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.

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.

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.

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.

Objective To investigate the effect of penehyclidine hydrochloride on brain injury induced by cardiopulmonary bypass (CPB) in rats. Methods Thirty adult male SD rats were randomly divided into 5 groups ( n = 6 each): sham operation group (group S), CPB group, and low, median and high dose penehyclidine hydrochloride groups (group PL, PM , PH). Penehyclidine hydrochloride 0.2, 0.6 and 2.0 mg/kg were added to the priming solution in group PL, PM and PH respectively, while the equal volume of normal saline was added instead in group S. Blood samples were obtained at 2 h after termination of CPB to determine the plasma concentrations of neuron specific enolase (NSE) and S-100β protein. The brain tissues were taken to observe the ultrastructure of hippocampal neurons with electron microscope. Results The concentrations of NSE and S-100β protein were significantly higher in the other groups than in group S, while lower in group PM and PH than in group CPB and PL( P＜ 0.05). The S-100β protein concentration was significantly lower in group PH than in group PM( P ＜ 0.05). The damage to hippocampal neurons was significantly attenuated in group PM and Ps. Conclusion Penehyclidine hydrochloride 0.6 or 2.0 mg/kg can reduce the CPB-induced brain injury in a dose-dependent manner in rats.

Objective To investigate the effects of cardiopulmonary bypass (CPB) on the expression of tight junction protein occludin in rat lung tissues.Methods Twenty adult male Sprague-Dawley rats were randomly divided into 2 groups (n=10 each): sham operation group (group S) and CPBgroup.The rats underwent 1 h of CPB and were observed 2 h later in group CPB.The lung water content,neutrophil percentage and protein concentration in bronchoalveolar lavage fluid (BALF) were measured.The expression of occludin in lung tissues was detected by immunohistochemistry and Western-blot analysis.The ultrastructure of alveolar epithelial barrier was observed with transmission electron microscope.Results Compared with group S,the lung water content,protein concentration in BALF and neutrophil percentage were significantly increased (P ＜ 0.05),the expression of occludin in lung tissues was significantly down-regulated (P ＜ 0.05) and the damage to alveolar epithelial barrier was aggravated in group CPB.Conclusion The expression of occludin in lung tissues is down-regulated and the damage to alveolar epithelial barrier is induced after CPB,which may be one of the important factors in acute lung injury induced by CPB.

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.

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 evaluate the effect of penehyclidine hydrochloride (PHC) on the level of angiopoietin-1 (Ang-1) and tyrosine kinase receptor-2 (Tie-2) during endotoxin-induced acute lung injury (ALI) in rats.Methods Forty adult male Sprague-Dawley rats,weighing 180-220 g,were randomly divided into 4 groups using a random number table (n =10 each):control group (group C),ALI group,low-dose PHC group (group L-PHC) and high-dose PHC group (group H-PHC).ALI was induced with iv injection of lipopolysaccharide 5.0 mg/kg via the tail vein.In L-PHC and H-PHC groups,PHC 0.6 and 2 mg/kg were injected,respectively,via the tail vein at 1 and 24 h after lipopolysaccharide injection.The rats were sacrificed at 48 h after the initial injection of PHC to measure the lung water content,protein concentration in bronchoalveolar lavage fluid (BALF),and the expression of Ang-1,Tie-2 and phosphorylated Tie-2 in lung tissues.The morphological changes of lung tissues were observed under light microscope and the ultrastructural changes of alveolar epithelial barrier under transmission electron microscope.Results Compared with group C,the lung water content and protein concentrations in BALF were significantly increased,and the expression of Ang-1 and phosphorylated Tie-2 was down-regulated in the other three groups (P ＜ 0.05).Compared with group ALI,the lung water content and protein concentrations in BALF were significantly decreased,and the expression of Ang-1 and phosphorylated Tie-2 was up-regulated in H-PHC group (P ＜ 0.05),and no significant changes were found in the parameters mentioned above in group L-PHC (P ＞0.05).The damage to lung tissues was significantly reduced in group H-PHC as compared with group ALI.Conclusion PHC can improve the permeability of pulmonary microvascular and reduce injury to alveolar epithelial barrier,thus ameliorating endotoxin-induced ALI in rats,and the effect is dose-related and up-regulation of Ang-1 expression and inhancement of Tie-2 activity are involved in the mechanism.