Because of the disunity use of the outcome measures in traditional Chinese medicinal clinical trials, we explain the application of outcome measures in clinical trials on insomnia, provide the international criteria and guideline on outcome reporting. According to analysis of the concrete cases, we in order to improve the misuse of outcome measures of insomnia, to make the selection and reporting of outcome measures follow with the international practices and, to accelerate the development of traditional Chinese medicine.

Visual analogue scales(VAS) is extensively applied on evaluating symptomatic outcome data,such as the pain intensity,but currently most of the management of relevant data can't conform to the statistical standard.This article categories the data measured with VAS and the eligible statistical methods,give a specific explanation about analysis of repeated measures data which may commonly misused in practice.It provides a reference criterion for statistical analysis with VAS in clinical research.

Objective To evaluate the effectiveness of Tai chi on quality of life of breast cancer patients. Methods Articles from 10 English and Chinese Databases from inception to March 2012 were recalled. 2 researchers independently screened titles and abstracts for eligible trials, methodological quality was assessed according to risk of bias items. Meta-analysis would be used if data available. Results 4 randomized trials with 169 participants were included. All trials had high risk of bias. 2 studies demonstrated significant improvement in Tai chi group for improving shoulder functional capacity which caused by breast cancer. The meta-analysis failed to demonstrate significant effects of Tai chi compared with control interventions (psychological support therapy, standard health care, routine rehabilitation training) in improving quality of life (SMD 0.03, 95%CI: -0.85, 0.91, P=0.94). Conclusion Tai chi is effective on shoulder functional capacity of breast cancer, but not significantly on quality of life.

Mild cognitive impairment (MCI) is considered as an intermediate clinical state between normal aging and Alzheimer’s disease (AD). The cognitive function and life ability of patients are normal, which have not met the criteria of AD. MCI is considered to be an earlier stage of AD. The clinical effects of AD in the middle or late stage are unsatisfactory. Therefore, studies on MCI have become the hot research areas both at home and abroad. The therapy of MCI is similar to AD. The treatment effect is uncertain. Hence, the understanding and treatment of MCI by TCM reflected TCM features. This article reviewed on TCM understanding of MCI, TCM syndrome differentiation criteria and TCM treatment methods of MCJ. Thus, it was aimed to further understand the dynamic of MCI in order to provide references for improving TCM clinical effects and reducing the incidence of AD.

Neuroblastoma (NB) is a common malignant solid tumor that occurs during childhood;it has a significant heterogene-ity in clinical symptoms and outcome. NB diagnosis is complicated, and various clinical techniques are often involved in examining im-agery, cellular morphology, immunohistochemical staining, gene and molecule biology, and operation excision scope. Diagnoses are graded based on danger extent, which is indicated by clinical stages and unfavorable prognosis factors. These characteristics are the ba-sis for formulating the corresponding synthetic treatment plan. Limited studies are available on treatment norms for adult cases of NB;such cases are currently diagnosed and treated in accordance with child NB diagnosis and treatment norms. An adult patient diagnosed with NB stage 4 is presented. This patient experienced obvious relief from the symptoms after whole body chemotherapy, with further surgery operation indications. This successful case of multi-disciplinary joint diagnosis and cooperative treatment may provide potential treatment techniques for similar patients.

Objective To evaluate the effect of hemorrhagic shock factor on the pharmacokinetics of rocuronium in pigs.Methods Sixteen pathogen-free Bama miniature pigs of both sexes,aged 3-5 months,weighing 22-25 kg,were divided into 2 groups (n=8 each) using a random number table:control group (group C) and hemorrhagic shock group (group HS).In group C,rocuronium 3.78 mg/kg was injected via the auricular vein.In group HS,the animals were subjected to volume-controlled hemorrhage,about 40％ of blood volume was withdrawn from the left femoral artery over 15 min (30 ml/kg),and rocuronium 3.78 mg/kg was injected via the auricular vein after the model was successfully established.At 0,2,4,7,10,15,20,30,60,120,180,240,300,360 and 420 min after rocuronium injection,blood samples were collected from the internal jugular vein for determination of the plasma concentration of rocuronium by high-performance liquid chromatography-tandem mass spectrometry.The pharmacokinetic parameters of rocuronium were calculated.Results Compared with group C,the plasma concentration of rocuronium was significantly increased at 20 and 60-420 min after rocuronium injection,the elimination half-life and mean residence time were prolonged,and the plasma effect-site equilibration rate constant was decreased in group HS (P＜0.05).There was no significant difference in the maximal concentration and area under the concentration-time curve between the two groups (P＞ 0.05).Conclusion The elimination of rocuronium is slower in a pig model of hemorrhagic shock.

Objective To investigate the effects of penehyclidine hydrochloride on blood-brain barrier in a rat model of cardiopulmonary bypass ( CPB) . Methods Sixty adult male SD rats, aged 4-6 months, weighing 320- 370 g, were randomly divided into 5 groups ( n = 12 each) : sham operation group (group S), CPB group, and low-, median- and high-dose penehyclidine hydrochloride groups (groups LP, MP and HP). The animals were anesthetized with intraperitoneal 10% chloral hydrate 350 mg/kg, intubated and mechanically ventilated. The femoral and jugular arteries and jugular vein were cannulated. CPB was performed for 60 min. Penehyclidine hydrochloride 0.2, 0.6 and 2.0 mg/kg were added to the priming solution in groups LP, MP and HP respectively, while the equal volume of normal saline was added in group CPB. Evans blue was injected via femoral vein at 1 h before the animals were sacrificed. Six rats in each group were sacrificed, their brains immediately removed and the hippocampi isolated for determination of Evans blue content. The other rats were sacrificed and the hippocampi isolated to determine the water content and observe the ultrastructure of blood-brain barrier. Results Compared with group S, the Evans blue content and water content were significantly increased in the other groups ( P ＜ 0.05) . Compared with groups CPB and LP, the Evans blue content and water content were significantly decreased in groups MP and HP ( P ＜ 0.05) . The Evans blue content was significantly lower in group HP than in group MP ( P ＜ 0.05). The CPB-induced changes were significantly attenuated in groups MP and HP compared with groups CPB and LP. Conclusion Penehyclidine hydrochloride can protect blood-brain barrier against the CPB-induced injury and the effect is related to the dose.

ObjectiveTo investigate the effect of penehyclidine hydrochloride on acute lung injury induced by cardiopulmonary bypass (CPB) in rats.MethodsForty adult male SD rats aged 4-6 months weighing 330-420 g were randomly divided into4 groups ( n =10 each): sham operation group (group S),acute lung injury group (group ALI) and low and high dose of penehyclidine hydrochloride groups (groups PL and PH ).Penehyclidine hydrochloride 0.6 and 2.0 mg/kg were added to the priming solution in groups PL and PH,while the equal volume of normal saline was added in group ALI instead.The rats of groups ALI,PL and PH were underwent 1 h of CPB.Arterial blood samples were collected before CPB and at 2 h after CPB for blood gas analysis.The superior vera cava blood samples and lung tissues were collected at 2 h after CPB for determination of concentrations of TNF-α and IL-6,lung tissue contents of water and malondialdehyde (MDA) and activity of glutathione peroxidase (GSH-px).The pathological change of lung tissue was also examined.ResultsCompared with group S,PaO2 was significantly decreased at 2 h after CPB,plasma concentrations of TNF-α and IL-6 and contents of water and MDA in lung tissues were increased,while activity of GSH-px in lung tissues was decreased in groups ALI,PL and PH ( R ＜ 0.05).Compared with group ALI,PaO2 was significantly increased at 2 h after CPB,plasma concentrations of TNF-α and IL-6 and contents of water and MDA in lung tissues were decreased,activity of GSH-px in lung tissues was increased (P ＜ 0.05),and the pathological change was reduced in groups PL and PH.Compared with group PL,PaO2 was significantly increased at 2 h after CPB,plasma concentrations of TNF-α and IL-6 and contents of water and MDA in lung tissues were decreased,activity of GSH-px in lung tissues was increased ( P ＜0.05),and the pathological change was reduced more obviously in group PH.ConclusionPenehyclidine hydrochloride 0.6 or 2.0 mg/kg can reduce the CPB-induced lung injury in a dose-dependent manner by antioxidant and anti-inflammatory mechanism in rats.

Objective To investigate the efficiency of transduction of recombinant adenovirus-mediated human endothelial nitric oxide synthase (eNOS) into lung tissue by repeated intratracheal transfection in rats.Methods Sixty 3-4 month old male Wistar rats weighing 220-280 g were randomly divided into 2 groups:control group (group C,n =10) and eNOS gene transduction group (group T,n =50).The animals were anesthetized with intraperitoneal 10％ chloral hydrate 35 mg/kg,tracheally intubated and mechanically ventilated (VT 2.5 ml,RR 60 bpm,FiO2 1.0).Recombinant adenovirus carrying human eNOS gene was given as gift by Professor Gerard from Texas University,Southwest Medical Center.In group T 50 μl of the recombinant adenovirus in concentration of 5 × 109 PFU/ml was instilled into trachea every 5 minutes for 12 times,while in group C equal volume of vector conservation solution was instilled instead.Pulmonary arterial blood samples were obtained at 2,5,7,14 and 21 d after intratracheal transfection (n =10 at each time point) for determination of serum NO concentration.The animals were immediately sacrificed after blood sample collection for determination of expression of eNOS protein in the lung tissue and RNA.The eNOS expression in the trachea,bronchus,lung,liver,spleen and kidney was detected by immuno-histochemistry.Results The serum NO concentrations were significantly higher at all time points in group T than in group C.The eNOS expression was detected in the epithelial cells of trachea and bronchi,and endothelial cells of alveoli and pulmonary blood vessels in group T but not in group C.eNOS expression was not detected in liver,spleen and kidney at 7 d after intratracheal transfection in group T.Conclusion Human eNOS gene mediated by recombinant adenovirus was transducted into rat lung tissue with normal enzyme activity by repeated intratracheal administration without being detected in distant organs.

Objective To verify the presence of anti-ovary antibodies in systemic lupus erythematosus (SLE) and its possible correlations with serum levels of hormone profile and menstrual disturbances in patients with SLE.Methods Clinical data of 78 consecutive paticnts who fulfilled 4 or more of the ACR 1997 revised criteria for SLE were studied and compared with 40 age-matched healthy controls,including anti-ovary antibodies.Results 27 (34.6％ ) patients with SLE,and 1 (2.5％) of the healthy controls tested positive of anti-ovary antibodies.The levels of E2 and T and P decreased[ E2:( 80.96 ± 36.2 ) ng/L vs ( 118.53 ± 42.4 ) ng/L; T:( 3.85 ± 1.18 ) nmol/L vs ( 6.43 ± 2.28 ) nmol/L; P:( 1.37 ± 0.59 ) μg/L vs ( 3.92 ± 1.23 ) μg/L],and the levels of FSH and LH and PRL increased in SLE patients when compared with healthy controls [ FSH:( 19.17 ± 9.26)IU/L vs (10.18 ±7.27 )IU/L; LH:( 21.19 ± 12.44)IU/L vs (13.79 ±8.27)IU/L;PRL:(6.18 ± 2.27 ) μg/L vs (2.37 ±0.63)μg/L,P ＜0.05 orP ＜0.01].The higher SLEDAI score,higher rate of menstrual disturbances (6.3 ±2.8 vs 3.5 ± 1.7,81％ vs 47％,P ＜0.05 or P ＜ 0.01 ) and decreased serum level of E2 [ (64.13 ± 26.36 ) ng/L vs ( 82.83 ± 28.71 ) ng/L,P ＜ 0.05 ]were found in SLE patients with anti-ovary antibodies positive than in SLE patients with anti-ovary antibodies negative.Conclusions The presence of anti-ovary antibodies was 34.6％ in SLE,and may correlate to decreased serum level of E2 and menstrual disturbance.