复方芪麻胶囊联合西药治疗气虚痰浊证高血压病的临床疗效与安全性研究  

Study on Clinical Efficacy and Safety of Compound Qi Ma Capsule and Western Medicine Treatment of Hypertension Patients with Qi Deficiency and Turbid Phlegm Syndrome

作　　者：赵自明 靳利利 王清海 苏慧 ZHAO Ziming;JIN Lili;WANG Qinghai;SU Hui(Guangdong 2nd Hospital of TCM,Guangdong Province Engineering Technology Research Institute of TCM,Guangzhou 510095 Guangdong,China)

机构地区：[1]广东省第二中医院,广东省中医药工程技术研究院,广东广州510095

出　　处：《中药新药与临床药理》2019年第7期879-884,共6页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广东省中医药局项目(粤中医办函[2015]102号);广东省科学技术厅项目(2017A020213010)

摘　　要：目的观察复方芪麻胶囊(QMC)治疗104例1~2级高血压病患者的临床效果和安全性。方法随机选择2013年9月—2018年6月广东省第二中医院心血管科住院部和门诊部就诊的气虚痰浊证1~2级原发性高血压(高血压病)患者,按随机数字-余数法分为治疗组和对照组,治疗组104例高血压病患者在对照组(100例)口服氨氯地平(5 mg·d-1)或硝苯地平(30 mg·d-1)基础上,加服QMC(216生药g·d-1,每日分3次口服),疗程8 w;检查测治疗前后患者证候积分(SI)、收缩压(SBP)、舒张压(DBP)、脉压(PP)及血清血谷丙转氨酶(ALT)、谷草转氨酶(AST)、血肌酐(Cr)和血尿素氮(BUN),并计算上述计量指标治疗前后的差值(d)、治疗后SI疗效分级、降压疗效分级和两疗效总有效率。结果与对照组比较,治疗后治疗组SI、PP均有显著性减小(P<0.01),SBP和BUN均有显著性减小(P<0.05),dBUN有显著性增加(P<0.05),dSBP和dAST均有显著性增加(P<0. 01),dSI有显著性增加(P<0.01),而DBP、dDBP、dPP、ALT、dALT、AST、Cr和dCr均无显著性差异(P>0.05),SI疗效、降压疗效均有显著性改善(P<0.05),证侯总有效率有显著升高(P<0.01),而降压疗效总有效率差异无统计学意义(P>0.05)。结论 QMC合用降压西药有协同降低SBP和PP且不影响DBP,同时可改善患者中医证侯疗效和降压疗效,减轻西药所致肝肾损害等治疗特色和优势。Objective To observe both the anti-hypertensive effect and safety of compound Qi Ma capsule(QMC)in104 patients with mild to moderate hypertension.Methods Essential hypertension patients with qi deficiency and turbid phlegm syndrome in cardiovascular inpatient and outpatient departments of Guangdong 2 nd TCM Hospital from September 2013 to June 2018 were randomly selected by means of random numbers-remainder method.One hundred and four patients in treatment group were orally given QMC(crude drug 216 g·d-1,separate into 3 doses equally)in addition to the treatments for control group(100 patients,5 mg·d-1 amlodipine or 30 mg·d-1 nifedipine)for 8 weeks.Syndrome integral(SI),systolic blood pressure(SBP),diastolic blood pressure(DBP),pulse pressure(PP),serum contents of alanine aminotransferase(ALT),aminotransferase(AST),creatini(Cr),and blood urine nitrogen(BUN)were measured before and after treatment.The differences of indexes between before and after treatments were calculated,and efficacy both of SI and of anti-hypotensive effect after treatment were observed at the same time.Results After treatments,compared with the control group,SI and PP in the treatment group decreased significantly(P<0.01);both SBP and BUN decreased significantly(P<0.05),dBUN was significantly higher(P<0.05);both dSBP and dAST increased significantly(P<0.01),dSI increased significantly(P<0.01).The DBP,dDBP,dPP,ALT,dALT,AST,Cr and dCr had no significant difference(P>0.05);curative effects of both SI and anti-hypotension improved(P<0.05),the total effective rate of SI was significantly increased(P<0.01),the total effective rate of anti-hypertension shown no significant difference(P>0.05).Conclusion QMC combined with western medicine has the therapeutic features and advantages of reducing SBP and PP,not affecting DBP,and improving the curative effect both of TCM syndromes and of anti-hypertensive effect,alleviating liver and kidney damage,which is worthy of clinical application.

关 键 词：复方芪麻胶囊 高血压病 气虚痰浊证 临床疗效 血压 安全性 肝肾功能 

分 类 号：R544.1[医药卫生—心血管疾病]