目的 探讨苏合香丸治疗新型冠状病毒感染患者的有效性和安全性。方法 选择2022年12月—2023年1月首都医科大学附属北京中医医院等17家医院收治的192例新型冠状病毒感染患者，随机分为对照组和试验组，试验组89例，对照组103例。对照组按照诊疗方案进行基础治疗，试验组在对照组的基础上口服苏合香丸，1丸/次，2次/d。两组患者均连续治疗5 d。比较两组治疗后的临床疗效及治疗前后头痛、胸痛、四肢酸痛评分以及炎症指标。结果 治疗后，试验组临床总有效率95.51%，明显高于对照组的81.55%（P＜0.05）。治疗后，两组患者头痛、胸痛、四肢酸痛评分均较治疗前显著下降（P＜0.05），试验组从治疗第1天开始头痛评分低于对照组且有统计学差异（P＜0.05），试验组在治疗第5天时胸痛评分低于对照组，且有统计学差异（P＜0.05），试验组从治疗第3天开始四肢酸痛评分低于对照组，且有统计学差异（P＜0.05）。治疗后，两组患者的C反应蛋白（C-reactive protein，CRP）、降钙素原（procalcitonin，PCT）、白细胞介素-6（interleukin-6，IL-6）水平均下降，与治疗前相比具有统计学差异（P＜0.05），且试验组患者治疗后的CRP、IL-6水平显著低于对照组（P＜0.05）。两组不良事件发生率没有显著差异。结论 苏合香丸对新型冠状病毒感染患者的头痛、胸痛及四肢酸痛有一定的疗效，并且能抑制新冠病毒感染患者的机体炎症反应，安全性良好。

Objective To explore the clinical effect and safety of Suhexiang Pills (苏合香丸) in the treatment of patients infected with SARS-CoV-2. Methods A total of 192 patients infected with SARS-CoV-2 admitted to 17 hospitals including Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University from December 2022 to January 2023 were randomly divided into control group and treatment group, with 89 patients in the treatment group and 103 in the control group. The patients in control group received basic treatment according to the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 10). The patients in treatment group were oral administered with Suhexiang Pills on the basis of the control group, one pill each time, twice day. The patients in two groups were treated for 5 d. The clinical efficacy of the two groups after treatment was compared. The differences in scores of headache, chest pain, limb pain and inflammatory indexes before and after treatment were compared. Results After treatment, the total clinical effective rate of the treatment group was 95.51%, which was significantly higher than that of the control group (81.55%, P < 0.05). After treatment, headache, chest pain and limb pain scores were significantly decreased in both groups (P < 0.05), the headache score of the treatment group was significantly lower than that of the control group from the first day of treatment (P < 0.05), the chest pain score of the treatment group was significantly lower than that of the control group on the fifth day of treatment (P < 0.05), the limb pain score of the treatment group was significantly lower than that of the control group from the third day of treatment (P < 0.05). After treatment, the levels of C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6) in the two groups were decreased significantly (P < 0.05) and the levels of CRP and IL-6 in the treatment group were significantly lower than those of the control group (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups. Conclusion Suhexiang Pills have a certain effect on headache, chest pain and limb pain, inhibiting the inflammatory response in patients infected with SARS-CoV-2, with good safety.

R285.64

国家中医药多学科交叉创新团队项目（ZYYCXTD-D-202201）