Department of Cardiovascular Disease, Shenzhen Traditional Chinese Medicine Hospital, Guangzhou University of Chinese Medicine, Shenzhen, PR China; Faculty of Chinese Medicine and State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Taipa, Macao, PR China.
Faculty of Chinese Medicine and State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Taipa, Macao, PR China; National Traditional Chinese Medicine Clinical Research Base and Department of Cardiovascular, Hospital (T.C.M) Affiliated to Southwest Medical University, Luzhou, Sichuan, PR China.
Phytomedicine. 2022 Sep;104:154243. doi: 10.1016/j.phymed.2022.154243. Epub 2022 Jun 10.
Xinkeshu tablets (XKS), a well-known Chinese patent drug, have been administered to coronary heart disease (CHD) patients with anxiety and depression after percutaneous coronary intervention (PCI).
This meta-analysis aimed to systematically evaluate the clinical effects of XKS for treating CHD patients with anxiety and depression after PCI.
Randomized controlled trials (RCTs) about XKS alone or combined with conventional drugs for the treatment of CHD patients with anxiety and depression after PCI were retrieved from 7 databases (MEDLINE, EMBASE, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP) Database, Chinese Biomedical Database (CBM) and Wanfang Database) through November 2021. First, the studies were reviewed and screened by two independent assessors according to the eligibility criteria. Second, the methodological quality of the eligible studies was evaluated based on the Cochrane Collaboration's tool for assessing the risk of bias. Subsequently, meta-analysis was performed by using RevMan 5.4 software, and publication bias was evaluated by Stata 12.0 software. Finally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was applied to rate the quality of the evidence.
In total, 11 clinical RCTs involving 1000 patients were included in this study. This meta-analysis found that compared with conventional treatment alone, XKS combined with conventional treatment significantly improved the anxiety scale scores (SMD = -1.97, 95% CI -3.13 to -0.82; p = 0.0008; I = 98%), the depression scores (SMD = -2.80, 95% CI -4.49 to -1.10; p = 0.001; I = 98%), the scores on the Medical Outcomes Study 36 Item Short Form Health Survey (SF36) (MD = 11.22, 95% CI 4.19 to 18.26; p =0.002; I = 95%) and the blood lipid levels of total cholesterol (TC) (MD = -0.38, 95% CI -0.62 to -0.13; p = 0.003; I = 0%) and triglyceride (TG) (MD = -0.31, 95% CI -0.46 to -0.17; p < 0.0001; I = 0%).
The current evidence suggests that XKS might benefit CHD patients experiencing anxiety and depression after PCI by helping to improve their depression symptoms, TC and TG blood lipid levels. However, due to insufficient methodological quality of the studies, several risks of bias and inadequate reporting of the clinical data, more rigorous, multicenter, sufficient-sample and double-blind randomized clinical trials are warranted.
心可舒片（XKS）是一种著名的中药专利药物，已被用于经皮冠状动脉介入治疗（PCI）后合并焦虑和抑郁的冠心病（CHD）患者。
本荟萃分析旨在系统评价 XKS 治疗 PCI 后合并焦虑和抑郁的 CHD 患者的临床疗效。
通过检索 7 个数据库（MEDLINE、EMBASE、Cochrane 图书馆、中国知网（CNKI）、中国科技期刊数据库（VIP）数据库、中国生物医学文献数据库（CBM）和万方数据库），检索了 XKS 单独或联合常规药物治疗 PCI 后合并焦虑和抑郁的 CHD 患者的随机对照试验（RCT）。首先，两名独立评估者根据纳入标准对研究进行了审查和筛选。其次，根据 Cochrane 协作组评估偏倚风险的工具评估合格研究的方法学质量。随后，使用 RevMan 5.4 软件进行荟萃分析，并使用 Stata 12.0 软件评估发表偏倚。最后，应用推荐评估、制定与评价（GRADE）方法对证据质量进行评级。
本研究共纳入 11 项临床 RCT，涉及 1000 例患者。荟萃分析发现，与单纯常规治疗相比，XKS 联合常规治疗可显著改善焦虑量表评分（SMD=-1.97，95%CI-3.13 至-0.82；p=0.0008；I²=98%）、抑郁评分（SMD=-2.80，95%CI-4.49 至-1.10；p=0.001；I²=98%）、医疗结局研究 36 项简明健康调查量表（SF36）评分（MD=11.22，95%CI4.19 至 18.26；p=0.002；I²=95%）和血脂总胆固醇（TC）水平（MD=-0.38，95%CI-0.62 至-0.13；p=0.003；I²=0%）和三酰甘油（TG）水平（MD=-0.31，95%CI-0.46 至-0.17；p<0.0001；I²=0%）。
目前的证据表明，XKS 可能通过改善抑郁症状、TC 和 TG 血脂水平，有益于 PCI 后合并焦虑和抑郁的 CHD 患者。然而，由于研究的方法学质量较低、存在多种偏倚风险以及临床数据报告不充分，需要进行更严格、多中心、足够样本量和双盲随机临床试验。
