丹红注射液治疗不同类型血瘀型心绞痛的疗效与安全性再评价

目的： 观察对丹红注射液治疗不同类型血瘀型心绞痛的疾病疗效、血瘀证疗效及安全性进行再评价，为临床合理使用提供科学数据。 方法： 226例患者根据不同的治疗方式分为观察组153例和对照组73例。对照组采用拜阿司匹林肠溶片，0.1 g/次，1次/d，晚饭后服用；阿托伐他汀钙片，20 mg/次，1次/d，晚饭后服用；倍他乐克片，47.5 mg/次，1次/d，晨服；硝酸甘油片，0.5 mg/次，必要时舌下含服。观察组在对照组治疗的基础上加用丹红注射液，20～40 mL，静脉滴注，1～2次/d。两组疗程均为14 d。记录观察期内心绞痛症状、性质、持续时间、发作次数及硝酸甘油片的用量；记录治疗前后血瘀证积分；监测患者心电图；记录观察期间不良反应。 结果： 治疗期间观察组不稳定性心绞痛（UAP）和稳定性心绞痛（SAP）心绞痛发作次数及硝酸甘油片使用量均少于对照组（P<0.01）；观察组胸闷、胸痛、心悸、胸胁胀满及血瘀证总分低于对照组（P<0.01）；观察组UAP患者临床疗效总有效率为89.7%，对照组为75.9%，观察组优于对照组（P<0.05）；观察组SAP患者临床疗效总有效率为94.6%，对照组为84.2%，观察组高于对照组，但差异无统计学意义；观察组UAP患者中医证候疗效总有效率为90.7%，对照组为74.1%，观察组优于对照组（P<0.01）；观察组SAP患者中医证候疗效总有效率为96.4%，对照组为78.9%，观察组高于对照组，但差异无统计学意义；观察组单纯血瘀证、气滞血瘀、气虚血瘀心绞痛疗效分别为97.9%，89.2%，87.5%，单纯血瘀证的疗效高于另两个组，但差异无统计学意义；观察组共有2例不良反应，不良反应发生率1.3%，程度均为轻、中度。 结论： 丹红注射液辅助用于不同类型血瘀型心绞痛，能减少心绞痛发作次数和硝酸甘油片的用量，对临床疗效和血瘀证证候疗效均较为确切；可能对SAP类患者疗效及血瘀证型心绞痛的疗效更好，但需要进一步大样本的数据支持；在说明书使用范围内使用丹红注射液不良反应少见，程度也轻，临床使用是安全的。

Danhong Injection to Curative Effect and Treating Different Types of Stable Angina of Blood Stasis Evaluation and Safety

Objective: Revaluation of curative effect of Danhong injection to curative effect of illness, curative effect of blood stasis and security in treating stable angina and providing scientific data its reasonable using in clinic. Method: One hundred and twenty-six patients were randomly divided into control group (73 cases) and observation group (153 cases) according to different methods of therapy.Patients in control group received bayaspirin enteric-coated tablets,0.1 g/time,1 time/day, after dinner take.Atorvastatin calcium tablets,20 mg/time,1 time/day,taken after dinner.Betaloc tablet,47.5 mg/time,1 time/day,taken in the morning.Nitroglycerin tablets,0.5 mg/time,taken sublingually when necessary.Based on the treatment of control group,patients in observation group received Danhong injection,20-40 mL,intravenous infusion,1-2 time/day.Course of treatment in two groups were both 14 days.Symptom,property,duration,attack number of times and volumes of nitroglycerin of stable angina were recorded during observation period.Before and after treatment,integral of blood stagnation was recorded. Patients' electrocardiogram were monitored.and untoward effect was recorded during observation period. Result: During period of treatment,attack number of times of unstable angina pectoris(UAP) and stable angina pectoris(SAP) and volumes of nitroglycerin tablets used to patients in observation group were less than those in control group(P<0.01).The total scores of chest distress,chest pain, palpitation,fullness chest and hypochondrium and blood stasis in observation group were lower than those in control group(P<0.01). The total effective rate curative effect of patients UAP in observation group was 89.7%superior to 75.9% in control group(P<0.05).The total total effective rate of clinical curative effect of patients with SAP in observation group was 94.6% higher than 84.2% in control group,which meant no statistical significance from the differences between two groups.The total total effective rate of curative effect of traditional Chinese medicine syndrome of patients with UAP in observation group was 90.7% superior to 74.1% in control group(P<0.01).The total total effective rate of curative effect of traditional Chinese medicine syndrome of patients with SAP in observation group was 96.4% more than 78.9% in control group but which meant no statistical significance from the differences between two groups.Curative effects of pure blood stasis,qi stagnation and blood stasis and qi deficiency and blood stasis of angina in observation group were 97.9%,89.2% and 87.5%,and curative effects of pure blood stasis was higher than which in other two groups,but there was no statistical significance from the differences.There were two cases of untoward effect in observation group,in which rate of untoward effect was 1.3%,and in which the degrees were mild and moderate. Conclusion: Danhong injection assistance for different types of blood stasis type of angina pectoris, reduce the frequency of angina and Nitroglycerin Tablets dosage,and there were significant curative effect to clinical efficacy and syndrome of blood stasis.It may have better curative effect to patients SAP and angina of blood stasis,but it still need a mass of forward data to support this conclusion. Adverse reaction of Danhong injection in the specification range rare,degree of untoward effect was also light, clinical use is safe.