Objective To retrieve and extract the best evidence for preventing intracranial infections related to ex-ternal cerebrospinal fluid(CSF)drainage,and provide evidence-based support for reducing the incidence of intracra-nial infection caused by external CSF drainage.Methods Evidence-based care issues were determined according to PIPOST,and the best evidence on intracranial infection related to external CSF drainage tube was retrieved from top to bottom.The literature retrieval period was 2013-2023.Quality control of the literatures,as well as extraction and summary of the evidence were carried out by 2 trained graduate students.Results A total of 17 literatures were included in the analysis,including 3 guidelines,5 expert consensus,8 systematic reviews,and 1 randomized con-trolled trial.Management strategies from 3 dimensions(pre-catheterization,in-catheterization and post-catheteriza-tion)were obtained,including 20 pieces of evidence for preventing intracranial infection,such as preparation for ex-ternal CSF drainage tube,precautions during catheterization,and post-catheterization disposal.Conclusion There are differences in the management of external CSF drainage tube in clinical practice.It is necessary to develop uni-fied,standardized,and rational bundle strategies to prevent intracranial infection,so as to reduce the incidence of catheter-related intracranial infection.

Objective:To assess the clinical effect and safety of comprehensive therapy of traditional Chinese medicine(TCM)in the treatment of erectile dysfunction(ED)with damp-heat stasis.Methods:We selected 108 cases of ED with damp-heat stasis meeting the inclusion criteria and treated with tadalafil(the control group,n=54)or tadalafil+comprehensive TCM therapy(the trial group,n=54)in the First Affiliated Hospital of Henan University of Chinese Medicine in the same period.After 8 weeks of treatment,we recorded the patients'scores on IIEF-5,TCM syndrome,erectile quality(EQS),9-Item Patient Health Questionnaire(PHQ-9)and Generalized Anxiety Scale 7(GAD-7).At 16 weeks of our study,we collected the efficacy parameters,safety indicators and adverse reactions by telephone follow-up and compared the data obtained between the two groups of patients.Results:Totally,103 of the patients completed the study,51 in the control and 52 in the trial group.Compared with the baseline,the IIEF-5 and EQS scores were both markedly increased after 8 weeks of treatment in the trial group(12.35±3.00 vs 18.36±2.82,P＜0.05;39.5[30.25-43]vs 67.5[54.5-76.75],P＜0.05)and the control(11.96±2.79 vs 15.88±3.86,P＜0.05;38.0[29-42]vs 56[49-64],P＜0.05),even more significantly in the former than in the latter(P＜0.05);the TCM syndrome and GAD-7 scores were remarkably decreased in the trial(9.5[8-12]vs 4.0[2.25-5],P＜0.05;5[2.25-6.75]vs 2.5[1-4.75],P＜0.05)and the control group(10.0[8-12]vs 5.0[3-6],P＜0.05;5.0[3-6]vs 4.0[2-5],P＜0.05),even more signif-icantly in the former than in the latter(P＜0.05),so were the PHQ-9 scores(P＜0.05),but with no statistically significant differ-ence between the two groups(P＞0.05).The IIEF-5 scores of the two groups remained significantly higher than the baseline during the follow-up(P＜0.05),even higher in the trial than in the control group(17.04±2.60 vs 14.16±3.34,P＜0.05).No obvious abnormal safety indicators or adverse events were observed during the study.Conclusion:Comprehensive TCM therapy combined with tadalafil is superior to tadalafil alone in the treatment of ED with damp-heat stasis,and has a better long-term efficacy and a higher safety.

Objective:To systematically evaluate the effect and safety of electroacupuncture in the treatment of chronic prostati-tis/chronic pelvic pain syndrome(CP/CPPS).Methods:We searched the major Chinese and English databases of CNKI,Wan-fang Data,VIP,CBM,PubMed,Cochrane Library,Web of Science and Embase for randomized controlled trials(RCT)on electroa-cupuncture or combination therapy in the treatment of CP/CPPS published from the establishment of the databases to August 2024.The dichotomous data and continuous data were represented by risk ratio(RR)and mean difference(MD)respectively,both with 95％confidence interval(CI).We analyzed the data with the Revman(v.5.4)software and assessed the quality of the evidence in each RCT using the Grading of Recommendations Assessment,Development and Evaluation system(GRADE).Results:Totally 17 RCTs were identified,involving 1 404 cases of CP/CPPS treated by electroacupuncture or combination of electroacupuncture with medication or with other therapies(the trial group)or by medication with Western or Chinese drugs alone(the control group).Compared with the control group,the trial group showed a significantly higher rate of clinical effectiveness(RR=1.25;95％CI:1.18-1.32;P＜0.05),decreased CPSI scores(MD=-4.56;95％CI:-5.01--4.11;P＜0.05),improved CPSI-pain,-urination and-quali-ty of life scores,and increased maximum and average urinary flow rates.And electroacupuncture did not increase the likelihood of ad-verse reactions.Conclusion:Medium-quality evidence suggests that electroacupuncture is beneficial complementary and alternative therapy for CP/CPPS,with a significant advantage in improving the NIH-CPSI scores of the patients.However,more high-quality multi-centered RCTs with larger sample sizes are still needed to further verify the effect of electroacupuncture on CP/CPPS.

Objective: To develop a nomogram model for the differential diagnosis of benign and malignant breast BI-RADS (Breast Imaging Reporting and Data System) category 4 nodules based on serum tumor specific protein 70 (SP70) and conventional laboratory indicators and validate its predictive efficacy. Methods: A case-control study design was used to retrospectively analyze the data of 429 female patients diagnosed with BI-RADS category 4 breast nodules by breast color doppler flow imaging at the First Affiliated Hospital of Nanjing Medical University from January 2021 to April 2022 with an age range of 16 to 91 years and a median age of 50 years, and the patients were divided into a training cohort (314 patients) and a validation cohort (115 patients) according to the inclusion time successively. Using postoperative pathological findings as the"gold standard", univariate and multivariate logistic regression analyses were used to identify the predictor variables used for the model. The nomogram, receiver operating characteristic (ROC) curves and calibration curves were drawn for the prediction model, and the discrimination and calibration of the model were evaluated using the consistency index (C-index) and calibration plots. Results: The postoperative pathological results showed that 286 (66.7%) were malignant nodules and 143 (33.3%) were benign nodules of 429 breast BI-RADS category 4 nodules. The serum SP70 (OR=1.227,95%CI: 1.033-1.458,P=0.020), NLR (OR=1.545,95%CI: 1.047-2.280,P=0.028), LDL-C (OR=2.215, 95%CI: 1.354-3.622, P=0.002), GLU (OR=2.050,95%CI:1.222-3.438,P=0.007), PT (OR=1.383,95%CI: 1.046-1.828,P=0.023), nodule diameter (OR=1.042, 95%CI: 1.008-1.076, P=0.015) and age (OR=1.062,95%CI: 1.011-1.116,P=0.016) were independent risk factors which could be used to distinguish benign and malignant breast BI-RADS category 4 nodules (P<0.05). The nomogram was plotted by the above seven independent variables, and the concordance index (C-index) for the training cohort and validation cohort were 0.842 (95%CI:0.786-0.898) and 0.787 (95%CI:0.687-0.886), respectively. The sensitivity and specificity of using this model to identify benign and malignant breast BI-RADS category 4 nodules in the training and validation cohort were 83.5%, 72.5% and 79.2%, 73.6%, respectively. The calibration curves showed good agreement between the predicted and actual values in the nomogram. Conclusions: This study combined serum SP70, conventional laboratory indicators and breast color doppler flow imaging to develop a nomogram model for the differential diagnosis of benign and malignant breast BI-RADS category 4 nodules. The model may have good predictive efficacy and may provide a basis for clinical treatment options, which is beneficial for guiding breast cancer screening and prevention.
Female ; Humans ; Middle Aged ; Adolescent ; Young Adult ; Adult ; Aged ; Aged, 80 and over ; Diagnosis, Differential ; Retrospective Studies ; Case-Control Studies ; Breast/pathology* ; Breast Neoplasms/pathology*

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.
Biomedical Research ; Clinical Trials as Topic ; Consensus ; Drugs, Chinese Herbal ; Ethical Review ; Humans ; Medicine, Chinese Traditional ; Multicenter Studies as Topic ; Pharmaceutical Preparations

Coronavirus disease-2019 (COVID-19) outbreaks were spreading rapidly around the world in early 2020. This disease is within the category of "damp epidemic" and "damp toxin epidemic" in traditional Chinese medicine, with lung and spleen as the lesion focuses, while dampness and toxin as especially prominent properties. Through clinical observation, we found that dampness would often transform into damp heat during the development and evolution of the disease, and the "triple energizer" treatment was an important therapeutic method, eliminating pathogens through purgation and diuresis: for those with damp-heat accumulation toxin diffused to the triple energizer, we could use Ganlu Xiaodudan as primary prescription, which can spread the upper part, smooth the middle part and infiltrate the lower part, so as to provide a way out for the pathogenic factors and regulate Qi movement. For those with damp-heat in Shaoyang channel, we could use Haoqin Qingdantang to clear heat and promote diuresis, harmonize Shaoyang, eliminate damp-heat and epidemic pathogenic factor. For those with pathogen hidden in membrane source dampness trapping and hidden heat, we could use Dayuanyin to eliminate pathogens between interior and exterior parts, and regulate Qi movement. At the same time we shared three typical cases treated in Wuhan, and conducted an in-depth analysis in this study. Clinically, the method of elimination of pathogens through purgation and diuresis is mainly used in the early and middle stage of this disease. When the disease is still located in Qi system, it also can be applied to mild, ordinary patients and severe patients that have accurate syndrome differentiation. In such cases, it can effectively improve symptoms, reduce pathogenic toxin, truncate and reverse the course of disease, give way to pathogen, and avoid disease aggravating.

Coronavirus disease-2019 (COVID-19) is highly contagious. In the early stages of the disease, the symptoms of coldness, dampness and depression in the lungs often appear, including fever, fatigue, soreness, dry cough, poor appetite, and white greasy tongue coating. During the development of the disease, the damp toxin epidemic often enters the inner and generates heat, and the damp heat epidemic toxin blocks pleurodiaphragmatic sites, the triple energizer and lungs, with manifestations of chest tightness, shortness of breath, exacerbation after exercise, or high fever without bringing down, poor appetite, bitterness in mouth, fatigue, diarrhea, loose stools, and yellow and thick tongue fur. As the pathogen can go outward or enter more deeply inside to cause death at the moment, it is the crucial time to treat the disease. In this study, Haoqin Qingdantang was used to clear dampness and heat, reconcile Shaoyang channel and recover the triple energizer, detoxify the dampness fever epidemic toxin, and block the toxin inside, with a good efficacy. This prescription focuses on smoothing the Shaoyang gallbladder channel and the triple energizer, and regards the spleen and stomach as the acquired essence. In the prescription, Erchentang reconciles the spleen and stomach, elevates clear Qi and lower turbid Qi. Bupleuri Radix is added to increase its detoxification function, and Paeoniae Rubra Radix is added to circulate the blood and prevent pathogen from the blood. When the condition improves, Sweet Wormwood Herb and talc are often withdrawn, and Codonopsis is added to nourish the spleen and stomach, to strengthening vital qi to eliminate pathogenic factor. Based on the cases of COVID-19 treated in Wuhan Jinyintan Hospital, this paper summarized some experience of applying Haoqin Qingdantang.

OBJECTIVE: To investigate the clinical features and outcome of neonatal acute respiratory distress syndrome (ARDS) in southwest Hubei, China. METHODS: According to the Montreux definition of neonatal ARDS, a retrospective clinical epidemiological investigation was performed on the medical data of neonates with ARDS who were admitted to Department of Neonatology/Pediatrics in 17 level 2 or level 3 hospitals in southwest Hubei from January to December, 2017. RESULTS: A total of 7 150 neonates were admitted to the 17 hospitals in southwest Hubei during 2017 and 66 (0.92%) were diagnosed with ARDS. Among the 66 neonates with ARDS, 23 (35%) had mild ARDS, 28 (42%) had moderate ARDS, and 15 (23%) had severe ARDS. The main primary diseases for neonatal ARDS were perinatal asphyxia in 23 neonates (35%), pneumonia in 18 neonates (27%), sepsis in 12 neonates (18%), and meconium aspiration syndrome in 10 neonates (15%). Among the 66 neonates with ARDS, 10 neonates (15%) were born to the mothers with an age of ≥35 years, 30 neonates (45%) suffered from intrauterine distress, 32 neonates (49%) had a 1-minute Apgar score of 0 to 7 points, 24 neonates (36%) had abnormal fetal heart monitoring results, and 21 neonates (32%) experienced meconium staining of amniotic fluid. Intraventricular hemorrhage was the most common comorbidity (12 neonates), followed by neonatal shock (9 neonates) and patent ductus arteriosus (8 neonates). All 66 neonates with ARDS were treated with mechanical ventilation in addition to the treatment for primary diseases. Among the 66 neonates with ARDS, 10 died, with a mortality rate of 15% (10/66), and 56 neonates were improved or cured, with a survival rate of 85% (56/66). CONCLUSIONS Neonatal ARDS in southwest Hubei is mostly mild or moderate. Perinatal asphyxia and infection may be the main causes of neonatal ARDS in this area. Intraventricular hemorrhage is the most common comorbidity. Neonates with ARDS tend to have a high survival rate after multimodality treatment.
China ; Female ; Humans ; Infant, Newborn ; Meconium Aspiration Syndrome ; Pregnancy ; Respiratory Distress Syndrome, Newborn ; Retrospective Studies

OBJECTIVE: To investigate the level and influencing factors of health-related quality of life in myasthenia gravis (MG) patients with myasthenia gravis quality of life-15 (MGQOL-15) Chinese version and to provide corresponding measures in one tertiary hospital of Sichuan Province. METHODS: We collected the general data (gender, age, body mass index BMI, marital status, educational level and employee status), clinical data [Osserman type, myasthenia gravis composite (MGC), other immunopathies, disease duration, frequency of outpatient visits per month, ratio of disease cost to income each month and frequency of symptoms during the past month] and the MGQOL-15 Chinese version from 168 myasthenia gravis patients in one tertiary hospital of Sichuan Province. RESULTS: The mean score of MGQOL-15 was 17.67±12.78. The score of the item "My occupational skills and job status have been negatively affected." was the highest, followed by "I have trouble using my eyes." and "I am frustrated by my MG." Single factor analysis showed that MG patients' QOL were different with different disease severity MGC (F=19.353, P<0.001), ratio of disease cost to income each month (F=5.831, P<0.001) and the frequency of symptoms during the past month (F=9.128,P<0.001). Multiple regression analysis showed that disease severity MGC (β=0.743,P<0.001), ration of disease cost to income each month (β=3.347,P<0.001) and the frequency of symptoms during the past month (β=2.216,P<0.003) were the main predictors of HRQOL in the MG patients. CONCLUSION Our study showed that the MGQOL-15 is helpful for clinicians to evaluate MG patients' QOL regularly, investigate the influencing factors and implement corresponding interventions the so as to improve the patients' quality of life. Disease severity MGC, ratio of disease cost to income each month and the frequency of symptoms during the past month were the main predictors of MG patients' QOL. Clinicians should pay more attention to MG patients' disease severity MGC and the frequency of symptoms during the past month.
Adult ; Aged ; Cost of Illness ; Female ; Humans ; Income ; Male ; Marital Status ; Middle Aged ; Myasthenia Gravis/psychology* ; Quality of Life

Sodium glucose co-transporter 2 (SGLT-2) inhibitors are newly developed but promising medicine for type 2 diabetes. However, patients with a different renal threshold for glucose excretion (RT(G)) may have a different reaction to this medicine. Therefore, the objective of this study was to investigate the characteristics of RT(G) and its impact factors in patients with type 2 diabetes mellitus (T2DM). The clinical and laboratory data of 36 healthy individuals and 168 in-hospital patients with T2DM were collected and analyzed, RTG was calculated using blood glucose (BG) measured by dynamic BG monitoring, urinary glucose excretion (UGE) and estimated glomerular filtration rate (eGFR). The characteristics of RT(G) were investigated. The risk factors for high RT(G) were analyzed using non-conditional logistic regression analysis. Our results found that RT(G) of the T2DM group was higher than that of the healthy individuals (P < 0.05); and 22.22% from the healthy individuals group but 58.33% from the T2DM group had high RT(G). Age, duration of diabetes, body mass index (BMI), and homeostasis model assessment insulin resistance index (HOMA-IR) were independently associated with high RT(G) (P < 0.05). Further stratified analysis revealed that RT(G) in T2DM patients increased with age, duration of diabetes, and BMI. In conclusion, RT(G) is increased in patients with T2DM, especially in those with longer diabetic duration, higher BMI, and those who are older. Therefore, these patients may be more sensitive to SGLT-2 inhibitors.