Objective:To establish a TAL gel-clot bacterial endotoxin test for aluminum hydroxide adjuvant.Methods:According to the bacterial endotoxin test in general chapter 1143 of the Chinese Pharmacopoeia 2020,pre-interference test was performed using 3 types of buffer solutions and Ca-Mg additive by orthogonal design.The interference test and sample preparation validation were carried out using different batches of aluminum hydroxide adjuvant from 2 TAL manufacturers.Results:No interference was obtained through pre-interference test.Under the validated conditions,aluminum hydroxide adjuvant combined with phosphate buffered saline and Ca-Mg additive was employed to remove interference in bacteria endotoxin test.Conclusion:The established TAL gel-clot method is applicable to bacterial endotoxin test for aluminum hydroxide adjuvant.

Objective To investigate the effects of abdominal massage combined with electroacupuncture point-through-point method on the expressions of circadian clock genes of Clock,BMAL1,PER1 and neurotransmitters contents of ACh and Glu in insomnia rats and its possible mechanism.Methods Totally 50 SD male rats were randomly divided into normal group,model group,abdominal massage group,electroacupuncture point-through-point group and combination group,with 10 rats in each group.Except for the normal group,an insomnia rat model was established by intraperitoneal injection of p-chlorophenylalanine.Abdominal massage group received abdominal massage;electroacupuncture point-through-point group was treated with flat acupuncture,"Baihui"through"Shenting","Sanyinjiao"through"Yinlingquan"(bilateral),"Shenmen"through"Neiguan"(bilateral),the electroacupuncture instrument dilatational wave,frequency of 1 Hz/20 Hz was connected;the combination group was treated with electroacupuncture through acupoints after abdominal massage;1 time/d for each treatment group,a total of 7 days.The normal group and model group were not intervened.HE staining was used to observe the pathological changes of neurons in hypothalamic tissue,the expression of Clock,BMAL1 and PER1 mRNA were detected by RT-qPCR,the expressions of Clock,BMAL1 and PER1 in hypothalamic tissue were detected by immunohistochemical staining,the expression of Clock,BMAL1 and PER1 protein in hypothalamic tissue were detected by Western blot,the contents of ACh and Glu in serum were detected by ELISA.Results Compared with the normal group,the model group rats had a longer sleep latency,shorter sleep duration,severe damage to the cellular structure of the hypothalamic tissue,and a vacuolar like change,with a decrease in the number of neuronal cells,the expressions of Clock and BMAL1 mRNA and protein in hypothalamic tissue increased,while the expressions of PER1 mRNA and protein decreased;the contents of serum ACh and Glu increased,with statistical significance(P<0.05).Compared with the model group,the abdominal massage group,electroacupuncture point-through-point group,and combination group could all shorten the sleep latency,prolong sleep duration,and improve the morphology of hypothalamic neurons,reduce the expressions of Clock and BMAL1 mRNA and protein in hypothalamic tissue,up-regulate the expressions of PER1 mRNA and protein,and reduce the contents of serum ACh and Glu,with statistical significance(P<0.05),the combination group showed the most obvious effects(P<0.05).Conclusion Abdominal massage combined with electroacupuncture point-through-point method can improve insomnia.Its mechanism may be related to the regulation of circadian clock genes Clock,BMAL1,PER1 mRNA and protein expression,as well as neurotransmitter content.

ObjectiveTo observe the therapeutic effect of Wang's Yijing decoction combined with conventional therapy on the treatment of polycystic ovary syndrome （PCOS） with kidney deficiency and phlegm-dampness syndrome and its regulating effect on the intestine-brain axis. MethodThe 132 patients from the gynecological clinic of Shanxi Bethune Hospital were randomly assigned into a control group and an observation group， with 66 patients in each group. The patients in the control group were treated with drospirenone and ethinylestradiol tablets and metformin tablets， and those in the observation group were administrated with Wang's Yijing decoction on the basis of the therapy in the control group. The treatment in both groups lasted for 3 menstrual cycles. The changes in menstrual blood volume， color， and texture， as well as that in the menstrual cycle before and after treatment were scored. Further， the Rosenfield， hirsutism， and kidney deficiency and phlegm-dampness syndrome were scored before and after treatment. Pelvic ultrasound was performed before and after treatment to compare the bilateral ovarian volume. The levels of anti-mullerian hormone （AMH）， estradiol （E₂）， luteinizing hormone （LH）， follicle-stimulating hormone （FSH）， testosterone （T）， dihydrotestosterone （DHT）， and sex hormone-binding globulin （SHBG） were measured before and after treatment， and the free androgen index （FAI） was calculated. After the fasting insulin and fasting blood glucose were examined before and after treatment， the homeostatic model assessment of insulin resistance （HOMA-IR） was calculated. The levels of ghrelin， glucagon-like peptide-1 （GLP-1）， peptide tyrosine-tyrosine （PYY） in serum and short-chain fatty acids （SCFAs） in fresh stool were measured before and after treatment. ResultThe treatments in both groups lowered the scores of irregular menstruation， Rosenfield， hirsutism， and kidney deficiency and phlegm-dampness syndrome （P<0.01）， and the scores in the observation group were lower than those in the control group （P<0.01）. After treatment， the T， DHT， FAI， AMH， E₂， LH， and FSH levels lowered （P<0.01）， while the SHBG level elevated （P<0.01）. In addition， the AMH， E₂， LH， T， DHT， and FAI in the observation group were lower than those in control group， while the SHBG level presented an opposite trend （P<0.01）. After treatment， the bilateral ovarian volume and HOMA-IR of the two groups decreased （P<0.01）， and were lower in the observation group than in the control group （P<0.05， P<0.01）. The treatments in both groups elevated the levels of ghrelin， GLP-1， PYY， and SCFAs （P<0.01）， which were higher in the observation group than in the control group （P<0.01）. After treatment， the recovery rate in the observation group was 65.57% （40/61）， which was higher than 44.83% （26/58） in the control group （χ²=5.180， P<0.05）. ConclusionWang's Yijing decoction combined with conventional western medicine treatment can regulate the intestine-brain axis， endocrine and metabolic disorders， and sex hormones， adjust the menstrual cycle， and alleviate clinical symptoms， demonstrating good clinical effect for the PCOS patients with kidney deficiency and phlegm dampness syndrome.

Objective To investigate the effect of blood pressure variability on early neurological deterioration (END) in patients with acute minor stroke or high-risk transient ischemic attack (TIA).Methods Consecutive patients with acute minor stroke or high-risk TIA admitted to the Department of Neurology, the Affiliated Hospital of Yangzhou University between March 2017 and December 2018 were enrolled prospectively. Minor stroke was defined as the National Institutes of Health Stroke Scale (NIHSS)score ≤3, and high-risk TIA was defined as ABCD2 score ≥4. The blood pressure monitored within 72 h after admission was analyzed. The mean, maximum (max), range (max-min), standard deviation (SD), and coefficient of variation (CV) of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were calculated. END was defined as highest NIHSS score increase ≥ 2 at re-evaluation within 72 h after admission compared with the baseline score. Multivariate logistic regression analysis was used to determine the independent correlation between blood pressure variability parameters and END. Results A total of 123 patients were enrolled in the study, including 54 females (43. 90％) and 69 males (56. 10％), aged (63. 74 ± 11. 94) years. Thirty-nine (31. 71％) of them were high-risk TIA, 84 (68. 29％) were minor strokes. END occurred in 33 patients (26. 8％) within 72 h on admission. Univariate analysis showed that there were significant differences in age, gender, white blood cell count, C-reactive protein, and SBPmax-min , SBPSD ,SBPCV, DBPmax-min , DBPSD , and DBPCV between the END group and the non-END group (all P < 0. 05).Multivariate logistic regression analysis showed that after adjusting for confounding factors, SBPmax-min (odds ratio [OR] 1. 019, 95％ confidence interval [CI] 1. 001-1. 038), SBPSD (OR 1. 099, 95％ CI 1. 005-1. 201),SBPCV(OR 1. 320, 95％ CI 1. 124-1. 550), DBPmax-min (OR 1. 065, 95％ CI 1. 017-1. 114), DBPSD (OR 1. 492,95％ CI 1. 186-1. 877), and DBPCV(OR 1. 543, 95％ CI 1. 263-1. 886) were the independent risk factors for END within 72 h on admission in patients with acute minor stroke or high-risk TIA. Conclusion Multiple blood pressure variability parameters are significantly independently correlated with the risk of END in patients with acute minor stroke or high-risk TIA.

Objective: To explore the relationships of neutrophil gelatinase-associated lipocalin (NGAL) with severity of skin lesions in children with psoriasis and peripheral neutrophil count, and to evaluate in vitro effect of NGAL on expression of tumor necrosis factor-α (TNF-α) and interleukin-22 (IL-22) by a human immortalized keratinocyte cell line HaCaT. Methods: From January 1st 2017 to December 31st 2018, 98 children who newly developed psoriasis were enrolled from Department of Dermatology of 6 hospitals in China, including 51 males and 47 females. Their age was 7.00 ± 2.99 years (range: 3-14 years) , and their course of disease was 7.4 ± 5.85 days (range: 3-28 days) . The serum level of NGAL was detected in all the patients before and two weeks after treatment, and the relationships of NGAL with psoriasis area and severity index (PASI) scores and peripheral neutrophil count were evaluated. Western blot analysis and reverse-transcription (RT) -PCR were performed to determine the protein and mRNA expression of TNF-α and IL-22 in HaCaT cells, respectively, after 12-hour treatment with NGAL at concentrations of 0 (control group) , 0.125, 0.25, 0.5, 1 mg/L. Statistical analysis was carried out with SPSS 16 software. by using t test and one-way analysis of variance. Results: After 2-week treatment, the PASI score, neutrophil count and NGAL level in children with psoriasis significantly decreased (1.80 ± 1.19, [6.16 ± 0.76] × 10⁹/L, 90.86 ± 0.75 μg/L, respectively) compared with those before the treatment (10.38 ± 3.42, [11.01 ± 2.85] × 10⁹/L, 113.48 ± 21.26 μg/L, respectively; t = 31.42, 18.34, 16.37 respectively, all P < 0.001) . Before the treatment, the serum level of NGAL in the patients was positively correlated with the PASI score and peripheral neutrophil count (r = 0.918, 0.799 respectively, both P < 0.05) . The mRNA and protein expression of IL-22 in HaCaT cells significantly differed among these groups treated with different concentrations of NGAL (F = 176.31, 296.96 respectively, both P < 0.001) , so did the mRNA and protein expression of TNF-α (F = 193.28, 318.80 respectively, both P < 0.001) . Additionally, the protein and mRNA expression of IL-22 and TNF-α in HaCaT cells was significantly higher in the 0.125-, 0.25-, 0.5- and 1-mg/L NGAL group than in the control group (all P < 0.05) . The NGAL level was positively correlated with the protein and mRNA expression of TNF-α and IL-22 in HaCaT cells (all P < 0.05) . Conclusions The serum level of NGAL was high in children with psoriasis, and positively correlated with severity of skin lesions and peripheral neutrophil count. NGAL can upregulate the expression of TNF-α and IL-22 in HaCaT cells in vitro.

Objective To investigate the correlation between blood pressure variability (BPV) and early neurological deterioration (END) in patients with acute anterior circulation large artery atherosclerotic (LAA)stroke. Methods From January 2015 to June 2018, consecutive patients with anterior circulation acute ischemic stroke admitted to the Department of Neurology, the Affiliated Hospital of Yangzhou University were enrolled prospectively. According to the etiological classification, they were divided into LAA group and non-LAA group. By monitoring the blood pressure within 72 h of hospitalization, the mean, maximum (max)and minimum (min) values, and the difference between max and min (max-min), standard deviation (SD),and coefficient of variation (CV; CV = SD × 100/mean) were calculated. END was defined as the highest score of the National Institutes of Health Stroke Scale (NIHSS) within 72 h of admission increased by ≥2than the baseline. Multivariate logistic regression analysis was used to determine the correlation between BPV parameters and END. Results A total of 271 patients with anterior circulation acute ischemic stroke were enrolled, including 101 females (37. 3％) and 170 males (62. 7％), with an average age of 64. 99 ± 11. 51 years. There were 95 patients (35. 1％) with LAA and 176 (64. 9％) with non-LAA. In the LAA group and non-LAA group, 36 patients (37.9％) and 50 patients (28.4％) developed END respectively. The comparison between END patients and non-END patients in the LAA group showed that there were significant differences in age, sex, diabetes mellitus, baseline NIHSS score and C-reactive protein, as well as SBPmax , SBPmax-min , SBPSD , SBPCV, DBPmax , DBPmax-min , DBPSD , and DBPCV in BPV indices (all P < 0. 05).Multivariate logistic regression analysis showed that many BPV indices were the independent risk factors for END, including SBPmax (odds ratio [OR] 1. 027, 95％ confidence interval [CI] 1. 003-1. 052; P = 0. 027),SBPmax-min (OR 1. 041, 95％CI 1. 015-1. 068; P = 0. 002), SBPSD (OR 1. 177, 95％ CI 1. 048-1. 322; P =0. 006), SBPCV (OR 1. 226, 95％ CI 1. 036-1.451; P = 0. 018), DBPmax (OR 1. 073, 95％ CI 1. 017-1. 133;P = 0. 010), DBPmax-min (OR 1. 107, 95％CI 1. 044-1. 174; P = 0. 001), DBPSD (OR 1. 693, 95％CI 1. 268- 2. 260; P < 0. 001), and DBPCV(OR 1. 726, 95％CI 1. 311-2. 271; P < 0. 001). In the non-LAA group, there were no significant association between all BPV parameters and the occurrence of END. Conclusion BPV was significantly correlated with END in patients with anterior circulation LAA.

Objective To study the clinical value of esophageal stent placement with radiation therapy for the middle-late pa-tients with esophageal cancer.Methods To perform esophageal stent placement and radiation therapy for the middle-late 35 pa-tients,and to perform radiation therapy for the middle-late 37 patients,then observe the clinical curative effects.Results The treat-ment group were significantly alleviated with dysphagia symptom after operation,which 32 cases sticked the entire radiation,ac-counting for 91.4%,no one can′t complete the treatment because of nutritional status reason.Survival time of one month after ra-diotherapy was up to 100.0%,and survival time of six months was 85.7% (30/35).But the contrast group with dysphagia symp-tom were aggravated or no relief,and needed parenteral nutrition.There were 23 cases to complete the entire radiation,accounting for 62.2%,and 5 cases happened esophageal tracheal fistula.Survival time of one month after radiotherapy was 83.8%(31/37),and survival time of six months was 62.2% (23/37).Two groups of cases in radiotherapy resistance difference was statistically signifi-cant,one month and six months of survival time were statistically significant (all P <0.05 ).Conclusion Esophageal stent place-ment with radiotherapy is more efficient than only radiation therapy to the middle-late patients with esophageal cancer.

Objective To explore the effect of quality control circle activities in correctly rate of intravenous fluid storage .Methods Six nurses from cardiovascular surgery ICU volunteered to form a “circle”and established the activities theme of “improving correctly rate of intravenous fluid storage”.The reason of low correctly rate in intravenous fluid storage was found and analyzed , then, the rectification measures were formed and implemented.Results The correctly rate of intravenous fluid storage was 82.35%after the quality control circle activities and 17.65%before the intervention , which was increased 64.70%.The application of quality control circle, team spirit, professional knowledge , problem solving skills and nursing quality after the quality control circle activities were significantly improved compared than before ( t =11.612,2.561,2.719,7.694, 7.478, respectively;P<0.05).Conclusions The quality control circle activities can not only improve the correctly rate of intravenous fluid storage , but also can improve the team spirit and quality management .

Objective To explore the application effects of the quality control circle activities in improving the qualified rate of venous blood specimens.Methods We imported the concept of quality control circle (QCC),found the QCC group,designed the questionnaire of specimen inspection,analyzed the cause of the unqualified samples,formulated and implemented the improvement measures.Results The qualified rate of venous blood specimens was increased from 90.33％ to 97.16％.The process of the venous blood specimen collection was standardized.The ability of nurses on finding and solving the problems was enhanced.The nurses who joined the QCC group were investigated by the questionnaire with 6 questions,which scored from 1 to 6 points.The team spirit,working passion,responsibility and honor,QCC method,creativity and the ability of self-presentation were improved significantlyafter applying QCC.Conclusions The QCC activities have made significant effect in improving the qualified rate of venous blood specimen.The venous blood specimen collection process has further standardized,and the ability of nursesis also improved.

To explore the influencing factors of major birth defects.The children of 0 -3 years and their mother from six different districts were surveyed from November 2009 to December 2009.The incidence rate was 134.27/10 000 (493/36 716)in 6 counties. And the first five birth defects were as follows:congenital heart disease,neural tube defects,cheilopalatognathus,polydactylia and hypophrenia.The risks and protective factors of the first 5 birth defects were different.Anamnesis of birth defects and defective children from relatives,multiple pregnancy & birth and intake of antipyretic analgesics during pregnancy were the common risk factor for the first 5 birth defects.The key points for the prevention of birth defects are to reinforce the pre-pregnancy guidance,the screening and evaluation of risk factors and disease prevention during pregnancy.