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[摘要]
目的 以氯沙坦钾片为对照评价松龄血脉康胶囊治疗原发性高血压(1级)的有效性及安全性。方法 采用随机、双盲双模拟、阳性药平行对照的临床试验设计方法。共随机入组原发性高血压(1级)受试者276例,分成试验组(137例)和对照组(139例),试验组用药:松龄血脉康胶囊+氯沙坦钾片安慰剂;对照组用药:氯沙坦钾片+松龄血脉康胶囊安慰剂,疗程8周。比较坐位收缩压(SeSBP)、舒张压(SeDBP)、血压达标率、中医证候以及不良反应发生情况。结果 治疗8周后,试验组、对照组坐位收缩压、舒张压均明显下降,与治疗前比较组内差异有统计学意义(P<0.05)。试验组、对照组两组患者收缩压下降均值分别为:(10.80±9.41)、(10.01±9.70)mmHg(1 mmHg=0.133 kPa),两组比较差异无统计学意义。两组患者舒张压下降均值分别为:(8.36±7.71)、(8.39±8.41)mmHg,两组比较差异无统计学意义;两组血压达标率分别为54.01%、51.80%,组间比较差异无统计学意义;治疗后中医证候组间比较差异无统计学意义。两组不良反应发生率比较无统计学差异。结论 松龄血脉康胶囊治疗原发性高血压(1级)可有效降压、改善中医症候积分,提高患者血压达标率,安全性好,且疗效与氯沙坦钾片相当。
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[Abstract]
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.
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