Median Recovery Time Research Articles

A Novel Recombinant Human Thrombopoietin Therapy for Promoting Platelet Engraftment in Haematological Malignancies after Single Umbilical Cord Blood Transplantation: A Prospective Randomized Controlled Trial

▪Background: Umbilical cord blood transplantation (UCBT) is an alternative to matched-unrelated or mismatched-related peripheral blood (PB) or BMT and has emerged as a widely accepted treatment for a wide variety of hematologic malignancies. However, delayed platelet engraftment (DPE) and platelet engraftment failure still remain the common problems following UCBT. So far, no standard therapy has been recommended. A few studies have demonstrated that recombinant human thrombopoietin (rHuTPO) could play an effective role in advancing platelet recovery after allo-HSCT. Nevertheless, it remains unknown whether rHuTPO plays the same role while it is applied in UCBT. We designed this prospective randomized controlled trial with the purpose of determining whether rHuTPO improves platelet engraftment in patients undergoing single UCBT(sUCBT) and further evaluating the function of rHuTPO in sUCBT.Methods: We enrolled 120 patients with haematological malignancies between October 2016 and March 2018 undergoing sUCBT in Department of Hematology, the First Affiliated Hospital of University of Science and Technology of China. This study was supported by National Natural Science Foundation, China (81670165) and International Cooperation Projects of Anhui Province, China(1804b06020352). The trial was approved by the Medical Ethics Committee of the First Affiliated Hospital of University of Science and Technology of China, and registered on www.chictr.org.cn(ChiCTR-IPR-16009357). 60 patients were randomly assigned into the experimental group, in which they received rHuTPO on Day 14 after sUCBT with a dose of 300 U/kg once daily for a period of 14 days; the remaining 60 patients formed the no-treatment control group. Among 120 patients, 19 received total body irradiation (TBI) based conditioning and others received modified myeloablative conditioning without antithymocyte globulin (ATG) as myeloablative conditioning. All patients were given cyclosporin (CsA) and mycophenolate mofetil (MMF) preventing graft-versus-host disease (GVHD). Supportive care and other treatments, including infectious disease prophylaxis and the use of granulocyte colony-stimulating factor, were provided following our center's protocols.Results: With a median follow-up of 336 days (ranging between 96-618) for the surviving patients, the cumulative incidence of PLT engraftment in the rHuTPO group (89.7%, 95% confidence interval [CI], 77-95.5) was significantly higher than that in the control group (78.9%, 95%CI, 65.3-87.6) (p=0.0294); the median time of PLT engraftment was 35 and 40days (ranging between 18-144 and 19-170 respectively, P=0.155). The median time of PLT recovery in the rHuTPO group was 43days(ranging between 25-171days), which was significantly shorter than that in the control group(53days, ranging between 28-195, P=0.034). The rHuTPO group also showed an advantage over the control group in infused PLT units (6 vs 8, p=0.0294). The cumulative incidence of ANC engraftment was 98.3% (95% CI, 75.2-99.9) and 94.9% (95% CI, 83.8-98.5) (p=0.111) respectively in two groups.Multivariate analysis confirmed the significance of differences in platelet engraftment between two groups. The cumulative incidences of grade II-IV and III-IV acute graft-versus-host disease (GVHD),relapse,non-relapse mortality (NRM) and cytomegalovirus viremia and the probabilities of overall survival(OS) and leukemia free survival (LFS) did not differ between the two groups. No severe adverse effects were observed in all patients.Conclusions: Our results demonstrate that rHuTPO could noticeably improve platelet engraftment and promote platelet recovery in patients with haematological malignancies receiving sUCBT; in the meantime, it could also reduce the requirement for platelet transfusion. This study indicated that rHuTPO could be a good option for promoting platelet engraftment and recovery in haematological malignancies after sUCBT. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Efficacy and Safety of C-CAG Regimen (cladribine in combination with granulocyte colony-stimulating factor, low-dose cytarabine and aclarubicin) in Patients with Refractory/Relapsed Acute Myeloid Leukemia: A Phase 2, Single Center, Single Arm Study

Introduction: Although the considerable advances have been made in the treatment of acute myeloid leukemia (AML) in recent decades, only one third of patients (except for acute promyelocytic leukemia) can be cured , and most suffer relapse or primary refractory (R/R). However, there is no standard regimen for R/R AML patients after conventional chemotherapy.A regimen consisting of granulocyte colony-stimulating factor (G-CSF) priming the combination of low-dose cytarabine (Ara-C) and aclarubicin, termed the CAG regimen,was first reported by a Japanese group in 1995. It has been proved that cladribine is a attractive drug in AML because of their significant synergy with other chemotherapeutic agents and favorable toxicity profile. Efforts were made to improve the efficacy of the CAG regimen among institutions, including combining it with other chemotherapy drugs. Therefore, the purpose of this study is to prospectively evaluate efficacy and safety of C-CAG regimen (cladribine in combination with granulocyte colony-stimulating factor, low-dose cytarabine and aclarubicin) in patients with R/R AML(This study was registered at www.chictr.org, the Clinical Trial Registration Number was ChiCTR-OPC-16010166).Methods: Enrolment began in August 2016 for a Phase II single-center clinical trial . The patients in this arm will receive C-CAG regimen for salvage treatment,detailed as following:Cladribine 5mg/㎡,d1-5; G-CSF 300ug,d0-9; aclarubicin 10mg,d3-6;cytarabine 10mg/㎡ q12h, SC, d3-9;4 weeks a cycle.The patients are permitted to quit the study if complete remission(CR) is not achieved after 2 course of chemotherapy. If conditions were right,the patients achieving CR were recommended to receive allogeneic hematopoietic stem cell transplantation(HSCT). Otherwise, the patients were given for a total of six cycles unless there was disease progression or unacceptable side effects, or withdrawal of patient consent.Results: Until June 1, 2018, we have completed the enrolment of 15 patients with R/R AML. The main clinical characteristics of the 15 patients are presented in Table 1. The median age was 38 years and ranged from 21 to 72 years. The majority of patients presented with FAB subtype of M2 or M5. All patients(n=15) have begun treatment and are evaluable for response. Of the 15 patients, complete remission rates is 73.3% to C-CAG regimen. No patients received allogeneic transplantation due to scarcity of bone marrow donors or inability of the patients to afford the expensive medical treatment.At a median follow-up of 6 months (2-24), the median DFS and OS for all 15 patients were 8 and 12 months, respectively.The most common adverse effect was myelosuppression. The incidence of grade 3 or 4 hematological toxicity was 80.0%.The respective median duration of neutropenia (neutrophils < 0.5×109/L) was 12 days. The median time of platelet recovery over 50 × 109/L was 23 days.All patients presented an incidence of 13.3% for Grade 3 or 4 infectious toxicity. No treatment-related deaths occurred. Non-hematological side effects were mild. Grade 3 or 4 gastrointestinal side effects were rarely observed, owing to the prophylactic antiemetic drug administration.Conclusions: Preliminary data indicate that the C-CAG regimen chemotherapy is significantly effective against R/R AML with a high remission rate and a low hematological toxicity, thus serves as an alternative treatment for R/R AML. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

A Pilot Prospective Single-Arm Clinical Study on Decitabine Plus CAG or IA Followed with HLA-Mismatched Nonmyeloablative Transplantation (micro transplantation) on De Novo Elderly Acute Myeloid Leukemia and Int-2/High Risk Myelodysplastic Syndrome Patients

Objective: To observe the efficacy and safety of Decitabine plus CAG or IA followed with HLA-mismatched nonmyeloablative transplantation (micro transplantation) on de novo elderly Acute Myeloid Leukemia and Int-2/high risk Myelodysplastic Syndrome patientsMethods: Till submission of this article, 10 patients were enrolled in this prospective clinical study. Patients were admitted from January 2017 to June 2018 to our centre. 6 of whom were elderly AML (≥60 years) and 4 were Int-2/high risk MDS according to IPSS-R scoring system. Induction chemotherapy were decitabine (15 mg/m2) for 5 days followed with CAG (cytarabine 10 mg/m2 q12h; aclarubicin 10 mg/day and G-CSF at 300 μg/day x 6 days for AML and 4 days for MDS), then followed with a transfusion of HLA-mismatched (≤7/10 matched HLA loci) related donor peripheral stem cells (micro transplantation) 24 hours after chemotherapy. Consolidation therapy was another 3 courses of chemotherapies which were decitabine (15 mg/m2) for 5 days with IA (3+7) for AML or CAG (6 days) for MDS, followed by micro transplantation 24 hours after each course. Till now, the total observable treatment courses were 21.Results: The average age of the patients was 63.5 years (range from 55 to 71 years). The average number of transfusion mononuclear cells (MNC) at per course was 3.26 (1.87-5.25) x 108/kg, the average CD34+ cells was 1.12 (0.34-3.16) x 106/kg, and the average of CD3+ T cells was 3.93 (1.87-7.17) x 107/kg. Among them, 5 cases (50%) obtained CR (CR+CRi), 3 cases obtained PR (30%). The ORR was 83.3% for elderly AML patients, 75% for MDS patients and 80% for all patients. The median recovery time of neutrophil (from the end of chemo to neutrophil ≥0.5 x 109) was 9 days and was 8.5 days for platelets (from the end of chemo to platelets ≥20 x 109). 1 patient developed severe aGVHD and died, 1 patient died of heart failure, no other serious adverse events were observed in rest patients. 7 of 10 cases developed peripheral T cell increase after stem cell transfusion, including the total CD3+ T cells, CD4+ and CD8+ T cells, with an average peak at day7. The increased T cells were verified as host origin by short tandem repeat (STR) detection performed on 1 patient. 8 of 10 cases occurred cytokine related fever (CRF) after stem cell transfusion. The fever was usually happened within 24 hours after stem cell transfusion, with an average duration of 5 days and a mean peak temperature at 39.7 ℃. With CRF there was an increase of cytokines with different patterns in different patients but majorly on IL-6, IL-2, IFN-r and TNF-a. Also there was an increase of C-Reactive Protein (CRP) which reached an average peak level as 116.9 mg/L. Patients with CRF had a CR+CRi rate at 62.5%.Conclusion: Our preliminary results of this study indicate that Decitabine plus CAG or IA followed with micro transplantation have an ORR at 80% in de novo elderly Acute Myeloid Leukemia and Int-2/high risk Myelodysplastic Syndrome patients with controllable recover time of neutrophils and platelets. Although the incidence of acute graft versus host disease (aGVHD) in micro transplantation was as low as 1-2% according to reports, it is still possible. How to predict and avoid severe aGVHD is still under investigate. The presence of cytokine related fever may associate with the increase of hosts' T cells, which may relate to the improvement of therapeutic response. Larger cohorts and more investigates need to be done to clarify above findings. DisclosuresNo relevant conflicts of interest to declare.

Analysis of 17948 pediatric patients undergoing procedural sedation with a combination of intranasal dexmedetomidine and ketamine.

Intranasal procedural sedation using dexmedetomidine is well described in the literature. The combination of intranasal dexmedetomidine and ketamine is a novel approach for which there are little data on the rate of successful sedation or adverse events. The aim of this study is to evaluate the rate of successful sedation and adverse events of intranasal procedural sedation using a combination of dexmedetomidine and ketamine for diagnostic examination in children. This was a retrospective study and data were collected after ethics approval. A total of 17948 pediatric patients (7718 females, 10230 males) in a tertiary hospital in China were evaluated. Patients received a combination of 2μgkg-1 of dexmedetomidine and 1mgkg-1 of ketamine intranasally for procedural sedation. The level of sedation and recovery was assessed by the Modified Observer Assessment of Alertness/Sedation scale and the Modified Aldrete Score. The rate of intranasal sedation success was 93% (16691/17948), intranasal sedation rescue was 1.8% (322/17948), and intranasal sedation failure was 5.2% (935/17948). Sedation success was defined as successful completed the diagnostic examination and obtained adequate diagnostic-quality images and reports. Intranasal sedation success, rescue and failure were respectively defined as sedation success with intranasal a single dose, additional bolus dose and the need for intravenous (IV) medications/inhalation agents. Median sedation time was 62min (interquartile range: 55-70min), median time for onset of sedation was 15min (interquartile range: 15-20min), and median sedation recovery time was 45min (interquartile range: 38-53min). Incidence of adverse events was low (0.58%; 105/17948), with major and minor adverse event being reported in 0.02% (4/17948) and 0.56% (101/17948) patients, respectively. Postoperative nausea and vomiting was the most common (0.3%; 53/17948) minor adverse event. Procedural sedation using a combination of intranasal dexmedetomidine and ketamine is associated with acceptable effectiveness and low rates of adverse events.

Outcomes of Intubation-induced Vocal Fold Motion Impairment

ObjectiveVocal fold motion impairment (VFMI) is a potential consequence of intubation. Studies describing the natural course of this complication are largely case reports. This study aims to evaluate outcomes for a cohort of patients who endured varying degrees of vocal fold immobility or hypomobility post-intubation. Study DesignRetrospective chart review. MethodsUpon excluding known causes of VFMI, such as surgeries and tumors involving the head and neck, VFMI cases (ICD-9 diagnosis code 478.3) were identified from 2008 to 2014 at a regional healthcare institution. A total of 2,387 were identified and of those, 25 were intubation-induced VFMI cases. This cohort was then examined for notable features. ResultsWith a mean prolonged intubation duration of 6.55 days, 68% of cases resulted in left unilateral, 8% right unilateral, and 24% bilateral VFMI. Overall, 80% of patients experienced a recovery outcome (voice improvement or restoration of vocal fold mobility). Median recovery time was 4.31 months (mean, 6.51 months; range, 19-715 days). In cases of unilateral VFMI, 95% of cases had a recovery outcome. In cases of bilateral VFMI, 33% of cases had a recovery outcome. Additionally, bilateral cases showed a statistically significant association with an approximately 36-fold lower odds of recovery than unilateral cases (odds ratio, 0.0278; 95% confidence interval, 0.0020-0.3868; P value, 0.0077). ConclusionsIntubation-induced VFMI is rare. In this cohort, most cases resulted from prolonged intubation. While spontaneous recovery was the most common outcome, full remission was not guaranteed in every case. A sizable proportion of cases revealed bilateral motion impairment which was less likely to resolve. Our results are informative for tracheostomy decision-making and differential diagnoses for post-intubation laryngeal symptomatology.

Mixture prepared with Chinese medicines in terms of releasing exterior cold and clearing interior heat: its efficacy and safety in patients with seasonal influenza-a randomized controlled trial

OBJECTIVETo assess the efficacy and safety in 105 patients with seasonal Influenza in Beijing, the mixture prepared with Chinese medicines follows the treatment regimen of releasing exterior cold and clearing interior heat. METHODSTotal 330 patients with seasonal influenza were enrolled and randomly and averagely divided into the Chinese herbal medicine, the western medicine and the Chinese patent medicine group. They were treated with Chinese medicine Oseltamivir Phosphate Capsules and the Scattering Wind and Resolving Toxins Capsules. The main efficacy indicators were the antifebrile onset time and recovery time of body temperature. The efficacy and safety of the mixture was scientifically evaluated. Comparisons of several variables were analyzed. RESULTSMedian antifebrile onset time of the Chinese herbal medicine group was significantly shorter than the western medicine group (P < 0.05) and the Chinese patent medicine group (P < 0.05). The median antifebrile recovery time of the Chinese herbal medicine group was significantly shorter than the Chinese patent medicine group (P < 0.05). The groups evaluated by TCM symptom pattern effect, both the Chinese herbal medicine group and Western Medicine group were better than the Chinese patent medicine group (P < 0.05). The disappearance rate of main symptoms and some minor symptom patterns of the Chinese herbal medicine group were higher than the other 2 groups. CONCLUSIONThe mixture of releasing exterior cold and clearing interior heat could significantly shorten the fever time with safety.

A COMPARISON OF ALFAXALONE AND TRICAINE METHANESULPHONATE (MS-222) IN TWO FISH SPECIES

The purpose of this study was to evaluate the effectiveness of the alfaxalone formulation Alfaxan™ as an immersion anesthetic in tropical fish species compared to that of tricaine methanesulfonate (MS-222). 22 black spot barbs (Puntius filamentosis) measuring (mean±SD) 11.4 ±1.4 cm in body length and 22 peacock cichlids (Aulonocara spp.) (measuring 8.4 ± 1.6cm were anesthetized in water baths containing 100 mg/L of MS-222 buffered with 200 mg/L of bicarbonate or 5 mg/L of alfaxalone following a 2-week washout period. Time to maximum effect, recovery periods, self-righting, spontaneous swimming movements, opercular movements, and response to noxious stimuli were recorded. The following results are for the black spot barbs following MS-222 and alfaxalone anesthesia, respectively: mean times (±SD) to surgical anesthesia were 5.5 ± 2.11 and 3.27 ± 1.72 minutes and mean recovery times were 2.95 ± 0.9 and 9.14 ± 3.15 minutes. The peacock cichlid anesthetic protocols for MS-222 (20 of 22 cichlids) and alfaxalone (20 of 21 cichlids) produced the following results, respectively: mean times (±SD) to surgical anesthesia were 14.75 ±5.43 and 11.1 ± 9.84 minutes and mean recovery times were 3.6 ±0.82 and 22.4 ±11.3 minutes. Median recovery time from 5 mg/L alfaxalone was significantly longer (P < 0.001) in both species, by 5 minutes for black spot barbs and by 17 minutes for peacock cichlids. Variation in induction and recovery times between species was observed, with black spot barbs having significantly (P < 0.0001) faster induction times when treated with both drugs, and a faster recovery time from 5 mg/L alfaxalone.

Comparison of nebulised dexmedetomidine, ketamine, or midazolam for premedication in preschool children undergoing bone marrow biopsy

BackgroundThe aim of our study was to compare the efficacy of dexmedetomidine, ketamine, and midazolam for sedative premedication administered by nebuliser 30 min before general anaesthesia in preschool children undergoing bone marrow biopsy and aspiration. MethodsNinety children aged 3–7 yr were randomly allocated into three equal groups to be premedicated with either nebulised ketamine 2 mg kg−1 (Group K), dexmedetomidine 2 μg kg−1 (Group D), or midazolam 0.2 mg kg−1 (Group M). The primary endpoint was a five-point sedation score on arrival in the operating room 30 min after end of study drug administration. Secondary outcomes included: parental separation anxiety scale; medication and mask acceptance scales; haemodynamic variables; recovery time; postoperative face, legs, activity, cry, and consolability scale; emergence agitation scale; and adverse effects. ResultsThe median (range) sedation score on arrival in the operating room was 3.5 (1–4), 2.0 (2–3) and 2.0 (1–3) in Groups M, D, and K, respectively (P=0.000). Subjects in Group D showed higher medication (P<0.03) and mask acceptance scores (P<0.015) and more satisfactory parental separation anxiety scale (P<0.044). The median (range) recovery time was significantly shorter in Group D [5.5 (4–8) min] compared with Group K [10.0 (5–15) min, P=0.000] and M [8.0 (6–15) min, P=0.000]. The incidence of emergence agitation was lower in Group D (P<0.008). ConclusionsPreschool children premedicated with nebulised dexmedetomidine had more satisfactory sedation, shorter recovery time, and less postoperative agitation than those who received nebulised ketamine or midazolam. Clinical trial registrationNCT02935959.

Multicentre observational study of gastrointestinal recovery after elective colorectal surgery.

Postoperative ileus (POI) is characterised by delayed gastrointestinal recovery and is common after colorectal surgery. Numerous strategies to optimise POI have been proposed but its management remains an unmet clinical need. This study aimed to characterise the duration and management of gastrointestinal recovery in patients undergoing elective colorectal surgery. A snapshot, prospective, observational study was undertaken between November 2016 and January 2017 at 10 regional hospitals in the United Kingdom. Adult patients undergoing elective colorectal surgery with resection of bowel or reversal of stoma were included. Outcomes included time until return of gastrointestinal function, timing of nasogastric tube (NGT) insertion, uptake of targeted interventions and clinical outcomes. Data were validated for accuracy by independent investigators. 204 patients met the eligibility criteria. The median time for gastrointestinal recovery was 3days (IQR 2-4); right-sided resections were associated with longer gastrointestinal recovery than left sided (4days (2.75-5.25) vs 3days (2-4); P=0.002). The rate of NGT insertion was 22.5% at a median time of 4 (4-4.75)days. NGT insertion after vomiting was associated with a higher incidence of bronchopneumonia compared to early placement (13.3% vs 29.0%). Targeted interventions, such as chewing gum (4.4%), selective mu-receptor antagonists (1.0%) and pro-kinetic agents (13.7%) were infrequently used. The average time to gastrointestinal recovery after elective colorectal surgery was three days. Late NGT insertion was associated with an increased incidence of bronchopneumonia. The clinical uptake of targeted interventions to improve gastrointestinal recovery was poor.

The Short Synacthen (Corticotropin) Test Can Be Used to Predict Recovery of Hypothalamo-Pituitary-Adrenal Axis Function.

The 250-μg short Synacthen (corticotropin) test (SST) is the most commonly used tool to assess hypothalamo-pituitary-adrenal (HPA) axis function. There are many potentially reversible causes of adrenal insufficiency (AI), but no data to guide clinicians as to the frequency of repeat testing or likelihood of HPA axis recovery. To use the SST results to predict adrenal recovery. A retrospective analysis of 1912 SSTs data. Seven hundred seventy-six patients with reversible causes of AI were identified who had at least two SSTs performed. A subgroup analysis was performed on individuals previously treated with suppressive doses of glucocorticoids (n = 110). Recovery of HPA axis function. SST 30-minute cortisol levels above or below 350 nmol/L (12.7 μg/dL) best predicted HPA axis recovery [area under the curve (AUC) receiver operating curve (ROC) = 0.85; median recovery time: 334 vs 1368 days, P = 8.5 × 10-13]: 99% of patients with a 30-minute cortisol >350 nmol/L recovered adrenal function within 4 years, compared with 49% in those with cortisol levels <350 nmol/L. In the subgroup analysis, delta cortisol (30-minute-basal) best predicted the recovery (AUC ROC = 0.77; median recovery time: 262 vs 974 days, P = 7.0 × 10-6). No patient with a delta cortisol <100 nmol (3.6 μg/dL) and a subsequent 1-year random cortisol <200 nmol/L (7.3 μg/dL) recovered HPA axis function. Cortisol levels across an SST can be used to predict recovery of AI and may guide the frequency of repeat testing and inform both clinicians and patients as to the likelihood of restoration of HPA axis function.

Cotransplantation of haploidentical hematopoietic stem cells and allogeneic bone marrow-derived mesenchymal stromal cells as a first-line treatment in very severe aplastic anemia patients with refractory infections.

In patients with very severe aplastic anemia (VSAA), neutropenia is prolonged and persistent, resulting in refractory overwhelming infections. Hematopoiesis recovery is urgently needed. Six patients with de novo VSAA lacking HLA-identical sibling donors and those who experienced refractory infections underwent haploidentical related donor (HRD) hematopoietic stem cell transplantation (HSCT) as a first-line therapy. The conditioning regimen consisted of busulfan, cyclophosphamide, and rabbit antithymocyte globulin. Culture-expanded allogeneic bone marrow-derived mesenchymal stromal cells were infused on day 0 and day +14. From diagnosis to HSCT, 6 patients experienced a total of 28 episodes of persistent fever, and the median number was 4 (range, 3-7). All cases developed major bacterial infections and invasive pulmonary fungal infection pre-HSCT. The median time from diagnosis to HSCT was 2months (range, 1-3.5months). All patients achieved sustained, full donor chimerism, and the median time of myeloid recovery and platelet engraftment was 13days (range, 9-19days) and 15.5days (range, 10-23days), respectively. One patient died of aGVHD, and 5 patients are alive after a median follow-up of 21months (range 17-40.5). Upfront HRD-HSCT may be a safe and promising choice for patients with VSAA in critical situations without suitably matched donors.

Recovery time and associated factors of severe acute malnutrition among children in Bahir Dar city, Northwest Ethiopia: an institution based retrospective cohort study

BackgroundMalnutrition commonly affects all groups in a community, but infants and young children are the most vulnerable. Worldwide, nearly 24 million under five children experience severe acute malnutrition (SAM) which contributes to one million child deaths yearly and 19 million severely wasted children are living in developing countries. While the treatment of severe acute malnutrition (SAM) is well established, achieving desired outcomes has proven to be challenging. There is limited evidence showing the success of treatments in the study area. Therefore, this study aimed to determine recovery time from severe acute malnutrition and identify predictors among children of 6–59 months of age.MethodsFacility based retrospective cohort study was conducted among 401 children 6–59 months of age who have been treated for SAM. Both descriptive and analytic analyses were executed. The results were determined using Kaplan-Meier procedure, log-rank test and Cox-regression. Variables having P-value ≤0.2 during binary analysis were entered into multivariate analysis. P value < 0.05 was considered as statistically significant.ResultsThe recovery rate was 51.9% and the median recovery time was 16 days (95%CI: 14.233–17.767). Controlling for other factors; having anemia at admission, no plumpy nut provision, failing to enter in to phase 2 on day 10 and a weight gain of more than 8 g/kg/day were significant predictors of recovery time.ConclusionsNutritional recovery rate was far outside of the accepted minimum international standard while median recovery time ranged in the accepted minimum international standard. Children had a lower chance of recovering early when they had anemia at admission, not provided plumpy nut, failed to enter phase 2 on day 10 and failed to gain more than 8 g/kg/day. Therefore, efforts should be strengthened to facilitate early recovery of children by considering the identified predictors of recovery time.

Clinical Analysis of Refractory Primary Central Nervouse System Lymphoma Treated with High-Dose MTX-Based Chemotherapy and Haploidentical Hematopoietic Stem Cell Infusion

To investigate the efficacy and safety of high-dose methotrexate-based chemotherapy combined with granulocyte-colony stimulating factor (G-CSF)-mobilized family related haploidentical donor peripheral blood hematopoietic stem cell (G-PBHSC) infusion for the treatment of patients with refractory primary central nervouse system lymphoma (PCNSL). Three patients with refractory PCNSL were treated in Department of Hematology of the General Hospital of the PLA's Rocket Force from March 2014 to September 2015. The sex ratio of male to female was 1:2 and the median age was 54(48-66)years old. All patients received programmed infusions of G-PBHSC after high-dose methotrexate-based chemotherapy without prophylaxis for graft-versus-host disease (GVHD). Three patients had received initial chemotherapy or radiotherapy after diagnosis, one patient achieved complete remission (CR) after 3 courses of treatment and remained in CR until the end of follow-up, 2 cases achieved partial remission (PR) and the progression-free survival (PFS) time was 10 and 7 months, respectively. The patients generally well-tolerated this therapy. The main adverse effects of patients were neutropenia, thrombocytopenia and infection related with chemotherapy after each course of treatment, the median recovery times of neutrophils and platelets were 11 and 12.5 days, respectively after of programmed infusions of G-PBHSC. No GVHD was observed in any of the patients during treatment. The combination of high-dose methotrexate-based chemotherapy with programmed haploidentical G-PBHSC infusion is a potential treatment alternative for refractory PCNSL patients.

Unmanipulated haploidentical transplantation conditioning with busulfan, cyclophosphamide and anti-thymoglobulin for adult severe aplastic anaemia.

We conducted a retrospective analysis to evaluate outcomes of haploidentical transplantation in adult severe aplastic anaemia (SAA) patients. Fifty-one adults received haploidentical transplantation between May 2011 and December 2016. Patients were administered busulfan (Bu), cyclophosphamide (Cy) and anti-thymoglobulin (ATG) as conditioning regimens, followed by bone marrow and peripheral blood transplantation. The patients' median age was 25 years. Forty-nine patients survived for more than 28 days and all achieved donor myeloid engraftment. The median time for myeloid engraftment and platelet recovery was 13 days (range, 10-21) and 17.5 (range, 7-101) days. The cumulative incidence (CI) of grade II-IV and III-IV acute GvHD) was 20.00±0.33% and 6.00±0.12%, respectively. The incidence of chronic GvHD was 14.00±0.36% and 25.90±0.71%, and that of moderate-severe chronic GvHD was 2.51±0.06% and 6.92±0.25% at 1 and 3 years, respectively. The 3-year estimated overall survival and failure-free survival were both 83.5±5.4% with a median follow-up of 21.1 months. Multivariate analysis showed hematopoietic cell transplantation-specific comorbidity index (HCT-CI) score of ⩾3 was significantly associated with worse outcome. Haploidentical transplantation conditioning including Bu/Cy/ATG was a safe and effective strategy for adult SAA patients, and HCT-CI might be an outcome predictor in these patients.

Modeling Time to Recovery of Adult Tuberculosis (Tb) Patients in MizanTepi University Teaching Hospital, South-West Ethiopia

Background: Tuberculosis (TB) is a chronic infectious disease that has a major health problem over the centuries and it has accounted for more human misery suffering and loss of earning and failure of economic and social development than any other disease. The aim of the study was to assess the effect of prognostic factors associated with time to recovery of adult TB patients who were under treatment follow-up of Mizan-Tepi University Teaching Hospital. Study Design: A retrospective cohort study. Methods: The data was obtained from medical records of TB patients registered during September 2011 to August 2016 and treated under the DOTS program. Kaplan-Meier and Cox proportional hazards model were applied. Backward selection procedure was used in variable selection. Results: In this study, 75% were recovered, 4.4% died, 9.7% defaulted, and 4.9% failure, while 6% transferred out rate. The median recovery time of the patients was 185 days (6 months and 5 days) but it varies depending on the covariates included in the study. TB Type (P<0.001), family size (P=0.035), Co-morbidity (P=0.045) and bodyweight (P=0.044) at baseline had a statistically significant. Conclusion: The effects of TB type, family size, co-morbidity and bodyweight at baseline had a statistically significant impact on time-to-recovery. The variables that are significant should be considered during the selection phase a treatment (combination of treatments) for TB.

The Clinical Utility of a Pulsed Bipolar System and Its Electrosurgical Device During Total Laparoscopic Hysterectomy

Objective: The aim of this research was to evaluate the efficacy and safety of the PlasmaKinetic™ (PK) PKS OMNI® (Gyrus ACMI, Maple Grove, MN) sealing device in laparoscopic hysterectomy. Materials and Methods: For this retrospective observational study, 60 patients who underwent multiport total laparoscopic hysterectomy between January 2014 and January 2015 in a tertiary-care university-based teaching hospital and an academically affiliated hospital were included in this study. The PKS OMNI is a bipolar electrosurgical device that takes energy from a PK generator workstation G400. This pulsed wave system has two different modes; cutting (High Cut 1,2,3) and coagulation (Vaporization 1,2,3). Results: Records of 60 patients were analyzed. The median age was 50 (range: ages 40–84), median body mass index was 26 kg/m2 (range: 22–32 kg/m2), and median parity was 2 (range: 1–8). The median total operation time was 100 minutes (range: 70–240 minutes), estimated blood loss was 80 mL (range: 30–250 mL), and uterine weight was 207 g (range: 50–900 g). Degree of Surgical Difficulty and postoperative pain scores at rest were evaluated with a visual analogue scale system, from 0 to 10, and the medians of these scores were 5 (range: 3–7) and 4 (range: 2–6), respectively. The median recovery time of bowel movement was 16 hours (range: 8–26 hours), median spontaneous urination time was 7 hours (range: 4–29 hours), and median postoperative mobilization time was 8 hours (range: 6–10 hours). Conversion to laparotomy was needed in 1 patient due to severe pelvic adhesions. The median duration of hospital stay was 2 days (range: 2–4 days). Vaginal cuff dehiscence was detected in 1 (1.7%) patient who engaged in sexual intercourse on the 122nd day after surgery. Cuff cellulitis in 1 (1.7%) patient and unexplained fever in 1 (1.7%) patient were the other recorded complications. The median follow-up time was 12 months (range: 6–17 months). Conclusions: The PKS OMNI is a novel, underused energy modality that promotes quick recovery and acceptable operation time with minimal blood loss. (J GYNECOL SURG 33:253)

Analysis of Hematopoietic Reconstitution in Auto-Peripheral Blood Hematopoietic Stem Cell Transplantation

To explore the factors which may have influences on hematopoietic reconstitution of the auto-peripheral blood stem cell transplantation(auto-PBHSCT). The successful rate, the time of hematopoietic reconstitution and implantation status at 28 days after transplantation of 177 patients received auto-PBSCT were retropectively analyzed, in order to explore the factors which may have influences on hematopoietic reconstitution. The median time of neutrophil recovery was 12 days (8-21 days), implantation rate was 98.9%, all patients' neutrophil were recovered in 28 days. The median time of platelet recovery was 17 days (7-420 days), implantation rate was 95.5%, the cumulative incidence of platelet recovery at day 28 was 80.8%. Univariate analysis showed that the CD34+ cell number and the use of TPO had effect on neutrophils recovery time; the disease kinds, conditioning regimen and the infused CD34+ cell number had influence on platelets recovery time. Multivariate analysis showed that the CD34+ cell number was the independent influencing factor of neutrophils reconstitution time; the disease kinds, the CD34+ cell number were the independent influencing factors of platelet reconstitution time. Disease kinds and the CD34+ cell number were the independent influencing factors of hematopoietic reconstitution status of 28 days after transplantation. In auto-PBHSCT patients, disease kinds, conditioning regimen, the infused CD34+ cell number and the use of TPO have been confirmed to be independent influencing factors on hematopoietic reconstitution.

A Study to Evaluate KM / Propofol versus KM Alone for Procedural Sedation in Children

Background: The co-administration of ketamine and propofol (CoKP) is thought to maximize the beneficial profile of each medication, while minimizing the respective adverse effects of each medication. Objective: Our objective was to compare adverse events between ketamine monotherapy (KM) and CoKP for procedural sedation and analgesia (PSA) in a pediatric emergency department (ED). Methods: This was a prospective, randomized, single-blinded, controlled trial of KM vs. CoKP in patients between 3 and 21 years of age. The attending physician administered either ketamine 1 mg/kg i.v. or ketamine 0.5 mg/kg and propofol 0.5 mg/kg i.v. The physician could administer up to three additional doses of ketamine (0.5 mg/kg/dose) or ketamine/propofol (0.25 mg/kg/dose of each). Adverse events (e.g., respiratory events, cardiovascular events, unpleasant emergence reactions) were recorded. Secondary outcomes included efficacy, recovery time, and satisfaction scores. Results: Thirty-two patients were randomized to KM and 29 patients were randomized to CoKP. There was no difference in adverse events or type of adverse event, except nausea was more common in the KM group. Efficacy of PSA was higher in the KM group (99%) compared to the CoKP group (90%). Median recovery time was the same. Conclusions: We found no significant differences in adverse events between the KM and CoKP groups. While CoKP is a reasonable choice for pediatric PSA, our study did not demonstrate an advantage of this combination over KM.

Disease-specific hematopoietic stem cell transplantation in children with inherited bone marrow failure syndromes.

Hematopoietic stem cell transplantation (HSCT) using an optimized conditioning regimen is essential for the long-term survival of patients with inherited bone marrow failure syndromes (IBMFS). We report HSCT in 24 children with Fanconi anemia (FA, n=12), Diamond-Blackfan anemia (DBA, n=7), and dyskeratosis congenita (DC, n=5) from a single HSCT center. The graft source was peripheral blood stem cells (n=19) or cord blood stem cells (n=5). FA and DC patients received reduced-intensity conditioning, while DBA patients had myeloablative conditioning. The median numbers of infused mononuclear cells and CD34+ cells were 14.20×108/kg and 4.3×106/kg, respectively. The median time for neutrophil and platelet recovery was 12 and 18days, respectively. Complete donor engraftment was achieved in 23 of 24 patients. There was one primary graft failure. During a median follow-up of 27.5months (range, 2-130months), the overall survival in all patients was 95.8%. The incidence of grade II-III acute graft versus host disease (GvHD) and chronic GvHD was 29.2% and 16.7%, respectively. We conclude that HSCT can be a curative option for patients with IBMFS. Modification of the conditioning regimen based on the type of disease may lead to encouraging long-term outcomes.

Predictors of renal function recovery among patients undergoing renal replacement therapy following orthotopic liver transplantation.

Renal dysfunction frequently occurs during the periods preceding and following orthotopic liver transplantation (OLT), and in many cases, renal replacement therapy (RRT) is required. Information regarding the duration of RRT and the rate of kidney function recovery after OLT is crucial for transplant program management. We evaluated a sample of 155 stable patients undergoing post-intensive care hemodialysis (HD) from a patient population of 908 adults who underwent OLT. We investigated the average time to renal function recovery (duration of RRT required) and determined the risk factors for remaining on dialysis > 90 days after OLT. Log-rank tests were used for univariate analysis, and Cox proportional hazards models were used to identify factors associated with the risk of remaining on HD. The results of our analysis showed that of the 155 patients, 28% had pre-OLT diabetes mellitus, 21% had pre-OLT hypertension, and 40% had viral hepatitis. Among the patients, the median MELD (Model for End-Stage Liver Disease) score was 27 (interquartile range [IQR] 22-35). When they were listed for liver transplantation, 32% of the patients had serum creatinine (Scr) levels > 1.5 mg/dL or were on HD, and 50% had serum creatinine (Scr) levels > 1.5 mg/dL or were on HD at the time of OLT. Of the transplanted patients, 25% underwent pre-OLT intermittent HD, and 14% and 41% underwent continuous renal replacement therapy (CRRT) pre-OLT and post-OLT, respectively. At 90 days post-OLT, 118 (76%) patients had been taken off dialysis, and 16 (10%) patients had died while undergoing HD. The median recovery time of these post-OLT patients was 33 (IQR 27–39) days. In the multivariate analysis, fulminant hepatic failure as the cause of liver disease (p<0.001), the absence of pre-OLT hypertension (p = 0.016), a lower intraoperative fresh-frozen plasma (FFP) transfusion volume (p = 0.019) and not undergoing pre-OLT intermittent HD (p = 0.032) were associated with performing RRT for less than 90 days. Therefore, a high proportion of OLT patients showed improved renal function after OLT, and those who were diagnosed with fulminant hepatic failure, had no pre-OLT hypertension, received a lower transfused volume of intraoperative FFP and did not undergo pre-OLT intermittent HD had a higher probability of recovery.