关心胸苏合丸穴位贴敷治疗慢性稳定型心绞痛有效性和安全性的多中心随机对照试验。

Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill () for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial.

机构信息

Department of Acupuncture and Moxibustion, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.

Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.

出版信息

Chin J Integr Med. 2021 Nov;27(11):838-845. doi: 10.1007/s11655-021-2870-3. Epub 2021 Aug 13.

DOI:10.1007/s11655-021-2870-3

PMID:34387828

Abstract

OBJECTIVE

To assess the clinical effectiveness of acupoint application (AP) of Guan Xin Su He Pill (, GXSHP) for patients with chronic stable angina pectoris (CSAP).

METHODS

This study was carried out in 3 local hospitals in Chengdu, China. After baseline evaluation, eligible patients were randomly assigned to the placebo application for acupoints (PAA) group or the herbal application for acupoints (HAA) group. Patients in the HAA group underwent AP with herbal powder, which was mainly GXSHP, and patients in the PAA group underwent AP with sham drugs. For each treatment session, unilateral acupoints including Neiguan (PC 6), Danzhong (RN 17), Xinshu (BL 15) and Jueyinshu (BL 14), were stimulated for both groups. AP was performed 3 times a week with a 2-day interval for 4 weeks. The primary outcome was the frequency of angina pectoris attacks per week, while the secondary outcomes included angina pain intensity measured by the Visual Analogue Scale (VAS), dose of rescue oral drugs (nitroglycerin), scores on the Seattle Angina Questionnaire (SAQ), Self-Rating Anxiety Scale scores (SAS) and Self-Rating Depression Scale scores (SDS). Clinical outcomes were measured at week 0, 4 and 8. The safety of AP of GXSHP treatment for CSAP were assessed.

RESULTS

A total of 121 patients were enrolled. Baseline characteristics were comparable across the 2 groups. After treatment, the angina attack numbers in the HAA group were significantly reduced from 11.00 to 4.81 (P<0.05). While, for PAA group, the angina frequency was not significantly improved (baseline 10.55; post-treatment 11.05). The HAA group had significantly fewer angina attacks than the PAA group (P<0.05). Pain intensity measured by VAS in HAA group was significantly reduced from 4.06 to 3.02 (P<0.05). While, for PAA group, the VAS was significantly increased (baseline 3.62; post-treatment 3.96; P<0.05). Clinical outcomes showed better improvement after treatment in the HAA group than in the PAA group in terms of oral administration of rescue drugs, SAS, SDS and SAQ scores (P<0.05). The adverse events were also reported.

CONCLUSION

AP of GXSHP is a safe and effective treatment for CSAP patients (Registration No. NCT02029118).

摘要

目的

评估穴位敷贴冠心舒心丸（GXSHP）治疗慢性稳定型心绞痛（CSAP）的临床疗效。

方法

本研究在中国成都的 3 家当地医院进行。在基线评估后，将符合条件的患者随机分配到穴位安慰剂敷贴（PAA）组或穴位草药敷贴（HAA）组。HAA 组患者接受主要为 GXSHP 的草药粉穴位敷贴治疗，PAA 组患者接受假药物穴位敷贴治疗。对于每个治疗疗程，两组患者均刺激单侧穴位，包括内关（PC6）、膻中（RN17）、心俞（BL15）和厥阴俞（BL14）。AP 每周进行 3 次，间隔 2 天，共进行 4 周。主要结局是每周心绞痛发作频率，次要结局包括心绞痛疼痛强度（视觉模拟量表，VAS）、急救口服药物（硝酸甘油）剂量、西雅图心绞痛问卷（SAQ）评分、焦虑自评量表（SAS）评分和抑郁自评量表（SDS）评分。临床结局在第 0、4 和 8 周进行测量。评估了 GXSHP 穴位敷贴治疗 CSAP 的安全性。

结果

共纳入 121 名患者。两组患者的基线特征无差异。治疗后，HAA 组心绞痛发作次数从 11.00 减少到 4.81（P<0.05）。而 PAA 组的心绞痛发作频率没有明显改善（基线 10.55；治疗后 11.05）。HAA 组心绞痛发作次数明显少于 PAA 组（P<0.05）。HAA 组 VAS 疼痛强度从 4.06 显著降低到 3.02（P<0.05）。而 PAA 组 VAS 显著增加（基线 3.62；治疗后 3.96；P<0.05）。HAA 组在急救药物口服、SAS、SDS 和 SAQ 评分方面的临床结局在治疗后改善明显优于 PAA 组（P<0.05）。也报告了不良事件。