Rationale and design of the RESTORE trial: A multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the effect of Shenfu injection on myocardial injury in STEMI patients after primary PCI.

BACKGROUND: The mortality following ST-segment elevation myocardial infarction (STEMI) remains substantial in the reperfusion era. Shenfu injection, as a traditional Chinese herbal formula, can alleviate ischemia-reperfusion injury through multiple pharmacologic effects. However, no robust data are available regarding the role of Shenfu injection in reducing infarct size for patients with STEMI undergoing primary percutaneous coronary intervention (PPCI). METHODS/DESIGN: This RESTORE trial is a multicenter, randomized, double-blind, parallel-group, placebo-controlled trial (NCT04493840). A total of 326 eligible patients with first-time anterior STEMI undergoing PPCI within 12 h of symptom onset will be enrolled from 10 centers in mainland China. Patients are randomized in a 1:1 fashion to receive either intravenous Shenfu injection (80mL Shenfu injection + 70mL 5% glucose injection) or placebo group (150mL 5% glucose injection) before reperfusion and followed by once a day until 5 days after PPCI. The primary end point is infarct size assessed by cardiac magnetic resonance (CMR) imaging 5±2 days after PPCI. The major secondary end points include enzymatic infarct size, microvascular obstruction, intramyocardial hemorrhage, left ventricular volume and ejection fraction assessed by CMR, as well as cardiovascular events at 30 days. CONCLUSIONS: The RESTORE trial is sufficiently powered to demonstrate the clinical effects of Shenfu injection on myocardial injury in STEMI patients undergoing PPCI in the contemporary era.

Effects of Transcutaneous Electrical Acupoint Stimulation on Systemic Inflammatory Response Syndrome of Patients after Percutaneous Nephrolithotomy: A Randomized Controlled Trial.

PURPOSE: Transcutaneous electrical acupoint stimulation (TEAS) is widely used. However, no study evaluated TEAS on systemic inflammatory response syndrome (SIRS) of patients after percutaneous nephrolithotomy (PCNL). The study was to evaluate TEAS on SIRS of patients after PCNL. METHODS: 67 patients were enrolled and divided into group TEAS and group sham TEAS. Data were collected from 60 participants finally. In the study, TEAS or sham TEAS on bilateral Shenshu (BL23), Yinlingquan (SP9), Hegu (LI4), and Neiguan (PC6) was performed continuously throughout the procedure. The primary outcome included the incidence of systemic inflammatory response syndrome (SIRS) within 48 h after surgery. The secondary outcomes included the serum levels of inflammatory cytokines, hemodynamics changes, complications, and hospital stay after surgery. The serum levels of tumor necrosis factor- (TNF-) α and interleukin- (IL-) 6, mean arterial pressure (MAP), and heart rate (HR) at 30 min before anesthesia (T 0), the time after surgery (T 1), 24 h postoperation (T 2), and 48 h postoperation (T 3) were recorded. The consumption of analgesic during surgery was also recorded, as well as the complications and duration of hospital stay after PCNL. RESULTS: The incidence of SIRS in group TEAS was lower than group sham TEAS (30% vs. 6.67%, p=0.023). Compared with the sham TEAS group, both levels of TNF-α and IL-6 at T 1, T 2, and T 3 were lower in the TEAS group (p < 0.05). The levels of MAP and HR in sham TEAS at T 1, T 2, and T 3 were markedly higher than that in the TEAS group (p < 0.05). The total consumption of propofol and remifentanil during surgery in group TEAS was lower than that in the sham TEAS group. The incidence of hypotension, hypertension, emergence agitation, and postoperative nausea and vomiting (PONV) was also lower in group TEAS after PCNL (p < 0.05). CONCLUSIONS: TEAS could effectively reduce the incidence of SIRS and inflammatory cytokines for patients who underwent PCNL. In addition, TEAS helped to maintain the hemodynamic stability and cut down the consumption of analgesics during PCNL, reducing the complications after PCNL.

Zinc oxide nanoparticles synthesized from Fraxinus rhynchophylla extract by green route method attenuates the chemical and heat induced neurogenic and inflammatory pain models in mice.

Fraxinus rhynchophylla belongs to the family of Oleaceae and also called as Chinese ash wood possesses various pharmacological properties such as neuroprotective, antimicrobial, anti-inflammatory, etc. Therefore we synthesized ZnO nanoparticles using Fraxinus rhynchophylla wood extract as reducing and capping agent. The synthesized nanoparticles were characterized with the aid of UV-Spec, DLS, FT-IR and TEM analysis. Green synthesized ZnO nanoparticles were then assessed for anti-nociceptive property by using various nociception models such as thermal stress-induced, acetic acid, glutamate, capsaicin, and formalin-induced nociception. The sedative effect of synthesized ZnO nanoparticles was evaluated with an open field test. UV-Spectroscopic analysis confirms the formation of ZnO nanoparticles and the characterization studies DLS, FT-IR, and TEM analysis prove it has ideal nanoparticle can be used as a nano-drug. Results of both thermal stress-induced methods hot plate and tail immersion nociception test verified the synthesized ZnO nanoparticles are a potent antinociceptive drug. ZnO nanoparticles effectively reduced the abdominal writhes in acetic acid-induced nociception and it also significantly decreased the nociception activity in another glutamate, capsaicin, and formalin-induced nociception models. Open field experiment proved that synthesized ZnO nanoparticles are less sedative compared to the standard antinociceptive drug morphine. Overall our findings authentically confirm ZnO nanoparticles synthesized from Fraxinus rhynchophylla wood extract is a novel drug that persuasively reduces nociception in different nociceptive induced mice models and can be the best alternative for allopathic drugs which renders severe side effects.

[Clinical effect of Liyan Tongqiao acupuncture in treatment of post-stroke dysphagia: an analysis based on diffusion tensor imaging].

OBJECTIVE: To investigate the clinical change of post-stroke dysphagia after the intervention of Liyan Tongqiao （relieving sore-throat and dredging orifices）acupuncture using cranial diffusion tensor imaging (DTI). METHODS: A total of 60 patients with post-stroke dysphagia were enrolled and randomly divided into Liyan Tongqiao acupuncture group and neurology treatment group, with 30 patients in each group. The patients in the neurology treatment group were given routine neurology treatment and swallowing rehabilitation training, and those in the Liyan Tongqiao acupuncture group received acupuncture at Sishencong (EX-HN1), Baihui (GV20), bilateral Tai-yang (EX-HN5), and bilateral Fengchi (GB20) and tongue triple acupuncture, with an electroacupuncture apparatus for EX-HN1, bilateral GB20, and tongue triple acupuncture, for a needle retaining time of 30 minutes each time, once a day and 5 times a week, in addition to the treatment in the neurology treatment group. Each course of treatment was 3 weeks, and both groups were treated for 2 courses. Swallowing function assessment and cranial DTI were performed after treatment. RESULTS: After 6 weeks of treatment, both groups had a marked improvement in swallowing function, a significantly greater change in video fluoroscopic swallowing study (VFSS) score and a higher mean FA value (P<0.05). Compared with the neurology treatment group, the Liyan Tongqiao acupuncture group had a marked improvement in swallowing function, a significantly greater change in VFSS score in the pharyngeal phase and a higher mean FA value (P<0.05). CONCLUSION: Liyan Tongqiao acupuncture can improve dysphagia and swallowing function in the pharyngeal phase in VFSS, possibly by promoting the remodeling of cerebral cortex and increasing the FA value of infarct zone through the stimulation of related acupoint signals.

Transcutaneous Electrical Acupoint Stimulation Improves Immunological Function During the Perioperative Period in Patients With Non-Small Cell Lung Cancer Undergoing Video-Assisted Thoracic Surgical Lobectomy.

The immunological function of patients with malignant tumors may be suppressed during the perioperative period. However, details on the effects of transcutaneous electrical acupoint stimulation (TEAS) on immunological function are relatively lacking. We designed this study to examine the effects of TEAS on the immunological function of patients with non-small cell lung cancer (NSCLC) during the perioperative period. Participants (n = 144) were enrolled and randomly assigned into group TEAS or group sham TEAS. TEAS on bilateral Feishu (BL13), Hegu (L14), and Zusanli (ST36) was performed continuously throughout the procedure. The primary outcome was the quantities of natural killer (NK) cells at 30 minutes before induction (T0), 5 minutes after intubation (T1), at the beginning of the operation (T2), at the beginning of the lobectomy (T3), at the beginning of the lymphadenectomy (T4), and immediately after extubation (T5). The secondary outcomes were the serum levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) at T0 to T5, the mean arterial pressure (MAP) and heart rate (HR), the intraoperative consumption of propofol and remifentanil, the incidence of hypoxemia, postoperative nausea and vomiting (PONV), and the length of hospital stay. The quantities of NK cells were decreased in group sham TEAS after intubation compared to that in group TEAS, while the quantities of NK cells in group TEAS were similar at T0 to T5. Meanwhile, the quantities of NK cells in group sham TEAS at T1 ( P = .012), T2 ( P < .001), T3 ( P = .027), T4 ( P = .045), and T5 ( P = .021) were lower than those in group TEAS. In group TEAS, the serum levels of TNF-α were lower at T1 to T5, while the levels of IL-6 were lower at T2 to T5. Furthermore, the intraoperative MAP and HR were more stable, the total propofol and remifentanil consumptions were lower, and the length of hospital stay was shorter than those in group sham TEAS. The application of TEAS can effectively reverse the decrease in NK cells, decrease the serum levels of TNF-α and IL-6, maintain hemodynamic stability during the perioperative period, decrease the consumption of propofol and remifentanil, and shorten the length of the hospital stay.