OBJECTIVETo evaluate the consistency between the clinical diagnostic criteria and the ascertained diagnostic criteria for diabetic peripheral neuropathy (DPN) in the Preventive and Treatment Guidelines of Diabetes in China (2013) and explore an economic, convenient, and accurate approach to DPN diagnosis.

METHODSThe patients with type 2 diabetes admitted in our department from April to June, 2014 were examined for nerve conduction velocity, 10 g nylon silk, vibration threshold value, sense of temperature and pain, and ankle reflex. The sensitivity, specificity, positive predictive value, negative predictive value, Youden index, and Kappa value were calculated to assess the diagnostic power of the two diagnostic criteria.

RESULTSOf the 151 patients enrolled, 106 (70.2%) had a diagnosis of DPN consistent with the ascertained diagnostic criteria, as compared to 86 (56.95%) who were diagnosed according to the clinical diagnostic criteria; the latter patients accounted for 81.13% of former cases. The sensitivity, specificity, positive predictive value, negative predictive value, Youden index, and Kappa value of the clinical diagnostic criteria were 80.19%, 97.78%, 98.84%, 67.69%, 77.97%, and 0.69, respectively, which were highly consistent with those of the ascertained diagnostic criteria; the sensitivity to compression showed a poor consistency between the two diagnostic criteria. In the 5 screening tests, the combined test of temperature sensation, vibration perception, and ankle reflex showed the highest AUC value among their different combinations.

CONCLUSIONThe clinical diagnostic criteria for DPN show good consistency with the ascertained diagnostic criteria, and for patients with clinical symptoms or with only one positive sign, combination of the two diagnostic criteria can achieve the maximum diagnostic power.

China ; Diabetes Mellitus, Type 2 ; Diabetic Neuropathies ; diagnosis ; Humans ; Neurologic Examination ; methods ; Predictive Value of Tests ; Sensitivity and Specificity

AIM: To study the clinical effects and safety of iontophoresis of xueshuantong injection combined with anti-vascular endothelial growth factor(VEGF)in the treatment of retinal vein occlusion(RVO)with macular edema(ME).

METHODS: Totally 106 patients(106 eyes)with RVO and ME in the hospital between June 2017 and June 2019 were divided into observation group and control group according to the random number table method with 53 cases(53 eyes)in each group, and they were all given intravitreal injection of conbercept, and observation group was additionally given iontophoresis of Xueshuantong injection for intervention, and they were treated for 3mo. Both groups were followed up for 1a and given supplementary therapy according to the condition of the disease. The best corrected visual acuity(BCVA), central retinal thickness(CRT)in macular area, supplementary therapy status, VEGF level in aqueous humor and adverse drug reactions were observed and compared between the two groups before and after treatment.

RESULTS: After treatment, the BCVA of the two groups was significantly improved(P<0.05)while the CRT in macular area was significantly thinned(P<0.05), and the BCVA on the 3, 6 and 12mo of treatment in observation group was better than that in control group while the CRT was thinner than that in control group(P<0.05). The macular volume and VEGF level in aqueous humor were significantly reduced in the two groups after treatment(P<0.05), and the macular volume and VEGF level on the 1, 3, 6 and 12mo of treatment in observation group were lower than those in control group(P<0.05). The injection frequencies of conbercept and triamcinolone acetonide and the proportion of patients with laser photocoagulation in observation group were lower than those in control group(P<0.05). During treatment, there was 1 eye of intraocular pressure increase and 3 eyes of subconjunctival hemorrhage in observation group, and there were 2 eyes of subconjunctival hemorrhage and 1 eye of endophthalmitis in control group(P>0.05).

CONCLUSION: Xueshuantong iontophoresis combined with intravitreal injection of conbercept for RVO with ME can effectively inhibit the expression of VEGF, reduce the ME and improve the visual acuity of the affected eyes. The efficacy and safety are worthy of recognition.

【Objective】 To investigate the resource allocation status of blood testing laboratories in 14 blood stations in Gansu Province, explore the impact of differences in basic conditions on the comprehensive testing ability of laboratories, so as to promote the homogenization and standardization of blood screening capacity in blood stations in Gansu and improve blood safety and effectivenes. 【Methods】 An evaluation index system of laboratory resource allocation was constructed and a question-naire was designed. The data of human resources, infrastructure and key equipment of 14 blood stations were collected. The entropy weight -TOPSIS method was used to evaluate and rank the resource allocation of 14 blood stations. 【Results】 In the comprehensive evaluation of blood testing laboratory resource allocation in 14 blood stations in Gansu, the top three were laboratories A, B and I, and the last three were laboratories G, M and J. On the whole, the main issue was unreasonable structure of human resources: most laboratories had unreasonable age structure; except for Laboratory A, there was no personnel with bachelor's degree or above in laboratories; most laboratories had not established a team with intermediate professional titles. In terms of infrastructure, the size of seven laboratories could not meet the needs of modern laboratory testing, and all eight blood stations had no spare nucleic acid laboratories nor a mutual spare laboratory with other blood stations As for the key equipment, 5 laboratories had no automatic blood grouping diagnostic instrument, 5 laboratories only had one set of enzyme immunoassay detection system, 3 laboratories had no spare equipment for the key equipment, which means if the equipment failure could not be repaired in time, the release of results would be affected. 【Conclusion】 There were significant differences in human resources, infrastructure and key equipment of blood testing laboratories in 14 blood stations in Gansu, which had a great impact on laboratory testing capacity and subsequent development. It is suggested that governments at all levels and health administrative departments optimize the input of laboratory resource allocation according to the blood collection volume of blood stations to gradually narrow the differences in resource distribution between different regions, improve the degree of laboratory automation and optimize the personnel structure, so as to build high-quality and efficient blood testing laboratories and ensure the safety of clinical blood use.

OBJECTIVE To establish a method for simultaneous determination of the contents of 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material and its formulations. METHODS GC-MS/MS was adopted to determine 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material， Losartan potassium tablet， Losartan potassium capsule and Losartan potassium hydrochlorothiazide tablets， such as N-nitrosodimethylamine （NDMA）， N-nitrosodiethylamine （NDEA）， N-ethyl-N-nitroso-2-propanamine （NEiPA）， N-nitrosodiisopropylamine （NDiPA）， N-nitrosodipropylamine （NDPA） and N-nitrosodibutylamine （NDBA）. The separation was performed on SHIMADZU SH-L-17Sil MS capillary column by temperature- programmed GC， with injector temperature of 250 ℃ ， sample size of 1 μL， carrier gas of helium， and carrier flow rate of 1 mL/min. Electron ionization and multiple reaction monitoring （MRM） data acquisition mode were used， with an ion source temperature of 250 ℃ and solvent delay time of 3.1 min. RESULTS The separation among NDMA， NDEA， NEiPA， NDiPA， NDPA， NDBA and adjacent chromatographic peaks was good， and the separation rate was higher than 3.8； the linear ranges of them were 4.9-486.0， 4.9-488.5， 4.5-451.5， 6.8-683.5， 5.2-525.0 and 5.2-520.0 ng/mL（all r≥0.999 8）. The limits of quantitation were 4.86， 4.88， 4.52， 6.84， 5.25 and 5.20 ng/mL； the limits of detection were 0.97， 0.98， 0.90， 1.37， 1.05 and 1.04 ng/mL. RSDs of repeatability tests were 2.2%-5.6%（n＝6）， those of precision tests were 0.5%-1.4%（n＝6）， and those of stability tests were 1.5%-3.4%（n＝5）， respectively. Average recoveries of low-， medium- and high-concentration solution were 83.4%-103.0% （RSDs were 1.2%-6.3%， n＝3）， respectively. No one among the 6 kinds of N-nitrosamines genotoxic impurities was detected in both losartan potassium raw material and formulations. CONCLUSIONS The method is good in separation effect， highly accurate， sensitive and simple. It can be used in the determination of the 6 kinds of N-nitrosamines genotoxic impurities.