升清降浊方治疗神经源性直立性低血压合并卧位高血压的随机对照研究

A Randomized Controlled Study of Shengqing Jiangzhuo Decoction(升清降浊方)in Treatment of Neurogenic Orthostatic Hypotension Combined with Supine Hypertension

目的观察升清降浊方治疗神经源性直立性低血压(neurogenic orthostatic hypotension,nOH)合并卧位高血压(supine hypertension,SH)的临床疗效。方法根据纳入与排除标准选取气虚痰瘀证nOH合并SH患者110例,采用随机数字表法分为试验组(55例)和对照组(55例)。试验组服用中药升清降浊方,1剂/d,100 mL/次,2次/d;对照组服用盐酸米多君,2.5 mg/次,2次/d,若临床观察期间SH加重需药物治疗,予睡前加服氯沙坦钾;两组均予健康教育、生活方式改善及家庭血压、心率监测指导;疗程8周。评价两组临床疗效,观察治疗前后两组中医证候评分、卧立位血压、直立性低血压自评量表(Orthostatic Hypotension Questionnaire,OHQ)评分。结果试验组总有效率为70.91%(39/55),显著优于对照组(41.82%,23/55)(P<0.05)。治疗后两组中医证候评分均较治疗前改善(P<0.05),试验组优于对照组(P<0.05)。两组立位收缩压均有升高(P<0.05),对照组优于试验组(P<0.05);两组立位舒张压均有升高(P<0.05),差异无统计学意义(P>0.05)。试验组卧位收缩压略有下降,舒张压波动不明显,与治疗前比较差异无统计学意义(P>0.05);对照组卧位收缩压、舒张压均显著高于治疗前(P<0.05)。两组OHQ评分均较治疗前改善(P<0.05),差异无统计学意义(P>0.05)。临床观察期间两组患者均未出现不良反应。结论升清降浊方治疗气虚痰瘀证nOH合并SH患者安全、有效,可改善患者症状,并可能具有调节SH的潜在作用。

Objective To observe the clinical effect of Shengqing Jiangzhuo Decoction(升清降浊方)on neurogenic orthostatic hypotension(nOH)combined with supine hypertension(SH).Methods According to the inclusion and exclusion criteria,110 patients with Qi deficiency and phlegm and blood stasis syndrome of nOH combined with SH were divided into test group(55 cases)and control group(55 cases)by random number table method.The test group took Shengqing Jiangzhuo Decoction,1 dose/d,100 mL/time,2 times/d.The control group was given midodrine,2.5 mg/time,2 times/d.If SH was aggravated during clinical observation which needed drug treatment,losartan potassium was added before sleep.Patients in both groups were given health education,lifestyle improvement and family blood pressure and heart rate monitoring guidance.The course of treatment was 8 weeks.The clinical efficacy,traditional Chinese medicine(TCM)syndrome scores,blood pressure and Orthostatic Hypotension Questionnaire(OHQ)score of the two groups were observed before and after treatment.Results The total efficiency of the test group was 70.91%(39/55),significantly better than that(41.82%,23/55)of the control group(P<0.05).After treatment,the TCM syndrome scores of the two groups were improved compared with those before treatment(P<0.05)and the scores of the test group was significantly better than those of the control group(P<0.05).The orthostatic systolic blood pressure increased in both groups(P<0.05)and the orthostatic systolic blood pressure of the control group was better than that of the test group(P<0.05).There was no significant difference between two groups(P>0.05).The supine systolic blood pressure decreased slightly along with little fluctuation of the diastolic blood pressure in the test group,there was no significant difference compared with that before treatment(P>0.05).In the control group,both of the supine systolic blood pressure and diastolic blood pressure were significantly higher than those before treatment(P<0.05).The OHQ scores of the two groups were improved compared with those before treatment(P<0.05)and there was no significant difference between two groups(P>0.05).During clinical observation,no adverse reactions occurred in the two groups.Conclusion Shengqing Jiangzhuo Decoction is safe and effective in treating nOH patients combined with SH of Qi deficiency and phlegm and blood stasis syndrome,which could relieve symptoms and may has potential effect on regulating SH.