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{"title"=>"A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction, in Ethiopia", "type"=>"journal", "authors"=>[{"first_name"=>"Saba M.", "last_name"=>"Lambert", "scopus_author_id"=>"36640013400"}, {"first_name"=>"Digafe T.", "last_name"=>"Alembo", "scopus_author_id"=>"57144618900"}, {"first_name"=>"Shimelis D.", "last_name"=>"Nigusse", "scopus_author_id"=>"57144509100"}, {"first_name"=>"Lawrence K.", "last_name"=>"Yamuah", "scopus_author_id"=>"18435544500"}, {"first_name"=>"Stephen L.", "last_name"=>"Walker", "scopus_author_id"=>"7403746154"}, {"first_name"=>"Diana N.J.", "last_name"=>"Lockwood", "scopus_author_id"=>"55543771700"}], "year"=>2016, "source"=>"PLoS Neglected Tropical Diseases", "identifiers"=>{"issn"=>"19352735", "scopus"=>"2-s2.0-84964907117", "pui"=>"610178170", "doi"=>"10.1371/journal.pntd.0004502", "isbn"=>"10.1371/journal.pntd.0004502", "sgr"=>"84964907117", "pmid"=>"27046330"}, "id"=>"b26c8385-60ef-333c-88ac-55003417877f", "abstract"=>"BACKGROUND: Leprosy Type 1 (T1R) reactions are immune-mediated events leading to nerve damage and preventable disability affecting hands, feet and eyes. Type 1 Reactions are treated with oral corticosteroids. There is little evidence on alternative treatments for patients who do not respond to steroids or experience steroid adverse effects. We report the results of a randomized controlled trial testing the efficacy and adverse effect profile of ciclosporin and prednisolone (CnP) in comparison to prednisolone only (P) in patients with new T1R in Ethiopia. Ciclosporin is a potent immunosuppressant. Outcomes were measured using a clinical severity score, recurrence rate, adverse events and quality of life.\\n\\nRESULTS: Seventy three patients with new T1R were randomized to receive CnP or P for 20 weeks. Recovery rates in skin signs was similar in both groups (91% vs 88%). Improvements in nerve function both, new and old, sensory (66% vs 49%) and motor (75% vs 74%) loss were higher (but not significantly so) in the patients on CnP. Recurrences rates of T1R (85%) were high in both groups, and recurrences occurred significantly earlier (8 weeks) in patients CnP, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were similar in patients in the two treatment arms of the study. Both groups had a significant improvement in their quality of life after the study, measured by the SF-36.\\n\\nCONCLUSIONS: This is the first double-blind RCT assessing ciclosporin, in the management of T1R in Africa. Ciclosporin could be a safe alternative second-line drug for patients with T1R who are not improving with prednisolone or are experiencing adverse events related to prednisolone. This study illustrates the difficulty in switching off leprosy inflammation. Better treatment agents for leprosy patients with reactions and nerve damage are needed.", "link"=>"http://www.mendeley.com/research/randomized-controlled-double-blind-trial-ciclosporin-versus-prednisolone-management-leprosy-patients", "reader_count"=>23, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>2, "Researcher"=>3, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>1, "Other"=>3, "Student > Master"=>3, "Student > Bachelor"=>3, "Lecturer"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>2, "Researcher"=>3, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>1, "Other"=>3, "Student > Master"=>3, "Student > Bachelor"=>3, "Lecturer"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>5, "Engineering"=>1, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>13, "Social Sciences"=>2, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>13}, "Social Sciences"=>{"Social Sciences"=>2}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Unspecified"=>{"Unspecified"=>5}}, "reader_count_by_country"=>{"Brazil"=>1}, "group_count"=>1}

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• http://doi.org/10.1371/journal.pntd.0006011
• http://doi.org/10.1016/j.jaad.2018.07.070
• http://doi.org/10.1371/journal.pntd.0005716
• http://doi.org/10.1111/ijd.14489
• http://doi.org/10.1371/journal.pntd.0005952

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• {"id"=>"718012404878090240", "text"=>"#PLOSNTDs: Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of ...... https://t.co/CYecrAPA3f", "created_at"=>"2016-04-07T09:47:52Z", "user"=>"Infolep", "user_name"=>"Jiske @ Infolep", "user_profile_image"=>"http://pbs.twimg.com/profile_images/512866079345885184/6cySbETv_normal.png"}
• {"id"=>"718057243074248704", "text"=>"#PLOSNTDs: A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Manag... https://t.co/Bhi8uVJ5WM #Leprosy", "created_at"=>"2016-04-07T12:46:02Z", "user"=>"doctorhugos", "user_name"=>"Hugo S?nchez MD MSc", "user_profile_image"=>"http://pbs.twimg.com/profile_images/713362418311774208/3Rh1_6tr_normal.jpg"}
• {"id"=>"718067804537139200", "text"=>"RT @doctorhugos: #PLOSNTDs: A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Manag... https://t.co/Bhi8…", "created_at"=>"2016-04-07T13:28:00Z", "user"=>"sanj971", "user_name"=>"Sanjaya Senanayake", "user_profile_image"=>"http://pbs.twimg.com/profile_images/552056555491700736/tsJBp0Fy_normal.png"}
• {"id"=>"718120933370757120", "text"=>"RT @doctorhugos: #PLOSNTDs: A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Manag... https://t.co/Bhi8…", "created_at"=>"2016-04-07T16:59:07Z", "user"=>"ISNTD_Press", "user_name"=>"ISNTD", "user_profile_image"=>"http://pbs.twimg.com/profile_images/2239025183/OneHealthNTD_Logo_normal.jpg"}
• {"id"=>"718341832296513538", "text"=>"RT @doctorhugos: #PLOSNTDs: A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Manag... https://t.co/Bhi8…", "created_at"=>"2016-04-08T07:36:53Z", "user"=>"Infolep", "user_name"=>"Jiske @ Infolep", "user_profile_image"=>"http://pbs.twimg.com/profile_images/512866079345885184/6cySbETv_normal.png"}

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Figshare

• {"files"=>["https://ndownloader.figshare.com/files/4920061"], "description"=>"<p>Number of T1R recurrence episodes by Clinical Severity Score.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158656, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.g009", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Number_of_T1R_recurrence_episodes_by_Clinical_Severity_Score_/3158656", "title"=>"Number of T1R recurrence episodes by Clinical Severity Score.", "pos_in_sequence"=>10, "defined_type"=>1, "published_date"=>"2016-04-05 08:38:02"}
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• {"files"=>["https://ndownloader.figshare.com/files/4920199"], "description"=>"<p>(Group mean, range and median in mg.)</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158737, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t006", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Additional_and_total_prednisolone_received_in_patients_/3158737", "title"=>"Additional and total prednisolone received in patients.", "pos_in_sequence"=>18, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920016"], "description"=>"<p>Sensory function change in nerves with new loss of sensation.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158611, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.g005", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Sensory_function_change_in_nerves_with_new_loss_of_sensation_/3158611", "title"=>"Sensory function change in nerves with new loss of sensation.", "pos_in_sequence"=>6, "defined_type"=>1, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920100"], "description"=>"<p>PF-physical functioning, RP-role physical, BP-bodily pain, GH-general health perceptions, VT-vitality, SF-social functioning, RE-role emotional, MH-mental health, PCS-physical component summary, MCS-mental component summary.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158680, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.g011", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Change_in_SF_36_scores_between_start_and_end_of_T1R_study_/3158680", "title"=>"Change in SF-36 scores between start and end of T1R study.", "pos_in_sequence"=>12, "defined_type"=>1, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4919962"], "description"=>"<p>Score A (skin), Score B (sensation) and Score C (motor). (0 marks the area in Score A where the difference between the treatment arms is significant).</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158554, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.g002", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Group_mean_and_standard_error_in_Clinical_Severity_Scores_with_time_by_treatment_arm_/3158554", "title"=>"Group mean and standard error in Clinical Severity Scores with time by treatment arm.", "pos_in_sequence"=>3, "defined_type"=>1, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920205"], "description"=>"<p>Reasons for additional prednisolone.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158746, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t007", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Reasons_for_additional_prednisolone_/3158746", "title"=>"Reasons for additional prednisolone.", "pos_in_sequence"=>19, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920028"], "description"=>"<p>Survival curve for patients without a T1R recurrence.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158623, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.g006", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Survival_curve_for_patients_without_a_T1R_recurrence_/3158623", "title"=>"Survival curve for patients without a T1R recurrence.", "pos_in_sequence"=>7, "defined_type"=>1, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920211"], "description"=>"<p>Number of patients experiencing minor and major adverse events per study arm (related to ciclosporin and/ or prednisolone).</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158752, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t008", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Number_of_patients_experiencing_minor_and_major_adverse_events_per_study_arm_related_to_ciclosporin_and_or_prednisolone_/3158752", "title"=>"Number of patients experiencing minor and major adverse events per study arm (related to ciclosporin and/ or prednisolone).", "pos_in_sequence"=>20, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920124"], "description"=>"<p>Treatment regimen for T1R trial.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158692, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t001", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Treatment_regimen_for_T1R_trial_/3158692", "title"=>"Treatment regimen for T1R trial.", "pos_in_sequence"=>13, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920217"], "description"=>"<p>Number of adverse events attributable to ciclosporin and/or prednisolone.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158758, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t009", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Number_of_adverse_events_attributable_to_ciclosporin_and_or_prednisolone_/3158758", "title"=>"Number of adverse events attributable to ciclosporin and/or prednisolone.", "pos_in_sequence"=>21, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920037"], "description"=>"<p>Time of first recurrence of T1R after initial control.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158632, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.g007", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Time_of_first_recurrence_of_T1R_after_initial_control_/3158632", "title"=>"Time of first recurrence of T1R after initial control.", "pos_in_sequence"=>8, "defined_type"=>1, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920148"], "description"=>"<p>Description of study participants in each arm.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158701, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t002", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Description_of_study_participants_in_each_arm_/3158701", "title"=>"Description of study participants in each arm.", "pos_in_sequence"=>14, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920229"], "description"=>"<p>Number of adverse events classified by severity.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158767, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t010", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Number_of_adverse_events_classified_by_severity_/3158767", "title"=>"Number of adverse events classified by severity.", "pos_in_sequence"=>22, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4919911"], "description"=>"<div><p>Background</p><p>Leprosy Type 1 (T1R) reactions are immune-mediated events leading to nerve damage and preventable disability affecting hands, feet and eyes. Type 1 Reactions are treated with oral corticosteroids. There is little evidence on alternative treatments for patients who do not respond to steroids or experience steroid adverse effects. We report the results of a randomized controlled trial testing the efficacy and adverse effect profile of ciclosporin and prednisolone (CnP) in comparison to prednisolone only (P) in patients with new T1R in Ethiopia. Ciclosporin is a potent immunosuppressant. Outcomes were measured using a clinical severity score, recurrence rate, adverse events and quality of life.</p><p>Results</p><p>Seventy three patients with new T1R were randomized to receive CnP or P for 20 weeks. Recovery rates in skin signs was similar in both groups (91% vs 88%). Improvements in nerve function both, new and old, sensory (66% vs 49%) and motor (75% vs 74%) loss were higher (but not significantly so) in the patients on CnP. Recurrences rates of T1R (85%) were high in both groups, and recurrences occurred significantly earlier (8 weeks) in patients CnP, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were similar in patients in the two treatment arms of the study. Both groups had a significant improvement in their quality of life after the study, measured by the SF-36.</p><p>Conclusions</p><p>This is the first double-blind RCT assessing ciclosporin, in the management of T1R in Africa. Ciclosporin could be a safe alternative second-line drug for patients with T1R who are not improving with prednisolone or are experiencing adverse events related to prednisolone. This study illustrates the difficulty in switching off leprosy inflammation. Better treatment agents for leprosy patients with reactions and nerve damage are needed.</p></div>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158512, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502", "stats"=>{"downloads"=>2, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/A_Randomized_Controlled_Double_Blind_Trial_of_Ciclosporin_versus_Prednisolone_in_the_Management_of_Leprosy_Patients_with_New_Type_1_Reaction_in_Ethiopia/3158512", "title"=>"A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction, in Ethiopia", "pos_in_sequence"=>1, "defined_type"=>6, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920235"], "description"=>"<p>Patients in the T1R studies who experienced ENL.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158770, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t011", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Patients_in_the_T1R_studies_who_experienced_ENL_/3158770", "title"=>"Patients in the T1R studies who experienced ENL.", "pos_in_sequence"=>23, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920166"], "description"=>"<p>Reaction type and nerve involvement in study participants.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158707, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t003", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Reaction_type_and_nerve_involvement_in_study_participants_/3158707", "title"=>"Reaction type and nerve involvement in study participants.", "pos_in_sequence"=>15, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920049"], "description"=>"<p>Number of T1R recurrence episodes per treatment arm.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158644, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.g008", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Number_of_T1R_recurrence_episodes_per_treatment_arm_/3158644", "title"=>"Number of T1R recurrence episodes per treatment arm.", "pos_in_sequence"=>9, "defined_type"=>1, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4919989"], "description"=>"<p>Median and inter-quartile ranges in Clinical Severity Scores.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158581, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.g003", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Median_and_inter_quartile_ranges_in_Clinical_Severity_Scores_/3158581", "title"=>"Median and inter-quartile ranges in Clinical Severity Scores.", "pos_in_sequence"=>4, "defined_type"=>1, "published_date"=>"2016-04-05 08:38:02"}
• {"files"=>["https://ndownloader.figshare.com/files/4920241"], "description"=>"<p>Serious adverse events.</p>", "links"=>[], "tags"=>["prednisolone", "T 1R reactions", "Better treatment agents", "Ethiopia Background Leprosy Type 1", "Type 1 Reactions", "Ciclosporin", "Randomized Controlled Double", "T 1R", "SF", "RCT", "vs", "nerve damage", "CnP", "New Type 1 Reaction"], "article_id"=>3158776, "categories"=>["Medicine", "Genetics", "Pharmacology", "Biotechnology", "Immunology", "Developmental Biology", "Marine Biology", "Cancer", "Science Policy", "Mental Health", "Infectious Diseases"], "users"=>["Saba M. Lambert", "Digafe T. Alembo", "Shimelis D. Nigusse", "Lawrence K. Yamuah", "Stephen L. Walker", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004502.t012", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Serious_adverse_events_/3158776", "title"=>"Serious adverse events.", "pos_in_sequence"=>24, "defined_type"=>3, "published_date"=>"2016-04-05 08:38:02"}
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PMC Usage Stats | Further Information

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Relative Metric

{"start_date"=>"2016-01-01T00:00:00Z", "end_date"=>"2016-12-31T00:00:00Z", "subject_areas"=>[]}

F1000Prime