scholarly journals Comparative evaluation of efficacy and safety of bepotastine besilate 1.5% ophthalmic solution versus olopatadine hydrochloride 0.1% ophthalmic solution in patients with vernal keratoconjunctivitis

Author(s):  
Priya Gupta ◽  
Seema Baishnab ◽  
Parveen Rewri

Background: Vernal keratoconjunctivitis (VKC) is a chronic, seasonally exacerbated, allergic ocular inflammation. It affect children and young adults and has male predominance. The first line of treatment often used is dual acting drugs like olopatadine and bepotastine. It combine the immediate histamine receptor antagonism, coupled with mast cell stabilization with other anti-inflammatory properties. The present study was conducted to compare the efficacy and safety of olopatadine 0.1% and bepotastine 1.5% eye drops in VKC patients.Methods: This was a prospective, open label, randomized and comparative clinical study conducted for 21 days. 65 patients of VKC of 5-15 years of either sex were randomized in two study arm. Arm A, given bepotastine 1.5% and arm B, given olopatadine 0.1% twice daily for 21 days. Symptoms and signs scoring of VKC along with safety assessment were recorded on baseline and at time of follow up on 7th day and 21st day.Results: After 3 weeks of drug therapy, patients in both arms showed improvement in the symptoms and signs scoring of VKC. There was no statistically significant difference between the two treatment arms. However, improvement in clinical parameters particularly ocular itching, which is the main complaint of patients with VKC was more in bepotastine arm as compared to olopatadine treated arm. Both the drugs were well tolerated without any serious adverse effect.Conclusions: Both olopatadine and bepotastine were found to be effective in alleviating the clinical symptoms and signs of VKC. However, bepotastine performed better in reducing ocular itch than olopatadine.

Author(s):  
Jyoti Dahiya ◽  
Vivek Sharma ◽  
Sumit Sachdeva ◽  
Srishti Srishti

The aim of this study is to Evaluation of Efficacy and Safety of Bepotastine Besilate 0.15% Ophthalmic Solution in Patients of Vernal Keratoconjunctivitis (VKC). This was a prospective, open label and randomized clinical study. Fifty patients of vernal keratoconjunctivitis between 6 to 20 years of age of either sex willing to give informed consent were enrolled in the study. Patients received Bepotastine besilate (0.15%) eye drops twice daily for 8 weeks. Symptoms scoring and signs scoring of VKC were recorded on baseline and at the time of follow up at 4 and 8 weeks. Safety assessments were also done in the drug group during the study period for any serious adverse effects. After the 2 months of drug therapy, patients showed improvement in the symptoms and signs scoring of Vernal keratoconjunctivitis. There was statistically significant difference between the treatment group at 4th and 8th week. The drugs were well tolerated without any serious adverse effect. Bepotastine besilate ophthalmic solution were found to be effective in alleviating the clinical symptoms and signs of VKC.


Author(s):  
Amatur R. Malahat ◽  
Sudhakar Kodudula ◽  
Vijaya L. Gali

Background: Vernal keratoconjunctivitis (VKC) is an allergic eye disease that especially affects young boys. Both olopatadine and bepotestine are dual acting drugs that provide rapid symptomatic relief coupled with the long-term disease-modifying benefit. The present study is conducted to compare the efficacy and safety of olopatadine eye drops and bepotastine eye drops in patients of vernal keratoconjunctivitis.Methods: A prospective, randomized, parallel-group, comparative study is conducted over a period of 4 weeks on paediatric patients with VKC. 50 patients are recruited and randomized into two treatment groups. They received the assigned drugs for 4 weeks and are called for follow up at the end of 1st week, 4th week and 12th week. At each follow-up, patients are examined and the clinical parameters are graded.Results: This study shows that both olopatadine and bepotastine are equally efficacious. Bepotastine provided quicker relief to symptoms of watering, ocular discomfort and conjunctival hyperaemia. Number of responders are also more in the bepotastine group. Absolute eosinophilic count improved with both the drugs but there is no statistically significant difference between them. Both drugs showed good safety profile. However, 24% patients reported aversion to bitter taste with bepotastine. There is no treatment related severe adverse effects in both the groups.Conclusions: Both olopatadine and bepotastine are effective in treating vernal keratoconjunctivitis. However, bepotastine performed better in reducing tearing, ocular discomfort and conjunctival hyperaemia.


2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Xiaochen Wang ◽  
Guiqiu Zhao ◽  
Jing Lin ◽  
Nan Jiang ◽  
Qian Wang ◽  
...  

Aims. The aim of this study was to assess the efficacy and safety of timolol in the treatment of myopic regression after laser in situ keratomileusis (LASIK).Methods. We searched MEDLINE, CENTRAL, EMBASE, China National Knowledge Infrastructure (CNKI), and Chinese Biological Medicine (CBM) from the inception to July 2015 for relevant randomized controlled trials that examined timolol therapy for myopic regression. The methodological quality of the studies included was assessed using the Revman 5.3 software.Results. We included six clinical trials involving 483 eyes in this review, including 246 eyes in treated group and 237 eyes in controlled group. We observed statistically significant improvements on the postoperative SE in the 3 months. However, the change of CCT was not statistically different between the control group and the experimental group. There were fewer cases of IOP, UDVA, and CDVA in treated group having significant difference from the controlled group.Conclusions. Topical timolol could be an effective treatment for reduction of myopic regression especially the spherical errors after myopic LASIK. Further RCTs with larger sample sizes for these trials are warranted to determine the efficacy and limitation for myopic regression after LASIK.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e20061-e20061
Author(s):  
Meifeng Tu ◽  
Jun Zhu ◽  
Yuqin Song

e20061 Background: To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF, brand name: Jinyouli) in the primary and secondary prevention of chemotherapy-induced neutropenia in patients with lymphoma. Methods: This single-center, one-arm and open-label clinical study enrolled 119 patients with lymphoma in Peking University Cancer Hospital & Institute from May 2016 to December 2018. Patients ≥45 kg received a single dose of PEG-rhG-CSF for 6mg, < 45kg for 3mg, subcutaneous injection once in 24-48 h after chemotherapy. Results: 119 lymphoma patients, including 60 primary and 59 secondary prevention patients, underwent a total of 427 cycles of chemotherapy. The overall incidence of febrile neutropenia (FN) was 6.32% (27/427), with rates of 5.39% and 7.17% in the primary and secondary prevention groups, respectively. There was no significant difference between two groups ( P> 0.05).The incidence of FN was significantly lower in the second cycle than in the first cycle in both the primary and secondary prevention groups ( In the primary group: cycle 1 vs. cycle 2: 15.00% vs. 2.22%, respectively, P= 0.027; In the secondary group: cycle 1 vs. cycle 2: 16.95% vs. 5.08%, respectively, P= 0.040). The overall incidence of grade Ⅳ neutropenia was 13.58% (58/427), with rates of 8.82% and 17.94% in the primary and secondary prevention groups, respectively. There was a significant difference between two groups ( P= 0.006). The incidence of grade Ⅳ neutropenia was significantly lower in the second cycle than in the first cycle (In the primary group: cycle 1 vs. cycle 2: 25.00% vs. 4.44%, respectively, P= 0.005; In the secondary group: cycle 1 vs. cycle 2: 47.46% vs. 11.86%, respectively, P< 0.001). The main treatment-related adverse event was bone pain, with an incidence of 2.52% (3/119). Conclusions: PEG-rhG-CSF can effectively reduce the incidence of FN and neutropenia with good safety in patients with lymphoma after chemotherapy. Primary prevention can significantly reduce the risk of grade IV neutropenia in all chemotherapy cycles compared with the secondary prevention. Clinical trial information: NCT02905916 .


Author(s):  
Gaurav Sharma ◽  
Kulbhushan P. Chaudhary ◽  
Sushma Sawaraj

Background: Vernal keratoconjunctivitis (VKC) is a chronic, bilateral, external ocular inflammatory disease primarily affecting young boys living in warm, dry climates with seasonal variations. The disease causes lot of discomfort to the patient and sometimes can predispose to serious problems like shield ulceration and keratoconus. A number of drugs are used in the management of the condition, with variable results. The aims and objectives of this study was to compare the efficacy and safety of the drugs, cromolyn sodium, azelastine and olopatadine ophthalmic solutions in the treatment of VKC.Methods: Sixty patients of VKC were studied over a period of 6 weeks. They were divided into 3 groups randomly to receive one of the drugs under study. Symptoms and signs were recorded after detailed questioning and examination according to modified criterion of Tabbara and Arafat.Results: There was significant reduction in the mean itching scores with olopatadine as compared to cromolyn sodium and azelastine (p<0.05). Olopatadine significantly decreased mean lacrimation scores as compared to cromolyn sodium and azelastine (p<0.005). Olopatadine, cromolyn and azelastine showed significant reduction of corneal stippling, but no drug was significantly better than the other. Both cromolyn and olopatadine showed reduction of limbal edema equally (p<0.05), olopatadine reduced limbal edema more significantly as compared to azelastine (p<0.05).Conclusions: All the three drugs were found to be safe in the treatment of VKC. Olopatadine may be preferred over the other two drugs since it reduced both itching and discharge most significantly.


Author(s):  
Mohammed Hidayathulla ◽  
Nagesh .

Background: The femoropopliteal artery is most frequently involved artery in peripheral artery disease. To treat femoropopliteal artery disease (FPAD), various revascularization approaches have been available such as simple balloon angioplasty, debulking techniques, stent implantation, and recently the drug-eluting balloon (DEBs). Nowadays, the paclitaxel DEBs have been emerged to treat FPAD with promising outcomes. We therefore evaluate the efficacy and safety of paclitaxel DEBs in patients with lower limb FPAD.Methods: In total, 25 patients with FPAD were enrolled in the study. All patients underwent peripheral angioplasty using paclitaxel DEBs via antegrade femoral approach or contralateral femoral artery using crossover sheath. Demographics, risk factors, clinical characteristics, and pre- and post-procedure VascuQol-6 score were noted.Results: Out of 25 patients, the majority of patients (52%) were in the 6th decades of life. The incidence of FPAD was most common in patients with an O +ve blood group. The common risk factors of FPAD, include smoking (88%), diabetes (68%), dyslipidemia (68%), and hypertension (64%). Rest pain (64%) and ulcer (32%) were the most frequent clinical symptoms of FPAD. The percent stenosis was 100% in 17 patients, and 70-99% in 32 patients. A statistically significant difference was found in VascuQol-6 score between pre and post peripheral angioplasty (p<0.001).Conclusions: We have concluded that the paclitaxel DEBs are safe and efficacious in treating FPAD. Authors recommend that clinician should educate FPAD patients pertaining to modification of controllable risk factors such as cessation of smoking, unhealthy diet, sedentary lifestyle, high blood pressure, and high blood sugar. 


Author(s):  
ABDUL FAHEEM KHAN ◽  
KHANETA PARVEEN

OBJECTIVES: The objectives of this study were to compare the efficacy and safety of Tolperisone tablets 50 mg three times daily versus Tizanidine 2 mg tablets thrice daily for the treatment of acute low back pain with muscle spasm. METHODS: The comparative study was carried out in 50 patients from orthopedics Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation, Vijayawada. Only those patients fulfilling the inclusion/exclusion criteria were enrolled into the study. Participants suffering from acute low back pain with muscle spasm were divided into two groups. The participants were followed up on Day-14 as final analysis. RESULTS: Subjects receiving Tolperisone showed a mean value of 16.43±1.16 in the Roland Morris low back pain and disability questionnaire both groups on day 1 and was reduced to 7.82±1.15 (51.94%) on day 7 and 2.56±1.53 (84.46%) on day 14. Similarly, the patients in the tizanidine group had mean value of 15.93±1.61 on day 1, which was reduced to 6.77±1.68 (57.64%) on day 7, and 2.88±1.92 (81.95%) on day 14, as comparable to the Tolperisone group. There was no statistically significant difference between the two groups, (p>0.05) for pain at rest, pain at night, restrictions of movement, changes in stiffness, changes in numbness, and changes in tenderness. There was a statistically significant difference between the two groups, (p<0.05) for pain on movement and kinesalgia. CONCLUSIONS: Tolperisone was found comparable in efficacy to Tizanidine in improving the clinical symptoms of changes in pain Self-assessment by the patient on different applied parameters.


2021 ◽  
Vol 11 ◽  
Author(s):  
Lin Wu ◽  
Chao Deng ◽  
Hui Zhang ◽  
Jie Weng ◽  
Youhua Wu ◽  
...  

Second-line treatment options for advanced/metastatic non-small cell lung cancer (NSCLC) patients are limited. We aimed to evaluate the efficacy and safety of docetaxel/sodium cantharidinate combination vs. either agent alone as second-line treatment for advanced/metastatic NSCLC patients with wild-type or unknown EGFR status. A randomized, open-label, phase III study was performed at 12 institutions. Patients with failure of first-line platinum regimens were randomized to receive either single-agent sodium cantharivsdinate (SCA) or single-agent docetaxel (DOX) or docetaxel/sodium cantharidinate combination (CON). The primary endpoints were centrally confirmed progression-free survival (PFS) and overall survival (OS). The secondary endpoints were objective response rate (ORR), disease control rate (DCR), quality of life (QoL) and toxicity. A total of 148 patients were enrolled in our study between October 2016 and March 2020. After a median follow-up time of 8.02 months, no significant difference was observed among the three groups in ORR (SCA vs. DOX vs. CON: 6.00% vs. 8.33% vs. 10.00%, respectively; p=0.814) and DCR (74.00% vs. 52.00% vs. 62.50%, respectively; p=0.080). In additional, the mOS was significantly higher in the CON group, compared with the single-agent groups (7.27 vs. 5.03 vs. 9.83 months, respectively; p=0.035), while no significant differences were observed in terms of PFS (2.7 vs. 2.9 vs. 3.1 months, respectively; p=0.740). There was no significant difference in the baseline QoL scores between the three groups (p&gt;0.05); after treatment, life quality in SCA and CON group was significantly better than that in the DOX group (p&lt;0.05). Furthermore, the incidence of adverse events (AEs) in the SCA group was significantly lower (46.00 vs. 79.17 vs. 25.00%, respectively; p=0.038) and the incidence of grade ≥3 AEs was also significantly lower in the SCA group compared with the DOX and CON groups (10.00 vs. 82.00 vs. 30.00%, respectively; p=0.042). Single-agent SCA and single-agent DOX has similar therapeutic efficacy in the second-line treatment of advanced/metastatic NSCLC with wild-type or unknown EGFR status, but single-agent SCA has fewer AEs and better QoL. Also, SCA plus DOX can significantly improve OS and exerted a significant synergistic effect, with good safety and tolerance profile.


Author(s):  
Kiranpreet Kaur ◽  
Anjleen Kaur ◽  
Prabhsimran Singh ◽  
Amandeep Singh Bakshi

Background: Osteoarthritis is a chronic and debilitating disease. Management of disease is a big challenge. NSAIDS play an important role but have many adverse reactions. So, this study was designed to evaluate the efficacy and safety of natural compound rosehip versus glucosamine and chondroitin sulphate in patients of osteoarthritis.Methods: An open label, randomized, parallel group comparative study, conducted on patients of either sex with confirmed diagnosis of osteoarthritis on standard NSAIDs therapy, attending the outpatient department of orthopedics in a tertiary care centre.  150 patients were enrolled and divided into three groups (group A, group B and group C) of 50 each. Patients of group A were given Glucosamine plus chondroitin sulphate for 12 weeks. Group B was given rosehip for 12 weeks and group C placebo.  These supplements were given as add on therapy.  Patients were monitored and adverse drug reactions were noted. The data was analysed statistically using t- test for efficacy and descriptive stats for assessing the safety.Results: Efficacy was assessed by comparing mean reduction in the pain intensity between group A and B, group B gives highly significant results as compared to group A. While comparing joint tenderness, swelling around joint, mean functional capacity and improvement in the overall assessment, group B gives significant results as compared to group A. It was also observed that group A and group B were better than group C in all the efficacy parameters. All the drugs were well tolerated and systemically safe.Conclusions: There was significant difference in efficacy of rosehip compared with glaucosamine and chondroitin sulphate in patients of osteoarthritis. In comparison there was no significant difference in safety of two drugs and both were considered safe in patients.


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