Safety Of Traditional Chinese Medicine Injections Research Articles

Effects of Traditional Chinese Medicine Injections for Anthracyclines-induced Cardiotoxicity: An Overview of Systematic Reviews and Meta-Analyses.

Traditional Chinese medicine (TCM) injections, as a relatively safe and low-cost treatment, have been widely used in the prevention and treatment of anthracyclines-induced cardiotoxicity in China. However, the quality of the relevant systematic reviews and meta-analyses published in recent years is uneven, so that the effectiveness and safety of TCM injections in preventing and treating anthracyclines-induced cardiotoxicity remain to be discussed. A systematic overview is therefore needed to provide a more advanced evidentiary reference for clinical practice. Eight Chinese and English databases were searched by computer to screen the meta-analyses/systematic reviews on the efficacy of traditional Chinese medicine injections for the prevention and treatment of anthracyclines-induced cardiotoxicity from the database establishment to October 2022. The methodological quality and evidence quality of outcome indicators included in the study were evaluated by AMSTAR 2 tool, PRISMA statement and GRADE classification. A total of 7 articles were included in the study. The quality evaluation of AMSTAR 2 showed that 7 studies were extremely low-level; PRISMA stated that the evaluation results showed that the reports of 7 studies were of intermediate quality; The GRADE rating indicated that most of the evidence was of low quality. The methodological quality and evidence quality of meta-analysis/system evaluation concerning the prevention and treatment of anthracyclines-induced cardiotoxicity by Chinese medicine are currently low, and the effectiveness of Chinese medicine in the treatment of anthracyclines-induced cardiotoxicity needs more high-quality evidence-based evidence.

Traditional Chinese Medicine Injections Combined With Oseltamivir for Influenza: Systematic Review and Network Meta-Analysis

Background: As a cause of respiratory tract infections in humans, influenza remains with high morbidity and mortality, with associated significant healthcare burden and increased financial burden. Traditional Chinese medicine injections (TCMIs) combined with oseltamivir (TCMIs + oseltamivir) are the representative therapeutic strategies for influenza, which is a compliant with clinical applications in China. The aim of this study was to describe the comparative efficacy and safety of TCMIs + oseltamivir in patients with influenza, based on the current evidence. Methods: PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, VIP information resource integration service platform databases, and the Chinese biomedical literature service system were searched to find randomized controlled trials where TCMIs + oseltamivir are the representative therapeutic strategies for influenza, from inception until October 2021, without language restriction. Two investigators independently screened eligibility criteria, extracted data, and appraised the risk of bias with the same criteria. We conducted a network meta-analysis using the Bayesian random method for each outcome and performed the sensitivity analysis, meta-regression, and Egger’s and Begg’s tests for the reliability and robustness of our results. Results: Thirty-one trials including 2,893 participants proved eligible and reported on four TCMIs + oseltamivir versus oseltamivir. Network meta-analysis showed Yanhuning (YHN) +oseltamivir (MD = −1.7, 95% CrI: −2.5 to −0.88; SUCRA = 0.89; low certainty of evidence) in fever disappearance time, Tanreqing (TRQ) +oseltamivir (MD = −1.9, 95% CrI: −2.8 to −1; SUCRA = 0.97; low certainty of evidence) in cough disappearance time, and Xiyanping (XYP) +oseltamivir (OR = 5.9, 95% CrI: 3.1 to 11; SUCRA = 0.82; very low certainty of evidence) in the response rate to be more efficacious than oseltamivir alone with the best SUCRA. Based on the combined SUCRA value for primary outcomes, TRQ + oseltamivir is probably better in cough disappearance time, and XYP + oseltamivir and YHN + oseltamivir may be better in fever disappearance time than others. No significant difference in safety between the treatments. Conclusion: In patients with influenza, TCMIs + oseltamivir only partially improve flu symptoms. Overall therapeutic efficacy and safety are inconclusive, based on low to very low certainty of evidence. However, the safety remains uncertain, and TCMI treatments for influenza should be considered with caution. More high-quality studies examining the efficacy and safety of TCMIs are needed. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42021286994

Efficacy and Safety of Traditional Chinese Medicine Injections for Heart Failure With Reduced Ejection Fraction: A Bayesian Network Meta-Analysis of Randomized Controlled Trials.

Background: Heart failure as an important issue in global public health, has brought a heavy economic burden. Traditional Chinese medicine injections (TCMIs) have significant effects on heart failure with reduced ejection fraction (HFrEF). However, it is difficult for clinicians to identify the differences in clinical efficacy and safety of various TCMIs. The purpose of this study is to compare the efficacy and safety of various TCMIs for treating HFrEF by conducting a Bayesian network meta-analysis (NMA) and to further provide references for clinical decision-making. Methods: The clinical randomized controlled trials of TCMIs for treating HFrEF were searched in seven database from inception to August 3rd, 2021. The Cochrane collaboration’s tool was used to assess the risk of bias. NMA was performed in a Bayesian hierarchical framework. The surface under the cumulative ranking curve (SUCRA), the multi-dimensional efficacy analysis, the comparison-adjusted funnel plot, and the node-splitting analysis were conducted using R software. Results: A total of 107 eligible RCTs involving 9,073 HFrEF patients and 6 TCMIs were included. TCMIs include Huangqi injection (HQ) also called Astragalus injection, Shenfu injection (SF), Shengmai injection (SGM), Shenmai injection (SM), Xinmailong injection (XML), and Yiqifumai lyophilized injection (YQFM). The results of NMA and SUCRA showed that with conventional treatment (CT) as a common control, in terms of clinical efficacy, CT + XML was most effective in New York Heart Association cardiac functional classification efficiency, brain natriuretic peptide, and N-terminal pro-brain natriuretic peptide; the CT + SM was most effective in 6-min walking test, left ventricular end-diastolic diameter, left ventricular end-systolic diameter and cardiac output; the CT + YQFM was most effective in left ventricular ejection fraction; the CT + HQ was most effective in stroke volume; the CT + SF was most effective in Minnesota Living with Heart Failure Questionnaire. In terms of safety, there was no significant difference between CT + TCMIs and CT. Conclusion: This Bayesian network meta-analysis results show that the combination of qualified TCMIs and CT is more effective for HFrEF patients than CT alone, and CT + XML and CT + SM may be one of the potential optimal treatments. Also, the safety of these TCMIs needs to be further observed. However, due to some limitations, the conclusions need to be verified by more large-sample, double-blind, multi-center RCTs.

Efficacy and Safety of TCMI in Patients With Combined Coronary Heart Disease and Heart Failure: A Systematic Review and Network Meta-Analysis.

Objective: To compare the efficacy and safety of conventional treatments (CTs) to those that included traditional Chinese medicine injections (TCMIs) in patients with combined coronary heart disease and heart failure (CHD-HF). Methods: Eight electronic literature databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, China National Knowledge Infrastructure Database, Chinese Scientific Journal Database, Wanfang Database, Chinese Biomedical Database) were searched from their inceptions to May 18, 2021, to identify relevant randomised controlled trials (RCTs). The primary outcomes analyzed included the total effectiveness rate and adverse events (ADRs). The secondary outcomes analyzed included the left ventricular ejection fraction (LVEF), N-terminal pro-brain natriuretic peptide (NT-proBNP), brain natriuretic peptide (BNP), and 6-min walk test (6MWT). Cochrane risk-of-bias tool was used to assess quality of the analyzed RCTs. Stata and OpenBUGS software were used to prior to the systematic review and network meta-analysis. Results: Sixty-one eligible trials involved 5,567 patients and one of the following 15 TCMIs: Shuxuetong, Shenmai, Shenfu, Shengmai, Danshenduofenyansuan, Danhong, Dazhuhongjingtian, Xinmailong, Dengzhanxixin, Gualoupi, Shuxuening, Xuesaitong, Yiqi Fumai, Shenqi Fuzheng, Huangqi. Network meta-analysis revealed that Shuxuetong injection + CT group was superior to CT only in improving the total effectiveness rate [odds ratio (OR): 7.8, 95% confidence interval (CI): 1.17–27.41]. Shenmai injection + CT was superior to CT only for LVEF (OR: 8.97, CI: 4.67–13.18), Xinmailong injection + CT was superior to CT only for NT-proBNP (OR: −317.70, CI: −331.10–303.10), Shenqi Fuzheng injection + CT was superior to CT only for BNP (OR: −257.30, CI: −308.40–242.80); and Danhong injection + CT was superior to CT only for 6MWT (OR: 84.40, CI: 62.62−106.20). Different TCMIs had different toxicity spectrums. Conclusion: TCMIs combined with CT are better than CT alone in treating CHD-HF. Different TCMIs improve different outcomes. Additional properly designed RCTs are needed to conduce a more refined comparison of various TCMIs. Systematic Review Registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42021258263].

Efficacy and safety of traditional Chinese medicine injections in the treatment of chronic obstructive pulmonary disease: A protocol for systematic review and network meta-analysis.

Background:Chronic obstructive pulmonary disease (COPD) is a widespread, heterogeneous disease characterized by chronic inflammation of the airway and the gradual blockage of air flow due to bronchial obstruction. At present, a large number of traditional Chinese medicine injections (TCMIs) has been applied in the clinical treatment of COPD. However, there is insufficient evidence of evidence-based medicine of the interaction between them. Therefore, the purpose of this study is through the network meta-analysis to evaluate the efficacy and safety of the different TCMIs treatment of COPD, offering reference and evidence for clinical application.Methods:We will search 7 databases for randomized controlled trials of TCMI for the COPD, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chinese Scientific Journals Database, and Wan-fang databases, from the date of the establishment of each database to October 31, 2021. The network meta-analysis will be implemented through Aggregate Data Drug Information System 1.16.8 and Stata 13.0 software. Pulmonary function included forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and FEV1/FVC will be the primary outcomes, FEV1 as a percentage of the estimated value (FEV1%pred), maximal voluntary ventilation (MVV), MVV as a percentage of the estimated value (MVV%pred), 6 minutes walking distance, The St. George's Respiratory Questionnaire score, and safety/adverse event will be evaluated as secondary outcomes. Mean differences or odds ratios will be used for statistical analysis. We will ensure the reliability of the results through node-split model and heterogeneity analysis. In addition, methodological quality will be evaluated based on the Cochrane Collaboration's tool, and the quality of evidence will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation system.Results:This study will provide reliable evidence for the clinical selection of TCMI in the treatment of COPD.Conclusion:The results of this study will evaluate the efficacy and safety of TCMI in the treatment of COPD, and provide decision-making references for future clinical and scientific research.

Effect of Traditional Chinese Medicine Injection on Cancer-Related Fatigue: A Meta-Analysis Based on Existing Evidence.

Methods We systematically searched randomized controlled studies reported through March 2020 in PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, Web of Science, China Biomedical Literature Database (CBM), the China National Knowledge Infrastructure (CNKI), Wanfang, and VIP databases. Two investigators independently screened the studies according to the predetermined criteria, extracted data, and evaluated the bias risk of the included studies, using RevMan5.3 software. Results Twelve studies enrolling 1005 participants were included in this systematic review. We found that TCMJ could improve the clinical efficacy of CRF patients (RR = 1.24, 95% CI: 1.05–1.46, P=0.01), ameliorate fatigue status (RR = 1.44, 95% CI: 1.27–1.65, P < 0.00001), and improve quality of life (MD = 8.34, 95% CI: 3.31–13.37, P=0.001), but there was no statistical significance in the fatigue score (MD = −1.10, 95% CI: −2.23–0.04, P=0.06). Referring to the number of adverse events, the safety of TCMJ was good. Subgroup analysis showed that TCMJ could improve clinical efficacy, fatigue, and quality of life in a short time (≤4 weeks). Among them, tonic TCMJ could improve the clinical efficacy. TCMJ had advantages in improving fatigue of lung cancer and gastric cancer. In addition, life quality of lung cancer patients improved significantly. Conclusion Current research evidence showed that TCMJ could improve the clinical efficacy, fatigue status, and life quality of patients with CRF. In addition, we found that TCMJ could improve the clinical efficacy of CRF patients in a short period of time. Tonic TCMJ could improve the clinical efficacy, but heat-clearing TCMJ could not. Life quality and fatigue status of lung cancer patients improved significantly. However, due to the sample size and quality of the included studies, the results of this analysis should be treated with caution. The above conclusions still need to be verified by more large-sample and high-quality randomized controlled trials.

Effect of traditional Chinese medicine injections on severe pneumonia: A protocol for systematic review and meta-analysis.

Background:Traditional Chinese medicine injections (TCMJ) used in the treatment of severe pneumonia have been widely implemented in clinical practice, but their overall efficacy and safety remain unclear. This paper aims to evaluate the efficacy and safety of TCMJ in the treatment of severe pneumonia.Methods:PubMed, EMbase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, WanFang, and the Chongqing VIP Chinese Science and Technology Periodical Database were all searched for randomized controlled trials focusing on the administration of TCMJ for severe pneumonia. Two researchers independently screened titles, abstracts, full texts, and extracted relevant data. The RevMan 5.3 software (The Cochrane Collaboration, Software Update, Oxford, UK) and Stata 14 software (STATA Corporation, College Station, TX) were used for statistical analysis.Results:This study summarizes the related randomized controlled trials to assess the effect and safety of TCMJ in the treatment of severe pneumonia.Conclusion:This article provides theoretical support for the clinical application of TCMJ in the treatment of severe pneumonia.PROSPERO Registration number:CRD42020185072

Retrospective analysis and discussion on 74 cases of adverse reactions of traditional Chinese medicine injection

As a modern dosage form drug with rapid effect, traditional Chinese medicine (TCM) injection has been more and more used in clinical practice. Meanwhile the safety of TCM injection has attracted more and more attention. The retrospective analysis on 74 cases of adverse reaction of TCM injections collected from 2007 to 2016 in the Third Affiliated Hospital of Beijing University of Chinese Medicine showed that the proportion of men and women with adverse reactions was 0.54:1; the average age was 62.5 years old; 21 kinds of TCM injections were involved. Among them, the most reported were blood-regulating agents. The top four kinds of TCM injections with highest adverse drug reactions (ADRs) were Tanreqing injection, Danhong Injection, Shuxuening Injection and Xuesaitong for injection. The top three clinical manifestations of adverse reactions were lesions of skin and its appendages, damage of circulatory system and damage of nervous system. The potential causes of the adverse reactions of TCM injections were analyzed, and it was believed that individual difference, medicine, pharmaceutical excipients, solvent and TCM syndrome differentiation may be the main five causes for the adverse reactions of TCM injections. In order to reduce the adverse reactions of TCM injections, it is suggested that the clinical pharmacists should participate in the application management of TCM injections in the hospital; the production enterprises shall strengthen the whole life cycle management of the drugs; and at the same time, the drug control and administration authorities should improve the drug management methods constantly and encourage the development of TCM injections to the high quality level.