Randomized Trial of Erythromycin and Azithromycin for Treatment of Chlamydial Infection in Pregnancy

Objective:The purpose of this study was to compare erythromycin and azithromycin in the treatment of chlamydial cervicitis during pregnancy with regard to efficacy, side effects, and compliance.Methods:In a prospective manner, 48 pregnant patients with cervical chlamydial infections diagnosed by routine screening tests were randomly assigned to receive either erythromycin, 500 mg q.i.d. for 7 days (N = 24), or azithromycin, 1 g as a one-time dose (N = 24). All sexual partners were given prescriptions for doxycycline, 100 mg b.i.d. for 7 days. The treatment efficacy was assessed by follow-up chlamydia testing 3 weeks after the therapy was completed. The side effects, intolerance to therapy, and overall compliance were evaluated by means of a standardized posttreatment questionnaire.Results:There was no significant difference in cure rates noted between the erythromycin group and the azithromycin group (77% vs. 91%, respectively;P= 0.24). Gastrointestinal side effects were reported more frequently among patients treated with erythromycin compared with patients treated with azithromycin (45% vs. 17%, respectively;P= 0.004). The patients who received erythromycin reported intolerance to therapy secondary to side effects more frequently than patients who received azithromycin (23% vs. 4%, respectively;P= 0.07). Furthermore, the patients in the azithromycin group were more likely to complete their course of therapy as prescribed than the patients in the erythromycin group (100% vs. 61%, respectively;P= 0.002).Conclusions:Azithromycin is efficacious and well tolerated for the treatment of chlamydial cervicitis in pregnancy. Erythromycin, though efficacious, is poorly tolerated, as demonstrated by the number of patients reporting significant side effects during the course of therapy. Since the cost of azithromycin is comparable to that of generic erythromycin, the present study supports the use of azithromycin as an alternative to erythromycin for the treatment of chlamydial cervicitis in pregnancy.

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EP20 Long term safety and efficacy of denosumab and zoledronate

Rheumatology ◽

10.1093/rheumatology/keaa109.019 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Ziad Alkutobi ◽

Deena Laila ◽

Mohammad Tariq

Keyword(s):

Side Effects ◽

Neck Of Femur ◽

Dxa Scan ◽

Safety And Efficacy ◽

Oral Bisphosphonate ◽

Retrospective Audit ◽

Number Of Patients ◽

Gastrointestinal Side Effects ◽

To Receive

Abstract Background Denosumab and zoledronate are increasingly prescribed for primary and secondary osteoporosis long-term management. Methods A retrospective audit was conducted at Basildon Hospital during 2012-2019 using the NICE guidelines standards to evaluate the long term safety and efficacy of denosumab and zoledronate. Number of patients was 84, diagnosed with osteoporosis or osteopenia, 34 of them received 10 or more denosumab injections and 50 patients planned to receive 5 zoledronate infusions (9 patients received 5 and 38 patients received 4). Results Forty percent of the patients were at their 8th decade followed by 28.57% and 21.42 % at their 9th and 7th decades respectively. More than 90% were Caucasian females. Primary prevention was in 39.28% and secondary prevention in 60.71%. The commonest sites of fracture were the wrist and vertebrae at 34.37% for each; followed by the neck of femur and humerous at 12.5% for each. Denosumab was the 1st, 2nd, 3rd or 4th line of treatment in 9.52%, 13.09%, 16.66% and 1.19% respectively; whereas zoledronate was the 1st, 2nd or 3rd line of treatment in 13.09%, 40.47% and 5.95% respectively. The commonest reason for choosing denosumab as the first line was chronic kidney disease, whereas the reason for choosing it as the 2nd or 3rd line was inefficacy of bisphosphonate in 69% or gastrointestinal side effects in 14%. Zoledronate was chosen in all cases because of intolerability to oral bisphosphonate or gastrointestinal side effects. Repeat DXA scan was performed after the 5th, 10th denosumab injections and the 3rd zoledronate infusions. After the 5th Denosumab, DXA scan showed improvement or stability in 100% and 85.29% at the spine and hip respectively whilst deterioration was seen in 14.7% at the hip. After the 10th denosumab, the rate of improvement or stability at the spine was reduced to 88.23% and decline was seen in 2.94%. At the hip area, 73.52% continued to show improvement or stability, whilst 17.66 % showed deterioration. After the 3rd zoledronate, 98% and 88% showed improvement or stability at the spine and hip respectively whilst deterioration seen in 2% and 12% at the spine and hip respectively. One patient on zoledronate experienced dental issues after the 4th injection and stopped treatment. There were no jaw osteonecrosis, no new fractures and no significant side effects with either denosumab or zoledronate. Ninety percent of patients who completed 10 denosumab injections were planned to continue for another 5 injections. Conclusion After the period of 3-5 years, denosumab and zoledronate were well tolerated and BMD was either stable or improved at both spinal and hip sites. There were few cases of deterioration mainly at the hip area with both zoledronate and denosumab. Future researches are needed to stratify guidelines on discontinuation of denosumab. Disclosures Z. Alkutobi None. D. Laila None. M. Tariq None. A. Nandagudi None.

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Natural History of Post-Allogeneic HSCT EBV-Reactivation: A Single Center Retrospective Survey.

Blood ◽

10.1182/blood.v106.11.3232.3232 ◽

2005 ◽

Vol 106 (11) ◽

pp. 3232-3232

Author(s):

Helene M. Schoemans ◽

Koen Theunissen ◽

Marc Boogaerts ◽

Johan Maertens

Keyword(s):

Opportunistic Infections ◽

Screening Tests ◽

Rt Pcr ◽

Post Transplantation ◽

Hematopoietic Stem ◽

Allogeneic Hsct ◽

Ebv Reactivation ◽

Number Of Patients ◽

Significant Difference

Abstract Epstein Barr Virus (EBV) reactivation occurs in about 50% of the allogeneic hematopoietic stem cell transplantation (HSCT) population in the first year post-transplantation. About 1-7% of these patients run the risk of developing a post-transplant lymphoproliferative disorder (PTLD). Several authors have thus advocated systematic screening by EBV real time PCR (RT-PCR) to initiate pre-emptive treatment of reactivations using Rituximab (van Esser 2002). However, the positive predictive value of EBV RT-PCR is only of 40% (van Esser 2001), implying that this algorithm overtreats a number of patients. Methods: We have retrospectively analyzed 60 consecutive allogeneic HSCT patients transplanted in our center between 1/1/2004 and 31/3/2005. Four patients were excluded because of absence of EBV follow-up (n=2) or autologous reconstitution (n=2). EBV reactivation (EBV (+)) was defined by at least two consecutive episodes of EBV RT-PCR above 1000 copies/ml of whole blood. Any other result was considered as negative (EBV (−)). Results: 1175 EBV RT-PCR samples were collected over a median follow up of 215 days (range: 21–511). The population observed was essentially adults (median age 42 years, range: 1–65) with leukemia (29 leukemia, 11 lymphomas, 16 other diseases), mixed graft types (26 matched sibling donors, 26 matched unrelated donors, 4 haploidentical donors; 77% peripheral blood stem cells; 20% CD34+ selection) and mixed conditioning (52% non-myeloablative conditioning containing ATG, and 48% full conditioning). The EBV(+) and EBV(−) cohorts were similar for all characteristics analyzed. We observed a median of 18 EBV RT-PCR per patient (range: 4–105), with a median interval between two tests of 7 days (range: 3–45). There were 30 true reactivations, 2 intermittent reactivations (non consecutive EBV titer rises above threshold), 8 isolated reactivations and 16 patients with no reactivation episode. EBV RT-PCR was first performed at a median of 6 days post HSCT (range: 0–245), and reactivation was noted at a median of 44 days post HSCT (range: 6–375). There were no significant difference in PCR follow up (first day of screening, median test interval and length of biological follow up) except for the total number of screening tests per patient, which was higher in the EBV(+) group (p= 0.01). There was only one case of biopsy-proven PTLD in the EBV(+) cohort. No patient was administered Rituximab post- HSCT. Survival curves of the two cohorts were similar regardless of EBV reactivation (log-rank, p= 0.201). Discussion: The incidence of EBV reactivation (n= 30; 54%) and of PTLD (n=1;1.7%) were standard compared to previous studies, resulting in a standard specificity of 47% for EBV screening. However, within our limited group of patients, we could not show any significant differences in mortality between the EBV(+) and EBV (−) cohorts. Therefore, absence of preventive treatment for EBV reactivation did not result in an increase in mortality in our EBV reactivating cohort. This suggests that systematic prophylactic use of Rituximab may not affect overall mortality, whilst potentially increasing the risk of other opportunistic infections. Conclusion: Further prospective studies are needed to better define the patients at risk for developing EBV-related PTLD, within the EBV reactivating allogeneic transplant patients group, before prophylactic treatment of reactivation becomes a routine procedure.

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288. Follow-Up Blood Cultures in Gram-Negative Bacteremia: How Do They Impact Outcomes

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.331 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S144-S144

Author(s):

Azza Elamin ◽

Faisal Khan ◽

Ali Abunayla ◽

Rajasekhar Jagarlamudi ◽

aditee Dash

Keyword(s):

Clinical Outcomes ◽

Antibiotic Treatment ◽

Readmission Rate ◽

Blood Cultures ◽

Categorical Variables ◽

Gram Negative ◽

Number Of Patients ◽

Significant Difference ◽

The Impact

Abstract Background As opposed to Staphylococcus. aureus bacteremia, there are no guidelines to recommend repeating blood cultures in Gram-negative bacilli bacteremia (GNB). Several studies have questioned the utility of follow-up blood cultures (FUBCs) in GNB, but the impact of this practice on clinical outcomes is not fully understood. Our aim was to study the practice of obtaining FUBCs in GNB at our institution and to assess it’s impact on clinical outcomes. Methods We conducted a retrospective, single-center study of adult patients, ≥ 18 years of age admitted with GNB between January 2017 and December 2018. We aimed to compare clinical outcomes in those with and without FUBCs. Data collected included demographics, comorbidities, presumed source of bacteremia and need for intensive care unit (ICU) admission. Presence of fever, hypotension /shock and white blood cell (WBC) count on the day of FUBC was recorded. The primary objective was to compare 30-day mortality between the two groups. Secondary objectives were to compare differences in 30-day readmission rate, hospital length of stay (LOS) and duration of antibiotic treatment. Mean and standard deviation were used for continuous variables, frequency and proportion were used for categorical variables. P-value < 0.05 was defined as statistically significant. Results 482 patients were included, and of these, 321 (67%) had FUBCs. 96% of FUBCs were negative and 2.8% had persistent bacteremia. There was no significant difference in 30-day mortality between those with and without FUBCs (2.9% and 2.7% respectively), or in 30-day readmission rate (21.4% and 23.4% respectively). In patients with FUBCs compared to those without FUBCs, hospital LOS was longer (7 days vs 5 days, P < 0.001), and mean duration of antibiotic treatment was longer (14 days vs 11 days, P < 0.001). A higher number of patients with FUBCs needed ICU care compared to those without FUBCs (41.4% and 25.5% respectively, P < 0.001) Microbiology of index blood culture in those with and without FUBCs Outcomes in those with and without FUBCs FUBCs characteristics Conclusion Obtaining FUBCs in GNB had no impact on 30-day mortality or 30-day readmission rate. It was associated with longer LOS and antibiotic duration. Our findings suggest that FUBCs in GNB are low yield and may not be recommended in all patients. Prospective studies are needed to further examine the utility of this practice in GNB. Disclosures All Authors: No reported disclosures

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Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression

Scientific Reports ◽

10.1038/s41598-021-87198-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Mona Dietrichkeit ◽

Marion Hagemann-Goebel ◽

Yvonne Nestoriuc ◽

Steffen Moritz ◽

Lena Jelinek

Keyword(s):

Side Effects ◽

Side Effect ◽

Statistical Power ◽

Controlled Trial ◽

Treatment Options ◽

Cognitive Remediation ◽

Negative Effects ◽

Metacognitive Training ◽

To Receive

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.

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Comparative study between fat plug and inlay butterfly cartilage grafts for myringoplasty in adults

The Egyptian Journal of Otolaryngology ◽

10.1186/s43163-021-00076-y ◽

2021 ◽

Vol 37 (1) ◽

Author(s):

Ahmed Gamal Khafagy ◽

Mohamed El-Begermy ◽

Marwa Mohamed El-Begermy ◽

Pretty O. Afifi

Keyword(s):

Tympanic Membrane ◽

Chronic Otitis Media ◽

Fat Graft ◽

Cartilage Graft ◽

Tympanic Membrane Perforations ◽

Number Of Patients ◽

Significant Difference ◽

Hearing Outcomes ◽

Age Range

Abstract Background This study aims to compare the graft uptake rate and hearing improvement of fat graft versus inlay butterfly tragal cartilage in the repair of perforations in chronic otitis media mucosal in adults. In this retrospective study, twenty-eight patients were included with small dry anteroinferior tympanic membrane perforations (less than 1/3 of the tympanic membrane). The age range was 18 to 44 years old. Myringoplasty was done under general anesthesia for 8 patients with a fat graft (FG) and 20 patients with inlay butterfly cartilage graft (IBCG). Six months postoperatively, a follow-up evaluation was done for successful graft uptake and hearing outcomes. Results The success rate of graft uptake in the first group (fat graft) was 6/8 cases (75%) while in the second group (IBCG) was 19/20 (95%) with no statistically significant difference (P = 0.0148). Also, there was no statistical difference between the two groups as regards postoperative ABG, improvement changes in ABG, and number of patients with improved hearing. Conclusions Inlay butterfly cartilage graft is a useful graft in repairing small tympanic membrane perforations as regard graft take and hearing outcomes.

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Reducing the anticholinergic and sedative load in older patients on polypharmacy by pharmacist-led medication review: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-019042 ◽

2018 ◽

Vol 8 (7) ◽

pp. e019042 ◽

Cited By ~ 11

Author(s):

Helene G van der Meer ◽

Hans Wouters ◽

Lisa G Pont ◽

Katja Taxis

Keyword(s):

Cognitive Function ◽

Side Effects ◽

Medication Review ◽

Community Dwelling ◽

Mortality Data ◽

Digit Symbol Substitution Test ◽

Significant Difference ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectiveTo evaluate if a pharmacist-led medication review is effective at reducing the anticholinergic/sedative load, as measured by the Drug Burden Index (DBI).DesignRandomised controlled single blind trial.Setting15 community pharmacies in the Northern Netherlands.Participants157 community-dwelling patients aged ≥65 years who used ≥5 medicines for ≥3 months, including at least one psycholeptic/psychoanaleptic medication and who had a DBI≥1.InterventionA medication review by the community pharmacist in collaboration with the patient’s general practitioner and patient.Primary and secondary outcomes measuresThe primary outcome was the proportion of patients whose DBI decreased by at least 0.5. Secondary outcomes were the presence of anticholinergic/sedative side effects, falls, cognitive function, activities of daily living, quality of life, hospital admission and mortality. Data were collected at baseline and 3 months follow-up.ResultsMean participant age was 75.7 (SD, 6.9) years in the intervention arm and 76.6 (SD, 6.7) years in the control arm, the majority were female (respectively 69.3% and 72.0%). Logistic regression analysis showed no difference in the proportion of patients with a≥0.5 decrease in DBI between intervention arm (17.3%) and control arm (15.9%), (OR 1.04, CI 0.47 to 2.64, p=0.927). Intervention patients scored higher on the Digit Symbol Substitution Test, measure of cognitive function (OR 2.02, CI 1.11 to 3.67, p=0.021) and reported fewer sedative side effects (OR 0.61, CI 0.40 to 0.94, p=0.024) at follow-up. No significant difference was found for other secondary outcomes.ConclusionsPharmacist-led medication review as currently performed in the Netherlands was not effective in reducing the anticholinergic/sedative load, measured with the DBI, within the time frame of 3 months. Preventive strategies, signalling a rising load and taking action before chronic use of anticholinergic/sedative medication is established may be more successful.Trial registration numberNCT02317666.

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Sulphadiazine/Trimethoprim Once Daily in Maxillary Sinusitis: A Randomized Double-Blind Comparison with Sulphamethoxazole/Trimethoprim B.I.D.

Journal of International Medical Research ◽

10.1177/030006058100900609 ◽

1981 ◽

Vol 9 (6) ◽

pp. 478-481 ◽

Cited By ~ 1

Author(s):

Pierre Federspil ◽

Peter Bamberg

Keyword(s):

Maxillary Sinusitis ◽

Favourable Result ◽

Double Blind Study ◽

Double Blind ◽

Once Daily ◽

Days Of Therapy ◽

Significant Difference ◽

Blind Comparison ◽

Cure Rates

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.

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Topical Diltiazem Versus Topical Glyceryl Trinitrate In The Management Of Chronic Anal Fissure

JMS SKIMS ◽

10.33883/jms.v17i2.241 ◽

2014 ◽

Vol 17 (2) ◽

pp. 55-58

Author(s):

Shams Ul Bari ◽

Ajaz Ahmad Malik ◽

Khurshid Alam Wani ◽

Ajaz A Rather

Keyword(s):

Side Effects ◽

Anal Fissure ◽

Chronic Anal Fissure ◽

P Value ◽

Double Blind ◽

Surgical Methods ◽

Significant Difference ◽

Topical Glyceryl Trinitrate ◽

One Year

Background: Chemical sphincterotomy is a novel way for treating patients of chronic anal fissure which avoids the risk of fecal incontinence associated with traditional surgical methods. Aims and objectives: The aim of this study was to compare the results of topical Diltiazem with topical Glyceril trinitrate in the management of chronic anal fissure. Methods: 71 patients in the age group of 15 - 61 years with chronic anal fissure were included in this prospective, randomized, double-blind trial over a period of two years with further follow up for one year. The patients were randomly allocated to either Diltiazem gel 2% (37 patients) or Glyceril trinitrate ointment 0.2% (34 patients) and were asked to use the treatment twice daily for 8 weeks. Each patient was reviewed every two weeks. Symptoms, healing, side effects and recurrence were compared using SPSS version 10 employing X2 test. A p-value below 0.05 was considered statistically significant. Results: Patients who received topical diltiazem (DTZ) showed statistically significant difference than those who were prescribed topical glyceril trinitrate in terms of symptoms, wound healing, side effects ( headaches) and recurrence (p=0.03 and 0.003 respectively). Healing occurred in 34 of 37 (92%) patients treated with Diltiazem after 6 weeks and 27 of 34 (80%) patients treated with Glyceril trinitrate after 8 weeks, which shows a significant difference in favour of Diltiazem (P < 0.001). The rest of the patients did not heal and underwent sphincterotomy (SILS). Headache occurred in all of the patients treated with Glyceril trinitrate but none of the patients treated with Diltiazem. Conclusion: Diltiazem gel was found to be better than Glyceril trinitrate ointment due to significantly higher healing rate and fewer side-effects. JMS 2014;17(2):55-58

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Postoperative craniospinal radiotherapy of medulloblastoma in children and young adults

Srpski arhiv za celokupno lekarstvo ◽

10.2298/sarh0306226g ◽

2003 ◽

Vol 131 (5-6) ◽

pp. 226-231

Author(s):

Ivana Golubicic ◽

Jelena Bokun ◽

Marina Nikitovic ◽

Jasmina Mladenovic ◽

Milan Saric ◽

...

Keyword(s):

High Risk ◽

Brain Stem ◽

Wilcoxon Test ◽

Time Interval ◽

Tumor Removal ◽

Shunt Placement ◽

Craniospinal Radiotherapy ◽

Number Of Patients ◽

Significant Difference

PURPOSE The aim of this study was: 1. to evaluate treatment results of combined therapy (surgery, postoperative craniospinal radiotherapy with or without chemotherapy) and 2. to assess factors affecting prognosis (extend of tumor removal, involvement of the brain stem, extent of disease postoperative meningitis, shunt placement, age, sex and time interval from surgery to start of postoperative radiotherapy). PATIENTS AND METHODS During the period 1986-1996, 78 patients with medulloblastoma, aged 1-22 years (median 8.6 years), were treated with combined modality therapy and 72 of them were evaluable for the study end-points. Entry criteria were histologically proven diagnosis, age under 22 years, and no history of previous malignant disease. The main characteristics of the group are shown in Table 1. Twenty-nine patients (37.2%) have total, 8 (10.3%) near total and 41 (52.5%) partial removal. Seventy-two of 78 patients were treated with curative intent and received postoperative craniospinal irradiation. Radiotherapy started 13-285 days after surgery (median 36 days). Only 13 patients started radiotherapy after 60 days following surgery. Adjuvant chemotherapy was applied in 63 (80.7%) patients. The majority of them (46 73%) received chemotherapy with CCNU and Vincristine. The survival rates were calculated with the Kaplan-Meier method and the differences in survival were analyzed using the Wilcoxon test and log-rank test. RESULTS The follow-up period ranged from 1-12 years (median 3 years). Five-year overall survival (OS) was 51% and disease-free survival (DFS) 47% (Graph 1). During follow-up 32 relapses occurred. Patients having no brain stem infiltration had significantly better survival (p=0.0023) (Graph 2). Patients with positive myelographic findings had significantly poorer survival compared to dose with negative myelographic findings (p=0.0116). Significantly poorer survival was found in patients with meningitis developing in the postoperative period, with no patient living longer than two years (p=0.0134) (Graph 3). By analysis of OS and DFS in relation to presence of the malignant cells in liquor, statistically significant difference, i. e. positive CSF cytology was not obtained, which was of statistical importance for survival (p=0.8207). Neither shunt placement nor shunt type showed any impact on survival (p=0.5307 and 0.7119, respectively). Children younger than three years had significantly poorer survival compared to those older than 16 years (p=0.0473). Although there was a better survival rate in females than in males this was not statistically significant (p=0.2386).The analysis results of treatment showed that significantly better survival occurred in patients in whom total or subtotal tumor removal was possible (p=0.0022) (Graph 4). Patients who started radiotherapy within two months after surgery have better survival, but again this was not statistically significant, probably due to the small number of patients receiving delayed radiotherapy (p=0.2231)(Graph5). CONCLUSION Based on this factors standard and high risk group could be defined. Combined chemotherapy should to be investigated particularly for high risk subgroup. Future research should be done to define new therapeutic modalities (gene therapy, compounds active in tumor antiangiogenesis etc).

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Reguliuojamos skrandžio apjuosimo juostos: lyginamųjų studijų apžvalga

Lietuvos chirurgija ◽

10.15388/lietchirur.2011.1.2090 ◽

2011 ◽

Vol 9 (1-2) ◽

pp. 0-0

Author(s):

Tomas Abalikšta ◽

Gintautas Brimas ◽

Kęstutis Strupas

Keyword(s):

Weight Loss ◽

Comparative Studies ◽

University Hospital ◽

Cochrane Library ◽

Band Slippage ◽

Lap Band ◽

Number Of Patients ◽

Significant Difference ◽

Gastric Bands

Tomas Abalikšta, Gintautas Brimas, Kęstutis Strupas Vilniaus universiteto Medicinos fakultetas, M. K. Čiurlionio g. 21, LT-03101 VilniusVilniaus universiteto ligoninės Santariškių klinikų Pilvo chirurgijos centras,Santariškių g. 2, LT-08661 VilniusEl. paštas: [email protected] Darbo tikslas: Remiantis literatūros duomenimis palyginti skirtingas skrandžio apjuosimo reguliuojamas juostas, naudojamas chirurginiam nutukimo gydymui. Tyriamoji medžiaga ir metodai: Publikacijų paieška atlikta elektroninėse MEDLINE, Current Contents ir Cochrane Library duomenų bazėse. Apžvelgtos visos skrandį apjuosiančių reguliuojamų juostų lyginamųjų studijų publikacijos, paskelbtos iki 2010 m. sausio 1 d. Rezultatai: Atlikus literatūros šaltinių paiešką rasta 10 publikacijų, lyginančių skirtingas skrandį apjuosiančias reguliuojamas juostas. Išsamiai atlikta viena studija: perspektyvi, atsitiktinių imčių, jos tiriamųjų skaičius didelis ir stebėjimo laikotarpis ilgas, įvertinti visi gydymo rezultatai. Statistiškai reikšmingo skirtumo tarp SAGB ir LAP-BAND juostų šioje studijoje nerasta. Kitos lyginamosios juostų studijos turi trūkumų: keturios buvo ne atsitiktinių imčių (dvi iš jų retrospektyvios), trijose tiriamųjų imtis maža, visų stebėjimo laikas trumpas. Vienoje iš šių studijų nustatytas kūno masės kritimo skirtumas tarp grupių: LAP-BAND grupėje pradinė viršnorminė kūno masė sumažėjo 41,7 %, Heliogast – 28,3 %. Mechaninių juostų komplikacijų dažnis skyrėsi vienoje studijoje: LAP-BAND – 7 %, SAGB – 1 %. Skirtumas tarp „mažo skrandžio“ išsiplėtimo arba juostos nuslinkimo dažnio rastas trijose studijose (MiniMizer Extra – 0 % ir LAP-BAND – 10,8 %; SAGB – 2,4 % ir LAP-BAND – 27,6 %; SAGB – 2 % ir LAP-BAND – 23 %). Skirtumo tarp gretutinių ligų ir gyvenimo kokybės pokyčio, hospitalizacijos trukmės, juostos reguliavimų skaičiaus/dažnio, juostos penetracijos/migracijos į skrandį bei infekcinių komplikacijų dažnio nerasta. Išvados: Tik viena studija atlikta laikantis šiuolaikinių įrodymais pagrįstos medicinos keliamų reikalavimų, skirtumo tarp lygintų juostų nerasta. Reikalingos perspektyvios, atsitiktinių imčių ilgalaikės (>5 metų) lyginamosios studijos, vertinančios juostų konstrukcijos ar formos skirtumų įtaką gydymo efektyvumui ar komplikacijoms. Reikšminiai žodžiai: nutukimas, bariatrinė chirurgija, skrandžio apjuosimo reguliuojama juosta operacija. Adjustable gastric bands: review of comparative studies Tomas Abalikšta, Gintautas Brimas, Kęstutis Strupas Vilnius University Medical Faculty, M. K. Čiurlionio Str. 21, LT-03101 Vilnius, LithuaniaVilnius University Hospital Santariškių Klinikos Centre of Abdominal Surgery,Santariškių Str. 2, LT-08661 Vilnius, LithuaniaEl. paštas: [email protected] Objective: The objective of this review is to compare different adjustable gastric bands according to the data of comparative studies. Materials and Methods: A search of articles published in any language before January 2010 was carried out through the MEDLINE, Current Contents and Cochrane Library electronic databases. All articles about comparative studies of different adjustable gastric bands were eligible for review. All possible data were extracted from accepted studies and reviewed. Results: Ten comparative studies of different adjustable gastric bands were accepted. Only one comparative study of the bands was accomplished properly. It was a prospective randomised study type with a large number of patients and a long follow-up period with all possible results evaluated. No statistically significant difference between SAGB and LAP-BAND gastric bands was found in this study. The other band studies had shortcomings: four studies were non-randomised (two of them retrospective), a small number of patients in three studies, and a too short follow-up period in all studies. The difference in weight loss was stated in one of these studies: 41.7% of initial excess weight loss in the LAP-BAND group and 28.3% in the Heliogast group. Band leakage frequency was different in one study: LAP-BAND – 7%, SAGB – 1%. A difference between pouch dilatation or band slippage frequency was found in three studies (MiniMizer Extra – 0% and LAP-BAND – 10.8%; SAGB – 2.4% and LAP-BAND – 27.6%; SAGB – 2% and LAP-BAND – 23%). There was no difference between the resolution of comorbidities, improvement of the quality of life, hospital stay, band adjustment frequency, band migration or band infection rate. Conclusion: Only one accepted study was accomplished properly. There was no difference between compared adjustable gastric bands in this study. Prospective randomised long-term (more than 5 years) comparative studies are needed for a proper evaluation of band construction or shape influence on weight loss and complications. Keywords: obesity, bariatric surgery, adjustable gastric banding.

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