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Real-world Data Study of the Efficacy and Toxicity of Nivolumab vs. Cetuximab and Predictors of Response to Nivolumab in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck in a European Population

Anticancer Res. 2023 Apr;43(4):1681-1688. doi: 10.21873/anticanres.16320.

ABSTRACT

BACKGROUND/AIM: This study aimed to assess the effectiveness and safety of nivolumab versus cetuximab in patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M HNSCC), as well as to analyze possible prognostic factors for response to treatment with nivolumab.

PATIENTS AND METHODS: We conducted an observational, retrospective, descriptive study of patients with R/M HNSCC who initiated treatment with nivolumab or cetuximab monotherapy in two periods of equivalent duration. Overall efficacy was measured in terms of progression-free survival (PFS) and overall survival (OS). Safety was evaluated using the Common Terminology Criteria for Adverse Events classification version 5.0 of the National Cancer Institute.

RESULTS: Median OS was 9.1 months with nivolumab (n=34) and 6.3 months with cetuximab (n=12). PFS was 4.3 months for nivolumab and 4.65 months for cetuximab. Any grade adverse events (AEs) were reported in 97% and 100% of the patients treated with nivolumab and cetuximab. Serious AEs were observed in 26% and 58% of the patients, respectively. Elevated albumin values, lymphocytosis, neutropenia, and elevated neutrophil/lymphocyte ratio values were found to have positive prognostic value on the response to nivolumab in R/M HNSCC.

CONCLUSION: Effectiveness of nivolumab in terms of OS remains superior to cetuximab. OS, PFS and severe or any grade AEs were superior in both arms of our study compared to those in clinical trials. The AEs profile of nivolumab differed in our study from that in the clinical trials’ observations. We have identified four statistically significant prognostic variables on the response to nivolumab in R/M HNSCC.

PMID:36974777 | DOI:10.21873/anticanres.16320

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Accuracy and reliability of tele-ultrasonography in detecting gastrointestinal obstruction in dogs and cats

J Small Anim Pract. 2023 Mar 27. doi: 10.1111/jsap.13604. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess the accuracy and interobserver agreement of tele-ultrasonography for the diagnosis of gastrointestinal obstruction in small animals by radiologists with different levels of experience.

MATERIALS AND METHODS: A retrospective cross-sectional study including dogs and cats admitted with gastrointestinal signs, between 2017 and 2019, that had abdominal ultrasonographic (US) examination performed and images saved for review. Patients were classified into two categories based on final diagnosis: animals with or without complete or partial gastrointestinal obstruction. Observers with four experience levels interpreted the archived ultrasound examinations, simulating a tele-ultrasonography consultation. Analyses of accuracy, sensitivity, specificity, positive and negative predictive values were obtained for each observer for detection of gastrointestinal obstruction. Agreement between observers for the gastrointestinal obstruction diagnosis was assessed using Fleiss’s Kappa statistics.

RESULTS: Ninety patients with gastrointestinal signs were included. Of these, 23 of 90 had partial or complete gastrointestinal obstruction. Interpretation of the images by observers via tele-ultrasonography showed intervals of accuracy, sensitivity, specificity, positive and negative predictive values, respectively, of 78.9% to 87.8%, 73.9% to 100%, 77.6% to 89.6%, 55.9% to 70.8% and 90.9% to 100% for diagnosis of gastrointestinal obstruction. Agreement for the gastrointestinal obstruction diagnosis across all reviewers was moderate (Kappa 0.6).

CLINICAL SIGNIFICANCE: Tele-ultrasonography had good accuracy for detection of gastrointestinal obstruction, however had a rather low positive predictive value and only moderate interobserver agreement. Therefore, this technique should be used with caution in this clinical context, given the potential surgical decision at hand.

PMID:36973863 | DOI:10.1111/jsap.13604

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Patient Complaints to the Saudi Medical Call Center: Representative Response Strategies

Health Commun. 2023 Mar 27:1-13. doi: 10.1080/10410236.2023.2189997. Online ahead of print.

ABSTRACT

This study aims to investigate the strategies and modifications employed by the Complaint Unit Representatives (CURs) in response to complaints recorded in the formal workplace of a medical institution in the Saudi Ministry of Health (MOH). A pragmatic discourse analytic approach was adopted to construct an analytical framework for authentic spoken complaint responses in the Saudi medical institution context. The data were randomly collected from 80 recorded phone conversations between patients and the CURs. It was transcribed verbatim, imported into MAXQDA for qualitative analysis of codes categorizations, and then into SPSS for statistical analysis. The findings showed that the staff employed a balance of transactional and interpersonal approaches in their response strategies, which varied in both quantity and quality depending on the phase or the major sequence of the moves made in the complaint call. Specifically, more transactional strategies were used during the main portion of a complaint and in the medial phase, while more interpersonal strategies were employed during the initial and the final phases of the call. The findings also showed that the CURs tended to downgrade and mitigate their responses to patients’ complaints, and they never used upgraders. The influence of the religious culture was also noticeable in their use of downgraders, including optimistic devices and religious expressions. These findings reveal practical implications that can aid the quality team of the Complaint Unit (CU) in assessing the effectiveness and efficiency of the CURs’ response strategies when handling complaints, and in providing more effective communication training as needed.

PMID:36973861 | DOI:10.1080/10410236.2023.2189997

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Application of nitrous oxide/oxygen inhalation comfort technique during tooth extraction of elderly hypertensive patients under electrocardiographic monitoring

Shanghai Kou Qiang Yi Xue. 2023 Feb;32(1):97-100.

ABSTRACT

PURPOSE: To investigate the application value of nitrous oxide/oxygen inhalation comfort technique during tooth extraction in elderly patients with hypertension under electrocardiographic(ECG) monitoring.

METHODS: According to the inclusion and exclusion criteria, sixty elderly patients (over 65 years old) with hypertension for tooth extraction were randomly divided into 2 groups: the experimental group(nitrous oxide/oxygen inhalation combined with ECG monitoring group, n=30) and the control group (routine ECG monitoring group, n=30). Mean arterial pressure (MAP) and heart rate (HR) at T0 (baseline values before surgery), T1 (on local anesthesia), T2 (during operation) and T3(5 minutes after operation) were recorded. SPSS 25.0 software package was used for statistical analysis.

RESULTS: There was no significant difference in MAP and HR at each time point in the experimental group(P>0.05). There was no significant difference in MAP and HR at T0 and T3 time points in the control group(P>0.05). At other time points, MAP and HR were significantly different (P<0.05). There was no significant differences in MAP and HR between the two groups at T0 and T3(P>0.05). MAP and HR at T1 and T2 in the experimental group were significantly less than those in the control group(P<0.05).

CONCLUSIONS: Nitrous oxide/oxygen inhalation comfort technology can stabilize patients’ emotions and maintain stable blood pressure and heart rate in elderly patients with hypertension during tooth extraction, thus improving the safety of tooth extraction.

PMID:36973852

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Three-dimensional assessment and study on temporomandibular joint and the maxillary characteristics of skeletal Class Ⅲ mandibular deviation patients

Shanghai Kou Qiang Yi Xue. 2023 Feb;32(1):91-96.

ABSTRACT

PURPOSE: To study the temporomandibular joint morphology and position and the maxillary characteristics of skeletal Class Ⅲ mandibular deviation patients with vertical disproportion in bilateral gonions.

METHODS: Overall 79 adult patients with skeletal Class Ⅲ malocclusions were selected. Craniofacial spiral CT scanning was performed, and three-dimensional reconstruction of the temporomandibular joint(TMJ) was carried out by using ProPlan CMF3.0 three-dimensional analysis software. The patients were divided into two groups according to the deviation degree of the mentum: symmetric group (the S group: n=24) and deviation group (n=55). The deviation group was divided into two subgroups according to whether there was vertical disproportion in bilateral gonions, i.e., ASV group: there were vertical differences in bilateral gonions(n=27), and ASNV group: there was no vertical difference in bilateral gonions (n=28). Seven condylar morphological and position indicators and nine maxilla-related indicators were measured. SPSS 22.0 software package was used for statistical analysis.

RESULTS: In deviation group, the condylar length on the deviated side was shorter than the opposite side, the difference value between the two sides was greater than the symmetric group, and there were asymmetry and different degrees of disproportion in the three-dimensional direction in the maxilla. In ASV group, the angle of the condylar axis to the horizontal plane on the deviated side was smaller and the anteroposterior diameter of the condyle was smaller. In ASV group, the mediolateral dimension of condyle on the deviated side were smaller. From variance analysis and multiple comparisons, the difference of condylar length on both sides in ASV group and ASNV group was greater than that in the symmetric group. There were asymmetries in the maxillae in ASV group and ASNV group, and the maxillary width on the deviated side was greater than that on non-deviated side. Transverse maxillary disproportion was more likely to occur in the ASNV group. The vertical maxillary disproportion on both sides in ASV group was larger than that in ASNV group and S group, and the deviated side was smaller than the opposite side.

CONCLUSIONS: The TMJ morphology and position of skeletal Class Ⅲ mandibular deviation patients with vertical disproportion in bilateral gonions and the maxillary asymmetry in the three-dimensional direction require attention in the diagnosis and conceptual design of surgical-orthodontic treatment.

PMID:36973851

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Expression level and clinical significance of CD44 and CD33 in 77 patients with benign lymphoadenosis of oral mucosa

Shanghai Kou Qiang Yi Xue. 2023 Feb;32(1):80-84.

ABSTRACT

PURPOSE: To investigate the expression and clinical significance of CD44 and CD33 in benign lymphoadenosis of oral mucosa(BLOM).

METHODS: From January 2017 to March 2020, seventy-seven BLOM wax blocks from the Department of Pathology of Qingdao Traditional Chinese Medicine Hospital were selected as the experimental group, and 63 cases of normal oral mucosal tissue wax blocks during the same period were selected as the control group. Immunohistochemical method was used to detect the positive expression of CD44 and CD33 in the two groups.Spearman correlation analysis was used to analyze the correlation between the positive expression of CD33 and the positive expression of CD44 in the diseased tissues of BLOM patients.The general information about patients were collected.The relationship between the expression of CD33 and CD44 in the diseased tissues of BLOM patients and the clinicopathological characteristics of BLOM patients were analyzed. SPSS 21.0 software package was used for statistical analysis of the data.

RESULTS: The positive expression rates of CD33 in the control group and the experimental group were 95.24% and 63.64%, respectively, and the difference was statistically significant(P<0.05). The positive expression rates of CD44 in the control group and the experimental group were 93.65% and 67.53%, respectively, and the difference was statistically significant(P<0.05). The results of Spearman correlation analysis showed that the positive expression of CD33 in the diseased tissues of BLOM patients was positively correlated with the positive expression of CD44 (r=0.834, P=0.002). The expression of CD33 and CD44 in the diseased tissues of patients with BLOM were related to clinical type, degree of inflammation, presence or absence of lymphoid follicles, and lymphocyte infiltration(P<0.05), but not related to age, gender, course of disease, location, and epithelial surface keratinization(P>0.05).

CONCLUSIONS: The positive expression rate of CD33 and CD44 in the BLOM tissues decreased, which was closely related to the clinical type, degree of inflammation, presence or absence of lymphoid follicles, and lymphocyte infiltration.

PMID:36973849

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Comparative study on extraction of impacted mandibular wisdom teeth by Er:YAG laser and turbine handpiece

Shanghai Kou Qiang Yi Xue. 2023 Feb;32(1):75-79.

ABSTRACT

PURPOSE: To compare the clinical effect of Er:YAG laser and turbine handpiece in the removal of lower horizontally impacted wisdom teeth, and to evaluate the operation time, postoperative pain, facial swelling, degree of mouth opening limitation and complications.

METHODS: From March 2020 to May 2022, forty patients with bilateral lower mandibular horizontally impacted wisdom teeth in the Department of Oral and Maxillofacial Surgery of Linyi People’s Hospital were selected,and all bilateral wisdom teeth were partially bone buried. The bilateral wisdom teeth of each patient were removed by Er:YAG laser on one side and turbine handpiece on the other side, respectively. The patients were divided into experimental(laser) group and control(turbine handpiece) group according to the ways of bone removal on each side. The clinical effect of the two groups was compared after a week of follow-up. Statistical analysis was performed with SPSS 19.0 software package.

RESULTS: There was no significant difference between the two groups in operation time(P>0.05). The incidence of postoperative pain, facial swelling, mouth opening limitation and complications in the experimental group were significantly lower than those in the control group(P<0.05).

CONCLUSIONS: The operation time of extraction with Er:YAG laser is similar to that with turbine handpiece, but laser can reduce postoperative reaction and the incidence of complications, which is easy to be accepted by patients and worthy of wide application.

PMID:36973848

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Impact of maternal caries risk on children’s caries susceptibility

Shanghai Kou Qiang Yi Xue. 2023 Feb;32(1):63-68.

ABSTRACT

PURPOSE: To evaluate the impact of caries risk of pregnant mothers on caries susceptibility of infants in order to provide a basis for effective control and prevention of the occurrence and development of early childhood caries.

METHODS: A total of 140 pregnant women and infants from 4 to 9 months of gestation in Xicheng and Miyun Maternal and Child Health Hospital were selected as the study subjects. According to WHO 2013 caries diagnosis standard, oral examination, questionnaire survey and stimulating saliva samples of pregnant mothers were collected. Caries activity was determined using the Dentocult SM, Dentocule LB and Dentobuff Strip standard kit. At 6 months, 1 year, and 2 years, caries was recorded and resting saliva samples were collected. Nested PCR was used to detect the colonization of S.mutans in infants at 6 months, 1 year, and 2 years of age. Statistical analysis was concluded with SPSS 21.0 software package.

RESULTS: After 2 years of observation, the rate of lost follow-up was 11.43%, 124 pairs of mother-child were followed up. The study was divided into moderate and low caries risk (LCR) group and high caries risk (HCR) group based on the number of open caries (untreated cavities) in mothers, detection of Streptococcus mutans by Dentocult SM, Lactobacillus by Dentocule LB, saliva buffering capacity by Dentbuff Strip, and questionnaire results. The results showed that the prevalence of white spot(18.33%) and dmft (0.3±0.087) in HCR group were significantly higher than those in LCR group (3.13%, 0.06±0.044) (P<0.05) at one-year old children. The prevalence of white spot (21.67%) and dmft (0.33±0.088) in HCR group were significantly higher than those in LCR group (6.25%, 0.09±0.048) (P<0.05) at two-year old children. The prevalence of caries (20.00%) and dmft (0.33±0.10) in HCR group were significantly higher than those in LCR group (6.25%, 0.11±0.055)(P<0.05) at two-year old children. The detection rate of S.mutans in HCR group was significantly higher than that in LCR group at 6 months, 1-year old and 2-year old children(P<0.05). The prevalence of dental caries (29.62%) and dmft (0.67±0.22) in children with S.mutans detected at 6 months were significantly higher than those in children without S.mutans detected (13.40%) and dmft (0.30±0.082) (P<0.05).

CONCLUSIONS: After 2 years of observation, mothers with high caries risk also had higher caries susceptibility in their children. At the same time, the high risk of dental caries in mothers affected the colonization of S.mutans in children’s oral cavity to a certain extent; and the earlier colonization of S.mutans, the higher risk of dental caries at 2-year old children. Therefore, intervention of oral health behaviors of mothers with high caries risk in early pregnancy can effectively prevent or reduce the occurrence and development of ECC to some extent by blocking or delaying the vertical transmission of S.mutans.

PMID:36973846

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Assessment of the reproducibility of occlusal morphology for digital full crown designed by mandibular trajectory data

Shanghai Kou Qiang Yi Xue. 2023 Feb;32(1):58-62.

ABSTRACT

PURPOSE: To metrically assess the reproducibility of mandibular trajectory data and mean frame parameter in guiding the design of occlusal morphology of prosthesis.

METHODS: Fifteen subjects with complete dentition were selected, including 6 females and 9 males, with an average age of 22-30 years old. The mandibular trajectory data and mean frame parameter were used to guide the design of occlusal morphology of the prosthesis in the CAD system, then the occlusal morphology was compared to the original natural teeth. The data were statistically analyzed by SPSS 25.0 software package.

RESULTS: The general deviation of occlusal morphology between the prosthesis guided by mandibular trajectory data and mean frame parameter with the natural teeth was as follows: mean positive distance was (269.9±63.1) μm, (318.7±51.3) μm; mean negative distance was (-175.8±78.2) μm, (-253.7±65.6) μm; root mean square (RMS) was (267.1±84.9) μm and (304.1±82.2) μm. The vertical distance on mesial buccal cusp was (197.6±86.2) μm and (288.0±79.6) μm,distal buccal cusp was (176.3±85.3) μm and (297.7±63.2) μm, mesial lingual cusp was (171.6±62.4) μm and (246.4±62.8) μm, distal lingual cusp was (166.2±64.6) μm and (232.5±70.7) μm, central fossa was (104.9±42.2) μm and (219.1±69.1) μm. RMS, mean(-) and vertical differences of central fossa and distal buccal cusp were significantly different(P<0.05).

CONCLUSIONS: The occlusal morphology of the prosthesis designed under the guidance of mandibular trajectory data and mean frame parameter both have significant differences with natural occlusion, but the deviation guided by mandibular trajectory data is lower.

PMID:36973845

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Relationship between sICAM-1, IL-1β and HIF-1α levels in gingival sulcus fluid and peri-implantitis in patients with implant restoration

Shanghai Kou Qiang Yi Xue. 2023 Feb;32(1):47-51.

ABSTRACT

PURPOSE: To investigate the relationship between the levels of soluble intercellular adhesion molecule-1 (sICAM-1), interleukin-1β (IL-1β) and hypoxia-inducible factor-1α (HIF-1α) in gingival sulcus fluid and peri-implantitis (PI) in patients with implant restoration.

METHODS: A total of 198 patients with implant restoration admitted to Fengcheng Hospital from January 2019 to December 2021 were selected, the patients were divided into PI and non-PI group according to whether the implant restoration was complicated by PI 3 months after restoration. The levels of sICAM-1, IL-1β and HIF-1α in the gingival sulcus fluid prior to implant restoration were measured by enzyme-linked immunosorbent assay. Multi-factor logistic regression was used to analyze the factors influencing concurrent PI in patients with implant restoration. ROC curves were used to analyze the predictive value of sICAM-1, IL-1β and HIF-1α levels in gingival sulcus fluid on concurrent PI in patients with implant restoration. SPSS 28.0 software package was used for statistical processing of the data.

RESULTS: The incidence of PI in 198 patients with implant restoration was 17.68% (35/198) 3 months after implant restoration. The levels of sICAM-1, IL-1β and HIF-1α in the gingival sulcus fluid were significantly higher in the PI group than in the non-PI group (P<0.05). Multi-factor logistic regression analysis showed that elevated sICAM-1(OR=1.135, 95%CI: 1.066-1.208), IL-1β (OR=1.106, 95%CI: 1.054-1.161) and HIF-1α (OR=1.008, 95%CI: 1.004-1.012) were independent risk factors for complications of PI in prosthetic patients(P<0.05). ROC curve analysis showed that the area under the curve for sICAM-1, IL-1β and HIF-1α levels in gingival sulcus fluid alone and in combination for the diagnosis of concurrent PI in patients with implantation was 0.787, 0.785, 0.794 and 0.930, respectively, with sensitivity of 80.00%, 74.29%, 62.86% and 88.57% and specificity of 66.87%, 74.85%, 78.53% and 85.28%, respectively.

CONCLUSIONS: Elevated levels of sICAM-1, IL-1β and HIF-1α in gingival sulcus fluid are independent risk factors for PI complications in patients with implant restoration and can be used as an auxiliary predictor of PI complications in patients with implant restoration.

PMID:36973843