Clinical efficacy of Kuanxiong aerosol for patients with prehospital chest pain: A randomized controlled trial.

BACKGROUND: Kuanxiong Aerosol (KXA)(CardioVent®), consisting of Asarum sieboldii Miq. oil, Santalum album L. oil, Alpinia officinarum Hance oil, Piper longum L. oil and borneol, seems to relieve the symptoms of chest pain and serve as a supplementary treatment for prehospital chest pain in emergency department. STYLE OF THE STUDY: This randomized controlled trial aimed to determine the clinical effect and safety of KXA for patients with prehospital chest pain. METHODS: A total of 200 patients were recruited from Guangdong Provincial Hospital of Chinese Medicine and randomly divided into KXA group (n = 100) and Nitroglycerin Aerosol (NA) group (n = 100) by SAS 9.2 software. All patients were treated with standardized Western medicine according to the pre-hospital procedure. The experimental group and NA group was additionally treated with KXA and NA respectively. The primary outcome was the relieving time of prehospital chest pain (presented as relief rate) after first-time treatment. The secondary outcomes included the evaluation of chest pain (NRS scores, degree of chest pain, frequency of chest pain after first-time treatment), efficacy in follow-up time (the frequency of average aerosol use, emergency department visits, 120 calls, medical observations and hospitalization at 4 weeks, 8 weeks, 12 weeks), alleviation of chest pain (Seattle angina questionnaire, chest pain occurrence, and degree of chest pain at 12-weeks treatment) and the change of TCM symptoms before and after 12-weeks treatment. In addition, the safety of KXA was also assessed by the occurrence of adverse events. The database was created using Epidata software, and statistical analysis was conducted by SPSS 23.0 software. RESULTS: A total of 194 participants finally completed the trial, the results showed that after first-time treatment, KXA had a higher relief rate (72.2%) of chest pain within 30 min than that of NA group (59.4%, p = 0.038), KXA group had a lower degree of chest pain (p = 0.005), lower NRS score (p = 0.011) and higher reduction of NRS score (p = 0.005) than the NA. In the follow-up period, KXA group decreased the frequency of 120 call better than that of NA group at 4 weeks (p = 0.040), but KXA had a similar efficacy as NA in the improvement on the of frequency of chest pain, aerosol use, emergency department visits, 120 call, medical observation and hospitalization at 4 weeks, 8 weeks and 12 weeks (p>0.05). There also had no difference between the two groups on the occurrence of chest pain, degree of chest pain, physical limitation, angina stability, treatment satisfaction, and disease perception between the two groups at 12 weeks (p>0.05). In addition, KXA and NA both improved the patient's chest pain, but not the TCM symptoms. In terms of safety, KXA showed similar safety as NA in this study. CONCLUSIONS: KXA relieved prehospital chest pain faster than NA and had a better remission effect on the prehospital chest pain than that of the NA group in short-period. In long-period, KXA showed similar efficacy on the improvement of prehospital chest pain as NA. KXA may be a safe and reliable therapy for prehospital chest pain.

[Expert consensus for diagnosis and treatment of post-cardiac arrest syndrome in adults by combining traditional Chinese and Western medicine in China (2023)].

Reperfusion injury occurs after return of spontaneous circulation (ROSC) in patients with cardiac arrest (CA), which leads to multiple organ dysfunction, called post-cardiac arrest syndrome (PCAS). PCAS is closely related to the prognosis of CA patients, and is an independent risk factor of survival. Integrated traditional Chinese and Western medicine diagnosis and treatment is critical for improving prognosis of PCAS. In order to guide and standardize integrated traditional Chinese and Western medicine diagnosis and treatment in PCAS among clinicians, nurses and research personnel in China, the Emergency Medicine Professional Committee of the Chinese Society of Integrated Chinese and Western Medicine has established an expert group to determine 14 clinical issues related to the diagnosis and treatment of PCAS with integrated traditional Chinese and Western medicine through clinical survey. The working group formulates a search strategy for each clinical issue according to the PICO principle. Chinese and English literature were searched from CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, and Cochrane Library. The grade of recommendations assessment, development and evaluation (GRADE) were used to form the level of evidence and recommendation. When the literature evidence was insufficient, the recommendations and level of recommendation were formed after expert discussion. Combined with the aspects of generalizability, suitability, and resource utilization, the expert consensus developed 28 recommendations around the 14 aspects of three stages of PCAS, including early circulation, respiratory support and reversible cause relief, mid-term neuroprotection, improvement of coagulation, prevention and treatment of infection, kidney and gastrointestinal protection and blood sugar control, post rehabilitation treatment, providing references for the integrated traditional Chinese and Western medicine of the diagnosis and treatment for PCAS.

Efficacy and Safety of Shenfu Injection on Acute Heart Failure: A Systematic Review and Meta-Analysis.

BACKGROUND: The adjunctive efficacy and safety of Shenfu Injection (SFI) for acute heart failure (AHF) still remains ambiguous even though previous studies made initial conclusions. OBJECTIVE: To comprehensively evaluate the adjunctive efficacy and safety of SFI in the treatment of AHF. STUDY DESIGN: This was a meta-analysis and systematic review. METHODS: 8 databases were searched for qualified randomized controlled trials (RCTs) from May 1990 to May 2022. The primary results included total clinical effective rate (TCER) and left ventricular ejection fraction (LVEF). The secondary results included left ventricular end diastolic dimension (LVEDD), heart rate (HR), N-terminal pro-B-type natriuretic peptide (NT-proBNP), brain natriuretic peptide (BNP) and adverse events (AE). The quality evaluation, meta-analysis, sensitivity analysis, subgroup analysis and publication bias were conducted by RevMan5.3 software. Meta-regression analysis was conducted using Stata software 15.0, and trial sequential analyses (TSA) was performed by TSA program. Finally, the GRADE (Grading of Recommendation, Assessment, Development, and Evaluation) system was applied for evaluating the quality of evidence. RESULTS: 61 RCTs containing 5505 AHF patients were included. The meta results demonstrated SFI combined with conventional western treatment (CWT) for AHF was superior to CWT alone in improving the TCER (RR = 1.21; 95% CI (1.18, 1.24); p < 0.001), improving LVEF (SMD = 0.85; 95% CI (0.77,0.92); p < 0.001) and reducing HR (SMD = -0.67; 95% CI (0.80, -0.54) p < 0.001). It had a lower AE rate in the SFI+CWT group (27/753, 3.59%) than the CWT group (68/739, 9.20%) (RR = 0.40; 95% CI (0.26, 0.61); p < 0.001). The outcomes' evidentiary quality of TCER, HR, LVEF and AE were assessed as moderate. CONCLUSION: Adjunctive use of SFI was safer to improve TCER and heart function of AHF, but the results should be interpreted with cautious for clinical practice until high quality-designed RCTs were require for further confirmation due to poor quality of part of the included studies.

Feasibility of electroacupuncture at Baihui (GV20) and Zusanli (ST36) on survival with a favorable neurological outcome in patients with postcardiac arrest syndrome after in-hospital cardiac arrest: study protocol for a pilot randomized controlled trial.

BACKGROUND: At present, even the first-line medication epinephrine still shows no evidence of a favourable neurological outcome in patients with sudden cardiac arrest (SCA). The high mortality of patients with postcardiac arrest syndrome (PCAS) can be attributed to brain injury, myocardial dysfunction, systemic ischaemia/reperfusion response, and persistent precipitating pathology. Targeted temperature management, the only clinically proven method in the treatment of PCAS, is still associated with a series of problems that have not been completely resolved. Acupuncture is a crucial therapy in traditional Chinese medicine. On the basis of the results of previous studies, we hypothesize that electroacupuncture (EA) might provide therapeutic benefits in the treatment of PCAS. This study will explore the feasibility of EA on SCA patients. METHODS: This is a prospective pilot, randomized controlled clinical trial. Eligible patients with PCAS after in-hospital cardiac arrest (IHCA) admitted to our department will be randomly allocated to the control group or the EA group. Both groups will receive standard therapy according to American Heart Association guidelines for cardiopulmonary resuscitation. However, the EA group will also receive acupuncture at the Baihui acupoint (GV20) and Zusanli acupoint (ST36) with EA stimulation for 30 min using a dense-dispersed wave at frequencies of 20 and 100 Hz, a current intensity of less than 10 mA, and a pulse width of 0.5 ms. EA treatment will be administered for up to 14 days (until either discharge or death). The primary endpoint is survival with a favourable neurological outcome. The secondary endpoints are neurological scores, cardiac function parameters, and other clinical parameters, including Sequential Organ Failure Assessment (SOFA) scores and Acute Physiology and Chronic Health Evaluation (APACHE) II scores, on days 0 to 28. DISCUSSION: This study will provide crucial clinical evidence on the efficacy of EA in PCAS when used as an adjunctive treatment with AHA standard therapy. TRIAL REGISTRATION: chictr.org.cn : ChiCTR2000040040. Registered on 19 November 2020. Retrospectively registered. http://www.chictr.org.cn/ .

Efficacy and safety of Shenfu injection for the treatment of post-acute myocardial infarction heart failure: A systematic review and meta-analysis.

Objective: This systematic review and meta-analysis aimed to investigate the adjuvant effect and safety of Shenfu injection (SFI) on the treatment of post-acute myocardial infarction heart failure (PAMIHF). Methods: Seven databases were searched to identify randomized controlled trials (RCTs) associated with SFI and PAMIHF treatment from May 1990 to May 2022. Primary outcomes included NT-proBNP and left ventricular ejection fraction (LVEF), and secondary outcomes included total effective rate, BNP, heart rate (HR), cardiac output (CO), and adverse event (AE). The risk of bias evaluation was assessed by the ROB2 tool, meta-analysis, subgroup analysis, sensitivity analysis, and publication bias were conducted by RevMan5.3 software, and the Grade of Recommendations, Assessment, Development, and Evaluations (GRADE) system was used to evaluate the quality of evidence of meta results. Results: A total of 36 studies with 3231 PAMIHF patients were included. The meta results suggested that adjuvant SFI therapy was superior to conventional medical therapy alone. It improved the total effective rate [RR = 1.33; 95% CI (1.25.1.40); p < 0.00001], increased LVEF [SMD = 0.98; 95% CI (0.71, 1.24); p < 0.00001], and decreased HR [SMD = -1.14; 95% CI (-1.28, -0.99); p < 0.00001]. In addition, adjuvant SFI therapy (9.73%, 66/678) had a rate of AE lower than that of conventional medical therapy alone (21.7%, 147/677) when regarding safety [RR = 0.45; 95% CI (0.35, 0.57); p < 0.00001]. The quality of the evidence for the outcomes was rated from "very low" to "moderate." Conclusion: Adjuvant SFI therapy was safer to improve the total effective rate and the heart function of PAMIHF patients. However, well-designed RCTs were needed to confirm the efficacy and safety of adjuvant SFI therapy in PAMIHF treatment due to the low quality of the evidence for the outcomes caused by a small sample size and unclear risk of bias existed in included studies. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=151856), identifier CRD42020151856.

[Effect of electroacupuncture at Baihui ameliorated neurologic deficit and hemodynamic stability in rat model of post-cardiac arrest syndrome].

OBJECTIVE: To observe the results of electroacupuncture (EA) on the resuscitation of a rat model of asphyxia cardiac arrest (CA). And to explore its effect on the neurologic deficits and hemodynamic instability of post-cardiac arrest syndrome (PCAS). METHODS: A total of 107 male SD rats were randomly divided into sham, CA, and EA groups. Each group received arterial catheterization and tracheal intubation. The sham group was not induced asphyxia. Asphyxial cardiac arrest was established by endotracheal tube clamping. Rats in the CA group received basic respiratory support and fluid resuscitation in return of spontaneous circulation (ROSC) and rats in the EA group received EA at Baihui based on the treatment of CA group after ROSC, with a dense-dispersed wave at frequencies of 4-20 Hz, while the current intensity was adjusted minimum to induce a twitch of the scalp, the course of treatment was 30 minutes. The baseline data, hemodynamics after ROSC, neurological deficit score (NDS), pathological changes of brain tissue, and levels of serum biomarker were recorded and compared among the three groups. The 72-hour survival of rats was analyzed by Kaplan-Meier survival curve. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of necrotic neurons in the hippocampal CA1 region of rat brain. Meanwhile, Nissl staining and TdT-mediated dUTP nick-end labeling (TUNEL) were used to detect cell apoptosis and injury. RESULTS: Compared with the CA group, the mean arterial pressure (MAP) in the EA group increased significantly at 15 minutes after ROSC [mmHg (1 mmHg ≈ 0.133 kPa): 125.00 (94.00, 136.25) vs. 92.00 (72.00, 122.50), P < 0.05]. There was no significant difference in the NDS score between the EA group and the sham group. Still, the NDS score of the rats in the CA group at 6 hours after ROSC were significantly lower than that in the sham group (46.00±10.61 vs. 80.00±0.00, P < 0.05). Kaplan-Meier survival curve analysis showed that EA did not improve the 72-hour survival rate of rats (100% in the sham group, 25% in the CA group, and 30% in the EA group, P > 0.05). The analysis by TUNEL showed that the apoptosis rate of neurons in CA1 region of the hippocampus in EA group at 6 hours after ROSC was significantly lower than that in CA group [(62.84±2.67)% vs. (71.29±3.70)%, P < 0.05]. Compared with the CA group, the level of serum S100 calcium binding protein B (S100B) in the EA group at 6 hours after ROSC was significantly lower (ng/L: 19.30±13.87 vs. 132.28±31.67, P < 0.05), but there were no significant differences in the levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) between these two groups. CONCLUSIONS: In the present study, EA at Baihui can stabilize the hemodynamic, moreover, it has a particular neuroprotective effect on PCAS rats. Still, EA at Baihui does not reduce the systemic inflammatory response and improve the survival rate of rats, and its mechanism remains to be verified in further research.

Efficacy and safety of Puerarin injection on acute heart failure: A systematic review and meta-analysis.

Objective: This study aimed to assess the adjunctive efficacy and safety of Puerarin injection (PI) on acute heart failure (AHF) based on a systematic review and meta-analysis. Methods: Nine databases were searched from March 1990 to March 2022 to identify randomized controlled trials (RCTs) related to the adjunctive treatment of PI for AHF. The Cochrane collaboration tool was used to assess the risk of bias in the included studies. Meta-analysis and subgroup and sensitivity analyses were conducted by RevMan 5.3 software. The evidence's certainty was evaluated by grading recommendations assessment, development, and evaluation (GRADE) methods. Results: A total of 8 studies were included with a total of 614 patients with AHF. The meta-analysis demonstrated that adjunctive treatment with PI on AHF was superior to conventional medicine alone. It increased the total effective rate (RR = 1.38; 95% CI, 1.22-1.55; p < 0.001) and improved left ventricular ejection fraction [SMD = 0.85; 95% CI (0.62, 1.09); p < 0.001]. Regarding safety, a total of 11.9% (23/194) adverse reactions were observed in the PI group and 9.8% (19/194) adverse reactions in the control group, and there were no significant differences in the incident rate of adverse events between both groups [RR = 1.16; 95% CI (0.66-2.05); p = 0.061]. The outcomes' evidentiary quality was assessed as "moderate." Conclusion: PI had an adjunctive effect on AHF combined with conventional medicine, and it seemed to be safe and more effective than the conventional medical treatment alone for improving the total clinical effective rate and left ventricular ejection fraction. But further well-designed RCTs are required to confirm the efficacy and safety of XBP in treating AHF due to the poor methodological quality of the included RCTs. Systematic Review Registration: [https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=327636], identifier [CRD42022327636].

Integrating Chinese and western medicine for COVID-19: A living evidence-based guideline (version 1).

BACKGROUND: The coronavirus disease 2019 (COVID-19) has turned into a pandemic and resulted in huge death tolls and burdens. Integrating Chinese and western medicine has played an important role in the fight against the COVID-19 pandemic. PURPOSE: We aimed to develop a living evidence-based guideline of integrating Chinese and western medicine for COVID-19. STUDY DESIGN: Living evidence-based guideline. METHODS: This living guideline was developed using internationally recognized and accepted guideline standards, dynamically monitoring the release of new clinical evidence, and quickly updating the linked living systematic review, evidence summary tables, and recommendations. Modified Delphi method was used to reach consensus for all recommendations. The certainty of the evidence, resources, and other factors were fully considered, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to rate the certainty of evidence and the strength of recommendations. RESULTS: The first version of this living guidance focuses on patients who are mild or moderate COVID-19. A multidisciplinary guideline development panel was established. Ten clinical questions were identified based on the status of evidence and a face-to-face experts' consensus. Finally, nine recommendations were reached consensus, and were formulated from systematic reviews of the benefits and harms, certainty of evidence, public accessibility, policy supports, feedback on proposed recommendations from multidisciplinary experts, and consensus meetings. CONCLUSION: This guideline panel made nine recommendations, which covered five traditional Chinese medicine (TCM) prescription granules/decoction (MXXFJD, QFPD, XFBD, TJQW, and JWDY), three Chinese patent medicines (LHQW granules/capsule, JHQG granules, and LHQK granules), and one Chinese herbal injection (XBJ injection). Of them, two were strongly recommended (LHQW granules/capsule and QFPD decoction), and five were weakly recommended (MXXFJD decoction, XFBD decoction, JHQG granules, TJQW granules, and JWDY decoction) for the treatment of mild and moderate COVID-19; two were weakly recommended against (XBJ injection and LHQK granules) the treatment of mild and moderate COVID-19. The users of this living guideline are most likely to be clinicians, patients, governments, ministries, and health administrators.

Systems pharmacology approach uncovers the therapeutic mechanism of medicarpin against scopolamine-induced memory loss.

BACKGROUND: Medicarpin is a natural pterocarpan-type phytoalexin widely distributed in many traditional Chinese medicines, such as Astragali Radix. A previous study showed that Astragali Radix demonstrated promising protective effects in neurons. However, there is no reported study on the neuroprotective function and the underlying mechanism of Medicarpin. PURPOSE: This study aimed to demonstrate the neuroprotective effect of Medicarpin on Alzheimer's disease (AD) and explore the therapeutic mechanisms. METHOD: First, we carried out animal behavioral tests and biochemical analysis to assess the anti-AD potential of Medicarpin for ameliorating spatial learning and memory and modulating cholinergic metabolism in scopolamine-induced amnesic mice. Subsequently, network proximity prediction was used to measure the network distance between the Medicarpin target network and AD-related endophenotype module. We identified Medicarpin-regulated AD pathological processes and highlighted the key disease targets via network analysis. Finally, experimental approaches including Nissl staining and Western blotting were conducted to validate our network-based findings. RESULT: In this study, we first observed that Medicarpin can ameliorate cognitive and memory dysfunction and significantly modulate cholinergic metabolism in scopolamine-induced amnesic mice. We then proposed an endophenotype network-based framework to comprehensively explore the AD therapeutic mechanisms of Medicarpin by integrating 25 AD-related endophenotype modules, gold-standard AD seed genes, an experimentally validated drug-target network of Medicarpin, and a global human protein-protein interactome. In silico prediction revealed that the effect of Medicarpin is highly relevant to neuronal apoptosis and synaptic plasticity, which was validated by experimental assays. Network analysis and Western blotting further identified two key targets, GSK-3ß and MAPK14 (p38), in the AD-related protein regulatory network, which play key roles in the regulation of neuronal apoptosis and synaptic plasticity by Medicarpin. CONCLUSIONS: This study presented a powerful endophenotype network-based strategy to explore the mechanisms of action (MOAs) of new AD therapeutics, and first identified Medicarpin as a potential anti-AD candidate by targeting multiple pathways.

Effect and safety of Chinese herbal medicine granules in patients with severe coronavirus disease 2019 in Wuhan, China: a retrospective, single-center study with propensity score matching.

BACKGROUND: Chinese herbal medicine (CHM) has been used for severe illness caused by coronavirus disease 2019 (COVID-19), but its treatment effects and safety are unclear. PURPOSE: This study reviews the effect and safety of CHM granules in the treatment of patients with severe COVID-19. METHODS: We conducteda single-center, retrospective study on patients with severe COVID-19 in a designated hospital in Wuhan from January 15, 2020 to March 30, 2020. The propensity score matching (PSM) was used to assess the effect and safety of the treatment using CHM granules. The ratio of patients who received treatment with CHM granules combined with usual care and those who received usual care alone was 1:1. The primary outcome was the time to clinical improvement within 28 days, defined as the time taken for the patients' health to show improvement by decline of two categories (from the baseline) on a modified six-category ordinal scale, or to be dischargedfrom the hospital before Day 28. RESULTS: Using PSM, 43 patients (45% male) aged 65.6 (57-70) yearsfrom each group were exactly matched. No significant difference was observed in clinical improvement of patients treated with CHM granules compared with those who received usual (p = 0.851). However, the use of CHM granules reduced the 28-day mortality (p = 0.049) and shortened the duration of fever (4 days vs. 7 days, p = 0.002). The differences in the duration of cough and dyspnea and the difference in lung lesion ratio on computerized tomography scans were not significant.Commonly,patients in the CHM group had an increased D-dimer level (p = 0.036). CONCLUSION: Forpatients with severe COVID-19, CHM granules, combined with usual care, showed no improvement beyond usual care alone. However, the use of CHM granules reduced the 28-day mortality rate and the time to fever alleviation. Nevertheless, CHM granules may be associated with high risk of fibrinolysis.

Clinical outcomes of influenza-like illness treated with Chinese herbal medicine: an observational study.

OBJECTIVE: To present and analyze treatments and clinical outcomes of Chinese patients with influenza-like illness. METHODS: We conducted a multi-site observational study from December 2009 to April 2010. Patients with influenza-like illness from 45 hospitals were enrolled. Patients received Chinese herbal medicine (CHM), conventional treatments, or CHM plus conventional treatments (combination treatment) according to the guidelines for influenza A/H1N1 2009 in China. The primary outcomes were the time to alleviation of symptoms and the incidence of complications. The secondary outcomes were the time until becoming afebrile, incidence of severe illness, testing negative on an influenza A viral test, and total medical fees. RESULTS: In total, 5967 patients were enrolled. The percentages of patients prescribed CHM alone, conventional treatment, and combination treatment were 27.8%, 5.1%, and 67.7%, respectively. There were no significant differences in the time to alleviation of symptoms, incidence of complications, time to becoming afebrile, or rate of severe illness among the CHM, conventional, and combination treatment groups. The rates of testing negative on the influenza virus A rapid test and H1N1 virus test were 90.3% and 76.3%, respectively. However, significant differences were found in the total medical fees among the three groups: CHM treatments were more economical than the other two treatments. CONCLUSION: The efficacy of CHM for influenza-like illness was not different from that of conventional treatments, but it was more economical.

[Launching an epidemiologic investigation on characteristics of syndrome for studying critical syndrome types].

Study on syndrome type should be combined with clinic closely to make clear the regularities of distribution and development of syndrome types in diseases, as well as the statues of different syndromes in the genesis and development processes of diseases. Aiming at this issue, the authors bring forward the concept of "critical syndrome types", and suggest that for resolving it, launching an epidemiologic investigation on characteristics of syndrome types is necessary.

[Progress of Chinese medicinal study on collateral circulation of coronary artery].

Effects of Chinese medicine on collateral circulation of coronary artery were reviewed, especially its regulatory effect through vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF).