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Nevin Manimala Statistics

Mammographic Screening in Routine Practice: Multisite Study of Digital Breast Tomosynthesis and Digital Mammography Screenings

Radiology. 2023 Mar 14:221571. doi: 10.1148/radiol.221571. Online ahead of print.

ABSTRACT

Background The use of digital breast tomosynthesis (DBT) is increasing over digital mammography (DM) following studies demonstrating lower recall rates (RRs) and higher cancer detection rates (CDRs). However, inconsistent interpretation of evidence on the risks and benefits of mammography has resulted in varying screening mammography recommendations. Purpose To evaluate screening outcomes among women in the United States who underwent routine DM or DBT mammographic screening. Materials and Methods This retrospective cohort study included women aged 40-79 years who underwent DM or DBT screening mammograms between January 2014 and December 2020. Outcomes of RR, CDR, positive predictive value of recall (PPV1), biopsy rate, and positive predictive value of biopsy (PPV3) were compared between DM and DBT with use of adjusted multivariable logistic regression models. Results A total of 2 528 063 screening mammograms from 1 100 447 women (mean age, 57 years ± 10 [SD]) were included. In crude analyses, DBT (1 693 727 screening mammograms vs 834 336 DM screening mammograms) demonstrated lower RR (10.3% [95% CI: 10.3, 10.4] for DM vs 8.9% [95% CI: 8.9, 9.0] for DBT; P < .001) and higher CDR (4.5 of 1000 screening mammograms [95% CI: 4.3, 4.6] vs 5.3 of 1000 [95% CI: 5.2, 5.5]; P < .001), PPV1 (4.3% [95% CI: 4.2, 4.5] vs 5.9% [95% CI: 5.7, 6.0]; P < .001), and biopsy rates (14.5 of 1000 screening mammograms [95% CI: 14.2, 14.7] vs 17.6 of 1000 [95% CI: 17.4, 17.8]; P < .001). PPV3 was similar between cohorts (30.0% [95% CI: 29.2, 30.9] for DM vs 29.3% [95% CI: 28.7, 29.9] for DBT; P = .16). After adjustment for age, breast density, site, and index year, associations remained stable with respect to statistical significance. Conclusion Women undergoing digital breast tomosynthesis had improved screening mammography outcomes compared with women who underwent digital mammography. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Bae and Seo in this issue.

PMID:36916891 | DOI:10.1148/radiol.221571

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Nevin Manimala Statistics

Cardiac MRI to Predict Sudden Cardiac Death Risk in Dilated Cardiomyopathy

Radiology. 2023 Mar 14:222552. doi: 10.1148/radiol.222552. Online ahead of print.

ABSTRACT

Background Sudden cardiac death (SCD) is one of the leading causes of death in individuals with nonischemic dilated cardiomyopathy (DCM). However, the risk stratification of SCD events remains challenging in clinical practice. Purpose To determine whether myocardial tissue characterization with cardiac MRI could be used to predict SCD events and to explore a SCD stratification algorithm in nonischemic DCM. Materials and Methods In this prospective single-center study, adults with nonischemic DCM who underwent cardiac MRI between June 2012 and August 2020 were enrolled. SCD-related events included SCD, appropriate implantable cardioverter-defibrillator shock, and resuscitation after cardiac arrest. Competing risk regression analysis and Kaplan-Meier analysis were performed to identify the association of myocardial tissue characterization with outcomes. Results Among the 858 participants (mean age, 48 years; age range, 18-83 years; 603 men), 70 (8%) participants experienced SCD-related events during a median follow-up of 33.0 months. In multivariable competing risk analysis, late gadolinium enhancement (LGE) (hazard ratio [HR], 1.87; 95% CI: 1.07, 3.27; P = .03), native T1 (per 10-msec increase: HR, 1.07; 95% CI: 1.04, 1.11; P < .001), and extracellular volume fraction (per 3% increase: HR, 1.26; 95% CI: 1.11, 1.44; P < .001) were independent predictors of SCD-related events after adjustment of systolic blood pressure, atrial fibrillation, and left ventricular ejection fraction. An SCD risk stratification category was developed with a combination of native T1 and LGE. Participants with a native T1 value 4 or more SDs above the mean (1382 msec) had the highest annual SCD-related events rate of 9.3%, and participants with a native T1 value 2 SDs below the mean (1292 msec) and negative LGE had the lowest rate of 0.6%. This category showed good prediction ability (C statistic = 0.74) and could be used to discriminate SCD risk and competing heart failure risk. Conclusion Myocardial tissue characteristics derived from cardiac MRI were independent predictors of sudden cardiac death (SCD)-related events in individuals with nonischemic dilated cardiomyopathy and could be used to stratify participants according to different SCD risk categories. Clinical trial registration no. ChiCTR1800017058 © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Sakuma in this issue.

PMID:36916890 | DOI:10.1148/radiol.222552

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Nevin Manimala Statistics

Flat-panel detector CT to assess intracranial hemorrhage immediately following mechanical thrombectomy

J Neuroimaging. 2023 Mar 14. doi: 10.1111/jon.13098. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: The risk of symptomatic intracranial hemorrhage (ICH) approaches 5% despite mechanical thrombectomy (MT) efficacy for ischemic stroke secondary to large vessel occlusion. Flat-panel detector CT (FDCT) imaging with Syngo Dyna CT imaging (Siemens Medical Solutions, Malvern, PA) can be used immediately following MT to detect ICH.

PURPOSE: To evaluate the accuracy and reliability of FDCT imaging with Dyna CT compared to conventional post-MT CT and MRI.

METHODS: Head FDCT (20 second, 70 kV) was performed immediately following MT on 26 consecutive patients; postprocedural CT or MRI was obtained ∼24 hours later. Two blinded, independent neuroradiologists evaluated all imaging, identifying ICH, stroke, and presence of subarachnoid contrast. Cohen’s κ statistic was used to assess interrater agreement for each imaging outcome and compared the FDCT to conventional imaging.

RESULTS: FDCT for ICH demonstrated a strong degree of interrater reliability (κ = 0.896; 95% confidence interval [CI], 0.734-1.057). Negligible reliability was seen for ischemia determination on immediate post-MT FDCT (κ = 0.149; 95% CI, -0.243 to 0.541). ICH evaluation between FDCT and post-MT conventional CT revealed modest interrater reliability (κ = 0.432; 95% CI, -0.100 to 0.965), which did not reach statistical significance. There was no substantive reliability in the evaluation of ICH between FDCT and post-MT MRI (κ = 0.118, 95% CI, -0.345 to 0.580).

CONCLUSION: FDCT, such as Dyna CT, immediately post-MT is a promising tool that can expedite the detection of ICH with a high degree of reliability, although the detection of ischemic parenchymal changes is limited.

PMID:36916873 | DOI:10.1111/jon.13098

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Nevin Manimala Statistics

Twelve-Month Outcomes of a Novel Iopromide-Based Paclitaxel-Coated Balloon for the Treatment of Chronic Total Occlusion of Femoropopliteal Arteries

Turk Kardiyol Dern Ars. 2023 Mar;51(2):112-118. doi: 10.5543/tkda.2022.25324.

ABSTRACT

OBJECTIVE: We designed a retrospective study to evaluate the performance and outcomes of a novel iopromide-based paclitaxel-coated balloon for the treatment of chronic total occlusion of femoropopliteal arteries.

METHODS: Patients with femoropopliteal chronic total occlusion (<100 mm) on angiogram were screened from hospital management system and were included in the study. The width and length of the drug-eluting peripheral balloon was chosen to ensure a vessel/balloon ratio of 1: 1 and exceed the lesion by 10 mm on both ends (based on visual estimation).

RESULTS: The proportion of patients with ankle-brachial index improvement was 89.8% (106 of 118). The mean ankle-brachial index was 0.5 (0.4-0.7) at baseline and 0.8 (0.7-0.9) at 12 months (P < 0.001). Changes in the Rutherford category between baseline and 12 months were statistically significant (P < 0.001), with the majority of patients (77.9%, 92/118) having ≥1 level improvement. The rate of clinically driven target lesion revasculariza-tion at 12 months was 13.5%(16/118). Overall, the 1-year primary patency rate was 86.4% (102 of 118). The major adverse limb event rate was 9.8% (16/162). Acute limb ischemia was detected in 14 patients, and amputation was performed in 2 patients.

CONCLUSION: Our study is a non-randomized clinical study focusing on the use of drug-eluting balloon as a single treatment strategy. There was significant clinical benefit to patients, as clearly demonstrated by the improvement in ankle-brachial index and the reduction in Rutherford class in the short term, and these results may offer clear insights on the revascularization strategy outlook of interventionalists.

PMID:36916806 | DOI:10.5543/tkda.2022.25324

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Nevin Manimala Statistics

Prognostic factors for delayed healing of complex wounds in adults: A scoping review

Int Wound J. 2023 Mar 14. doi: 10.1111/iwj.14128. Online ahead of print.

ABSTRACT

Complex or hard-to-heal wounds continue to be a challenge because of the negative impact they have on patients, caregivers, and all the associated costs. This study aimed to identify prognostic factors for the delayed healing of complex wounds. Five databases and grey literature were the sources used to research adults with pressure ulcers/injuries, venous leg ulcers, critical limb-threatening ischaemia, or diabetic foot ulcers and report the prognostic factors for delayed healing in all care settings. In the last 5 years, a total of 42 original peer-reviewed articles were deemed eligible for this scoping review that followed the JBI recommendations and checklist PRISMA-ScR. The most frequent prognostic factors found with statistical significance coinciding with various wound aetiologies were: gender (male), renal disease, diabetes, peripheral arterial disease, the decline in activities of daily life, wound duration, wound area, wound location, high-stage WIfI classification, gangrene, infection, previous ulcers, and low ankle brachial index. It will be essential to apply critical appraisal tools and assessment risk of bias to the included studies, making it possible to make recommendations for clinical practice and build prognostic models. Future studies are recommended because the potential for healing through identification of prognostic factors can be determined, thus allowing an appropriate therapeutic plan to be developed.

PMID:36916415 | DOI:10.1111/iwj.14128

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Nevin Manimala Statistics

Integrated gene profiling of fine-needle aspiration sample improves lymph node metastasis risk stratification for thyroid cancer

Cancer Med. 2023 Mar 14. doi: 10.1002/cam4.5770. Online ahead of print.

ABSTRACT

BACKGROUND: Lymph node metastasis risk stratification is crucial for the surgical decision-making of thyroid cancer. This study investigated whether the integrated gene profiling (combining expression, SNV, fusion) of Fine-Needle Aspiration (FNA) samples can improve the prediction of lymph node metastasis in patients with papillary thyroid cancer.

METHODS: In this retrospective cohort study, patients with papillary thyroid cancer who went through thyroidectomy and central lymph node dissection were included. Multi-omics data of FNA samples were assessed by an integrated array. To predict lymph node metastasis, we built models using gene expressions or mutations (SNV and fusion) only and an Integrated Risk Stratification (IRS) model combining genetic and clinical information. Blinded histopathology served as the reference standard. ROC curve and decision curve analysis was applied to evaluate the predictive models.

RESULTS: One hundred and thirty two patients with pathologically confirmed papillary thyroid cancer were included between 2016-2017. The IRS model demonstrated greater performance [AUC = 0.87 (0.80-0.94)] than either expression classifier [AUC = 0.67 (0.61-0.74)], mutation classifier [AUC = 0.61 (0.55-0.67)] or TIRADS score [AUC = 0.68 (0.62-0.74)] with statistical significance (p < 0.001), and the IRS model had similar predictive performance in large nodule [>1 cm, AUC = 0.88 (0.79-0.97)] and small nodule [≤1 cm, AUC = 0.84 (0.74-0.93)] subgroups. The genetic risk factor showed independent predictive value (OR = 10.3, 95% CI:1.1-105.3) of lymph node metastasis in addition to the preoperative clinical information, including TIRADS grade, age, and nodule size.

CONCLUSION: The integrated gene profiling of FNA samples and the IRS model developed by the machine-learning method significantly improve the risk stratification of thyroid cancer, thus helping make wise decisions and reducing unnecessary extensive surgeries.

PMID:36916410 | DOI:10.1002/cam4.5770

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Nevin Manimala Statistics

Differences in Beliefs About Suicide by Occupation in a Representative Sample of Adults in the United States, General Social Survey 2002-2021

Arch Suicide Res. 2023 Mar 14:1-15. doi: 10.1080/13811118.2023.2190363. Online ahead of print.

ABSTRACT

OBJECTIVE: Beliefs about suicide are important aspects of suicide prevention gatekeeper trainings. This study sought to determine if workers in finance- and legal/judicial-related industries have significantly different levels of suicide acceptability compared to the general US population.

METHOD: Cross-sectional data are from the 2002 to 2021 General Social Survey (GSS). Suicide acceptability was measured with four dichotomous items to which respondents indicated yes/no if they thought someone has the right to end their life in four negative life scenarios. Occupational categories were coded based on U.S. Census Bureau occupation and industry codes. Covariates for multiple logistic regression analyses included age, educational attainment, sex, race, ethnicity, survey year, and religiosity.

RESULTS: Among the 15,166 respondents, 651 people worked in finance-related occupations and 319 people worked in legal/judicial-related occupations. In adjusted models, people in finance-related occupations had greater odds of endorsing suicide as acceptable if one has an incurable disease (aOR = 1.25, 95%CI = 1.03-1.52) and marginally greater odds of endorsing suicide as acceptable if one dishonors their family (aOR = 1.31, 95%CI = 0.99-1.74) than the general adult population. People in legal/judicial-related occupations were more likely to endorse 3 of the 4 suicide acceptability items compared to the general adult population, however these differences were not statistically significant after accounting for demographic factors.

CONCLUSION: Workers in non-clinical industries that frequently see clients during negative life events are prime audiences for gatekeeper trainings but may have entrenched beliefs about suicide acceptability. Research is needed to determine how these beliefs may impact gatekeeper training.HIGHLIGHTSNegative life events (e.g., divorce) are common correlates of suicidal crisisSuicide acceptability differed by occupation type compared to the general US adult populationFinancial- and legal/judicial workers may need more tailored suicide gatekeeper training.

PMID:36916390 | DOI:10.1080/13811118.2023.2190363

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Nevin Manimala Statistics

Cross-sectional survey of preoperative nutritional status of cardiac surgery patients in southwest China

Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2023 Feb;35(2):195-200. doi: 10.3760/cma.j.cn121430-20221215-01100.

ABSTRACT

OBJECTIVE: To investigate the preoperative nutritional status of cardiac surgery patients in southwest China, analyze the incidence and characteristics of nutritional risk, and provide basis for establishing a standardized individualized nutritional intervention program for cardiac surgery patients.

METHODS: A cross-sectional survey was conducted on the nutritional status and intervention status of preoperative patients in cardiac surgery department of 23 general hospitals in Yunnan, Guizhou, Sichuan and Chongqing districts. At 00: 00 on July 7, 2022, the patients aged > 18 years old in cardiac surgery departments of the above hospitals who planned to undergo surgical treatment were enrolled as the survey objects to investigate the nutritional status on July 6, 2022 (the survey date), including basic information (general information, nutrition indicators, etc.), nutrition screening and evaluation (nutrition risk screening and organ support, etc.), nutrition treatment (nutrition supplement methods and prescriptions, etc.) and nutrition awareness of medical staff.

RESULTS: The 126 questionnaires were collected, of which 125 were valid (99.2%). (1) Basic information: of the 125 patients, 67 patients were male (53.6%) and 58 patients were female (46.4%). The age ranged from 19 years old to 86 years old, with an average of (53.13±14.74) years old. Body mass index (BMI) was (22.21±3.78) kg/m2. The age and BMI of men were significantly higher than those of women [age (years old): 56.63±13.34 vs. 49.09±15.35, BMI (kg/m2): 22.74±3.86 vs. 21.59±3.61, both P < 0.05]. Of the 125 patients, 75 had valvular disease and 50 were with non-valvular diseases, which mainly included congenital heart disease [19 cases (15.2%)], aortic dissection [13 cases (10.4%)], coronary heart disease [12 cases (9.6%)], etc. The course of disease was 0.5 hour to 36 years, of which 93 patients (74.4%) were more than 6 months and 32 patients (25.6%) were equal to or less than 6 months. The proportion of female patients with disease duration > 6 months was significantly higher than that of male patients [87.9% (51/58) vs. 62.7% (42/67), P < 0.01]. The basic diseases mainly included hypertension [38 cases (30.4%)], coronary heart disease [12 cases (9.6%)], diabetes [7 cases (5.6%)], chronic obstructive pulmonary disease [COPD, 6 cases (4.8%)], etc. Among 125 patients, total protein (TP) < 60 g/L in 24 cases (19.2%), albumin (Alb) < 40 g/L in 64 cases (51.2%), anemia [male hemoglobin (Hb) < 120 g/L, female Hb < 110 g/L] in 33 cases (26.4%). A total of 60 cases of prealbumin data were collected, of which 23 cases (38.3%) were less than 200 mg/L. (2) Nutrition screening and assessment: 33.6% of the 125 patients did not undergo routine nutrition screening after admission, including the provincial and municipal tertiary hospitals. Among the 83 patients undergoing nutritional screening, 41 (32.8%) were at nutritional risk. Further analysis of patients with nutritional risk showed that of the 41 patients, 20 were male (48.8%) and 21 were female (51.2%); 27 cases (65.9%) was with valvular diseases and 14 cases (34.1%) was with non-valvular diseases; the course of disease was more than 6 months in 30 cases (73.2%), and ≤ 6 months in 11 cases (26.7%). Statistical comparison of the above 83 patients showed that women, basic disease, long term-valvular disease, anemia, low TP, and low Alb before operation were more prone to innutrition. (3) Nutritional therapy: of the 125 patients, 5 were receiving mechanical ventilation (4.0%) and 2 were using vasoactive drugs (1.6%); there were 5 cases with gastrointestinal dysfunction (4.0%), mainly manifested as abdominal distension, abdominal pain, constipation and diarrhea. One patient was treated with enteral nutrition through gastric tube combined with parenteral nutrition support, 124 patients were fed orally, and an irregular phenomenon of injecting amino acid fat emulsion through peripheral vein in 2 patients. (4) Nutrition awareness of medical staff: 124 (99.2%) of the 125 patients had a nutrition department in their hospital; 71 cases (56.8%) received nutrition education, of which 37 cases (52.1%) were consulted by the nutrition department. Of all the cases, only 38 (30.4%) were consulted by the nutrition department, of which 1 (2.6%) did not receive nutrition education after consultation.

CONCLUSIONS: At present, the incidence of preoperative malnutrition in patients undergoing cardiac surgery is high in southwest China. The incidence of malnutrition in patients with basic diseases, long term-valvular disease, low TP, low Alb and anemia before operation is higher, and the incidence of malnutrition is hidden in women. The course of disease of women is longer than that of men at the time of treatment, and malnutrition is more likely to occur. The attending physicians should pay attention to the above groups. It is necessary to establish a standardized individualized nutritional intervention program and apply it to actual clinical diagnosis and treatment, so as to ultimately improve the prognosis of patients undergoing cardiac surgery and increase the benefits of patients in treatment.

PMID:36916381 | DOI:10.3760/cma.j.cn121430-20221215-01100

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Nevin Manimala Statistics

Predictive value of diaphragm thickening fraction and intra-abdominal pressure monitoring-oriented risk prediction model for weaning failure in patients with severe acute pancreatitis

Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2023 Feb;35(2):177-181. doi: 10.3760/cma.j.cn121430-20220930-00873.

ABSTRACT

OBJECTIVE: To establish a risk prediction model dominated by diaphragm thickening fraction (DTF) and intra-abdominal pressure (IAP) monitoring, and to explore the predictive value of the model for weaning failure in patients with severe acute pancreatitis (SAP).

METHODS: A prospective research was conducted. Sixty-three patients undergoing invasive mechanical ventilation treatment who diagnosed with SAP admitted to intensive care unit of the First Affiliated Hospital of Jinzhou Medical University from August 2020 to October 2021 were enrolled. The spontaneous breathing trial (SBT) was carried out when the clinical weaning criteria was met. The stable cardiovascular status, good pulmonary function, no chest and abdominal contradictory movement, and adequate oxygenation were defined as successful weaning. Otherwise, it was defined as failure weaning. The clinical indicators such as SBT 30-minure DTF, IAP, tidal volume (VT), respiratory rate (RR), body mass index (BMI), and blood lactic acid (Lac) were compared between the weaning success group and the weaning failure group. The indicators with statistically significant differences in the single-factor analysis were included in the secondary multivariable Logistic regression analysis to establish a risk prediction model. The correlation between the DTF and IAP at 30 minutes of SBT was analyzed. Receiver operator characteristic curve (ROC curve) was drawn to analyze the predictive value of the risk prediction model for SAP patient withdrawal failure at 30 minutes of SBT.

RESULTS: Finally, 63 patients with SAP were enrolled. Among the 63 patients, 42 were successfully weaned and 21 failed. There were no significant differences in age, gender, and oxygenation index (PaO2/FiO2), sequential organ failure assessment (SOFA) score, acute physiology and chronic health evaluation II (APACHE II) score at admission between the two groups, indicating that the data in the two groups were comparable. Compared with the weaning success group, IAP, RR, BMI and Lac at 30 minutes of SBT in the weaning failure group were significantly increased [IAP (mmHg, 1 mmHg ≈ 0.133 kPa): 14.05±3.79 vs. 12.12±3.36, RR (times/min): 25.43±8.10 vs. 22.02±5.05, BMI (kg/m2): 23.71±2.80 vs. 21.74±3.79, Lac (mmol/L): 5.27±1.69 vs. 4.55±1.09, all P < 0.05], while DTF and VT were significantly decreased [DTF: (29.76±3.45)% vs. (31.86±3.67)%, VT (mL): 379.00±98.74 vs. 413.60±33.68, both P < 0.05]. Secondary multivariable Logistic regression analysis showed that DTF [odds ratio (OR) = 0.758, 95% confidence interval (95%CI) was 0.584-0.983, P = 0.037], IAP (OR = 1.276, 95%CI was 1.025-1.582, P = 0.029), and RR (OR = 1.145, 95%CI was 1.014-1.294, P = 0.029) were independent risk factors for SBT withdrawal failure in 30 minutes in SAP patients. The above risk factors were used to establish the risk prediction model of aircraft withdrawal failure at 30 minutes of SBT: Logit P = -0.237-0.277×DTF+0.242×IAP+0.136×RR. Pearson correlation analysis showed that SBT 30-minute DTF was significantly correlated with IAP in SAP patients, and showed a significant positive correlation (r = 0.313, P = 0.012). The ROC curve analysis results showed that area under the ROC curve (AUC) of the risk prediction model for SAP patient withdrawal failure at 30 minutes of SBT was 0.716, 95%CI was 0.559-0.873, P = 0.003, with the sensitivity of 85.7% and the specificity of 78.6%.

CONCLUSIONS: DTF, IAP and RR were independent risk factors for SBT withdrawal failure in 30 minutes in SAP patients. The DTF and IAP monitoring-oriented risk prediction model based on the above three variables has a good predictive value for weaning failure in patients with SAP.

PMID:36916378 | DOI:10.3760/cma.j.cn121430-20220930-00873

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Dachengqi decoction reduces inflammatory response and promotes recovery of gastrointestinal function in patients with mild acute pancreatitis by regulating the intestinal microbiota

Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2023 Feb;35(2):170-176. doi: 10.3760/cma.j.cn121430-20220921-00852.

ABSTRACT

OBJECTIVE: To explore the therapeutic effect and mechanism of Dachengqi decoction on patients with mild acute pancreatitis (MAP).

METHODS: A parallel randomized controlled trial was conducted. Sixty-eight patients with acute pancreatitis (AP) admitted to Shanghai Traditional Chinese Medicine (TCM)-Integrated Hospital from March 2018 to February 2021 were enrolled. Referring to the condition on admission of the patients and whether they agreed to receive the Dachengqi decoction or not, they were divided into conventional treatment group and Dachengqi decoction group according to the principle of 1:1 equal randomness. Meanwhile, 20 healthy volunteers were recruited as controls. Both groups of patients were treated with octreotide, fasting, gastrointestinal decompression, antipyretic and analgesic, anti-inflammatory, inhibition of gastric acid and pancreatic juice secretion, maintenance of electrolyte balance and other western conventional medicine. The patients in the Dachengqi decoction group received Dachengqi decoction orally on the basis of routine treatment, 100 mL each time, twice a day, for seven consecutive days. The inflammation parameters [white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6)] before and after treatment and the recovery time of gastrointestinal function (first exhaust time, time to recover bowel sounds, first defecation time) of patients were recorded. 16S rRNA gene sequencing of stool samples was recorded, and normalized data were obtained after quality control and other related processing. The data were subjected to diversity analysis (Alpha diversity and Beta diversity) and linear discriminant analysis effect size analysis (LEfSe analysis) to observe changes in the gut microbiota of MAP patients. Spearman rank correlation coefficient was used to analyze the correlation between inflammatory indexes and microorganisms at the intestinal genus level. Blood, urine, stool samples, renal function, and electrocardiogram (ECG) during treatment of MAP patients were detected to assess the safety of the treatment.

RESULTS: Of the 68 patients with AP, 16 were excluded from moderate-severe AP, 4 were not collected or voluntarily abandoned treatment. Finally, 48 patients with MAP were enrolled, 24 in the conventional treatment group and 24 in the Dachengqi decoction group. The inflammation parameters levels at 7 days of treatment in both groups were significantly lower than those before treatment. CRP, PCT and IL-6 levels in the Dachengqi decoction group were significantly lower than those in the conventional treatment group [CRP (mg/L): 8.50 (3.50, 13.00) vs. 16.00 (9.25, 29.75), PCT (μg/L): 0.06 (0.03, 0.08) vs. 0.09 (0.05, 0.11), IL-6 (ng/L): 6.36 (3.96, 10.79) vs. 13.24 (6.69, 18.87), all P < 0.05]. The first exhaust time, time to recover bowel sounds and first defecation time in the Dachengqi decoction group were significantly shorter than those in the conventional treatment group [first exhaust time (days): 1.62±0.65 vs. 2.80±0.65, time to recover bowel sounds (days): 1.13±0.58 vs. 2.31±0.76, first defecation time (days): 3.12±0.75 vs. 4.39±0.76, all P < 0.05]. The analysis of intestinal microflora diversity showed that both the diversity and abundance of microbial communities were the highest in the healthy control group and the lowest in the conventional treatment group. In addition, the coincidence degree of microbial communities in healthy controls and MAP patients was small, while the coincidence degree of MAP patients among different treatment methods was relatively large. LEfSe analysis showed that Dachengqi decoction reduced the relative abundance of Escherichia coli-Shigella and Clostridium erysipelae, and increased the relative abundance of three beneficial bacteria, namely Lactobacillus, Rombutzia and Brutella. In the intestines of MAP patients, Lactobacillus mucilaginus and Lactobacillus conjunctus were significantly enriched. Correlation analysis showed that positive correlations between Escherichia coli-Shigella and the four inflammatory indicators including WBC, CRP, PCT, IL-6 were statistically significant (r value was 0.31, 0.41, 0.57, 0.43, respectively, all P < 0.05). There was no significant correlation between other bacteria and inflammatory indicators. During the treatment, there was no obvious abnormality in blood, urine and feces, renal function and ECG of MAP patients.

CONCLUSIONS: Dachengqi decoction could reduce inflammatory responses and promote recovery of intestinal microecological balance and gastrointestinal function in patients with MAP by regulating the composition of intestinal flora. No significant adverse effects were observed during the treatment period.

PMID:36916377 | DOI:10.3760/cma.j.cn121430-20220921-00852