We found that the number of institutions made use of the undocumented in vitro diagnostic reagent in the survey. The phenomenon poses some risks and problems. In use this paper, we analyzed the situation and the reasons for the use of the undocumented in vitro diagnostic reagents, and put forward the corresponding measures.
Humans ; Indicators and Reagents ; standards

Objective To evaluate the clinical value of small doses of solifenacin to treat children of primary nocturnal enuresis. Methods Children (n=78) of primary nocturnal enuresis were randomly divided into treatment group(39 cases) and control group(39 cases). All children received behavioral intervention therapy, while children in the treatment group were given Solifenacin(5 mg/tablet, 1/3 tablet, 1 times a day for 3 months) orally besides behavioral therapy. Children were followed up for 3 months after the end of the treatment, and the curative effect and recurrence rate were compared between two groups. Results Compared with that of children in control group, cure rate of children in treatment group is higher at the end of treatment (89.7%vs 69.2%, P<0.05) as well as by 3 month of follow-up time (82.1%vs 46.2%, P<0.05). The re?currence rate of children in treatment group, by three months follow-up time, was lower than that of children in control group (8.6%vs 33.3%,P<0.05). Conclusion Small dose of Solifenacin in addition to behavioral intervention is safe and effec?tive in treatment of children with enuresis, which enhance cure rate and reduce recurrence.

Objective To investigate clinical efficacy of additive LiuJunZi decoction in treatment of patients with chronic obstructive pneumonia ( COPD) of both lung and spleen deficiency in stable phase.Methods A total of 58 patients with deficiency of both lung and spleen type stable COPD patients were randomly divided into treatment group and control group by a random number table, 29 cases in each group, patients in two groups were treated with salmeterol and fluticasone propionate powder for inhalation.On this basis, the treatment group were given additive Liujunzi Decoction, orally, with 3 months treatment.The clinical signs and symptoms of patients, pulmonary function, index of sputumand acute attack proportion in a year were observed and compared.Results After different treatment, total efficiency was 93.1% in treatment group, which was obviously higher than 65.5%in control group (P<0.05).After treatment, the values of FEV1 and FEV1/FVC improved compared with before treatment, and the above indexes of treatment group significantly improved compared with control group (P<0.05).The HDACs activety, levels of TNF-αand IL-8 mproved compared with before treatment, and the above indexes of treatment group significantly improved compared with control group (P<0.05).The acute attack was two cases in treatment group(6.9%), seven cases in control group(24.1%), but the difference had no statistically significant.Conclusion The additive Liujunzi decoction in the treatment of both lung and spleen deficiency type chronic obstructive pulmonary disease ( COPD) in stable phase has exact clinical curative effect, can significantly improve clinical symptoms and laboratory indexes, control the progression of the disease, and improve life quality of the patients.

Objective To analyze the risk factors of post-operative respiratory failure in elderly cardiac carcinoma patients.Methods 28 elderly patients with respiratory failure (respiratory failure group) after the resection of cardiac carcinoma and 56 controls (control group) were studied.Preoperative respiratory function,the other complications,the site of incision,intravenous infusion,age of patients and smoking between two groups were compared by Logistic regression.Results Univariate risk factors included MVV<50% ,RV/TLC>50% ,FEV1<1.5L,PEF<70% ,DLCO<80% ,V75<70% ,the venous input,incision at chest.Multivariate logistic regression analysis identified that MVV<50% ,RV/TLC>50% ,FEV,<1.5 L,DLCO<80% were risk factors.Conclusion These results suggested that the patients with risk factors described above need more careful pre and post operative surveillance and management.

Objective To compare the perioperative safety and curative effects oflaparoscopic adrenal sparing surgery (ASS) with laparoscopic total adrenalectomy (TA) for aldosterone producing adenoma (APA).Methods An online systematical retrieval was performed with Pubmed,ScienceDirect,Springerlink,the Cochrane library,CNKI and China Biology Medicine disc for clinical comparative studies published before May 2016,these studies reported the treatment of ASS/partial adrenalectomy (PA) versus TA for APA.The selected studies were applied to Revman 5.3 software for meta-analysis.The main contents were perioperative outcomes (operative time,intra-operative blood loss,and length of hospital stay) and postoperative efficacy (cure rate,partial response rate,inefficiency rate).Results A total of 9 clinical studies (3 English documents and 6 Chinese documents) with 1036 patients were included into the final analysis,among which 544 patients were assigned to ASS group and 492 in TA group.The analyzed results demonstrated no statistical significance between ASS group and TA group on operative time (WMD:-2.09min,95％CI:-9.86-5.67,P=0.60),length of hospital stay (WMD:-0.10d,95％CI:-0.32-0.12,P=0.36),intra-operative blood loss (WMD:1.13ml,95％CI:-8.86-11.12,P=0.82),cure rate (OR=l.07,95％CI:0.73-1.58,P=0.72),partial response rate (OR=0.85,95％CI:0.57-1.27,P=0.43) and inefficiency rate (OR=2.15,95％CI:0.32-14.34,P=0.43).Conclusion For surgical treatment of APA,ASS is technically safe,can achieve reliable postoperative efficacy and a similar therapeutic effect compared with TA,so deserves further application in clinical practice.

Objective Analyse the causes,diagnosis and treatment for delayed hemorrhage after distal radical gastrectomy.Methods Retrospective study on 45 patients combined with intro-abdominal hemorrhage after distal radical gastrectomy from January 2008 to June 2013.Results Thirteen patients combined with delayed hemorrhage in these 45 patients,all of 13 patients had intro-abdominal hemorrhage in 1week to 4 weeks after operation.And 5 of the 13 patiens were intermittent intro-abdominal hemorrhage 1 week after operation,these patients were demonstrated the blood come from gastroduodenal artery pseudoaneurysm fracture by CT and DSA examine,and they were cured by interventional embolization.Other 8 patients were marginal ulcer hemorrhage diagnosed by gastroscope,and they stoped bleeding with the help of gastroscope.Conclusions The causes of delayed hemorrhage after distal radical gastrectomy were complicated,and CT,DSA and endoscope can use for diagnosis.What was more,interventional embolization and endoscope were helpful for curing the intro-abdominal hemorrhage,avoiding re-operation.

Objective:To examine the inhibitory effect and mechanism of niclosamide combined with low-dose cisplatin on adrenocor-tical carcinoma xenografts in nude mice. Methods:A SW-13 cell transplanted tumor model was first established in nude mice. The nude mice were then divided into the control group, niclosamide group, cisplatin group, and combined drug group. The groups were compared in terms of tumor body volume, tumor weight, and biochemical index. The cell apoptosis rate of the transplanted tumor tis-sue was detected by TUNEL assay, while Bcl-2 and caspase-3 protein expression in the transplanted tumor tissue was detected by im-munohistochemistry and Western blot. Results:The terminal tumor volume and weight of the combined drug group were lower than those of the niclosamide and cisplatin groups (all P<0.001). The white blood cell count of the cisplatin and combined drug groups were lower than that of the control group (all P<0.001). Meanwhile, no difference was observed between the cisplatin and combined drug groups (P=0.29). The creatinine and glutamic pyruvic transaminase of the cisplatin and combined drug groups were higher than those of the control group (all P<0.001), whereas no significant difference was observed in the levels of creatinine and alanine aminotransfer-ase between cisplatin and combined drug groups (all P>0.05). TUNEL test results showed that the cell apoptotic rate of the combined drug group was higher than that of the niclosamide group (P=0.004) and cisplatin group (P=0.005). Immunohistochemistry and West-ern blot test results showed that Bcl-2 expression in the combined drug group was lower than those of the niclosamide and cisplatin groups (all P<0.001), while caspase-3 expression in the combined drug group was the highest among those of other groups (all P<0.001). Conclusion:Niclosamide can enhance the inhibitory effect of low-dose cisplatin on the growth of adrenocortical carcinoma and has no additional side effects. This enhancement is probably related to the influence of niclosamide on Bcl-2 and caspase-3 expres-sion levels. Niclosamide promotes the apoptosis of the tumor cells by influencing Bcl-2 and caspase-3 expression.

Objective:To search for potential protein biomarkers of papillary thyroid carcinoma (PTC) and thyroid borderline lesion. Dif-ferentially expressed proteins between the two were analyzed and identified. Methods:A total of 118 cases of thyroid resection sam-ples were obtained from patients who underwent surgery at the First People's Hospital of Yunnan Province from April 2013 to Febru-ary 2015. Experimental groups included 43 PTCs (40 classic and 3 follicular variants) and 33 thyroid borderline lesions (with equivocal PTC type nuclear features and papillary structure, but without metastasis, and lacking capsular or vascular invasion;8 cases with atypi-cal adenoma), respectively. The control group included 42 normal thyroid tissues adjacent to carcinoma. The total protein extracts from frozen thyroid samples of 10 cases in each group were profiled with 2D electrophoresis. The differential protein spots were then revealed by PDQUEST 7.3 software and identified by matrix-assisted laser desorption ionization time-of-fight/time-of-fight mass spec-trometry and Swiss-Prot database search. Six differentially expressed proteins of these spots were further validated using 118 samples through immunohistochemistry. Results:A set of 24 differentially expressed spots significant in discriminating between the sample groups were found, and 18 proteins were identified. Immunohistochemistry revealed the following six proteins located in the cyto-plasm:keratin, type II cytoskeletal 8 (CK8);keratin, type I cytoskeletal 18 (CK18);60 kDa heat shock protein (HSP60);actin, cytoplasmic 2 (γ-actin);14-3-3 protein beta/alpha (14-3-3β/α);and 14-3-3 protein epsilon (14-3-3ε). All six proteins were overexpressed in PTC compared with normal tissues (P<0.001). Meanwhile, CK8, CK18, HSP60, andγ-actin were overexpressed in PTC compared with bor-derline lesions (P<0.01). Except for CK8, the five other proteins were overexpressed in borderline lesions compared with normal tis-sues (P<0.001). Conclusion:Proteomic analysis is useful in searching for new biomarkers of PTC and thyroid borderline lesion. The ex-pression patterns of these differentially expressed proteins can be further validated using immunohistochemistry. The newly identified protein biomarkers can positively contribute to early PTC diagnosis.

Objective To explore the effects of cyclosporin A (CsA) and tacrolimus (Tac) on biological behaviors of lung cancer A549 cells in nude mice.Methods Thirty-six models of transplanted tumor in Balb/c mice were established by using lung cancer A549 cells and divided into three groups:control group,without given any immunosuppressant; CsA group,intraperitoneally given CsA; Tac group,intraperitoneally given Tac.The transplanted tumor growth curve was drawn according to the transplanted tumor volume,and the influencing ratio was calculated according to the final tumor weight.The changes in cell migration ability were observed by using Transwell system.Terminal deoxynucleotidyl transferase mediated UTP nick end labeling (TUNEL) assay was used to examine the apoptosis index of the transplanted tumor.Quantitative RT-PCR was used to detect the expression levels of Bcl-2 mRNA and Bax mRNA.Results The growth of transplanted tumor in CsA and Tac groups was faster than in control group.Final tumor volume and final tumor weight in CsA and Tac groups were greater than those in control group.The influencing ratio in CsA and Tac groups was 19％ (P＜0.05) and 25％ (P＜0.05),respectively.The migration ability was greater in CsA and Tac groups than in control group (P＜0.01).The apoptosis index of the transplanted tumor in CsA and Tac groups was lower than in control group (P＜0.05).The expression level of Bcl-2 mRNA was higher in CsA and Tac groups than in control group (P＜0.05),and that of Bax mRNA was lower in CsA and Tac groups than in control group (P＜0.05).Conclusion Both CsA and Tac can promote the growth of transplanted tumor in nuce mice bearing 549 cells and enhance the invasion forces,which is probably related with the apoptosis induction of tumor cells.

Objective To evaluate the clinical value of the combination of S-shaped urethral dilator and nephro-scope for the treatment of male urethral stricture disease. Methods Guidewires were inserted into bladder through the nephroscope under direct vision. The urethral dilation with S-shaped urethral dilator was carried out by nephroscope in 41 male patients. All catheters were located across the strictures and remained for 4-6 weeks. The regular follow-up was done on all cases to assess the clinical effect on urine flow. Results All surgeries were successful without serious complications. The mean operative time was (40.16 ± 5.78) min. The voiding symptoms were significantly improved after catheter removal compared with those of preoperation in all cases. Patients were followed up after surgery and were regularly urethral dilation at least 6 weeks. The mean follow-up time was (34.75±6.42) weeks.There were incontinence, diminished sexual function and other complications after operation in all cases. Conclusion Nephroscope combined with S-shaped urethral dilator for the treatment of male urethral stricture disease is feasible, minimally invasive and safe, which is worthy of recommendation.