The efficacy of Chinese herbal medicines on acute coronary syndrome with renal insufficiency after percutaneous coronary intervention
Graphical abstract
Introduction
Approximately 25%–30% of patients who present with an acute coronary syndrome (ACS) had an estimated glomerular filtration rate (eGFR)≤60 ml min−1·1.73 m−2 (Medi et al., 2009; Szummer et al., 2009). eGFR is an independent risk factor for death and recurrent myocardial infarction (MI) in patients with an ACS. Chronic kidney disease is associated with 3-fold increase in mortality for patients with MI (Saran et al., 2016; Fox et al., 2010). Early percutaneous coronary intervention (PCI) and western medicine standard therapy can improve the 1 year survival rate for patients of ACS with mild-to-moderate renal insufficiency (Szummer et al., 2009), but they have poor prognosis compared with that with normal renal function. Traditional Chinese medicine is still practiced in China. In recent years, traditional Chinese medicine plays an important role in improving renal function (Li et al., 2017); however, it is lack of evidence whether the Chinese medicine can improve the prognosis of ACS patients with chronic renal insufficiency.
Xinyue Capsule and Fufang Chuanxiong Capsule have been approved by the State Food and Drug Administration (SFDA) of China for clinical use in patients with coronary artery disease (Chinese Pharmacopoeia Commission, 2017). Xinyue capsule is composed of panax quinquefolius saponin extracted from leaves and stems of Panax quinquefolium L, which has the functions of anti-myocardial ischemia, improving myocardial energy metabolism and inhibiting apoptosis of cardiomyocytes (Wang et al., 2012; Liu et al., 2015). Meanwhile, panax quinquefolius saponin can also improve acute kidney injury through suppression of oxidative stress, inflammatory response and apoptosis (Ma et al., 2017). Fufang Chuanxiong capsule consists of Angelica sinensis radix (rhizomes of Angelica sinensis (Oliv.) Diels) and Chuanxiong rhizome (rhizomes of Ligusticum striatum) (Chinese Pharmacopoeia Commission, 2017), whose most important components are ligustrazine and ferulic acid. both of which have the effects of anti-platelet, dilating blood vessels and scavenging oxygen free radicals (Jiang and Chen, 2013; Wang and Ou-Yang, 2005), and ligustrazine also has the role of antagonizing intracellular calcium overload (Jiang and Chen, 2013). In terms of improving kidney function, Angelica sinensis radix and Chuanxiong rhizome were useful in deferring the advance of chronic renal failure (Tong et al., 2010), Ligustrazine can also prevent the decline of glomerular filtration rate and renal plasma flow and improve cadmium-induced nephrotoxicity (Lan et al., 2014, Liu, 1992).
An Open-Label Randomized Controlled, Multicenter Study (5C trial) (Wang et al., 2013) indicated that treatment with Chinese herbal medicines plus conventional treatment further reduced the occurrence of cardiovascular primary endpoint (cardiac death, nonfatal recurrent MI and ischemia-driven revascularization) and secondary endpoint (stroke, congestive heart failure and readmission for ACS) for patients with ACS after PCI. This study, as a sub-study of 5C trial, was designed to investigate the efficacy of Chinese herbal medicines plus western medicine standardized therapy on ACS patients with mild-to-moderate renal insufficiency after PCI from cardiovascular prognosis and renal function.
Section snippets
Study design and subjects
This study was a sub-study of 5C trial, the multicenter, open-label, randomized controlled design of the 5C trial (chictr.org number: chictr-trc-07000021) that has been previously described (Wang et al., 2013). 426 ACS patients with mild-to-moderate renal insufficiency were selected from the 5C trial consisted of 211 subjects in the treatment group and 215 subjects in the control group (Fig. 1). ACS was diagnosed based on AHA/ACC guidelines for the management of patients with unstable
Baseline characteristics
There was no statistically significant difference between the treatment group and the control group in baseline characteristics except for the gender factor. (Table 1).
Primary endpoint
After 12 months of follow-up, there were 16 cases of primary endpoint in the control group (7.4%) and 6 cases of primary endpoint in the treatment group (2.8%) (absolute risk reduction: 0.046, 95%CI: 0.004–0.088; relative risk: 0.38, 95%CI: 0.15–0.96, P = 0.040; Table 2).
To determine the impact of gender on observational target,
Discussion
In recent years, the status of traditional Chinese medicine in the intervention of cardiovascular disease has been gradually concerned (Xian et al., 2016; Li et al., 2013). In particular, the effectiveness and safety of traditional Chinese medicine on coronary heart disease has been reported by multiple randomized studies (Mao et al., 2016; Wang et al., 2015a, Wang et al., 2015b; Luo et al., 2015). However, it was lack of related study whether Chinese medicine can improve the prognosis of ACS
Conclusions
This study is a multi-center randomized controlled study that evaluates the role of traditional Chinese medicine in clinical practice by means of objective and direct research evaluation system on the basis of syndrome differentiation and individualized diagnosis and treatment, which is also the only clinical study of traditional Chinese medicine on two important target organs of heart and kidneys. However, there are still some deficiencies. This study had relatively few cases, as well as the
Author contributions
Study Design: CLW, HX, DZS, Data Collection: DWZ, SLW, PLW, DJP, GZY, Statistical Analysis: DWZ, Data Interpretation: DWZ, SLW DZS, Manuscript Preparation: DWZ, DZS, All authors have read and approved the final manuscript for publishing.
Declaration of competing interest
The funding agencies had no role in the design, conduct, analysis, or publication of the study. All other authors have no conflicts of interest to declare.
Acknowledgment
We thank all of the research assistants and clinical coordinators for their dedication to clinical trial coordination, data collection, and management. This study was supported by grants from the Supporting Program of the “Eleventh Five-Year Plan” for Sci & Tech Research of China (China) (grant no. 2006BA104A01), and National Natural Science Foundation (China) (grant no. 81303128).
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