Computerized tomography-guided therapeutic percutaneous puncture catheter drainage-combined with somatostatin for severe acute pancreatitis: An analysis of efficacy and safety

BACKGROUND Severe acute pancreatitis(SAP),a condition with rapid onset,critical condition and unsatisfactory prognosis,poses a certain threat to human health,warranting optimization of relevant treatment plans to improve treatment efficacy.AIM To evaluate the efficacy and safety of computerized tomography-guided the-rapeutic percutaneous puncture catheter drainage(CT-TPPCD)combined with somatostatin(SS)in the treatment of SAP.METHODS Forty-two SAP patients admitted to The Second Affiliated Hospital of Fujian Medical University from June 2020 to June 2023 were selected.On the basis of routine treatment,20 patients received SS therapy(control group)and 22 patients were given CT-TPPCD plus SS intervention(research group).The efficacy,safety(pancreatic fistula,intra-abdominal hemorrhage,sepsis,and organ dysfunction syndrome),abdominal bloating and pain relief time,bowel recovery time,hospital stay,inflammatory indicators(C-reactive protein,interleukin-6,and pro-calcitonin),and Acute Physiology and Chronic Health Evaluation(APACHE)II score of both groups were evaluated for comparison.RESULTS Compared with the control group,the research group had a markedly higher total effective rate,faster abdominal bloating and pain relief and bowel recovery,INTRODUCTION Pancreatitis,an inflammatory disease occurring in the pancreatic tissue,is classified as either acute or chronic and is associated with high morbidity and mortality,imposing a socioeconomic burden[1,2].The pathogenesis of this disease involves early protease activation,activation of nuclear factor kappa-B-related inflammatory reactions,and infiltration of immune cells[3].Severe acute pancreatitis(SAP)is a serious condition involving systemic injury and subsequent possible organ failure,accounting for 20%of all acute pancreatitis cases[4].SAP is also characterized by rapid onset,critical illness and unsatisfactory prognosis and is correlated with serious adverse events such as systemic inflammatory response syn-drome and acute lung injury,threatening the health of patients[5,6].Therefore,timely and effective therapeutic inter-ventions are of great significance for improving patient prognosis and ensuring therapeutic effects.Somatostatin(SS),a peptide hormone that can be secreted by endocrine cells and the central nervous system,is in-volved in the regulatory mechanism of glucagon and insulin synthesis in the pancreas[7].It has complex and pleiotropic effects on the gastrointestinal tract,which can inhibit the release of gastrointestinal hormones and negatively modulate the exocrine function of the stomach,pancreas and bile,while exerting a certain influence on the absorption of the di-gestive system[8,9].SS has shown certain clinical effectiveness when applied to SAP patients and can regulate the severity of SAP and immune inflammatory responses,and this regulation is related to its influence on leukocyte apoptosis and adhesion[10,11].Computerized tomography-guided therapeutic percutaneous puncture catheter drainage(CT-TPPCD)is a surgical procedure to collect lesion fluid and pus samples from necrotic lesions and perform puncture and drainage by means of CT image examination and precise positioning[12].In the research of Liu et al[13],CT-TPPCD applied to pa-tients undergoing pancreatic surgery contributes to not only good curative effects but also a low surgical risk.Baudin et al[14]also reported that CT-TPPCD has a clinical success rate of 64.6%in patients with acute infectious necrotizing pan-creatitis,with nonfatal surgery-related complications found in only two cases,suggesting that this procedure is clinically effective and safe in the treatment of the disease.In light of the limited studies on the efficacy and safety of SS plus CT-TPPCD in SAP treatment,this study performed a relevant analysis to improve clinical outcomes in SAP patients.

Efficacy and safety of perioperative therapy for locally resectable gastric cancer:A network meta-analysis of randomized clinical trials

BACKGROUND Gastric cancer(GC)is the fifth most commonly diagnosed malignancy worldwide,with over 1 million new cases per year,and the third leading cause of cancer-related death.AIM To determine the optimal perioperative treatment regimen for patients with locally resectable GC.METHODS A comprehensive literature search was conducted,focusing on phase II/III randomized controlled trials(RCTs)assessing perioperative chemotherapy and chemoradiotherapy in treating locally resectable GC.The R0 resection rate,overall survival(OS),disease-free survival(DFS),and incidence of grade 3 or higher nonsurgical severe adverse events(SAEs)associated with various perioperative regimens were analyzed.A Bayesian network meta-analysis was performed to compare treatment regimens and rank their efficacy.RESULTS Thirty RCTs involving 8346 patients were included in this study.Neoadjuvant XELOX plus neoadjuvant radiotherapy and neoadjuvant CF were found to significantly improve the R0 resection rate compared with surgery alone,and the former had the highest probability of being the most effective option in this context.Neoadjuvant plus adjuvant FLOT was associated with the highest probability of being the best regimen for improving OS.Owing to limited data,no definitive ranking could be determined for DFS.Considering nonsurgical SAEs,FLO has emerged as the safest treatment regimen.CONCLUSION This study provides valuable insights for clinicians when selecting perioperative treatment regimens for patients with locally resectable GC.Further studies are required to validate these findings.

Efficacy and safety of trastuzumab combined with chemotherapy for first-line treatment and beyond progression of HER2-overexpressing advanced breast cancer

Objective： To observe the efficacy and safety of trastuzumab combined with chemotherapy in patients with human epidermal growth factor receptor 2 （HER2）-overexpressing advanced breast cancer. Methods： A total of 90 patients with HER2-overexpressing advanced breast cancer were enrolled in this study. All patients were diagnosed with ductal invasive breast cancer by pathological analysis, and were aged between 31-73 years with a median of 51 years. HER2-positivity was defined as 3（＋） staining in immunochemistry or amplification of fluorescence in situ hybridization （FISH, ratio ≥2.0）. Trastuzumab was administered in combination with chemotherapy as first-line treatment and beyond progression as a second- line, third-line, and above treatment in 90, 34, 14, and 6 patients, respectively. The chemotherapy regimen was given according to normal clinical practice. The response rate was evaluated every two cycles, and the primary endpoints were progression-free survival （PFS） and overall survival （OS）. Survival curves were estimated by using Kaplan-Meier graphs and were compared by using log-rank test statistics. Multivariate analysis was done using Cox＇s proportional hazards regression model, and the level of significance was P〈0.05. Results： All 90 patients received at least one dose of trastuzumab, and efficacy could be evaluated in 85 patients. The median follow-up was 50 months. In total, 72 （80.00%） patients had visceral metastasis, and 43 （47.78%） patients had progressed after one or more extensive chemotherapy regimens for metastatic diseases. The median PFS for first-line trastuzumab was 10 months （range, 2-59 months）, and the median OS after metastasis or initially local advanced disease was 22 months （range, 2-1 16 months）. Conclusions： Trastuzumab combined with chemotherapy was active and well-tolerated as a first-line treatment and even beyond progression in HER2-overexpressing advanced breast cancer as a second-line or third-line treatment. However, its efficacy is certainly less beyond this point.

Efficacy and safety of single-bolus tenecteplase compared with front-loaded alteplase in Chinese patients with acute myocardial infarction

Following ST-segment elevation myocardial infarction(STEMI), early and complete epicardial reperfusion is associated with improved survival.……

Respiratory support for severe acute respiratory syndrome: integration of efficacy and safety

Severe acute respiratory syndrome （SARS） is an acute respiratory illness caused by infection with the SARS virus. The most obvious clinical characteristic of SARS is rapidly progressive pneumonia, and about 20% patients need intensive care due to acute lung injury （ALI） and acute respiratory distress syndrome （ARDS）.1-3 In the absence of effective drugs for SARS, supportive care, especially respiratory support techniques （RSTs）, is of primary importance. On the other hand, offering RSTs to SARS patients may carry a high-risk of infection to healthcare workers because of the high infectivity of SARS. Therefore, the strategy of RSTs for SARS should be the integration of efficacy and safety. In this issue of the Chinese Medical Journal, an article from Hong Kong has retrospectively compared both the safety and efficacy of noninvasive positive pressure ventilation （NIPPV） with that of invasive mechanical ventilation （IMV） in the treatment of respiratory failure in SARS.

Regulatory evaluation of efficacy and safety of new drugs in China

Accessibility, availability, and rational use of medicines are widely recognized priorities for guaranteeing equity in health care. Commercial pressure can twist health policy if pharmaceutical companies are allowed to promote and impose their products beyond clear public-health interest. National regulatory

Efficacy and safety of evolocumab in reducing lipids and cardiovascular events

Background Evolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 （PCSK9）, significantly reduced low-density lipoprotein （LDL） cholesterol levels in short-term studies. We con- ducted two extension studies to obtain longer-term data.

Efficacy and safety analysis of the combination of cladribine,cytarabine,granulocyte colony stimulating factor( CLAG ) regime in patients with refractory or relapsed acute myeloid leukemia

Objective To analyze efficacy and safety of CLAG regimen in patients with refractory or relapsed acute myeloid leukemia(AML).Methods Efficacy and adverse events of patients with refractory or relapsed AML who were treated with one course of CLAG from April 1st,2014 through December 9th,2015 in our hospital were retrospectively reviewed.Results Thirty-three

A comparison of efficacy and safety between Chinese generic imatinib and branded imatinib in patients with newly-diagnosed chronic myeloid leukemia in the chronic phase:a single-center prospective cohort study

Objective To compare the efficacy and safety between Chinese generic imatinib(Xinwei~,Jiansu Hansoh Pharmaceutical Group Co.,Ltd.)and branded imatinib(Glivec~,Novartis)in patients with newly-diagnosed chronic myeloid leukemia in chronic phase(CML-CP).Methods Patients with newly diagnosed CML-CP

Efficacy and safety of thalidomide in the treatment of 29 refractory Crohn's disease patients

Objective To evaluate the efficacy and safety of thalidomide(100 to 200 mg per day)in the treatment of adult refractory Crohn’s disease(CD).Methods From July 2008 to February 2013,29 refractory CD patients were enrolled in thalidomide(100 to 200 mg per day)cohort study.The clinical activity was evaluated by

Effect of cetuximab plus FOLFOX4 regimen on clinical outcomes in advanced gastric carcinoma patients receiving evidence-based care

BACKGROUND Although chemotherapy is effective for treating advanced gastric carcinoma(aGC),it may lead to an adverse prognosis.Establishing a highly effective and low-toxicity chemotherapy regimen is necessary for improving efficacy and outcomes in aGC patients.AIM To determine the efficacy and safety of cetuximab(CET)combined with the FOLFOX4 regimen(infusional fluorouracil,folinic acid,and oxaliplatin)as firstline therapy for patients with aGC,who received evidence-based care(EBC).METHODS A total of 117 aGC patients who received EBC from March 2019 to March 2022 were enrolled.Of these,60 in the research group(RG)received CET+FOLFOX4 as first-line therapy,whereas 57 in the control group(CG)received FOLFOX4.The efficacy[clinical response rate(RR)and disease control rate(DCR)],safety(liver and kidney dysfunction,leukopenia,thrombocytopenia,rash,and diarrhea),serum tumor marker expression[STMs;carbohydrate antigen(CA)19-9,CA72-4,and carcinoembryonic antigen(CEA)],inflammatory indicators[interleukin(IL)-2 and IL-10],and quality of life(QOL)of the two groups were compared.RESULTS A markedly higher RR and DCR were observed in the RG compared with the CG,with an equivalent safety profile between the two groups.RG exhibited notably reduced CA19-9,CA72-4,CEA,and IL-2 levels following treatment,which were lower than the pre-treatment levels and those in the CG.Post-treatment IL-10 was statistically increased in RG,higher than the pre-treatment level and the CG.Moreover,a significantly improved QOL was evident in the RG.CONCLUSION The CET+FOLFOX4 regimen is highly effective as first-line treatment for aGC patients receiving EBC.It facilitates the suppression of STMs,ameliorates the serum inflammatory microenvironment,and enhances QOL,without increased adverse drug effects.

Stereotactic body radiotherapy combined with sintilimab in patients with recurrent or oligometastatic hepatocellular carcinoma: A phase Ⅱ clinical trial

BACKGROUND Stereotactic body radiotherapy(SBRT)and programmed cell death 1 inhibitors have shown potential in treating hepatocellular carcinoma(HCC)in retrospective studies.AIM To evaluate the efficacy of combining SBRT with sintilimab for patients with recurrent or oligometastatic HCC.METHODS This trial involved patients with recurrent or oligometastatic HCC intravenously treated with SBRT plus sintilimab every 3 wk for 12 mo or until disease progression.The primary endpoint was progression-free survival(PFS).RESULTS Twenty-five patients were enrolled from August 14,2019,to August 23,2021.The median treatment duration was 10.2(range,0.7-14.6)months.SBRT was delivered at a median dose of 54(range,48-60)Gy in 6(range,6-10)fractions.The median follow-up time was 21.9(range,10.3-39.7)mo,and 32 targeted lesions among 25 patients were evaluated for treatment response according to the Response Evaluation Criteria in Solid Tumors version 1.1.The median PFS was 19.7 mo[95%confidence interval(CI):16.9-NA],with PFS rates of 68%(95%CI:52-89)and 45.3%(95%CI:28-73.4)at 12 and 24 mo,respectively.The median overall survival(OS)was not reached,with OS rates of 91.5%(95%CI:80.8-100.0)and 83.2%(95%CI:66.5-100.0)at 12 and 24 mo,respectively.The 1-and 2-year local control rate were 100%and 90.9%(95%CI:75.4%-100.0%),respectively.The confirmed objective response rate and disease control rate was 96%,and 96%,respectively.Most adverse events were graded as 1 or 2,and grade 3 adverse events were observed in three patients.CONCLUSION SBRT plus sintilimab is an effective,well-tolerated treatment regimen for patients with recurrent or oligometastatic HCC.

Clinical evidence of neoadjuvant immunotherapy for resectable locally advanced esophageal carcinoma:A systematic review

Background:Immune checkpoint inhibitors(ICIs)as the neoadjuvant therapy for resectable locally advanced esophageal carcinoma(rlaEC)remains challenging given the poor reports of efficacy and safety.This study aimed to summarize reliable evidence for the preoperative neoadjuvant immunotherapy of rlaEc by analyzing all the published clinical trials on the ICIs as the neoadjuvant therapy for rlaEC.Methods:PubMed,Cochrane Library,Embase and ClinicalTrials.gov were searched from inception until June 1st,2023,for available reports to perform a meta-analysis.The primary endpoints were RO resection,objective response rate(ORR),pathological complete response(pCR)and major pathological response(MPR),as well as treatment-related adverse events(AEs)and postoperative complications.The Stata 14.0 software was employed to estimate pooled effect size.Results:A total of 18 single-arm clinical trials involving 625 patients met the inclusion criteria.Meta-analysis showed that,among these patients with rlaEC,the pooled R0 resection rate was 97.0%(95%CI:94.0%-99.0%),the p0oled ORR was 70.0%(95%CI:64.0%-76.0%),the p0oled pCR and MPR rate were 34.0%(95%CI:29.0%-39.0%)and 56.0%(95%CI:47.0%-65.0%)respectively.The incidence of main treatment-related AEs and postoperative complications was about 6%-45% and 8%-19% respectively.Conclusions:Patients with rlaEC were tolerated to neoadjuvant immunotherapy and it might be beneficial to improve efficacy.But this meta-analysis had limitations and the conclusions still needed to be validated by more rigorous phase II randomized controlled clinical trials.

Classical and Emerging Therapies against Chronic Obstructive Pulmonary Disease

INTRODUCTION Chronic obstructive pulmonary disease （COPD） is a worldwide respiratory disease which always co-exists with multiple extrapulmonary comorbidities such as cardiovascular diseases and osteoporosis. The World Health Organization pointed out that till 2030, COPD would be the third leading reason of mortality. In spite of the advanced medical research and health-care efforts, COPD still shows continuously increasing quantity of death. Tobacco smoking, indoor and outdoor air pollution （for example, biomass thel）, virus, and pulmonary dysplasia are the main risk factors for COPD. All these factors eventually destroy lung parenchymal tissue and disturb repair and defense system, which eventually lead to emphysema and small airway fibrosis [Figure 1].

Misoprostol in labour induction of term pregnancy: a meta-analysis

Data sources Data from published English and Chinese literatures about misoprostol in term labour induction were identified from Medline and CBMdisk (using the search terms “misoprostol” and “labour induction”) before 2001; hand searches of reference lists of original studies and reviews (including meta-analyses) and contact with investigators in this field before 2001. Study selection Studies were included if they had data on misoprostol and labour induction. Altogether 623 articles were found and 124 were admitted, including 19 287 cases. Data extraction Data were collected on efficacy and incidence of side-effects of misoprostol and oxytocin. Data were checked for consistency within the published articles and converted into a standard format for incorporation into a centra l database. Data synthesis The average successful induction rate, rates of caesarean section; incidence of tachysystole, hypertonus of uterus and precipitous labour, and rates of meconium stained amniotic fluid between the misoprostol and oxytocin groups were significantly different (P<0.05). There were no significant differences between the two groups concerning the average interval from the administration of misoprostol and oxytocin to the onset of labour, duration of the total stage of labour, incidence rate of foetal distress, neonatal asphyxia (1-minute Apgar score≤7), post partum haemorrhage or amount of blood loss in postpartum.Conclusions Misoprostol is a superior agent over oxytocin on the induction of term labour, but its application might increase the risk of prec ipitatous labour, abnormal uterine contractions or meconium stained amniotic fluid. Therefore, the doasges and regimens of the agent need further investigation.