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.

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.

CONCLUSIONS

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.