目的 以氯沙坦鉀片為對照評價松齡血脈康膠囊治療原發(fā)性高血壓（1級）的有效性及安全性。方法 采用隨機、雙盲雙模擬、陽性藥平行對照的臨床試驗設計方法。共隨機入組原發(fā)性高血壓（1級）受試者276例，分成試驗組（137例）和對照組（139例），試驗組用藥：松齡血脈康膠囊+氯沙坦鉀片安慰劑；對照組用藥：氯沙坦鉀片+松齡血脈康膠囊安慰劑，療程8周。比較坐位收縮壓（SeSBP）、舒張壓（SeDBP）、血壓達標率、中醫(yī)證候以及不良反應發(fā)生情況。結(jié)果 治療8周后，試驗組、對照組坐位收縮壓、舒張壓均明顯下降，與治療前比較組內(nèi)差異有統(tǒng)計學意義（P<0.05）。試驗組、對照組兩組患者收縮壓下降均值分別為：（10.80±9.41）、（10.01±9.70）mmHg（1 mmHg=0.133 kPa），兩組比較差異無統(tǒng)計學意義。兩組患者舒張壓下降均值分別為：（8.36±7.71）、（8.39±8.41）mmHg，兩組比較差異無統(tǒng)計學意義；兩組血壓達標率分別為54.01%、51.80%，組間比較差異無統(tǒng)計學意義；治療后中醫(yī)證候組間比較差異無統(tǒng)計學意義。兩組不良反應發(fā)生率比較無統(tǒng)計學差異。結(jié)論 松齡血脈康膠囊治療原發(fā)性高血壓（1級）可有效降壓、改善中醫(yī)癥候積分，提高患者血壓達標率，安全性好，且療效與氯沙坦鉀片相當。

Objective To evaluate the efficacy and safety of Songlingxuemaikang Capsule in the treatment of hypertension (level 1),and to compared with the positive drug Losartan Potassium Tablets. Methods A total of 276 patients were enrolled into this multicentre, double blind, controlled clinical study with 137 cases for the experimental group and 139 cases for the control group. The patients in the experimental group were treated with Songlingxuemaikang Capsule and Losartan Potassium Tablets placebo for 8 weeks;The control group were treated with Losartan Potassium Tablets and Songlingxuemaikang Capsule placebo for 8 weeks. After the treatment, the changes of SeSBP, SeDBP, lood pressure Success rate and TCM syndrome integral and The rate of ADR were observed in the two groups. Results After the treatment, the changes of SeSBP, SeDBP, lood pressure Success rate and TCM syndrome integral in the two groups were statistically significant (P<0.05). The drop of SeSBP of the experimental group and the control group were (10.80±9.14) mmHg and (10.01±9.70) mmHg, there were not statistically significant in the two groups. The drop of SeDBP of the experimental group and the control group were (8.36±7.71) mmHg and (8.39±8.41) mmHg, there were not statistically significant in the two groups. The differences of lood pressure Success rate and TCM syndrome integral between the two groups were not statistically significant. The adverse drug reactions (ADR) in the two groups were not statistically significant. Conclusion Songlingxuemaikang Capsule Can effective decompression, improve TCM symptoms integral, increase blood pressure in patients with success rate, good safety, and it is worth promoting.