OBJECTIVE:To provide reference for small interfering ribonucleic acid (SiRNA) R&D and registration in China. METHODS:The situation of SiRNA R&D at home and abroad were introduced,and problems encountered in the evaluation and approval process were summed up to put forward suggestions. RESULTS & CONCLUSIONS:SiRNA has developed slowly in Chi-na,with a gap of 5-10 years at least compared with foreign developed countries. The registration category of SiRNA is not clear;applicants lack of guidance documents;production workshop which meet requirement is in shortage;the efficiency of drug registra-tion allows of no optimism. It is recommended that pharmaceutical registration departments carry out the pilot reform for SiRNA registration,publish SiRNA registration guide,relax regulations for IND gradually,encourage applicants to participate in the inter-national multicenter clinical trials in order to improve the efficiency of SiRNA evaluation and approval efficiency.

Objective To compare the effectiveness of the forced-air warming system and the conventional warming care practice in preventing hypothermia in patients undergoing major surgeries.Methods A total of 62 patients were enrolled in this study. Patients of both sexes,aged≥18 years,and with an ASA physical status Ⅰ-Ⅲ were included and allocated randomly into intervention group(n=30)or control group(n=32). Patients in the intervention group were provided forced-air warming,either prior to induction or during the surgery procedure depending on core temperature monitoring results. In the control group,patients were warmed with conventional warming care without any intervention. Core temperature was measured by Spot-On sensor and tympanic membrane thermometer,blood pressure,the electrocardiogram,heart rate,pulse oxygen staturation,and partial pressure of end-tidal COwere also monitored continuously in the two groups.Crystalloid,colloid,and allogeneic blood were also recorded by strict protocol. Results Intraoperative hypothermia monitored with tympanic thermometer was observed in 23 patients(71.87%)in the control group,which was significantly higher than that (0) in the intervention group(P=0.00). In addition,the incidence of hypothermia monitored by Spot-On sensor was 81.25%(n=26)in control group and 13.33%(n=4)in intervention group(P=0.00). Conclusion Compared with the conventional warming care,forced-air warming system is more effective in preventing hypothermia during major surgeries.

Objective To longitudinally analyze the unit costs and technical efficiency of the model of male circumcision in the different kinds of persons .Methods Unit costs were calculated by the person and period using longitudinal data from 3 kinds of persons ,and then technical efficiency and Malmquist indices were measured with an approach to data envelopment analysis . Results Theunit costs for changing the willingness to accept surgery changed dramatically ,decreasing from 7 166 .67 yuan(mean) to 737 .31 yuan ,while the costs for changing the ratio of the surgery increased from 666 .64 yuan (mean) to 744 .58 yuan ,and its technical efficiency was averaging between 0 .95-0 .96 .Conclusion The time series of unit costs for changing the willingness to ac-cept surgery dramatically dropped ,while changing the ratio of the surgery formed a U-shape curve with an inflection point before which unit costs dramatically dropped and another inflection point beyond which unit costs went up .These findings can inform pro-gram managers of the changing unit costs when extending or expanding the program .

Objective To investigate the clinical characteristic,diagnosis and treatment of familial adenomatous polyposis (FAP).Methods According to family history of the proband,we surveyed the pedigree and retrospectively analyzed the clinical characteristics of 10 FAP patients in 3 generations of the family.Result Among all 10 cases,3 died of colorectal cancer including two of whom had history of intestinal obstruction.Seven people of the third generation were all diagnosed as FAP.Among them,only 2 patients had clinical symptoms.Colonoscopy was done in all 7 patients before 35 years old.However,none of them had polyps or evidence of cancer.Surgical operation was performed on 1 patient and high frequency electric cutting under endoscopy was performed on 6 patients.Conclusions The early clinical manifestations of FAP are nonspecific.Pedigree investigation and colonoscopy screening for high-risk population are important to find early asymptomatic FAP patients.

Objective To explore the application value of plastic biliary stent and fully covered self-expandable metallic stent (FCSEMS) in endoscopic retrograde cholangio pancreatography (ERCP) for treatment of benign biliary stricture after liver transplantation.Methods The retrospective cross-sectional study was conducted.The clinical data of 54 patients with benign biliary stricture after liver transplantation undergoing ERCP treatment who were admitted to the First Affiliated Hospital of Xi'an Jiaotong University between January 2010 and August 2016 were collected.Among 54 patients,44 had simple anastomotic stricture and 10 had non-anastomotic stricture.All the patients underwent stent implantation by ERCP.Patients with stricture within 1 month postoperatively initially selected single plastic stent or endoscopic nasobiliary drainage (ENBD),and then changed into multiple plastic stents at the second stent replacement.Patients with stricture after 1 month postoperatively selected multiple plastic stents,multiple plastic stents after balloon dilation or FCSEMS.Observation indicators:ERCP situations,stent implantation,time of stent indwelling,postoperative complications,stent dislocation,treatment outcome and follow-up situations.Patients were followed up by outpatient examination and telephone interview up to November 2016.Clinical symptoms of patients were observed within 1 month postoperatively and liver function and abdominal ultrasound were retested.Liver function and remission degree of biliary stricture were monitored regularly once every 3 months.Measurement data were described as average (range).Results All the patients underwent successful ERCP,of which 53 completed the process of ERCP and 1 rejected treatment due to economic problems.All the 54 patients received 140 times ERCPs with an average of 2.59 times per person,21 times ENBDs,11 times FCSEMSs and 108 times plastic stent implantations (including 35 times single stent implantations,46 times double stents implantations,23 times 3-stents implantations and 4 times 4-stents implantations).All the 54 patients were followed up for 3-143 months,with an average time of 73 months.Of 44 with anastomotic stricture,34 received plastic stent implantation and 98 times ERCPs,with an average number of stent implantation of 2 (range,1-4) and an average time of stent indwelling of 10.7 months (range,9.0-13.0months);the postoperative acute pancreatitis,biliary infection,hyperamylasemia and adverse stent implantation or dislocation were detected in 4 persons every time,7 persons every time,10 persons every time and 3 persons every time,respectively;26 patients were cured and 5 were improved,with an effective rate of 91.2％ (31/34);3 patients with noneffective treatment continued to undergo ERCP and 3 patients had recurrence of anastomotic stricture.Among 10 patients with initial FCSEMS implantation,12 times ERCPs were performed,with an average time of stent indwelling of 7.6 months (range,6.0-12.0 months);postoperative biliary infection,hyperamylasemia and stent dislocation were detected in 1 person every time,1 person every time and 1 person every time,respectively;8 patients were cured,with an effective rate of 8/10;of 2 patients with persistent stricture,1 patient received contrast examination after stent removal,showing a comparative stricture in level 1 branch of intrahepatic duct and considering combined ischaemia,and then underwent the second implantation using multiple plastic stents;the other patient had elevated level of jaundice at 3 months after stents removal and received ERCP,showing anastomotic inflammatory polyp,and then underwent FCSEMS implantation again.Ten patients with non-anastomotic stricture received plastic stent implantation and 30 times ERCPs,with an average number of stent implantation of 3 (range,2-4) and an average time of stent indwelling of 11.3 months (range,10.0-14.0 months);the postoperative acute pancreatitis,biliary infection,hyperamylasemia and adverse stent implantation or dislocation were detected in 2 persons every time,5 persons every time,2 persons every time and 1 person every time,respectively;3 patients were cured and 3 were improved,with an effective rate of 6/10;of 4 patients with noneffective treatment,2 died of gradually deteriorating liver function and 2 underwent the second liver transplantation.Conclusions Stent implantation in ERCP is safe and effective for treatment of benign biliary stricture after liver transplantation,single plastic stent should be used in the early period (within 1 month) and multiple plastic stents should be used in the later period.Although FCSEMS has a higher displacement rate,it should be recommended due to a better clinical effect,lower incidence of complications and simple operation.For patients with non-anastomotic stricture,plastic stent should be used for extrahepatic biliary stricture,with a good clinical effect,and there is worse effect in stent implantation through ERCP for multiple intrahepatic biliary strictures.

Objective To explore the effects of upper limb robot-assisted therapy on motor function and activities of daily living in con-valescent stroke patients. Methods From June to September, 2016, 12 chronic stroke patients at their first-ever stroke were enrolled and ran-domized into experimental group (n=6) and control group (n=6). Both groups received routine rehabilitation. Additional robot-assisted thera-py was provided to the experimental group, and additional repetitive movement training was provided to the control group, 20 minutes a day, five days a week for four weeks. Fugl-Meyer Assessment-Upper Extremities (FMA-UE), modified Ashworth Scale (MAS) and Func-tional Independent Measure (FIM) were used to assess the motor function of the upper limbs and hands, the muscular tension of shoulder and elbow, and activities of daily living (ADL) before and after treatment. Results After treatment, the scores of FMA-UE and FIM were bet-ter in both groups (Z>2.032, P<0.05), and no significant difference was found between two groups (t<0.723, P>0.05), however, the scores were a little bit higher in the experimental group than in the control group. After treatment, for the experimental group, the MAS scores of shoulder abduction/adduction and elbow flexion/extension improved (Z>2.121, P<0.05);for the control group, the MAS scores of shoulder abduction/adduction improved (Z>2.000, P<0.05), but the MAS scores of elbow flexion/extension were not significantly different (Z<1.890,P>0.05). There was no significant difference in the MAS scores of shoulder abduction/adduction and elbow flexion/extension between two group (Z<1.734, P>0.05). The moving trail recorded by the computer, gradually became a regular pattern from the mass, saying the motor control ability became better. Conclusion Upper limb robot-assisted therapy can promote the recovery of the motor function of upper limbs and ADL in convalescent stroke patient, similar to the repetitive movement training.

Aim To study and compare the pharmaco-kinetic parameters of roxithromycin under normoxic and hypoxic rats. Methods A highly effective and rapid ultra-performance liquid chromatography with tandem mass spectrometry ( UPLC-MS/MS) method with posi-tive electrospray ionization source was successfully de-veloped and validated for quantification of roxithromy-cin in rat plasma. Sprague-Dawley rats were randomly divided into the hypoxia and normoxic groups. Each rat obtained a single dose of roxithromycin with 10 mg · kg-1 via intragastric administration. The pharmacoki-netic parameter comparison between normoxic and hy-poxic groups was calculated by SPSS software using in-dependent sample t test method. Results The main pharmacokinetic parameters of roxithromycin between the normoxic and hypoxic rats were:the AUC(0-t) 7 576 and 3 761 μg·h·L-1 , MRT(0-t) 5. 6 and 7. 7 h, T1/2 3. 4 h and 3. 9 h, CL 1. 5 and 3. 0 L · h-1 · kg-2 , tmax3. 1 and 3. 4 h, Cmax 1 116 and 372 μg·L-1 , re-spectively. The levels of Cmax and AUC of roxithromy-cin in hypoxic rats were statistically lower than those in normoxic rats. Conclusion The exposure level of rox-ithromycin in hypoxic rats markedly decreased. Our re-sults may provide an important experimental basis to adjust the dosage for roxithromycin in hypoxic clinical practice.

OBJECTIVEThe purpose of the present study was to investigate the in vitro effects of baicalin on induction of apoptosis in human prostate cancer cell line DU145.

METHODHuman prostate cancer cell line DU145 was treated with different concentration of baicalin in vitro. The apoptosis rate was determined by FACS analysis, cell cycle distribution was detected by flow cytometry, morphological changes and protein analysis were determined by means of electron microscope techniqueand immunohistochemical techniquerespectively.

RESULT50micromol x L(-1) and 125 micromol x L(-1) of baicalin dose-dependently induced apoptosis and inhibited the proliferation of prostate cancer cell DU145 in a dose and time-dependent manner. DNA flow cytometric analysis indicated that baicalin induced a arrest in G1 phase, showing a typical apoptosis peak. Electron microscopy detected a characteristic appearance of the apoptotic cells morphology. Immunohistochemical analysis revealed that induction of apoptosis by ways of inhibition of the bcl-2, loss of the Bax, and upregulation of Fas.

CONCLUSIONThe results indicate that baicalin may induce apoptosis and inhibit proliferation of prostate cancer cells, and has direct anti-tumor effects on human prostate cancer cells.

Antineoplastic Agents, Phytogenic ; pharmacology ; Apoptosis ; drug effects ; Cell Line, Tumor ; Cell Proliferation ; drug effects ; Dose-Response Relationship, Drug ; Flavonoids ; isolation & purification ; pharmacology ; G1 Phase ; Humans ; Male ; Plants, Medicinal ; chemistry ; Prostatic Neoplasms ; metabolism ; pathology ; Proto-Oncogene Proteins c-bcl-2 ; metabolism ; Scutellaria ; chemistry ; bcl-2-Associated X Protein ; fas Receptor ; metabolism

Background Nowadays,customized ablation is widely used in the excimer laser corneal refractive Burgery.And the Q-value guide LASIK is one of the research hotspots. Objective Present study was to evaluate and compare the effectiveness of Q-value guide LASIK and standardized LASIK for myopia.Methods A systematic literature retrieval from 2003 through 2010 was conducted in the MEDLINE,CNKI,Cochrane Library,EMBASE.The literature examine possible difierences in uncorrected visual acuity(UCVA),Q-value,higher order aberrations(HOAs),and spherical equivalent(SE) between Q-value guide LASIK and standardized LASIK for correcting myopia.Statistical analysis was performed using a Review Manager 5.0 software.The data was extracted,and the methodological quality was evaluated by two reviewers independently.The quality of included literature was scored according to the Jadad Scale. Results A total of 14 studies involving 1617 patients(2956 eyes)was included in the meta-analysis.Of these fourteen studies,six studies were randomized trials and the other eight studies were retrospective cohort studies.According to the Jadad Scale,2 studies scored 3 points,and the other 12 studies scored 1～2 points.The results showed that the Q-value guide LASIK group had a better postoperative effectiveness in uncorrective visual acuity(UCVA)(WMD=0.04.95% CI 0.00 to 0.08,P<0.05).Q-value(SMD=-1.52,95% CI -2.23 to-0.81,P=0.00),total HOAs (SMD=-1.63,95% CI-2.57 to-0.69,P<0.05) and spherical-like aberrations ( SMD =-1.49,95% CI-2.22 to-0. 76,P<0. 00) after surgery. However, the number of eyes achieved UCVA≥20/20 ( OR= 1.16,95% CI 0. 61 to 2. 19,P=0. 65) ,coma-like aberrations (SMD=-1. 02,95% CI-0. 36to 0.11,P=0.29) and SE (WMD=0.10,95% CI-0.11 to 0.31,P=0.34) after surgery were comparable.Conclusion The effectiveness of Q-value guide LASIK is superior to standardized LASIK for treatment of myopia.High-quality clinical randomized-controlled study should be performed to further evaluate the comparable outcome of Q-value guide LASIK with standard LASIK.

Objective To design a new type of biliary stent to be used in the common bile duct probe and evaluate its biocompatibility, safety and effectiveness in a canine model.Methods Magnesium alloy (AZ 31B) was used to make biliary stents.A canine model of acute obstructive jaundice was established by ligating the distal end of the common bile duct.These dogs were divided into two groups with either placement of magnesium stent or not.The incidence of bile duct leakage and survival were evaluated.Meanwhile, we determined the concentration of magnesium in various body fluids and organs, liver function test, and ultrasonic and histological studies.Results The concentrations of magnesium in the blood, feces, liver, heart, brain and lungs were similar between the two groups.Bile leakage rate in experimental group and control group was 0％ and 16.7％, respectively.The mortality was 16.7％ and 33.3％.There were no significant differences in ALP and TBIL between experimental group and control group (P>0.05) before building and bile duct exploration.There were significant differences in ALP andTBIL between the two groups one and three months after bile duct probe (P<0.05).Biliary tract specimens showed obviously anastomotic stenosis performances and expansion performances of extrahepatic biliary in the control group, but in experimental group such changes were not observed.Ultrasonography showed that the patency of biliary anastomosis was good and there was no anastomotic biliary stricture in experimental group.However, progressive stenosis and expansion performances of extrahepatic biliary occurred in control group.There were fewer collagen fibers but more muscle fibers in experimental group than in control group.Conclusion Biliary stent made of magnesium alloy is of good biocompatibility and has the potential to prevent the postoperative stenosis in the common bile duct probe.