Least Absolute Shrinkage and Selection Operator-Based Prediction of the Binding Constant of p-Sulfonatocalix[6]/[8]arenes with Alkaloids.

p-Sulfonatocalix[n]arenes (SCnA) have demonstrated great potential for drug encapsulation through host-guest complexation to improve solubility, stability, and bioavailability. In this study, the solubilization effect of SCnA (n = 4, 6, 8) on 95 active compounds derived from traditional Chinese medicine (TCM) was investigated. Based on the significant solubilization effect on alkaloids, SC6A/SC8A and 76 alkaloids were selected as the host and guest, respectively, to determine the binding constant by competitive fluorescence titration. LASSO regression was adopted to investigate the mechanism of the complex of SCnA with alkaloids. The binding constant of alkaloids-SC6A and alkaloids-SC8A was related to the alkaloid alkalinity. Also, the electronegativity, polarization, first ionization potential, hydrogen bond potential, the molecular size, and shape of alkaloids are critical properties to determine alkaloids-SC6A binding constant as well as electronegativity, polarization, hydrophobicity, and the molecular size and shape of alkaloids play an important role for the alkaloids-SC8A binding constant.

An eco-friendly extraction and purification method of nuciferine from Folium nelumbinis with p-sulfonatocalix[6]arenes.

INTRODUCTION: Folium nelumbinis is used as vegetable, functional food and herbal medicine in Asia. p-Sulfonatocalix[6]arene (SC6A) is a water-soluble supramolecular macrocycle and has never been applied to the extraction of herbal products. OBJECTIVE: In this study, SC6A-assisted extraction of nuciferine from Folium nelumbinis has been carried out to develop an eco-friendly extraction process with high extraction efficacy and easy operation. METHODS: Single-factor experiments were adopted to obtain the optimal conditions for the SC6A-assisted extraction of nuciferine from Folium nelumbinis, and then nuciferine and SC6A were separated easily by one-step alkalization. The host-guest complexes between nuciferine and SC6A were analyzed by competitive fluorescence titration, DSC, FT-IR and 1 H-NMR. RESULTS: The optimal SC6A/Folium nelumbinis/solution ratio for extraction was 0.4:1:20 (g/g/mL), with a granulometric fraction below 180 µm and an extraction time of 1 h with soaking. The purity and recovery of nuciferine extracted with SC6A were increased 29.24 and 35.73 times compared with extraction with aqueous solution, respectively. Moreover, a good reusability of SC6A in the extraction of nuciferine was demonstrated. Competitive fluorescence titration, DSC, FT-IR and 1 H-NMR characterization indicated that SC6A could form host-guest complexes with nuciferine at a ratio of 1:1. CONCLUSION: The study provided an eco-friendly, safe and effective nuciferine extraction method, which can be used for the development of nutrition supplements containing nuciferine.

The Effect of Bergamot Essential Oil Aromatherapy on Improving Depressive Mood and Sleep Quality in Postpartum Women: A Randomized Controlled Trial.

BACKGROUND: The postpartum period is a physiologically and psychologically crucial transition phase for every woman who gives birth. Aromatherapy may improve mood and alleviate sleep challenges. However, few randomized controlled clinical trials have focused on the effect of aromatherapy in postpartum women. PURPOSE: This study was designed to explore the effect of a bergamot essential oil aromatherapy intervention on depressive mood and sleep quality in postpartum women. METHODS: This randomized controlled trial used consecutive sampling. The participants were all women in a postpartum care center in eastern Taiwan and were randomly assigned to either the experimental (n = 29) or control (n = 31) group. Bergamot essential oil aroma was used in the experimental group, and pure water aroma was used in the control group. The experimental and control interventions were both performed while the participants were residents at the postpartum care center in the afternoon for 15 minutes each day. Before the aroma intervention, pretests were conducted using the Edinburgh Postnatal Depression Scale and the Postpartum Sleep Quality Scale. The first and second posttests were conducted using the same two scales at 2 and 4 weeks after the intervention, respectively. RESULTS: At both the first and second posttests, depressive mood was significantly lower (p < .001) in the experimental group than in the control group, supporting the positive effect of the bergamot essential oil aroma intervention on depressive mood in postpartum women. No significant intergroup difference in sleep quality (p > .05) was observed at either the first or second posttest, indicating an uncertain effect of the bergamot essential oil aroma intervention on sleep quality. CONCLUSIONS/IMPLICATIONS FOR PRACTICE: The results of this study support the effectiveness of bergamot essential oil aromatherapy in alleviating depressive mood in postpartum women. In addition, the results provide a practical reference for clinical postpartum nursing care.

Moxibustion Regulates Gastrointestinal Motility via HCN1 in Functional Dyspepsia Rats.

BACKGROUND Moxibustion therapy has been found to ameliorate clinical symptoms of functional dyspepsia (FD). We aimed to examine the regulatory effect of moxibustion on the gastrointestinal (GI) motility in FD and explore the underlying mechanism based on the hyperpolarization-activated cyclic nucleotide-gated cation channel 1 (HCN1). MATERIAL AND METHODS Moxibustion therapy was used in FD rats induced by using classic tail-pinch and irregular feeding. Weight gain and food intake were recorded weekly, followed by detecting gastric residual rate (GRR) and small intestine propulsion rate (IPR). Next, western blotting was performed to determine the expression levels of HCN1 in the gastric antrum. qRT-PCR was used to detect HCN1 in the small intestine and hypothalamic satiety center. Double immunolabeling was used for HCN1 and ICCs in gastric antrum and small intestine. RESULTS The obtained results suggested that moxibustion treatment could increase weight gain and food intake in FD rats. The GRR and IPR were compared among the groups, which showed that moxibustion treatment could decrease GRR and increase IPR. Moxibustion increased the expression of HCN1 in the gastric antrum, small intestine, and hypothalamic satiety center. Histologically, the co-expressions of HCN1 and ICCs tended to increase in gastric antrum and small intestine. Meanwhile, HCN channel inhibitor ZD7288 prevented the above-mentioned therapeutic effects of moxibustion. CONCLUSIONS The results of the present study suggest that moxibustion can effectively improve the GI motility of FD rats, which may be related to the upregulation of HCN1 expression in gastric antrum, small intestine, and satiety center.

Case Report: Fainting During Acupuncture Treatment.

CONTEXT: The first issue to be considered in acupuncture is the safety of and adverse effects from treatment. Fainting is an uncommon adverse reaction. Some researchers believe that fainting is related to the mechanism underlying acupuncture treatment, but due to moral and technical issues, studies involving fainting during the acupuncture process haven't been conducted. OBJECTIVE: The study intended to determine if specific risk factors are associated with fainting during acupuncture treatment. DESIGN: The research team performed 2 case studies involving fainting during acupuncture. SETTING: The study took place in the Physiotherapy Departments of the Leribe Motebang Hospital and the Mamohau Hospital in the Kingdom of Lesotho. PARTICIPANTS: Participants were 2 out of 2050 patients who received acupuncture treatment between October 2017 and April 2018 at one of the hospitals. They had fainted, with different clinical manifestations, during acupuncture treatment. Their main symptoms were dizziness, general weakness associated forehead sweating, palpitations, dyspnea, and nausea. RESULTS: In both cases, the patient had complained of hunger before treatment. Both claimed that they had never experienced such a situation previously. CONCLUSIONS: The research team suggests that the fainting occurred for the patients in the two case studies secondary to the hungry state. Hunger may be one of the most important causes of fainting connected to acupuncture. The failure of a practitioner to perform treatment for fainting in a timely and effective manner, or his or her improper handling of it, can lead to serious consequences. Therefore, factors that may cause fainting should be minimized to avoid their occurrence during acupuncture.

Xin-Ji-Er-Kang Alleviates Myocardial Infarction-Induced Cardiovascular Remodeling in Rats by Inhibiting Endothelial Dysfunction.

The present study was designed to elucidate the beneficial effects of XJEK on myocardial infarction (MI) in rats, especially through the amelioration of endothelial dysfunction (ED). 136 Sprague-Dawley rats were randomized into 13 groups: control group for 0wk (n = 8); sham groups for 2, 4, and 6 weeks (wk); MI groups for 2, 4, and 6 wk; MI+XJEK groups for 2, 4, and 6w k; MI+Fosinopril groups for 2, 4, and 6 wk (n = 8~10). In addition, 8 rats were treated for Evans blue staining and Tetrazolium chloride (TTC) staining to determine the infarct size. Cardiac function, ECG, and cardiac morphological changes were examined. Colorimetric analysis was employed to detect nitric oxide (NO), and enzyme-linked immunosorbent assay (ELISA) was applied to determine N-terminal probrain natriuretic peptide (NT-ProBNP), endothelin-1 (ET-1), angiotensin II (Ang II), asymmetric dimethylarginine (ADMA), tetrahydrobiopterin (BH4), and endothelial NO synthase (eNOS) content. The total eNOS and eNOS dimer/(dimer+monomer) ratios in cardiac tissues were detected by Western blot. We found that administration of XJEK markedly ameliorated cardiovascular remodeling (CR), which was manifested by decreased HW/BW ratio, CSA, and less collagen deposition after MI. XJEK administration also improved cardiac function by significant inhibition of the increased hemodynamic parameters in the early stage and by suppression of the decreased hemodynamic parameters later on. XJEK also continuously suppressed the increased NT-ProBNP content in the serum of MI rats. XJEK improved ED with stimulated eNOS activities, as well as upregulated NO levels, BH4 content, and eNOS dimer/(dimer+monomer) ratio in the cardiac tissues. XJEK downregulated ET-1, Ang II, and ADMA content obviously compared to sham group. In conclusion, XJEK may exert the protective effects on MI rats and could continuously ameliorate ED and reverse CR with the progression of MI over time.

Xin-Ji-Er-Kang ameliorates kidney injury following myocardial infarction by inhibiting oxidative stress via Nrf2/HO-1 pathway in rats.

AIM: Cardiovascular diseases, such as coronary heart disease and myocardial infarction (MI) are currently considered as the leading causes of death and disability. The aim of the present study is to investigate the effects of Xin-Ji-Er-Kang (XJEK) on kidney injury and renal oxidative stress. In addition, the associated mechanism involved in these processes was examined in an MI model, and particularly focused on the nuclear factor erythroid 2-related factor (NRF2)/heme oxygenase-1 (HO-1) pathway. MATERIALS AND METHODS: A total of 138 Sprague-Dawley rats were used in the present study. The control group was designated as 0 wk (n = 8). A total of 3 phases (2, 4, 6 wk) of administration were used in the sham-operated groups (sham, n = 10), MI groups (MI, n = 10), MI + XJEK groups (XJEK, n = 10) and MI + fosinopril groups (fosinopril, n = 10). Additional 10 rats were used to evaluate the infarct area. At 2, 4 or 6 wk post-MI, the hemodynamic parameters were monitored, the rats were sacrificed, then blood, heart and renal tissues were collected for furtherly analysis. RESULTS: The results indicated that XJEK administration continuously ameliorated renal hypertrophy index, blood urea nitrogen and cystatin C concentrations. XJEK further improved post-MI cardiac function by limiting scar formation and caused a downregulation in the hemodynamic parameters at the end of 2 and 4 wk. The hemodynamic parameters were upregulated after 6 wk treatment with XJEKcompared with those noted in the MI groups. Similarly, XJEK treatment for 2 wk potentiated Nrf2 nuclear translocation and HO-1 expression and inhibited the deficiency of nuclear Nrf2 and HO-1 at 6 wk post-MI compared with that of the MI groups, indicating the attenuation of the renal oxidative stress condition. The levels of malondialdehyde and angiotensin II (Ang II) in plasma and renal tissues, as well as the levels of aldosterone, 8-hydroxydeoxyguanosine, angiotensin II type 1 receptor and NADPH Oxidase-4 in the kidney tissue significantly decreased following XJEK treatment for 6 wk. In addition, the XJEK treatment groups revealed a significant upregulation in the activity of superoxide dismutase and in the total antioxidant capacity activity compared with those noted in the corresponding MI groups. CONCLUSION: These results demonstrated that progressive nephropathy in MI rats was associated with intrarenal activation of the renin-angiotensin-aldosterone system. Concomitantly, this process was associated with oxidative stress and impaired Nrf2 activation. The improvement in the severity of nephropathy by XJEK in this model may be associated with the reversal of these abnormalities.

Protective effect of Xin-Ji-Er-Kang on cardiovascular remodeling in high-salt induced hypertensive mice: Role ofoxidative stress and endothelial dysfunction.

BACKGROUND: Xin-Ji-Er-Kang (XJEK) is a Chinese herbal formula that has beenreported to exert effective protection against cardiovascular diseases, such as hypertension and myocarditis. OBJECTIVE: The aim of the present study was to investigate the effect of XJEK on high-salt-induced hypertensive mice and its possible mechanism. METHODS: The model of hypertension was established through a high-salt diet. Sixty male Kunming mice were randomized into six groups, namely the Control, Model, Low-dose XJEK, Middle-dose XJEK, High-dose XJEK and Fosinopril groups (n=10 per group). Different steady interventions were given to each group: 0.9% Sodium chloride was added to the diet of the Control group and 8% sodium chloride to the diet of the other five groups from the very beginning. An additional 4, 8 and 12 g/kg/day XJEK were intragastrically administered to the Low-dose, Middle-dose and High-dose XJEK groups, respectively, and 2 mg/kg/day fosinopril to the fosinopril group, from the start of week 5. Systolic blood pressure (SBP) was measured weekly from weeks 1 to 8 using the tail-cuff method. At the end of week 8, left ventricular (LV) systolic pressure, LV end-diastolic pressure and rate of rise of LV pressure were examined using a TransonicScisense catheter (Transonic Systems Inc,Ithaca, NY,USA). Endothelium-dependent relaxations induced by acetylcholine were observed in an isolated thoracic aorta ring. Serum and heartsweresampled for the measurement of the following indexes:Serum nitric oxide (NO), superoxide dismutase (SOD) activity and malondialdehyde (MDA) content (determined by colorimetricanalysis); serum angiotensin II(Ang II), endothelin-1, endothelial NO synthase (eNOS), asymmetric dimethylarginine (ADMA), tetrahydrobiopterin (BH4) concentration and l-arginine (determined by enzyme-linked immunosorbent assay); heart to body weight (HW/BW) ratio; myocardial morphological change (determined by HE and VG staining); myocardial eNOS expression (determined by immunofluorescence), and myocardial endothelin receptor A (ETA) expression (determined by western blotting). RESULTS: Statistical data showed that the HW/BW ratio was significantly decreased in the drug treatment group. XJEK treatment could improve the heart systolic and diastolic function and ameliorate hemodynamic parameters and vascular remodeling indexes. Colorimetric results showed that, compared with the model group, XJEK increased serum SOD, NOlevels, and decreased those of serum MDA and Ang II. XJEK reverted changes in cardiac pathology, decreased the myocardial cross-sectional area, collagen volume fraction and perivascular collagen area and improved endothelial dysfunction (ED) by promoting eNOS activity, enhancing NO bioavailability, increasing the expression of BH4 and decreasing ETA content. In addition, treatment with XJEK decreased ADMA content in the myocardium. CONCLUSION: In conclusion, XJEK mitigates cardiac remodeling in high-salt-induced hypertensive mice. The potential mechanism involves improved oxidative stress and endothelial dysfunction, independently of ameliorating BP.

Characterization of Inulin-Type Fructan from Platycodon grandiflorus and Study on Its Prebiotic and Immunomodulating Activity.

Platycodon grandiflorus is a plant widely used in traditional Chinese medicine, of which polysaccharides are reported to be the main components responsible for its bio-functions. In this work, the inulin-type fructan (PGF) was obtained by DEAE anion exchange chromatography from the water extracted from P. grandifloras. Characterization was performed with methanolysis, methylation, and NMR and the results showed that PGF is a ß-(2-1) linked fructan, with terminal glucose and with a degree of polymerization of 2⁻10. In order to study its biofunctions, the prebiotic and immunomodulation properties were assayed. We found that PGF exhibited good prebiotic activity, as shown by a promotion on six strains of lactobacillus proliferation. Additionally, the PGF also displayed direct immunomodulation on intestinal epithelial cells and stimulated the expressions of anti-inflammatory factors. These results indicated that the inulin from P. grandiflorus is a potential natural source of prebiotics as well as a potential intestinal immunomodulator, which will be valuable for further studies and new applications.

BuShenKangShuai Tablet Alleviates Hepatic Steatosis via Improving Liver Adiponectin Resistance in ApoE-/- Mice.

BuShenKangShuai tablet (BSKS) is a Chinese herbal compound, which has been used to treat nonalcoholic fatty liver disease and cardiovascular diseases in clinic for over four decades. This study intends to explore whether BSKS administration can alleviates hepatic steatosis via improving liver adiponectin resistance in ApoE-/- mice. ApoE-/- mice were fed with western-type diet for 6 weeks and then were administrated with BSKS or atorvastatin for 6 weeks by gavage, and then blood and liver were collected for analysis. The results showed that BSKS attenuated hepatic steatosis, decreased blood lipids, and increased the serum level of adiponectin. We also found that adiponectin resistance in the liver was improved by BSKS, while the expression of TLR4 and NF-κB p65 was inhibited, followed by the suppression of proinflammatory mediators of TNF-α. Our data provided evidence that BSKS was able to alleviate hepatic steatosis in vivo. The underlying mechanism of BSKS was focused on improving liver adiponectin resistance, thereby regulating dyslipidemia and inhibiting inflammatory signaling pathway.

Bushenkangshuai Tablet Reduces Atherosclerotic Lesion by Improving Blood Lipids Metabolism and Inhibiting Inflammatory Response via TLR4 and NF-κB Signaling Pathway.

Bushenkangshuai tablet (BSKS) is a Chinese herbal compound which has been used for the treatment of cardiovascular and cerebrovascular diseases in China for decades. This study intends to explore the molecular mechanism of BSKS against atherosclerosis in ApoE-/- mice. ApoE-/- mice were fed with western-type diet for 6 weeks and then were given BSKS for 6 weeks. The results showed that BSKS attenuated the size of the atherosclerotic lesion, reduced visceral adipose content, and decreased blood lipids. We also found that BSKS promoted the expression of adiponectin and its receptors, inhibited the expression of Toll-like receptor 4 and nuclear factor-kappa B, decreased the levels of interleukin-1 beta, monocyte chemotactic protein-1, and vascular cell adhesion molecule-1, and increased the levels of interleukin-10 and adiponectin. Our data provided evidence that BSKS exerted an antiatherosclerotic effect by lowering blood lipids and inhibiting inflammatory response via TLR4 and NF-κB signaling pathway.

The Effect of Hypnosis on Anxiety in Patients With Cancer: A Meta-Analysis.

BACKGROUND: Anxiety is a common form of psychological distress in patients with cancer. One recognized nonpharmacological intervention to reduce anxiety for various populations is hypnotherapy or hypnosis. However, its effect in reducing anxiety in cancer patients has not been systematically evaluated. AIM: This meta-analysis was designed to synthesize the immediate and sustained effects of hypnosis on anxiety of cancer patients and to identify moderators for these hypnosis effects. METHODS: Qualified studies including randomized controlled trials (RCT) and pre-post design studies were identified by searching seven electronic databases: Scopus, Medline Ovidsp, PubMed, PsycInfo-Ovid, Academic Search Premier, CINAHL Plus with FT-EBSCO, and SDOL. Effect size (Hedges' g) was computed for each study. Random-effect modeling was used to combine effect sizes across studies. All statistical analyses were conducted with Comprehensive Meta-Analysis, version 2 (Biostat, Inc., Englewood, NJ, USA). RESULTS: Our meta-analysis of 20 studies found that hypnosis had a significant immediate effect on anxiety in cancer patients (Hedges' g: 0.70-1.41, p < .01) and the effect was sustained (Hedges' g: 0.61-2.77, p < .01). The adjusted mean effect size (determined by Duvan and Tweedie's trim-and-fill method) was 0.46. RCTs had a significantly higher effect size than non-RCT studies. Higher mean effect sizes were also found with pediatric study samples, hematological malignancy, studies on procedure-related stressors, and with mixed-gender samples. Hypnosis delivered by a therapist was significantly more effective than self-hypnosis. LINKING EVIDENCE TO ACTION: Hypnosis can reduce anxiety of cancer patients, especially for pediatric cancer patients who experience procedure-related stress. We recommend therapist-delivered hypnosis should be preferred until more effective self-hypnosis strategies are developed.

[Chemical Constituents from Semiliquidambar cathayensis Roots].

OBJECTIVE: To study the chemical constituents from the roots of Semiliquidambar cathayensis. METHODS: The roots of Semiliquidambar cathayensis were extracted with 80% ethanol for reflux. Chemical constituents were isolated by silica gel chromatography and Sephadex LH-20 column chromatography from petrol ether part and ethyl acetate part of extracts. Their structures were identified on the basis of physico-chemical characters and spectroscopic analysis. RESULTS: Eleven compounds were obtained from the roots of Semiliquidambar cathayensis, and identified as 3-acetyl-12-ene-oleanolic acid methyl ester (1), ß-sitosterol (2), 3-acetyl-12-ene-oleanol-ic acid (3), 2α,3ß-dihydroxy-lup-20(29)-en-28-oic acid (4), (24R)-5α-stignast-3,6-dione (5), betulonic acid (6), stearic acid (7), hexadecanoic acid (8), 3-oxo-olean-12-en-28-oic acid (9), arjunolic acid (10) and daucosterol (11). CONCLUSION: Compounds 1,3 - 6 and 8 are isolated from this genus for the first time.

Weight change trajectory in women with breast cancer receiving chemotherapy and the effect of different regimens.

AIMS AND OBJECTIVES: To investigate the trajectory of weight change in Taiwanese women with breast cancer after starting chemotherapy and the impact of chemotherapy regimens on weight change while controlling for age, menopausal status, body mass index, lymph node involvement and changes in habits of dietary fat intake and exercise. BACKGROUND: Weight gain after adjuvant chemotherapy in women with breast cancer has negative impact on health outcomes. DESIGN: Longitudinal, clinical observational study. METHODS: Weights were repeatedly measured in 147 women with breast cancer stages I-III. Hierarchical linear modelling was used to analyse these longitudinal data. RESULTS: The overall pattern of weight change was a cubic form beginning with a mean of 56·9 kg before chemotherapy. It gradually increased to 59·4 kg at 8·5 months after the first chemotherapy followed by a decrease to 58·5 kg at 21·5 months. During the last 2·5 months, weight increased slightly and never returned to the initial level. After controlling for confounders, steeper weight change was observed among women receiving cyclophosphamide, methotrexate and fluorouracil. The highest weight gain in the cyclophosphamide, methotrexate and fluorouracil group was 2·9 kg (5%) vs. 0·9 kg (1%) in the anthracycline-based group. CONCLUSION: The trajectory of body weight change within two years after chemotherapy shows a trend of gradual ascent, followed by a small decline and a slight increase in the last 2·5 months. The chemotherapy regimen can predict the trend after controlling for other confounders; women on cyclophosphamide, methotrexate and fluorouracil have a steeper weight change. RELEVANCE TO CLINICAL PRACTICE: Nurses can inform women with breast cancer about the expected changes in body weight after chemotherapy to reduce their uncertainty. Future studies on effective interventions to minimise chemotherapy-induced weight gain are needed.

Different Effects of Six Antibiotics and Ten Traditional Chinese Medicines on Shiga Toxin Expression by Escherichia coli O157:H7.

This study compared the effects of ten types of traditional Chinese medicines (TCMs) and six different antibiotics on E. coli O157:H7 Shiga toxin gene (stx2) mRNA expression level based on real-time PCR and the expression level of Stx toxin using an ELISA quantitative assay. We also compared their effects on the induction of the SOS response. The results clearly indicated that all ten TCMs had negative results in the SOS response induction test, while most TCMs did not increase the levels of stx2 mRNA and the Stx toxin. Some TCMs did increase the mRNA levels of the stx2 gene and the Stx toxin level, but their increases were much lower than those caused by antibiotics. With the exception of cefotaxime, the six antibiotics increased the Stx toxin level and increased the stx2 gene mRNA level. With the exceptions of cefotaxime and tetracycline, the antibiotics increased the SOS induction response. These results suggest that TCMs may have advantages compared with antibiotics, when treating E. coli O157:H7; TCMs did not greatly increase Stx toxin production and release.

HPLC-DAD method for comprehensive quality control of Semen Strychni.

CONTEXT: Semen Strychni is the seed of Strychnos nux-vomica L. (Loganiaceae). Its quality control procedure remains an issue since previous reports only focused on Strychnos alkaloids. To the best of our knowledge, chlorogenic acid (a phenolic acid) and loganin (an iridoid glycoside) are selected for the first time as marker constituents of quality control for Semen Strychni because of their bioactive activity correlating with therapeutic effects. OBJECTIVE: This study aimed to develop a simple and comprehensive quantity control method for Semen Strychni. MATERIALS AND METHODS: The optimal ultrasonic extraction procedure was carried out for 45 min using 50% aqueous methanol with 1% formic acid. The satisfactory chromatographic separation was achieved on an Ultimate LP-C18 column with gradient elution using acetonitrile and water containing 30 mmol/L ammonium acetate and 1% formic acid. The high performance liquid chromatography method with diode array detector was validated for linearity, limit of detection and quantification (LOQ), precision, repeatability, accuracy and stability. RESULTS: All the calibration curves showed good linearity (r(2) ≥ 0.999). The LOQ values for chlorogenic acid, loganin, strychnine, brucine, strychnine N-oxide and brucine N-oxide were 0.54, 0.83, 0.48, 0.50, 0.52 and 0.54 µg/mL, respectively. The method was reproducible with good accuracy in the range 95.6-104.4% and relative standard deviation (RSD) values less than 4.55%. The method was then applied to determine the components of the seed coat, seed leaf, endosperm and whole seed of Semen Strychni. CONCLUSION: This newly established method is validated as a simple and practical tool for authentication and quality control of Semen Strychni.

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.

Traditional Chinese medicine, Xin-yi-san, reduces nasal symptoms of patients with perennial allergic rhinitis by its diverse immunomodulatory effects.

BACKGROUND: Perennial allergic rhinitis (AR) is a common health problem with a high prevalence rate of 43.6% in Taiwan. In our previous study, a mixed formula of Chinese herbs consisted of Xin-yi-san, Xiao-ging-long-tang, and Xiang-sha-liu-jun-zi-tang, exerted diverse immunomodulatory effects in the treatment of patients with perennial allergic rhinitis. OBJECTIVE: The aim of the present study was to determine whether Xin-yi-san (XYS) alone is effective in the treatment of AR and tried to explore its molecular mechanism of anti-allergic activity. METHODS: In a randomized double-blind study, 108 patients with AR received either XYS or a placebo for 3 months. The effectiveness of XYS was evaluated by nasal symptoms, nasal airflow resistance, nostril dissection area, and serum titer of specific IgE antibodies against house dust mite allergens. In addition, the production of T helper (Th) 1 (represented by interferon-gamma) and Th2 [represented by interleukin (IL)-4, IL-10, and IL-13] cytokines, the proinflammatory cytokine IL-8, soluble intercellular adhesion molecule (sICAM), and arachidonate metabolites prostagladin E(2) (PGE(2)) and leukotriene C(4) (LTC(4)) by polymorphonuclear neutrophils (PMNs) were compared before and after treatment between the two groups. RESULTS: XYS attenuated nasal symptoms (sneezing and rhinorrhea) and nasal congestion through reduction of nasal airflow resistance and increase in nostril dissection areas. We also found that XYS exerted diverse immunomodulatory effects, including suppression of serum IgE levels and increased production of IL-10, sICAM-1, and IL-8 compared to placebo group. However, XYS treatment did not affect the release of PGE(2) and LTC(4) from PMNs. CONCLUSIONS: This study originally provides the evidence that Xin-yi-san alone is an effective herb in the treatment of perennial allergic rhinitis.

Evoked response of heart rate variability using short-duration white noise.

To investigate and to establish a model for evaluation of the instant cardiovascular responses to the noises of low-to-moderate intensity, sixteen healthy subjects were enrolled. The white noises were binaurally presented with a supra-aural earphone. The test intensities of noises were no noise, 50, 60, 70 and 80 dBA. Each noise was continued for 5 min and the electrocardiogram was simultaneously recorded. The cardiac autonomic responses were evaluated using power spectral analysis of the R-R contour obtained from digital signal processing of the ECG tracings. The result showed that the mean heart rate and mean blood pressure did not change significantly with the noises. However, the low-frequency power (LF) which represents cardiac autonomic modulations and the ratio (LHR) of LF to high-frequency power (HF) which reflects cardiac sympathetic modulations were significantly greater in the noise intensity of 50, 60, 70 and 80dBA (p<0.01, repeated measures ANOVA). In addition, the LHR was significantly correlated with the noise intensity (rho=0.90, p<0.05, Spearman's correlation analysis). The instant autonomic responses to white noises can be detected using power spectral analysis of heart rate variability and the evoked responses may provide a sensitive way to evaluate the instant effect of noise to humans.

Hospice utilization in Taiwan by cancer patients who died between 2000 and 2004.

To facilitate utilization of hospice services, Taiwan uses the National Health Insurance (NHI) as a major policy instrument. To evaluate the effect of this policy on hospice utilization by cancer patients during their final year of life, a retrospective cohort study was conducted by linking individual patient-level data from the National Register of Deaths Database and the NHI claims database to examine changes in the rates of hospice utilization, durations of patient survival (DOS) after enrollment, and the rates of late referrals to hospice care from 2000 to 2004. Among the 103,097 cancer patients who died between 2000 and 2004, the rate of hospice utilization during their final year of life grew substantially from 5.5% to 15.4%. However, Taiwanese cancer patients were enrolled in hospice care close to death (median DOS ranged from 14 to 47 days). Except for the small proportion of patients who received both inpatient hospice care and hospice home care, one-third to one-fourth of cancer decedents died within 7 days after being enrolled in hospice care. Although the rate of late referrals to hospice care did not vary much over time, the mean DOS for hospice care changed significantly. Many Taiwanese cancer patients who could potentially benefit from hospice care do not receive it in time. Further research is warranted to investigate factors influencing hospice use and the timing of hospice referrals to facilitate appropriate use of hospice care for cancer patients in Taiwan.