Compound Application of Thalidomide and Recombinant Human Interferon-α-1b, Interleukin-2 in Different Disease Status of Acute Myeloid Leukemia a Multi-Center Prospective Study of a New Combination of Old Drugs

Abstract Objectives: The aim of this study was to investigate the therapeutic effects of combinational application of thalidomide and recombinant human interferon-α-1b, interleukin-2 (the ITI scheme) in treating acute myeloid leukemia (AML) in different settings. Methods: AML patients with different disease states were categorized into three groups and received treatments following the ITI scheme. Group A consisted of relapsed or refractory AML patients (R/R-AML) and primary AML patients who were unable to receive chemotherapy. Group B included patients with morphologically complete remission (CR) and consistently positive minimal residual disease (MRD). Group C is composed of AML patients with initial complete remission and negative MRD. The CR rate, partial remission rate, MRD status, quality of life, and long-term survival were observed accordingly. ITI scheme is administrated as: IFNα-1b 60ug/d qod ih, IL-2 1001 million units/d qod ih, Thalidomide 200mg qn po. the Compound Salvia Tablets were recommended orally taken in order to prevent deep venous thrombosis. Results: a. With a total response rate of 30% in 60 AML patients of Group A, 4 CR, 6 CRi and 8 PR, who maintained good quality of life with no transfusion with red blood cells or platelet components any more (Table1).The MRD of 13 cases (72.2%) turned negative among 18 patients in Group B. MRD levels turned unmeasurable in seven patients receiving a conventional dose of ITI regimen, and MRD levels significantly decreased in three patients. MRD levels turned unmeasurable after receiving a higher dose of ITI regimen in two patients, and one patients MRD level decreased. Five patients failed to this regimen and suffered a hematologic recurrence. The efficacy is positively correlated with level of MRD level before ITI administration. 81.8% (9/11) patients responded to ITI regimen in whose MRD level ≤1.0%. However, only 57.1% (4/7) responded in whose MRD≥1.0%. 3 patients responded to a extra dose of ITI after no response to a normal dose. Indicated that the efficacy of this regimen is positively correlated with the dose of the regimen.(Table 2)In group C of 88 patients, 11 patients failed to maintain MRD negative, and the relapse rate was 12.5% (Table 3and figure 1). Conclusions: The ITI scheme can provide a new, effective, and affordable treatment option for AML patients that are intolerant to conventional chemotherapy, including R/R-AML patients, patients with CR status but MRD positive, and patients after initial CR. Disclosures No relevant conflicts of interest to declare.

Download Full-text

Combined Thalidomide and Recombinant Human Interferon-α-1b and Interleukin-2 for Acute Myeloid Leukemia of Various Disease Status: A Multi-Center Prospective Study

Blood ◽

10.1182/blood-2019-128431 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 3865-3865

Author(s):

Ruihua Mi ◽

Lin Chen ◽

Xudong Wei ◽

Xiaojiao WANG ◽

Yongping Song

Keyword(s):

Acute Myeloid Leukemia ◽

Myeloid Leukemia ◽

Response Rate ◽

Interleukin 2 ◽

Disease Status ◽

Human Interferon ◽

Interferon Α ◽

Group B ◽

Acute Myeloid ◽

Human Interferon Α

AML (acute myeloid leukemia) patients with relapsed refractory diseases or in poor physical conditions have very limited choices of appropriate treatment regimens, and most alternative options are costly. Here, we reported that an affordable regimen with combined recombinant human interferon-α-1b (IFN-α1b), thalidomide, and recombinant interleukin-2 (IL-2) (the ITI regimen) achieved varying degrees of therapeutic effects in AML patients of various disease status and vulnerabilities. ITI regimen was administrated as follow: a subcutaneous injection of IFN-α1b 60 μg qod, IL-2 1 million unit qod, and 200mg thalidomide tablet orally taken every night before sleep. Group A Sixty-eight patients who were with relapsed or refractory AML were enrolled, sixty finished at least one course, a response rate (CR+CRi) of 16.7% (10/60) was observed, and, and 7 (11.7%) patients achieved partial remission.(Table 1) Group B Eighteen patients with morphologically complete remission and consistently positive MRD were enrolled, each patients underwent ITI regimen for 2 months at least. According to the criteria of the WHO risk stratification, 7 were with a favorable risk, 8 were with a intermediate risk, and 3 were with a high risk. Patients with FLT3-ITD mutations were treated with oral sorafenib during early induction and consolidation treatment. These 18 patients received conventional dosage of ITI regimen. Seven patients had a negative MRD after 1 or 2 months. The MRD levels of 3 patients significantly decreased after one or two months. Five patients suffered a Morphological relapse. Another 3 patients failed to the conventional dosage of ITI regimen with an increased MRD rate, but it decreased after we made a modification of IFN-α1b and IL-2 administration daily. The response rate of the 18 patients in Group B was 72.2%, where MRD < 0.01% was defined as the negative threshold. (Table 2) Group C Eighty-eight patients with MRD-negative AML after consolidation were enrolled. Among the 88 patients with initial CR, 11 (12.5%) relapsed during the maintenance period (Figure 1). All these 11 patients relapsed within 2 years, with a median recurrence period of 20 months, of which 2, 4, and 5 patients, respectively, were with favorable, intermediate, and high risk. The indicated that this regimen effectively reduced the relapse rate.(Table 3) Disclosures No relevant conflicts of interest to declare.

Download Full-text

Combined Thalidomide and Recombinant Human Interferon-α-1b and Interleukin-2 for Acute Myeloid Leukemia of Various Disease Status: A Multi-Center Prospective Study

10.21203/rs.3.rs-562417/v1 ◽

2021 ◽

Author(s):

Ruihua Mi ◽

Lin Chen ◽

Xiaojiao Wang ◽

Qingsong Yin ◽

Zhanfang Wang ◽

...

Keyword(s):

Complete Remission ◽

Myeloid Leukemia ◽

Response Rate ◽

Interleukin 2 ◽

Disease Status ◽

Human Interferon ◽

Interferon Α ◽

Cytokine Levels ◽

Acute Myeloid

Abstract Objectives: This study investigated the therapeutic effects of combined recombinant human interferon-α-1b (IFN-α1b), thalidomide, and recombinant interleukin-2 (IL-2) in treating acute myeloid leukemia (AML) in patients of various disease status and vulnerabilities. Methods: Patients with AML (n = 166) were treated with combined recombinant IFN-α1b, thalidomide, and recombinant IL-2 (ITI regimen). The rates of partial and complete remission, minimal residual disease (MRD) status, quality of life, and long-term survival were compared among 3 patient groups. Lymphocyte profiles and relevant cytokine levels determined from peripheral blood samples of patients (pre- and post-treatment) and healthy individuals were compared. (Registration number: ChiCTR-ONC-14004688; Registered 23 May 2014, www.chictr.org.cn)Results: Sixty patients with primary AML who were unable to receive chemotherapy, or with relapsed/refractory AML, showed a total response rate of 30% after undergoing the ITI regime, and maintained a good quality of life. Eighteen patients with morphologically complete remission and consistently positive MRD achieved a response rate of 72.2%: the MRD converted to negative or was mitigated in 9 and 4 patients, respectively; 5 patients did not respond. For 88 patients with initial complete remission and negative MRD, 11 failed to maintain the negative MRD, and the relapse rate was 12.5%. The ITI regime was associated with substantial anti-leukemic changes in peripheral blood lymphocyte profiles and cytokine levels. Conclusions: The ITI regimen may be an effective and affordable option for patients with AML who cannot tolerate conventional chemotherapy, including those with relapsed/refractory disease, or complete remission status but MRD-positive, or after initial complete remission.

Download Full-text

Joint involvement influences quality of life in systemic lupus erythematosus patients

Lupus ◽

10.1177/0961203320979039 ◽

2020 ◽

pp. 096120332097903

Author(s):

Francesco Natalucci ◽

Fulvia Ceccarelli ◽

Enrica Cipriano ◽

Carlo Perricone ◽

Giulio Olivieri ◽

...

Keyword(s):

Quality Of Life ◽

Lupus Erythematosus ◽

Disease Duration ◽

Joint Involvement ◽

Systemic Lupus ◽

Median Disease Duration ◽

Group A ◽

Musculoskeletal Manifestations ◽

Group B

Introduction Joint involvement represents the major determinant in quality of life (QoL)in Systemic Lupus Erhytematosus (SLE) patients. However, QoLhas been generally evaluated by non-specific questionnaires. We evaluated the relationship between SLE musculoskeletal manifestations and QoL, assessed by LupusQoL. Methods Patients with joint involvement (group A) were compared with those without this feature (group B). Disease activity was assessed by SLEDAI-2k in the whole population, while DAS28 and swollen to tender ratio were applied to assess joint activity. LupusQoL was administered to all the patients. Results Group A included 110 patients [M/F 8/102; median age 49 years (IQR 13), median disease duration 156 months (IQR 216)], group B 58 [M/F 11/47; median age 40 years (IQR 15), median disease duration 84 months (IQR 108)].We found significanlty lower values in all the LupusQoL domains except for one (burden to others) in group A in comparison with group B. A significant correlation between DAS28 values and all the LupusQoL domains in group A was found; only three domains correlated with SLEDAI-2k. Conclusions SLE-related joint involvement significantly influences disease-specific QoL. DAS28 better correlated with LupusQoL domains in comparison with SLEDAI-2k, confirming the need for specific musculoskeletal activity indices.

Download Full-text

Comparison of Post-Operative Quality of Life between Vaginal Hysterectomy and Abdominal Hysterectomy

10.53350/pjmhs211571801 ◽

2021 ◽

Vol 15 (7) ◽

pp. 1801-1803

Author(s):

Nazia Sajjad ◽

Sara Qadir ◽

Rukhsana Kasi ◽

Tayyaba Rasheed ◽

Fozia Unar ◽

...

Keyword(s):

Quality Of Life ◽

Vaginal Hysterectomy ◽

Controlled Trial ◽

Abdominal Hysterectomy ◽

Study Group ◽

Randomized Controlled ◽

Group A ◽

Group B ◽

Satisfactory Quality

Objectives: To compare the frequency of satisfactory quality of life between vaginal hysterectomy and abdominal hysterectomy. Study Design: Randomized controlled trial. Place and Duration of Study: Department of Obstetrics and Gynecology, Niazi Medical & Dental College, Sargodha from 1st April 2020 to 31st December 2020. Methodology: Ninety patients were comprised and they were divided in two groups; group A (vaginal hysterectomy) and Group B (abdominal hysterectomy) were performed. Hysterectomies (vaginal or abdominal) were performed by consultant gynecologist having experience at having least 5 years). Results: Mean age of the patients was 49.82±3.207 years, mean age of the patients of group A was 49.82±3.193 years and mean age of the patients of group B was 49.82±3.256 years. Satisfactory quality of life was noted in 38 (84.44%) patients of study group A and 29 (64.44%) patients of study group B. Statistically significant (P = 0.051) difference between the frequency of satisfactory quality of life between the both groups was noted. Conclusion: Results of this study reveals that post hysterectomy quality of life found more satisfactory in vaginal hysterectomy group as compared to abdominal hysterectomy group. Insignificant association of post hysterectomy quality of life with age group, marital status, parity and socio-economical status was found. Findings of this study also revealed that post hysterectomy satisfactory quality of life is not associated with education of the patients. Key words: Hysterectomy, Quality of life, abdomen, vagina, WHO, Uterus

Download Full-text

Immediate Effect of Muscle Energy Technique and Kalternborn Mobilisation Technique on Pain in Diabetic Patients with Periarthritis of Shoulder

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i42a32758 ◽

2021 ◽

pp. 220-228

Author(s):

Kamya Somaiya ◽

G. D. Vishnu Vardhan ◽

Ashish Bele

Keyword(s):

Quality Of Life ◽

Adhesive Capsulitis ◽

Frozen Shoulder ◽

Diabetic Patients ◽

Tissue Degeneration ◽

Muscle Energy Technique ◽

Group A ◽

Muscle Energy ◽

Group B

Background: Periarthritis Shoulder, also known as adhesive capsulitis, is a condition that results in tissue degeneration, thickening of the joint capsule, and a narrowing of the glenoid cavity. Diabetes mellitus is linked to many debilitating musculoskeletal disorders of the hand and shoulder. Prevalence of adhesive capsulitis or frozen shoulder is estimated to be 11-30 percent in people with diabetes. Various interventions have already been used to prevent pain and improve quality of life. Both Muscle Energy Technique and Kalternborn Mobilization Technique are thought to have a pain-relieving effect. Aim & Objective: The study's aim is to compare the effects of both techniques on pain in diabetic patients. Methods/Design: In this study experimental study, the participants will be divided into two groups: Kalternborn Mobilization Technique Group (A) and Muscle Energy Technique Group (B) based on inclusion and exclusion criteria. Both interventions include 30-45 min session which will be carried out for duration of four days. Outcome will be Pain and Quality of Life and outcome measures will be evaluated at beginning and at the end of intervention period. Result: Successful Completion of trial of Muscle Energy Technique and Kalternborn Mobilisation Technique will provide evidence for best strategy targeting Pain and quality of life in diabetic patients with Periarthritis of Shoulder. Conclusion: The study will be concluded with the significant effect of Muscle Energy Technique and Kalternborn Mobilisation Technique on Periarthritis shoulder of diabetic patients.

Download Full-text

BIOBRAN MGN-3

The Professional Medical Journal ◽

10.29309/tpmj/2013.20.01.4869 ◽

2012 ◽

Vol 20 (01) ◽

pp. 13-16

Author(s):

Ahmad Ijaz Masood ◽

RABEETA SHEIKH ◽

RANA ATIQUE ANWER

Keyword(s):

Quality Of Life ◽

Side Effects ◽

Hair Loss ◽

White Blood Cells ◽

Food Supplement ◽

Severe Nausea ◽

Treatment Side Effects ◽

Group A ◽

Group B

Objective: The aim of study was to assess the effect of Biobran in reducing of chemotherapy induced side effects in termsof tiredness, anorexia, vomiting and hair loss and quality of life in terms of weight loss. Setting: Radiotherapy Department, NishtarHospital Multan. Material and Methods: Fifty patients of breast cancer were enrolled randomly in two groups. Group-A patients weregiven 3 gram dose of Biobran MGN-3 per day one week before and one week after chemotherapy. Group-B patient were givenchemotherapy alone. Total six cycles of chemotherapy were given. No multivitamin or food supplements were given during this study.Chemotherapy induced side effects (tiredness, anorexia, and vomiting, hair loss) were assessed by questionnaire to the patients beforestart of each cycle. Weight was checked before each cycle to assess weight gain or loss. White blood cells were checked by completeblood count just before and one week after chemotherapy. Results: Between six months, 50 patients were enrolled in RadiotherapyDepartment, Nishtar Hospital Multan. There was a significant reduction in tiredness and anorexia in group-A patients. 20 (80%) patients ofgroup-A felt increase in their diet and no tiredness without any appetizer or multivitamin. But group-B patients demanded for appetizer dueto severe anorexia after chemotherapy except 3 (12%) patients who didn’t use any appetizer or food supplement. In group-A, 15 (60%)patients didn’t need any anti-emetic as compared to group-B all patient (100%) experienced severe nausea during and afterchemotherapy. Group-A patients experienced less hair fall 7 (28%) patients as compared to other group which is 25 (100%) patients.Conclusions: The study showed that, by helping to optimize the immune system, Biobran MGN-3 can not only help maximize treatmentsuccess, but also minimize treatment side effects and improve quality of life during treatment and in recovery.

Download Full-text

Effects of Nonsurgical Spinal Decompression Treatment on the Level of Pain and Quality of Life in Patients with Cervical or Lumbar Disc Herniation: A Retrospective Observational Study

Journal of Acupuncture Research ◽

10.13045/jar.2020.00220 ◽

2020 ◽

Vol 37 (4) ◽

pp. 259-269

Author(s):

Beom Seok Kim ◽

Ye Ji Lee ◽

Hyo Bin Kim ◽

Ki Jung Sung ◽

Ju Hyun Jeon ◽

...

Keyword(s):

Quality Of Life ◽

Observational Study ◽

Analysis Of Covariance ◽

Retrospective Observational Study ◽

Spinal Decompression ◽

Traditional Korean Medicine ◽

Korean Medicine ◽

Group A ◽

Group B

Background: This study aims to statistically analyze and compare the curative effect and satisfaction level between typical traditional Korean medicine treatment and nonsurgical spinal decompression treatment.Methods: Of the patients who were diagnosed with the cervical or lumbar herniated intervertebral disc at the Department of Acupuncture and Moxibustion Medicine at the Daejeon Korean Medicine Hospital from April 14th to August 25th, 2019, this study retrospectively analyzed the medical records of 31 patients who underwent nonsurgical spinal decompression treatment and traditional Korean medicine (assigned to Group A) and another 31 patients who received typical traditional Korean medicine alone (assigned to Group B). The clinical data were analyzed using IBM SPSS Version 23.0.Results: No statistically significant differences appeared in terms of sociodemographic, condition, and therapeutic characteristics, except whether the patient received Western medicine treatment, before or after a treatment with traditional Korean medicine. Group A exhibited higher variations in numeric rating scale, EuroQol- 5 dimension and EuroQol visual analogue scale scores compared to Group B as determined by independent sample t test and analysis of covariance. In addition, the satisfaction score of Group A was higher than that of Group B The result of cross analysis revealed that desire for continued treatment in Group A was higher than that of Group B.Conclusion: This retrospective observational study showed that the patients with nonsurgical spinal decompression treatment reported a greater reduction in pain, improved quality of life and satisfaction than patients receiving typical traditional Korean medicine.

Download Full-text

Quality of life, clinical outcomes and safety of early prophylactic levothyroxine administration in patients with Graves' hyperthyroidism undergoing radioiodine therapy: a randomized controlled study

Acta Endocrinologica ◽

10.1530/eje-15-1099 ◽

2016 ◽

Vol 174 (4) ◽

pp. 491-502 ◽

Cited By ~ 13

Author(s):

David Taïeb ◽

Claire Bournaud ◽

Marie-Claude Eberle ◽

Bogdan Catargi ◽

Claire Schvartz ◽

...

Keyword(s):

Quality Of Life ◽

Primary Endpoint ◽

Radioiodine Therapy ◽

Controlled Study ◽

Thyroid Function Tests ◽

Randomized Controlled ◽

Sf 36 ◽

Group A ◽

Group B

ObjectiveWhile radioiodine therapy is commonly used for treating Graves' disease, a prolonged and clinical hypothyroidism may result in disabling symptoms leading to deterioration of quality of life (QoL) of patients. Introducing levothyroxine (LT4) treatment in the early post-therapeutic period may be an interesting approach to limit this phenomenon.MethodsA multicenter, prospective, open-label randomized controlled trial enrolled 94 patients with Graves' hyperthyroidism randomly assigned to the experimental group (n=46) (group A: early prophylactic LT4treatment) or the control group (n=48) (group B: standard follow-up). The primary endpoint was the 6-month QoL. The secondary endpoints were other QoL scores such as Graves' ophthalmopathy (GO) outcomes, thyroid function tests and safety.ResultsThe primary endpoint at 6 months was achieved: the mental composite score (MCS) of Short Form 36 (SF-36) was significantly higher in group A compared to group B (P=0.009). Four other dimension scores of the SF-36 and four dimension scores of the thyroid-specific patient-reported outcome (ThyPRO) significantly differed between the two groups, indicating better QoL in group A. After adjustment for variables, the early LT4administration strategy was found as an independent factor for only two scores of SF-36: the MCS and the general health (GH) score. There were no differences in GO, final thyroid status and changes in the anti-TSH receptor antibodies (TRAbs) levels between the two groups. No adverse cardiovascular event was reported.ConclusionEarly LT4administration post-radioactive iodine (RAI) could represent a safe potential benefit for patients with regard to QoL. The optimal strategy taking into account administered RAI activities and LT4treatment dosage and timing remains to be determined.

Download Full-text

COMPARISON BETWEEN THERAPEUTIC ULTRASOUND AND SCAR MOBILIZATION OVER PERSISTENT POSTNATAL DYSPAREUNIA

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2017.v10i9.18757 ◽

2017 ◽

Vol 10 (9) ◽

pp. 48

Author(s):

Mariyam Farzana Sf ◽

Ponmathi P ◽

Sivakumar Pvr

Keyword(s):

Quality Of Life ◽

Analogue Scale ◽

Therapeutic Ultrasound ◽

Ultrasound Therapy ◽

Age Group ◽

Functional Index ◽

Significant Difference ◽

Group A ◽

Group B

Objective: Dyspareunia is known as the painful sexual intercourse. This study was conducted to compare the effectiveness between therapeutic ultrasound and scar mobilization in persistent postnatal dyspareunia.Methods: This is an experimental study. 30 subjects with superficial dyspareunia, age group between 25 and 35 years are taken in this study and 15 subjects in Group A were treated with ultrasound therapy, 15 subjects in Group B were treated with scar mobilization. Female sexual functional index questionnaire (FSFI) and visual analogue scale (VAS) were used as the outcome measure.Results: Results showed a significant difference in FSFI and VAS measurements in both the groups, but clinically Group A showed better improvement in pain and quality of life than Group B.Conclusion: There is no significant difference between ultrasound therapy and scar mobilization over the pain and quality of life in patients with persistent postnatal dyspareunia.

Download Full-text