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 syn...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 （丹参注射液, 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 , Ⅱand 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.展开更多
目的探讨血塞通冻干粉联合硫辛酸治疗糖尿病伴脑梗死的临床效果。方法选取2019年7月至2021年7月收治的110例糖尿病伴脑梗死患者为研究对象,根据入院单双号将其分为对照组(55例,丹参注射液+硫辛酸)和研究组(55例,血塞通冻干粉+硫辛酸)。...目的探讨血塞通冻干粉联合硫辛酸治疗糖尿病伴脑梗死的临床效果。方法选取2019年7月至2021年7月收治的110例糖尿病伴脑梗死患者为研究对象,根据入院单双号将其分为对照组(55例,丹参注射液+硫辛酸)和研究组(55例,血塞通冻干粉+硫辛酸)。比较两组的治疗效果。结果研究组的治疗总有效率高于对照组(P<0.05)。治疗后,研究组的空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)、胰岛素抵抗指数(HOMA-IR)、可溶性细胞间黏附分子-1(sICAM-1)、白细胞介素-6(IL-6)、超敏C反应蛋白(hs-CRP)、美国国立卫生院卒中量表(NIHSS)评分、全血黏度、红细胞压积、红细胞最大聚集指数及纤维蛋白原水平低于对照组,胰岛素分泌指数(HOMA-β)高于对照组(P<0.05)。结论相较于丹参注射液,血塞通冻干粉联合硫辛酸治疗糖尿病伴脑梗死的效果更优,其可改善胰岛功能,调节血糖水平及血液流变学指标,促进神经功能恢复。展开更多
基金Supported by the Fund of National Project of High.technicResearch and Development,(No.2003AA223269)
文摘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 （丹参注射液, 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 , Ⅱand 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.
文摘目的探讨血塞通冻干粉联合硫辛酸治疗糖尿病伴脑梗死的临床效果。方法选取2019年7月至2021年7月收治的110例糖尿病伴脑梗死患者为研究对象,根据入院单双号将其分为对照组(55例,丹参注射液+硫辛酸)和研究组(55例,血塞通冻干粉+硫辛酸)。比较两组的治疗效果。结果研究组的治疗总有效率高于对照组(P<0.05)。治疗后,研究组的空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)、胰岛素抵抗指数(HOMA-IR)、可溶性细胞间黏附分子-1(sICAM-1)、白细胞介素-6(IL-6)、超敏C反应蛋白(hs-CRP)、美国国立卫生院卒中量表(NIHSS)评分、全血黏度、红细胞压积、红细胞最大聚集指数及纤维蛋白原水平低于对照组,胰岛素分泌指数(HOMA-β)高于对照组(P<0.05)。结论相较于丹参注射液,血塞通冻干粉联合硫辛酸治疗糖尿病伴脑梗死的效果更优,其可改善胰岛功能,调节血糖水平及血液流变学指标,促进神经功能恢复。
