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[目的]观察通脉化浊汤(免煎颗粒)联合西药及健康教育综合干预痰瘀互结高血压疗效。[方法]使用双盲安慰剂随机平行对照方法,将120例住院及门诊患者,按就病志号抽签简单随机分为两组;健康教育(低盐低脂饮食、适量运动、控制体质量等);双盲干预(对患者与临床医务人员设盲)。对照组60例西药常规治疗+安慰剂,西药原服影响血压药物,保持原剂量继续使用;因其他疾病需合并用药时,详细记录药品名称、用药原因及用药时间;安慰剂委托治疗组药物生产厂家四川新绿色药业科技发展股份有限公司制作;两组干预药物包装上均印有相同名称、药名、用量、保质期等信息。治疗组60例通脉化浊汤(红花10g,半夏法9g,丹参10g,茯苓15g,蒲黄生、山楂生、莱菔子炒颗粒各10g),1剂/d,早饭前/晚餐后30~60min冲服100m L/次;西药治疗同对照组。连续治疗4周(28d)为1疗程。观测临床症状、收缩压、舒张压,日间/夜间平均收缩压/舒张压、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、血糖(FPG)、中医证候积分、不良反应。治疗1疗程(28d),判定疗效。[结果]血压:治疗组显效20例,有效30例,无效10例,总有效率83.3%;对照组显效5例,有效36例,无效19例,总有效率68.3%;治疗组优于对照组(P<0.05)。中医证候积分疗效:治疗组痊愈3例,显效17例,有效24例,无效16例,总有效率73.3%;对照组痊愈0例,显效0例,有效32例,无效28例,总有效率53.3%,治疗组优于对照组(P<0.05)。TC均有改善(P<0.05),组间无明显差异(P>0.05);TG治疗组有所改善(P<0.05),对照组无显著变化(P>0.05);HDL-C均无明显变化(P>0.05);LDL-C治疗组显著改善(P<0.01),对照组无显著变化(P>0.05);FPG均无明显变化(P>0.05)。收缩压均显著下降(P<0.01),治疗组下降优于对照组(P<0.05);舒张压均明显下降(P<0.01),组间无显著差异(P>0.05)。日间平均收缩压、夜间平均收缩压均显著下降(P<0.05),治疗组下降优于对照组(P<0.05);日间平均舒张压、夜间平均舒张压均显著下降(P<0.05),组间无明显差异(P>0.05)。[结论]通脉化浊汤颗粒联合健康教育及西药综合干预痰瘀互结高血压,疗效满意,无严重不良反应,值得推广。
[Objective] To observe the curative effect of Tongmai Huazhuo Decoction combined with western medicine and health education on hypertension with phlegm and blood stasis. [Methods] A total of 120 inpatients and outpatients were randomized into two groups randomly according to the random number of patients who were randomly selected from the two groups. Health education (low-salt and low-fat diet, moderate exercise, control of body weight, etc.) ); Double-blind intervention (blind to patients and clinical staff). The control group of 60 western medicine routine treatment + placebo, the original Western medicine affect blood pressure drugs, to maintain the original dose continue to use; due to other diseases need to be combined with medication, a detailed record of the drug name, medication reasons and medication time; placebo entrusted treatment group drug production Manufacturers Sichuan New Green Pharmaceutical Technology Development Co., Ltd. production; two groups of interventions are printed on the same drug packaging name, drug name, dosage, shelf-life and other information. Treatment group, 60 cases of Tongmai Huaizhuo Decoction (safflower 10g, Pinellia 9g, Salvia 10g, Poria 15g, Puhuang Health, Hawthorn Health, Radish seed particles 10g), 1 / d, breakfast before / after dinner 30 ~ 60min blunt 100m L / time; western medicine treatment with the control group. Continuous treatment for 4 weeks (28d) for a course of treatment. The clinical symptoms, systolic blood pressure, diastolic blood pressure, average systolic / diastolic blood pressure, total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), blood glucose (FPG), TCM syndrome score, adverse reactions. Treatment of a course of treatment (28d), determine the efficacy. [Results] Blood pressure: The treatment group was markedly effective in 20 cases, effective in 30 cases, ineffective in 10 cases, the total effective rate was 83.3%; the control group markedly effective in 5 cases, effective in 36 cases, ineffective in 19 cases, the total effective rate was 68.3% Group (P <0.05). TCM syndrome integral effect: The treatment group cured 3 cases, markedly effective in 17 cases, effective in 24 cases, ineffective in 16 cases, the total effective rate was 73.3%; control group recovered 0 cases, effective in 0 cases, effective in 32 cases, ineffective in 28 cases, Efficiency 53.3%, the treatment group was better than the control group (P <0.05). (P <0.05), but there was no significant difference between the two groups (P> 0.05), TG improved (P <0.05), but there was no significant difference in the control group (P> 0.05) (P> 0.05). The LDL-C treatment group was significantly improved (P <0.01), but there was no significant change in the control group (P> 0.05). Systolic blood pressure decreased significantly (P <0.01), treatment group decreased better than the control group (P <0.05), diastolic pressure decreased significantly (P <0.01), no significant difference between groups (P> 0.05). Mean systolic blood pressure at daytime and mean systolic blood pressure at night decreased significantly (P <0.05), while those in treatment group were significantly lower than those in control group (P <0.05); daytime mean diastolic pressure and nighttime mean diastolic pressure were significantly decreased (P <0.05) , No significant difference between groups (P> 0.05). [Conclusion] Tongmai Huazhuo Decoction combined with health education and western medicine comprehensive intervention have the effect of phlegm and blood stasis and hypertension, satisfactory curative effect and no serious adverse reactions, which deserves promotion.