A randomized, placebo-controlled, double-blind trial to evaluate efficacy and safety of Shen-Yuan-Dan capsules, a traditional Chinese medicine, for treatment of peri-procedure myocardial injury following percutaneous coronary intervention.

BACKGROUND: Peri-procedural myocardial injury (PMI) is a common complication of percutaneous coronary intervention (PCI), which cannot be entirely avoided using available treatments. The findings of earlier research have shown that Shen-Yuan-Dan (SYD) capsules, a traditional Chinese medicine, can potentially alleviating PMI. This study aimed to confirm further this hypothesis in a rigorous, well-designed randomized controlled study. METHODS: Our clinical trial was randomized, double-blinded, and placebo-controlled. A total of 181 patients with unstable angina (UA) undergoing elective PCI were randomized to pretreatment with SYD or a placebo under the basis of conventional treatment; 87 patients were pretreated with SYD (4 capsules, 3 times a day, with a further 4 capsules 2 h before PCI) 3 days before the procedure, and 94 patients were given a placebo. No patients received reloading statins before PCI, and SYD or placebo was maintained for 1 month after PCI. The primary endpoint was the incidence of PMI. The secondary endpoint was calculating the incidence rate of all 30-day major adverse cardiovascular events (all-cause mortality, non-fatal myocardial infarction, unplanned revascularization). The safety outcomes, including abnormalities in electrocardiogram and serum biochemical examinations caused by drug use, were also tested. RESULTS: The levels of creatine kinase-myocardial band (CK-MB) in both the SYD and placebo groups were increased at 4 h and 24 h after PCI compared with before the procedure (P < 0.05). The incidence rate of PMI in the SYD group (10.3 %) was lower than that in the placebo group (34 %) (absolute difference, 23.7 % [95 % CI, 11.7-34.8 %], P < 0.01). After taking SYD, the relative risk reduction (RRR) and absolute risk reduction (ARR) were 69.7 % and 24.3 %, respectively; further, number needed to treat (NNT) was 4.2. The 30-day major adverse cardiovascular event (MACE) rate was not statistically different between the SYD and placebo groups (6.9 % vs. 9.6 %, P = 0.352). There were no abnormal situations during the trial. CONCLUSION: These findings showed that pretreatment with SYD could safely reduce the incidence rate of PMI in patients with UA undergoing elective PCI. Further study on the effects of SYD and how it can improve adverse cardiovascular events outcomes is needed.

Synthesis of K[B3H7NH2BH2NH2B3H7] for a K-ion solid-state electrolyte.

All-solid-state K batteries are ideal energy storage devices for grid-scale applications of renewable energies. A novel electrolyte K[B3H7NH2BH2NH2B3H7] with weakly coordinating anions was synthesized. It has a high K+ conductivity of 1.01 × 10-4 S cm-1 at 75 °C, which is probably due to the increased electrostatic potential and size of the anions.

[Clinical trials of treatment of woman menopause insomnia due to disharmony between heart and kidney by body and auricular acupuncture].

OBJECTIVE: To observe the therapeutic effect of body acupuncture combined with auricular acupuncture in the treatment of woman menopause insomnia induced by disharmony between the heart and kidney. METHODS: A total of 111 outpatients with menopausal insomnia were randomly divided into treatment group (n＝55, body acupoints plus auricular points) and control group (n＝56, body acupoints). For control group, Shenmen (HT7), Sanyinjiao (SP6), Anmian, Zhaohai (KI6), Shenmai (BL62), Sishencong (EX-HN1), Xinshu (BL15) and Shenshu (BL21) were needled with filiform needles, and HT7, SP6, Anmian, BL15 and BL21 were also stimulated with electroacupuncture (EA) for 30 min, once every other day, 3 times a week for 3 weeks. For the treatment group, auricular points as Kidney, Shenmen, Sympathetic and Endocrine around the ear canal and the ear cavity were punctured with filiform needles in combination with the same intervention methods mentioned above in the control group. The quality and efficiency of sleep were assessed by using Pittsburgh Sleep Quality Index (PSQI) scale before and after the treatment. The symptom scores of traditional Chinese medicine (TCM) and the therapeutic effect were determined according to the "Guide Principles for Clinical Research of New Drugs of TCM" (formulated by Chinese Ministry of Health, 1997). RESULTS: After the treatment, the scores of sleep quantity and effective rate of PSQI scale, and those of insomnia and dreaminess, dysphoria with feverish sensation in chest, palms and soles, paplpitation and irritability, fatigue and forgetfulness of TCM were reduced significantly in both groups compared with their own pre-treatment (P<0.05). Of the 56 and 55 cases in the control and treatment groups, 18 (32.1%) and 30 (54.5%) experienced a marked improvement in their symptoms, 28 (50.0%) and 22 (40.0%) were effective, and 10 (17.9%) and 3 (5.5%) failed, with the effective rate being 82.1% and 94.5%, respectively. The therapeutic effect of stimulation of the body acupoints plus auricular acupoints was significantly superior to that of stimulation of simple body acupoints in lowering scores of PSQI scale, insomnia and dreaminess, dysphoria with feverish sensation in chest, palms and soles, dizziness and tinninus, paplpitation and irritability, and tital fever and night sweating of TCM, as well as the effective rate (P<0.05). CONCLUSION: Both body acupuncture and body acupuncture combined with auricular acupuncture are effective in the treatment of woman menopause insomnia due to disharmony between the heart and kidney, and the two combined treatment was evidently better.

Efficacy and safety of Shen-Yuan-Dan capsules for peri-procedural myocardial injury following percutaneous coronary intervention: study protocol for a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Peri-procedural myocardial injury (PMI) during percutaneous coronary intervention (PCI) will result in an unfavorable clinical prognosis in patients, thus urgently necessitating effective drug treatment measures. Shen-Yuan-Dan (SYD) capsules are a traditional Chinese medicine (TCM) preparation that have been found to have potential myocardial protection effects during the peri-procedural phase of PCI in previous clinical and basic research; however, there is a lack of rigorous, randomized, and controlled studies. The aim of this study is to evaluate the efficacy and safety of SYD in decreasing PMI. METHODS: This is a randomized, double-blind, placebo-controlled clinical trial. A total of 284 patients with unstable angina will be randomized into test and control groups. The two groups will be given SYD or a placebo (three times each day, four capsules each time) 3 days before PCI on the basis of conventional treatment. Twelve hours before PCI, an additional 4 capsules will be given, and drug treatment is planned to be maintained for 1 month after surgery. Dynamic changes in the myocardial enzyme in four time-points (before PCI, and 4, 24, 48 hours after PCI) in both groups of patients that will be observed. The follow-up period will be 1 month. The primary observation markers are planned to evaluate the efficacy and safety of SYD in decreasing PMI. The secondary observation markers will be to evaluate the major adverse cardiovascular events (MACEs) status at day 30 after PCI, (all-cause mortality, non-fatal myocardial infarction, repeated revascularization of target blood vessel) and Seattle Angina Questionnaire scores. GRACE scores will be used for risk stratification, and the intervention efficacy of SYD on PMI patients with different risks will be retrospectively evaluated. DISCUSSION: This study will provide a rigorous clinical evidence to evaluate the efficacy and safety of SYD in decreasing PMI and the results are worth anticipating. TRIAL REGISTRATION: The design of this trial has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-IPR-17011069).