scholarly journals Assessing efficacy and safety of rectally vs. intravenously administered Sibazon in treatment of generalized epileptic seizures in children

2021 ◽  
Vol 13 (3) ◽  
pp. 200-210
Author(s):  
A. G. Prityko ◽  
K. V. Osipova ◽  
P. L. Sokolov ◽  
E. A. Ezhova ◽  
I. G. Kotel’nikova ◽  
...  
Keyword(s):  
Drug Administration ◽  
Epileptic Seizures ◽  
Blood Analysis ◽  
Intramuscular Administration ◽  
Final Visit ◽  
Fisher Exact Test ◽  
Efficacy And Safety ◽  
Clonic Seizures ◽  
Group 2 ◽  
Group 1

Objective: to prove the therapeutic equivalence and similar safety profile of “Sibazon, rectal solution” (international nonproprietary name: diazepam) and “Sibazon, solution for intravenous and intramuscular administration” in children with primary generalized and bilateral tonic, clonic and tonic-clonic seizures.Material and methods. An open-label, randomized clinical trial on efficacy and safety was conducted in 20 patients suffering from epilepsy with generalized seizures aged 1 to 17 years. Clinical blood and urine tests, biochemical blood analysis were used for diagnostics (glucose, total protein, albumin, total bilirubin, cholesterol, aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, creatinine, urea, creatinine clearance), as well as data on electrocardiographic (ECG) and electroencephalographic (EEG) studies. The patients were divided into two groups: in Group 1 (n=8), a rectal solution was used, in Group 2 (n=12) – a solution for intravenous and intramuscular administration.Results. The number of cases in which seizures were completed within 10 minutes after using the drug without resuming within subsequent 60 minutes, in Group 1 was 7 (87.5%), and in Group 2 – 9 (75.0%) (Fisher exact test (FET): p=0.617). Repeated primary generalized or bilateral tonic/clonic/tonic-clonic seizures within 24 hours after drug administration, in Group 1 were absent in 5 (62.5%) patients, in Group 2 – in 6 (50%) (FET: p=0.670); within 48 hours after drug administration – in 5 (62.5%) and 7 (58.3%) children, respectively (FET: p=1.00). Physical examination revealed no pathology in all patients at the final visit. While comparing ECG and EEG data at the final visit, no inter-group differences were found by the number of children with deviations from the norm. The results of laboratory studies confirmed that using the studied drugs had no negative effect on the main indicators of clinical and biochemical blood tests as well as clinical urine analysis.Conclusion. The effectiveness of the rectal form of Sibazon in relieving pediatric generalized epileptic seizures is comparable to that of Sibazon for intramuscular administration. The drug rectal form, due to easy-to-use administration, is preferable for outpatient practice. “Sibazon, rectal solution” is safe and has good tolerability.

scholarly journals Assessing efficacy and safety of buccally inoculated midazolam and intravenously administered diazepam for relieving pediatric primary generalized epileptic seizures

2021 ◽  
Vol 13 (2) ◽  
pp. 97-105
Author(s):  
A. G. Prityko ◽  
K. V. Osipova ◽  
P. L. Sokolov ◽  
E. A. Ezhova ◽  
I. G. Kotel’nikova ◽  
...  
Keyword(s):  
Drug Administration ◽  
Safety Profile ◽  
Convulsive Seizure ◽  
Intramuscular Administration ◽  
Age Group ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Clonic Seizures ◽  
Group 2 ◽  
Group 1

Objective: to confirm a therapeutic equivalence and similar safety profile of “Midazolam, oromucosal (buccal) solution” and “Sibazon, solution for intravenous and intramuscular administration” used in children aged from 1 year to 18 years suffering from primary generalized and bilateral tonic, clonic and tonic-clonic seizures.Material and methods. An open-label, randomized clinical trial on efficacy and safety was conducted with 25 patients having primary generalized and bilateral tonic, clonic and tonic-clonic seizures due to epilepsy or epileptic syndrome. The study used age-appropriate doses of Midazolam with a single buccal administration as well as diazepam (Sibazon) for single intramuscular administration. Midazolam dosing was as follows: 5 mg for children of the younger age group (1 tube-dropper 5 mg/ml), 7.5 mg for children of the middle age group (1 tube-dropper 5 mg/ml and 1 tube-dropper 2.5 mg/ml), 10 mg for older children (2 tube-droppers 5 mg/ml). The drug effectiveness was assessed by primary and secondary criteria. The number of cases of drug administration in each group was used as the primary criteria, in which the convulsions ended up within 10 minutes after using the drug and did not resume within 60 minutes after drug administration. The following criteria were used as secondary: no repeated convulsive seizures within 24 hours after drug administration, no repeated convulsive seizure within 48 hours after drug administration, time before repeated convulsive seizure within 48 hours after drug administration. Clinical assessment was carried out according to clinical data, electroneurophysiologic (electroencephalographic) studies, electrocardiography, clinical blood and urine tests, aswell as biochemical blood tests by measuring glucose, total protein, albumin, total bilirubin, cholesterol, aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, creatinine, urea, and creatinine clearance level.Results. Compliance with the first efficacy criterion after using Midazolam and Sibazon was observed in 11 (84.6%) and 9 (75%) patients in Group 1 and Group 2, respectively, showing insignificant differences (Fisher's exact test (FET): p=0.645). The number of no cases of repeated convulsive seizure within 24 hours after drug administration differed significantly and was 12 (92.3%) and 6 (50%), respectively (FET: p=0.030). The number of cases with no second seizures within 48 hours after drug administration in Group 1 and Group 2 was 12 (92.3%) and 5 (41.7%), respectively, showing insignificant differences (FET: p=0.0112). No serious adverse events were reported during the study. No patients cancelled participation in the study due to developed adverse event.Conclusion. The data obtained evidence about compatibility of therapeutic efficacy profile and similar safety profile for “Midazolam, oromucosal (buccal) solution” and “Sibazon, solution for intravenous and intramuscular administration” that agrees with multiple data of earlier studies.

scholarly journals 173TRANSFER OF VITRIFIED BLASTOCYSTS FROM ONE OR TWO SUPEROVULATED LARGE WHITE HYPERPROLIFIC DONORS TO MEISHAN RECIPIENTS: REPRODUCTIVE PARAMETERS AT DAY 30 OF PREGNANCY

2004 ◽  
Vol 16 (2) ◽  
pp. 208
Author(s):  
C. Cuello ◽  
F. Berthelot ◽  
F. Martinat-Botté ◽  
P. Guillouet ◽  
V. Furstoss ◽  
...  
Keyword(s):  
Pregnancy Rate ◽  
Fisher Exact Test ◽  
Corpora Lutea ◽  
Large White ◽  
Embryo Survival ◽  
Exact Test ◽  
Group 2 ◽  
Fresh Semen ◽  
Group 1

The present study was designed to determine the effect of pooling embryos from two donors on the reproductive success of transfer of vitrified/warmed porcine blastocysts. Superovulated Large White hyperprolific gilts (n=24) were used as embryo donors. Gilts were artificially inseminated 12 and 24h after initial detection of estrus using fresh semen, and slaughtered on Days 5.5 to 6 of the estrous cycle (Day 0=Onset of estrus). Embryos were recovered by flushing the uterine horns, and unhatched blastocysts were selected. Vitrification and warming were performed as reported previously (Berthelot et al., 2000 Cryobiology 41, 116–124). Embryo transfers were conducted in asynchronous (−24h) Meishan gilts (n=20). Twenty vitrified/warmed blastocysts were surgically transferred into one uterine horn. Ten recipients received embryos from one donor (group 1) and the other ten transfers were performed with mixed embryos from two donors (group 2). Pregnancy was assessed ultrasonographically at Day 25 after estrus and recipients were slaughtered five days later. The pregnancy rate from the different groups was compared using Fisher exact test. The GLM procedure of SAS was used to determine the effect of the origin of embryos (one or two donors) on the number of developed fetuses and viable fetuses at Day 30 of pregnancy. The ovulation rate was 32.5±11.8 (mean±SD). The total number of embryos collected was 634, of which 57 (9.0%), 36 (5.7%), 513 (80.9%) and 28 (4.4%), were unfertilized oocytes and degenerated embryos, morulae, unhatched blastocysts and hatched blastocysts, respectively. The ratio of collected embryos to the number of corpora lutea was 81.3%. The pregnancy rate for group 1 (70%) was not different (P>0.05) than that for group 2 (90%). No significant differences were detected between group 1 and group 2 for in vivo embryo development (number fetuses/transferred embryos in pregnant recipients; 33.3% v. 40%) or in vivo embryo survival (number viable fetuses/transferred embryos in pregnant recipients; 27.9% v. 33.9%). However, the in vivo efficiency (number viable fetuses/total transferred embryos) was higher (P<0.05) when transfers were performed with embryos from two donors (19.5% v. 30.5%). These results indicate that pooling embryos from two donors increases the in vivo efficiency after transfer of vitrified/warmed porcine blastocysts. This study was supported by grant from SENECA (FPI/99, Spain).

1260Transvenous lead extraction: efficacy and safety of the procedure in octogenarian patients

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Giannotti Santoro ◽  
L Segreti ◽  
G Zucchelli ◽  
V Barletta ◽  
F Fiorentini ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Electronic Device ◽  
Clinical Success ◽  
Lead Extraction ◽  
Efficacy And Safety ◽  
Cardiac Implantable Electronic Device ◽  
Major Complications ◽  
Group 2 ◽  
Manual Traction ◽  
Group 1

Abstract Introduction the management of patients with infection or malfunction of a cardiac implantable electronic device (CIED) may be challenging. Purpose The aim of the study is to evaluate the safety and efficacy of transvenous lead extraction (TLE) in elderly patients. Methods a retrospective analysis of patients who underwent to TLE in our center was performed. Patients were divided in two groups: 1) patients 80 years of age or older, 2) patients younger than 80 years. All patients were treated with manual traction or mechanical dilatation. Results our analysis included 1316 patients, with a total of 2513 leads extracted. Group 1 (≥80 years) counted 202 patients and group 2 (<80 years) 1114 patients. The group of elderly patients presented more comorbidities, as hypertension, chronic kidney disease, atrial fibrillation and pulmonary disease. Patients 80 years of age or older had more pacemakers than ICDs, whereas the dwelling time of the oldest lead, the number of leads and the presence of abandoned leads was similar despite patients age. In group 1 the rate of radiological success for lead was higher than in group 2 (99.0% vs 95.9%; P < 0.001). The clinical success was obtained in 1273 patients (96.7%), without significative differences between groups (98.0% vs 96.4%; P = 0.36). Major complications occurred in 10 patients (0.7%), without significative differences (1.5% vs 0.6%; P = 0.24) (figure 1). Conclusion TLE in elderly patients is a safe and effective procedure. In patients older than 80 years there are not more major complications than in younger patients, and the efficacy of the procedure seems to be superior. Abstract Figure 1

scholarly journals Efficacy and safety of mifepristone-misoprostol combination with extraamniotic ethacridine lactate-misoprostol for termination of second trimester pregnancy

2018 ◽  
Vol 7 (10) ◽  
pp. 4229
Author(s):  
Hemavathi G. ◽  
Jagruthi C.
Keyword(s):  
Gestational Age ◽  
Second Trimester ◽  
Efficacy And Safety ◽  
Trimester Abortion ◽  
Medical College ◽  
Incomplete Abortion ◽  
Ethacridine Lactate ◽  
Second Trimester Pregnancy ◽  
Group 2 ◽  
Group 1

Background: Mid trimester termination of pregnancy is one of the most controversial areas of gynecological practice. It has moral, emotional, social and technical issues. This study was designed for comparison of efficacy and safety of Mifepristone-Misoprostol combination with exrtaamniotic Ethacridine Lactate-misoprostol for termination of second trimester pregnancy.Methods: The present was undertaken among the patients admitted to hospitals attached to J.J.M. Medical College; Bapuji hospital, Women and Children hospital and Chigateri general hospital Davangere during the study period   from November 2016 - October 2017.  Patients coming for second trimester abortion to above mentioned hospitals were assigned serial number from 1 to 80 and all patients with even number will be allocated to group 1 and all patients with odd number will be allocated in group 2, each group comprising 40 women each.Results: Majority of the cases in both the groups were between 21-25 yrs. Majority of the cases in both the groups were multigravidas. 11 cases from group 1 and 12 cases from group 2 were of gestational age between 14-16 wks. 29 cases from group 1 and 28 cases from group 2 were of gestational age between 18-20 wks. In the present study the mean induction abortion interval for group 1 was 19.56±1.82 hours and group 2 was 14.13±2.72 hours. This was statistically significant. Of the 40 cases in each group, 37 had complete abortion i.e. 92.5% 3 cases (7.5%) from both the groups had incomplete abortion. The side effects were relatively more in more in group 1 when compared to group 2.Conclusions: It was concluded that with this combination success rate was high (92.5 %), with Short induction abortion interval, less rate of incomplete abortion without any major complications.

scholarly journals Comparison between use of combination of mifepristone and misoprostol versus misoprostol alone in the management of intrauterine fetal death

2018 ◽  
Vol 7 (7) ◽  
pp. 2778
Author(s):  
Sreeveena Talasani ◽  
Pran Hitha Venkamolla ◽  
Kalpana Betha
Keyword(s):  
Side Effects ◽  
Fetal Death ◽  
Intrauterine Fetal Death ◽  
P Value ◽  
Ultrasound Scan ◽  
Efficacy And Safety ◽  
Medical Sciences ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Background: Intrauterine fetal death (IUFD) is estimated to occur in 1% of all pregnancies. The advent of prostaglandins has revolutionized the management of IUFD. There are limited studies using a combined regimen of mifepristone and misoprost for induction of labor in IUFD. Hence this study was undertaken to assess the efficacy and safety of combined regimen with misoprostol alone, in the management of IUFD.Methods: This hospital based prospective study included 60 pregnant women with IUFD admitted at Mediciti Institute of Medical Sciences, during the period January 2015 to July 2016. An ultrasound scan was performed to confirm IUFD and localize the placenta. Women were divided alternatively into 2 groups with 30 in each group (group 1- women received 200 mg mifepristone orally followed by misoprostol after 24 hours & in group 2, 100 µg misoprostol  every 6 hourly for a maximum of 4 doses between gestational age  24-26 weeks, 25-50 µg 4 hourly for a maximum of 6 doses beyond 26 weeks).Results: The mean induction to delivery interval was 10 hours in group 1 and 16.3 hours in group 2 (p value 0.007). Mean dose of misoprostol required in group 1 was 1.87 and 2.67 in group 2 (p value 0.008). With respect to side effects, the two groups did not differ significantly.Conclusions: The combined regimen was more effective than misoprostol for the induction of labour in IUFD, in terms of higher rate of successful delivery and shorter induction to delivery interval. 

scholarly journals Elevated antimeasles antibody titre: An association in autoimmune encephalitis

2015 ◽  
Vol 06 (04) ◽  
pp. 536-540 ◽  
Author(s):  
S. R. Chandra ◽  
Thomas Gregor Issac ◽  
Mariamma Philip ◽  
A. Krishnan
Keyword(s):  
Subacute Sclerosing Panencephalitis ◽  
Autoimmune Encephalitis ◽  
Virus Infections ◽  
Exact Test ◽  
Double Incontinence ◽  
Antibody Positivity ◽  
Antibody Titers ◽  
Clonic Seizures ◽  
Group 2 ◽  
Group 1

ABSTRACT Introduction: Autoimmune encephalitis is a group of treatable noninfective encephalitic disorders with great clinical implications. They have a close resemblance to prion disease and some slow virus infections. We report the presence of significant titers of antimeasles antibody in some of our patients with autoimmune encephalitis resulting in diagnostic and therapeutic problems. Patients and Methods: Patients seen by us in the last 4 years with high titers (1:625 dilution) cerebrospinal fiuid (CSF) antimeasles antibody positivity were reviewed retrospectively. The data collected were assessed using SPSS- Statistical Package for Social Sciences Version 15.0 (IBM corporation) software. The groups which showed elevated antimeasles antibody titers but did not have other parameters suggestive of subacute sclerosing panencephalitis (Group 2) were segregated and compared with those who had the typical features (Group 1) using Fisher's Exact Test. Results: There were 33 patients with antimeasles antibody in CSF. Group 1 had 27 and Group 2 had 6 patients. Group 1 had lower age, cognitive dysfunction, slow myoclonus, less generalized tonic-clonic seizures, and focal seizures. Group 2 patients belonged to the higher age, had significant psychosis (P = 0.02), incontinence of bowel and bladder (P = 0.0001). Slow myoclonus was significant in the first group (P = 0.028), and weakness was significant in the second group (P = 0.028) and double incontinence in the second group (P = 0.0001). Magnetic resonance imaging showed significant gray matter and cerebellar involvement in Group 2 P = 0.005 and P = 0.028, respectively. Conclusions: Patients who show significant titers of antimeasles antibodies in the CSF but belonging to older age group with psychosis, generalized tonic-clonic seizures, double incontinence, focal myoclonus, and electroencephalographic and imaging noncorroborative need to be investigated for autoimmune encephalitis in view of the great prognostic and therapeutic relevance.

scholarly journals Evaluation of the Efficacy and Tolerability of Oral Ciprofloxacin used in the Comprehensive Treatment of External Bacterial Otitis: An Observational Prospective Study

2017 ◽  
Vol 21 (04) ◽  
pp. 329-335 ◽  
Author(s):  
Alexander Gurov ◽  
Andrey Kriukov ◽  
Vera Kunelskaya ◽  
Galina Isotova ◽  
Georgiy Shadrin ◽  
...  
Keyword(s):  
Otitis Externa ◽  
Prospective Observational Study ◽  
Comprehensive Treatment ◽  
Bacteriological Examination ◽  
Efficacy And Safety ◽  
Ear Canal ◽  
Microbiological Test ◽  
Group 2 ◽  
Oral Ciprofloxacin ◽  
Group 1

Introduction Otitis Externa is common ear infection with a prevalence of 1%. Objective The objective of this study is to evaluate the clinical and microbiological efficacy and safety profile with oral ciprofloxacin in the external bacterial otitis (EBO) management. Methods This is a prospective observational study conducted with EBO outpatients referred to the otorhinolaryngology center in Moscow between March and August 2013. Our study included patients from two cohorts, acute external bacterial otitis (AEBO) - Group 1 - and exacerbation of chronic otitis externa (CEBO) - Group 2. We administered Ciprofloxacin 500 mg twice daily with standard topical EBO treatment for up to 10 days. Patients underwent evaluation on study visit days 1, 3, 5, and 10 for the severity. Bacteriological examination of ear canal cultures took place on Day 1 and Day 10. Results We collected data from 60 EBO outpatients (AEBO: N = 30 and CEBO: N = 30). Swimming was the major risk factor associated with the disease in addition to the most common pathogenic organisms - Staphylococcus aureus and Pseudomonas aeruginosa. was We attained complete resolution of the inflammatory process in 28 (93%) and 27 (90%) patients in the AEBO and CEBO group, respectively. We confirmed this by microbiological test with almost complete eradication of the causative organisms. Overall, we observed good positive dynamics of ear canal with no major side effects. Conclusion We found that Ciprofloxacin 500 mg, when administered orally twice daily for 7 to 10 days in otitis externa patients is clinically and microbiologically effective and comparatively safer than other antimicrobials.

The impact of kidney function on the efficacy and safety of pazopanib in metastatic renal cell carcinoma (mRCC) patients: CORE-URO-01 study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16063-e16063
Author(s):  
Maria Giuseppa Vitale ◽  
Cristina Masini ◽  
Giuseppe Procopio ◽  
Ugo De Giorgi ◽  
Sebastiano Buti ◽  
...  
Keyword(s):  
Renal Function ◽  
Side Effects ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Therapy Initiation ◽  
Frequent Monitoring ◽  
Group 2 ◽  
Grade 3 ◽  
The Impact ◽  
Group 1

e16063 Background: Pazopanibhas been approved for treatment of patients (pts) with mRCC based on the prospective randomized trial that enrolled only pts with adequate renal parameters. There are no data on the toxicity profile and efficacy of pazopanib in pts with renal insufficiency (RI).The aim of this study is to investigate the effect of renal function on treatment outcomes in pts treated with pazopanib for mRCC. Methods: We retrospectively analyzed the data of the mRCC pts treated with pazopanib with respect to renal function in eleven Italian institutions from January 2010 to June 2016. Baseline glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula at the time of therapy initiation. Pts with MDRD < 60 mL/min/1.73 m2 (group 1) were compared with pts with MDRD ≥60 mL/min/1.73 m2(group 2) in terms of response rates, progression free survival (PFS), overall survival (OS) and side effects. Results: One hundred and twenty-ninepts with mRCC were included in this study: 70 pts in group 1 and 59 pts in group 2. 67% of pts were male, median age was 66 years (34-83) and median CrCl was 49 ml/min (6.3-59.5) in group 1. In group 2, 64% of pts were male, median age was 65 years (38-80), and median CrCl was 64 ml/min (58.1-137.1) Pts with MDRD < 60 were more likely to have had a previous nephrectomy (84.3% vs 79.7%). No difference between the 2 groups was observed in terms of outcomes: PFS was 9.6 months (0.6–56.9) and 9.0 months (0.4–60.1), OS was 16.1 months (1.3–56.9) and 17.0 months (1.2–60.1), for MDRD < 60 group and MDRD ≥60 respectively. The disease control rate was 85.8% in group 1, and 72.9% in group 2. About grade 1-2 toxicity, no difference between the 2 groups was reported (67.1% vs 67.8%) while a higher incidence of grade 3-4 toxicity was evident in the group 1 (25.7% vs 18.6%). Conclusions: RI was commonly observed in pts with mRCC. Renal function at therapy initiation does not adversely affect the efficacy and safety of pazopanib. More frequent monitoring of side-effects in patients with RI is recommended.

scholarly journals Efficacy and Safety of Human Placental Extract Solution on Fatigue: A Double-Blind, Randomized, Placebo-Controlled Study

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Kang-Kon Lee ◽  
Whan-Seok Choi ◽  
Keun-Sang Yum ◽  
Sang-Wook Song ◽  
Sun-Myeong Ock ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Study ◽  
Common Symptom ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Extract Solution ◽  
Group 2 ◽  
Fatigue Recovery ◽  
Placental Extract ◽  
Group 1

Introduction. Fatigue is a common symptom, but only a few effective treatments are available. This study was conducted to assess the efficacy and safety of the human placental extract solution, which has been known to have a fatigue recovery effect.Methods. A total of 315 subjects were randomly assigned to three groups: group 1 (with Unicenta solution administration), group 2 (with exclusively human placental extract administration, excluding other ingredients from the Unicenta solution), and the placebo group. Subsequently, solutions were administered for four weeks.Results. The fatigue recovery rate was 71.00% in group 1, 71.72% in group 2, and 44.21% in the placebo group, which show statistically significant differences between the group 1 and the placebo group (Pvalue = 0.0002), and between group 2 and the placebo group (Pvalue = 0.0001).Conclusion. The human placental extract solution was effective in the improvement of fatigue.

scholarly journals Comparative evaluation of efficacy and safety of methotrexate either alone or in combination with hydroxychloroquine in patients suffering from rheumatoid arthritis

2017 ◽  
Vol 6 (8) ◽  
pp. 1996
Author(s):  
Amanjot Kaur ◽  
Shakti B. Dutta ◽  
Amandeep Singh ◽  
Amit Varma ◽  
Mirza A. Beg ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Combination Therapy ◽  
Adverse Drug Reactions ◽  
Positive Family History ◽  
Efficacy And Safety ◽  
Drug Reactions ◽  
Intergroup Comparison ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Background: Rheumatoid arthritis (RA) a chronic autoimmune inflammatory disease and Methotrexate being widely used as monotherapy and in combination for the treatment of RA. Combination therapy provides additional or even more potentiating effects, therefore have been widely used. This study is aimed at comparing the efficacy and safety of Methotrexate either alone or in combination.Methods: This study was conducted for one year from 1st January to 31st December 2015. 52 patients diagnosed with RA were included in this study and were divided in two groups, Group-1 (n=29) patients received methotrexate (MTX) 7.5-15mg/week and Group-2 (n=23) patients received methotrexate 7.5mg once a week + Hydroxychloroquine (HCQ) 200mg twice daily. The patients were followed up for a period of 16 weeks. Statistical analysis was done by using graph pad insta and p value of <0.05 was considered significant.Results: A total of 52 patients were included in the study. The mean age of patients was 50.53±14.81 years. 43 (82.69%) patients were females and 9 (17.30%) were males. 23 (44.23%) patients had positive family history of the disease. The Rheumatoid factor was positive in 42 (80.70%) and anti-CCP was raised in 50 (96.15%) patients. The RAPID-3 and DAS-28 scores on intragroup comparison was highly significant (p <0.0001) and the intergroup comparison was significant (p <0.01) between baseline and 16 weeks in both the groups. The improvement in inflammatory marker CRP was highly significant on intragroup (p <0.0001) and intergroup (p<0.001) comparison between baseline and 16 weeks in both the groups. The mean changes in Vitamin-D3 between baseline and at 16 weeks were insignificant (p >0.05) in both the groups. Total of Adverse drug reactions reported were 42 (50.60%) in group-1 and 41 (49.40%) in group-2.Conclusions: The combination therapy was found to be more efficacious than MTX monotherapy in improving symptoms and quality of life. The adverse drug reactions were mild, more in combination therapy and none of the patients required withdrawal of treatment.

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