OBJECTIVE:To discuss the countermeasure on the quality improvement of the drug clinical trials in our hospital based on the discovery of key links of the quality of clinical trials. METHODS:Quality results of 14 drug clinical trials in 10 ma-jors from the drug clinical trial institute in our hospital in 2014 were investigated. Referring to the grading and classifying methods of the inspection problems in European Medicines Agency,the key links of occurring problems were analyzed,and the effects of interventions for key links were evaluated. RESULTS:In 2014,totally 125 important and general problems were found,in which, the numbers of problems occurred in case report form filling,informed consent of subjects,enrolling and screening of subjects,in-vestigational products management accounted for 79.20%. The above 4 links were the key links affecting quality of drug clinical tri-als. According to strengthening the training about relevant knowledge of the researchers,improving system and standard operation procedures management,enhancing link quality control,introducing project clinical research coordinator,developing centralized drug management and other interventions,the total numbers of found important and general problems in 2015 and 2016 were 68 and 59,respectively. Compared with 2014,the differences were statistically significant(P<0.05). The numbers of found important problems in 2015 and 2016 were 7 and 4,respectively. Compared with 2014(4 important problems),the differences were not sta-tistically significant (P>0.05). There were no severe problems during 2014-2016. After interventions,numbers of occurring prob-lems in majors with less complex drug clinical trial had obviously declined in 2016. Compared with 2014,the differences were sta-tistically significant (P<0.05). While the major with relatively high complexity of drug clinical trial had no obvious decline in 2016. Compared with 2014,the differences were not statistically significant(P>0.05). CONCLUSIONS:Controlling the key links in drug clinical trial process can obviously reduce the occurrence of general problems while has little effect on the occurrence of im-portant problems. It is different for different majors in undertaking drug clinical trial projects,so as the links and degree of occur-ring problems. It should be distinguished in quality control checking.

The purpose of this study was to evaluate the effect and safety of Jinlong capsule combined with chemotherapy or radio-therapy for non-small cell lung cancer (NSCLS) using Meta-analysis. PubMed, Embase, CNKI and Wanfang databases were all searched without language restriction, and searching time was from January 1990 to July 2015. All eligible published studies were included in this study for quality assessment and data extraction. All the data were analyzed using Revman 5.3. A total of ten studies including 736 subjects (370 in Jinlong capsule plus chemoradiotherapy and 366 in chemoradiotherapy only) were finally included in this Meta-analysis. The result of Meta analysis showed that compared with pure chemoradiotherapy group, Jinlong capsule combined with chemoradiotherapy for NSCLC could improve the patients' curative effect (OR = 1.77, 95% CI: 1.29-2.43, P < 0.05), clinical benefit rate (OR = 1.89, 95% CI: 1.22-2.91, P < 0.05), life quality improvement rate (OR = 2. 56, 95% CI: 1.61-4.05, P < 0.05), and decrease leucopenia incidence rate (OR = 0.35, 95% CI: 0. 22-0.56, P < 0.05) and gastrointestinal reaction rate (OR = 0.67, 95% CI: 0.40-1.11, P < 0.05). The pooled results showed that Jinlong capsule combined with chemoradiotherapy for NSCLC could improve the curative effect and life quality, and decrease the adverse reaction of patients.
Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; Capsules ; administration & dosage ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; radiotherapy ; Chemoradiotherapy ; Combined Modality Therapy ; Drugs, Chinese Herbal ; administration & dosage ; Humans ; Lung Neoplasms ; drug therapy ; radiotherapy

Objective To investigate the pharmacodynamics of different local anesthetics administered intrathecally for elderly patients undergoing transurethral resection of the prostate (TURP). Methods Ninety ASA Ⅰ - Ⅲ elderly patients, aged 69-82 yr, with body mass index less than 30 kg/m2 , undergoing TURP under combined spinal-epidural anesthesia, were randomly divided into 3 groups ( n = 30 each): levobupivacaine group (group L), ropivacaine group (group R) and bupivacaine group (group B). Group L, R and B received intrathecai (IT) 0.5 % levobupivacaine, 0.5 % ropivacaine and 0.5 % bupivacaine respectively. The initial dose was 7,10 and 6 mg in group L, R and B respectively. The ratio of two successive doses was 0.9. If the upper sensory block reached T10 within the 20 min after IT injection, the IT analgesia was considered to be effective. The median effective dose (EDs0) and 95 % confidence interval (95 % CI) were calculated by Dixon. Results The ED50 and 95% CI of levobupivacaine, ropivacaine and bupivacaine were 6.781 (95% CI 6.561-7.024) mg, 9.135 (95%CI8.670-9.616) mg and 5.170 (95% CI 5.012-5.333) ng respectively. The relative potency ratio between levobupivacaine, ropivacaine and bupivacaine is 0.76∶0.57∶1.00. ConclusionThe relative potency ratio be tween levobupivacaine, ropivacaine and bupivacaine is 0.76∶0.57∶1.00.

To assess methodological quality of clinical studies using Aidi Injection as an adjunct therapy for non-small cell lung cancer (NSCLC) and to evaluate the effects of Aidi Injection.

One hundred and forty six elderly patients with constipation undergoing colonoscopy during March 2012 and August 2013 were randomly assigned to trial and control groups.Seventy patients in trial group received Macrogol electrolytes powder combined with Chinese herb medicine Simo decoction for bowel preparation and 76 patients in control group received macrogol electrolytes powder only.The first defecation,times of defecation and tolerance of patients were compared between two groups.The quality of bowel preparation was evaluated by endoscopists with Boston Bowel Preparation Scale (BBPS).The first defecation time was shorter in trial group than that in control group (55.7 ± 27.9 vs.72.9 ± 34.8,P ＜ 0.05).However,no statistical significance was found in the times of defecation and tolerance of patients between two groups.The mean BBPS score in trial groups was higher than that in control group (7.87 ± 1.08 vs.6.97 ± 0.96,P ＜ 0.05).Chinese herb medicine Simo decoction combined with conventional method shows satisfactory result for bowel preparation in elderly patients with constipation undergoing colonoscopy.

Objective To investigate the total number, reasons, and distributing characteristics of vagrant psychosis patients in Xi'an. Methods The colony random sample in 4 objective research units from 2005 to 2010 in Xi'an, Shaanxi were included. Databank was set up according to the total number of vagrant psychosis patients based on basic information. Grading statistics was used. Results Total number of vagrant psychosis patients and salvation needs increased year by year in Xi'an. Home return and social assistance were the main approaches for distributing characteristics of medical assistance. Conclusion The total number of vagrant psychosis patients is relative large. Such number is increasing year by year in Xi'an. A better treatment and diagnostic system for vagrant psychosis patients should be set up governmentally as quickly as possible.

Brassinosteroids, a group of plant steroid hormones, regulate many aspects of plant growth and development. We and other have previously solved the crystal structures of BRI1(LRR) in complex with brassinolide, the most active brassinosteroid identified thus far. Although these studies provide a structural basis for the recognition of brassinolide by its receptor BRI1, it still remains poorly understood how the hormone differentiates among its conserved receptors. Here we present the crystal structure of the BRI1 homolog BRL1 in complex with brassinolide. The structure shows that subtle differences around the brassinolide binding site can generate a striking effect on its recognition by the BRI1 family of receptors. Structural comparison of BRL1 and BRI1 in their brassinolide-bound forms reveals the molecular basis for differential binding of brassinolide to its different receptors, which can be used for more efficient design of plant growth regulators for agricultural practice. On the basis of our structural studies and others' data, we also suggest possible mechanisms for the activation of BRI1 family receptors.
Amino Acid Sequence ; Arabidopsis ; metabolism ; Arabidopsis Proteins ; chemistry ; metabolism ; Binding Sites ; Brassinosteroids ; chemistry ; Crystallography, X-Ray ; Molecular Sequence Data ; Protein Kinases ; chemistry ; metabolism ; Protein Structure, Tertiary ; Recombinant Proteins ; genetics ; Sequence Alignment ; Steroids, Heterocyclic ; chemistry

Objective To summarize the clinical experience of standard piggyback liver transplantation(SPBLT) and modified piggy-back liver transplantation(MPBLT) in the treatment of Wilson′s disease(WD).Methods The clinical records of 29 cases of WD who underwent piggyback liver transplantation over the recent 12 years were analyzed retrospestively.Among them,there were 22 male and 7 female patients,with 6cases aged 8-14y and 23 cases aged 24-37y,who underwent liver transplantation because of chronic advanced liver disease(18cases),fulminant hepatic failure(2 cases),or with normal liver function(9 case),and among them,24 cases showed neurological dysfunction.The modes of operation included SPBLT(13 cases) and MPBLT(16 cases).Results The patients were followed up for 1 month-12 years with the median follow-up time of 47 months.Four patients died in the perioperative period,of which 2 died of hepatic failure due to obstruction of hepatic venous return after SPBLT,and 2 died of hepatic artery thrombosis and bile leakage combined with severe infection.The recipient survival rate at 1 year and 3 years was 86% and 79% respectively.One patient has survived for 12 years.All the levels of serum copper and copper-protein recovered to normal in four weeks post-operatively.Neurological symptoms improved in varying degrees after operation.Conclusions WD patients who undergo PBLT can expect a satisfactory clinical outcome and a good quality of life,and MPBLT can effectively reduce the complications of operation and improve the operation survival rate.

Objective:To explore the effect of Aryl hydrocarbon receptor (AhR) activated dendritic cell (DC) on T helper cell 17 (Th17) differentiation in primary biliary cholangitis (PBC) patients.Methods:Per-ipheral blood samples of 10 patients with PBC and 10 healthy people were collected. CD14 + mononuclear cells were isolated and induced to differentiate to DCs. After stimulated by 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin (TCDD), these DCs were co-cultured with the na?ve CD4 + T cells. Then, the proliferation activity of T cells was detected by Cell Counting Kit-8 (CCK-8) and cytokines related to Th17 differentiation were detected by quantitative real-time-polymerase chain reaction (qRT-PCR) and enzyme-linked immuno sorbent assay (ELISA). Results:A large number of DCs were obtained, and the microscopic observation showed that the cells were enlarged in size, irregular in shape, and numerous protrusions on the surface. The CD11 and CD14 double positive cells accounted for 96.48%. After co-culture, the proliferation capacity of na?ve CD4 + T cells in the PBC group was significantly higher than that in the healthy control group. Absorbance ( A) value measured by CCK-8 method at 72 hours (1.02±0.04) was significantly higher than that at 24 hours (0.69±0.04) and 48 hours (0.82±0.04), and the difference was statistically significant ( LSD- t1=10.2, P<0.05; LSD- t2=6.3, P<0.05). The expression level of na?ve CD4 + T cells IL-17 in the PBC patients group was(1.24±0.40) higher than that in the healthy control group (0.61±0.18), and the difference was statistically significant ( t=3.90, P<0.05). The expression level of IL-22 (0.96±0.46) was also higher than that of the healthy control group (0.42±0.43), and the difference was statistically significant ( t=2.76, P<0.05). The expression of IL-22 in the culture supernatant of the PBC patients group was (77.4±2.9) ng/ml, significantly higher than that of the healthy control group (49.6±4.0) ng/ml, the difference was statistically significant ( t=5.58, P<0.01). The expression level of IL-17 (170.9±2.7) ng/ml was also higher than that of the healthy control group (130.6±7.1) ng/ml, and the difference was statistically significant ( t=9.10, P<0.05). Conclusion:DCs activated by AhR can promote the differentiation of Th17 and the production of related cytokines. Thus, DCs activated by AhR may promote the occurrence of PBC.

OBJECTIVETo explore an ideal method of digestive tract reconstruction and tolerance to adjuvant chemotherapy after radical proximal gastrectomy.

METHODSThirty patients in the reconstruction group were treated by jejunal interposition, and other 30 patients received gastroesophagostomy (control group). The operation time, operation risk, occurrence of reflux esophagitis and postoperative 1-, 3-, 6-month nutrition statuses were evaluated. Forty-three patients received postoperative adjuvant chemotherapy with mFOLFOX-6 and tolerance to the chemotherapy was assessed.

RESULTSThe operation time of the reconstructional group was (162.2 ± 14.0)min and that of the control group was (137.6 ± 18.9)mi, with a statistically significant difference. (t = -5.7, P<0.01). There were no significant differences of operation risk, postoperative 2-, 4-, and 6-day C-reactive protein, 2-, 4- and 6-day systemic inflammatory response syndrome between the two groups. The differences of the occurrence of postoperative 1-, 3- and 6-month reflux esophagitis and 3- and 6-month nutritional status between the two groups were statistically significant. 18 of 19 (94.7%) patients in the reconstruction group completed all six cycles of chemotherapy, 24 patients in the control group received chemotherapy, and 12 (50.0%) of them completed 6 cycles of chemotherapy. There was a significant difference in the completion rate of chemotherapy of the two groups (P<0.05).

CONCLUSIONSThe postoperative complications of jejunal interposition are not inceased, the symptoms of reflux esophagitis are alleviated, the quality of life can be improved, and there is a better tolerance to adjuvant chemotherapy. Therefore, jejunal interposition after radical proximal gastrectomy is a rational method of digestive tract reconstruction.

Aged ; Anastomosis, Surgical ; adverse effects ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; C-Reactive Protein ; metabolism ; Chemotherapy, Adjuvant ; Female ; Fluorouracil ; therapeutic use ; Follow-Up Studies ; Gastrectomy ; adverse effects ; methods ; Gastroesophageal Reflux ; etiology ; Humans ; Jejunum ; surgery ; Leucovorin ; therapeutic use ; Male ; Middle Aged ; Operative Time ; Organoplatinum Compounds ; therapeutic use ; Quality of Life ; Reconstructive Surgical Procedures ; adverse effects ; methods ; Retrospective Studies ; Stomach Neoplasms ; drug therapy ; metabolism ; surgery ; Systemic Inflammatory Response Syndrome ; etiology