Comparison of clinical outcomes of sitagliptin+metformin combination and glimepiride in the management of uncomplicated type 2 diabetics

Background: To evaluate the comparison of clinical outcomes of sitagliptin +metformin and glimepride in uncomplicated Type-2 diabetics.Methods: This one year (July 2016 to August 2017) prospective, open label, observational clinical cohort study was carried out on type-2 diabetics. In this study 299 Type-2 diabetics patients were enrolled and were randomly allocated to two groups viz Group A and Group B. Group A received sitaglitin+metformin (50+500) mg/day and Group B received glimepride 1mg/day respectively. The follow up started after 10 days of stabilization of the patient and data recorded on 10th day was considered Zero month data and follow up continued up to Six month in each group. Comparison of FPG, PPG and HbA1c was evaluated between zero and six months within group and at six month between groups. Adverse events were recorded and summarized by treatment group.Results: At the end of six months follow up the patients of Group A who received sitaglitin+metformin (50+500) mg/day had greater reduction in FPG, PPG and HbA1c (all P<0.001) was recorded when compared between zero and six month within group. A significant reduction in FPG, PPG and HbA1c (all P<0.01) also recorded in Group B who received glimepride 1mg/day when compared between zero and six months within group. A statically significant difference (all P<0.05) was recorded at six months between group. The adverse events like hypoglycemic episodes, gastrointestinal adverse events etc were greater in Group B than Group A. Changes in weight also noted in both Groups. Weight loss in Group A and weight gain in Group B was recorded.Conclusions: The present study suggests that a significant difference may be existing in the clinical outcome interm of glycemia control and adverse events between sitagliptin+metformin combination and glimepride in type-2 diabetic patients.

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Clinical Outcomes for Isolated Subscapularis Tears With Advanced Fatty Infiltration: Nonoperative Treatment Versus Arthroscopic Single-Row Repair

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120975754 ◽

2021 ◽

Vol 9 (2) ◽

pp. 232596712097575

Author(s):

Tae-Hwan Yoon ◽

Sung-Jae Kim ◽

Yun-Rak Choi ◽

Ho-Sung Keum ◽

Yong-Min Chun

Keyword(s):

Clinical Outcomes ◽

Operative Treatment ◽

Fatty Infiltration ◽

Supraspinatus Tendon ◽

Significant Difference ◽

Group A ◽

Grade 3 ◽

Group B ◽

Retear Rate

Background: No study has investigated the treatment outcomes of isolated subscapularis tears with advanced fatty infiltration and tear progression to the supraspinatus tendon. Purpose: To assess the natural progression of isolated subscapularis tears with advanced fatty infiltration and compare clinical outcomes between nonoperative and operative treatment. Study Design: Cohort study; Level of evidence, 3. Methods: This study included 52 patients who received either operative (group A) or nonoperative (group B) treatment at our institution for isolated subscapularis full-thickness tears with grade 3 or 4 advanced fatty infiltration. All study patients had a minimum 2-year follow-up. The following 4 functional measures were used: visual analog scale for pain, Subjective Shoulder Value, American Shoulder and Elbow Surgeons score, and University of California Los Angeles score. The modified belly-press test was used to assess subscapularis muscle strength. In group A, structural integrity was evaluated using magnetic resonance imaging at 6 months after surgery. In addition, ultrasonographic evaluation was performed on both groups during the follow-up period to assess tear progression into the supraspinatus tendon. Results: At initial presentation, all functional assessment scores were significantly worse in group A versus group B ( P ≤ .05 for all 4 scores). When we compared the mean change in scores before treatment versus after treatment, the group A patients were found to have significantly greater improvement than group B patients ( P < .001 for all 4 scores); however, no significant difference was seen in final outcome scores between the groups. Although a high retear rate of 78.6% (22/28) was identified in group A, both groups showed no further tear progression to the supraspinatus tendon at the final ultrasonographic evaluation. Conclusion: For isolated subscapularis tears with advanced fatty infiltration, clinical improvement was seen with both nonoperative and operative treatment. Although the operatively treated group started with lower baseline scores, there were no significant differences in outcomes at final follow-up. Considering the high retear rate even after repair, surgical treatment of these lesions may not be warranted. Early detection and prompt repair of subscapularis tears, before the lesion becomes advanced with grade 3 or 4 fatty infiltration, are important for better outcomes.

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FRI0284 EFFECTIVENESS AND SAFETY OF SECUKINUMAB IN NAÏVE OR TNF-INHIBITORS FAILURE PSORIATIC ARTHRITIS PATIENTS IN REAL LIFE: A 24-MONTHS PROSPECTIVE MULTICENTER STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3702 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 730.1-730

Author(s):

M. Lorenzin ◽

A. Carletto ◽

R. Foti ◽

M. S. Chimenti ◽

A. Semeraro ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Adverse Events ◽

Disease Activity ◽

Real Life ◽

Tnf Inhibitors ◽

Significant Difference ◽

Group A ◽

Group B

Background:Secukinumab (SEC) is a novel treatment for psoriatic arthritis (PsA),but data from real life are still missing.Objectives:1)to evaluate the effectiveness and safety of a wide cohort of PsA patients on SEC followed in 7 Italian rheumatologic centers for 24 months;2)to compare the features and disease activity indices of SEC-treated PsA patients subdivided in naïve biological drugs (group A) and in TNF-inhibitors (TNFi) failure patients (group B).Methods:Consecutive patients with moderate-severe PsA,who begun SEC treatment were evaluated prospectively.Data on disease characteristics,previous and ongoing treatments,comorbidities and duration of follow-up were collected.Disease activity,functional and clinimetric scores and biochemical values were recorded at baseline (t0),at 6 (t6),12 (t12),and 24 (t24) months.Anova (Kruskal Wallis) and generalized linear models were used to compare variables over time.Infections and adverse events were also collected.Results:PsA345patients [38.84% men;mean age 52.9 (11.27) years] were enrolled;mean treatment duration was 18.53 (9.97) years.SEC was prescribed as first line biologic treatment in 133 (38.55%) patients and as second or more line biological treatment in 212 (61.45%) patients. Enthesitis was present as a prominent manifestation in 61.44% of patients (Figure 1).In all population significant decrease in tender/swollen joints;Visual Analogue Scale of pain (VASp) and general health (VASgh);Psoriasis Area Severity Index (PASI);Leeds Enthesitis Index (LEI);number of dactylitis;Health Assessment Questionnaire modified for spondyloarthritis (HAQ-S);Bath Ankylosing Spondylitis Disease Activity Index (BASDAI);Bath Ankylosing Spondylitis Functional Index (BASFI);C-reactive protein (CRP) was achieved.Effectiveness of all PsA patients was associated to an improvement in Ankylosing Spondylitis disease activity score (ASDAS) [t0=3.45 (0.69) vs t24=1.48 (0.23);p<0.01] and in Disease Activity in PsA (DAPSA) [t0=29.52 (12.56) vs t24=11.41 (7.63);p<0.001].At t0group Bhad a more erosive (p=0.04) and polyarticular pattern (p=0.04),a longer disease duration (p=0.001),a greater prevalence (p=0.04) of psoriasis and dactylitis (p=0.01),a higher PASI score (p=0.01),while no significant difference was observed for uveitis,inflammatory bowel diseases,enthesitis.At t24group Ashowed better physical functioning and lower disease activity compared togroup B[HAQs A vs B=0.03 (0.16) vs 0.69 (0.73);BASDAI A vs B=2.37 (0.66) vs 4.27 (2.33);ASDAS A vs B=1.4 (0.62) vs 1.99 (0.86);CRP A vs B=2.03 (1.94) vs 3.11 (1.55) mg/L;DAPSA A vs B=7.03 (3.57) vs 12.41 (8.05)].After t24 of treatment 74.6% ofGroup Aand 72.8% ofGroup Barticular had an inactive\low disease activity (MDA),accordingly to ASDAS and DAPSA respectively.Forty-three patients (12.46%) stopped the treatment during the follow-up mainly because of primary or secondary loss of efficacy (29 and 24, respectively).Only 14 patients suspended SEC because of adverse events (of which 9 for reactions at site of injection).A low number of episodes of mild infections (16) occurred;SEC was instead permanently discontinued in 7 cases for:oral refractory mucositis (3);recurrent aphthosis (2);diverticulitis (2).The retention rate at t24 was good in the whole population.Interestingly no differences were found betweenGroup AandB(p=0.815).Conclusion:In a real life clinical setting,SEC was safe and effective in PsA. as shown by a significant decrease of DAPSA and ASDAS over a 24-months follow up.Disclosure of Interests:Mariagrazia Lorenzin: None declared, Antonio Carletto: None declared, Rosario Foti Consultant of: lilly, sanofi, MSD, Janssen, Abbvie, BMS, celgene, roche, Speakers bureau: lilly, sanofi, MSD, Janssen, Abbvie, BMS, celgene, roche, Maria Sole Chimenti: None declared, Angelo Semeraro: None declared, Luisa Costa: None declared, Leonardo Santo: None declared, Elena Fracassi: None declared, Ilaria Montanari: None declared, Mara Felicetti: None declared, Giulia Lavinia Fonti: None declared, Francesco Caso: None declared, Andrea Doria Consultant of: GSK, Pfizer, Abbvie, Novartis, Ely Lilly, Speakers bureau: UCB pharma, GSK, Pfizer, Janssen, Abbvie, Novartis, Ely Lilly, BMS, Augusta Ortolan: None declared, Roberta Ramonda Speakers bureau: Novartis, Celgene, Janssen, Pfizer, Abbvie, Lilly

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The Role of Obesity in Predicting the Clinical Outcomes of COVID-19

Obesity Facts ◽

10.1159/000517180 ◽

2021 ◽

pp. 1-9

Author(s):

Serdar Sahin ◽

Havva Sezer ◽

Ebru Cicek ◽

Yeliz Yagız Ozogul ◽

Murat Yildirim ◽

...

Keyword(s):

Clinical Outcomes ◽

Health Care Providers ◽

Study Groups ◽

Normal Weight ◽

Overweight And Obesity ◽

Care Providers ◽

Significant Difference ◽

Group A ◽

Group B ◽

Group D

Introduction: The aim of this was to describe the predictors of mortality related to COVID-19 infection and to evaluate the association between overweight, obesity, and clinical outcomes of COVID-19. Methods: We included the patients >18 years of age, with at least one positive SARS-CoV-2 reverse transcriptase-polymerase chain reaction. Patients were grouped according to body mass index values as normal weight <25 kg/m2 (Group A), overweight from 25 to <30 kg/m2 (Group B), Class I obesity 30 to <35 kg/m2 (Group C), and ≥35 kg/m2 (Group D). Mortality, clinical outcomes, laboratory parameters, and comorbidities were compared among 4 groups. Results: There was no significant difference among study groups in terms of mortality. Noninvasive mechanical ventilation requirement was higher in group B and D than group A, while it was higher in Group D than Group C (Group B vs. Group A [p = 0.017], Group D vs. Group A [p = 0.001], and Group D vs. Group C [p = 0.016]). Lung involvement was less common in Group A, and presence of hypoxia was more common in Group D (Group B vs. Group A [p = 0.025], Group D vs. Group A [p < 0.001], Group D vs. Group B [p = 0.006], and Group D vs. Group C [p = 0.014]). The hospitalization rate was lower in Group A than in the other groups; in addition, patients in Group D have the highest rate of hospitalization (Group B vs. Group A [p < 0.001], Group C vs. Group A [p < 0.001], Group D vs. Group A [p < 0.001], Group D vs. Group B [p < 0.001], and Group D vs. Group C [p = 0.010]). Conclusion: COVID-19 patients with overweight and obesity presented with more severe clinical findings. Health-care providers should take into account that people living with overweight and obesity are at higher risk for COVID-19 and its complications.

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Management of fresh odontoid fractures using posterior C1–2 fixation without fusion: a long-term clinical follow-up study

Journal of Neurosurgery Spine ◽

10.3171/2021.9.spine21822 ◽

2021 ◽

pp. 1-11

Keyword(s):

Scale Score ◽

Neck Disability Index ◽

Implant Removal ◽

Odontoid Fractures ◽

Significant Difference ◽

Flexion Extension ◽

Group A ◽

Group B

OBJECTIVE Posterior C1–2 fixation without fusion makes it possible to restore atlantoaxial motion after removing the implant, and it has been used as an alternative technique for odontoid fractures; however, the long-term efficacy of this technique remains uncertain. The purpose of the present study was to explore the long-term follow-up outcomes of patients with odontoid fractures who underwent posterior C1–2 fixation without fusion. METHODS A retrospective study was performed on 62 patients with type II/III fresh odontoid fractures who underwent posterior C1–2 fixation without fusion and were followed up for more than 5 years. The patients were divided into group A (23 patients with implant removal) and group B (39 patients without implant removal) based on whether they underwent a second surgery to remove the implant. The clinical outcomes were recorded and compared between the two groups. In group A, the range of motion (ROM) of C1–2 was calculated, and correlation analysis was performed to explore the factors that influence the ROM of C1–2. RESULTS A solid fracture fusion was found in all patients. At the final follow-up, no significant difference was found in visual analog scale score or American Spinal Injury Association Impairment Scale score between the two groups (p > 0.05), but patients in group A had a lower Neck Disability Index score and milder neck stiffness than did patients in group B (p < 0.05). In group A, 87.0% (20/23) of the patients had atlantoodontoid joint osteoarthritis at the final follow-up. In group A, the C1–2 ROM in rotation was 6.1° ± 4.5° at the final follow-up, whereas the C1–2 ROM in flexion-extension was 1.8° ± 1.2°. A negative correlation was found between the C1–2 ROM in rotation and the severity of tissue injury in the atlantoaxial region (r = –0.403, p = 0.024) and the degeneration of the atlantoodontoid joint (r = –0.586, p = 0.001). CONCLUSIONS Posterior C1–2 fixation without fusion can be used effectively for the management of fresh odontoid fractures. The removal of the implant can further improve the clinical efficacy, but satisfactory atlantoaxial motion cannot be maintained for a long time after implant removal. A surgeon should reconsider the contribution of posterior C1–2 fixation without fusion and secondary implant removal in preserving atlantoaxial mobility for patients with fresh odontoid fractures.

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Comparison Between With Kirschner-wires Only And Combined Screw Fixation in Proximal Reverse Chevron osteotomy(PCMO) For Hallux Valgus Deformity

Foot & Ankle Orthopaedics ◽

10.1177/2473011417s000231 ◽

2017 ◽

Vol 2 (3) ◽

pp. 2473011417S0002

Author(s):

Hwa Jun Kang ◽

Hong-Geun Jung ◽

Jong-Soo Lee ◽

Sungwook Kim ◽

Mao Yuan Sun

Keyword(s):

Hallux Valgus ◽

Screw Fixation ◽

Fixation Method ◽

Kirschner Wires ◽

Significant Difference ◽

Group A ◽

The Mean ◽

Group B ◽

Severe Hallux Valgus

Category: Bunion Introduction/Purpose: Kirschner-wires fixation, sometimes we have encountered pin irritation or pull-out. This is the reason why we consider additional fixation. Moreover, there are few reports according to comparison of fixation method, and Most of them focused on comparison K-wires or screw fixation only. Purpose of study is to compare clinical and radiographic outcome between Kirschner-wires only and combined screw fixation. Methods: The study included two different groups according to fixation methods. One with Kirschner-wires fixation (KW group) included 117 feet(of 98 patients), the other with combined screw fixation (KWS group) 56 feet (of 40 patients) with moderate to severe hallux valgus. Clinically, the preoperative and final follow-up visual analog scale (VAS) pain scores, the preoperative and final follow-up American Orthopaedic Foot & Ankle Society (AOFAS) hallux metatarsophalangeal (MTP)-interphalangeal (IP) scores, and patient satisfaction after the surgery were evaluated. Radiographically, the hallux valgus angle (HVA), intermetatarsal angle (IMA), medial sesamoid position (MSP), and first to fifth metatarsal width (1-5MTW) were analyzed before and after surgery. Results: The mean AOFAS score improved preoperative 65.5 to 95.3 at final follow up in group A, while preoperative 56.5 to 88.6 at final follow up. Pain VAS decreased from 5.7 to 0.5 in group A, whereas from 6.2 to 1.6 in group B. The mean HVA all improved from preoperative 38.5 to 9.3 at final follow up in group A and 34.7 to 9.1 in group B. The mean IMA and MSP also improved significantly at final follow up. In comparative analysis, the IMA did not show significant difference between postoperative and final state in group A, while showed significant increase in group B. Conclusion: We achieved favorable clinical and radiographic outcomes with minimal complications in patient with moderate to severe hallux valgus in both groups. However, this study shows no statistically significant difference in IMA during follow-up period and lower recurrence rate. Therefore we need to consider combined fixation method to provide better stability and can expect lower recurrence rate.

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Maintenance treatment of diabetic patients, associating arterial obstructive tibio-peroneal disease

Sao Paulo Medical Journal ◽

10.1590/s1516-31801995000100007 ◽

1995 ◽

Vol 113 (1) ◽

pp. 701-705

Author(s):

Nelson Wolosker ◽

Ruben Miguel Ayzin Rosoky ◽

Baptista Muraco Neto ◽

Berilo Langer

Keyword(s):

Maintenance Treatment ◽

Diabetic Patients ◽

Type I ◽

Group I ◽

Significant Difference ◽

Therapeutic Procedures ◽

Arterial Pulsation ◽

Group A ◽

Group B ◽

Better Than

When a melito-diabetic patient presents trophic infected injury on the limb, it is essential an evaluation of the circulatory conditions for therapeutic procedures orientation. In some circumstances, although arterial pulsation is absent, there is no ischemia of tissues. In these cases, the maintenance treatment, with eventual resection of the necrosed and infected tissues may be adopted. Evolution of 70 diabetic patients with trophic injuries on extremities were submitted to a maintenance treatment. Age of patients varied from 28 to 88 years, with an average of 56.8. The most occurrence was verified in women, with 42 cases. Diabetes non-dependant on insuline (type II) was observed in 64 patients (91.5%), being the remaining 6 patients of type I. Diabetic retinopathy was observed in 14 (20%) of the patients, neuropathy in 22 (31%) and nephropathy in 8 patients (11.4%). All the patients presented arterial pulsation until the popliteal region. They were divided in 2 groups, considering trunk arteries of legs: Group I, pervial legs arteries, composed by 48 patients; Group II, occluded legs arteries, with 22 patients. In what refers to the anatomic local of the injuries, patients were classified in three groups: Group A, formed by 32 patients (45.7%), presenting injuries in one or two toes only, without affecting the metatarsic region; Group B, formed by 16 patients (22.9%), trophic injuries affecting the metatarsic region and Group C, formed by 22 patients (31.4%), injuries affecting the calcaneous region. Injuries in both of the groups were caused by mechanical traumatism. Duration of the injury in the inferior member varied from 7 to 48 days, resulting in a 12 days average. Analyzing pervicacity in trunk arterias and evolution of patients, it may be observed that there has been a significantly better result in those with all the pulses present (81.3% x 45.5%)(p<0,01). Studying the injury locals associated to the evaluation of the cases, we may observe that for injuries in the extreme digital, result is significantly better than in locals more nearly. When distal pulses are absent, there is no significant difference in the result of the treatment, being performed in distal injuries or in the more near ones (p>0,05)(Table IV).

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ARE CD44+/CD24– CELLS THE ASSUMED CANCER STEM CELLS IN BREAST CANCER

Experimental Oncology ◽

10.31768/2312-8852.2017.39(3):224-228 ◽

2017 ◽

Vol 39 (3) ◽

pp. 224-228 ◽

Cited By ~ 4

Author(s):

D E Ryspayeva ◽

I I Smolanka ◽

A S Dudnichenko ◽

A A Lyashenko ◽

Yu A Grinevich ◽

...

Keyword(s):

Breast Cancer ◽

Stem Cells ◽

Cancer Stem Cells ◽

Clinical Outcomes ◽

Disease Free Survival ◽

Immunohistochemical Method ◽

Risk Of Death ◽

Significant Difference ◽

Group A ◽

Group B

Identification and characterization of the population of cancer stem cells (CSC) depends on several cellular markers, which combination is specific for the phenotype of CSC in the corresponding tumor. Several markers of CSC have already been identified in breast cancer (BC), but there are no universal indicators that could specifically identify the CSC in BC. Aims: To determine the validation of the CSC model for cell surface markers such as CD44 and CD24 and their clinical significance. Materials and Methods: Primary tumor samples of 45 patients with invasive BC without chemotherapy prior to surgery exposure were examined in paraffin blocks. CD44 and CD24 antigens expression was evaluated by the percentage of positive cells using different chromogens and the MultiVision detection system by immunohistochemical method. In this research the evaluation was determined by the following criteria: (-), negative — expression in < 10% of tumor cells; (+), positive — expression in ≥10% of cells. The same scoring system was applied for the expression of CD44+/CD24−. Results: 62.2% of investigated patients are patients older than 50 years and most of them with stage II of disease (71.0%) and luminal tumor subtypes (68.9%). We analysed the expression of CD44, CD24 and CD44+/CD24− for different patients with dividing them into two groups. The group A consists of patients with unfavorable prognosis (relapses and metastases have occurred in the first three years after diagnosis), and the group B — with a favourable prognosis (the development of metastases after three years). Median disease-free survival in the group A is 19 months, in the group B — 46 months. The difference between the overall survival (OS) curves in the groups A and B is statistically significant (p < 0.001), the risk of death was higher in the group A (hazard ratio (HR) 5.9; confidence interval (CI) 2.3–15.2). The content of CD44 cells did not differ statistically between groups A and B (p = 0.18), but there was a tendency for increasing in OS with the existence of CD44+ cells (p = 0.056). The distribution of the expression of CD24 marker did not differ between the groups (p = 0.36) as well as the OS curves (p = 0.59). Analysis of the expression of CD44+/CD24− which were considered as possible CSC, revealed a paradoxical increase (p = 0.03) of the frequency in patients of the group B (40.9%) compared to the group A (8.7%). Nevertheless, the comparison of the clinical outcomes did not reveal a statistically significant difference in the survival curves in the groups with existence and absence of CD44+/CD24– expression (p = 0.08). The analysis showed the increasing of the risk of worse clinical outcomes in the cases of expression absence of CD44+/CD24− (HR 2.8; CI 1.1–6.8). Conclusions: As a result of our research, the analysis of the quantity of assumed stem cells of the BC, which were identified by immunohistochemistry as CD44 and CD24 cells, failed to detect a statistically significant relation between groups of patients with different prognosis, and the identification of their expression is not enough for the characteristics of CSC. The obtained data demonstrating the worst clinical outcome in the cases of absence of CD44+/CD24− expression apparently require further investigations and the validation of the immunohistochemical method with the determination of the cut-off line in defining of CD44 and CD24 status.

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A study to evaluate and compare the expulsion and continuation rates of post placental insertion of Cu 375 and CuT 380A in Indian women at a premier hospital in New Delhi, India

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20174051 ◽

2017 ◽

Vol 6 (9) ◽

pp. 3992 ◽

Cited By ~ 1

Author(s):

Mansi Kumar ◽

Mahesh Kumar ◽

Parul Aggarwal ◽

Archna Gangania ◽

Rupali Dewan

Keyword(s):

Removal Rate ◽

New Delhi ◽

Contraceptive Device ◽

Indian Women ◽

Significant Difference ◽

Group A ◽

Post Placental ◽

Group B ◽

Continuation Rates

Background: The Study was planned to evaluate and compare the expulsion and continuation rates of post placental insertion of Cu 375 and CuT380A in Indian women at Safdarjung Hospital New Delhi, after approval was obtained from Institutional Ethical committee.Methods: Study group consisted of 300 women, divided into two groups: Group A and Group B. The data was analysed by using ‘student “t” test/ non-parametric ‘Wilcoxon Mann Whitney’ for quantitative variables to evaluate the safety, efficacy and acceptability.Results: Mean age was 24.99 years (range: 19-35years), All women were married (off which 64% literate) and Mean parity in group A was 1.97 and 2.06 in group B. Mean pain score during intrauterine contraceptive device (IUCD) insertion on visual analogue scale was 2.93 in group A and 3 in group B and was not statistically different. 84% women completed 12 months follow up in group A and 83.33% women in group B. Strings were visible in 74% women in group A and in 34% women in group B at 1 month of IUCD insertion. Visibility of strings increased in successive follow up visits and was visible in >80% of women at the end of one year in the both groups. String visibility after intra-Caesarean insertion was delayed. Fifty one percent (n=77) subjects in group A and 54% (n=81) in group B experienced amenorrhea up to six months. Menorrhagia was reported in 7.33% in group A and women 8.66% in group B at the end of 1 year of follow up. Pain was complained by 26 out of 150 (17.3%) women in group A as compared to 36 out of 150 (24%) women in group B after 1 month of insertion. There was no case of PID in group A whereas there were 3 cases of PID in group B. There was no perforation/trauma and pregnancy in either group.Conclusions: Overall expulsion rate was 13% and removal rate was 5% in our study. Continuation rate was 83.3% in Cu 375 and 80.6% in CuT380A at 12 months. There was no significant difference between the IUCDs regarding the safety, efficacy and complications such as expulsion, bleeding etc.

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The association of renal function with safety and efficacy of cisplatin plus S-1 (CS) therapy and docetaxel plus cisplatin plus S-1 (DCS) therapy in patients with advanced gastric cancer (AGC): An additional analysis of JCOG1013.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e16035 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e16035-e16035

Author(s):

Shuichi Hironaka ◽

Ryo Sadachi ◽

Nozomu Machida ◽

Satoru Iwasa ◽

Yasuhide Yamada ◽

...

Keyword(s):

Renal Function ◽

Adverse Events ◽

Objective Response ◽

Exploratory Analysis ◽

Phase Iii ◽

Fixed Dose ◽

Hematological Toxicity ◽

Significant Difference ◽

Group A ◽

Group B

e16035 Background: A phase III study, JCOG1013, did not show the superiority of docetaxel plus cisplatin plus S-1 (DCS) to cisplatin plus S-1 (CS) in overall survival (OS) (Yamada Y, Lancet GH 2019). It is known that cisplatin and gimeracil (an inhibitor of dihydropyrimidine dehydrogenase contained in S-1) are excreted in urine. We previously reported (abstr 197, ASCO-GI 2021) exploratory analysis of JCOG1013 which showed creatinine clearance (CrCl) was associated with safety (Grade [G]4 hematological toxicity for CS, and G3-4 non-hematological toxicity for CS and DCS), but not with efficacy in either group. Here, we report the additional detail results of this exploratory analysis. Methods: Among 741 participants in JCOG1013, patients with serum creatinine level < 1.2 mg/dL were included in this analysis and categorized by CrCl and treatment into A1 (CrCl ≥ 80 mL/min, CS), A2 (60 < CrCl < 80, CS), A3 (CrCl < 60, CS), B1 (CrCl > 80, DCS), B2 (60 < CrCl < 80, DCS), and B3 (CrCl < 60, DCS). The dose (mg/m2) of C/S was 60/80 regardless renal function in group A (A1, A2 and A3), and that of D/C/S was adjusted in group B as follows: 40/60/80 in B1, 40/50/80 in B2, and 40/40/65 in B3. Adverse events, OS, progression-free survival (PFS), and objective response rate (ORR) were compared by CrCl in group A (A1 vs. A2 vs. A3) and group B (B1 vs B2 vs B3), respectively. Results: Of 723 pts (169/136/57 in A1/A2/A3 and 170/138/53 in B1/B2/B3), the median CrCl (mL/min) was 94.1/71.9/53.4 in A1/A2/A3 and 98.2/70.0/55.6 in B1/B2/B3. The relative dose intensity of C/S was 90.4/75.3%, 87.8/74.9% and 85.7/72.8% in A1, A2 and A3, and that of D/C/S was 87.5/77.7/74.9%, 85.8/61.2/72.7% and 87.8/49.4/58.3% in B1, B2 and B3. The incidence of G4 white blood cell decreased, G4 neutrophil count decreased, and G3-4 anorexia were 1.2/4.4/9.3% (P < 0.01), 4.8/11.1/18.5% (P < 0.01), 14.4/28.1/28.6% (P < 0.01) in A1/A2/A3, and 1.8/3.0/4.0% (P = 0.36), 27.3/24.8/20.0% (P = 0.28), 22.4/29.3/32.0% (P = 0.11) in B1/B2/B3, respectively. No significant association between CrCl and other adverse events was observed either in CS or in DCS group. The median OS was 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.89) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.72). The median PFS was comparable among A1/A2/A3 (7.1/6.8/6.2 months, P = 0.88) and B1/B2/B3 groups (7.5/7.2/7.8 months, P = 0.85). ORR showed no significant difference in A1/A2/A3 (58.9/57.8/46.9%, P = 0.31) and B1/B2/B3 groups (62.0/61.5/51.5%, P = 0.36). Conclusions: Dose modification according to renal function in the DCS arm could control the increase of severe toxicities, which were observed frequently in patients with low renal function in patients receiving fixed dose of CS. Clinical trial information: 000007652.

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Comparison of the Effects of Two Different Hollow Nails in the Treatment of the Young Pauwels Type Ⅲ Femoral Neck Fractures

10.21203/rs.3.rs-592204/v1 ◽

2021 ◽

Author(s):

WENJING CHENG ◽

GUOZHENG - DING

Keyword(s):

Femoral Neck ◽

Femoral Neck Fractures ◽

Harris Hip Score ◽

Avascular Osteonecrosis ◽

Significant Difference ◽

Group A ◽

Random Number Table ◽

Screw Withdrawal ◽

Group B

Abstract Background: At present, there is a higher complication rate after treatment of femoral neck fractures with three parallel hollow nails (PHN) in the young Pauwels type Ⅲ femoral neck fractures.For better effect,F-shape hollow nails(FHN) is used to treat femoral neck fractures.The purpose of this study is to compare the clinical efficacy of FHN and PHN and provide reference for clinical application.Methods: Thirty-eight consecutive patients admitted from January 2017 to January 2020 were selected for the study. According to random number table method, the patients were divided into two groups:group A (FHN) and group B (PHN). The gender, age, BMI, comorbidities, time from injury to operation and other general preoperative demographics were not statistically different (P>0.05). The data of the two groups can be comparable.The occurrence of avascular osteonecrosis of the femoral head (AVN), femoral neck shortening, hollow screw withdrawal was recorded in follow-up.Then, Harris hip score (HHS), pain visual analog score (VAS) of two group were obtained at the last follow-up. Results: The mean follow-up period after surgery was 21.4±10.1 (range, 14–29) months. There were 18 cases(mean age, 47.5±9.6) in group A, 20 cases (mean age, 48.6±10.1) in group B. There was no significant difference between the two groups in AVN, femoral neck shortening (P>0.05), the two groups had statistically significant differences in screw withdrawal (F=4.416, P<0.05). There was no significant difference in HHS and VAS between the two groups at the last follow-up (P>0.05).Conclusion: Three parallel hollow nails (PHN) and F-shape hollow nails (FHN) have similar short-term effects in the young Pauwels type Ⅲ femoral neck fractures, but the nail withdrawal rate of FNH is lower.

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