【作者】 林韵忠；

【导师】 廖世煌；

【作者基本信息】 广州中医药大学 ， 中医临床基础， 2010， 博士

【摘要】 目的本临床采用双盲随机对照试验,探讨半夏白术天麻汤合温胆汤加减治疗高血压痰湿壅盛证的临床有效性和安全性,进而为痰湿壅盛证方证相应研究提供临床依据。方法研究对象选取自2008年11月至2009年12月到台湾崇光中医门诊就诊的高血压病人60例。西医诊断按照《1999年WHO／ISH高血压治疗指南》中的高血压病诊断及分级标准执行；中医诊断参照2000年《中医新药临床研究指导原则》(试行)中的高血压病辨证标准及中医症状分级量化标准。以痰湿壅盛型为主证的高血压病患者60例均符合上述诊断标准,分级属Ⅰ～Ⅱ级。排除继发性高血压,合并有肝、脑、心、肾和造血系统严重原发疾病者。按照1：1的比例采用简单随机法实施随机分组,治疗组采用与痰湿壅盛证相对应的半夏白术天麻汤合温胆汤加减治疗,对照组采用不对证的四君子汤治疗。两种方药均按照一日份9克装在0号胶囊里制成GMP科学中药胶囊,要求两组药物的外形、颜色、包装、服法基本一致,以保证双盲的实施。两组患者早晚各服5粒(相当于生药4.5g),1月为1个疗程。治疗前、治疗1疗程后,分别记录高血压患者的临床症状体征(眩晕、头痛、头重如裹、胸闷、呕吐痰涎等)和血压,并进行中医证候疗效和高血压疗效评定。在临床试验过程中,密切观察可能出现的不良反应症状,并须如实记录。数据处理方法：统计方法：分类资料用χ2检验,等级资料用两样本比较采用Ridit分析,两样本均数比较用t检验,自身前后比较用配对t检验。采用Epi Data3.01软件建立数据库,SPSS17.0软件进行统计分析,Graph Pad Prism4.03软件进行统计图形绘制。结果本研究共有合格受试者例60例,治疗组和对照组各30例,两组平均年龄分别为57.9和60.5岁,男34例,女26例。两组治疗前年龄、性别、病程、高血压分期及中医临床症状体征分布、血压水平(收缩压、舒张压)比较,差异均无统计学意义(P>0.05)。说明两组治疗前的基线基本一致,具有可比性。经过一个疗程的治疗后,疗效结果比较如下：(1)两组中医证候疗效治疗组显效率23.3%,有效率63.3%,总有效率86.7%；对照组显效率10%,有效率66.7%,总有效率76.7%。两组中医证候疗效比较,差异无统计学意义(P>0.05)。说明治疗组和对照组在改善中医症候总体疗效评分上均有较好的疗效,虽然两组之间没有差异,但说明了中医药对治疗痰湿壅盛证高血压的有效性。(2)两组高血压疗效Ⅰ期高血压治疗后疗效：治疗组显效率20.0%,有效率50.0%,总有效率70.0%；对照组显效率0%,有效率28.6%,总有效率28.6%。治疗组的总有效率高于对照组近45个百分点,尽管没有统计学差异,但说明半夏白术天麻汤合温胆汤相对于四君子汤,在降低Ⅰ期高血压患者血压方面略有优势。Ⅱ期高血压治疗后疗效：第Ⅱ期高血压治疗后疗效：治疗组显效率5.0%,有效率80.0%,无效15.0%；对照组显效率0%,有效率43.5%,总有效率43.5%,两组疗效比较,差异有统计学意义(P<0.05)。治疗组治疗Ⅱ期高血压的总有效率显著高于对照组。说明半夏白术天麻汤+温胆汤可以有效降低Ⅱ期高血压。(3)临床症状体征改善程度及消失情况治疗组治疗后,眩晕、头痛、头重如裹、胸闷、呕吐痰涎、心悸、失眠改善1级以上的高血压患者分别占90.0%、96.3%、88.5%、90.0%、80.0%、50.0%、95.5%,对照组分别为48.0%、57.1%、78.3%、83.3%、50.0%、23.1%、47.6%。两组比较,治疗组和对照组在眩晕、头痛、头重如裹、胸闷、失眠症状方面具有统计学意义(P<0.01),以治疗组疗效较好。而在呕吐痰涎、心悸方面无统计学意义(P>0.05)。可见治疗组对痰湿壅盛证高血压的临床症状体征改善均较为显著,对照组对上述症状也均有一定的改善,尤其是对头重如裹、胸闷改善较好。临床症状消失率比较,治疗组眩晕、头痛、头重如裹、胸闷、失眠症状消失率均高于对照组(均P<0.05)；呕吐痰涎、心悸、症状消失率治疗组虽比对照组稍高,但经比较差异均无统计学意义(均P>0.05)。由此可知,半夏白术天麻汤合温胆汤加减在改善高血压痰湿壅阻型的临床症状体征均比四君子汤疗效好。(4)治疗前后收缩压、舒张压改变情况治疗后收缩压,治疗组平均下降2.80±2.02kpa,前后比较差异显著(P<0.01)；对照组收缩压平均下降0.80±0.32 kpa,前后比较差异有统计学意义(P<0.05)；两组组间比较,差异有统计意义(P<0.01)。治疗后舒张压,治疗组平均下降2.86±1.14 kpa,前后比较差异显著(P<0.01)；对照组平均下降0.76±0.71 kpa,前后比较差异有统计学意义(P<0.05)；两组治疗后舒张压比较,差异有统计意义(P<0.05)。两组均能降低高血压患者的收缩压和舒张压,治疗组比对照组疗效略高一筹。特别是治疗前后疗效显著。(5)血压恢复正常情况以收缩压≥21.3Kpa或／和舒张压≥12.7为标准来评价血压是否恢复正常,结果发现治疗组83.3%的患者血压恢复正常,对照组为30.0%,两组血压恢复正常的比率差异有统计学意义(P<0.01)。治疗组优于对照组,这应该就是应用方证相应的结果。安全性评价结果：治疗前后及治疗期间均无发现任何不良反应。结论1.半夏白术天麻汤合温胆汤对痰湿壅盛证高血压病不同分期的疗效相似。对收缩期和舒张期的血压均有效。2.半夏白术天麻汤合温胆汤能够有效改善痰湿壅盛证高血压病临床常见症状,特别是眩晕、头痛、头重、胸闷、呕吐痰涎、失眠等临床症状。3.半夏白术天麻汤合温胆汤能够有效消除眩晕和头痛这两个高血压病的主要症状。4.半夏白术天麻汤合温胆汤治疗痰湿壅盛证高血压病具有安全有效的特点,同时与四君子汤相比,应用半夏白术天麻汤合温胆汤进行方证相应的方法治疗痰湿壅盛证高血压有明显优势。更多还原

【Abstract】 ObjectiveThe research deployed clinical marched ran-control study, which was observed the clinical curative effect and safety of combined Pinelliae and Atractylodis Macrocephalae and Gastrodiae Decoction (PAD) and Decoction for Clearing Away Gallbladder Heat (DCH) for treating high blood pressure (HBP) with phlegmatic hygrosis flourishing syndrome patients in order to approach the clinical basement of formula and syndrome corresponding research for phlegmatic hygrosis flourishing syndrome.MethodsTo select the 60 candidates that treated in the TCM clinic service department of Chongguang in Taiwan from Nov.2008 to Dec.2009, which coincidence with the bolting standard of HBP. The diagnosis and classification of standard in western medicine was refered to the Treatment Guidance of WHO/ISH HBP 1999. The diagnosis and classification of standard in Chinese medicine was refered to Clinical Research Guidance Principle of Chinese New Drug (2000, sample version). The 60 candidates were all consistent with the standard as above, who belong to phlegmatic hygrosis flourishing syndrome andⅠ～Ⅱdegree. The patient who had secondary hypertension combined liver、brain、heart、kidney and hematopoietic system serious primarily disease was not included. Divided the candidates at the ratio of 1:1 into the treatment group and the control group randomly. The treatment group was treated with combined PAD and DCH for HBP patients with phlegmatic hygrosis flourishing syndrome. The control group was treated with Decoction of Four Mild Drugs. These two kinds of medicine that packed 9g in NO.0 Chinese medicine caps with GMP standard were all reqused at similar shape、color、package and regimen in ord to guarantee the practice of double-blind. Each group was taken 5pills at morning and evening time respectively, lmonth as a course of treatment. Before and after a course of treatment, respectively recorded the clinical symptom (dizzy、headache、heaviness of head、chest distress、spit phlegm) and blood pressure and evaluated the curative effect of symptom and high blood pressure. Observed and recorded the possible adverse effect in the treatment procedure.Statistical methods:Database was set up with the software of Epi Data3. 1.The statistical analysis was used with the software of SPSS17.0. Two group mean comparison was observed using t-test. Matched t-test was applied for self-AP:PA comparison. The classification data was observed using 2 Test. The ranked data was observed using Ridit analysis. The software of Graph Pad Prism 4.03 was used for statistical figure.ResultsThere were 60 candidates and each group was 30 cases. The ages of two groups were 57.9 years old and 60.5 years old respectively.34 cases were male and 26 cases were female. Comparability of baseline characteristics of patients in two groups of age、gender、disease course、high blood pressure staging、clinical symptom in TCM distribution and the level of blood pressure, there was no statistical significance between two groups which showed that the baseline data were comparable (P>0.05)After a course of treatment, results of research as follows:(1) The clinical curative effect in two groups It was showed that the excellence rate of the treatment group was 23.3%, and the effective rate was 63.3%, the total effective rate was 86.7%. While in the control group, the excellence rate of the treatment group was 10%, and the effective rate was 66.7%, the total effective rate was 76.7%. It was showed that the excellence rate of the treatment group was 23.3%, and the effective rate was 63.3%, the total effective rate was 86.7%. While in the control group, the excellence rate of the treatment group was 10%, and the effective rate was 66.7%, the total effective rate was 76.7%. There was not significant difference between two groups of symptom effect in TCM (P>0.05).It was presented that these two groups had good effect on improving the total effect score in TCM symptom. Athough there was not statistically significant, it was showed that there was effective of treating phlegmatic hygrosis flourishing syndrome with TCM.(2)The hypertension curative effect in two groupsThe hypertension curative effect after I stage:It was showed that the excellence rate of the treatment group was 20.0%, and the effective rate was 50.0%, the total effective rate was70.0%. While in the control group, the excellence rate of the treatment group was 0%, and the effective rate was28.6%, the total effective rate was 28.6%. The total effective rate was 40% highter than the control group, although there was not statistically significant, it showed that there was more effective of treating in Pinelliae and Atractylodis Macrocephalae and Gastrodiae Decoction than Decoction of Four Mild Drugs in degrading blood pressurein II stage.The hypertension curative effect after II stage:It was showed that the excellence rate of the treatment group was 5.0%, and the effective rate was 80.0%, the ineffective rate was70.0%. While in the control group, the excellence rate of the treatment group was 0%, and the effective rate was43.5%, the total effective rate was 43.5%. Compare with the two groups, there was statistically significant (P<0.05), it showed that there was more effective of treating in the II stage in treatment group than the control group. It shows that the Pinelliae and Atractylodis Macrocephalae and Gastrodiae Decoction plus Decoction for Clearing Away Gallbladder Heat have excellence effective in degrading blood pressure in II stage.(3) The improvement extent and the disappearance situation of the clinical symptomIn the treatment group, the patients who had improved more than 1 degree extent in dizzy、headache、heaviness of head、chest distress、spit phlegm and insomnia were account for 90.0%、96.3%、88.5%、90.0%、80.0%、50.0%、95.5% respectively after treatment, while in the control group for 48.0%、57.1%、78.3%、83.3%、50.0%、23.1%、47.6% respectively. There was statistical significance between two groups in dizzy、headache、heaviness of head、chest distress、and insomnia(P<0.01). The treatment group was better then the control group. There was not statistical significance between two groups in spit phlegm and cardiopalmus (P>0.05).It was presented that the treatment group had more significant effect than the control group on improving the clinical symptom for HBP patients with phlegmatic hygrosis flourishing syndrome, especially on heaviness of head and heaviness of head.The disappearance rate of dizzy、headache、heaviness of head、chest distress and insomnia in treatment group was higher then that of the control group (P<0.05). while there was not statistical significance between two groups in spit phlegm and cardiopalmus (P>0.05).It was showed that the effect of combined PAD and DCH for treating HBP patients with phlegmatic hygrosis flourishing syndrome was better than Decoction of Four Mild Drugs.(4) the changeable situation of systolic blood pressure and diastolic blood pressure at the AP:PA treatment timeAfter treatment, the diastolic blood pressure of the treatment group averagely decreased 2.86±1.14 kpa and there was significant difference compared with at the before and after treatment time (P<0.05). There was statistical significance in diastolic blood pressure between two groups (P<0.05). It was considered that these two groups could decrease the systolic blood pressure and diastolic blood pressure. The treatment group was better then the control group, especially at the treatment before.(5) The situation of blood pressure back to normalIt was showed that there was 83.3% patients of blood pressure had back to normal with the evalution stardurd of blood pressure was≥21.3Kpa and/or diastolic blood pressure was≥12.7, while of which in the control group was 30.0%. There was statistical significance wihin the rate of blood pressure back to normal between two groups. The treatment group was better then the control group.The results of safety evaluation:there was not any adverse effect at the periold of before and after treatment.Conclusion1. Combined PAD and DCH had the same effect on the HBP patients with phlegmatic hygrosis flourishing syndrome in different stage, alos had the effect on the improvement of the systolic blood pressure and diastolic blood pressure.2. Combined PAD and DCH could effectively improve the symptom of the HBP patients with phlegmatic hygrosis flourishing syndrome, especially for dizzy、headache、heaviness of head、chest distress、spit phlegm and insomnia.3. Combined PAD and DCH could effectively curing dizzy and headache of two cardinal symptoms.4. It was safe that combined PAD and DCH for treating the HBP patients with phlegmatic hygrosis flourishing syndrome, which had more obviously advantage than Decoction of Four Mild Drugs.更多还原