心灵丸治疗稳定性劳力性心绞痛:随机、双盲、安慰剂平行对照、多中心临床试验

Effect of Xinling Wan in treatment of stable angina pectoris:a randomized,double-blinded,placebo parallel-controlled,multicenter trial

为评价心灵丸治疗稳定性劳力性心绞痛的有效性和安全性，开展了随机、双盲、安慰剂平行对照、多中心的临床试验。对纳入的232名受试者随机分为2组，斌验组给予心灵丸，安慰剂组给予心灵丸模拟剂，1次2丸，每日3次，连服4周。通过观察有效性和安全性评价指标，发现心灵丸治疗稳定性劳力性心绞痛能显著增加患者平板运动试验总运动时间，FAS分析显示试验组治疗前后总运动时间的差值为（72．11±139．32）s，安慰剂组（31．25±108．32）S；显著升高心绞痛症状评分总有效率，FAS分析显示试验组总有效率78．95％，安慰剂组42．6l％；减少硝酸甘油用量，FAS分析显示试验组减量（2．45±2．41）片／周，安慰剂组减量（0．50±2．24）片／周；明显降低中医症状记分，FAS分析显示试验组降低（4．68±3．49），安慰剂组（3．19±3．31）；降低每周心绞痛发作频率、心绞痛持续时间等。PPS分析结果与FAS结果相似。与安慰剂相比，心灵丸治疗稳定性劳力性心绞痛疗效显著。此外，试验组不良事件和不良反应发生率低，安全性良好。

To evaluate the effectiveness and safety of Xinling Wan on patients with stable angina pectoris, a randomized, double- blinded, placebo parallel-controlled, muhicenter clinical trial was conducted. A total of 232 subjects were enrolled and randomly divid- ed into experiment group and plaeebo group. The experiment group was treated with Xinling Wan （ two pills each time, three times dai- ly） for 4 weeks, and the placebo group was treated with placebo. The effectiveness evaluation showed that Xinling Wan could signifi- candy increase the total duration of treadmill exercise among patients with stable angina pectoris. FAS analysis showed that the differ- ence value of the total exercise duration was between experiment group （72. 11 ± 139. 32） s and placebo group （31.25 ± 108. 32） s. Xinling Wan could remarkably increase the total effective rate of angina pectoris symptom score, and the analysis showed that the total effective rate was 78. 95% in experiment group and 42. 61% in placebo group. The reduction of nitroglycerin dose was （2. 45 ±2.41 ） tablets in experiment group and （ 0. 50 ±2. 24） tablets in placebo group on the basis of FAS analysis. The decrease of symptom integral was （4. 68 ±3.49） in experiment group and （3.19 ±3.31 ） in placebo group based on FAS analysis. Besides, Xinling Wan could de- crease the weekly attack time and the duration of angina pectoris. PPS analysis results were similar to those of FAS analysis. In conclu- sion, Xinling Wan has an obvious therapeutic effect in treating stable angina pectoris, with a good safety and a low incidenee of adverse event and adverse reaction in experiment group.