Randomized-controlled Clinical Study Research Articles

COMPARATIVE STUDY BETWEEN MEPERIDINE, KETAMINE, AND ONDASETRON FOR PROPHYLACTIC MANAGEMENT OF POST-SPINAL SHIVERING IN PATIENTS UNDERGOING LOWER ABDOMINAL SURGERIES

Background: Shivering can be very unpleasant and physiologically stressful for the patient. It can be detrimental to patients with low cardio-respiratory reserve. Objective: The study was done to compare the effect of Meperidine, Ketamine, and Ondansetron in prevention of post-spinal shivering. Patients and Methods: This prospective randomized single blinded controlled clinical study was conducted on 120 patients under spinal anesthesia ASA I, II, undergoing lower abdominal and lower limb surgical procedures not exceeding 60 minutes. Patients were randomized into three equal groups. Group (A) received meperidine in a dose of 0.5 mg/kg.i.v, Group(B) received ketamine in a dose of 0.25 mg/kg.iv, and Group (C) received ondansetron in a dose of 4 mg. iv . All these drugs were given after subarachnoid block. Patients were evaluated by measuring shivering grade, HR, Systolic BP every 5 minutes for 60 minutes after interthecal injection. Shivering during spinal anesthesia was determindeded using a scale validated by Tsai and Chu. Blood pressure, heart rate and side effects were recorded. Results: There were statistical significant differences between Meperidine, Ketamine, and Ondansetron as Meperidine has a superior effect in prevention of shivering. No changes in systolic BP and HR. Conclusion: Meperidine and low dose ketamine (0.25mg/kg) were significantly more effective than ondansetron for prevention of post-spinal shivering in patients undergoing lower abdominal surgeries.

EFFECT OF JAW RELAXATION TECHNIQUE ON LOW BACK PAIN AND SELECTED VITAL SIGNS AMONG NURSING STAFF: A RANDOMIZED CONTROLLED TRIAL

Background: Nurses are repeatedly exposed to many forms of occupational hazards such as low back pain while doing their jobs. Aim: The aim of this study was to examine the effect of jaw relaxation technique on low back pain and selected vital signs among nursing staff. Methodology: A randomized control clinical trial study design was utilized. A randomized sample composed of 60 adult male and female nurses working in both medical and surgical specialty departments in a governmental hospital in Egypt were recruited. Three tools were utilized for data collection: I. Demographic- and Work-Related Data, II. Numeric Pain rating scale (NPRS) and III. Medical related data. Results: There was a statistically significant difference in mean systolic and diastolic blood pressure, heart and respiratory rates, as well as low back pain score among nurses before and after practicing Jaw relaxation technique. While, no statistically significant difference was found in low back pain mean score and selected vital signs between post intervention 1& 2. Conclusion: Low back pain mean score improved among nurses after implementation of the jaw relaxation technique. Recommendation: Jaw relaxation technique is recommended to be endorsed as an adjuvant non-pharmacological pain management and coping strategy.

The effect of conbercept combined with 577 nm subthreshold micropulse laser photocoagulation on diabetic macular edema

Objective To observe the effect of conbercept combined with 577 nm subthreshold micropulse laser photocoagulation on diabetic macular edema (DME). Methods A prospective randomized controlled clinical study. From June 2016 to June 2017, 68 eyes of 68 patients with DME diagnosed in Central Theater Command General Hospital were enrolled in the study. The patients were randomly assigned to two different treatment groups: 36 eyes (36 patients) in the conbercept combined with 577 nm subthreshold micropulse lase group (combined treatment group) and 32 eyes (32 patients) in conbercept group (drug treatment group). All patients received three initial intravitreous injection of conbercept and re-treatment was performed according to the criteria which has been disigned before. BCVA was measured by ETDRS charts. The central macular thickness (CMT), total macular volume (TMV) were measured by Topcon 3D-OCT 2000. The BCVA, CMT and TMV in the combined treatment group and the drug treatment group were 57.9±12.4 letters, 427.8±129.4 μm, 10.14±1.50 mm3 and 59.0±16.0 letters, 441.0 ± 135.7 μm, 10.43±2.10 mm3, respectively. There was no significant difference (t=0.321, 0.410, 0.641; P=0.749, 0.683, 0.524). The follow-up period was more than 12 months. The changes of BCVA, CMT and TMV were compared between the two groups. Comparison of BCVA, CMT, TMV before and after treatment in and between groups using repeated measures analysis of variance. Results The average annual injection times was 5.8±1.9 in the combined treatment group and 8.5±2.4 in the drug treatment group. The difference was statistically significant (t=5.12, P=0.000). The BCVA in the 3rd, 6th, 9th and 12th month were 64.9±11.1, 65.6±10.5, 67.0±10.8, 66.6±10.7 letters and 65.7±15.8, 66.9±15.7, 66.4±13.0, 67.3±16.4 letters, respectively, and there were significant differences compared with BCVA before treatment (F=34.234, 10.137; P=0.000, 0.000). The CMT were 335.2±105.9, 352.6±106.6, 336.2±120.8, 305.9±97.0 μm and 323.9±92.8, 325.5±90.2, 327.6±108.2, 312.2±106.8 μm, respectively. The TMV were 9.20±1.08, 9.26±1.20, 9.20±1.63, 9.05±1.18 mm3 and 9.19±1.21, 9.35±1.69, 9.09±1.20, 8.92±1.10 mm3, respectively. Compared with the CMT (F=12.152, 12.917; P=0.000, 0.000) and TMV (F=11.198, 11.008; P=0.000, 0.000) before treatment, the differences were statistically significant. Conclusion Conbercept combined with 577 nm subthreshold micropulse laser and conbercept can effectively reduce CMT, TMV and improve BCVA in patients with DME, but combination therapy can reduce the injection times of conbercept. Key words: Diabetic retinopathy/complications; Macular edema/drug therapy; Angiogenesis inhibitors/therapeutic use; Antibodies, monoclonal/therapeutic use; Laser coagulation

Intra-articular injection of platelet - rich plasma and therapeutic exercise in knee osteoarthritis

ContextThere is no definite treatment strategy capable of decreasing destruction of cartilage and enhancing its healing. Intra-articular injection of platelet-rich plasma (PRP) provides a lot of growth factors that are capable of stimulating regeneration of cartilage and is supposed to be a future solution to patients with osteoarthritis (OA).AimTo detect the efficacy of intra-articular injection of PRP or therapeutic exercise (Ex) alone as well as a combination of both in the treatment of idiopathic knee OA.Settings and designA prospective randomized controlled clinical study was conducted.Patients and methodsA total of 60 patients, 44 to 65 years of age, having idiopathic unilateral knee OA were included in the study and were divided into three groups: PRP group included 20 patients and were treated with intra-articular PRP injection, Ex group included 20 patients and were treated with only therapeutic Ex, and PRP and Ex group included 20 patients who were treated with both PRP intra-articular injection and therapeutic Ex. Evaluation of all patients was done by visual analogue scale, tenderness, range of motion, thigh circumference, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores at baseline and 1 and 6 months later. Objective evaluation was done through MRI of osteoarthritic knee at baseline and 6 months later.Statistical analysisStatistical analyses were performed using SPSS for windows, version 20.0.ResultsBaseline WOMAC score differences among the three groups were not statistically significant but were significant 6 months after treatment. In PRP and Ex groups, there was a significant improvement after treatment, whereas a highly significant improvement in PRP+Ex group. MRI grading differences among the three groups were not significant before or after treatment, with no improvement in all three groups after treatment.ConclusionA combination of intra-articular injection of PRP and therapeutic Ex resulted in significantly lesser visual analogue scale, WOMAC score, and joint tenderness compared with PRP or Ex alone.

Registry-based research in ophthalmology

Medical registries and registry studies are frequently used for health services research as they represent avaluable means of capturing real-life data. Registry studies are particularly suitable for rare diseases for which epidemiological population-based or randomized controlled clinical studies are difficult. The are many examples of successful medical registries that have not only contributed to both epidemiological and clinical research, but which have also improved health service delivery. Only few ophthalmological medical registries are currently available. For non-infectious uveitis in children and adolescents with juvenile idiopathic arthritis (JIA), arare disease entity, there is a need for data on, e.g., treatment, long-term outcomes, and risk factors for progression. The advantages for this disease of aregistry with uveitis module from which numerous scientific publications and guidelines have been derived has been proven. Thus, we use the example of non-infectious uveitis to discuss the benefits of registries for other areas of ophthalmology.

Clinical effectiveness and versatility of a sealing hemostatic patch (HEMOPATCH) in multiple surgical specialties

ABSTRACTIntroduction: Intraoperative surgical sealants and hemostatic agents have been shown to reduce postoperative complications, transfusions, and hospital resource utilization. Despite availability of these agents, the incidence and burden of bleeding remains high and surgeons’ requirements for hemostatic control continue to evolve. A burgeoning class of hemostatic agents are hemostatic patches, which offer package-to-patient readiness and direct application. In addition, hemostatic patches may provide tissue sealing capabilities.Areas covered: This review focuses on the clinical effectiveness, versatility, and surgical efficiency of HEMOPATCH as a surgical sealant and hemostatic agent in various surgical specialties including: cardiac, digestive (hepatic, gastrointestinal, pancreatic), urological, neurological, and endocrine.Expert commentary: Among hemostatic patches, HEMOPATCH is a valuable tool to stop bleeding without adverse events across various surgical specialties. Clinical evidence demonstrates the safety, clinical effectiveness, and versatility of HEMOPATCH as a unique surgical adjunct in patients undergoing complex and routine surgical procedures. Larger randomized-controlled clinical studies, or clinical registries, will continue to be used to evaluate its performance and versatility, particularly for sealing tissues and closing the dura. In the current field of surgical sealing and hemostasis, however, HEMOPATCH represents the next step in improving patient outcomes.

Comparison Between Tea Tree Oil and Chlorhexidine Mouth Rinse in Treatment of Gingivitis Induced by Orthodontic Treatment: A Randomized Control Clinical Study

Aim: This study was designed to compare the effects of tea tree oil and chlorhexidine mouth rinse in the treatment of gingivitis induced by orthodontic treatment.Materials and Methods: Sixty patients undergoing orthodontic treatment and suffering from gingivitis were included and divided randomly into three groups, group I (20 patients): Patients received scaling and oral hygiene instructions, group II (20 patients): Patients received scaling, oral hygiene instructions and chlorhexidine mouth rinse and group III (20 patients): Patients received scaling, oral hygiene instructions and tea tree oil mouth rinse.Results: The results of this study revealed that all treatment modalities achieved a statistically significant reduction of the mean plaque index, gingival index and papillary bleeding index throughout the six months evaluation period as compared to the mean base-line values (P<0.001). This 6-month controlled clinical study demonstrated that the tea tree oil mouth rinse had comparable anti-gingivitis activity with chlorhexidine mouth rinse which is known to produce significantly higher levels of extrinsic stain.Conclusion: Due to side effects associated with the chlorhexidine mouth rinse, it is suggested that tea tree oil mouth rinse can be used instead, as it proved to have a distinct role in the management of gingivitis induced by orthodontic treatment.

A randomized controlled clinical study on reverse-chopper prechop technique with phaco-and-chop technique for high myopia associated with hard nucleus cataract

Background The innovation of pre-chop technique lies in shortening surgery duration, reducing ultrasound power, and deseasing the loss of corneal endothelial cells (CECs). Objective This study was to compare the efficacy and safety of pre-chop technique using a reverse-chopper and phaco-and-chop phaco technique to super high myopia associated with hard nucleus cataract. Methods A prospective randomized-controlled-clinical interventional study was performed.Fourty eyes of 40 high myopia associated with cataract patients with Ⅲ-Ⅳ degree of nucleus were enrolled in Beijing Tongren Hospital from March to September 2016.The patients were randomized into the pre-chop group and matched phaco-and-chop group according to random number table, and the self-made reverse chopper-assisted pre-chop phacoemulsification (phaco) surgery and phaco-and-chop phaco surgery were performed on the eyes of different groups, respectively.The phaco power, effective phaco duration and best corrected visual acuity (BCVA) were recorded and compared between the two groups to evaluate the efficacy, and the loss rate of corneal endothelial cells and eyes in different grades of cornea edema after operation were compared between the two groups to assess the safety of surgery procedure.Written informed consent from each patient was obtained prior to relevant examination and surgery. Results The surgery was finished smoothly in the eyes.The mean effective phaco duration was (47.30±11.29) seconds and (57.70±14.51) seconds in the pre-chop group and phaco-and-chop group, respectively, with a significant difference between them (t=-2.530, P=0.016). The BCVA was better at the seventh day after surgery in the pre-chop group than that in the phaco-and-chop group (4.75±0.11 vs.4.67±0.14), showing a significant difference between the two groups (t=2.147, P=0.038). In 1 month after surgery, the CECs loss rate was (10.82±3.77)% in the pre-chop group, which was lower than (16.11±6.47)% in the phaco-and-chop group (t=-3.758, P=0.001). The number of the eyes with grade 2-3 of corneal edema in the pre-chop group was significantly decreased in comparison with the phaco-and-chop group 7 days after surgery (Z=11.822, P=0.008). Conclusions Compared with the conventional phaco-and-chop technique, reverse-chopper prechop technique appears to have a better efficacy and safety in phaco surgery for high-myopia associated with hard nuclear cataractous eyes. Key words: Cataract extraction/methods; Phacoemulsification/methods; High myopia; Lens nucleus, crystalline/surgery; Treatment outcome; Pre-chopping technique; Phaco-and-chop technique; Randomized-controlled clinical study; Reverse-chopper

Karydakis Flap With Compressing Tie-over Interrupted Sutures Without Drain versus Standard Karydakis for Treatment of Sacrococcygeal Pilonidal Sinus Disease.

Sacroccygeal pilonidal sinus disease is a worldwide health problem, affecting young adults, mainly males, with a tendency for recurrence. Various modalities have been used for treating this condition. The Karydakis procedure is one of most commonly used asymmetric flaps for treating this condition. The study aimed to evaluate the Karydakis procedure with tie-over compressing sutures instead of the routine use of a drain in the treatment pilonidal sinus. This prospective randomized controlled clinical study was conducted between January 2010 and January 2015. The study was conducted at Minia University Hospital. The study included 154 patients. Patients were randomly assigned into 2 equal groups. The patients in group 1 were operated on by the standard Karydakis procedure, and the patients in group 2 were operated on by the Karydakis procedure with tie-over compressing sutures without a drain. The primary outcomes measured were the incidence of seroma formation, wound complications, length of hospital stay, off-work time, and recurrence rate. All patients were discharged on the same day of surgery in group 2 compared with a mean hospital stay of 4.9 ± 2.4 days in group 1. No patients developed seroma in group 2 compared with 7.8% in group 1. In group 2, 1.3% of patients developed wound infection compared with 9.1% in group 1. The average time for return to work in group 2 was 10.2 ± 1.4 days compared with 12.6 ± 4 days in group 1. No recurrences were noted in group 2 compared with 2.6% in group 1. The feedback about postoperative pain and patient satisfaction about the scar were not investigated. The extent of the disease in both groups was not investigated. The duration of follow-up too short to accurately weight recurrence rate. Karydakis flap with tie-over compressing interrupted sutures without a drain is safe, 1-day surgery with the lowest complications rate.

Comparison of therapeutic effects between a new warm moist air device assisted with eyelid massage and eyedrops with only eyedrops for meibomian gland dysfunction

Background Meibomian gland dysfunction (MGD) is a common eye disease that leads to ocular surface damage.Conventional treating method is hot compress with heating pads or warm towels combined with eyelid massage, but the temprature of heat source is difficult to ensure precisely.A new warm moist air device is used in ophthalmology now, however, its clinical effect for MGD is under evaluation. Objective This study was to evaluate the therapeutic effects of a new warm moist air device assisted with eyelid massage for MGD. Methods A randomized-controlled clinical trail was performed.Sixty MGD patients were recruited in Tonghua Eye Hospital from January to June 2015.The patients were divided into two groups according to random number table with matched age, gender and the findings of ocular surface, and the unilateral eyes of the patients were used to analysis.The eyes in the trail group received topical administration of polyethylene glycol eye drops and new warm moist air device combined with eyelid massage, and the eyes in the control group received only topical administration of polyethylene glycol eye drops.The eye examinations were carried out before treatment and 2, 4 weeks after treatment, including ocular surface disease index questionnaire (OSDI), meibomian gland function under the slit lamp microscope, breakup time of tear film (BUT), corneal fluorescein staining scores and Schirmer Ⅰtest (SⅠt). The treating results over time were intergrouply compared.This study protocol was approved by Ethic Committee of Tonghua Eye Hospital, and written informed consent was obtained from each patient prior to entering the group. Results All the patients finished this therapeutic process.In the trail group, the OSDI scores were 13.29±4.06 and 9.29±3.21 at 2 and 4 weeks after treatment, which were significantly lower than those in the control group (16.82±3.21 and 15.41±4.03) (t=-3.5, -6.12, both at P 0.05). In addition, there were not significant differences in SⅠt and meibomian gland secretory levels over time between two groups (SⅠt: Fgroup=0.10, P>0.05; Ftime=0.72, P>0.05; secretion: Fgroup=1.64, P>0.05; Ftime=0.92, P>0.05). Conclusions This new warm moist air device assisted with eyelid massage and polyethylene glycol eye drops can effectively treat MGD, and this combination therapy appears to have a favorable therapeutic effects in comaprison with only polyethylene glycol eye drops. Key words: Meibomian gland dysfunction/therapy; Ocular surface diseases/therapy; Tear film; Prospective study; Randomized-controlled clinical study; Water vapor heating apparatus, ophthalmology/therapeutic use

Pain perception during debridement of hypersensitive teeth elicited by two ultrasonic scalers

ObjectivesThe ultrasonic NO PAIN technology (Electro Medical Systems, Nyon, CH) promises minimal pain during debridement due to linear oscillating action combined with a sinusoidal power output and feedback control. The aim of the present study was to measure pain perception on a visual analogue scale (VAS) during supportive periodontal therapy including debridement of hypersensitive teeth. Two ultrasonic scalers were used, one with and one without NO PAIN technology.Material and methodsIn a randomized-controlled clinical study with split-mouth design, 100 hypersensitive teeth matched for air blast hypersensitivity were either treated with the ultrasonic device Piezon Master 700 or the Mini Piezon (both EMS, Nyon, CH). Pain perception during debridement was assessed by a VAS (range 0–10).ResultsThe average VAS for the test device Piezon Master 700 with NO PAIN technology was 3.16 ± 2.10, and for the control device Mini Piezon without NO PAIN technology 3.40 ± 2.59 (p = 0.490). Placing an arbitrary threshold at the VAS score of 3 for significant pain experience, 60 % of the subjects experienced no significant pain with either instrument.ConclusionNo statistically significant difference in perceived pain between the instruments used was found.Clinical relevanceBoth ultrasonic devices showed very small pain intensities during debridement of highly hypersensitive teeth and can therefore be recommended for supportive periodontal therapy.

A comparative study on visual acuity and stereopsis outcomes between perceptual learning based on cloud services and conventional therapy for amblyopia

Background Amblyopia is a developmental disorder of spatial vision that results in both monocular and binocular deficits.Conventional therapy for amblyopia which focuses on monocular training can improve visual acuity.However, how to improve the binocular function, especially stereopsis is rarely studied. Objective This study was to evaluate the outcome of perceptual learning based on cloud services of improving stereopsis and visual acuity for amblyopia. Methods A randomized-controlled clinical study was performed.One hundred and seven amblyopic patients (178 eyes) with the age of 5—18 years old were recruited in The Second Affiliated Hospital of Anhui Medical University from July 2013 to March 2014.The patients were randomized into the perceptual learning group and the conventional therapy group.A perceptual learning based on cloud services with computer under the best corrected visual acuity was carried out in the perceptual learning group with 30-day duration as a course for 5—6 cycles, and training feedback data was obtained after each cycle for the regulation of following treatment.The dominant eye was covered during the training process.In the conventional therapy group, a training regimen of health eye covering that combined with eyesight training of amblyopic eye was performed.The stereopsis and visual acuity of the patients were estimated after training.Written informed consent was obtained from the parents or custodians of the children before entering the cohort. Results The total effective rate of visual acuity improvement is significantly higher in the perceptual learning group than that in the conventional therapy group after training (Z=6.368, P=0.012). The mean stereopsis value of the amblyopic eyes in the perceptual learning group and the conventional therapy group was (127±53)″ and (174±67)″ after training, which was significantly higher than (273±95)″ and (311±103)″ before training, respectively, and the increasing range of the mean stereopsis was considerably larger in the perceptual learning group than that in the conventional therapy group(t=12.329, 9.557, 15.649; all at P<0.05). In the perceptual learning group, the improving range of mean stereopsis was larger in the severe or moderate amblyopic eyes than that in the mild amblyopic eyes, and the improving range of mean stereopsis in ametropic amblyopia was larger than that in anisometropic amblyopia (all at P<0.05). Conclusions Both perceptual learning based on cloud services and conventional therapy can improve stereopsis and visual acuity in amblyopic eyes.However, perceptual learning based on cloud services can improve the treating compliance of children. Key words: Amblyopia/physiopathology; Vision, binocular/physiology; Visual acuity/physiology; Amblyopia/therapy; Children; Randomized controlled trials; Cloud services; Perceptual learning

Premedication With Single Dose of Acetazolamide for the Control of Referral Shoulder Pain After Laparoscopic Cholecystectomy

Background:The use of laparoscopic surgeries is escalating thanks to their advantages over the open surgeries. However, several complications can be observed following laparoscopy operation. Postoperative pain is a major concern in cholecystectomy surgeries. Pain can be both experienced in operated areas and radiated to the right shoulder. Acetazolamide is used for glaucoma, acute mountain sickness prophylaxis, and epilepsy in few patients with recurrent epilepsy. It seems that patients’ pain can be reduced by preventing carbonic acid production in abdomen after operation.Objectives:We aimed at evaluating if administration of acetazolamide preoperatively could affect early or late postoperative pain following laparoscopic surgery.Patients and Methods:In a randomized-controlled clinical trial study, 70 subjects (30 - 60 years) scheduled for laparoscopic cholecystectomy were included after obtaining a written informed consent. Patients were divided into two groups randomly (intervention and control). The intervention group received 5 mg/kg oral acetazolamide one hour before the operation. The control group did not receive any further medication.Results:Administration of a single dose of acetazolamide did not have any statistically significant impact on sleep quality (P = 1.000). Moreover, there was no statistically significant difference between groups regarding nausea and vomiting on single dose administration of acetazolamide (P = 1.000). Single dose of acetazolamide was associated with statistically significant decrease in shoulder pain immediately after laparoscopy (P = 0.017). However, there was no statistically significant difference regarding shoulder pain between the studied groups 2, 4, 6, 8, 10, 12, and 24 hours after laparoscopy. Single dose of acetazolamide did not significantly affect analgesic administration in 2, 4, 6, 8, 10, 12, and 24 hours after laparoscopy.Conclusions:Single dose of acetazolamide was associated with statistically significant decrease in shoulder pain immediately after laparoscopy. However, this effect was limited to the first postoperative hours and it failed to reduce postoperative pain of right shoulder during 24 hours after the operation.

Use of short implants (6 mm) in a single-tooth replacement: a 5-year follow-up prospective randomized controlled multicenter clinical study.

To evaluate prospectively clinical and radiographic outcomes of 6- or 10 mm-long implants with moderately rough surface (SLA(®) ) loaded within 7 weeks from installation and supporting single crowns in the posterior regions in the course of 5 years of loading. Sixty implants with a moderately rough surface, 30 tests (6 mm long, 4.1 mm in diameter) and 30 controls (10 mm long, 4.1 mm in diameter), were placed in posterior regions in 45 patients. After 6 weeks, impressions were taken and the implants were restored with a single fixed prosthesis made with gold-palladium alloy and porcelain. Survival rate and marginal bone loss were evaluated yearly. The clinical crown/implant ratio was calculated. During the follow-up period, five implants, four tests and one control, were lost. Of the four test implants, one was lost before loading, two between the 2nd and the 3rd years, and one during the 4th year of the follow-up period. The control implant was lost during the first year of function. Consequently, after 5 years of follow-up, a survival rate of 86.7% and 96.7% was observed at the test and control sites, respectively. The results of this study showed that 6-mm-long implants supporting single crowns loaded within 7 weeks from installation lose a small amount of marginal bone during 5 years of functional loading, similar to that of 10-mm-long implants. However, a higher degree of implant loss was recorded at the short implants, probably due to the fracturing of the surrounding bone.

Radiographic evaluation of immediately loaded implants supporting 2-3 units fixed bridges in the posterior maxilla: a 3-year follow-up prospective randomized controlled multicenter clinical study.

To compare the survival rate and alveolar bone levels at implants installed in healed sites and functionally loaded within 1 h from installation or after 3 months. A total of 30 patients (17 male and 13 female) were recruited and 71 implants with a SLA(®) surface, 4.1 mm in diameter and 8-12 mm long, were installed in a fully healed alveolar ridge, 36 as test and 35 as control implants. The test implants were immediately loaded with a temporary reconstruction in proper occlusion, while the randomly selected control sites received the final reconstruction after 3 months. Radiographic bone levels were determined after implant installation, prosthesis delivery, and at annual intervals thereafter. One patient of the control and one patient of the test were excluded from evaluation. No further losses of implants or patients were seen up to the 3-year follow-up. Hence, data from 28 patients were accounted for. A total of 37 and 36 metal-ceramic crowns were provided at the test and control sites, respectively. No biological and technical complications were observed during the 3-year follow-up. Bone levels at the time of implant installation were at 1.6 ± 0.8 and 1.7 ± 0.9 mm from the implant shoulder at the test and control sites, respectively. At prosthesis delivery, the bone levels were located at 2.4 ± 0.7 mm at the control sites 3 months after implant placement. After 1 year of function, similar bone levels were observed at both sites, displaying 2.4 ± 1.0 and 2.5 ± 0.8 mm at the test and control sites, respectively. No differences were found in the subsequent observation periods. Survival rates and radiographic bone levels after 1, 2, and 3 years of observation did not differ between conventionally installed implants loaded immediately or delayed (after 3 months). Moreover, insertion torque values did not affect osseointegration.

Can platelet-rich plasma enhance anterior cruciate ligament and meniscal repair?

The use of platelet-rich plasma (PRP) to improve clinical outcome following a soft tissue injury, regeneration, and repair has been the subject of intense investigation and discussion. This article endeavors to relate clinical and basic science strategies focused on biological augmentation of the healing response in anterior cruciate ligament (ACL) and meniscus repair and replacement using PRP. Therein, a translational feedback loop is created in the literature and targeted towards the entire multidisciplinary team. Ultimately, it is hoped that the theoretical benefits of PRP on soft-tissue interfacial healing will emerge clinically following a careful, focused characterization at the benchtop, and prospective randomized controlled clinical study.

The influence of parenteral glutamine supplementation on glucose homeostasis in critically ill polytrauma patients—A randomized-controlled clinical study

Rapid onset of resistance to insulin is a prominent component of stress metabolism in multiple trauma patients. Recent studies have clarified the role of amino acids (especially glutamine) in glucose transportation and the benefits of parenteral alanyl-glutamine supplementation (0.3-0.6 g/kg/day) in glucose homeostasis. The aims of this study are to evaluate the incidence of hyperglycemic episodes and the need for exogenous insulin to maintain stable glucose levels in critically ill polytrauma patients supplemented with parenteral glutamine dipeptide (Dipeptiven(®)) versus standard nutritional support. This was an open-label randomized-controlled trial of 82 polytrauma patients aged 20-60 years old, randomly assigned into two equal groups independent of sex, age and Injury Severity Score. We excluded patients with diabetes mellitus, or renal or hepatic failure. One group received parenteral Dipeptiven(®) supplementation of 0.5 g/kg/day and the other received standard isocaloric isoproteinic nutritional support. We found that 63% of patients in the glutamine-supplemented group had no hyperglycemic episodes; only 37% required exogenous insulin (mean daily requirement of 44 units/day). In the control group, 51% of patients required insulin (mean daily requirement 63 unit/day; p = 0.0407). The effect of glutamine supplementation on glucose homeostasis is associated with a lower incidence of hyperglycemia among critically ill polytrauma patients, and leads to a lower mean daily dose of insulin. Controlled-trials.com Identifier: ISRCTN71592366 (http://www.controlled-trials.com/ISRCTN71592366/ISRCTN71592366).

Reversal effect of sugammadex in isoflurane, sevoflurane, and desflurane induced anesthesia: a randomized-controlled clinical study

Amac. Bu calismada sugamadeksin noromuskuler blokor etkisini geri dondurucu etkisine isofluran, sevofluran ve desfluranin etkilerini kiyaslamayi amacladik. Yontem. Genel anestezi altinda elektif alt batin operasyonu planlanan 90 hasta calismaya alindi ve rasgele 15 er kisilik 6 gruba ayrildi. Entubasyondan sonra, grup I1 ve I2 hastalar izofluran, grup S1 ve S2 hastalarda sevofluran ve grup D1 ve D2 hastalarda desfluran volatil anestetik olarak 1.25 MAC den aldi. TOF degerleri gruplardan habersiz bir anestezist tarafindan operasyonda 10, 20, 30, 60. ve 90. dakikalarda kaydedildi. I1, S1 ve D1 grubu hastalara son rokuronyum dozunun ardindan TOF a alinan ikinci yanitin tekrar gozelnmesi sonrasi 2 mg kg-1 sugamadeks ve I2, S2 ve D2 grubu hastalarada yine ayni sekilde neostigmine verildi. Her hastaya, sugamadeks uygulanmasi ile % 10,% 25 ve% 90 TOF orani arasindaki sure kaydedildi. Bulgular. Gruplar arasinda TOF un %10 a ulasmasina kadar gecen sure acisindan fark bulunamazken TOF un % 90 a ulasma suresi sevofluran grubunda kisa ve izofluran grubunda en uzun oldugu bulunmustur. Sonuc. Genel anestezi pratiginde kullanilan inhalasyon anesteziklerinin sugamamdeksin noromuskuler blokaj geri dondurucu etkinligini farkli oranlarda etkiledigini ve sevofluran anestezisinde sugamadeksin geri dondurucu etkisinin en hizli oldugunu dusunmekteyiz.

A Review of the Evidence for Using Bedaquiline (TMC207) to Treat Multi-Drug Resistant Tuberculosis.

Existing therapies for multi-drug resistant tuberculosis (MDR-TB) have substantial limitations, in terms of their effectiveness, side-effect profile, and complexity of administration. Bedaquiline is a novel diarylquinoline antibiotic that has recently been investigated as an adjunct to existing therapies for MDR-TB. Currently, limited clinical data are available to evaluate the drug’s safety and effectiveness. In two small randomized-controlled clinical studies, bedaquiline given for 8 or 24 weeks has been shown to improve surrogate microbiological markers of treatment response, but trials have not yet evaluated its impact on clinical failure and relapse. Safety concerns include an increased mortality in the bedaquiline arm of one study, an increased incidence of QT segment prolongation on electrocardiogram, and hepatotoxicity. Until further research data are available, the use of bedaquiline should be confined to settings where carefully selected patients can be closely monitored.

Survival patterns by line of treatment of stage IIIb/v NSCLC patients from community U. S. oncology practice.

e18097 Background: Lung cancer is the most common cause of cancer-related death in men and women worldwide. 80% of the lung cancer patients are diagnosed with NSCLC. Patients have varying survival results from multiple lines of treatment. The objective of this study was to evaluate in a real world context, treatment patterns with survival, and the impact of adding a third line of chemotherapy to a stage III/IV NSCLC population. Methods: The Georgia Cancer Specialist database (2005-2011) was used. Patients with stage III or IV primary NSCLC and treated with chemotherapy were followed from initial NSCLC diagnosis until death, study end or lost to follow-up. Patients were stratified into lines and type of protocol for treatments. Kaplan-Meier curves were used to compare the overall survival results between lines of therapy. Results: A total of 291 patients with advanced NSCLC were identified and included in the primary analysis. Of these, 40 patients received third line therapy. The most commonly used treatment regimens in third line were Pemetrexed with 11 patients (3.8%), Docetaxel with 10 patients (3.4%), Gemcitabine with 4 patients (1.4%), Vinorelbine with 3 patients (1%) Cisplatin/Gemcitabine/Bevacizumab with 2 patients (0.7%). No single treatment regimen was predominantly used in third line. No association of survival gain was seen in patients who received third line therapy over those who received second line therapy (Log-Rank test P=0.4926) Conclusions: In a large EMR physician practice based database of advanced NSCLC patients, we failed to find a difference in the median overall survival of patients who received third line therapy compared to those who received second line therapy. Limitations include a small sample size and no standardized timing of diagnosis and treatment. The lack of a standard of care in third line therapy necessitates the need of further randomized controlled clinical studies to establish a benefit for a particular combination.