcing qi, reinforcing yin, the most commonly used prescription:Jingguishenqi pill
     Type Ⅱ diabetes gastroparesis most common syndrome:mixed cold and heat or each knot,yin deficiency, spleen and stomach,phlegm drink. The most commonly used Therapeutic law:built spleen and stomach, phlegm wet drink, Qi, Jiangni flat stomach. The most commonly used prescription:BanxiaxiexinTang, wheat Asp soup.
     Type Ⅱ diabetes neurogenic bladder disease research is not a particularly outstanding syndrome type the literature into a smaller number.
     The three most common syndrome type of type2diabetic nephropathy:yin, yang, kidney. The three most commonly used TreatmentLaw:eradicates wet phlegm, expel stasis, warming yang and. The three most commonly used prescription:Jingguishenqi pill, Wulingsan, Zhen Wu Tang.
     Type2diabetes and cerebral infarction is a common finding cure the two most common syndromes:stasis, yin deficiency. The four most commonly used Treatment Law:expel stasis, qi, yang, Yin Zi. Most commonly used the prescription:Jinkuishenqitang soup.
     Type2diabetes and hyperlipidemia Therapeutic law heat, phlegm, reinforcing kidney, spleen adjustment, warming yang and, Yin. Most common syndrome type spleen disease.
     Conelusion
     XThe results show that, classical prescriptions the treatment of diabetes and complications than Western.
     Diabetes late emergence of blood stasis, inefficient of qi is more common in recent years, pathogenesis, and inefficient of qi different stages Individually appear. The Early Diabetes visible heat syndrome, the late kidney deficiency syndrome is more common.
     The diabetes Therapeutic law more common in the late circulation drugs, adjusting qi or liver qi stagnation can improve part of the traditional three-consumer poor efficacy of the treatment of patients.
     Type2diabetic peripheral neuropathy stasis-oriented, and the blood circulation throughout the entire process, such as the most common treatment method is qi law
     Type Ⅱ diabetic foot bleeding throughout the whole of this disease, the deficiency of this disease is also common, but due to blood stasis with positive imaginary proportion of different, the amount is also different. Warming Yang is also the most used treatment method.
     Type2diabetic gastroparesis Pinellia eradicates wet goods, common in all the evidence the main square or subtraction drugs, of which to Pinellia Xiexin soup the most multi-purpose. Built the General Law of the spleen and stomach of the disease, but also help to treatment method. Eradicates stasis method applied in this disease compared to other complication, but after a long illness into each other.
     Type Ⅱ diabetes neurogenic bladder lesions with the experiment of the control classical prescriptions the treatment of this disease is still insufficient.
     Type2diabetic nephropathy, a serious condition than complex, multi-syndrome and folders, evil is real positive imaginary cross, but based on syndrome-based virtual type, evil is real syndrome-based type is relatively small, but positive virtual shall see the real evil, real evil shall see the positive imaginary. Virtual syndrome type, mainly in the kidney, stasis symptoms of the disease has been throughout the entire process.
     Problems of this thesis
     1. Part of the literature of complications insufficient, due to the insufficient clinical studies of present classical prescriptions treatment with the control group
     2. Part of the literature on the etiology and pathogenesis or Therapeutic law or sub-type or prescription records are incomplete or ambiguous record.
     3. Most of the literature, addition and subtraction drugs with the card becomes even more than the main square with the drug.
     In this thesis, the problems found indicating future research directions, the following is the outlook for the future clinical papers:
     1. Increase classical prescriptions the main prescriptions, a controlled clinical study, so the future research and analysis can be more convincing.
     2. Documented etiology and pathogenesis, classification, medication should be more systematic and clear.
     3. To minimize changes in the main prescriptions after subtraction drug, to ensure that the square of specificity.
     4. Control study should be set during the studying of classical prescriptions.
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