ObjectiveTo confirm the clinical efficacy and safety of Yishen Yangxin Anshen tablets in the treatment of insomnia （heart-blood deficiency and kidney-essence insufficiency syndrome）. MethodA randomized block， double-blind， placebo-controlled， multi-center clinical trial design method was adopted， and a total of 480 patients with insomnia due to deficiency of heart blood and insufficiency of kidney essence （treatment group-control group 3∶1） from seven hospitals （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， The First Clinical Hospital， Jilin Province Academy of Traditional Chinese Medicine（TCM）， The Second Affiliated Hospital of Liaoning University of TCM， The First Affiliated Hospital of Henan University of Chinese Medicine， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine） were enrolled. The treatment group was given Yishen Yangxin Anshen tablets and the control group received placebo tablets （4 tablets/time， 3 times/day， 4 weeks of administration， 4 weeks of follow-up after drug withdrawal）. The sleep dysfunction rating scale （SDRS） score， pittsburgh sleep quality index （PSQI） score， TCM， polysomnography （PSG） indicators from four hospital （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine）， and other efficacy indicators were compared between the two groups before and after treatment. Through general physical examination， laboratory examination， and observation of adverse events， the safety of the drugs was evaluated. ResultThe baseline indexes of the two groups showed no significant difference and thus the two groups were comparable. After treatment， the total score of SDRS in the treatment group was lower than that in the control group （P<0.01）. After drug withdrawal for 4 weeks， the total score of SDRS demonstrated no significant change in the treatment group as compared with that at the end of treatment， indicating that the rebound change of curative effect was not obvious. After treatment， the total score of PSQI in the treatment group decreased as compared with that in the control group （P<0.01）， and the change of total score of PSQI in the treatment group was statistically significant （P<0.05） after drug withdrawal for 4 weeks but small， indicating that the rebound change of curative effect was not obvious. After treatment， the total effective rate about the TCM symptoms in the treatment group was higher than that in the control group （χ²=137.521，P<0.01）. After treatment， the disappearance rates of single indexes in the treatment group， such as difficulty in falling asleep， easily waking up after sleeping， early awakening， short sleep time， dreamfulness， palpitation， forgetfulness， dizziness， mental fatigue， and weakness of waist and knee， increased compared with those in the control group （P<0.01）. After treatment， the treatment group demonstrated fewer awaking times （AT）， longer total sleep time （TST）， lower ATA/TST ratio， and higher sleep efficiency （%） than the control group （P<0.05）. No abnormal value or aggravation related to drugs was observed in either group. The incidence of adverse events in the treatment group and the control group was 5.57% and 8.40% respectively. No serious adverse events or adverse events leading to withdrawal happened in either group. ConclusionYishen Yangxin Anshen tablets is effective and safe for patients with insomnia of deficiency of heart-blood and insufficiency of kidney-essence.

Abstract OBJECTIVE To develop LC-MS method for the simultaneous determination of impurities A, C, and D of caspofungin acetate. METHODS Waters CORTECS® C18+(4.6 mm×150 mm, 2.7 μm) was used as the chromatography column. Mobile phase A and B were 0.1% formic acid-H2O and 0.1% formic acid-CH3CN, respectively. Electrospray ion source-single quadrupole mass spectrometry was used to detect impurities A and C in positive ion mode and impurity D in negative ion mode. RESULTS The correlation coefficient r was ≥ 0.999 in linearity ranges of impurities A, C and D. The average recoveries were 100.5%, 104.1% and 105.2%, respectively, with RSD<4%(n=6). The LOQs (S/N=10) of impurities A, C and D were 31.8, 6.99 and 15.5 ng·mL-1 respectively. The contents of impurities A, C and D in the three samples were all below the limits. CONCLUSION The developed LC-MS method is simple, sensitive, and applicable, which can be used to simultaneously determine impurities A, C and D in caspofungin acetate and can also provide a reference for the detection of other impurities in caspofungin acetate.

OBJECTIVE To analyze caspofungin acetate and the samples under different strong degradation conditions by LC-QTOF-MS, and to study the characteristics in mass spectra of caspofungin and its related impurities(impurities A, B, C, D and E). METHODS Chromatographic separation was accomplished on Waters CORTECS® C18+(4.6 mm×150 mm, 2.7 μm) column using a gradient elution with monile phase of 0.1% formic acid-H2O(A) and 0.1% formic acid-CH3CN(B) at a flow velocity of 0.6 mL·min-1; The analytes was detected in positive ion scan mode by ESI-QTOF-MS. RESULTS In MS1 spectra, except that impurity D mainly showed single-charge quasi-molecular ion, caspofungin and the other four impurities showed muti-charge quasi-molecular ions with high abundance; In MS2 spectra, caspofungin and its impurities that containing ethylenediamine generated fragment ions at m/z 1 033 by losing the ethylenediamine and the groups attached to it; caspofungin and its impurities produced a series of fragment ions mainly through the cleavage of peptide bonds, as well as through the loss of hydroxyl, acyl, or amino groups from amino acid residues; Impurity A and C showed characteristic fragment ions m/z 137.070 8 and m/z 77.071 1 with high abundance, respectively, which could be used to distinguish them from caspofungin and the other impurities. CONCLUSION Caspofungin and its five impurities have distict characteristics in their mass spectra. The research results can provide reference for identifying the structures of unknown impurities that may occur in the production process of caspofungin, so as to quickly discover the potential problems in the production process and reduce the quality risk of the products.

Objective:To investigate the reparative efficacy and mechanism of pressure-adjustable macroporous antibacterial hydrogel in the treatment of infected wounds.Methods:Staphylococcus aureus was used to establish wound infection models in healthy C57BL/6 mice. The models were divided into 3 groups subjected to 3 different treatments: a negative control group with no hydrogel treatment (group A), a control group treated by common medical hydrogel (group B) and an experiment group treated by pressure-adjustable macroporous antibacterial hydrogel (group C). On days 1, 3, 6, 9 and 12, the effects of 3 treatments were compared on the wound area and the number of bacterial colonies under scab, on the apoptosis of fibroblasts based on the changes of type Ⅰ procollagen, and on the inhibition of inflammation during wound repair by detecting the expression of interleukin-6 (IL-6) and tumor necrosis factor (TNF-α).Results:On days 1 and 3, there was no significant difference between the 3 groups in the wound area ( P>0.05), but on days 6, 9 and 12, there were significant differences between the 3 groups in the wound area ( P<0.05). On day 6, the wound areas in group B (1.23 cm 2 ± 0.16 cm 2) and in group C (1.14 cm 2 ± 0.12 cm 2) were significantly smaller than that in group A (1.56 cm 2 ± 0.16 cm 2) ( P<0.05), but there was no significant difference between groups B and C ( P>0.05). On days 9 and 12, the wound areas in group B (0.97 cm 2 ± 0.13 cm 2 and 0.76 cm 2 ± 0.10 cm 2) and in group C (0.66 cm 2 ± 0.06 cm 2 and 0.48 cm 2 ± 0.07 cm 2) were significantly smaller than those in group A (1.49 cm 2 ± 0.11 cm 2 and 1.39 cm 2 ± 0.13 cm 2), and those in group C were significantly smaller than those in group B (all P<0.05). On day 1, there was no significant difference between the 3 groups in the number of bacterial colonies under scab ( P>0.05). On days 3, 6, 9 and 12, the numbers of bacterial colonies under scab in groups B and C were significantly smaller than that in group A ( P<0.05), and that in group C was significantly smaller than that in group B ( P< 0.05). The nucleic acid electrophoresis showed that the grayscale bands in group C were significantly darker than those in groups A and B. The early apoptosis rate of the fibroblasts in group C[low-right positive fluorescence (LR%): 9.72%] was significantly lower than that in group A (43.99%) and that in group B (38.43%), and that in group B was significantly lower than that in group A ( P<0.05). On day 12, the ratio of the gray values of IL-6 and β-actin (0.64 ± 0.10) and the ratio of the gray values of TNF-α and β-actin (0.34 ± 0.05) in the fibroblasts in group C were significantly higher than those in group A (1.22 ± 0.21 and 0.60 ± 0.14) and in group B (0.88 ± 0.02 and 0.41 ± 0.06) ( P<0.01). Conclusion:The pressure-adjustable macroporous antibacterial hydrogel is an effective treatment of infected wounds and its mechanism may be related to the reduced apoptosis of fibroblasts.

BACKGROUND:Vertebroplasty and kyphoplasty can effectively repair osteoporotic vertebral compression fractures, but bone cement injection can cause the change of stress in the fractured vertebrae and adjacent vertebrae after surgery, leading to new fractures.
OBJECTIVE: To analyze the stress changes of the fractured vertebrae and adjacent vertebrae after vertebroplasty with different elastic modulus bone cement by a three-dimensional finite element method.
METHODS: One healthy adult male volunteer was selected for lumbar spine CT scan. The acquired images were imported for three-dimensional reconstruction using Mimics. The three-dimensional model was smoothed, polished and denoised by Geomagic software, and then the solid mode was built under Workbench Ansys. An osteoporotic vertebral compression fracture model in L2-4 segments was established after assignment. Bone cement (4 mL) with different elastic moduli (8 000, 4 000, 2 000 and 1 000 MPa) injected into the L3 segment distributed in the middle of the vertebrae as spherical shape. 500 N pre-load was applied on the L2 surface with an additional bending moment of 50 N?m. The lower surface free degree of L4 was restrained. The L2-4 forward flexion, posterior extension, right flexion and axial rotation on the right side were stimulated. The stress changes of the fractured vertebrae and the upper and lower adjacent vertebrae before and after bone cement injection with different elastic moduli were compared.
RESULTS AND CONCLUSION:The stress of the fractured vertebrae and adjacent vertebrae were significantly increased compared with that before operation. With the increase of elastic modulus, the stress of the fractured vertebrae increased, but there were no changes in the stress of adjacent vertebrae. These findings indicate that the elastic modulus of bone cement may be a method to reduce new fractures of the fractured and adjacent vertebrae after bone cement injection.

BACKGROUND:Vertebroplasty and kyphoplasty can effectively repair osteoporotic vertebral compression fractures, but postoperative change of stress in the fractured vertebrae and adjacent vertebrae can lead to new fractures. OBJECTIVE:To analyze the stress changes of the fractured and adjacent vertebrae with different bone cement injection volume by three-dimensional finite element method. METHODS:One healthy adult male volunteer was selected for lumbar spine CT scan. The acquired images were imported for three-dimensional reconstruction using Mimics. The three-dimensional model was smoothed, polished and denoised by Geomagic software, and then the solid mode was built under Workbench Ansys. The osteoporotic vertebral compression fracture model in L2-L4 segments was established after assignment. Bone cement of 1, 2, 4, 6 mL was injected into the L3 vertebrae respectively and distributed in the middle of the vertebrae as spherical shape. 500 N pre-load was applied on L2 surface with an additional moment of 50 N·m. The lower surface free degree of L4 was restrainted. The L2-L4 forward flexion, extension, right flexion and axial rotation on the right side were stimulated to compare the stress changes of fractured vertebrae and adjacent vertebrae before and after the bone cement injection with different volume. RESULTS AND CONCLUSION:The stresses of fractured and adjacent vertebrae after the bone cement injection were significantly increased; meanwhile, the stresses of fractured and adjacent vertebrae increased with the increase of bone cement injection volume, which may be one of the factors leading to the compression fractures of adjacent vertebrae.

Objective To evaluate the efficacy of the autologous epidermal grafting combining with NB-UVB radiation on the treatment of stable vitiligo.Methods Autologous epidermal graft acquired by suction blister under negative pressure were transplanted onto the laser-abraded depigmented areas,then the narrow-band UVB radiation was given after grafting to 35 patients with stable vitiligo.The onset time and the area repigmentation of every epidermal graft 3 months latter were observed (digital image contrasted before and after treatment).The results were compared with 37 cases only treated with autologous epidermal grafting.Results Both onset time and the cure rate in combined treatment group were statistically significant (P＜0.05) as compared with control group.Conclusions The combination of autologous epidermal grafting with NB-UVB radiation can shorten the onset time of repigmentation and promote generation and extension of the melanin.

OBJECTIVETo explore the influences of di-(2-ethylhexyl)phthalate (DEHP) and its principle metabolite mono(2-ethylhexyl)phthalate (MEHP) on spermatogenic cell apoptosis in young male Wistar rats.

METHODSNinety-eight 2-week-old male Wistar rats were randomly divided into 14 equal groups to receive daily intragastric administration of 0.2 ml/kg normal saline for 3 weeks (normal control), 100 mg/kg cyclophosphamide (CTX) for 1 week (positive control), 100, 200, and 300 mg/kg DEHP or MEHP for 1 week, or 100 mg/kg DEHP or MEHP for 1, 2, and 3 weeks. After the treatments, the pathological changes of the testicular tissues were examined, spermatogenic cell apoptosis was detected, and serum sex hormones levels were measured using TUNEL assay or radioimmunoassays.

RESULTSCTX, DEHP, and MEHP all caused shrinkage, development retardation and quantitative reduction of spermatogenic cells with and mitochondrial swelling vacuolar changes. The damage of spermatogenic cells increased significantly with the increment of DEHP and MEHP doses and exposure time. Both DEHP and MEHP treatments resulted in significantly increased cell apoptosis index (AI) in close correlation with the exposure doses and duration (P<0.01). DEHP and MEHP treatments also significantly increased serum levels of follicle stimulating hormone and luteinizing hormone and decreased testosterone levels in a dose- and time-dependent manner (P<0.05).

CONCLUSIONDEHP and MEHP can induce obvious apoptosis of spermatogenic cells in young male rats with a dose- and time-dependent effect.

Animals ; Apoptosis ; drug effects ; Diethylhexyl Phthalate ; analogs & derivatives ; toxicity ; Dose-Response Relationship, Drug ; Environmental Exposure ; Male ; Rats ; Rats, Wistar ; Spermatozoa ; cytology ; drug effects

Objective To analyze the patterns of amino acid changes in liver failure patients treated with non-bioartificial liver support system (ALSS), and to explore the efficacy of ALSS in liver failure treatment. Methods A total of 146 liver failure patients treated with ALSS from June 2009 to August 2010 were recruited in this study. Paired blood samples were collected from every patient and serum amino acids and ammonia were tested by automatic amino acid analyzer. The changes of amino acids in patients with different prognoses, different types/phases of liver failure were evaluated.Measurement data were compared by paired t test. Results After ALSS treatment, liver failure patients experienced a significant decrease in serum glutamic acid and lysine [(395.62±200.24)μmol/Lvs (260. 05±169.56) μmol/L and (436. 73±326. 18)μmol/L vs (407. 12±292.01) μmol/L,respectively; t= 8. 611 and 2. 659, respectively; both P＜0.01)], while experienced greatly increases in threonine and branched-chain amino acids/aromatic amino acid ratio [( 1302. 90 ±1288.70) μmol/L vs (1406.70 ±1272. 34) μmol/L and 1. 23 ± 0. 53 vs 1. 36 ± 0.57, respectively; t = 2. 895 and 1. 061,respectively; both P＜0. 01)]. The changes of glutamic acid, tyrosine, arginine and methionine before and after ALSS treatment in patients with different prognoses, different types/phases of liver failure were all significantly different. Conclusions ALSS treatment could improve the serum amino acid disorder in liver failure patients. The amino acids in patients with different types/phases or different prognoses of liver failure change significantly after ALSS treatment.

ive] Therapeutic effect of western medicine combined with Chinese herbal medicine for central serous chorioretinopathy (CSC) is observed. [Methods] Sixty-four patients with CSC were ran domly allocated to Group A ( n = 33) and Group B ( n = 31) . Group B were treated only with routine western medicine, and Group A added with Chinese herbal medicine with the actions of nourishing liver and kidney, invigorating spleen for eliminating dampness and activating blood-flow to remove blood-sta sis. Plasma catecholamine (CA) content and the activities of tissue plasminogen activator (tPA) and plasminogen activator inhibitor (PAI) were measured before and after treatment. [Results] The cure rate was 57.58% and 32.26%in Group A and Group B respectively, the difference being significant (P