scholarly journals Comparison of Endoscopic Injection of Botulinum Toxin and Steriods Immediately after Endoscopic Submucosal Dissection to Prevent Esophageal Stricture: A Prospective Cohort Study

Author(s):  
Xiaoying Zhou ◽  
Han Chen ◽  
Meihong Chen ◽  
Chao Ding ◽  
Guoxin Zhang ◽  
...  

Abstract Background: Widespread endoscopic submucosal dissection (ESD) in early esophageal cancer patients is closely associated with esophageal stricture, which dramatically reduces patients’ quality of life and increases huge medical burdens. Endoscopic injection of steroid was proved as a protective method for post-ESD strictures. Other materials such as botulinum toxin type A (BTX-A) may be potential candidates. We conducted this prospective cohort study to compare the efficacy and feasibility of endoscopic injection of BTX-A and triamcinolone acetonide (TA) for the prevention of esophageal stricture.Methods: Seventy-eight patients with esophageal mucosal defects of more than two thirds of the circumference were successively enrolled and divided into 3 groups: BTX-A group (group A, n=26), TA group (group B, n=16) and control group (group C, n=36). Patients in group A were immediately injected with BTX-A after ESD, in group B were immediately injected with TA and in group C received ESD only. Endoscopy was performed when patients reported dysphagia symptoms and at 6 and 12 weeks post-ESD in patients without symptoms. Patients who experienced post-ESD esophageal strictures in all groups received bougie dilation. All patients were followed up for one year.Results: The proportion of patients developing stricture in BTX-A group was 30.00% (intention to treat analysis, 9/30) and 26.92% (per protocol analysis, 7/26), in TA group was 40.90% (intention to treat analysis, 9/22) and 43.75% (per protocol analysis, 7/16), and in control group was 84.21% (intention to treat analysis, 32/38) and 83.33% (per protocol analysis, 30/36) (p<0.001). When further comparing between each of the two groups, the incidence of esophageal stricture was lower in BTX-A group than that in control group (p<0.001), and lower in TA group than that in control group (p=0.004). Furthermore, in entire circumference mucosal defect subgroup, the esophageal stricture was significantly lower in BTX-A group than that in TA group (33.3% vs 100%, p=0.0454).Conclusions: Endoscopic injection of BTX-A and TA were effective in preventing post-ESD esophageal strictures and BTX-A injection was particularly effective in entire circumference mucosal defect patients. Multi-centered, randomized prospective study with larger sample size should be conducted. (Clinical trial registration number: ChiCTR2100042970, registered 1 February 2021, retrospectively registered, http://www.chictr.org.cn/listbycreater.aspx)

2006 ◽  
Vol 24 (1_suppl) ◽  
pp. 15-24 ◽  
Author(s):  
Jorge Vas ◽  
Camila Méndez ◽  
Emilio Perea-Milla

Aims To determine the effectiveness of acupuncture as a therapy complementary to the pharmacological treatment of osteoarthritis of the knee. Methods Randomised, single blind, placebo controlled trial. Patients with osteoarthritis of the knee were randomly assigned to either 12 sessions of true acupuncture or 12 sessions of placebo acupuncture (Streitberger needle), these sessions taking place once a week. A baseline measurement was carried out, followed by further observations at 4, 8, 12 and 16 weeks. The clinical variables were the WOMAC (Western Ontario and McMaster Universities Osteoarthritis) index, knee pain measured by a visual analogue scale (pain VAS), the weekly consumption of diclofenac and the Profile of the Quality of Life of the Chronically Ill (PQLC). The two groups were compared for each of the clinical variables per protocol and by intention to treat. A multiple linear regression model for the dependent variables was constructed. Results Ninety seven outpatients were selected, with 88 remaining for the per protocol analysis; the analysis of homogeneity concluded that the lost subjects were not significantly different from those that completed the study. The multivariate per protocol model for the relative pain VAS variable showed a difference in improvement of 43.7% (95% CI 29.4% to 58.0%) for acupuncture, compared with the control group. In an intention to treat analysis, the relative improvement was 32.4% (20.3% to 44.4%). In a per protocol analysis, the total WOMAC showed a relative decrease of 52.0% (34.3% to 69.6%) in favour of the acupuncture group, or 37.6% (22.4% to 52.8%) in an intention to treat analysis. Conclusions The group treated with acupuncture showed significantly better effects, both clinically and statistically, in the reduction of pain intensity as measured by pain VAS, on the WOMAC index and in decreased consumption of diclofenac.


2014 ◽  
Author(s):  
Γεώργιος Βαλασούλης

Σκοπός: Μελέτη της συστηματικής επίδρασης της χρήσης προφυλακτικού στη δραστηριότητα του ιού HPV μετά από συντηρητική θεραπεία για CIN.Υλικό και Μέθοδοι:Σχεδιασμός: Τυχαιοποιημένη κλινική δοκιμή.Πληθυσμός: Γυναίκες στις οποίες αποφασίστηκε αφαιρετική μέθοδος θεραπείας (LLETZ) για CIN. Μεθοδολογία: Αμέσως πριν την θεραπεία όλες οι γυναίκες τυχαιοποιήθηκαν σε δύο groups. Στο group Α εκτός από τις μετεγχειρητικές πληροφορίες ρουτίνας δινόταν αυστηρή σύσταση για χρήση προφυλακτικού για το πρώτο μετεγχειρητικό εξάμηνο, ενώ στο group B δινόταν μόνο μετεγχειρητικές πληροφορίες ρουτίνας. Επιπλέον, πριν την επέμβαση σε όλες τις γυναίκες γινόταν δειγματοληψία τραχηλικού επιχρίσματος κυτταρολογίας υγρής φάσης (Thin Prep Pap Smear), το οποίο αποστελλόταν για μοριακή ανάλυση HPV-δεικτών (ανίχνευση και τυποποίηση HPV DNA, HPV E6 & E7 mRNA με τη τεχνική NASBA και κυτταρομετρίας ροής καθώς και ανίχνευση έκφρασης της p16INK4a). Στις μετεγχειρητικές επισκέψεις (6ος, 12ος, 18ος, 24ος, 36ος, 48ος και 60ος μήνας) πραγματοποιούνταν επαναληπτική κολποσκόπηση και δειγματοληψία Thin Prep Pap Smear και οι γυναίκες συμπλήρωναν ερωτηματολόγιο σχετικό με την συμμόρφωσή τους στη χρήση προφυλακτικού.Ανάλυση: Η ανάλυση των αποτελεσμάτων έγινε με βάση την αρχική τυχαιοποίηση των γυναικών στα δύο groups. Υπολογίστηκαν ο relative risk (RR) και absolute RR (ARR) στην Intention To Treat analysis καθώς επίσης το number needed to treat (NNT) όπως επίσης και η συμμόρφωση των γυναικών στη σύστασή για χρήση προφυλακτικού. Έγινε επίσης υπολογισμός των παραμέτρων αξιοπιστίας στην ανίχνευση των θεραπευτικών αποτυχιών για κάθε HPV-σχετιζόμενο βιοδείκτη ξεχωριστά [Sensitivity (S), Specificity (Sp), Positive (PPV) and Negative Predictive Value (NPV)].Αποτελέσματα: Στη μελέτη συμπεριλήφθησαν 204 γυναίκες, 98 στο group Α και 104 στο group B. Τα αποτελέσματα έδειξαν στατιστικά σημαντική μείωση της θετικότητας στην πλειονότητα των HPV-δεικτών στο group A (p<0.05). Ειδικότερα, μόνο το 29.8% των γυναικών παρέμεινε θετικό στο ΗPV DNA test στο group Α σε σύγκριση με το 69.2% στο group B στην 1η μετεγχειρητική επίσκεψη [p<0.001, RR=0.431, RRR=0.569, ARR=0.394, NNT=2]. Στατιστικά σημαντικά μειωμένη φάνηκε να είναι και η έκφραση των υπόλοιπων HPV-σχετιζόμενων βιοδεικτών όπως του mRNA E6 & E7 test καθώς επίσης και του p16INK4a, στο Group A έξι μήνες μετά τη θεραπεία. Εννέα γυναίκες χρειάστηκε να υποβληθούν σε επαναληπτική θεραπεία με σημαντικό ποσοστό αυτών να προέρχεται από το control group (p=0.001, RR=1.032, RRR=-0.032, ARR=-0.03, NNT=-34). Το HR HPV test εμφάνισε την καλύτερη ευαισθησία (Sensitivity: 90%) στην ανίχνευση των CIN2+ θεραπευτικών αποτυχιών στους 24 μήνες από την επέμβαση, ενώ το test με την καλύτερη ειδικότητα (Specificity: 90%) ήταν το NASBA. Αξιοσημείωτο ήταν το χαμηλό ποσοστό συμμόρφωσης (56%) του πληθυσμού στη σύσταση για συστηματική χρήση προφυλακτικού (>75%).Συμπεράσματα: Η χρήση προφυλακτικού μετά από θεραπεία για CIN φαίνεται να αυξάνει στατιστικά σημαντικά την αρνητικοποίηση του HPV και να μειώνει εξίσου σημαντικά τον κίνδυνο θεραπευτικής αποτυχίας. Η συμμόρφωση του πληθυσμού στη συστηματική χρήση προφυλακτικού την πρώιμη μετεγχειρητική περίοδο, είναι χαμηλή και μειώνεται σημαντικά με την πάροδο του χρόνου από τη στιγμή της θεραπείας. Βασιζόμενοι στην παραδοχή ότι η χρήση προφυλακτικού στο γενικό πληθυσμό (χωρίς θεραπεία για CIN), εμφανίζει ευεργετικά αποτελέσματα όσον αφορά την HPV κάθαρση και την υποστροφή των αλλοιώσεων από τους 3 πρώτους μήνες, θα μπορούσαμε να αναμένουμε σημαντική μείωση της HPV θετικότητας και στις γυναίκες μετά από θεραπεία για CIN, και αυτή η προσαρμογή θα μπορούσε να αυξήσει τα ποσοστά συμμόρφωσης. Η μετεγχειρητική διαχείριση γυναικών μετά από θεραπεία για CIN ακολουθώντας τον προτεινόμενο άξονα: θεραπεία για CIN – αυστηρή χρήση προφυλακτικού για χρονικό διάστημα 6 μηνών - HPV DNA test στην πρώτη μετεγχειρητική επίσκεψη και επί αρνητικού αποτελέσματος αυτού την εφαρμογή εμβολιασμού, με στόχο την απόλυτη προστασία αυτών των γυναικών έναντι σε νέες λοιμώξεις από τον ιό, θα μπορούσε να αποτελέσει παγκόσμια κατευθυντήρια οδηγία για όλες τις γυναίκες που υποβλήθηκαν σε θεραπεία για CIN.


2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Jia-Xu Chen ◽  
Yue-Yun Liu ◽  
Shao-Xian Wang ◽  
Xiao-Hong Li

Objective. Evaluation of the efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat.”Methods. This was a randomized, double-blind, controlled parallel design clinical test of a product that was already on the market. 72 subjects were randomly assigned to control group (group A with Colgate Herbal Salty Toothpaste) or treatment group (group B with Crest Herbal Crystal Toothpaste) with ratio of 1 : 2. Subjects were instructed to brush with 1g toothpaste for 2 minutes each time, 2 times per day in a 4-aweek test period; measurement with the rating scale on the efficacy of “clearing internal heat” for the herbal toothpaste was done at baseline, 2 weeks, and 4 weeks of toothpaste usage.Results. The rating scale on efficacy of “clearing internal heat” for the herbal toothpaste reveals that the primitive points of 72-case intention-to-treat (ITT) analysis and 67-case per-protocol (PP) analysis for subjects in group A and subjects in group B were found to be reduced progressively with statistical significance (P<0.05). The overall effective rates for group A and group B were, respectively, 62.50%, 56.25% (ITT) and 62.50%, 60.64% (PP). The statistical results indicated that the symptoms of fire-heat for both groups of subjects have been improved after application of toothpaste.Conclusion. The efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat” was confirmed by the trial as compared to Colgate Herbal Salty Toothpaste. And its efficacy was objectively evaluated by the rating scale on efficacy of “clearing internal heat.”


Lupus ◽  
2019 ◽  
Vol 28 (11) ◽  
pp. 1368-1377
Author(s):  
M Oliveira-Santos ◽  
J F S Verani ◽  
L A B Camacho ◽  
C A F de Andrade ◽  
E M Klumb

Objective Studies have been conducted to determine the causal factors and clinical consequences of non-adherence to treatment in systemic lupus erythematosus (SLE). However, no interventions have been performed to increase drug adherence. Our objective was to assess the effectiveness of pharmaceutical care (PC) for drug treatment adherence in lupus nephritis (LN). Methods This was a randomized clinical trial (pragmatic trial) in patients with LN in Rio de Janeiro, Brazil, allocated in two groups: an intervention group (Dader Method for PC) and a control group (institution's usual care). Drug treatment adherence was measured by the combination of five questions normally used in clinical practice. Results A total of 131 patients were randomized, and 122 completed the study, with a mean follow-up of 12.7 months and use of six drugs per day and 10–12 doses per day. Low adherence was observed at baseline (intervention group: 30%; control group: 29%). PC showed 27% effectiveness (95% confidence interval (CI) –6% to 50%) in the intention to treat analysis and 31% (95% CI 0–52%) in per protocol analysis, considering all drugs. As for adherence to specific drugs for SLE, effectiveness of PC was 64% (95% CI 34–80%) with intention-to-treat analysis and 62% (95% CI 32–79%) in per protocol analysis. Conclusions PC was effective for increasing drug treatment adherence in SLE. The detailed account provided by the Dader Method of the difficulties with patients' drug therapy proved invaluable to approach non-adherence.


Author(s):  
Patil Aniket ◽  
Dindore Pallavi ◽  
Arbar Aziz ◽  
Kadam Avinash ◽  
Saroch Vikas

The quest for excellence in mental and physical health is not new. We find various references and formulations in Ayurvedic classics meant for promoting mental and physical health of a child. Suvarna Prashan is one of the formulations explained in age old Ayurvedic classic Kashyap Samhita. This formulation is very widely used now days as a memory and immune booster for children. But there is very little systematic documented study which can be used to evaluate the efficacy of the formulation. Suvarna Bhasma was prepared in Ayurved Rasayani Pharmacy, Pune. Madhu and Ghrita were collected from KLE Ayurveda Pharmacy, Belgaum. Suvarna Bindu Prashan was prepared in KLE Ayurved pharmacy, Belgaum. It contains Suvarna Bhasma, Ghrita and Madhu. Twenty apparently healthy male and female children with age group of three to four years were ready to sign inform consent form were selected into two groups each. Subjects in Group A received Suvarna Bindu Prashan where as Group B (Control group) did not receive any treatment. Both the groups were observed for six months. Children in Suvarna Bindu Prashan group showed significant reduction in the scores of eating habits, behavior, mood, temperament and scores of event of illness. However there was no significant difference in the score of sleeping habit. There was significant increase in IQ percentage.


2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Jianguo Liu ◽  
Liehui Xiao ◽  
Hezhongrong Nie ◽  
Yong Pan ◽  
Yan Liu ◽  
...  

Abstract Objective To investigate the impact of microecological preparation combined with modified low-carbon diet on the glucolipid metabolism and cardiovascular complication in obese patients. Methods From August 2017 to July 2020, 66 obese patients were recruited, and administrated with an modified low-carbon diet with (group A) or without (Group B) microecology preparation and a balanced diet in control group (group C) for 6 months. Meanwhile, 20 volunteers administrated with a balanced diet were recruited as the healthy control group (group D). Results After 6-month intervention, obese subjects in group A and B showed significant improvement of body and liver fat mass, reduction of serum lipid levels, intestinal barrier function markers, insulin resistance index (IRI), high blood pressure (HBP) and carotid intima thickness, as compared with subjects in group C. More importantly, subjects in group A had better improvement of vascular endothelial elasticity and intimal thickness than subjects in group B. However, these intervention had no effect on carotid atherosclerotic plaque. Conclusion Administration of microecological preparation combined with modified low-carbon diet had better improvement of intestinal barrier function, glucose and lipid metabolism, and cardiovascular complications than low-carbon diet in obese patients, but the effect of a simple low-carb diet on carotid atherosclerotic plaque need to be further addressed.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Guanyu Yang ◽  
Zefei Zhu ◽  
Hongyu Zheng ◽  
Shifeng He ◽  
Wanyue Zhang ◽  
...  

Abstract Background This study explored the comparison of the thermal insulation effect of incubator to infusion thermometer in laparoscopic hysterectomy. Methods We assigned 75 patients enrolled in the study randomly to three groups: Group A: Used warming blanket; group B: Used warming blanket and infusion thermometer; group C: Used warming blanket and incubator. The nasopharyngeal temperature at different time points during the operation served as the primary outcome. Results The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001). Besides, the nasopharyngeal temperature of the incubator group was significantly higher compared to that of the control group 60 min from the beginning of surgery (T3): 35.81 ± 0.20 vs 35.62 ± 0.18 (P<0.001); 90 min from the beginning of surgery (T4): 35.85 ± 0.17 vs 35.60 ± 0.17 (P<0.001). Regarding the wake-up time, that of the control group was significantly higher compared to the infusion heating group: 24 ± 4 vs 21 ± 4 (P = 0.004) and the incubator group: 24 ± 4 vs 22 ± 4 (P = 0.035). Conclusion Warming blanket (38 °C) combined infusion thermometer (37 °C) provides better perioperative thermal insulation. Hospitals without an infusion thermometer can opt for an incubator as a substitute. Trial registration This trial was registered with ChiCTR2000039162, 20 October 2020.


Biology ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. 12
Author(s):  
David Chavarri-Prado ◽  
Aritza Brizuela-Velasco ◽  
Ángel Álvarez-Arenal ◽  
Markel Dieguez-Pereira ◽  
Esteban Pérez-Pevida ◽  
...  

Objectives: To determine the effect of mechanical loading of bone on the stability and histomorphometric variables of the osseointegration of dental implants using an experimental test in an animal model. Materials and Methods: A total of 4 human implants were placed in both tibiae of 10 New Zealand rabbits (n = 40). A 6-week osseointegration was considered, and the rabbits were randomly assigned to two groups: Group A (Test group) included 5 rabbits that ran on a treadmill for 20 min daily during the osseointegration period; Group B (Controls) included the other 5 that were housed conventionally. The monitored variables were related to the primary and secondary stability of the dental implants (implant stability quotient—ISQ), vertical bone growth, bone to implant contact (BIC), area of regenerated bone and the percentage of immature matrix. Results: The results of the study show a greater vertical bone growth (Group A 1.26 ± 0.48 mm, Group B 0.32 ± 0.47 mm, p < 0.001), higher ISQ values (Group A 11.25 ± 6.10 ISQ, 15.73%; Group B 5.80 ± 5.97 ISQ, 7.99%, p = 0.006) and a higher BIC (Group A 19.37%, Group B 23.60%, p = 0.0058) for implants in the test group, with statistically significant differences. A higher percentage of immature bone matrix was observed for implants in the control group (20.68 ± 9.53) than those in the test group (15.38 ± 8.84) (p = 0.108). A larger area of regenerated bone was also observed for the test implants (Group A 280.50 ± 125.40 mm2, Group B 228.00 ± 141.40 mm2), but it was not statistically significant (p = 0.121). Conclusions: The mechanical loading of bone improves the stability and the histomorphometric variables of the osseointegration of dental implants.


Author(s):  
Akinleye Stephen Akinrinde ◽  
Halimot Olawalarami Hameed

Abstract Objectives This study examined the possible protective roles of exogenous glycine (Gly) and L-Arginine (l-Arg) against Diclofenac (DIC)-induced gastro-duodenal damage in rats. Methods Rats were divided into Group A (control), Group B (DIC group) and Groups C–F which were pre-treated for five days with Gly1 (250 mg/kg), Gly2 (500 mg/kg), l-Arg1 (200 mg/kg) and l-Arg2 (400 mg/kg), respectively, before co-treatment with DIC for another three days. Hematological, biochemical and histopathological analyses were then carried out. Results DIC produced significant (p<0.05) reduction in PCV (13.82%), Hb (46.58%), RBC (30.53%), serum total protein (32.72%), albumin (28.44%) and globulin (38.01%) along with significant (p<0.05) elevation of serum MPO activity (83.30%), when compared with control. In addition, DIC increased gastric H2O2 and MDA levels by 33.93 and 48.59%, respectively, while the duodenal levels of the same parameters increased by 19.43 and 85.56%, respectively. Moreover, SOD, GPx and GST activities in the DIC group were significantly (p<0.05) reduced in the stomach (21.12, 24.35 and 51.28%, respectively) and duodenum (30.59, 16.35 and 37.90%, respectively), compared to control. Treatment with Gly and l-Arg resulted in significant amelioration of the DIC-induced alterations although l-Arg produced better amelioration of RBC (29.78%), total protein (10.12%), albumin (9.93%) and MPO (65.01%), compared to the DIC group. The protective effects of both amino acids against oxidative stress parameters and histological lesions were largely similar. Conclusions The data from this study suggest that Gly or l-Arg prevented DIC-induced gastro-duodenal toxicity and might, therefore be useful in improving the therapeutic index of DIC.


Antibiotics ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 277
Author(s):  
Raluca Cosgarea ◽  
Sigrun Eick ◽  
Ionela Batori-Andronescu ◽  
Søren Jepsen ◽  
Nicole B. Arweiler ◽  
...  

The aim of this study was to evaluate the clinical and microbiological effects of subgingival instrumentation (SI) alone or combined with either local drug delivery (LDD) or photodynamic therapy (PDT) in persistent/recurrent pockets in patients enrolled in supportive periodontal therapy (SPT). A total of 105 patients enrolled in SPT were randomly treated as follows: group A (n = 35): SI +PDT and 7 days later 2nd PDT; group B (n = 35): SI+LDD; group C (n = 35): SI (control). Prior intervention, at 3 and 6 months after therapy, probing pocket depths, clinical attachment level, number of treated sites with bleeding on probing (n BOP), full mouth plaque and bleeding scores (gingival bleeding index, %BOP) were recorded. At the same time points, 8 periodontopathogens were quantitatively determined. All three treatments resulted in statistically significant improvements (p < 0.05) of all clinical parameters without statistically significant intergroup differences (p > 0.05). Several bacterial species were reduced in both test groups, with statistically significantly higher reductions for LDD compared to PDT and the control group. In conclusion, the present data indicate that: (a) In periodontal patients enrolled in SPT, treatment of persistent/recurrent pockets with SI alone or combined with either PDT or LDD may lead to comparable clinical improvements and (b) the adjunctive use of LDD appears to provide better microbiological improvements for some periodontal pathogens than SI alone or combined with PDT.


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