Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Male ; Double-Blind Method ; Drugs, Chinese Herbal/therapeutic use* ; Tic Disorders/drug therapy* ; Treatment Outcome

OBJECTIVE: The aim of this study is to investigate the independent risk factors of benign prostatic hyperplasia (BPH) complicated with bladder stones, and construct a nomogram prediction model for clinical progression of bladder stones in patients with BPH. METHODS: The clinical data of 368 BPH patients who underwent transurethral resection of the prostate in the Second Affiliated Hospital of Zhengzhou University from January 2018 to January 2021 were retrospectively analyzed. Patients with BPH were divided into group 1 (with bladder stones, n=94) and group 2 (without bladder stones, n=274). Univariate and multivariate logistic regression analyses were performed to determine the independent risk factors of bladder stones in patients with BPH. A nomogram model was developed, and the areas under the ROC curve and calibration curve were calculated to assess the accuracy of clinical application. RESULTS: Logistic analysis showed that age (HR:1.075,95%CI:1.032 to 1.120), hypertension (HR:2.801,95%CI:1.520 to 5.161), blood uric acid (HR:1.006,95%CI:1.002 to 1.010), intravesical prostatic protrusion (HR:1.189,95%CI1.119 to 1.264）, prostatic urethral angel（HR:1.127,95%CI:1.078to 1.178）were independent risk factors for bladder stones in patients with BPH. The discrimination of the nomogram model based on independent risk factors to predict the occurrence of bladder stones in patients with BPH was 0.874. CONCLUSION The nomogram model can predict the risk of bladder stones in BPH patients with good differentiation and calibration, which is a good guide for clinical work on BPH patients with high risk of bladder stones.
Humans ; Male ; Prostatic Hyperplasia/complications* ; Nomograms ; Urinary Bladder Calculi/etiology* ; Retrospective Studies ; Risk Factors ; Aged ; Logistic Models ; Middle Aged ; ROC Curve ; Transurethral Resection of Prostate

With the increasing proportion of human papilloma virus(HPV)infection in the pathogenic factors of oro-pharyngeal cancer,a series of changes have occurred in the surgical treatment.While the treatment mode has been im-proved,there are still many problems,including the inconsistency between diagnosis and treatment modes,the lack of popularization of reconstruction technology,the imperfect post-treatment rehabilitation system,and the lack of effective preventive measures.Especially in terms of treatment mode for early oropharyngeal cancer,there is no unified conclu-sion whether it is surgery alone or radiotherapy alone,and whether robotic minimally invasive surgery has better func-tional protection than radiotherapy.For advanced oropharyngeal cancer,there is greater controversy over the treatment mode.It is still unclear whether to adopt a non-surgical treatment mode of synchronous chemoradiotherapy or induction chemotherapy combined with synchronous chemoradiotherapy,or a treatment mode of surgery combined with postopera-tive chemoradiotherapy.In order to standardize the surgical treatment of oropharyngeal cancer in China and clarify the indications for surgical treatment of oropharyngeal cancer,this expert consensus,based on the characteristics and treat-ment status of oropharyngeal cancer in China and combined with the international latest theories and practices,forms consensus opinions in multiple aspects of preoperative evaluation,surgical indication determination,primary tumor re-section,neck lymph node dissection,postoperative defect repair,postoperative complication management prognosis and follow-up of oropharyngeal cancer patients.The key points include:① Before the treatment of oropharyngeal cancer,the expression of P16 protein should be detected to clarify HPV status;② Perform enhanced magnetic resonance imaging of the maxillofacial region before surgery to evaluate the invasion of oropharyngeal cancer and guide precise surgical resec-tion of oropharyngeal cancer.Evaluating mouth opening and airway status is crucial for surgical approach decisions and postoperative risk prediction;③ For oropharyngeal cancer patients who have to undergo major surgery and cannot eat for one to two months,it is recommended to undergo percutaneous endoscopic gastrostomy before surgery to effectively improve their nutritional intake during treatment;④ Early-stage oropharyngeal cancer patients may opt for either sur-gery alone or radiation therapy alone.For intermediate and advanced stages,HPV-related oropharyngeal cancer general-ly prioritizes radiation therapy,with concurrent chemotherapy considered based on tumor staging.Surgical treatment is recommended as the first choice for HPV unrelated oropharyngeal squamous cell carcinoma(including primary and re-current)and recurrent HPV related oropharyngeal squamous cell carcinoma after radiotherapy and chemotherapy;⑤ For primary exogenous T1-2 oropharyngeal cancer,direct surgery through the oral approach or da Vinci robotic sur-gery is preferred.For T3-4 patients with advanced oropharyngeal cancer,it is recommended to use temporary mandibu-lectomy approach and lateral pharyngotomy approach for surgery as appropriate;⑥ For cT1-2N0 oropharyngeal cancer patients with tumor invasion depth＞3 mm and cT3-4N0 HPV unrelated oropharyngeal cancer patients,selective neck dissection of levels ⅠB to Ⅳ is recommended.For cN+HPV unrelated oropharyngeal cancer patients,therapeutic neck dissection in regions Ⅰ-Ⅴ is advised;⑦ If PET-CT scan at 12 or more weeks after completion of radiation shows intense FDG uptake in any node,or imaging suggests continuous enlargement of lymph nodes,the patient should undergo neck dissection;⑧ For patients with suspected extracapsular invasion preoperatively,lymph node dissection should include removal of surrounding muscle and adipose connective tissue;⑨ The reconstruction of oropharyngeal cancer defects should follow the principle of reconstruction steps,with priority given to adjacent flaps,followed by distal pedicled flaps,and finally free flaps.The anterolateral thigh flap with abundant tissue can be used as the preferred flap for large-scale postoperative defects.

Tranexamic acid is widely used in joint orthopedic surgery.At the same time,it has high safety and few adverse drug reactions.It can effectively improve intraoperative bleeding and promote early functional recovery of patients.This article reviews the mode of administration,safe dose,administration time and adverse drug reactions of tranexamic acid in the perioperative period of joint replacement and arthroscopic surgery,in order to provide reference for the clinical application of tranexamic acid.

Objective To observe the clinical efficacy and safety of spironolactone combined with sacubitril/valsartan in the treatment of patients with hypertensive nephropathy.Methods The patients with hypertensive nephropathy were randomly divided into control group and treatment group.The control group was treated with sacubitril/valsartan(100-200 mg·d-1 in the morning),and treatment group was combined with low-dose spironolactone treatment(20 mg·d-1 in the morning)on the basis of control group.Both groups were treated continuously for 12 weeks.The clinical efficacy was compared;the blood pressure,urinary microalbumin(mAlb),urinary β2 microglobulin(β2-MG)and serum cystatin C(Cys-C),transforming growth factor-β1(TGF-β1),connective tissue growth factor(CTGF)and angiotensin Ⅱ(Ang Ⅱ)and adverse drug reactions were observed before and after treatment.Results There were 87 cases in treatment group and 86 cases in control group were included respectively.After treatment,the total effective rates in treatment group and control group were 95.40％(83 cases/87 cases)and 82.56％(71 cases/86 cases),with significant difference(P＜0.05).After treatment,the systolic blood pressure values in treatment group and control group were(124.65±9.65)and(130.27±8.93)mmHg,the diastolic blood pressure values were(75.08±7.14)and(80.45±7.35)mmHg,urinary mAlb levels were(42.58±5.65)and(51.28±6.64)mg·L-1,urinary β2-MG levels were(0.46±0.17)and(0.75±0.25)mg·L-1,24 h urinary protein quantitation levels were(138.49±46.64)and(216.48±65.27)mg,serum Cys-C levels were(0.63±0.26)and(0.85±0.24)mg·L-1,TGF-β1 levels were(98.67±21.43)and(112.46±26.72)pg·mL-1,CTGF levels were(1 206.54±236.56)and(1 340.51±248.25)pg·mL-1,Ang Ⅱ levels were(101.55±17.62)and(115.65±20.08)pg·mL-1,all with significant difference(all P＜0.05).The incidence of adverse drug reactions in treatment group and control group were 6.90％(6 cases/87 cases)and 2.33％(2 cases/86 cases),with no significant difference(P＞0.05).Conclusion Compared with sacubitril/valsartan alone,spironolactone combined with sacubitril/valsartan can better reduce blood pressure,improve renal function and delay progression of renal fibrosis in the treatment of hypertensive nephropathy,and has definite efficacy,with good safety.

Objective:To investigate the correlation of the clinical characteristics,fever characteristics,serum biomarkers with cytokine release syndrome (CRS) in patients with relapsed/refractory multiple myeloma (R/R MM) treated with chimeric antigen receptor T cell (CAR-T) immunotherapy. Methods:104 R/R MM patients who received CAR-T cell therapy at the Affiliated Hospital of Xuzhou Medical University from June 2017 to November 2021 were included,and the correlations of their clinical characteristics,fever characteristics,serum biomarkers with the severity of CRS were analyzed. Results:Among 104 R/R MM patients receiving CAR-T treatment,no CRS was observed in 8 cases (7.7％),and 96 cases (92.3％) developed CRS. Patients with high-risk cytogenetics had a higher risk of developing CRS (P=0.040),while patients who had previously received autologous hematopoietic stem cell transplantation (ASCT) had a lower risk of developing CRS (P=0.004). There was a significant difference in the duration of fever between patients with grade 1-2 and grade 3-5 CRS (P=0.006). The highest body temperature varied among patients with different treatment regimens (P=0.001). The decrease in total protein in patients with CRS was more significant than in patients without CRS (P=0.002). Within one month after CAR-T cell infusion,the degree of albumin recovery in patients with grade 3-5 CRS was lower than that in patients with grade 0-2 CRS (P=0.037). Compared to patients with grade 1-2 CRS,patients with grade 3-5 CRS showed a significant increase in heart rate after CAR-T cell infusion (P=0.013),while IL-6,C-reactive protein (CRP),and serum ferritin (SF) also showed significant increases (P=0.007,P<0.001,P=0.003). Conclusion:High-risk cytogenetics is a risk factor for severe CRS. Long duration of fever is a clinical characteristic of severe CRS. CRP can better reflect the severity of CRS.

Aim To investigate the regulatory mecha-nism of arrhythmia of sodium channel ubiquitination af-ter MI and to study the electrophysiological remodeling mechanism of lncRNA-CCRR after MI for the preven-tion and treatment of arrhythmia after MI.Methods LncRNA-CCRR transgenic mice and C57BL/6 mice injected with lncRNA-CCRR overexpressed adeno-asso-ciated virus were used.Four weeks after infection,the left anterior descending branch of the coronary artery was ligated for 12 h to establish a mouse acute myocar-dial infarction model,and the incidence of arrhythmia was detected by programmed electrical stimulation.Ln-cRNA-CCRR overexpression/knockdown adeno-associ-ated virus and negative control were transfected into neonatal mouse cardiomyocytes(NMCMs),and the model was prepared by hypoxia for 12 h.LncRNA-CCRR expression was detected by FISH,Nav1.5 and UBA6 protein and Nav.1.5 mRNA expression were de-tected by Western blot and real-time quantitative poly-merase chain reaction(qRT-PCR),Nav1.5 and UBA6 expressions were detected by immunofluores-cence,and the relationship between lncRNA-CCRR and UBA6 was detected by RIP.INa current density af-ter CCRR overexpression and knockdown was detected by Whole-cell clamp patch.Results In MI mice,the expression of lncRNA-CCRR decreased,the incidence of arrhythmia increased,the expression of CCRR and Nav1.5 mRNA was down-regulated,the protein ex-pression of Nav1.5 was down-regulated,and the pro-tein expression of UBA6 was up-regulated compared with sham group.Overexpression of CCRR could re-verse the above changes.AAV-CCRR could reverse the down-regulated CCRR and Nav1.5 mRNA levels af-ter hypoxia,and improve the expression of Nav1.5 and UBA6 protein.The direct relationship between ln-cRNA-CCRR and UBA6 was identified by RIP analy-sis.The INa density increased after transfection with AAV-CCRR.The INa density decreased after transfec-tion with AAV-si-CCRR.Conclusions The expres-sion of lncRNA-CCRR decreases after MI,and ln-cRNA-CCRR can improve arrhythmia induced by MI by inhibiting UBA6 to increase the protein expression level of Nav1.5 and the density of INa.

Objective To summarize the clinical characteristics of 2 cases of styloid-carotid syndrome(SCS)and review the literature to enhance understanding of the disease.Methods A retrospective analysis was conducted on the clinical manifestations,auxiliary examinations,and diagnosis and treatment of 2 patients with SCS admitted to the Neurology Department of Kaifeng Central Hospital.Additionally,relevant literature was searched through domestic and foreign databases such as PubMed,WOS,Embase,CNKI and VIP.The clinical characteristics of SCS were summarized based on the literature results.Results The 2 cases were diagnosed as transient cerebral ischemia(TIA)combined with SCS through head and neck CT angiography(CTA)and styloid process CT.Apart from the 2 cases treated in our hospital,a total of 11 cases of SCS have been reported in Chinese and English literature up to October 2023.Among the 13 cases,11 cases(84.6%)started with episodic TIA symptoms,and 11 cases(84.6%)had obvious inducing factors related to specific head position changes.Common clinical manifestations included unilateral limb weakness with or without sensory disturbance(10 cases,76.9%),slurred speech(7 cases,53.8%),unilateral limb sensation disorder(4 cases,30.7%),syncope(3 cases,23.1%)and amaurosis(2 cases,15.4%).All 13 cases underwent 64-row head and neck CTA examination,and 6 cases(46.2%)dynamically observed the changes in blood flow velocity through examinations such as transcranial Doppler ultrasound(TCD),cervical vascular ultrasound,and digital subtraction angiography(DSA).All patients were followed up for more than 3 months;and 10 cases(76.9%)achieved clinical cure after treatment,of which 8 cases underwent styloid process shortening surgery;3 cases(23.1%)achieved clinical symptom improvement after treatment.Conclusions For patients with recurrent TIA and/or cerebral infarction,it is necessary to identify whether there are inducing factors related to specific body position changes.For patients highly suspected of SCS,routine examinations such as styloid process CT and 64-row head and neck CTA should be performed,and if necessary,whole brain DSA,dynamic TCD and/or carotid ultrasound should be conducted to guide the diagnosis and treatment.When non-surgical treatment is ineffective,radical styloid process truncation can be considered as a treatment option.

Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75％(27/36);boys accounted for 64％(23/36).Among the 36 neonates,31(86％)had disease onset within 3 days after birth,and 19(53％)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61％)had left cerebral infarction and 13(36％)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75％)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72％)and seizures in 10 neonates(34％).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33％,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44％(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.

Background/Aims: Chronic hepatitis C (CHC) patients who failed antiviral therapy are at increased risk for hepatocellular carcinoma (HCC). This study assessed the potential role of metformin and statins, medications for diabetes mellitus (DM) and hyperlipidemia (HLP), in reducing HCC risk among these patients. Methods: We included CHC patients from the T-COACH study who failed antiviral therapy. We tracked the onset of HCC 1.5 years post-therapy by linking to Taiwan’s cancer registry data from 2003 to 2019. We accounted for death and liver transplantation as competing risks and employed Gray’s cumulative incidence and Cox subdistribution hazards models to analyze HCC development. Results: Out of 2,779 patients, 480 (17.3%) developed HCC post-therapy. DM patients not using metformin had a 51% increased risk of HCC compared to non-DM patients, while HLP patients on statins had a 50% reduced risk compared to those without HLP. The 5-year HCC incidence was significantly higher for metformin non-users (16.5%) versus non-DM patients (11.3%; adjusted sub-distribution hazard ratio [aSHR]=1.51; P=0.007) and metformin users (3.1%; aSHR=1.59; P=0.022). Statin use in HLP patients correlated with a lower HCC risk (3.8%) compared to non-HLP patients (12.5%; aSHR=0.50; P<0.001). Notably, the increased HCC risk associated with non-use of metformin was primarily seen in non-cirrhotic patients, whereas statins decreased HCC risk in both cirrhotic and non-cirrhotic patients. Conclusions Metformin and statins may have a chemopreventive effect against HCC in CHC patients who failed antiviral therapy. These results support the need for personalized preventive strategies in managing HCC risk.