Emergency Department, Xi'an Hospital of Traditional Chinese Medicine, Xi'an, China.
Department of Cardiology, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China; First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, China.
J Ethnopharmacol. 2023 Aug 10;312:116486. doi: 10.1016/j.jep.2023.116486. Epub 2023 Apr 16.
The incidence of coronary heart disease (CHD) complicated with anxiety or depression is increasing year by year. However, many anti-anxiety drugs or antidepressants have a certain degree of adverse reactions and are not easily accepted by patients. Xinkeshu (XKS), as a proprietary Chinese patent medicine with "psycho-cardiology" effect, is one of the commonly used drugs in the treatment of CHD complicated with anxiety or depression in China.
To systematically evaluate the efficacy and safety of XKS for CHD complicated with anxiety or depression.
Nine different electronic databases were independently searched to include randomized controlled trials (RCTs) of XKS for CHD complicated with anxiety or depression published from inception to February 2022, and the methodological quality was evaluated using the bias risk assessment tool from Cochrane Handbook 5.0 and the modified Jadad scale. Meta-analysis was performed using RevMan 5.3 and Stata 16.0 software. The GRADE Profiler 3.6.1 and TSA 0.9.5.10 beta were adopted to evaluate the certainty and conclusiveness of the evidence.
A total of 18 RCTs involving 1907 subjects were included. There were 956 subjects in the XKS group and 951 subjects in the control group. Baseline conditions were consistent and comparable between the groups. Compared with single-use western medicine (WM), XKS combined with WM significantly reduced scores of Hamilton Anxiety Scale (HAMA) [Mean difference (MD) = -7.60, 95% confidence interval (95% CI) (-10.37, -4.83), P < 0.000 01], Zung Self-rating Anxiety Scale (SAS) [MD = -10.05, 95% CI (-12.70, -7.41), P < 0.000 01], Hamilton Depression Scale (HAMD) [MD = -6.74, 95% CI (-11.58, -1.90), P = 0.006], and Zung Self-rating Depression Scale (SDS) [MD = -10.75, 95% CI (-17.05,-4.45), P = 0.000 8], as well as improved clinical effective rate [odds ratio (OR) = 4.24, 95% CI (2.47, 7.27), P < 0.000 01]. In terms of safety, 4 studies reported the adverse reactions in detail. The severity was mild and symptoms disappeared after treatment.
Current evidence indicates that XKS may be effective and safe in the treatment of patients with CHD complicated with anxiety or depression. Since the quality of the literature included in this study was generally low, there is an urgent need for more RCTs with high quality, low bias risk and sufficient sample size to validate our conclusions.
冠心病（CHD）并发焦虑或抑郁的发病率逐年上升。然而，许多抗焦虑药物或抗抑郁药都有一定程度的不良反应，不易被患者接受。心可舒（XKS）作为一种具有“心-脑-心理”作用的中药专利药，是中国治疗 CHD 并发焦虑或抑郁的常用药物之一。
系统评价心可舒治疗冠心病并发焦虑或抑郁的疗效和安全性。
独立检索从建库至 2022 年 2 月发表的关于心可舒治疗冠心病并发焦虑或抑郁的随机对照试验（RCT），纳入 9 个不同的电子数据库，并使用 Cochrane 手册 5.0 的偏倚风险评估工具和改良 Jadad 量表评估方法学质量。使用 RevMan 5.3 和 Stata 16.0 软件进行荟萃分析。采用 GRADE Profiler 3.6.1 和 TSA 0.9.5.10 beta 评估证据的确定性和结论性。
共纳入 18 项 RCT，涉及 1907 例受试者。XKS 组 956 例，对照组 951 例。两组基线条件一致，具有可比性。与西药单药治疗相比，XKS 联合西药治疗可显著降低汉密尔顿焦虑量表（HAMA）评分[均数差（MD）=-7.60，95%置信区间（95%CI）（-10.37，-4.83），P<0.00001]、Zung 自评焦虑量表（SAS）评分[MD=-10.05，95%CI（-12.70，-7.41），P<0.00001]、汉密尔顿抑郁量表（HAMD）评分[MD=-6.74，95%CI（-11.58，-1.90），P=0.006]和 Zung 自评抑郁量表（SDS）评分[MD=-10.75，95%CI（-17.05，-4.45），P=0.0008]，提高临床有效率[比值比（OR）=4.24，95%CI（2.47，7.27），P<0.00001]。安全性方面，4 项研究详细报告了不良反应。严重程度较轻，治疗后症状消失。
现有证据表明，心可舒可能对冠心病合并焦虑或抑郁患者有效且安全。由于本研究纳入的文献质量普遍较低，因此迫切需要更多高质量、低偏倚风险和足够样本量的 RCT 来验证我们的结论。
