复方鬼针草颗粒治疗1级高血压病湿热血瘀证患者的临床疗效

Clinical Observation of Compound Guizhencao Granule in Treatment of Grade 1 Hypertension with Dampness Heat and Blood Stasis Syndrome

目的:观察复方鬼针草颗粒剂对1级高血压病湿热血瘀证患者的临床疗效及对相关生物指标、安全性指标的影响。方法:采用随机、双盲、安慰剂对照临床试验设计方法,将80例符合纳入标准的研究对象随机分为治疗组(40例)和对照组(40例)。在健康教育的基础上,治疗组口服复方鬼针草颗粒剂,6.5 g/次,2次/d,对照组口服复方鬼针草颗粒模拟剂,6.5 g/次,2次/d,两组疗程均为4周。观察两组患者24 h动态血压(24 h ABPM),中医证候积分,血管紧张素Ⅱ(AngⅡ),内皮素-1(ET-1),同型半胱氨酸(Hcy)及安全性指标。结果:与本组治疗前比较,诊室血压收缩压(SBP),舒张压(DBP)治疗组显著降低(P<0.01),对照组差异无统计学意;对照组日间DBP和24 h DBP显著降低(P<0.01),治疗组24 h SBP,24 h DBP,日间SBP,日间DBP,夜间SBP,夜间DBP显著降低(P<0.01)。24 h ABPM临床疗效,夜间血压治疗组总有效率为57.14%(20/35),明显高于对照组的28.57%(10/35),差异有统计学意义(Z=-2.310,P<0.05);日间血压和24 h血压治疗组总有效率有升高趋势,但差异无统计学意义。中医证候积分,与本组治疗前比较,两组患者均明显降低(P<0.05,P<0.01),与治疗后对照组比较,治疗组显著降低(P<0.01)。治疗组患者中医证候积分总有效率为51.43%(18/35),明显高于对照组的28.57%(10/35),差异有统计学意义(χ^(2)=9.973,P<0.05)。AngⅡ,ET-1,Hcy水平,与本组治疗前比较,对照组ET-1,Hcy水平明显降低(P<0.05),治疗组AngⅡ,ET-1,Hcy水平显著降低(P<0.01);与治疗后对照组比较,治疗组AngⅡ,ET-1水平显著降低(P<0.01)。结论:复方鬼针草颗粒剂可以调节患者的血压水平,降低患者的中医证候积分,调节生物相关指标且安全性较好。

Objective:To observe the clinical effect of compound Guizhencao granule(CGG)on grade1 hypertension patients with dampness heat and blood stasis syndrome and its influence on related biological indicators and safety indexes. Method:A randomized,double-blind,placebo-controlled clinical trial design was used. 80 subjects who met the inclusion criteria were randomly divided into the treatment group(40 cases)and control group(40 cases). On the basis of health education,patients in the treatment group received 6.5 g CGG,twice daily,for four weeks. Patients in the control group received CGG simulant in a similar dosing scheme. The24-hour ambulatory blood pressure monitoring(24 h ABPM),traditional Chinese medcine(TCM)syndrome score,angiotensin Ⅱ(Ang Ⅱ ),endothelin-1(ET-1),homocysteine(Hcy)and safety indexes were observed.Result: Compared with that before treatment,systolic blood pressure(SBP)and diastolic blood pressure(DBP)of the consulting room in the treatment group were significantly lower(P<0.01),and there was no significant difference in the control group;The daytime DBP and 24 h DBP in the control group decreased significantly(P<0.01),and the 24 h SBP,24 h DBP,daytime SBP,daytime DBP,nighttime SBP and nighttime DBP in the treatment group decreased significantly(P<0.01). The total effective rate of 24 h ABPM on the nighttime blood pressure was 57.14%(20/35)in the treatment group,which was significantly higher than28.57%(10/35)in the control group(Z=-2.310,P<0.05);The total effective rate of daytime blood pressure and 24-hour blood pressure treatment group increased,but the difference was not statistically significant. The TCM syndrome score of two groups was significantly lower than that of the control group before treatment(P< 0.05,P< 0.01),and that of the treatment group was significantly lower than that of the control group after treatment(P<0.01). The total effective rate of TCM syndrome score in the treatment group was 51.43%(18/35),which was significantly higher than 28.57%(10/35)in the control group(χ^(2)= 9.973,P<0.05).Compared with that before treatment,the levels of ET-1 and Hcy in the control group decreased significantly(P<0.05),and the levels of Ang Ⅱ,ET-1 and Hcy in the treatment group decreased significantly(P<0.01);Compared with the control group after treatment,the levels of Ang Ⅱ and ET-1 in the treatment group decreased significantly(P < 0.01). Conclusion: CGG is safe and effective in reducing the blood pressure level,improving the TCM syndrome score,and regulating related biological indicators of patients with Grade 1 hypertension.