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.

The biological characteristic of carcinomas is determined both by the stromal microenvironment and the oncogene or anti-oncogene.The tumor stroma is also known as the reactive stroma which is composed of base member,immunocell,capillary,fibroblasts and ECM.Fibroblasts are the majority of tumor stromal cells.The relationship between fibroblasts and the initiation,progression of carcinoma has being in the spot light.In this review,we summarized the advance in the study of carcinoma-associated fibroblasts.

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.

Objective: To evaluate the surgView-RFT electromagnetic navigation system in radiofrequency thermocoagulation(RFT). Methods: 6 foramen ovales of 3 cadavers were punctured by 3 beginners. Every one tried 5 times by free-hand and 5 times by SurgView-RFT electromagnetic navigation-guidance. After each puncture, CT scans were used as golden standard to measure the distance between the tip of needle and the anterior margin of the foramen ovale. T test and variance of SAS 6.12 statistical software was used to do the statistic analysis. Results: The punctures by free-hand failed, and the distances between the tip of needle and the anterior margin of the foramen ovale were 8-10.6 mm. The punctures by navigation guidance were successful, and the distances between the tip of needle and the anterior margin of the foramen ovale were 2.68-3.54 mm. The error of navigation system was 0.59 mm which was verified by CT scan. There was significant difference between free-hand puncture and navigation-guided puncture. Conclusion: The surgView-RFT electromagnetic navigation system is characteristic with high performance, high accuracy and minimal invasion, while it is applied in training or clinical using.

For advanced pulmonary metastases or melanoma, radiotherapy combined with immune checkpoint inhibitor can block the immunosuppression pathway, enhance the antitumor immune response, and significantly improve survival. Stereotactic body radiation therapy ( SBRT ) delivers a large dose of radiation to the tumor target with high precision while sparing irradiation of the surrounding normal tissues. It is suggested that SBRT could be the most appropriate radiotherapy modality to be combined with immunotherapy since it induces the expression of a series of cytokines and immune molecules and is more likely to cause intense immune response and exert an abscopal effect than conventional radiotherapy. Previous studies have explored that total dose and fractionation seem to be important parameters for determining the immune response;the timing of radiation with immunotherapy significantly influences the outcome, and tumor infiltrating lymphocytes, the expression level of programmed death-ligand 1, and mismatch repair defect may be important predicators of the outcome. With appropriate radiotherapy dose and fractionation, the optimal timing of radiation with immunotherapy, and effective predictive markers, a combination of SBRT and immunotherapy may eliminate advanced malignancies while activating the systemic immune response to exert an abscopal effect.

Objective To evaluate the effects of enteral immunonutrition on cell immunity level and clinical efficacy in patients with severe tuberculosis. Methods Sixty patients with severe tuberculosis were admitted to the department of tuberculosis intensive care unit of Hangzhou Red Cross Hospital from June 2015 to June 2017, and they were randomly divided into a conventional enteral nutrition group (EN group) and a enteral immunonutrition group (EIN group), each group 30 cases. Based on the patients' gastrointestinal tolerance condition, the EN group was treated with therapies of normal nutrition support, anti-tuberculosis, anti-infection, etc.; the EIN group was treated with enteral immunonutrition (TPF-T), and simultaneously with anti-tuberculosis, anti-infection, etc. therapies according to the disease situation. The target energy maintained at 104.6 kJ·d-1·kg-1and the therapeutic course was 14 days in the two groups. The levels of interleukins (IL-6, IL-10) and interferon-γ (IFN-γ), white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT), cell immune indexes (T cell subgroup CD4+, CD8+) were observed before treatment and on day 14 after treatment in the patients of two groups; the changes of acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score before treatment and after treatment and 28-day mortality rate were recorded in the two groups. Results After treatment, the levels of WBC, CRP, PCT were obviously lower than those before treatment, while the levels of IL-6, IFN-γ, CD4+in the two groups were significantly higher than those before treatment, and the changes of the EIN group were more significant than those in the EN group [WBC (×109/L): 8.0±3.1 vs. 10.0±2.4, CRP (mg/L): 30.3±9.1 vs. 45.8±6.6, PCT (μg/L): 2.2±1.8 vs. 4.3±2.2, IL-6 (mg/L): 182.53±8.52 vs. 168.42±7.62, IFN-γ (mg/L): 32.52±3.5 vs. 25.41±2.6, CD4+: 0.56±0.06 vs. 0.45±0.08, all P < 0.05]. The level of CD8+after treatment in the two groups was higher than that before treatment (the EN group: 0.28±0.06 vs. 0.27±0.07, the EIN group: 0.27±0.08 vs. 0.26±0.09), the APACHE Ⅱ scores in the two groups were lower than those before treatment (the EN group: 11±6 vs. 18±4, the EIN group: 10±3 vs. 17±6), the 28-day mortality in the EIN group was lower than that in the EN group [13.3% (4/30) vs. 16.7% (5/30)], no statistical significant difference in CD8+, APACHE Ⅱscore, 28-day mortality between the two groups being found (all P > 0.05). Conclusion Enteral immunonutrition can improve the level of cell immunity and decrease the degree of inflammatory response, and increase the clinical curative effect in patients with severe tuberculosis.