通心络胶囊对气虚血瘀型慢性冠脉综合征患者抗缺血药物使用的影响： 一项多中心、前瞻性队列研究

Effect of Tongxinluo Capsules on Use of Anti-ischemic Drugs in Patients with Chronic Coronary Syndrome of Qi Deficiency and Blood Stasis： A Multicenter， Prospective Cohort Study

摘要:

目的 探讨通心络胶囊对气虚血瘀型慢性冠脉综合征患者抗缺血药物使用的影响。方法 采用多中心、前瞻性队列研究的方法，将通心络胶囊干预治疗作为暴露因素，分为暴露组（中西医结合治疗组）和非暴露组（西医治疗组），随访1年，分别观察入组当天，3、6、12个月时各组抗缺血药物使用的情况。结果 研究共纳入186例患者，暴露组128人，非暴露组58人。2组基线资料差异无统计学意义。第3月随访时，与非暴露组比较，暴露组患者使用一线抗缺血药种类显著降低（P<0.01）；此差异在第6月时仍具有统计学意义（P<0.05）；至第12月时差异无统计学意义。在第3、6月随访时，两组使用二线抗缺血药种类差异无统计学意义；在第12月随访时，与非暴露组比较，暴露组使用二线抗缺血药物的种类显著减少（P<0.01）。第3月随访时，与基线比较，两组使用一线抗缺血药种类均有减少（P<0.05），暴露组减少更明显（P<0.05）。第6月随访时，与基线比较，暴露组使用二线抗缺血药物种类明显减少（P<0.05），而非暴露组无明显变化，差异无统计学意义。第12月随访时，与非暴露组比较，暴露组使用二线抗缺血药物种类差异有统计学意义（P<0.05），一线药物比较差异无统计学意义。结论 通心络胶囊能有效减少气虚血瘀型慢性冠脉综合征患者抗缺血药物的使用。

Abstract:

Objective To investigate the effect of Tongxinluo capsules on the use of anti-ischemic drugs in patients with chronic coronary syndrome （CCS） of Qi deficiency and blood stasis.Method A multicenter，prospective cohort study was conducted，with Tongxinluo capsules intervention as the exposure factor. Patients were divided into an exposed group （combination of traditional Chinese and western medicine） and a non-exposed group （western medicine alone），and followed up for one year. The use of anti-ischemic drugs was observed on the day of enrollment and at 3，6，12 months.Result A total of 186 patients were enrolled，with 128 in the exposed group and 58 in the non-exposed group. There were no statistically significant differences in baseline characteristics between the two groups. At the 3-month follow-up，the types of first-line anti-ischemic drugs used in the exposed group were significantly fewer than those in the non-exposed group （P<0.01），and this difference remained statistically significant at 6 months （P<0.05） but was no longer significant at 12 months. At the 3- and 6-month follow-ups，there were no significant differences between the two groups in the types of second-line anti-ischemic drugs used. However，at the 12-month follow-up，the types of second-line anti-ischemic drugs used in the exposed group were significantly fewer than those in the non-exposed group （P<0.01）. At the 3-month follow-up，both groups showed a reduction in the types of first-line anti-ischemic drugs used compared to baseline （P<0.05），with a more pronounced reduction in the exposed group （P<0.05）. At the 6-month follow-up，the exposed group showed a significant reduction in the types of second-line anti-ischemic drugs used compared to baseline （P<0.05），while no significant changes were observed in the non-exposed group. At the 12-month follow-up，the difference in the types of second-line anti-ischemic drugs between the exposed and non-exposed groups was statistically significant （P<0.05），while there was no significant difference in the types of first-line anti-ischemic drugs.Conclusion Tongxinluo capsules can effectively reduce the use of anti-ischemic drugs in patients with CCS of Qi deficiency and blood stasis.