OBJECTIVE:To optimize the formulation of Mirabegron sustained-release tablets. METHODS:Using polyethylene oxide(PEO)and hydroxypropylmethyl cellulose(HPMC K4M)as the sustained release matrix,Mirabegron sustained-release tab-lets were prepared by powder direct compression technology. Using 1,3,5,7 h accumulative release rate as indexes,the amounts of PEO,HPMC K4M and OPADRY? were optimized by composite design-response surface method,and then validated. Accumula-tive release rates of sustained-release tablet and original tablet (MyrbetriqTM) were compared in different pH mediums (water,pH 1.0 simulated gastric fluid,pH 4.5 acetate buffer solution,pH 6.8 phosphate buffer solution) at different rotation rates (100,50 r/min),and similiar factor f2 was calculated to fit drug release model of sustained-release tablet. RESULTS:In the optimized firmu-lation each Mirabegron sustained-release tablet contained mirabegron 25 mg,PEO 108.02 mg,HPMC K4M 21.69 mg,OPADRY? 2.27%. Relative error of accumulative release rates at 1,3,5,7 h to predicted value were 4.78%,3.48%,0.69% and -1.41%, respectively. f2 of release curves of sustained-release tablet and original tablet were higher than 65 in different pH medium at differ-ent rotation rates. The drug release of sustained-release tablet was fitted to zero-order release equation. CONCLUSIONS:Mirabe-gron sustained-release tablet by optimized technology is similar to original tablet in drug release behavior.

Objective To study the clinical efficacy of the injection Salvia (freeze-dried, abbr: Salvia powder needle), with fallopian tube recanalization on the treatment of oviduct obstructive infertility. Methods One hundred and ninety-five patients of oviduct obstructive infertility were enrolled in this study and divided into drug group and control group. Salpingography with modified catheter, recanalization and perfusion operation were performed in both two groups. Salvia powder, gentamicin, α-ACT and dexamethasone were injected into test group, while Gentamicin, α-ACT and dexamethasone were injected into control group. Recanalization rate of fallopian tube, rate of intrauterine gestation and rate of ectopic pregancancy were measured and compared between two groups. Results Twelve months after operation, recanalization of fallopian tube of test group and control group was 94.39% and 85.87%, respectively. Twenty-four months after operation, intrauterine gestation rate of test group and control group was 50.00% and 35.71%, respectively. Conclusion Salvia powder combined with modified recanalization operation is helpful to improve the rate of intrauterine gestation.

Objective To understand how about the female consumers know the skin conditions of themselves and which they concern by a comprehensive questionnaire. Methods Three hundred and twenty-eight healthy volunteers in Shanghai were involved in this study. They were divided into 5 age groups equally. The questionnaire included the skin conditions, i.e. skin moisture, sebum, whiteness, redness, xanthochromia, homogeneity, spots, fine line, wrinkle, elasticity, angiotelectasis,pore, sagging, smoothness, gloss, roughness, scales and sensitivity. Each condition was divided into 10 grades to assess the skin conditions of the face (exposed site), upper arm (non-exposed site) and the perfect skin status. SPSS11.5 software was used to analyze the correlations of the skin conditions with ages. Results The skin concerns were difference in the 5 groups. Skin aging of sagging, wrinkle, spots and fine line became prominent from group C (35 to 40 years old). The correlations between the skin concerns of facial moisture, sebum, whiteness, homogeneity, spots, wrinkle, fine line, elasticity, sagging, sensitivity, upper arm sebum, spots, elasticity, angiotelectasis, sagging and roughness with ages were very significant (P＜0.01). Conclusion The changes of the volunteers'concerns about sebum, pore, sagging, elasticity, fine line and wrinkle with age in different age group are consistent with the quantitative measurement results from the oversea studies.

Objective To examine the concurrent validity of Peabody'S developmental motor scale number 2(PDMS-2)and Gesell's developmental scales with 1 2 to 30 month-old children with cerebral palsy (CP)and to assess the value of PDMS-2 in measuring motor function in children with CP.Methods Eighty-four children with CP aged 12 to 30 months were assessed with both PDMS-2 and Gesell's developmental scales.The correlation between PDMS-2 gross motor quotients and Gesell gross motor developmental quotients,and be-tween PDMS-2 fine motor quotients and Gesell fine motor developmental quotients were compared using Spearman rank correlation coefficients. Results The correlation coefficient between PDMS-2 gross motor quo-tient and the Gesell gross motor developmental quotient was 0.89.Between PDMS-2 fine motor quotient and Gesell's fine motor developmental quotient it was 0.87.The concurrent validities were 0.28 and 0.42 respec-tively. Conclusion PDMS-2 gross motor quotient and Gesell's gross motor developmental quotient are highly correlated,as are PDM S-2 fine motor quotient and Gesell's fine motor developmental quotient.The concurrent validities were between classifications using the PDMS-2 gross motor quotient and Gesell's gross motor develop- mental quotient were weakly correlated,but there was moderate correlation between PDM S-2 fine motor quotientsand Gesell fine gross developmental quotients.There may be limitations in assessing motor function children aged12 to 30 months with cerebral palsy using PDMS-2.

Objective To investigate the characteristics of motor development in children with mental retardation. Methods Motor development was assessed with the Peabody Developmental Motor Scale 2 (PDMS-2) and mental development with adaptive developmental quotient (ADQ) of Gesell developmental schedules (GDS) in 430 infants (6~36 months old) with mental retardation. Results The gross (GDQ), fine (FDQ) and total motor developmental quotient were poor in all the children, and significantly different among children with slight, mild, and serious retardation (P<0.01). ADQ correlated with each sub-score of PDMS-2 (P<0.01). For PDMS-2, FDQ correlated with sub-scores of gross motor, and GDQ with sub-scores of fine motor (P<0.01) in all the mental retardate children. Conclusion The development of both gross and fine motor is poor in children with mental retardation. Mental development correlate with motor development, and gross with fine motor development.

Objective To analyze the relationship between intelligence development and clinical types and high-risk factors in the children with cerebral palsy (CP).Methods 363 CP children were tested using Gesell Developmental Scale (GDS), the relationship between intelligence development delay and clinical types and high-risk factors was analyzed.Results There was a significant relation between asyphxia, pathologic jaundice and intelligence development delay of CP children. The rate of intelligence development delay in athetotic and mixed type CP was significantly higher than the spastic type ( P<0.01).Conclusion Asyphxia and pathologic jaundice are the high-risk factors inducing intelligence development delay, and there is a relationship between intelligence development delay and clinical type of CP.

Objective To investigate the impact of enhanced recovery after surgery (ERAS)on immune function in patients undergoing laparoscopic hepatectomy.Methods Sixty patients undergoing laparoscopic hepatectomy (34 males,26 females,aged 38-57 years,ASA Ⅰ or Ⅱ),were randomly divided into two groups:enhanced recovery after surgery group (group E)and non-enhanced recovery after surgery group (group C).The patients in group E received enhanced recovery after surgery,while the patients in group C received routine perioperative management and anesthesia methods.The operation method and time,the volume of bleeding,the intraoperative fentanyl con-sumption,the volume of fluid input,the preoperative and postoperative CVP and temperature were recorded in the two groups.Blood samples were obtained before induction (T0 ),at the end of opera-tion (T1 ),on day 1 (T2 ),day 3 (T3 ),day 7 (T4 )after operation for determination of plasma con-centration of IgA,IgM,IgG and the percentages of T lymphocyte subsets (CD3+ ,CD4+ ,CD8+ ) and CD4+/CD8+ ratio were detected with flow cytometry.Furthermore,the visual analogue scale (VAS)score and Ramsay score were evaluated 4 hours,8 hours,24 hours and 48 hours after opera-tion in two groups.Results Compared with group C,the intraoperative fentanyl consumption,the volume of fluid input and the postoperative CVP in group E were significantly decreased,while the postoperative temperature was significantly increased (P < 0.05 ).Compared with T0 , the percentages of CD3+ ,CD4+ ,the CD4+/CD8+ ratio and the plasma concentration of IgA,IgM,IgG in group E on T1-T3 were significantly decreased,the percentages of CD3+ ,CD4+ ,the CD4+/CD8+ratio and the plasma concentration of IgA,IgM,IgG in group C on T1-T4 were significantly decreased (P <0.05).Compared with group C,the percentages of CD3+ ,CD4+ ,the CD4+/CD8+ ratio and the plasma concentration of IgA,IgM,IgG in group E on T1-T4 were significantly increased (P <0.05),the visual analogue scale (VAS)score 4 hours,8 hours,24 hours after operation were signifi-cantly decreased (P <0.05).The comparision of Ramsay scores at all the time points between two groups were similar.Conclusion ERAS applied to patients undergoing laparoscopic hepatectomy can reduce the intraoperative fentanyl consumption,prevent the occurrence of hypothermia and provide satisfactory postoperative analgesia,which can significantly improve the immune function in patients.

Objective To identify the efficacy and safety of aspirin in reducing the serum high sensitivity C reactive protein(hsCRP)level and preventing the internal arteriovenous fistulas(AVF)embolism in maintenance hemodialysis patients. Methods One hundred and ten hemodialysis patients using AVF more than 3 months were randomly divided into 2 groups,the intervention group(n=55,received aspirin 100 mg/d)and the control group(n=55).Examinations were performed at baseline and 6-month after treatment.Serum hsCRP level,platelet aggregates ratio(PAR),coagulation and inflammation indicators were measured.AVF embolism and the adverse events were monitored. Results Six months later.PAR and hsCRP level of the intervention group patients aged≤60 years decreased significantly [(68.14±8.45)%vs (82.37±9.12)%;(4.79±4.81)mg/L vs(6.94±10.26)mg/L,all P＜0.05],and were significantly lower as compared to.the control group[(68.14±8.45)%vs(74.7±11.50)%,(4.79±4.81)mg/L vs(5.12±9.25)mg/L,all P＜0.05].There were 2 cases of AVF embolism occured in both groups,which showed no statistical difierence (P=0.676).The incidence of adverse effeets was higher in the intervention group than that in the control group but no statistical significance was found (20.0%vs 7.2%,P=0.052),while the mortality rate had no difference between 2 groups (3.6%vs 0,P=0.495).Conclusion Use of aspirin 100 mg/d for 6 months can significantly reduce the serum hsCRP level and PAR in hemodialysis patients under 60-year-old without serious adverse reactions.

: Objective To evaluate the value of rehabilitation direction for the treatment of the children with spastic cerebral palsy. Methods 116 children with spastic cerebral palsy were investigated. 56 children who accepted rehabilitation direction and training in family participated in study group and 60 children who wouldn't accept rehabilitation direction participated in control group. All the children received comprehensive rehabilitation treatment in hospital, including physical therapy, acupuncture, low frequency electrotherapy and occupational therapy. All the children were assessed with Gross Motor Function Measure-88 (GMFM) before and 3 months after treatment. Results There was a significant difference before and after treatment in scores of GMFM in each dimension and total in both groups (P<0.01), and the treatment group improved more than control group(P<0.05). Conclusion Rehabilitation direction can facilitate the recovery of spastic cerebral palsy children.

ObjectiveTo study the effects of botulinum toxin type A (BTX-A) injection combined with functional training on the tiptoe deformation and gross motor function in children with spastic cerebral palsy (SCP). Methods60 SCP children with tiptoe deformation whose family consented to inject BTX-A were as treatment group and treated with BTX-A combined with function training, while other 46 SCP children as control group were only treated with functional training. They were assessed with Composite Spasticity Scale (CSS), the angle of ankle passive dorsiflexion motion and D and E domains of Gross Motor Function Measure (GMFM) before and 1 week, and 3 months after treatment. ResultsThe effect of BTX-A began from 24 to 72 h after injection, reached the peak from 1 to 2 weeks, maintained beyond 3 months with few side effects. There were significant differences between 2 groups in the outcome of CSS,the angle and the standing and walking value (GMFM) 1 week and 3 months after treatment (P<0.01). ConclusionBTX-A combined with functional training is more effective on reducing spasticity of the lower extremity, correcting the tiptoe deformation, increasing the range of ankle motion, improving gross motor function.