scholarly journals Clinical Outcomes and Safety of Partial Full-Thickness Myotomy versus Circular Muscle Myotomy in Peroral Endoscopic Myotomy for Achalasia Patients

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Chenyu Li ◽  
Aixia Gong ◽  
Jingwen Zhang ◽  
Zhijun Duan ◽  
Linmei Ge ◽  
...  

Background. Here we aimed to evaluate and compare the efficacy and safety between partial full-thickness myotomy and circular muscle myotomy during POEM procedure in achalasia patients. Methods. Clinical data of achalasia of cardia (AC) patients who underwent POEM in our center during January 2014 to January 2015 was collected (34 cases). 19 patients who received partial full-thickness myotomy were assigned to group A and 14 patients who received circular muscle myotomy were assigned to group B. The procedure-related parameters between the two groups were compared. Symptom relief rate and postprocedure manometry outcomes were compared to evaluate the efficacy. Procedure-related adverse events and complications were compared to evaluate the safety. Results. (1) Mean operation times were significantly shorter in group A than group B (62.42±23.17 vs 87.86±26.44 min, p<0.01). (2) Symptom relief rate and postprocedure manometry outcomes had no statistical differences when compared between the two groups (all p>0.05). (3) Comparison of procedure-related adverse events and complications had no statistical differences (all p>0.05). Conclusion. Partial full-thickness myotomy had no significant differences in efficacy or safety with circular myotomy, but partial full-thickness myotomy significantly reduced the procedure time.

2020 ◽  
Vol 33 (1) ◽  
pp. 41-47
Author(s):  
Mohsena Akhter ◽  
Ishrat Bhuiyan ◽  
Zulfiqer Hossain Khan ◽  
Mahfuza Akhter ◽  
Gulam Kazem Ali Ahmad ◽  
...  

Background: Scabies is one of the most common skin diseases in our country. It is caused by the mite Sarcoptes scabiei var hominis, which is an ecto-parasite infesting the epidermis. Scabies is highly contagious. Prevalence is high in congested or densely populated areas. Individuals with close contact with an affected person should be treated with scabicidal which is available in both oral and topical formulations. The only oral but highly effective scabicidal known to date is Ivermectin. Amongst topical preparations, Permethrin 5 % cream is the treatment of choice. Objective: To evaluate the efficacy & safety of oral Ivermectin compared to topical Permethrin in the treatment of scabies. Methodology: This prospective, non-randomized study was conducted at the out-patient department of Dermatology and Venereology of Shaheed Suhrawardy Medical College & Hospital over a period of 6 months, from August 2016 to January 2017. The study population consisted of one hundred patients having scabies, enrolled according to inclusion criteria. They were divided into two groups. group A was subjected to oral Ivermectin and the group B to Permethrin 5% cream. Patients were followed up on day 7 and 14 for assessment of efficacy and safety. Result: The mean scoring with SD in group A (Ivermectin) and group B (Permethrin) were 8.26 ± 2.22 and 7.59 ± 2.01 respectively at the time of observation. The difference between the mean score of the two group is not significant (p=0.117) the mean scoring with SD in group A and group B were 4.54 ± 2.05 and 1.64 ± 1.84 respectively at 7thdays. The difference between the mean score of the two group is significant (p<0.001). The mean scoring with SD in group A and group B were 2.68± 2.35 and .36± 1.10 respectively at 14th day difference between the mean score of the group is significant (p<0.001). Conclusion: Topical application of permethrin 5% cream is more effective and safer than oral Ivermectin in the treatment of scabies. TAJ 2020; 33(1): 41-47


2021 ◽  
Vol 09 (07) ◽  
pp. E1108-E1115
Author(s):  
Sudhir Maharshi ◽  
Shyam Sunder Sharma ◽  
Sandeep Ratra ◽  
Bharat Sapra ◽  
Dhruv Sharma

Abstract Background and study aims Walled-off necrosis (WON) is a known complication of acute necrotizing pancreatitis (ANP). There is no study comparing nasocystic irrigation with hydrogen peroxide (H2O2) versus biflanged metal stent (BMS) in the management of WON. The aim of this study was to compare the clinical efficacy of both the treatment strategies. Patients and methods This study was conducted on patients with symptomatic WON who were randomized to nasocystic irrigation with H2O2 (Group A) and BMS placement (Group B). Primary outcomes were clinical and technical success while secondary outcomes were procedure time, adverse events, need for additional procedures, duration of hospitalization, and mortality. Results Fifty patients were randomized into two groups. Group A (n = 25, age 37.8 ± 17.6 years, 16 men) and Group B (n = 25, age 41.8 ± 15.2 years, 17 men). There were no significant differences in baseline characteristics between the two groups. The most common etiology of pancreatitis was alcohol, observed in 27 (54 %) patients. Technical success (100 % vs 96 %, P = 0.98), clinical success (84 % vs 76 %, P = 0.76), requirement of additional procedures (16 % vs 24 %, P = 0.70) and adverse events (4 vs 7, P = 0.06) were comparable in both the groups. The duration to clinical success (34.4 ± 12 vs 14.8 ± 10.8 days, P = 0.001) and procedure time (36 ± 15 vs 18 ± 12 minutes, P = 0.01) were longer in Group A compared to Group B. Conclusions Nasocystic irrigation with H2O2 and BMS are equally effective in the management of WON but time to clinical success and procedure time is longer with nasocystic irrigation.


RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001519
Author(s):  
Roberta Ramonda ◽  
Mariagrazia Lorenzin ◽  
Antonio Carriero ◽  
Maria Sole Chimenti ◽  
Raffaele Scarpa ◽  
...  

ObjectivesTo evaluate in a multicentric Italian cohort of patients with psoriatic arthritis (PsA) on secukinumab followed for 24 months: (1) the long-term effectiveness and safety of secukinumab, (2) the drug retention rate and minimal disease activity (MDA), (3) differences in the outcomes according to the biological treatment line: biologic-naïve patients (group A) versus multifailure (group B) patients.MethodsConsecutive patients with PsA receiving secukinumab were evaluated prospectively. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were collected. Disease activity/functional/clinimetric scores and biochemical values were recorded at baseline (T0), 6(T6), 12(T12) and 24(T24) months. Effectiveness was evaluated overtime with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug-discontinuation and MDA at T6. Infections and adverse events were recorded.Results608 patients (41.28% men; mean (SD) age 52.78 (11.33)) were enrolled; secukinumab was prescribed as first-line biological treatment in 227 (37.34%) patients, as second (or more)-line biological treatment in 381 (62.66%). Effectiveness of secukinumab was shown with an improvement in several outcomes, such as Ankylosing Spondylitis Disease Activity Score (T0=3.26 (0.88) vs T24=1.60 (0.69) ;p=0.02) and Disease Activity Index for Psoriatic Arthritis (T0=25.29 (11.14) vs T24=7.69 (4.51); p<0.01). At T24, group A showed lower Psoriasis Area Severity Index (p=0.04), erythrocyte sedimentation rate and C reactive protein (p=0.03 ;p=0.05) and joint count (p=0.03) compared with group B. At T24, MDA was achieved in 75.71% of group A and 70.37% of group B. Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness, and in 22 due to adverse events. Retention rate at T24 was 71% in the whole population, with some difference depending on secukinumab dosage (p=0.004) and gender (p=0.05).ConclusionsIn a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11545-11545
Author(s):  
Daniel Pink ◽  
Dimosthenis Andreou ◽  
Anne Flörcken ◽  
Alexander Golf ◽  
Stephan Richter ◽  
...  

11545 Background: Single-agent PD-1 inhibitors have modest activity in the treatment of most STS. Potential strategies to increase efficacy include combination therapies targeting the tumor microenvironment. Considering that apart from direct growth inhibition and death of malignant cells, trabectedin (Tr) also induces macrophage depletion and/or different immunologic effects, suggesting a possible synergistic effect of combined Tr plus anti-PD-1 treatment. We therefore aimed to evaluate the efficacy and safety of combined Tr and nivolumab (Ni) as a second-line treatment in STS. Methods: The prospective, explorative, two group, non-randomized phase II NiTraSarc trial enrolled pretreated patients (pt) with advanced STS (Group A: lipo- or leiomyosarcomas, Group B: non-L-sarcomas). Pt were initially treated with 3 cycles of Tr 1.5 mg/m2, followed by the combination of Tr 1.5 mg/m2 + Ni 240 mg (“late combination cohort” (LCC)) for up to 16 cycles. After positive results of a preplanned interim analysis, pt received the combination therapy starting with cycle 2 (“early combination cohort” (ECC)). 92 pt were recruited to the trial (55 in Group A, 37 in Group B). Primary efficacy endpoint is progression-free survival rate after 6 months (PFSR6) according to RECIST v.1.1. This is a first analysis of the primary efficacy endpoint in Group B based on a modified intention-to-treat (mITT) population of evaluable 36 pt: 23 and 13 pt from the LCC and ECC, respectively. Results: The most common Group B subtypes comprised undifferentiated pleomorphic/not otherwise specified sarcoma (UPS/NOS, 13pt) and fibromyxoid sarcoma (FMS, 6pt). After a median follow-up of 5 months (m) PFSR6 was 13.9% for all pt, 8.7% in LCC and 23.1% in ECC. Median duration of disease stabilization (DoDS) was 4m in all pt, the LCC and the ECC. Two pt had a partial response (PR), 10 had disease stabilization (SD), while 13 pt progressed, and 11 had missing data. By subtype: PR- UPS/NOS=2 (DoDS 12.7m/12.5m). SD: UPS/NOS=3, epithelioid=2, synovial=2, FMS=1, fibrosarcoma=1, other=1. All 36 pt experienced at least one adverse event (AE) reaching a total of 579 AEs, 141 (24.4%) of which were considered to be grade ≥3 treatment-related AEs. The main grade ≥3 AEs were: leukopenia (47.2% of pt), neutropenia (41.7% of pt), thrombocytopenia (33.3% of pt), increased ALT (30.6% of pt), and anemia (27.8% of pt). Conclusions: Tr+Ni was well tolerated and showed activity in at least some patients with non-L-sarcomas (mostly UPS/NOS) especially in the ECC. Analyses of the collected data, including PD-L1 expression profile, with the goal to establish whether Tr+Ni should be further pursued in these patients, are ongoing. ClinicalTrials.gov Identifier: NCT03590210; EudraCT: 2017-001083-38. Clinical trial information: NCT03590210.


2019 ◽  
Author(s):  
Yanhui Cui ◽  
Peng Sun ◽  
Lixing Tang ◽  
Chengyue Zhang ◽  
Qian Wu ◽  
...  

Abstract Introduction This study was performed to compare the efficacy of marsupialization under nasal endoscopy versus Lacrimal probing in the treatment of congenital dacryocystocele. Methods Forty neonates (43 eyes) diagnosed with congenital dacryocystoceles were divided into Group A (nasal endoscopic marsupialization) and Group B (Lacrimal probing). The patients were followed up for 1 year after surgery. The efficacy, incidence of complications, and reoperation rate were compared between the two groups. Results The male:female ratio was 25:15 patients (27:16 eyes). In Group A, the success rate was 100%, the incidence of complications was 5%, and the reoperation rate was 0%. In Group B, the success rate was 90%, the incidence of complications was 20%, and the reoperation rate was 30%. Conclusion Compared with Lacrimal probing, marsupialization under nasal endoscopy provides greater efficacy and safety for congenital dacryocystoceles.


2020 ◽  
Author(s):  
Xiaoxia Gu ◽  
Jingjing Wang ◽  
Huihua Liao ◽  
Jian Mo ◽  
Weiming Huang ◽  
...  

Abstract Background: To compare the efficacy and safety of different compatibility schemes in the prevention of visceral pain after gynecological laparoscopic surgery. Methods: from April 2019 to April 2020, patients undergoing elective gynecological laparoscopic surgery in our hospital were randomly divided into four groups: group A: sufentanil 3 μ g / kg; group B: low-dose nalbuphine group: 0.1 mg / kg of nabufen + 3 μ g / kg of sufentanil; group C: medium dose of nabufen group: 1 mg / kg of nabufen + 2 μ g / kg of sufentanil; group D: high-dose nabufen 2 There were 30 cases in each group. The degree of pain and the number of adverse reactions at 2, 4, 8, 12, 24 and 48 hours after operation were observed and recorded. The number and dosage of morphine used as a remedial analgesic were recorded. The pain degree was assessed by visual analogue scale (VAS). The total amount of analgesic pump used, the total number of times of pressing and the effective times of pressing were recorded. The adverse reactions included respiratory depression, nausea and vomiting, drowsiness, restlessness and skin The skin itches. Results: the analgesic effect of group B was similar to that of group A, and there was no significant difference in the number of invalid pressing, total pressing times and rescue analgesia rate (P > 0.05), while the invalid pressing times, total pressing times and remedial analgesia rate of group C and group D were significantly lower than those of group A (P < 0.05). There was no significant difference between group C and group D in the number of invalid compressions, the total number of compressions and the rate of remedial analgesia (P > 0.05), suggesting that increasing the dose of nalbuphine could not significantly increase the analgesic effect. The incidence of postoperative nausea and vomiting, skin pruritus, lethargy and Ramsay Sedation score in group B and group C were significantly lower than those in group A (P < 0.05). Ramsay Sedation score and incidence of drowsiness were lower than those in group D, which indicated that the incidence of adverse reactions was higher in group D than group B and group C.Conclusion: the combination of 1 mg / kg nabufen and 2 μ g / kg sufentanil is a safe and effective combination scheme for the prevention of visceral pain after gynecological laparoscopic surgery with small adverse reactions.Trial registration: http://www.chictr.org.cn/showproj.aspx?proj=40635Registration number:ChiCTR1900025076 . Prospectively registered on 10 August 2019.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16035-e16035
Author(s):  
Shuichi Hironaka ◽  
Ryo Sadachi ◽  
Nozomu Machida ◽  
Satoru Iwasa ◽  
Yasuhide Yamada ◽  
...  

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.


Author(s):  
Raj M. Mehta ◽  
Babulal S. Patel ◽  
Akshay C. Shah ◽  
Shashwat K. Jani ◽  
Vismay B. Patel ◽  
...  

Background: Induction of labour defined as artificial initiation of uterine contractions before the onset of spontaneous labour, after the period of viability, by any methods. The successful outcome depends on the Bishop Score, maternal age and parity. Authors compared the most preferred two routes; vaginal and oral for induction and outcome, adverse events and side effects were noted.Methods: This was a prospective comparative study carried out at SVPIMSR, Ahmedabad, from January 2019 to June 2019, Gujarat, 100 patients who required induction were randomly divided in two groups- Group A received 25µg oral misoprostol, Group B - received 25µg vaginal misoprostol repeated 4 hourly up to maximum five doses in both groups. The induction to delivery interval, mode of delivery, maternal and neonatal outcome and complications were observed.Results: The mean induction to delivery interval was less in vaginal group than oral (18.7 hours in vaginal versus 22.4 hours in oral). Vaginal delivery and caesarean section rates were comparable in both groups. 60% patients in Group A required more than two doses as compared to 36% in Group B. No major complications or adverse events were observed.Conclusions: Both oral misoprostol in a dose of 25μg and vaginal misoprostol 25μg every four hours, to a maximum of five doses, have safety and efficacy for induction. With The vaginal route, delivery occurs in less time and few doses required as compared to oral.


2019 ◽  
Vol 47 (12) ◽  
pp. 6215-6222 ◽  
Author(s):  
Hongtu Li ◽  
Na Zhang ◽  
Ke Zhang ◽  
Yanhua Wei

Object To investigate the clinical efficacy and safety of dexmedetomidine in flexible bronchoscopy under general anesthesia. Methods A total of 114 patients were randomly divided into intervention group A and control group B. Group A received dexmedetomidine, fentanyl, and propofol as anesthesia, while Group B received fentanyl and propofol only. Changes in heart rate, mean arterial pressure, pulse oxygen saturation, stress indices (blood cortisol, adrenaline, and norepinephrine levels), incidence of adverse events, anesthesia dose, duration of procedure, and recovery time were compared between the groups at specific time points T0, T1, and T2 during bronchoscopy. Results There was no statistical difference between the groups at T0. At T1 and T2, pulse oxygen saturation, mean arterial pressure, heart rate, and stress indices in group A were significantly more favorable than those in group B. The incidence of adverse events (5.26%) in group A was significantly lower than that in group B (17.54%), and patients in group A required less propofol and had a faster recovery time than patients in group B. Conclusion Dexmedetomidine use in flexible bronchoscopy under general anesthesia is safe and effective and decreases the stress response in synergy with propofol to provide hemodynamic stability.


2016 ◽  
Vol 15 (1) ◽  
pp. 17-21
Author(s):  
Sakhawat Mahmud Khan ◽  
Md Matiar Rahaman Khan ◽  
Shahin Akhter ◽  
Md Mizanur Rahman

Background: Lower urinary tract symptoms suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) are a very common disease in elderly men .The incidence of benign prostatic hyperplasia is age related.Objectives: To compare the efficacy and safety of Tamsulosin and Terazosin in the treatment of symptomatic Benign Prostatic Hyperplasia.Methods: This was a prospective study carried out in the Department of Urology, Chittagong Medial College Hospital, Chittagong, Bangladesh during the period of July to December 2014. Total 40 patients of 45-80 years of age were consequently selected according to inclusion criteria. After completion of baseline clinical evaluation and investigations, participants were divided into two groups, group A and group B. Group A (n=20) was given Terazosin 1mg daily for 3 days at bed time and then 2 mg daily at bed time for 2 months. Group B (n=20) was given Tamsulosin, 0.4 mg per day for 2 months. Efficacy was evaluated of each group after 2 month follow up and lastly a comparison was made between them. The parameters monitored were International Prostate Symptoms Score (IPSS) Maximum urine flow rate (Qmax) and Post Voidal Residual Volume (PVR). Tamsulosin 0.4 mg and Terazosin 2 mg once daily for 8 weeks both are effective in relieving symptoms of BPH but Tamsulosin is superior to Terazosin in improvement of total IPSS (p<0.001) and Qmax (p<0.01) PVR (p<0.01) at the end point.Results: Outcome of parameters at follow up after 2 months. Tamsulosin group showed significant improvement of IPSS (p<0.05) PVR (p<0.001) and Qmax (p<0.001) than Terazosin. The incidence of adverse events by administration of Tamsulosin was less than that by Terazosin.Conclusion: Tamsulosin appears to have more efficacy and safety than Terazosin in symptomatic BPH.Chatt  Shi Hosp Med Coll J; Vol.15 (1); Jan 2016; Page 17-21


Sign in / Sign up

Export Citation Format

Share Document