OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

Objective This study investigated the epidemic characteristics and spatio-temporal dynamics of hemorrhagic fever with renal syndrome (HFRS) in Qingdao City,China. Methods Information was collected on HFRS cases in Qingdao City from 2010 to 2022. Descriptive epidemiologic,seasonal decomposition,spatial autocorrelation,and spatio-temporal cluster analyses were performed. Results A total of 2,220 patients with HFRS were reported over the study period,with an average annual incidence of 1.89/100,000 and a case fatality rate of 2.52％. The male:female ratio was 2.8:1. 75.3％ of patients were aged between 16 and 60 years old,75.3％ of patients were farmers,and 11.6％ had both "three red" and "three pain" symptoms. The HFRS epidemic showed two-peak seasonality:the primary fall-winter peak and the minor spring peak. The HFRS epidemic presented highly spatially heterogeneous,street/township-level hot spots that were mostly distributed in Huangdao,Pingdu,and Jiaozhou. The spatio-temporal cluster analysis revealed three cluster areas in Qingdao City that were located in the south of Huangdao District during the fall-winter peak. Conclusion The distribution of HFRS in Qingdao exhibited periodic,seasonal,and regional characteristics,with high spatial clustering heterogeneity. The typical symptoms of "three red" and"three pain" in patients with HFRS were not obvious.

【Objective】 To analyze the effects of different fortified feeding methods on nutritional metabolism and growth rate of preterm very low birth weight infants (VLBWI), in order to provide new clues for improving the prognosis of the preterm infants. 【Methods】 A total of 115 cases of premature VLBWI admitted to Department of Neonatology, The First Affiliated Hospital of Kunming Medical University from January 2019 to December 2020 were included in this study, and were divided into fortified breastfeeding group (HFM group), mixed feeding group, and premature formula feeding group (PF group) based on their feeding methods. The effects of different feeding methods on the nutritional metabolism and growth rate of premature VLBWI were analyzed. 【Results】 1) The hospitalization time of infants in the HFM group was shorter than that in PF group and mixed feeding group (t=7.185, 6.924, P<0.05). 2) The proportion of necrotizing enterocolitis (NEC) in the HFM group during hospitalization was lower than that in the PF group (P<0.05); the proportions of late onset septicemia(LOS) and extra uterine growth restriction(EUGR) in the HFM group during hospitalization were lower than those in the PF group (χ²=5.030, 4.147, P<0.05); the proportion of LOS was lower than that of the mixed feeding group(χ²=6.589, P<0.05). 3) During hospitalization, the proportions of abdominal distension, bloody stools and increased eosinophils in the HFM group were lower than those in the PF group (P<0.05), which in mixed feeding group was lower than those in PF group (Fisher exact test, P<0.05). 4) At discharge, the weight and length growth rate of the HFM group were higher than those of the mixed feeding group (t=3.722, 0.425, P<0.001) and the PF group (t =6.015, 0.496, P< 0.001). 【Conclusion】 Fortified breastfeeding can more effectively increase the growth rate of VLBWI in premature infants, improve nutritional metabolism, reduce complications and adverse feeding reactions related to premature infants, and is safer and more effective.

Objective:To investigate the relationship between serum thyroid hormone levels in the normal range and body weight, blood glucose, blood lipids, and other obesity-related indexes in patients with type 2 diabetes mellitus.Methods:Seventy obese patients with type 2 diabetes mellitus and ninety-two patients with type 2 diabetes mellitus with normal weight who were treated in the Nangang Branch of Heilongjiang Provincial Hospital from May 2020 to May 2021 were included in this study. Thyroid-stimulating hormone level was in the normal range (0.35-4.94 mU/L) in all participants. Serum levels of free triiodothyronine, free thyroxine, thyroid-stimulating hormone, thyroid peroxidase antibody, thyroglobulin antibody, triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, fasting blood glucose, glycosylated hemoglobin, fasting C peptide, fasting insulin, systolic blood pressure, diastolic blood pressure, and serum uric acid were measured in all participants.Results:Free triiodothyronine level was positively correlated with fasting blood glucose and glycosylated hemoglobin levels ( r = 0.19, P = 0.021; r = 0.21, P = 0.017). Free thyroxine level was positively correlated with serum glycosylated hemoglobin level ( r = 0.25, P = 0.009) and negatively correlated with total cholesterol ( r = -0.17, P = 0.029). Thyroid-stimulating hormone level was positively correlated with body mass index as well as total cholesterol and low-density lipoprotein cholesterol levels ( r = 0.33, P < 0.001; r = 0.33, P < 0.001; r = 0.32, P < 0.001). Conclusion:Thyroid hormones in the normal range play an important role in the regulation of body weight, blood glucose, and blood lipids in patients with type 2 diabetes mellitus. Blood glucose level increases markedly in patients with relatively high free triiodothyronine and free thyroxine levels. The risks of obesity and dyslipidemia increase in patients with relatively high serum thyroid-stimulating hormone levels

OBJECTIVE To develop a whole-process intelligent model of pharmaceutical care for peritoneal dialysis （PD） patients， and to provide a reference for clinical pharmacists to provide standardized PD pharmaceutical care. METHODS The pharmaceutical care mode of PD patients at home and abroad was investigated and analyzed. Based on the actual situation of the First Affiliated Hospital of Soochow University （hereinafter referred to as “our hospital”）， with “home→PD center outpatient→ inpatient department” as the main node， the recycling process of medication reconciliation was optimized. The whole-process intelligent pharmaceutical care model of PD was illustrated by improving the Chinese version of the drug-related problems （DRPs） classification tool， developing the corresponding pharmaceutical care process， and presenting specific cases. RESULTS Based on the medication therapy management （MTM） platform， our hospital had built a closed-loop PD whole-process intelligent pharmaceutical care model of “in-hospital pharmaceutical care （building document）-PD outpatient MTM-home pharmaceutical care （online App management）”. A “double cycle” workflow of “admission→discharge→outpatient” medication reconciliation cycle and “discovery-analysis-intervention-follow-up-record-evaluation” DRPs cycle was formed. CONCLUSIONS The establishment of the whole-process intelligent pharmaceutical care model for PD in our hospital provides experience for standardizing pharmaceutical care for PD patients， and can reduce DRPs.

OBJECTIVES: Patients from different social environments and cultural backgrounds have different nursing needs. If nurses ignore the cultural differences of patients, it is easy to lead to the strained nurse-patient relationship, affect the nursing effect and cause harm to patients. Critical cultural competence (CCC) can help nurses to meet the nursing needs of patients from different cultural backgrounds, which is beneficial to building a harmonious nurse-patient relationship and improving the quality of nursing. Almutairi, et al designed the Critical Cultural Competence Scale (CCCS) which can be used to evaluate accurately nurses' CCC. No studies have reported the development of a critical cultural competence measurement tool for nurses or the introduction of foreign scales in China. This study aims to conduct Chinese and cross-cultural debugging and test the reliability of the English version of the CCCS in order to form CCCS suitable for Chinese cultural background and provide an effective evaluation tool for investigating the current situation of clinical nurses' CCC. METHODS: This study used Brislin's back-translation model to translate and back-translation the English version of CCCS. The Chinese version of CCCS was then created through cross-cultural debugging by expert consultation and a pre-survey with a sample size of 30 clinical nurses. From August to October 2019, 580 clinical nurses were surveyed using a whole group sampling method. The participants were randomly divided into 2 groups with a 7꞉3 ratio. One group (n=406) was used for exploratory factor analysis and reliability analysis, while the other group (n=174) was used for confirmatory factor analysis. Six experts used the scale-level content validity index (S-CVI) and the item-level content validity index (I-CVI) to assess content validity. In the exploratory factor analysis, items were screened using the critical ratio method, and were tested using the KMO (Kalser-Meyer-Olkin) index, Bartlett's sphericity test, and principal component analysis. In the confirmatory factor analysis, average variance extracted (AVE), goodness of fit index (GFI), adjusted goodness of fit index (AGFI), and root mean square error of approximation (RMSEA) were used to assess the degree of fit of the constructed model. For the total scale and the 4 subscales, the Cronbach's α coefficient, split-half reliability, and retest reliability were used to assess the scale's reliability. RESULTS: The S-CVI was 0.930, while the I-CVI ranged from 0.833 to 0.944. For all items, the critical ratio exceeded 3, and the difference between the high and low subgroups was statistically significant (P<0.05). Exploratory factor analysis revealed critical knowledge subscale had a KMO value of 0.676, with the total scale and other 3 subscales all having a KMO value >0.8 and a chi-square value of 814.32 to 12 442.45 for the Bartlett's spherical test, with degree of freedom ranging from 21 to 136 (P<0.001), indicating that all items were suitable for factor analysis. The principal component analysis showed that 17, 12, 7, and 7 items were extracted from the 4 subscales, with 4, 3, 2, and 2 components whose eigenvalues were more than 1, and the cumulative variance contribution was 66.0%, 54.3%, 56.6%, and 70.2%, respectively. The confirmatory factor analysis showed that the AVE of the 4 subscales were 0.637, 0.499, 0.560, and 0.565, GFI was 0.904, AGFI was 0.863, and RMSEA was 0.076. The Cronbach's α coefficient for the total scale and subscales ranged from 0.811 to 0.878, the split-half reliability ranged from 0.707 to 0.842, and the retest reliability was 0.827. CONCLUSIONS The Chinese version of the CCCS has good reliability and validity, and it can be used as a valid assessment tool for clinical nurses' critical cultural competence in China.
Humans ; Cultural Competency ; Reproducibility of Results ; Psychometrics/methods* ; Factor Analysis, Statistical ; China

OBJECTIVETo assess the value of genetic testing for Fragile X syndrome (FXS).

METHODSA domestically made diagnostic kit based Tri-primer-PCR method was used to detect mutations of the FMR1 gene among 6 pedigrees with unexplained intellectual disability. The results were verified by methylation PCR and Southern blotting.

RESULTSPedigrees 1 and 6 were positive for the screening. In pedigree 1, a full-mutation allele with methylation was identified in the proband and his mother, which was passed on to the fetus. In pedigree 6, the proband was mosaic for a full-mutation allele and a pre-mutation allele. His sister was asymptomatic with a full-mutation. His mother carried pre-mutation allele, while his father and sister's baby were normal. The number of CGG repeats of the pedigrees 2 to 5 were in the normal range.

CONCLUSIONGenetic testing can provide an effective way to prevent FXS caused by FMR1 mutations and enable prenatal diagnosis for families with a high risk for the disease.

Objective To investigate the predictive effect of hypersensitive C-reactive protein(Hs-CRP)and neutrophil and lymphocyte ratio(NLR)on the prognosis in young patients with ischemic stroke. Methods From October 2016 to October 2017,110 consecutive young patients(18-45 years old)with ischemic stroke admitted to the Department of Neurology,Xuanwu Hospital,Capital Medical University were enrolled retrospectively. According to the modified Rankin scale(mRS)scores,they were divided into either a good prognosis group(mRS≤2;n=90)or a poor prognosis group(mRS>2;n=20).The patients completed the related examinations within 24 h after admission,including blood routine and Hs-CRP.The NLR value was calculated according to the count of neutrophils and lymphocyte in blood routine.The age,gender,underlying diseases(hypertension,diabetes,hyperlipidemia,hyperhomocysteinemia),histories of smoking and drinking,National Institutes of Health stroke scale(NIHSS)scores of both groups of patients were documented.The poor prognosis after discharge at 90 d was used as the dependent variable,the independent variables of P<0.05 in univariate analysis were further performed with multivariate logistic regression analysis.The receiver operating characteristic(ROC)curve was used to evaluate the sensitivity and specificity of the independent risk factors. The Youden index was calculated and the optimal cut-off value was determined. Results (1)Compared with the good prognosis group,the poor prognosis group had higher NIHSS score,NLR and Hs-CRP at admission.The differences between the 2 groups were statistically significant(9.0[4.5,13.0]vs.2.5[2.0,4.0],2.97[2.31,4.20]vs.2.13[1.76,2.70],4.65 [2.70,9.52]mg/L vs.2.06[0.87,4.54]mg/L;all P<0.05).There were no significant differences in other baseline data and clinical characteristics between the two groups(all P>0.05).(2)The results of the multivariate logistic regression analysis indicated that the high level of Hs-CRP(OR,1.086,95%CI 1.009-1.169)and higher NIHSS score(OR,1.487,95%CI 1.229-1.797)at admission were the independent risk factors for poor prognosis(all P < 0. 05),and there was no significant relation between NLR and prognosis(P>0.05).(3)The area under the ROC curve of the Hs-CRP levels at admission was 0.722(95%CI 0.591-0.853,P=0.002).When the predictive value of Hs-CRP level at admission was 3.365 mg/L,the maximum Youden index was 0.367,its corresponding sensitivity was 70.0%and specificity was 66.7%. Conclusions The higher Hs-CRP level and NIHSS score at admission may independently predict the poor prognosis of young patients with ischemic stroke at 90 d after discharge to a certain extent.It is not appropriate to use Hs-CRP≥3.365 mg/L alone for poor prognosis screening,but NLR may not be associated with the prognosis at admission.

OBJECTIVETo observe the differences in the clinical therapeutic effects on insomnia of spleen and stomach disharmony pattern in comparison of the combination of acupoint catgut-embedding therapy and auricular point pressure with the simple application of auricular point pressure.

METHODSOne hundred and eighty patients of insomnia of spleen and stomach disharmony pattern were randomized into an observation group (93 cases) and a control group (87 cases). In the observation group, the combination of acupoint catgut-embedding therapy and auricular point pressure was adopted. The acupoint catgut-embedding therapy was applied at Zhongwan (CV 12), Anmian (Extra), Xinshu (BL 15), Pishu (BL 20), Weishu (BL 21), Zusanli (ST 36), Yinlingquan (SP 9) and Sanyinjiao (SP 6), once every two weeks. The auricular point pressure was applied to Shenmen (TF), Pizhixia (AT), Xin (CO), Pi (CO), Wei (CO) on both sides alternatively, twice a week. The duration of treatment was 2 months for the two groups. In the control group, the auricular point pressure was simply used with the same points, manipulation and treatment duration as the observation group. After treatment, the clinical therapeutic effects were observed in the patients of the two groups. The Pittsburgh sleep quality index (PSQI) score was compared before and after treatment in the two groups. The recurrence was followed up in 3 months after the end of treatment.

RESULTSIt was observed that 2 cases were dropped out in the observation group, 4 cases in the control group. The dropped out cases were considered to be ineffective. After treatment, the total effective rate was 92.5% (86/93) in the observation group and was 80.5% (70/87) in the control group. The result in the observation group was better than that in the control group (<0.05). After treatment, PSQI scores were all reduced apparently in the two groups as compared with those before treatment (both<0.05). The score after treatment and the different value before and after treatment in the observation group were lower than those in the control group (both<0.05). In 3-month follow-up after treatment, the recurrence rate was 3.2% (3/93) in the observation group, which was lower than 13.8% (12/87) in the control group (<0.05).

CONCLUSIONIn the treatment of insomnia of spleen and stomach disharmony pattern, the acupoint catgut-embedding therapy combined with auricular point pressure are superior to the simple application of auricular point pressure in the clinical therapeutic effects, improving sleep quality and reducing the recurrence rate.

Objective To observe and compare the clinical efficacy of fire needling versus electroacupuncture in treating knee osteoarthritis of kidney and marrow deficiency type.Methods One hundred and ten patients with knee osteoarthritis of kidney and marrow deficiency type were randomly allocated to two groups, a fire needling group of 56 cases and an electroacupuncture group of 54 cases. The fire needling group received filiform needle acupuncture and fire needle pricking and the electroacupuncture group, electroacupuncture. Treatment was given once every other day, for a total of four weeks as one course. The Visual Analogue Scale (VAS) score and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score were recorded in the two groups before and after treatment. The clinical therapeutic effects were compared between the two groups.Results The VAS score and the WOMAC subscores significantly decreased in both groups after treatment compared with those before treatment (P<0.01). There were no statistically significant post-treatment differences in the VAS score and the WOMAC subscores between the two groups (P>0.05). The VAS score and the WOMAC subscores decreased further in both groups at four weeks after treatment compared with those at the end of treatment (P<0.01). In the electroacupuncture group, there were statistically significant differences in the VAS score and the WOMAC pain and stiffness subscores between eight weeks and four weeks after treatment (P<0.01) and in the WOMAC pain, stiffness and joint function subscores between at eight weeks after treatment and at the end of treatment (P<0.01). In the fire needling group, there were statistically significant differences in the VAS score and the WOMAC pain, stiffness and joint function subscores between at eight weeks after treatment and at the end of treatment (P<0.01). At four weeks after treatment, the VAS score and the WOMAC pain, stiffness and joint function subscores were significantly lower in the fire needling group than in the electroacupuncture group (P<0.05,P<0.01). At eight weeks after treatment, the VAS score and the WOMAC pain and stiffness subscores were still significantly lower in the fire needling group than in the electroacupuncture group (P<0.01). The total efficacy rate was 94.6% in the fire needling group and 90.7% in the electroacupuncture group; there was no statistically significant difference between the two groups (P>0.05).Conclusions Both filiform needle acupuncture plus fire needle pricking and electroacupuncture can markedly relieve the pain and stiffness and improve joint function in knee osteoarthritis of kidney and marrow deficiency type. Both have an equivalent short-term therapeutic effect. Filiform needle acupuncture plus fire needle pricking has a better long-term therapeutic effect than electroacupuncture.