Clinical Observation of Compound Guizhencao Granule in Treatment of Grade 1 Hypertension with Dampness Heat and Blood Stasis Syndrome / 中国实验方剂学杂志

ABSTRACT

Objective:To observe the clinical effect of compound Guizhencao granule （CGG） on grade 1 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. The 24-hour ambulatory blood pressure monitoring（24 h ABPM），traditional Chinese medcine（TCM） syndrome score，angiotensin Ⅱ （AngⅡ），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 （<italic>P</italic><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 （<italic>P</italic><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 （<italic>P</italic><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 than 28.57% （10/35） in the control group （<italic>Z</italic>=-2.310， <italic>P</italic><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 （<italic>P</italic>< 0.05， <italic>P</italic>< 0.01）， and that of the treatment group was significantly lower than that of the control group after treatment （<italic>P</italic><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 （<italic>χ</italic>²= 9.973， <italic>P</italic><0.05）. Compared with that before treatment， the levels of ET-1 and Hcy in the control group decreased significantly （<italic>P</italic><0.05）， and the levels of Ang Ⅱ， ET-1 and Hcy in the treatment group decreased significantly （<italic>P</italic><0.01）； Compared with the control group after treatment， the levels of Ang Ⅱ and ET-1 in the treatment group decreased significantly （<italic>P</italic> < 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.