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Table of Contents
ORIGINAL ARTICLE
Year : 2022  |  Volume : 8  |  Issue : 1  |  Page : 87-91

Interim analysis report of kuanxiong aerosol in improving angina and quality of life after percutaneous coronary intervention


1 The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China
2 Department of Cardiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China
3 Department of Cardiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou; Postdoctoral Research Station, Institute of Integrative Chinese and Western Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China

Date of Submission17-Nov-2020
Date of Acceptance17-Jan-2021
Date of Web Publication09-Apr-2021

Correspondence Address:
Prof, Dan-Ping Xu
Department of Cardiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120; Postdoctoral Research Station, Institute of Integrative Chinese and Western Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou 350122
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/wjtcm.wjtcm_26_21

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  Abstract 


Objective: The objective is to observe the effect of Kuanxiong aerosol (KXA) on angina and the quality of life of patients after percutaneous coronary intervention (PCI). Materials and Methods: Six hundred patients with angina after PCI (AAP) were randomly assigned to an experimental group and a control group (n = 300 in each group) and received basic treatment with KXA or basic treatment (respectively) for 8 weeks. The Seattle Angina Questionnaire (SAQ) and visual analog scale (VAS) scores of the two groups during the screening period and five follow-up periods were compared. Results: A total of 179 patients were included in this interim report, including 85 in the experimental group and 94 in the control group. Among the five-dimensional scores of the SAQ, the improvement in the angina frequency and quality of life scores in the experimental group was better than those in the control group after treatment (P < 0.01), and the difference in scores of the remaining dimensions was not statistically significant (P > 0.01). The difference in VAS scores between the two groups was not statistically significant (P > 0.01). No obvious adverse reactions were observed between the two groups. Conclusions: KXA can reduce the frequency of AAP and improve patients' quality of life.

Keywords: Angina; Kuanxiong aerosol; percutaneous coronary intervention; quality of life


How to cite this article:
Lin LQ, Wu BX, Lin MY, Chen QX, Xu DP. Interim analysis report of kuanxiong aerosol in improving angina and quality of life after percutaneous coronary intervention. World J Tradit Chin Med 2022;8:87-91

How to cite this URL:
Lin LQ, Wu BX, Lin MY, Chen QX, Xu DP. Interim analysis report of kuanxiong aerosol in improving angina and quality of life after percutaneous coronary intervention. World J Tradit Chin Med [serial online] 2022 [cited 2022 May 18];8:87-91. Available from: https://www.wjtcm.net/text.asp?2022/8/1/87/336828




  Introduction Top


Coronary heart disease (CHD) accounts for about one-third of total global deaths, and the total number of deaths due to CHD in China is still increasing.[1],[2] Percutaneous coronary intervention (PCI) is commonly used for patients with CHD, and the PCI ratio in China is much higher than that in many other countries.[3],[4] However, patients may continue to suffer from or relapse into angina after PCI (AAP).[5] Kuanxiong aerosol (KXA) is a quick-acting proprietary Chinese medicine preparation jointly developed by Professor Shikui Guo, a famous traditional Chinese medicine doctor, and Academician Keji Chen of the Chinese Academy of Sciences. A prospective, multicenter, randomized controlled clinical study found that the therapeutic effect of KXA was not inferior to that of nitroglycerin tablets in the process of angina pectoris remission, according to electrocardiography (ECG).[6] In this study, we conducted a randomized controlled trial to evaluate the effect of KXA on patients with AAP, using the Seattle Angina Questionnaire (SAQ) as the primary index and a visual analog scale (VAS) of chest pain as a secondary index.


  Materials and Methods Top


Subjects

A total of 600 patients with AAP at the Guangdong Provincial Hospital of Traditional Chinese Medicine since July 2019 were included and randomly divided into experimental and control groups, with 300 cases in each group.

Inclusion and exclusion criteria

  • Inclusion criteria: (1) 1 week to 1 year after PCI; (2) occurrence of angina pectoris twice a week or more; (3) patients aged between 18 and 85 years; (4) no traditional Chinese medicine or Chinese patent medicine used for angina pectoris within 2 weeks, and no anti-angina drugs added or dosed to the original Western medicine standard treatment within 2 weeks; (5) voluntary informed consent
  • Exclusion criteria: (1) high-risk unstable angina pectoris; (2) acute myocardial infarction (AMI); (3) severe hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg); (4) severe arrhythmia causing hemodynamic disorders;(5) decompensated heart failure; (6) severe liver or kidney disease, cerebrovascular disease, mental disease, malignant tumor, or other systemic diseases; (7) participation in other clinical research within 30 days; (8) nursing or pregnancy; and (9) allergies to the components of KXA.


Interventions

According to the relevant guidelines,[7] the control group used standardized medical treatment for at least 2 weeks. On the basis of the control group's intervention, the experimental group added KXA (produced by Hangzhou SUPOR Nanyang Pharmaceutical Co., Ltd., Hangzhou, China; batch no. z20063477), 3 times a day, with a sublingual spray of 2 beats each time.

Course of treatment

The treatment lasted for 8 weeks. A total of 6 visits were conducted, including the screening period (days - 14 to 1 before enrollment), follow-up 1 (day 1), follow-up 2 (day 14 ± 2), follow-up 3 (day 28 ± 2), follow-up 4 (day 42 ± 2), and follow-up 5 (day 56 ± 2).

Evaluation indexes

Efficacy indicators

  • Primary index: SAQ, divided into five dimensions: physical limitation (PL), angina stability (AS), angina frequency (AF), treatment satisfaction (TS), and quality of life (QL)
  • Secondary index: VAS for chest pain.


Safety indicators

  • Adverse event (AE)
  • Vital signs (blood pressure, body temperature, respiratory rate, and heart rate after 5 min of rest)
  • Routine blood test, routine urinalysis, routine stool, serum biochemistry (hepatorenal function, cardiac enzyme, blood lipid, blood glucose), and ECG.


Statistical analysis

In this study, data analysis and statistical modeling were completed using R v3.6.1 software (R Foundation, Vienna, Austria). Normally distributed data are expressed as mean ± standard deviation, and nonnormally distributed data are described as median (quartile 1, quartile 3). Owing to the characteristics of repeated measurements, the conservative Bonferroni correction method was adopted, and the P value was corrected to 0.05/5 = 0.01. The generalized estimation equation model from the R package “geepack” was used to solve the problem, and the R package “ggplot” was used for data visualization.

This study was approved by the ethics examination committee of Guangdong Provincial Hospital of Traditional Chinese Medicine and written permission was obtained from all participants who participated in the study (Ethical approval number: BF2019-060-01)


  Results Top


Baseline characteristics

A total of 201 patients in accordance with the research protocol were included in this interim report, 22 cases were dropped, and 179 cases were finally included, including 94 cases in the control group and 85 cases in the experimental group [Figure 1]. There were 18 (21.7%) patients in the experimental group and 7 (7.8%) in the control group with a history of hyperlipidemia; this difference was statistically significant (P < 0.05). Differences in age, sex, included institution, blood pressure, heart rate, respiration, temperature, combined hypertension and diabetes, combined use of antihypertensive drugs, hypoglycemic drugs, and lipid-lowering drugs were not statistically significant (P > 0.05) [Table 1].
Figure 1: Enrollment and outcomes. E Group: Experimental Group, C Group: Control Group

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Table 1: Baseline characteristics of the patients

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Comparison of Seattle Angina Questionnaire score between groups after treatment

The data of five patients without a screening period were excluded because the difference could not be calculated. There were no significant differences in the changes in PL, AS, or TS between the two groups after treatment (P > 0.01), while the changes in AF and QL were statistically significant (P < 0.01) [Table 2] and [Figure 2], [Figure 3].
Table 2: Comparison of the Seattle Angina Questionnaire score between the two groups after treatment

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Figure 2: The change of angina frequency. E Group: Experimental Group, C Group: Control Group

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Figure 3: The change of quality of life. E Group: Experimental Group, C Group: Control Group

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Comparison of visual analog scale between groups after treatment

The data of six patients without a screening period were excluded since the difference could not be calculated. There was no significant difference in the change in VAS scores between groups after treatment (P > 0.01) [Table 3] and [Figure 4].
Table 3: Comparison of the Visual Analogue Scale between the two groups after treatment

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Figure 4: The change of visual analogue scale. E Group: Experimental Group, C Group: Control Group

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Safety

There were no AEs related to the test drug, and there were no obvious abnormalities in the relevant laboratory tests and examination results of the subjects before and after treatment

Compliance

In this interim study, the shedding rate of the experimental group was 6.59%, and that of the control group was 14.55%. This showed that the compliance of patients using KXA was better than that of the control group.


  Discussion Top


In recent years, with the development of PCI, the mortality of AMI has been greatly reduced, and it has gradually become an important method for CHD revascularization. According to the registration data of interventional therapy for CHD by the National Health Commission of China, the total number of interventional treatment cases of CHD in mainland China in 2017 increased by 13% compared with that in 2016, and the average number of stents implanted was 1.47. Among these, interventional operations through the radial artery route are the most frequent (90.89%). Although the mortality rate of patients after PCI can be stabilized at a low level, up to 50% of patients still suffer from persistent angina,[8] which seriously impairs their prognosis and quality of life. Modern medicine mainly treats AAP by adjusting lifestyle, controlling risk factors, and relieving symptoms with drugs. Among them, beta blockers, nitrates, calcium antagonists, and other drugs that improve myocardial metabolism are commonly used in clinical practice, which have the characteristics of rapid onset and good targeting. However, there are some problems such as patient intolerance, poor drug compliance, and recurrent angina pectoris after drug withdrawal.

KXA is composed of sandalwood oil, piper longum oil, galangal oil, asarum oil, and borneol. It is absorbed into the body through the sublingual vein. The main ingredient of sandalwood is α-santalol, which has antibacterial, antitumoral, antioxidant, and anti-inflammatory effects.[9] Piper longum oil has antibacterial, anti-inflammatory, antiarrhythmic, and hypolipidemic effects.[10] Its main component, piperine can reduce cardiac fibrosis by activating the receptor PPAR-γ and inhibiting AKT/GSK3 β.[11] Galangal oil has antioxidant effects.[12] It was proven to exert a significantly higher penetration enhancement effect.[13] Asarum volatile oil can resist acute myocardial ischemia caused by the pituitary gland in rabbits and increase the tolerance of mice under decompression and hypoxia.[14] Borneol oil can exert local analgesia through the TRPM8 channel and involve the downstream glutamatergic mechanism in the spinal cord.[15] Therefore, from the perspective of modern pharmacological research, KXA has the effects of protecting myocardial cells, inhibiting platelet aggregation, reducing myocardial oxygen consumption, and anti-inflammatory effects. It can ease AAP, thereby improving patients' prognosis and quality of life.

A total of 179 patients with AAP were finally included in this interim study. According to baseline data, the number of patients with hyperlipidemia in the experimental group was significantly different from that in the control group (P < 0.05), which might be related to the small sample size and sampling error in this interim study. The experimental and control groups had a history of hypertension accounting for 57.8% and 68.9%, respectively. At the same time, 32.5% and 22.2% of patients had a history of diabetes. The results indicated that patients with CHD were prone to have two or more comorbid diseases. When managing patients after PCI, it is important to control for risk factors such as hypertension, hyperlipidemia, and hyperglycemia and to standardize the treatment.

The SAQ is a specific self-assessment tool used to measure the body function and quality of life of patients with CHD.[16] It has been recognized by the International Consortium for Health Outcomes Measurement as a standardized outcome indicator of CHD.[17] It can be divided into five dimensions and 19 items. A high score indicates good physical function and a high quality of life. In this study, the SAQ was used as the primary efficacy indicator. The results showed that KXA could effectively reduce the frequency of angina pectoris and improve the quality of life of patients after PCI. In a clinical study of cardiopulmonary exercise,[18] it was found that KXA could effectively increase the cardiac output of patients with CHD, alleviate coronary artery ischemia, and improve exercise tolerance and quality of life. This may be related to the fact that KXA can reduce myocardial cell damage caused by myocardial ischemia through multiple targets and multiple signal pathways.[19] A randomized controlled trial[20] found that the mechanism of KXA in relieving angina pectoris may be related to the pathway between NO and cGMP. NO can increase the cGMP level and promote the opening of the ion channel of the myocardial cell membrane, thus relaxing smooth muscle, expanding blood vessels, increasing blood flow, and relieving angina pectoris.

In this study, the VAS was used as a secondary efficacy indicator. However, there was no significant difference in VAS scores between the two groups after treatment (P > 0.01). This may be related to the small sample size of this interim study, which should be expanded in future studies.

In terms of safety analysis, there were no AEs related to the experimental drug in this study, which was consistent with the results of previous clinical studies. The combination of KXA and conventional Western medicine for the treatment of patients with AAP is safe. In a follow-up study, a limitation to be addressed is that the observation time of endpoint events, such as the readmission rate and incidence of cardiovascular events, should be prolonged.


  Conclusions Top


KXA combined with conventional Western medicine treatment of AAP has a good curative effect, can effectively reduce the frequency of AAP attacks, improve the patient's medication compliance and quality of life, and has good safety.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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Dong J, Zhu XM, Wu FY, Yang BQ, Feng H, Dong YF, et al. Development of galangal essential oil-based microemulsion gel for transdermal delivery of flurbiprofen: Simultaneous permeability evaluation of flurbiprofen and 1,8-cineole. Drug Dev Ind Pharm 2020;46:91-100.  Back to cited text no. 13
    
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Xu DP, Wu BX, Li Q, Ding YN, Zhong BY, Lin JH, et al. Clinical study of kuanxiong aerosol's efficacy on exercise tolerance of patients with coronary heart disease complicated with chest tightness pain after activities. Chin J Integr Chin West Med 2020;40:287-9.  Back to cited text no. 18
    
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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