scholarly journals Feasibility of Non-Anesthesiologist-Administered Propofol Sedation for Emergency Endoscopic Retrograde Cholangiopancreatography

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Nobuhito Ikeuchi ◽  
Takao Itoi ◽  
Takuji Gotoda ◽  
Chika Kusano ◽  
Shin Kono ◽  
...  
Keyword(s):  
Adverse Events ◽  
Endoscopic Retrograde Cholangiopancreatography ◽  
Acute Cholangitis ◽  
Careful Monitoring ◽  
Endoscopic Retrograde ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Technical Safety

Background. The safety of non-anesthesiologist-administered propofol (NAAP) sedation in emergent endoscopic retrograde cholangiopancreatography (ERCP) has not been fully clarified. Thus, the aim of this study was to assess the safety of NAAP sedation in emergent ERCP.Materials and Methods. We retrospectively analyzed 182 consecutive patients who had obstructive jaundice and who underwent ERCP under NAAP sedation. The patients were divided into Group A (with mild acute cholangitis or without acute cholangitis) and Group B (moderate or severe acute cholangitis). And technical safety and adverse events were assessed.Results. The adverse events were hypoxia (31 cases), hypotension (26 cases), and bradycardia (2 cases). There was no significant difference in the rate of each adverse event of hypoxia and bradycardia in either group. Although the rate of transient hypotension associated in Group B was higher than that in Group A, it was immediately improved with conservative treatment. Moreover, there were no patients who showed delayed awakening, or who developed other complications.Conclusions. In conclusion, NAAP sedation is feasible even in emergent ERCP. Although some transient adverse events (e.g., hypotension) were observed, no serious adverse events occurred. Thus, propofol can be used in emergent ERCP but careful monitoring is mandatory.

scholarly journals Comparison of Recovery Time of Propofol and Midazolam with Propofol Alone for Sedation in Endoscopic Retrograde Cholangiopancreatography

2021 ◽  
Vol 15 (5) ◽  
pp. 1024-1027
Author(s):  
Asma Samreen ◽  
Aamir Waseem ◽  
Muhammad Azam ◽  
Itrat Hussain Kazmi ◽  
Aamir Bashir ◽  
...  
Keyword(s):  
Endoscopic Retrograde Cholangiopancreatography ◽  
Recovery Time ◽  
Controlled Trial ◽  
P Value ◽  
Time Data ◽  
Endoscopic Retrograde ◽  
Intravenous Anesthetic ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background: Procedural sedation is required for multiple short duration procedures outside of the operating rooms especially in radiology and endoscopy suites. Intravenous anesthetic agent with rapid recovery profile is desirable in such circumstances. This study aims to compare two regimens of intravenous anesthetic agents. Aim: To compare the mean recovery time of propofol and midazolam with propofol alone for sedation in endoscopic retrograde cholangiopancreatography. Study Design: Randomized controlled trial. Settings: Department of Anesthesia, Shalamar Hospital, Lahore. Study Duration: June 2017 to December 2017. Methods: A total of 70 adult patients aged 20-60 years undergoing ERCP under sedation were included. Patients were given a combination of propofol and midazolam in group A while propofol alone was given in group B. After procedure, pts were transferred to recovery room and were followed for assessment of recovery time. Data were analyzed in SPSS vr 21, Independent t-test was applied & p-value ≤0.05 was considered statistically significant. Results: Significant difference was found in mean recovery time amongst both the groups. Mean recovery time in Group A (propofol and midazolam) was 19.29±4.50 minutes while in Group B (propofol alone) was 26.66±3.70 minutes showing statistically significant result with p-value = 0.0001. Conclusion: We conclude that mean recovery time with propofol plus midazolam is shorter as compared to propofol alone for sedation in ERCP. Keywords: Propofol, midazolam, sedation outside operation theatre.

scholarly journals Epinephrine in the Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Preliminary Study

2018 ◽  
Vol 12 (1) ◽  
pp. 125-136 ◽  
Author(s):  
Behzad Hatami ◽  
Seyed Mohammad Hossein Kashfi ◽  
Mohammad Abbasinazari ◽  
Ehsan  Nazemalhosseini Mojarad ◽  
Mohammad Amin Pourhoseingholi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Endoscopic Retrograde Cholangiopancreatography ◽  
Univariate Analysis ◽  
Combination Group ◽  
Endoscopic Retrograde ◽  
Significant Difference ◽  
Blinded Manner ◽  
Group A ◽  
Group B ◽  
Double Blinded

Background: Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) ranges between 15 and 20% among patients at high risk of developing PEP. The efficacy of indomethacin administration in the prevention of PEP is rather debatable. In the present randomized trial study, we evaluated whether or not the combination of indomethacin and epinephrine in comparison to the single administration of indomethacin differs in the pathogenesis and prevention of post-ERCP pancreatitis. Patients and Methods: One hundred and ninety-two patients were randomized in a double-blinded manner into 3 groups: the epinephrine group (group A), the indomethacin group (group B), and the combined epinephrine and indomethacin group (group C). After the procedure, patients were evaluated for the PEP development. Results: During the procedure, 66 patients were randomized to the epinephrine group (group A), 68 cases to the indomethacin group (group B), and 58 individuals to the indomethacin-epinephrine group (group C). The mean age of patients in the epinephrine group was 59.59 ± 15.680 years, in the indomethacin group it was 58.06 ± 17.125 years, and in the combination group it was 59.62 ± 15.369 years. In the present study, we did not observe a significant difference between the 3 groups in sex, age, pre-ERCP amylase, lipase, and patient and procedure risk factors including pancreatic duct (PD) dilation (p = 0.404), PD cannulation (p = 0.329), and difficult cannulation (p = 0.076) among others. PEP developed in 7 of the 192 individuals (3.6%), 6 PEP cases occurred in the indomethacin group and 1 in the epinephrine group (p = 0.016). Univariate analysis of risk factors for PEP in patients with and without pancreatitis revealed no significant difference between the pancreatitis group and the non-pancreatitis group. Conclusion: In comparison to the administration of indomethacin alone, a single application of epinephrine and the combination of epinephrine and indomethacin seem to be effective in reducing the cases of PEP. A further randomized clinical trial with a larger sample size is required to confirm the efficacy of our medication in the prevention of pancreatitis after ERCP.

scholarly journals Palonosetron for the prevention of chemotherapy induced nausea and vomiting: a comparative study in a tertiary care hospital from India

2019 ◽  
Vol 8 (10) ◽  
pp. 2197
Author(s):  
Shubhatara Swamy ◽  
Vijaya Rajendran ◽  
Durga Prasan ◽  
Pratibha Nadig
Keyword(s):  
Tertiary Care ◽  
Nausea And Vomiting ◽  
Research Centre ◽  
Care Hospital ◽  
Serious Adverse Events ◽  
Female Ratio ◽  
First Line Therapy ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background: Despite advances in symptom management, chemotherapy-induced nausea and vomiting (CINV) remains one of the most dreadful consequences of cancer therapy.Methods: The study was carried out at Medical Oncology Department, Vydehi Institute of Medical Sciences and Research Centre, Bangalore. Hundred and forty-four cancer patients of either sex, aged 18-65 years with adequate blood counts requiring moderately emetogenic chemotherapy (MEC) as per Hesketh classification were included. The patients were prospectively divided into two groups before the initial cycle of chemotherapy. Patients in Group A (n=71) received ondansetron, and dexamethasone along with aprepitant capsules, Whereas, Group B (n=73) received palonosetron, and dexamethasone along with placebo capsules, 30 minutes before chemotherapy. Thereafter the patients were administered with the drugs and observed for nausea and vomiting. The efficiency of both regimens was assessed by adopting validated functional living index emesis (FLIE) questionnaire. Analysis of the data was done using the SPSS 21.0 software.Results: The mean age of the patients was 40.5 years and the male to female ratio was 1:2.4. In all the patients, no changes were detected in the ECG readings after MEC. The nausea and vomiting score were comparable in both groups. No significant difference (p>0.05) was noticed between group A and group B in both mm and in FLIE points. No serious adverse events were found relating to antiemetic treatment.Conclusions: Palonosetron in combination with corticosteroids was non inferior to ondansetron in combination with aprepitant and corticosteroids in controlling acute and delayed stages of CINV in patients requiring MEC. Thus, it can be recommended as first-line therapy for patients treated with MEC.

The association of renal function with safety and efficacy of cisplatin plus S-1 (CS) therapy and docetaxel plus cisplatin plus S-1 (DCS) therapy in patients with advanced gastric cancer (AGC): An additional analysis of JCOG1013.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16035-e16035
Author(s):  
Shuichi Hironaka ◽  
Ryo Sadachi ◽  
Nozomu Machida ◽  
Satoru Iwasa ◽  
Yasuhide Yamada ◽  
...  
Keyword(s):  
Renal Function ◽  
Adverse Events ◽  
Objective Response ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Hematological Toxicity ◽  
Significant Difference ◽  
Group A ◽  
Group B

e16035 Background: A phase III study, JCOG1013, did not show the superiority of docetaxel plus cisplatin plus S-1 (DCS) to cisplatin plus S-1 (CS) in overall survival (OS) (Yamada Y, Lancet GH 2019). It is known that cisplatin and gimeracil (an inhibitor of dihydropyrimidine dehydrogenase contained in S-1) are excreted in urine. We previously reported (abstr 197, ASCO-GI 2021) exploratory analysis of JCOG1013 which showed creatinine clearance (CrCl) was associated with safety (Grade [G]4 hematological toxicity for CS, and G3-4 non-hematological toxicity for CS and DCS), but not with efficacy in either group. Here, we report the additional detail results of this exploratory analysis. Methods: Among 741 participants in JCOG1013, patients with serum creatinine level < 1.2 mg/dL were included in this analysis and categorized by CrCl and treatment into A1 (CrCl ≥ 80 mL/min, CS), A2 (60 < CrCl < 80, CS), A3 (CrCl < 60, CS), B1 (CrCl > 80, DCS), B2 (60 < CrCl < 80, DCS), and B3 (CrCl < 60, DCS). The dose (mg/m2) of C/S was 60/80 regardless renal function in group A (A1, A2 and A3), and that of D/C/S was adjusted in group B as follows: 40/60/80 in B1, 40/50/80 in B2, and 40/40/65 in B3. Adverse events, OS, progression-free survival (PFS), and objective response rate (ORR) were compared by CrCl in group A (A1 vs. A2 vs. A3) and group B (B1 vs B2 vs B3), respectively. Results: Of 723 pts (169/136/57 in A1/A2/A3 and 170/138/53 in B1/B2/B3), the median CrCl (mL/min) was 94.1/71.9/53.4 in A1/A2/A3 and 98.2/70.0/55.6 in B1/B2/B3. The relative dose intensity of C/S was 90.4/75.3%, 87.8/74.9% and 85.7/72.8% in A1, A2 and A3, and that of D/C/S was 87.5/77.7/74.9%, 85.8/61.2/72.7% and 87.8/49.4/58.3% in B1, B2 and B3. The incidence of G4 white blood cell decreased, G4 neutrophil count decreased, and G3-4 anorexia were 1.2/4.4/9.3% (P < 0.01), 4.8/11.1/18.5% (P < 0.01), 14.4/28.1/28.6% (P < 0.01) in A1/A2/A3, and 1.8/3.0/4.0% (P = 0.36), 27.3/24.8/20.0% (P = 0.28), 22.4/29.3/32.0% (P = 0.11) in B1/B2/B3, respectively. No significant association between CrCl and other adverse events was observed either in CS or in DCS group. The median OS was 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.89) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.72). The median PFS was comparable among A1/A2/A3 (7.1/6.8/6.2 months, P = 0.88) and B1/B2/B3 groups (7.5/7.2/7.8 months, P = 0.85). ORR showed no significant difference in A1/A2/A3 (58.9/57.8/46.9%, P = 0.31) and B1/B2/B3 groups (62.0/61.5/51.5%, P = 0.36). Conclusions: Dose modification according to renal function in the DCS arm could control the increase of severe toxicities, which were observed frequently in patients with low renal function in patients receiving fixed dose of CS. Clinical trial information: 000007652.

scholarly journals Short Practical Regimen of Acupuncture for Melasma: A Prospective Cohort Study in a Tertiary Hospital in Thailand

2021 ◽  
Vol 9 ◽  
Author(s):  
Thanan Supasiri ◽  
Nuntida Salakshna ◽  
Krit Pongpirul
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Severity Index ◽  
Tertiary Hospital ◽  
Optimal Number ◽  
Significant Difference ◽  
Patient Reported ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Acupuncture shows benefits for patients with melasma, although no optimal number of sessions have been determined.Methods: The prospective observational study was conducted in melasma patients who were treated with acupuncture procedures two times a week and were evaluated after the 5th and the 10th sessions of acupuncture, with a 1-week follow-up after the last session. Participants Groups A and B received five and 10 acupuncture sessions, respectively. Melasma was assessed by using the melanin index (MI), melasma area and severity index (MASI), patient-reported improvement scores, and acupuncture-related adverse events.Results: Out of 113 participants, 67 received five sessions of acupuncture treatment while 39 received 10 sessions. At 1 week after five sessions of acupuncture in Group A, the mean MI decreased by 28.7 (95% CI −38.5 to −18.8, p &lt; 0.001), whereas the median MASI decreased by 3.4 (95% CI −6.9 to −1.2, p &lt; 0.001) points. At 1 week after ten sessions of acupuncture in Group B, the mean MI decreased by 31.3 (95% CI −45 to −17.6, p &lt; 0.001), whereas the median MASI decreased by 5.4 (95%CI −9.9 to −3, p &lt; 0.001) points. The first five sessions of acupuncture had a higher incremental effect than the last five sessions, although there was no statistically significant difference. Twenty-nine participants reported minor side effects. Group B had a risk ratio (RR) of having adverse events 1.8 times (95% CI 1.0–3.4, p = 0.05) compared with Group A.Conclusion: Short acupuncture regimens of 5–10 sessions in melasma seem to be effective and practical with minor side effects.

scholarly journals Proposal for a new therapeutic high dosage of Pidotimod in children with Periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) syndrome: an observational study.

2020 ◽  
Author(s):  
Sara Manti ◽  
Federica Filosco ◽  
Giuseppe Fabio Parisi ◽  
Giuseppe Germano Finocchiaro ◽  
Maria Papale ◽  
...  
Keyword(s):  
Adverse Events ◽  
Periodic Fever ◽  
Phase 1 ◽  
Aphthous Stomatitis ◽  
Potential Treatment ◽  
Phase 2 ◽  
Serious Adverse Events ◽  
Group A ◽  
Pfapa Syndrome ◽  
Group B

Abstract Background. Despite to PFAPA syndrome is considered a benign and self-limited condition in childhood its impact on patients and families can be remarkable in many cases. Currently, the therapeutic options for managing are non-specific and no consensus exists about the best treatment to use. Pidotimod has been suggested as a new potential treatment in PFAPA syndrome for its immunodulatory effects. We conducted a preliminary, prospective, controlled, open, cross-over trial to assess the efficacy and the safety of Pidotimod in the treatment of children with PFAPA syndrome.Methods. 22 children with PFAPA syndrome were randomly allocated to treatment with Pidotimod (with 2 vials of 400 mg daily) in combination with betamethasone 0.5-1 mg on need (group A) or betamethasone 0.5-1 mg on need (group B). Each treatment period was for 3 months (Phase 1), after that patients were switched to the other arm for other 3 months (Phase 2). Efficacy was expressed in terms of number of episodes of fever, tonsillitis, and aphthous stomatitis, as well as the additional use of betamethasone on need. Safety and tolerability of the Pidotimod were evaluated on the basis of the number and type of adverse events (AEs) recorded during the treatment.Results. Patients receiving Pidotimod and betametasone showed a significant decrease in frequency of fevers (p = 0.002); number of episodes of tonsillitis (p = 0.049); aphthous stomatitis (p = 0.036) as well as the betamethasone use on need (p = 0.007). Overall, 19/22 (86.4%) showed benefits from Pidotimod administration. The safety profile of Pidotimod was excellent as no serious adverse events have been reported in the treated groups.Conclusions. We firstly showed that high dosage of Pidotimod is an effective and safe to reduce the PFAPA attacks in children.

scholarly journals Proposal for a new therapeutic high dosage of Pidotimod in children with Periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) syndrome: an interventional study.

2020 ◽  
Author(s):  
Sara Manti ◽  
Federica Filosco ◽  
Giuseppe Fabio Parisi ◽  
Giuseppe Germano Finocchiaro ◽  
Maria Papale ◽  
...  
Keyword(s):  
Adverse Events ◽  
Periodic Fever ◽  
Phase 1 ◽  
Aphthous Stomatitis ◽  
Interventional Study ◽  
Serious Adverse Events ◽  
Group A ◽  
Pfapa Syndrome ◽  
Decision Group ◽  
Group B

Abstract Background. Despite to PFAPA syndrome is considered a benign and self-limited condition in childhood its impact on patients and families can be remarkable in many cases. Currently, the therapeutic options for managing are non-specific and no consensus exists about the best treatment to use. Pidotimod has been suggested as a new potential treatment in PFAPA syndrome for its immunodulatory effects. We conducted a preliminary, prospective, controlled, open, cross-over trial to assess the efficacy and the safety of Pidotimod in the treatment of children with PFAPA syndrome. Methods. 22 children with PFAPA syndrome were randomly allocated to treatment with pidotimod (with 2 vials of 400mg daily) in combination with betamethasone 0.5-1 mg on need, based on parents/caregivers' decision (group A) or betamethasone 0.5-1mg on need, based on parents/caregivers' decision (group B). Each treatment period was for 3 months (Phase 1), after that patients were switched to the other arm for other 3 months (Phase 2). Efficacy was expressed in terms of number of episodes of fever, pharyngitis, or aphthous stomatitis, as well as the additional use of betamethasone on need. Safety and tolerability of the Pidotimod were evaluated on the basis of the number and type of adverse events (AEs) recorded during the treatment.Results. Patients receiving Pidotimod and use betametasone showed a significant decrease in frequency of fevers (p=0.002); number of episodes of pharyngitis (p=0.049); aphthous stomatitis (p=0.036) as well as the betamethasone use on need (p=0.007). Overall, 19/22 (86.4%) showed benefits from Pidotimod administration. The safety profile of Pidotimod was excellent as no serious adverse events have been reported in the treated groups.Conclusions. We firstly showed that high dosage of Pidotimod could be an effective and safe to reduce the PFAPA attacks in children.

Ophthalmic artery catheterization for retinoblastoma treatment: does reflux affect tumor response?

2020 ◽  
Vol 12 (9) ◽  
pp. 915-920 ◽  
Author(s):  
Ahmad Sweid ◽  
Batoul Hammoud ◽  
Joshua H Weinberg ◽  
Pavlos Texakalidis ◽  
Vivian Xu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Ophthalmic Artery ◽  
Tumor Response ◽  
Retrospective Chart Review ◽  
Primary Treatment ◽  
Study Cohort ◽  
Significant Difference ◽  
Group A ◽  
Poor Outcomes ◽  
Group B

BackgroundIntra-arterial chemotherapy (IAC) for retinoblastoma (Rb) has been established as a primary treatment for the disease. To determine whether the presence of reflux into the ICA is associated with tumor response or with any other adverse events in pediatric retinoblastoma patients.MethodsA retrospective chart review was performed for patients diagnosed with Rb and managed with ophthalmic artery catheterization (OAC).ResultsThe total study cohort included 205 Rb tumors of 205 eyes in 194 consecutive patients who underwent 624 successful intra-arterial chemotherapy infusions using OAC. Of the 205 eyes, 65 eyes (32.7%) underwent 157 OAC procedures constituted group A (no reflux), 64 eyes (31.2%) underwent 236 OAC procedures constituted group B (variable pattern), and 74 eyes (36.1%) underwent 231 OAC procedures constituted group C (reflux). There was no significant difference in baseline characteristics between the three cohorts. Also, there was no significant difference in tumor characteristics between the three groups, except for genetic status. There was no significant difference between the three groups in terms of tumor response at completion of the treatment regimen. Complete tumor response was achieved at 70.2% in Group A, at 83.3% in Group B, and at 78.5% in group C (P=0.39). Similarly, eye enucleation occurred at 38.5% in group A, 31.8% in group B, and 31.5% in group C. None of the patients in both groups had any neurological adverse events or new onset of seizures.ConclusionsThe presence of reflux, which may complicate the procedure and prolong it, was not associated with poor outcomes in our analysis.

scholarly journals CO2 or air cholangiography reduces the risk of post-ERCP cholangitis in patients with Bismuth type IV hilar biliary obstruction

2020 ◽  
Author(s):  
wenhui zhang ◽  
Peng peng Ding ◽  
lei liu ◽  
yanling wang ◽  
wenhui lai ◽  
...  
Keyword(s):  
Liver Function Tests ◽  
Complication Rates ◽  
Endoscopic Retrograde ◽  
Type Iv ◽  
Significant Difference ◽  
Group A ◽  
Hilar Biliary Obstruction ◽  
The Mean ◽  
Malignant Hilar Obstruction ◽  
Group B

Abstract Background: Endoscopic biliary stenting by endoscopic retrograde cholangiopancreatography (ERCP) is the most common form of palliation for malignant hilar obstruction. However, ERCP in such cases is associated with a risk of cholangitis. The incidence of post-ERCP cholangitis is particularly high in Bismuth type IV hilar obstruction, and this risk is further increased when the contrast injected for cholangiography is not drained. The present study aims to compare the incidence of cholangitis associated with the use of a contrast agent, air and CO2 for cholangiography in type IV hilar biliary lesions. Methods: The clinical data of consecutive 70 patients with type IV hilar obstruction, who underwent ERCP from October 2013 to November 2017, were retrospectively analyzed. These patients were divided into three groups based on the agent used for cholangiography: group A, contrast (n=22); group B, air (n=18); group C, CO2 (n=30). These three methods of cholangiography were chronologically separated. Prior to the ERCP, MRCP was obtained from all patients to guide the endoscopic intervention. Results: At baseline, there was no significant difference in terms of the patient’s age, gender, symptoms and liver function tests among the three groups (P>0.05). The complication rates were significantly higher in group A than in groups B and C (63.6% vs. 26.7% and 27.8%, P<0.05). The incidence of post-ERCP cholangitis was significantly higher in group A (P<0.05), while the incidence of post-ERCP pancreatitis and bleeding were similar in the three groups. After the ERCP, the mean hospital stay was shorter in groups B and C, when compared to group A (P<0.05). However, there was no significant difference in the 30-day mortality rate among the three groups (P>0.05). Furthermore, there was no significant difference between groups B and C in terms of primary end points. Conclusion: CO2 or air cholangiography during ERCP for type IV hilar obstruction is associated with reduced risk of post-ERCP cholangitis, when compared to conventional contrast agents.

Therapeutic Superiority and Safety of Combined Hydroxyurea with Recombinant Human Erythropoietin Over Hydroxyurea in B-Thalassemia Intermedia Patients

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 252-252
Author(s):  
Mohsen Saleh Elalfy ◽  
Amira Adly ◽  
Yassmine Elhanawy
Keyword(s):  
Adverse Events ◽  
Short Form ◽  
Single Agent ◽  
Random Allocation ◽  
Thalassemia Intermedia ◽  
Transfusion Requirements ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Age Range

Abstract Abstract 252 Background: Both Hydroxyurea (HU) as a single agent or in combination with Erythropoietin (rHuEPO) became a therapeutic option for β-Thalassemia intermedia(TI) over last 2 decades. However superiority and safety of combination therapy over HU alone needs further evaluation. Aim: to assess the increase of hemoglobin levels in TI patients by at least 1g/dl above baseline during therapy using combined HUO and rHuEPO compared to single HUO therapy, also to report decline in transfusion requirements, quality of life (QoL), and any drug related adverse events. Patients and methods: An interventional prospective randomized open-labeled study; was approved from the local ethical committee and was registered in the Clinical Trials. Goverment (NCT01624038 ). Eighty Patients 18 years or less will be assigned into one of 2 groups using a random allocation method. Group A: Forty TI patients (age range: 5–18 years) considered as interventional arm 1 and received combined daily HUO (25 mg/kg/day orally) and rHuEPO (1000 IU/kg/week subcutaneously divided in three times/week). Group B: Forty TI patients (age range: 4–18 years) considered as arm 2 (control arm) and received daily single HUO therapy of 25 mg/kg/day. Both groups were followed up both clinically and laboratory for a mean period of one year with assessment of transfusion requirements, blood pressure weekly, liver and renal functions, Hemoglobin (Hb), HbF monthly, basal serum erythropiotin levels and QoL was assessed at study entry and end using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Diagnosis of TI was based on both genetic mutations and absence of transfusion during the 1st 2 years of life. Exclusion criteria were: evidence of active hepatitis (ALT>5 times) or renal impairment. Results: There were a significant improvement in the QoL in 80% and 60% of patients on combined compared to single therapy(p<0.05). There was a significant increase in both Hb and HbF (p <0.001), and the increments were strongly correlated (r =0.84; p <0.001) in both groups more in group A patients. The median Hb level in groups A and B during the study was 9.1 and 7.9 g/dL, respectively (p=0.03). In 68% (n=27) of TI patients group (A) were responded by a 0.5–3 g/dl increase in Hb level. There was significant difference between the 2 groups as only 20% (n=8) of patients in group B show intended improvement in their hemoglobin levels (p<0.01). In studied thalassemics 40%(n=16) of group A compared to 15%(n=6) of group B (p=0.01) became transfusion independent with 20% in group A showed decrease in their transfusion requirements with significant decrease in transfusion index compared to group B thalassemics (p<0.001). There was no significant change in absolute Hb-F, and serum ferritin levels during treatment. splenectomized patients and those with serum EPO less than 500 mU/mL, and intial HbF% > 40% had best response to combined therapy. Side effects from rHuEPO included bone pain in 2 patients, headache in 4 patients, however no uncontrolled hypertension was reported. Gastrointestinal irritation was observed in 3 patients and resolved when the dose was given at bedtime. No renal or hepatic toxicity were reported. A single case of mild neutropenia was reported and recovered within one week of temporary discontinuation Conclusions: Hu was effective in management of TI however combination with erythropiotin had an additive therapeutic effect and was well tolerated with no further serious adverse events. Disclosures: No relevant conflicts of interest to declare.

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