scholarly journals Calcitonin as an Additive to Local Anesthetic and Steroid Injection Using a Modified Coronoid Approach in Trigeminal Neuralgia

2016 ◽  
Vol 7;19 (7;9) ◽  
pp. 457-464
Author(s):  
Yasser Mohamed Amr
Keyword(s):  
Pain Relief ◽  
Trigeminal Neuralgia ◽  
Local Anesthetic ◽  
Interventional Procedure ◽  
Small Sample Size ◽  
Small Sample ◽  
Group 2 ◽  
Effective Pain Relief ◽  
One Year ◽  
Group 1

Background: Pharmacotherapy is the main treatment for management of trigeminal neuralgia. However, many patients become refractory to drugs. Objectives: The present study aimed to evaluate the effect of adding calcitonin to local anesthetic and methylprednisolone using a modified coronoid approach in management of trigeminal neuralgia pain involving the mandibular and/or maxillary branches. Study Design: Randomized double blind clinical trial. Setting: Hospital outpatient setting. Methods: Thirty-three patients received maxillary and mandibular blocks by a modified coronoid approach. Patients were allocated into 2 groups. Group 1 received a block with 3 mL of lidocaine 0.5% plus 40 mg of methylprednisolone and another syringe contained 1 mL of 0.9% saline. Group 2 received a block with 3 mL of lidocaine 0.5% plus 40 mg of methylprednisolone and another syringe contained 50 international units of calcitonin. Pain was evaluated by visual analog scale (VAS) before the block (basal), at 2 weeks, one month after the procedure, and monthly for one year. Duration of the effective pain relief of the first block (VAS ≤ 3) was reported. Repeated blockade was allowed for any patient reporting a VAS > 30 mm during one year of follow-up and the number of blocks were reported. Adverse effects were also reported. Results: A significantly longer duration of effective pain relief was noticed in group 2 compared with group 1 (P < 0.0004) while the duration of effective pain relief of the second block in group 1 was 28.5 ± 8.9 weeks. Four patients did not need repeated blocks in group 1 versus 15 in group 2. Six patients received 2 blocks versus 2 patients in each group, respectively. Moreover, 6 patients needed 3 blocks in group1 versus none in group 2. No serious adverse events were reported during or after the interventional procedure. VAS was comparable in both groups (P > 0.05). Limitations: Small sample size. Conclusion: Calcitonin may be a useful additive to local anesthetic and steroid in management of trigeminal neuralgia. Also, a modified coronoid approach for maxillary and mandibular nerve is simple, free of radiation, safe, and may be an effective percutaneous procedure in trigeminal neuralgia. Key words: Calcitonine, modifed, coronoid approach, trigeminal neuralgia

scholarly journals Pulsed Radiofrequency for Chronic Inguinal Neuralgia

2015 ◽  
Vol 2;18 (2;3) ◽  
pp. E147-E155
Author(s):  
Yasser M. Amr
Keyword(s):  
Pain Relief ◽  
Nerve Root ◽  
Small Sample ◽  
Pulsed Radiofrequency ◽  
Group 2 ◽  
One Year ◽  
The One ◽  
Inguinal Neuralgia ◽  
Group 1

Background: Chronic inguinal neuralgia has been reported after inguinal herniorrhaphy, caesarean section, appendectomy, and trauma to the lower quadrant of the abdomen or inguinal region. Objectives: This study was designed to evaluate the efficacy of pulsed radiofrequency in management of chronic inguinal neuralgia. Study Design: Randomized, double-blind controlled trial. Setting: Hospital outpatient setting. Methods: Twenty-one patients were allocated into 2 groups. Group 1 received 2 cycles of pulsed radiofrequency (PRF) for each nerve root. In Group 2, after stimulation, we spent the same time to mimic PRF. Both groups received bupivacaine 0.25% + 4 mg dexamethasone in 2 mL for each nerve root. Visual Analogue Scale (VAS) was assessed. Duration of the first block effective pain relief was reported. Repeated PRF blockade was allowed for any patient who reported a VAS > 30 mm in both groups during the one year follow-up period. The number and duration of blocks were reported and adverse effects were also reported. Results: Significantly longer duration of pain relief was noticed in Group 1 (P = 0.005) after the first block, while the durations of pain relief of the second block were comparable (P = 0.59). In Group 1 the second PRF produced pain relief from the twenty-fourth week until the tenth month while in Group 2, pain relief was reported from the sixteenth week until the eighth month after the use of PRF. All patients in Group 2 received 3 blocks (the first was a sham PRF) during the one year follow-up period. Meanwhile, 2 PRF blocks were sufficient to achieve pain relief for patients in Group 1 except 4 patients who needed a third PRF block. No adverse events were reported. Limitations: Small sample size. Conclusion: For intractable chronic inguinal pain, PRF for the dorsal root ganglion represents a promising treatment modality. Key words: Radiofrequency, chronic, inguinal neuralgia

CD14 and Tissue Factor Positive Extracellular Vesicles Predict Response to Dovitinib in Patients with GBM: A Pilot Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4999-4999
Author(s):  
Nikolaos Papadantonakis ◽  
Manmeet S Ahluwalia ◽  
Micheal Khoury ◽  
Shruti Chaturvedi ◽  
Keith R. McCrae
Keyword(s):  
Growth Factor ◽  
Sample Size ◽  
Progressive Disease ◽  
Small Sample Size ◽  
Small Sample ◽  
Malignant Cells ◽  
Angiogenic Therapy ◽  
Pre Treatment ◽  
Group 2 ◽  
Group 1

Abstract BACKGROUND: Glioblastoma (GBM) is most common primary malignant brain tumor, and has a median survival of 15-18 months. Dovitinib, an oral multi-tyrosine kinase inhibitor of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet derived growth factor (PDGF) is currently under study in a phase II trial for GBM at the Cleveland Clinic. Dovitinib is administrated 5 days on and 2 days off every 4 weeks until progressive disease (PD) or intolerable toxicity are observed. Extracellular vesicles (EV) are submicron particles that express or contain cellular proteins and nucleic acids and are released from a variety of non-malignant cells (e.g. endothelial cells, platelets, leucocytes) and malignant cells. In some settings, EV may serve as biomarkers of inflammation, thrombosis and tumor spread/burden. OBJECTIVE: The aim of our study was to characterize levels of circulating EV and their relation to disease course in patients with GBM enrolled in the Dovitinib study (with or without prior treatments with anti-angiogenic agents). We also examined the association between EV levels and the development of venous thromboembolism (VTE). METHODS: Patients previously treated with anti-angiogenic therapy (Group 1, n=14) or without prior anti-angiogenic treatment (Group 2, n=14) were examined separately. EV were measured at study enrollment (pre-treatment), at the end of cycle 1 (day 28), and at PD. EV were isolated from citrated whole blood by differential centrifugation and incubated with fluorochrome-conjugated monoclonal antibodies to CD144-PE (endothelial cells), CD41-PECy4 (platelets), CD14-PE (monocytes) and CD142 (tissue factor, Alexa Fuor 647), then analyzed by flow cytometry. Depending on sample size, the Student t-test or Wilcoxon test was used to compare EV levels (due to the small sample size and skewed distribution of EV levels). P<0.05 was considered significant for all analyses. RESULTS: Three patients from group 1 and 6 patients from group 2 were not included in the analysis secondary to lack of an EV sample, withdrawal of consent or complications leading to early drug discontinuation. Of theremaining 11 patients in Group 1, 3 had PD and 8 had stable disease (SD) at the end of cycle 1. Of the 8 patients in group 2 available for analyses after cycle 1, 2 had PD and 6 had SD (one of these developed VTE but continued on the study). In the pretreatment sample of patients from group 1, patients who developed PD had significantly higher levels of CD14+ EV (89977±12121 vs. 42237±27651, p =0.048) and CD142+ EV (68701±9010 vs. 9695±12462, p=0.048) compared to those with SD. However, there was no statistically significant difference in EV levels (all sub-populations) from pre-treatment to the end of cycle 1 in patents with either PD or SD. EV levels did not correlate with peripheral blood counts. Due to the small number of patients in group 2 with progressive disease, we were unable to assess the correlation with EV. Six (2 in group 1, 4 in group 2) of the 27 patients for which pre-treatment EV were available developed VTE during the study. The EV levels were not significantly different between patients who developed VTE compared to those who did not both at pretreatment and at the day 28 evaluation. However, most patients who developed VTE demonstrated profound increases in EV before or in association with their thrombotic event. CONCLUSIONS: In patients with GBM receiving Dovitinib without prior exposure to anti-angiogenic therapy, elevated pre-treatment levels of CD14+ and CD142+ EV were associated with progressive disease, suggesting their potential role as a predictor of poor response to Dovitinib. Due to the relatively small sample size, no significant differences were observed between patients that developed VTE and those that did not, either pretreatment or at the Day 28 evaluation; however, these studies are ongoing. In the majority of patients with VTE, EV levels increased substantially before or in association with VTE development. Acknowledgment: This work was supported by a grant from the Scott Hamilton Cares Initiative Disclosures No relevant conflicts of interest to declare.

Efficacy of Neurolytic Celiac Plexus Block in Varying Locations of Pancreatic Cancer

2000 ◽  
Vol 92 (2) ◽  
pp. 347-347 ◽  
Author(s):  
Jan J. Rykowski ◽  
Maciej Hilgier
Keyword(s):  
Computed Tomography ◽  
Pancreatic Cancer ◽  
Pain Relief ◽  
Celiac Plexus ◽  
Celiac Plexus Block ◽  
Head Of The Pancreas ◽  
Group 2 ◽  
Effective Pain Relief ◽  
Plexus Block ◽  
Group 1

Background Neurolytic celiac plexus block (NCPB) is an effective way of treating severe pain in some patients with pancreatic malignancy. However, there are no studies to date that evaluate the effectiveness of NCPB related to the site of primary pancreas cancer. The aim of the study was to assess the effectiveness of NCPB in pancreatic cancer pain, depending on the location of the pancreatic tumor. Methods The prospective study was conducted in 50 consecutive patients diagnosed with pancreatic cancer. The patients were categorized into two different groups depending on tumor localization: group 1: patients with the cancer of the head of the pancreas and group 2: patients with the cancer of the body and tail of the pancreas. The qualitative and quantitative pain analyses were performed before and after NCPB. The patients underwent prognostic celiac plexus block with bupivacaine, followed by neurolysis during fluoroscopic control within the next 24 h. Results After NCPB, 37 patients (74%) had effective pain relief during the first 3 months or until death. Of the 37 patients who had effective pain relief, 33 (92%) were from group 1 and 4 (29%) were from group 2. In the remaining 13 patients (3 patients from group 1 and 10 patients from group 2), pain relief after NCPB was not satisfactory. Those patients were scheduled for repeated retrocrural neurolysis during computed tomography control. Computed tomography showed massive growth of the tumor around the celiac axis with metastases. After repeated neurolysis, pain relief clinically still was not satisfactory, necessitating additional opioid treatment. Conclusion In this study, unilateral transcrural celiac plexus neurolysis has been shown to provide effective pain relief in 74% of patients with pancreatic cancer pain. Neurolysis was more effective in cases with tumor involving the head of the pancreas. In the cases with advanced tumor proliferation, regardless of the technique used, the analgesic effects of NCPB were not satisfactory.

scholarly journals Assessment of advice to reduce dietary fat and non-milk extrinsic sugar in a free-living male population

1999 ◽  
Vol 2 (2) ◽  
pp. 187-197 ◽  
Author(s):  
Sandra Drummond ◽  
Terry Kirk
Keyword(s):  
Energy Intake ◽  
Dietary Fat ◽  
Small Sample Size ◽  
Small Sample ◽  
Dietary Advice ◽  
Control Group ◽  
Free Living ◽  
Initial Decrease ◽  
Group 2 ◽  
Group 1

AbstractObjectiveTo compare the effect of advice to reduce both dietary fat and sugar with advice to reduce fat alone on subsequent dietary intake in Scottish men.DesignA parallel design intervention study was employed to measure compliance to the two types of dietary advice. Subjects were randomly assigned to Group 1 (advice to reduce fat and non-milk extrinsic (NME) sugar), Group 2 (advice to reduce fat only, ad libitum sugar) or a control Group 0 (no advice). Compliance was assessed by two 4-day food diaries over 6 months.SettingThe study was conducted in the Strathclyde area of Scotland.SubjectsSubjects were normal to moderately overweight Scottish men. The men recruited were non-dieting and volunteered for a ‘healthy eating’ study with the aim to improve the ‘healthiness’ of their diet.ResultsGroups 1 and 2 achieved the dietary target for fat, reducing their mean intake to below 35% energy. Group 1 achieved a statistically significant reduction in percentage energy from NME sugar in the short term (6 weeks), decreasing their mean intake from 9.9% to 7.2% energy. This initial decrease appeared to slip back towards baseline levels at 6 months (8.1% energy from NME sugar) and was no longer significantly different from baseline. At 6 months Group 1 reported a significantly lower mean energy intake than at baseline, whereas Group 2 adjusted for an initial decrease in energy intake and by 6 months energy intakes were not significantly different from baseline intakes. Group 2 appeared to compensate for the absolute reduction in dietary fat with a slight increase in total sugars and the maintenance of NME sugar intakes.ConclusionsSubjects in Group 1 complied with advice to reduce both fat and sugar over 6 weeks but to a lesser extent over 6 months. The 1.8% reduction in percentage energy from NME sugars in Group 1 at 6 months may not have reached significance due to the small sample size. Alternatively it may be that free-living populations find it hard to maintain concurrent reductions in fat and sugar owing to the well-documented inverse relationship between intakes of these macronutrients when expressed as a proportion of energy.

scholarly journals Treatment of glioblastoma multiforme with “classic” 4:1 ketogenic diet total meal replacement

2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Pavel Klein ◽  
Ivana Tyrlikova ◽  
Giulio Zuccoli ◽  
Adam Tyrlik ◽  
Joseph C. Maroon
Keyword(s):  
Survival Time ◽  
Ketogenic Diet ◽  
Outcome Measures ◽  
Small Sample Size ◽  
Small Sample ◽  
Secondary Outcome ◽  
Meal Replacement ◽  
Group 2 ◽  
Recurrent Gbm ◽  
Group 1

Abstract Introduction Glioblastoma (GBM) has poor survival with standard treatment. Experimental data suggest potential for metabolic treatment with low carbohydrate ketogenic diet (KD). Few human studies of KD in GBM have been done, limited by difficulty and variability of the diet, compliance, and feasibility issues. We have developed a novel KD approach of total meal replacement (TMR) program using standardized recipes with ready-made meals. This pilot study evaluated feasibility, safety, tolerability, and efficacy of GBM treatment using TMR program with “classic” 4:1 KD. Method GBM patients were treated in an open-label study for 6 months with 4:1 [fat]:[protein + carbohydrate] ratio by weight, 10 g CH/day, 1600 kcal/day TMR. Patients were either newly diagnosed (group 1) and treated adjunctively to radiation and temozolomide or had recurrent GBM (group 2). Patients checked blood glucose and blood and urine ketone levels twice daily and had regular MRIs. Primary outcome measures included retention, treatment-emergent adverse events (TEAEs), and TEAE-related discontinuation. Secondary outcome measures were survival time from treatment initiation and time to MRI progression. Results Recruitment was slow, resulting in early termination of the study. Eight patients participated, 4 in group 1 and 4 in group 2. Five (62.5%) subjects completed the 6 months of treatment, 4/4 subjects in group 1 and 1/4 in group 2. Three subjects stopped KD early: 2 (25%) because of GBM progression and one (12.5%) because of diet restrictiveness. Four subjects, all group 1, continued KD on their own, three until shortly before death, for total of 26, 19.3, and 7 months, one ongoing. The diet was well tolerated. TEAEs, all mild and transient, included weight loss and hunger (n = 6) which resolved with caloric increase, nausea (n = 2), dizziness (n = 2), fatigue, and constipation (n = 1 each). No one discontinued KD because of TEAEs. Seven patients died. For these, mean (range) survival time from diet initiation was 20 months for group 1 (9.5–27) and 12.8 months for group 2 (6.3–19.9). Mean survival time from diagnosis was 21.8 months for group 1 (11–29.2) and 25.4 months for group 2 ( 13.9–38.7). One patient with recurrent GBM and progression on bevacizumab experienced a remarkable symptom reversal, tumor shrinkage, and edema resolution 6–8 weeks after KD initiation and survival for 20 months after starting KD. Conclusion Treatment of GBM patients with 4:1 KD using total meal replacement program with standardized recipes was well tolerated. The small sample size limits efficacy conclusions. Trial registration NCT01865162 registered 30 May 2013, and NCT02302235 registered 26 November 2014, https://clinicaltrials.gov/

scholarly journals Bony Union and Flap Resorption in Cranioplasty with Autologous Subcutaneous Pocket Preserved Bone Flap: Early Report on an Ambidirectional CT Scan-Based Study

2021 ◽  
Vol 10 (01) ◽  
pp. 026-036
Author(s):  
Sudip Kumar Sengupta ◽  
Andrews Navin Kumar ◽  
Vinay Maurya ◽  
Harish Bajaj ◽  
Krishan Kumar Yadav ◽  
...  
Keyword(s):  
Sample Size ◽  
Small Sample Size ◽  
Early Report ◽  
Small Sample ◽  
Bony Union ◽  
Randomized Controlled Studies ◽  
Superficial Skin ◽  
Size Discrepancy ◽  
Group 2 ◽  
Group 1

Abstract Introduction Absence of sufficient number of prospective randomized controlled studies and comparatively small sample size and short follow-up period of most of the studies, available so far, have left ambiguity and lack of standardization of different aspects of cranioplasty. Materials and Methods This is an early report of a computed tomography scan image-based ambidirectional study on cranioplasties performed with autologous subcutaneous pocket preserved bone flaps. Retrospective arm compared bony union and factors influencing it between cranioplasties and craniotomies. Patients with poor bony union and aseptic resorption were followed up in the prospective arm. Results Retrospective arm of the study, followed up for five years (mean 32.2 months), comprised 42 patients as cases (Group 1) and 29 as controls (Group 2). Twenty-seven individuals (64.3%) in Group 1 had good bony union, as compared with 20 (68.9%) good unions in Group 2 out of the 29 patients. Four patients (9.5%) in Group 1 showed evidence of flap resorption, a finding absent in any patient in Group 2. Age, sex, smoking habits, superficial skin infection, and method of fixation did not appear to have any implication on bony union. Craniotomies done using Gigli saws fared better as compared with those done with pneumatic saw with lesser flap size–craniectomy size discrepancy, though it was not statistically significant. Fifteen patients have been included in the Prospective arm at the time of submission of this article. Conclusion Ours is a study with a small sample size, unable to put its weight on any side, but can surely add some more data to help the Neurosurgeons in choosing the best for their patients.

scholarly journals Effect of Prenatal Lactation Education on Lactation Success in Mothers at Risk of Preterm Delivery

2018 ◽  
Vol 20 (1) ◽  
Author(s):  
Morgan Leigh Richburg
Keyword(s):  
At Risk ◽  
Preterm Delivery ◽  
Preterm Infants ◽  
Small Sample Size ◽  
Small Sample ◽  
Stage Ii ◽  
Breast Pump ◽  
Group 2 ◽  
Time To Onset ◽  
Group 1

Background:Mothers of preterm infants often produce insufficient amounts of breast milk (BM).  Early initiation of BM expression following delivery is associated with increased lactation success, but lack of nursing time delays BM expression in this population.Purpose:To determine if providing antenatal breast expression education to the support person (SP) of mothers at risk of preterm delivery improves lactation success.Methods: Twenty women at risk for delivering a preterm infant and their SP were randomized into two groups. Mothers and their SP in Group 1 received education regarding how to use a breast pump and a breast pump was placed into their hospital room. Group 2 received standard care. Data regarding BM volume produced, time to initiation of BM expression and time to onset of lactogenesis stage II was collected.Results: While there was no difference in time to onset of lactogenesis stage II, mothers in Group 1 initiated BM expression 2.5 hours earlier than those in Group 2.   Overall, BM production was higher in Group 1.Limitations: This study had a relatively small sample size (n=19). Only mothers delivering 31-33 weeks gestation were included. This is a single-center study, which may limit generalizability.Conclusion: Prenatal lactation education of mothers of preterm infants and their SP is feasible and may increase lactation success.

scholarly journals Prevalence of myopia in school children in Southern Rajasthan

2021 ◽  
Vol 9 (3) ◽  
pp. 786
Author(s):  
Utkarsh Deshmukh ◽  
Rishi Mehta
Keyword(s):  
Sample Size ◽  
School Children ◽  
Refractive Error ◽  
High Myopia ◽  
Small Sample Size ◽  
Small Sample ◽  
P Value ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background: Among the refractive errors, myopia is the most common in school children. Due to myopia, school children are unable to see the blackboard which severely affects their performance. Moreover, they are unable to play outdoor sports thereby hampering their all-round development.Methods: This is a cross-sectional observational and analytical study. All children from 5-12 years attending eye OPD were included. Detailed history was taken and complete ophthalmic examination was done. Low myopia was defined as refractive error of -0.25D to -3D. Moderate myopia was defined refractive error of -3.25 D to -6 D. High myopia was defined as refractive error of ≥-6D. The children were divided into 3 groups according to their age (in years): group-1 (5-7), group-2 (8-9) and group-3 (10-12). The data obtained was subjected to statistical analysis using IBM SPSS version 24.  P value was calculated by chi-square test. P<0.05 was considered statistically significant.Results:   153 children were examined, out of which 72 (47.1%) were males and 81 (52.9%) were females. Group-1, group-2 and group-3 had 38, 38, 77 children respectively. Out of 153 children, 26 (16.99%) were found to be myopic. Out of 26 myopic children, males were 11 (42.3%) and females were 15 (57.69%) (p>0.05), Low, moderate and high myopia was found in 19 (73.07%), 6 (23.07%) and 1 (3.84%) child respectively.Conclusions: The prevalence of myopia in school children is 16.99%. There is a need for regular screening of school children to diagnose myopia in them. The limitation of this study is hospital based and small sample size. So, we recommend a community-based study with a larger sample size.

scholarly journals Cryoablation for the Treatment of Occipital Neuralgia

2015 ◽  
Vol 3;18 (3;5) ◽  
pp. E363-E368 ◽  
Author(s):  
Chong H. Kim
Keyword(s):  
Pain Relief ◽  
Adverse Effects ◽  
Pain Score ◽  
Local Anesthetic ◽  
Treatment Options ◽  
Occipital Neuralgia ◽  
Average Improvement ◽  
Average Pain ◽  
Group 2 ◽  
Group 1

Background: Treatment of occipital neuralgia (ON) can be complex, though many treatment options exist. Cryoablation (CA) is an interventional modality that has been used successfully in chronic neuropathic conditions and is one such option. Objective: To study and evaluate the efficacy and safety of cryoablation for treatment of ON. Study Design: Retrospective evaluation. Setting: Academic university-based pain management center. Methods: All patients received local anesthetic injections for ON. Patients with greater than or equal to 50% relief and less than 2 week duration of relief were treated with CA. Results: Thirty-eight pateitns with an average age of 49.6 years were included. Of the 38 patients, 20 were treated for unilateral greater ON, 10 for unilateral greater and lesser ON, and 8 for bilateral greater ON. There were 10 men and 28 women, with an average age of 45.2 years and 51.1 years, respectively. The average relief for all local anesthetic injections was 71.2%, 58.3% for patients who reported 50 – 74% relief (Group 1) and 82.75% for patients who reported greater than 75% relief (Group 2). The average improvement of pain relief with CA was 57.9% with an average duration of 6.1 months overall. Group 1 reported an average of 45.2% relief for an average of 4.1 months with CA. In comparison, Group 2 reported an average of 70.5% relief for 8.1 months. The percentage of relief (P = 0.007) and duration of relief (P = 0.0006) was significantly improved in those reporting at least 75% relief of pain with local anesthetic injections (Group 2 vs Group 1). Though no significance in improvement from CA was found in men, significance was seen in women with at least 75% benefit with local anesthetic injections in terms of duration (P = 0.03) and percentage (P = 0.001) of pain relief with CA. The average pain score prior to CA was 8 (0 – 10 visual analog scale, VAS), this improved to 4.2, improvement of 3.8 following CA at 6 months (P = 0.03). Of the 38 patients, 3 (7.8%) adverse effects were seen. Two patients reported post procedure neuritis and one was monitored for procedure-related hematoma. Limitations: Study limitations include the retrospective nature of the study. Additionally, only the percentage of relief, pain score, and duration of relief were collected. Conclusions: CA is safe, and should be considered in patients with ON. Key words: Cryoablation, cryoanalgesia, occipital neuralgia, treatment, adverse effects

scholarly journals Intracoronary Injection of Autologous CD34+ Cells Improves One-Year Left Ventricular Systolic Function in Patients with Diffuse Coronary Artery Disease and Preserved Cardiac Performance—A Randomized, Open-Label, Controlled Phase II Clinical Trial

2020 ◽  
Vol 9 (4) ◽  
pp. 1043 ◽  
Author(s):  
Pei-Hsun Sung ◽  
Yi-Chen Li ◽  
Mel S. Lee ◽  
Hao-Yi Hsiao ◽  
Ming-Chun Ma ◽  
...  
Keyword(s):  
Systolic Function ◽  
Coronary Intervention ◽  
Left Ventricular ◽  
Diffuse Coronary Artery Disease ◽  
Cd34 Cells ◽  
Group 2 ◽  
Artery Disease ◽  
One Year ◽  
Lv Systolic Function ◽  
Group 1

This phase II randomized controlled trial tested whether intracoronary autologous CD34+ cell therapy could further improve left ventricular (LV) systolic function in patients with diffuse coronary artery disease (CAD) with relatively preserved LV ejection fraction (defined as LVEF >40%) unsuitable for coronary intervention. Between December 2013 and November 2017, 60 consecutive patients were randomly allocated into group 1 (CD34+ cells, 3.0 × 107/vessel/n = 30) and group 2 (optimal medical therapy; n = 30). All patients were followed for one year, and preclinical and clinical parameters were compared between two groups. Three-dimensional echocardiography demonstrated no significant difference in LVEF between groups 1 and 2 (54.9% vs. 51.0%, respectively, p = 0.295) at 12 months. However, compared with baseline, 12-month LVEF was significantly increased in group 1 (p < 0.001) but not in group 2 (p = 0.297). From baseline, there were gradual increases in LVEF in group 1 compared to those in group 2 at 1-month, 3-months, 6-months and 12 months (+1.6%, +2.2%, +2.9% and +4.6% in the group 1 vs. −1.6%, −1.5%, −1.4% and −0.9% in the group 2; all p < 0.05). Additionally, one-year angiogenesis (2.8 ± 0.9 vs. 1.3 ± 1.1), angina (0.4 ± 0.8 vs. 1.8 ± 0.9) and HF (0.7 ± 0.8 vs. 1.8 ± 0.6) scores were significantly improved in group 1 compared to those in group 2 (all p < 0.001). In conclusion, autologous CD34+ cell therapy gradually and effectively improved LV systolic function in patients with diffuse CAD and preserved LVEF who were non-candidates for coronary intervention (Trial registration: ISRCTN26002902 on the website of ISRCTN registry).

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