| 王丽洁,罗心平,王涌,陈为民,陆云,李勇,施海明,范维琥,戴瑞鸿.冠心病稳定性心绞痛患者长期应用麝香保心丸的临床耐受性与安全性评价[J].,2008,(5):399-401 |
| 冠心病稳定性心绞痛患者长期应用麝香保心丸的临床耐受性与安全性评价 |
| Evaluation on Tolerability and Safety of Long-term Administration with Shexiang Baoxin Pill in Patients with Coronary Heart Disease of Stable Angina Pectoris |
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| DOI： |
| 中文关键词: 麝香保心丸 冠心病 耐受性 安全性 |
| 英文关键词:Shexiang Baoxin Pill coronary heart disease tolerability safety |
| 基金项目: |
| Author Name | Affiliation | | WANG Li-jie | 复旦大学附属华山医院心内科 上海200040 | | LUO Xin-ping | 复旦大学附属华山医院心内科,上海,200040 | | WANG Yong | 复旦大学附属华山医院心内科,上海,200040 | | 陈为民 | 复旦大学附属华山医院心内科,上海,200040 | | 陆云 | 复旦大学附属华山医院心内科,上海,200040 | | 李勇 | 复旦大学附属华山医院心内科,上海,200040 | | 施海明 | 复旦大学附属华山医院心内科,上海,200040 | | 范维琥 | 复旦大学附属华山医院心内科,上海,200040 | | 戴瑞鸿 | 复旦大学附属华山医院心内科,上海,200040 |
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| 中文摘要: |
| 目的评价冠心病稳定性心绞痛患者口服麝香保心丸6个月的耐受性及安全性。方法采用随机非盲两组平行对照研究方法,将200例冠心病患者随机分为两组,各100例。对照组采用冠心病基础用药包括抗血小板、调脂、抗缺血等常规治疗;治疗组采用冠心病基础用药加麝香保心丸口服每日3次、每次2丸,共6个月。随访6个月,观察两组用药的耐受性,药物不良反应,治疗前后血常规、肝肾功能、血糖及血脂的变化。结果试验总完成率92%,其中治疗组5例、对照组11例脱落,无患者因不耐受治疗药物而脱落。与麝香保心丸相关的不良反应共1例;两组治疗前后血糖、血脂亦无明显变化,无严重肝肾功能损害及其他严重不良反应发生。结论冠心病患者长期服用麝香保心丸的临床耐受性和安全性良好。 |
| 英文摘要: |
| ObjectiveTo evaluate the safety and tolerability of long-term(6 months) administration with Shexiang Baoxin Pill(SBP) in patients with coronary heart disease(CHD) of stable angina pectoris.Methods Adopting randomized non-blinded and parallel controlled trial,200 patients with CHD were randomly and equally assigned to the SBP group and the control group.Both received basic therapy for CHD,including anti-platelet,lipid regulating and anti-ischemia with additional SBP 2 pills,taken orally three times per day in the SBP group.They were followed up for 6 months.The drug tolerability and adverse drug reactions occurred in the observation period were recorded,and the laboratory indexes involving blood routine,liver function,renal function,blood glucose and blood lipids were detected before and after treatment.ResultsThe trial was completed in 92% of the patients,5 patients withdrew in the SBP group and 11 patients in the control group;but none for the intolerable therapy.There were 1 case of adverse reaction related to SBP.No obvious change was found in blood glucose and blood lipids in the two groups before and after treatment.No serious adverse reaction and injury of liver and renal function or others happened.ConclusionLong-term administration of SBP has favorable clinical tolerability and safety for CHD patients. |
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