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首页> 外文期刊>Chinese Jouranl of Integrative Medicine >Clinical Non-inferiority Trial on Treatment of Coronary Heart Disease Angina Pectoris of Xin-blood Stasis Syndrome Type with Lyophilized Salvia Salt of Lithospermic Acid Powder for Injection
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Clinical Non-inferiority Trial on Treatment of Coronary Heart Disease Angina Pectoris of Xin-blood Stasis Syndrome Type with Lyophilized Salvia Salt of Lithospermic Acid Powder for Injection

机译：注射用紫精酸粉冻干丹参盐治疗冠心病心绞痛心血瘀阻型心绞痛的临床研究

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Objective: To evaluate the effectiveness and safety of lyophilized Salvia salt of lithospermic acid powder for injection (SSLA) in treating coronary heart diseases angina pectoris (CHD-AP) of Xin-blood stasis syndrome type, and to conduct the non-inferiority trial with Danshen injection (DSI) as positive control. Methods: An non-inferiority clinical layered, segmented, randomized, and blinded trial on three parallel and multiple centered groups was conducted in 480 patients with stable effort angina grade Ⅰ , Ⅱ and Ⅲ, who had two or more times of attack every week. The 240 patients in test group A were treated with SSLA 200 mg added in 250 ml of 5% glucose solution for intravenous dripping every day; the 120 patients in test group B were treated with SSLA but the dosage doubled; and the 120 patients in the control group were treated with DSI 20 ml daily in the same method as SSLA was given. The clinical effectiveness and safety were evaluated after the patients were treated for 14 days. Results: The results showed that the markedly effective rate in test groups A, B and control group was 37.45%, 36.75% and 30.09 % respectively, while the total effective rate in them was 88.09% , 89.74% and 67.26% respectively. Statistical significance was shown in comparisons of the therapeutic effect between control group with test group A and test group B, with that in the two test groups superior to that in the control group, and non-inferiority trial showed eligibility (P < 0.01). Adverse reaction appeared in 8 patients in the test groups and 2 in the control group. Conclusion: SSLA has definite therapeutic effect in treating patients with CHD-AP, with its effect not inferior to that of DSI, and no evident toxic-adverse reaction.
机译：目的：评价丹参精粉冻干丹参盐注射液（SSLA）治疗心血瘀阻型冠心病心绞痛（CHD-AP）的有效性和安全性，并进行非劣效性试验。丹参注射液（DSI）为阳性对照。方法：对480例Ⅰ，Ⅱ，Ⅲ类稳定心绞痛患者，每周发作两次或更多次，对三个平行和多中心组进行了非劣效性临床分层，分段，随机和盲法试验。测试组A的240名患者每天接受SSLA 200 mg的治疗，并添加250 ml 5％葡萄糖溶液进行静脉滴注； B组的120例患者接受了SSLA治疗，但剂量增加了一倍；对照组120例患者，每天给予DSI 20 ml，采用与SSLA相同的方法。治疗14天后评估临床疗效和安全性。结果：结果表明，试验组A，B和对照组的显着有效率分别为37.45％，36.75％和30.09％，而总有效率分别为88.09％，89.74％和67.26％。对照组与试验组A和试验组B的疗效比较具有统计学意义，两个试验组的疗效均优于对照组，非劣效性试验显示合格（P <0.01）。试验组8例出现不良反应，对照组2例出现不良反应。结论：SSLA对CHD-AP患者具有一定的治疗作用，其疗效不逊于DSI，且无明显的毒副反应。

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