心血宁胶囊治疗高血压伴高同型半胱氨酸血症的随机、阳性对照、多中心临床试验  

A randomized,positive-controlled and multicenter trial of Xinxuening capsule for treatment of hypertension with hyperhomocysteinemia

作　　者：刘小云[1] 华琦[2] 马庆春[1] 韩凌[3] 宋丽萍 孙宁玲[1] Liu Xiaoyun;Hua Qi;Ma Qingchun;Han Ling;Song Liping;Sun Ningling(Hypertension Research Laboratory,Peking University People’s Hospital,Beijing 100044,China;不详)

机构地区：[1]北京大学人民医院高血压研究室,北京100044 [2]首都医科大学宣武医院心血管内科 [3]首都医科大学附属复兴医院心血管内科 [4]北京海淀医院心血管内科

出　　处：《临床内科杂志》2020年第10期704-707,共4页Journal of Clinical Internal Medicine

摘　　要：目的探讨心血宁胶囊治疗高血压伴高同型半胱氨酸(Hcy)血症(HHT)的有效性和安全性。方法将89例HHT患者随机分为试验组(心血宁胶囊治疗)42例和对照组(叶酸片治疗)47例,连续治疗12周。分别于治疗后4、8、12周进行随访。主要终点为治疗后12周血Hcy降低的有效率。比较两组患者不同时间的血压,同时记录高血压症状和不良反应。结果治疗后4周、12周试验组和对照组血Hcy降低的有效率分别为52.4%比51.1%、47.6%比42.6%,组间同一时间比较差异均无统计学意义(P>0.05)。治疗后12周试验组和对照组患者血Hcy水平均明显低于同组治疗前(P<0.05)。治疗后两组患者收缩压、舒张压均明显降低(P<0.05),但组间同一时间比较差异均无统计学意义(P>0.05)。随访期间两组患者均未发生不良事件。结论心血宁胶囊可降低HHT患者血Hcy水平,其降低血Hcy效果与叶酸片相当,且临床用药安全。Objective To explore the efficacy and safety of Xinxuening Capsule for treatment of hypertension with hyperhomocysteinemia(HHT).Methods A total of 89 patients with HHT were randomly divided to experimental group(treat with Xinxuening capsules)and control group(treat with Folic acid),and patients in two groups were continuously treated for 12 weeks.Follow-up were conducted at 4,8 and 12 weeks after treatment respectively.Primary endpoint was effective rate of blood Hcy reduction at 12 week after treatment.Blood pressure was compared at different time in two groups,hypertension symptoms and adverse reactions were recorded at the same time.Results Effective rate of reducing blood Hcy were 52.4%v.s.51.1%at 4 weeks after treatment,47.6%v.s.42.6%at 12 weeks after treatment in experimental group and control group respectively,and no significant differences were found between two groups of the same time(P>0.05).Blood Hcy level at 12 weeks after treatment in experimental group and control group were lower than those before treatment in the same group(P<0.05).After treatment,the systolic blood pressure and diastolic blood pressure in the two groups were reduced sighificantly(P<0.05),but there were no significant differences between two groups at the same time(P>0.05).During the follow-up period,there were no adverse events in the two groups.Conclusion Xinxuening capsule can reduce blood Hcy level in patients with HHT,and its efficacy on reducing blood Hcy is similar to folic acid which is with high safety of clinical use.

关 键 词：心血宁胶囊 叶酸片 高血压 同型半胱氨酸 

分 类 号：R259[医药卫生—中西医结合]