Real-world retrospective study of prostate-specific antigen and safety assessment with darolutamide plus androgen deprivation therapy for metastasis hormone-sensitive prostate cancer.

Background: ARASENS has demonstrated the efficacy and safety for darolutamide (DARO) with androgen deprivation therapy (ADT) plus docetaxel in metastasis hormone-sensitive prostate cancer (mHSPC). There is a lack of reports for DARO with ADT in mHSPC though the regimen is used in clinical from time to time. Moreover, recent studies have supported the importance of early and rapid prostate-specific antigen (PSA) reduction, which correlates with reduced disease progression and improved survival in patients with mHSPC. This study aims to evaluate PSA reduction as a primary endpoint for DARO with ADT in the treatment of mHSPC and to evaluate the real-world short-term PSA control of DARO with ADT from two leading medical centers in China. Methods: We retrospectively reviewed the clinical records of patients with mHSPC receiving ADT and DARO (600 mg, b.i.d.). The collection of data spanned from March 1, 2022, to July 31, 2023. The main observation indicators were PSA level and drug-related adverse events (AE) after medication. PSA levels were closely monitored prior to treatment initiation and at 2-week intervals, as well as at 1, 3, and 6 months after the initiation of treatment. We also conducted an analysis to determine the proportion of patients achieving a PSA reduction of 50% or more (PSA50) and 90% or more (PSA90) as well as the percentage of patients with a notable decrease in PSA level to 0.2 ng/mL and PSA nadir of ≤0.02 ng/mL. Results: Fifty-one patients were included in the study, with a median age of 73 years. At diagnosis of HSPC, the majority of patients had a Gleason score ≥8 (n=40, 78.40%) and a median baseline PSA level of 88 ng/mL. Approximately 45.1% (n=23) of patients had a Charlson Comorbidity Index over 1 and were receiving one or more nontumor-related treatments. The median follow-up time was 9.3 months (range, 1.16-15.8 months). The median reductions in PSA levels compared to baseline were 84.37%, 91.48%, 94.67% and 99.81% at 2 weeks, 1 month, 3 months and 6 months after administration of DARO with ADT, respectively. The median time to PSA50, PSA90, significant PSA reduction (PSA <0.2 ng/mL), and PSA nadir (PSA <0.02 ng/mL) was 0.97, 1.27, 1.98, and 2.08 months, respectively. AE mainly included fatigue (two patients) and arm pain (one patient), all of which were grade I or II AE. No grade III or AE were observed. Conclusions: For treating prostate cancer, DARO with ADT has good early efficacy, demonstrating prompt and substantial control of PSA levels, with a favorable safety profile.

Study on early efficacy of UBED and PEID in the treatment of L5/S1 intervertebral disc herniation.

INTRODUCTION: This study aimed to compare early efficacy of UBED and PEID in the treatment of L5/S1 IDH. MATERIAL AND METHODS: Forty-two patients who underwent surgical treatment for L5/S1 IDH were divided into two groups: UBED and PEID. Operation time, complications, VAS/ODI score were recorded. MacNab evaluation was completed one and three months postoperatively. RESULTS: All patients were successfully operated without infection, nerve injury, or huge hematoma in the spinal canal. There were no significant differences in operation time and hospitalization days between the two groups (p > 0.05). All patients were followed up after the operation and low back/leg pain was significantly reduced. VAS for low back pain, VAS for leg pain, ODI scores in both groups one and three months after the operation were significantly lower than pre-operation (p < 0.05). There were no significant differences between one and three months after the operation in both groups (p > 0.05). There were no significant differences in VAS for low back pain, leg pain, ODI score, and overall efficacy between the two groups one and three months post-operation (p > 0.05). CONCLUSION: UBED and PEID have very good early efficacy in treating L5/S1 IDH. Because UBED has a wider vision field and more flexible operation, it can be used as a useful complement to PEID.

CT-based radiomics models may predict the early efficacy of microwave ablation in malignant lung tumors.

PURPOSE: To establish and validate radiomics models for predicting the early efficacy (less than 3 months) of microwave ablation (MWA) in malignant lung tumors. METHODS: The study enrolled 130 malignant lung tumor patients (72 in the training cohort, 32 in the testing cohort, and 26 in the validation cohort) treated with MWA. Post-operation CT images were analyzed. To evaluate the therapeutic effect of ablation, three models were constructed by least absolute shrinkage and selection operator and logistic regression: the tumoral radiomics (T-RO), peritumoral radiomics (P-RO), and tumoral-peritumoral radiomics (TP-RO) models. Univariate and multivariate analyses were performed to identify clinical variables and radiomics features associated with early efficacy, which were incorporated into the combined radiomics (C-RO) model. The performance of the C-RO model was evaluated by the area under the receiver operating characteristic (ROC) curve (AUC), calibration curve, and decision curve analysis (DCA). The C-RO model was used to derive the best cutoff value of ROC and to distinguish the high-risk group (Nomo-score of C-RO model below than cutoff value) from the low-risk group (Nomo-score of C-RO model higher than cutoff value) for survival analysis of patients. RESULTS: Four radiomics features were selected from the region of interest of tumoral and peritumoral CT images, which showed good performance for evaluating prognosis and early efficacy in three cohorts. The C-RO model had the highest AUC value in all models, and the C-RO model was better than the P-RO model (AUC in training, 0.896 vs. 0.740; p = 0.036). The DCA confirmed the clinical benefit of the C-RO model. Survival analysis revealed that in the C-RO model, the low-risk group defined by best cutoff value had significantly better progression-free survival than the high-risk group (p<0.05). CONCLUSIONS: CT-based radiomics models in malignant lung tumor patients after MWA could be useful for individualized risk classification and treatment.

Early Efficacy of Antipsychotic Medications at Week 2 Predicts Subsequent Responses at Week 6 in a Large-scale Randomized Controlled Trial.

BACKGROUND: Since the early clinical efficacy of antipsychotics has not yet been well perceived, this study sought to decide whether the efficacy of antipsychotics at week 2 can predict subsequent responses at week 6 and identify how such predictive capacities vary among different antipsychotics and psychotic symptoms. METHODS: A total of 3010 patients with schizophrenia enrolled in a randomized controlled trial (RCT) and received a 6-week treatment with one antipsychotic drug randomly chosen from five atypical antipsychotics (risperidone 2-6 mg/d, olanzapine 5-20 mg/d, quetiapine 400-750 mg/d, aripiprazole 10-30 mg/d, and ziprasidone 80-160 mg/d) and two typical antipsychotics (perphenazine 20-60 mg/d and haloperidol 6-20 mg/d). Early efficacy was defined as the reduction rate using the Positive and Negative Syndrome Scale (PANSS) total score at week 2. With cut-offs at 50% reduction, logistic regression, receiver operating characteristic (ROC) and random forests were adopted. RESULTS: The reduction rate of PANSS total score and improvement of psychotic symptoms at week 2 enabled subsequent responses to 7 antipsychotics to be predicted, in which improvements in delusions, lack of judgment and insight, unusual thought content, and suspiciousness/ persecution were endowed with the greatest weight. CONCLUSION: It is robust enough to clinically predict treatment responses to antipsychotics at week 6 using the reduction rate of PANSS total score and symptom relief at week 2. Psychiatric clinicians had better determine whether to switch the treatment plan by the first 2 weeks.

Early Efficacy Predictors of Bushen Shengxue Prescription Combined with Western Medicine in Treatment of Aplastic Anemia / 中国实验方剂学杂志

ObjectiveTo investigate the predictive indicators of early efficacy of Bushen Shengxue prescription combined with western medicine in the treatment of aplastic anemia， and provide prognosis indicators for the treatment of aplastic anemia （AA） with kidney-tonifying therapy in traditional Chinese medicine （TCM） combined with western medicine. MethodA total of 126 patients treated by Bushen Shengxue prescription combined with western medicine in 19 hospitals including Xiyuan Hospital of the China Academy of Chinese Medical Sciences from September 2018 to March 2021 were selected for a retrospective study. The therapy was proven to be effective after six months of treatment. According to the efficacy after 4 months of treatment， the patients were assigned into a 4-month effective group and a 4-month ineffective group. The age， sex， disease severity （including severe aplastic anemia and non-severe aplastic anemia）， course of disease， degree of bone marrow nucleated cell proliferation， baseline hemogram levels ［including white blood cell count （WBC）， absolute neutrophil count （ANC）， hemoglobin （HGB）， platelets （PLT）， and reticulocytes （RET）］， T lymphocytes subsets， and the expression levels of T-box transcription factor （T-bet） and GATA-binding protein-3 （GATA-3） were compared between the two groups before treatment. ResultThe proportions of patients within the age ranges of ［20， 40） and ［60， 80） were higher in the 4-month effective group （P<0.05）. The sex， disease severity， course of disease， and comorbidities had no significant differences between the two groups. The 4-month effective group had higher baseline levels of HGB， WBC， ANC， and PLT than the 4-month ineffective group （P<0.05）， and there was no significant difference in the RET level between the two groups before treatment. Binary Logistic regression analysis showed that the PLT level before treatment was an independent factor affecting the onset time， while other indicators did not affect the onset time. The receiver operating characteristic （ROC） curve was established to analyze the value of PLT level before treatment for predicting the onset time， and the area under the curve was 0.691. With the critical value of 40.5×109/L， the sensitivity and specificity of the prediction that the therapy will take effect within 4 months were 0.569 and 0.893， respectively. The two groups of patients were graded according to age ｛（14， 20）， ［20， 40）， ［40， 60）， and ［60， 80）｝ and PLT level before treatment （PLT<40×109/L， PLT≥40×109/L）. The proportion of the patients with PLT≥40×109/L before treatment in the 4-month effective group was significantly higher than that in the 4-month ineffective group （P<0.05）. The degree of bone marrow nucleated cell proliferation before treatment had no significant difference between the two groups. The level of total T lymphocytes in the 4-month effective patients was lower than that in the 4-month ineffective patients before treatment （P<0.05）. The levels of Th1 cells， Th2 cells， CD4+ T cells， and CD8+ T cells showed no significant differences between the two groups before treatment. The T-bet expression level in the 4-month effective group was higher than that in the 4-month ineffective group before treatment （P<0.05）， while the expression level of GATA-3 showed no significant difference between the two groups before treatment. ConclusionBushen Shengxue prescription combined with western medicine will achieve faster effect for the patients within the age ranges of ［20， 40） or ［40， 60）， with higher levels of HGB， WBC， ANC， and PLT （especially those with PLT≥40×109/L）， lower level of total T lymphocytes， or higher T-bet expression level before treatment.

Characteristics of dust mite sublingual immunotherapy-associated adverse events in the early phase.

Background: Few studies reported the characteristics of house dust mite (HDM) sublingual immunotherapy (SLIT) adverse events (AEs) during early phase treatment. The aim of this prospective study was mainly to explore the characteristics of AEs in allergic rhinitis (AR) patients during 6 months of HDM SLIT. Methods: A total of 242 patients with AR were enrolled in this study. Telephone follow-up and administration were conducted in the every week of the first month, the third month, and the sixth month of SLIT treatment. Furthermore, the early efficacy, AEs, and compliance were analyzed in our study. Results: Overall, 70.25% (170/242) of the AR patients completed the study, while 29.75% (72/242) of the AR patients failed to complete the whole 6 months of SLIT treatment process. On the whole, symptoms improved in 87.65% (149/170) of patients including 34.12% (58/170) well-controlled and 53.53% (91/170) partially controlled. The correlation analysis results showed that the treatment effect was negatively correlated with the age (r = -0.1614, P = 0.0355). The AEs mainly occurred in the first month, comprised of local rashes, gastrointestinal reactions, and itching of mouth and tongue. Subgroup analysis in the first month showed the itching of mouth and tongue, gastrointestinal reactions, fatigue, and other AEs in ≥14 years old group (14-65 years old, n = 42) were significant differences when compared with that in the <14 years old group (4-13 years old, n = 128, all P < 0.05). In the study, the main reasons for terminated immunotherapy were drug inaccessibility, loss of follow-up and long course of treatment. Conclusion: Patients with AR who received HDM SLIT revealed an early efficacy after 6 months, with AEs mostly occurred in the first month.

Effect of OTX-101 in Patients with Dry Eye Disease at Day 14 of Treatment: Ocular Surface Endpoint Results from the Phase 2b/3 Clinical Trial.

Dry eye disease (DED) is a multifactorial disorder characterized by loss of tear film homeostasis, which initiates a cycle of ocular surface inflammation and damage. As ocular discomfort symptoms associated with DED can decrease quality of life, affected patients prefer treatments that rapidly improve the underlying disease process. OTX-101 0.09% (CEQUA®) is indicated to increase tear production in patients with DED. The current analysis assessed early efficacy of OTX-101 0.09% in adult patients with bilateral DED by evaluating ocular surface endpoints after 14 days of treatment in the phase 2b/3 trial. In this randomized, double-masked, vehicle-controlled, dose-ranging study, patients received one drop of OTX-101 0.05%, OTX-101 0.09%, or vehicle per eye twice daily for 84 days. Corneal staining, conjunctival staining, tear breakup time (TBUT), and modified Symptom Assessment iN Dry Eye (SANDE) total global symptom score were assessed at baseline and Days 14, 28, 42, 56, and 84/early discontinuation. Overall, 455 patients were randomized (OTX-101 0.05%, n=151; OTX-101 0.09%, n=152; vehicle, n=152); only baseline and Day 14 results for the approved OTX-101 0.09% formulation and vehicle are presented. Least squares (LS) mean (standard error [SE]) change from baseline in conjunctival staining score was -1.3 (0.1) for OTX-101 and -1.0 (0.1) for vehicle. LS mean (SE) change from baseline in corneal staining score was -1.1 (0.17) for OTX-101 and -0.7 (0.17) for vehicle. LS mean (SE) change from baseline in TBUT was 0.52 (0.15) for OTX-101 and 0.36 (0.15) for vehicle. LS mean (SE) change from baseline in modified SANDE total global symptom score was -4.93 (1.54) for OTX-101 and -9.1 (1.54) for vehicle. OTX-101 0.09% demonstrated a numerically greater treatment effect compared with vehicle in conjunctival staining, corneal staining, and TBUT after 14 days.

Early evaluation of adjuvant effects on topramezone efficacy under different temperature conditions using chlorophyll fluorescence tests.

Proper selection of adjuvant applications is an important strategy to enhance herbicide efficacy and reduce active ingredient input especially under adverse environmental conditions. In this study, a two-factor split-plot-design experiment was conducted to evaluate the effects of two adjuvants on the efficacy of topramezone on the grassy weed species giant foxtail (Setaria faberi Herrm.) and the broadleaved weed species velvetleaf (Abutilon theophrasti Medik.) under three different temperature conditions. The two tested adjuvants were methylated seed oil (MSO) and organosilicone. Three temperature levels, 35/30°C, 25/20°C, and 15/10°C (day/night), were used in the laboratory and greenhouse experiment. Plant chlorophyll fluorescence measurements shortly after herbicide application and classic whole-plant bioassay methods were used to evaluate the herbicide efficacy among the different treatments. Results indicated that the maximum quantum efficiency (Fv/Fm) of the top leaf of the weeds treated with topramezone mixed with MSO was significantly lower than that of the weeds treated with topramezone mixed with organosilicone and without an adjuvant at 2-3 days after treatment under all three temperature levels. The herbicide response of the plants treated with topramezone mixed with organosilicone and topramezone alone was not significantly different. These results corresponded well with the results of the classic whole-plant test. MSO has been shown to be good at enhancing the efficacy of topramezone on these weed species under all three temperature conditions. The measurement of chlorophyll fluorescence is a promising technique for evaluating the effects of adjuvants on the efficacy of herbicides shortly after herbicide treatment.

A meta-regression of methodological features that predict the effects of medications on the subjective response to alcohol.

BACKGROUND: Alcohol administration paradigms have been used for early efficacy testing of novel compounds for alcohol use disorder (AUD). There has been an ongoing debate about sample characteristics and methodological features that affect the likelihood of detecting an early efficacy signal for AUD medications. We conducted a meta-regression to test whether the drinking level of the study sample and the peak breath alcohol concentration (BrAC) in the alcohol administration study predict the efficacy of AUD pharmacotherapies on the subjective responses to alcohol. METHODS: We computed the effects of 21 medications on alcohol-induced stimulation, sedation, negative mood, and craving during alcohol administration in 49 studies. RESULTS: Meta-regression analyses indicated a significant and positive effect of pre-study drinks per month on alcohol-induced stimulation (ß = 0.142, p < 0.0001), such that as drinking increases, the benefit of medication over placebo decreases. There was an effect of drinks per month on negative mood (ß = -0.164, p = 0.0248), such that at higher levels of drinks per month, the effects of medications on negative mood are stronger. For sedation, there was an effect of peak BrAC (ß = 0.119, p = 0.0002), such that at low levels of peak BrAC, the effects of medication on sedation were null. For craving, there was a peak BrAC × drinks per month interaction such that at low levels of BrAC, a heavier drinking sample is required to detect the effects of medication on craving. Sensitivity analyses comparing naltrexone studies and non-naltrexone studies suggested that naltrexone was less sensitive to drinks per month across subjective response domains. CONCLUSIONS: These analyses show that design features are critical in studies that test the effects of medications on the subjective responses to alcohol. By specifying the significance and directionality of these effects, as well as the specific points in BrAC or drinks per month at which medication effects are detectable, the study offers recommendations for design features of alcohol administration studies that aim to inform AUD medication development.

Progression-Free Survival as Early Efficacy Endpoint in Resectable Esophageal Cancer Treated With Neoadjuvant Therapy: A Systematic Review.

To investigate literature-based evidence regarding progression-free survival (PFS) as an early efficacy endpoint in patients with resectable esophageal or gastroesophageal junction (GEJ) cancer receiving neoadjuvant therapy, this study identified large-scale randomized controlled trials (RCTs) with strict quality control. Twenty-four RCTs involving 7,514 patients were included. Trial-level correlation analysis was conducted to analyze the relationship between PFS hazard ratio (HR) and overall survival (OS) HR, Δ median PFS and Δ median OS. Correlation analysis at the neoadjuvant treatment arm level was performed between 1- to 5-year PFS and 5-year OS, median PFS and median OS. Subgroup analysis was performed in patients treated with standard neoadjuvant chemoradiotherapy (NCRT). The correlation was evaluated using the Pearson correlation coefficient r in weighted linear regression, with weight equal to patient size. In trial-level correlation, PFS were strongly associated with OS HR (r, 0.82 [95% confidence interval (CI), 0.42-0.97]) and Δ median survival (r, 0.83 [95% CI, 0.54-0.96]). In neoadjuvant treatment arms, there was a strong correlation between 1 to 5-year PFS rates and 5-year OS (r, 0.83-0.95), and median PFS and median OS (r, 0.97 [95% CI, 0.85-0.99]). NCRT subgroup analysis demonstrated acceptable consistency. In conclusion, we recommend PFS as an early efficacy endpoint in resected esophageal or GEJ cancer treated with neoadjuvant therapy.

Are tumor size changes predictive of survival for checkpoint blockade based immunotherapy in metastatic melanoma?

BACKGROUND: In oncology clinical development, objective response rate, disease control rate and early tumor size changes are commonly used as efficacy metrics for early decision-making. However, for immunotherapy trials, it is unclear whether these early efficacy metrics are still predictive of long-term clinical benefit such as overall survival. The goal of this paper is to identify appropriate early efficacy metrics predictive of overall survival for immunotherapy trials. METHODS: Based on several checkpoint blockade based immunotherapy studies in metastatic melanoma, we evaluated the predictive value of early tumor size changes and RECIST-based efficacy metrics at various time points on overall survival. The cut-off values for tumor size changes to predict survival were explored via tree based recursive partitioning and validated by external data. Sensitivity analyses were performed for the cut-offs. RESULTS: The continuous tumor size change metric and RECIST-based trichotomized response metric at different landmark time points were found to be statistically significantly associated with overall survival. The predictive values were higher at Week 12 and 18 than those at Week 24. The percentage of tumor size changes appeared to have comparable or lower predictive values than the RECIST-based trichotomized metric, and a cut-off of approximately 10% tumor reduction appeared to be reasonable for predicting survival. CONCLUSIONS: An approximate 10% tumor reduction may be a reasonable cut-off for early decision-making while the RECIST-based efficacy metric remains the primary tool. Early landmark analysis is especially useful for decision making when accrual is fast. Composite response rate (utilizing different weights for PR/CR and SD) may be worth further investigation. TRIAL REGISTRATION: Clinical trials gov, NCT01295827 , Registered February 15, 2011; NCT01704287 , Registered October 11, 2012; NCT01866319 , Registered May 31, 2013.

Early results of thoracic remodeling for patients with bar removal after pectus excavatum correction in minimal-procedure / 中华胸心血管外科杂志

Objective To study thoracic re-remodeling and therapeutic effect after the bar removal for pectus excavatum corrected by minimal-invasive technique.Methods 145 cases with pectus excavatum,male 115,femal 30;adults in 59,children 86;corrected by minimal-invasive technique improved and performed by the same group surgeon.Bar removed 12-82 months after the procedure,appraising index of curative effects include in chest appearance,thoracic index,thoracic computer tomography(CT) and the distance between the behind of sternum to the anterior border of thoracic spine in the sagittal view.Results The chest shape was good.Thoracic index:before bar removal 2.36 ± 0.32 in children,2.60 ± 0.45 in adults;after that,2.77 ± 0.44 in children,3.04 ± 0.56 in adults.There was all subsidence on the each point of the sternum,descent the maximum at the inferior end of the midsternum,(15.18 ±7.95)mm in children,(14.93 ± 8.81) mm in adults,comparing with bar removal before and after.There was statistical significance.Not the signs of compressing the heart on the CT view.The time interval of the bar removed 3-year in children,5-year in adults without affecting the development of the patients' thorax.Conclusion The sternum descended slightly after bar removal when pectus excavatum corrected to expecting effects.After that,thoracic remodeling again,the chest shape well.

Design and monitoring of multi-arm multi-stage clinical trials.

Two-arm group sequential designs have been widely used for over 40 years, especially for studies with mortality endpoints. The natural generalization of such designs to trials with multiple treatment arms and a common control (MAMS designs) has, however, been implemented rarely. While the statistical methodology for this extension is clear, the main limitation has been an efficient way to perform the computations. Past efforts were hampered by algorithms that were computationally explosive. With the increasing interest in adaptive designs, platform designs, and other innovative designs that involve multiple comparisons over multiple stages, the importance of MAMS designs is growing rapidly. This article provides break-through algorithms that can compute MAMS boundaries rapidly thereby making such designs practical. For designs with efficacy-only boundaries the computational effort increases linearly with number of arms and number of stages. For designs with both efficacy and futility boundaries the computational effort doubles with successive increases in number of stages.

Related factors of cognitive behavior therapy for adults with attention-deficit/hyperactivity disorder / 中国心理卫生杂志

Objective:To explore the related factors to the effect of cognitive behavior therapy (CBT) for adults with attention-deficit/hyperactivity disorder(ADHD).Methods:A prospective and open-label,self-control study was designed.Eighty-five adult patients from outpatient department with ADHD diagnosed with the Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition(DSM-Ⅳ).All the patients received 12 weeks of CBT,the ADHD Rating Scale (ADHD-RS) was used to evaluate ADHD core symptoms,and according to the post-treat ADHD-RS reduction ratio,41 patients were divided into responders(ADHD-RS reduction ratio≥25％)and 44 patients were divided into non-responders(ADHD-RS reduction ratio ＜ 25％).The t-test and chi-square test were used to analyze the differences of sociodemographic variables,clinical variables and early efficacy (ADHD-RS reduction ratio≥25％ in the fourth week) between the two groups,and logistics regression was used to analysis the related factors.Results:Comparing with the group of non-responders,there was more cases with early efficacy (P ＜ 0.05)in the group of responders.Logistic models indicated that higher scores of BIS-motor (OR =1.27),early efficacy (OR =11.87) were associated with better CBT efficacy.Conclusion:It suggests that ADHD adults with more sever motor impulsiveness symptom,and early efficacy may get favorable response to CBT.

External Versus Internal Pancreatic Duct Drainage for the Early Efficacy After Pancreaticoduodenectomy: A Retrospectively Comparative Study.

PURPOSE: To compare the early efficacy of external versus internal pancreatic duct drainage after pancreaticoduodenectomy (PD), providing clinical evidence for selecting the optimal approach to pancreatic duct drainage. MATERIAL AND METHODS: The clinical data of 395 consecutive patients undergoing PD from 2006 to 2013 were analyzed retrospectively. All the patients were divided into external and internal drainage group. Intraoperative blood loss, surgery duration, postoperative hospitalization duration, mortality rate, PF, and other complications were compared between the two groups. The perioperative relative risk factors that might induce PF were analyzed. RESULTS: External drainage significantly reduced the incidences of post-PD PF, delayed gastric emptying, abdominal infection, bowel obstruction, overall complications, and shortened the healing time of PF (p < .05). The univariate analysis showed that the pancreatic duct drainage method, body mass index (BMI), preoperative serum bilirubin level, perioperative blood transfusion, pancreaticojejunostomy approach, pancreatic texture, pancreatic duct diameter, and primary disease differed markedly between the two groups (p < .05). A multivariate analysis revealed that BMI ≥ 25 kg/m(2), internal pancreatic duct drainage, pancreatic duct diameter <3 mm, soft pancreatic texture, and ampullary disease were independent risk factors for PF. CONCLUSIONS: External pancreatic duct drainage can effectively reduce the morbidity of PF and overall complications after PD.