In order to safeguard the legitimate rights and interests of the subjects and the interests of the whole society , a relaxed and harmonious environment was created to ensure the normal medical research , clini-cal research trials which fit in trial of ethical review. The protocol assessment form and ICF assessment form to review are two cornerstones of protecting subjects. A good ICF assessment form is a necessary means to help improve the quality of the Ethics Committee for review .

Biomedical research involving human subjects must be approved by the ethical review. The method of improving ethics committee members of the examination quality is not only by the members themselves , but also a good plan of the work table, which is also a necessary means to improve the quality of the ethical review.

Objective To evaluate the feasibility and safety of laparoscopic surgery in the treatment of acute pyogenic cholecystitis. Methods From January 2005 to May 2008,laparoscopic surgery was performed on 156 cases with acute pyogenic cholecystitis in our hospital. The clinical data of the patients were retrospectively reviewed. Four trocars were used for cholecystotomy. Major resection of the gallbladder or cholecystostomy was carried out if the anatomy of the Calot triangle was complex. Results Among the 156 operations,laparoscopic cholecystectomy was succeeded in 139 cases (89.1%); cholecystostomy was performed on 6 cases (3.8%); and 11 patients (7.1%) received laparoscopic subtotal cholecystectomy (LSC). None of the patients were converted to open surgery. The operation time ranged from 35 to 180 minutes with a mean of 75. Thirteen patients showed increased level of direct bilirubin and/or stones in the common bile duct (revealed by cholangiography during the bile duct dilation),and were cured by removing the stones under laparoscope and T tube drainage. The T tube was withdrawn in 2 months after cholangiography. Follow-up was available in all of the patients for 3 to 6 months. No jaundice,abdominal pain,fever or other complications occurred during the period. Conclusion Laparoscopic surgery is feasible,effective,and safe for acute pyogenic cholecystitis.

Objective To investigate clinical effect of Danhong injection combined with edaravone in patients with idiopathic pulmonary fibrosis (IPF) and influence on TNF-αand TGF-β1 in serum.Methods 67 patients were randomly divided into Treatment Group (n=35) and Control Group (n=32) in Xuanwu hospital of Nanjing from March 2011 to December 2014.All the patients were treated by comprehensive conventional treatment, and then control group was treated by edaravone, treatment group were treated by Danhong injection on the basis of control group.The clinical efficiency, PaO2 , carbon monoxide diffusing capacity (Dlco) and the levels of inflammatory factors between two groups were compared.Results After treatment, the clinical total effective rate(97.14%) of treatment group was statistically higher than that of control group (75.00%, Z=-2.035,P=0.042).After treatment, partial pressure of oxygen(PaO2) and Dlco in treatment group were increased significantly(all P<0.05);and it was statistically higher then control group (all P<0.05).TNF-αand TGF-β1 in treatment group were decreased significantly (all P<0.05);and it was also statistically higher then control group (all P<0.05).Conclusion Danhong injection combined with edaravone is effective in treatment of IPF, which can significantly improve the pulmonary function and levels of inflammatory factors.

[Objective] To observe the effect of HQSM on PGI_2/TXA_2 in blood plasma of acute myocardial ischemia rats caused by injecting pituitrin. [Methods] 84 SD rats were divided into seven groups at random: normal control group,model control group,three HQSM groups(210mg/kg,150mg/kg,105mg/kg),Huangqi Shengmaiyin and DI’ao Xinxuekang. Intragastric administration was adopted once a day for 30 days.Acute myocardial ischemia model rat was established by injecting pituitrin from tail vein 1h after the last administration, and blood plasma was separated to be determined the activity of 6-Keto-PGF_ 1? and TXB_2, which is the metabolite of PGI_2 and TXA_2 in blood plasma of SD rats. [Results] Having been injected pituitrin,the activity of TXB2 upgraded while 6-Keto-PGF_ 1? /TXB_2 decreased(P

Objective To explore the procedures of 3Q validation for blood coagulation analyzer under the good laboratory prac‐tice(GLP) system based on the Sysmex CA7000 automatic blood coagulation analyzer .Methods Four test indicators of PT ,APTT , TT and FIB were chosen to conduct the performance verification in the within‐run precision ,between‐day precision ,accuracy ,linear‐ity ,carry‐over contamination rate of the automatic blood coagulation analyzer .They were prothrombin time(PT) ,activated partial thromboplastin time(APTT) ,thrombin time(TT) ,and fibrinogen(FIB) .Results The within‐run precision CV values of PT , APTT ,TT and FIB were 1 .33% ,1 .57% ,1 .47% and 1 .90% ,respectively ;the inter‐day precision CV values of PT ,APTT ,TT and FIB were 1 .73% ,1 .52% ,1 .55% and 2 .14% respectively ;in terms of accuracy ,the normal quality control CV values were 7 .45% ,3 .88% ,-4 .98% and 4 .36% respectively ;the abnormal quality control CV values of PT and APTT were 8 .11% and 8 .77% respectively ;the r value of FIB linear correlation coefficient was 0 .999 3 ,the a value was 1 .02 ;the highest CV value of car‐ry‐over contamination rate was 2 .15% ;the detected results all conformed to the general industry standards and requirements of in‐strument manufacturer .Conclusion The 3Q validation under the GLP system proves that the Sysmex CA7000 automatic blood co‐agulation analyzer is good in performance and is appropriate for the laboratory work of clinical laboratory department .

Objective To evaluate the impact of 120 W 2 μ m continuous-wave laser vapoenucleation versus and transurethral resection of the prostate (TURP) in patients with symptomatic benign prostatic hyperplasia (BPH) on sexual function.Methods One hundred and twenty-two patients with BPH were selected,63 cases were treated with 120 W 2 μ m continuous-wave laser vapoenucleation versus(2 μ m laser group),59 cases were treated with TURP(TURP group).International index of erectile function(IIEF) scores and self-made general assessment questions were completed before and 12 months after treatment to determine the impact on sexual function.IIEF scores included erectile function (EF),sexual desire,orgasm,sexual satisfaction and overall satisfaction.Results The IIEF scores difference was no significant before treatment between two groups (P ＞ 0.05).In two groups,there was no significant difference in EF,sexual desire,sexual satisfaction and overall satisfaction score between before treatment and 12 months after treatment(P＞ 0.05),orgasm score 12 months after treatment was significantly lower than that before treatment [2 μm laser group:(5.9 ± 1.5) scores vs.(8.6 ± 2.7) scores;TURP group:(5.5 ± 1.6) scores vs.(8.7 ± 1.8) scores] (P ＜0.05).Multiple linear regression analysis showed that two groups EF score and the international prostate symptom score,quality of life score and Q.~ positive linear correlation.Logistic regression analysis showed that the incidence of retrograde ejaculation and orgasm reduced significantly assoeiated(P ＜ 0.05),as an independent predictor of orgasm reduced after treatment(P ＜ 0.05).Conclusions There is no difference between these two surgical techniques regarding to impact on sex function.No significant EF improvement after surgery in both groups,but these two techniques can significantly decrease the IIEF orgasmic function domain and this is mainly caused by retrograde ejaculation.

This study was aimed to optimize Qinshuang particle best spray granulation process conditions. The or-thogonal test method was used with grain yield and baicalin transfer rate as the inspection indexes. The main in-fluence factors of Qinshuang particle spray granulation process were investigated. The results showed that the best technological parameters are atomization pressure of 1 800 Pa, inlet temperature at 90°C - 100°C, outlet temper-ature at 50 ° C - 60 ° C , and the extract relative density of 1 . 10 ( 60 ° C ) . It was concluded that the reasonable pro-cess conditions make particles with stable quality, which provide the experimental basis for industrial production.

Objective To establish the quality standard for Zaizao Nongsuo Wan. Methods Artificial Calculus Bovis, Radix Paeoniae Rubra, Rhizoma Coptidis and Herba Ephedrae were identified by TLC. The content of Muscone was determined by GC. Results Under the selected conditions, the clear and distinguished spots were obtained. For content determination, the linear range of Muscone was 0.101 2 ? g～ 1.012 ? g, r=0.999 9, the average recovery was 99.11 % ( n=5) and RSD was 3.59 % . Conclusion The methods are proved to be simple, specialization with a good reproducibility, and can be used to control the quality of Zaizao Nongsuo Wan.

Objective To explore the application of cancer pain standardized treatment in patients with lung cancer pain and clinical results.Methods 120 cases of lung cancer pain patients as the research object in Our hospital from April 2015 to June 2016,The patients were randomly divided into study group and control group,60 cases in each group,the patients in the control group were treated with routine therapy and nursing,and the patients in the study group were treated with normalized treatment and care of cancer pain,and then compared the two groups after treatment Pain status changes and adverse events and patient satisfaction statistics.Results There was no significant difference in pain status and VAS score between the two groups before treatment,but the pain status was relieved after treatment.The pain status of patients in the study group after standardized treatment of cancer pain changed significantly,the VAS score was lower than the control,the difference between the two groups was statistically significant(P<0.05).After treatment,the adverse events of the study group including non-on-time medication,syncope pressure sores and the incidence of self-mutilation or suicide were statistically significant And the difference was statistically significant(P<0.05).The satisfaction of the patients in the two groups showed that the satisfaction of the patients in the study group was significantly higher than that of the control group,The difference between groups was statistically significant(P<0.05).Conclusion The standardized treatment of cancer pain is effective in the treatment of patients with lung cancer pain.It can effectively relieve the pain and improve the quality of life and satisfaction of patients with lung cancer pain.It has broad clinical application and popularization value.