目的： 结合临床经验，探讨单独使用复方丹参滴丸治疗冠心病心绞痛和与其他西药联合使用治疗冠心病心绞痛的不良反应发生规律与发生特点，为复方丹参滴丸的合理用药提供参考。方法：回顾分析2010年1月至2016年1月在我院诊治的资料齐全的1359例冠心病心绞痛患者病例，其中单独使用复方丹参滴丸的658例（单独组），联合其他西药治疗的701例（联合组），对两组患者出现的不良反应进行统计分析。结果：研究结果显示，单独组的658例患者中有27例发生不良反应，不良反应发生率为4.10%（27/658）；联合组的701例患者中有61例患者发生不良反应，不良反应发生率为8.70%（61/701）。单独用药组性别、年龄、用药剂量与患者不良反应之间无密切相关，但联合用药组消化系统反应与患者年龄和用药剂量密切相关。联合用药组中，联合应用马来酸桂哌奇特患者的皮肤反应最为严重，联合单硝酸异山梨酯患者的全身反应最为严重，联合前列地尔患者的血液系统和过敏性休克最为严重。单独组的不良反应发生率明显低于联合组，两者相比，具有显著性差异（χ²=11.85，P<0.05）；两者在过敏性休克、皮肤反应、血液系统反应、消化系统反应、呼吸系统反应之间相比较为类似，但在全身反应方面，联合组明显高于单独组，两者相比具有显著性差异（χ²=4.06，P<0.05）。结论：复方丹参滴丸单独使用治疗冠心病心绞痛比联合西药使用时不良反应发生率低；在联合西药治疗时更应注意合理使用，减少不良反应的发生。

Objective: To investigate the occurrence patterns and features of adverse events caused by CSDP (Compound Danshen drop pill) alone or combined with western medicine in treatment of angina pectoris, so as to provide some clinical experience for rational drug use of CSDP. Methods: Retrospective analysis was conducted on the complete information of 1359 cases of angina pectoris patients treated in our hospital from January 2010 to January 2016, including 658 cases of CSDP monotherapy as well as 701 cases of CSDP in combination with other western medicine, and the adverse reactions in the two groups of patients were also analyzed. Results: 27 adverse events were reported in the 658 patients with CSDP monotherapy (the occurrence rate of adverse reaction is 4.10%),whereas 61 patients out of 701 patients in the combined group experienced adverse reactions and the reporting rate was 8.70% (61/701). There was no significant correlation between the gender, age, drug dosage of patients and the occurrence of adverse reactions in the monotherapy group. In the combination group, the skin reaction of the patients with combined use of cinepazide maleate was the most serious, and the systemic reaction was the most serious in patients with combined use of isosorbide mononitrate. The blood system and anaphylactic shock were the most serious in patients with combined use of alprostadil. The incidence of adverse reactions was significantly lower in CSDP monotherapy group than in combination group (χ²=11.85, P<0.05). There was no significant difference between the two groups in occurrence of anaphylactic shock, skin reaction, hematologic reaction, and digestive system reaction, but there was significant difference between the two groups (χ²=4.06, P<0.05) in the systemic response. Conclusion: The adverse reaction rate was lower when CSDP was used alone as compared to combined use with western medicine in treatment of angina pectoris. Therefore, special attention should be paid to rational drug use in combination with western medicine so as to reduce the occurrence of adverse reactions.