Toussaint Rouamba, Houreratou Barry, Esperance Ouédraogo, Marc Christian Tahita, Nobila Valentin Yaméogo, Armel Poda, Arnaud Eric Diendéré, Abdoul-Salam Ouedraogo, Innocent Valea, Amariane M Koné, Cherileila Thiombiano, Isidore Traoré, Zekiba Tarnagda, Serge A Sawadogo, Zakaria Gansané, Yibar Kambiré, Idrissa Sanou, Fatou Barro-Traoré, Maxime K Drabo, Halidou Tinto
{"title":"氯喹或羟氯喹加阿奇霉素治疗布基纳法索COVID-19患者的安全性:一项观察性前瞻性队列研究","authors":"Toussaint Rouamba, Houreratou Barry, Esperance Ouédraogo, Marc Christian Tahita, Nobila Valentin Yaméogo, Armel Poda, Arnaud Eric Diendéré, Abdoul-Salam Ouedraogo, Innocent Valea, Amariane M Koné, Cherileila Thiombiano, Isidore Traoré, Zekiba Tarnagda, Serge A Sawadogo, Zakaria Gansané, Yibar Kambiré, Idrissa Sanou, Fatou Barro-Traoré, Maxime K Drabo, Halidou Tinto","doi":"10.2147/TCRM.S330813","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Though chloroquine derivatives are used in the treatment of coronavirus disease 2019 (COVID-19) in many countries worldwide, doubts remain about the safety and efficacy of these drugs, especially in African communities where published data are scarce.</p><p><strong>Methods: </strong>We conducted an observational prospective cohort study from April 24 to September 03, 2020, in Burkina Faso to assess (as primary outcome) the clinical, biological, and cardiac (electrocardiographic) safety of chloroquine or hydroxychloroquine plus azithromycin administered to COVID-19 patients. The main secondary outcomes were all-cause mortality and median time of viral clearance.</p><p><strong>Results: </strong>A total of 153 patients were enrolled and followed for 21 days. Among patients who took at least one dose of chloroquine or hydroxychloroquine (90.1% [138/153]), few clinical adverse events were reported and were mainly rash/pruritus, diarrhea, chest pain, and palpitations. No statistically significant increase in hepatic, renal, and hematological parameters or electrolyte disorders were reported. However, there was a significant increase in the QTc value without exceeding 500ms, especially in those who received chloroquine phosphate. Three adverse events of special interest classified as serious (known from chloroquine derivatives) were recorded namely pruritus, paresthesia, and drowsiness. One case of death occurred. The average onset of SARS-CoV-2 PCR negativity was estimated at 7.0 (95% CI: 5.0-10.0) days.</p><p><strong>Conclusion: </strong>Hydroxychloroquine appeared to be well tolerated in treated COVID-19 patients in Burkina Faso. In the absence of a robust methodological approach that could generate a high level of scientific evidence, our results could at least contribute to guide health decisions that should be made based on different sources of scientific evidence including those from our study.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a5/32/tcrm-17-1187.PMC8604637.pdf","citationCount":"4","resultStr":"{\"title\":\"Safety of Chloroquine or Hydroxychloroquine Plus Azithromycin for the Treatment of COVID-19 Patients in Burkina Faso: An Observational Prospective Cohort Study.\",\"authors\":\"Toussaint Rouamba, Houreratou Barry, Esperance Ouédraogo, Marc Christian Tahita, Nobila Valentin Yaméogo, Armel Poda, Arnaud Eric Diendéré, Abdoul-Salam Ouedraogo, Innocent Valea, Amariane M Koné, Cherileila Thiombiano, Isidore Traoré, Zekiba Tarnagda, Serge A Sawadogo, Zakaria Gansané, Yibar Kambiré, Idrissa Sanou, Fatou Barro-Traoré, Maxime K Drabo, Halidou Tinto\",\"doi\":\"10.2147/TCRM.S330813\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Though chloroquine derivatives are used in the treatment of coronavirus disease 2019 (COVID-19) in many countries worldwide, doubts remain about the safety and efficacy of these drugs, especially in African communities where published data are scarce.</p><p><strong>Methods: </strong>We conducted an observational prospective cohort study from April 24 to September 03, 2020, in Burkina Faso to assess (as primary outcome) the clinical, biological, and cardiac (electrocardiographic) safety of chloroquine or hydroxychloroquine plus azithromycin administered to COVID-19 patients. The main secondary outcomes were all-cause mortality and median time of viral clearance.</p><p><strong>Results: </strong>A total of 153 patients were enrolled and followed for 21 days. Among patients who took at least one dose of chloroquine or hydroxychloroquine (90.1% [138/153]), few clinical adverse events were reported and were mainly rash/pruritus, diarrhea, chest pain, and palpitations. No statistically significant increase in hepatic, renal, and hematological parameters or electrolyte disorders were reported. However, there was a significant increase in the QTc value without exceeding 500ms, especially in those who received chloroquine phosphate. Three adverse events of special interest classified as serious (known from chloroquine derivatives) were recorded namely pruritus, paresthesia, and drowsiness. One case of death occurred. The average onset of SARS-CoV-2 PCR negativity was estimated at 7.0 (95% CI: 5.0-10.0) days.</p><p><strong>Conclusion: </strong>Hydroxychloroquine appeared to be well tolerated in treated COVID-19 patients in Burkina Faso. 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Safety of Chloroquine or Hydroxychloroquine Plus Azithromycin for the Treatment of COVID-19 Patients in Burkina Faso: An Observational Prospective Cohort Study.
Introduction: Though chloroquine derivatives are used in the treatment of coronavirus disease 2019 (COVID-19) in many countries worldwide, doubts remain about the safety and efficacy of these drugs, especially in African communities where published data are scarce.
Methods: We conducted an observational prospective cohort study from April 24 to September 03, 2020, in Burkina Faso to assess (as primary outcome) the clinical, biological, and cardiac (electrocardiographic) safety of chloroquine or hydroxychloroquine plus azithromycin administered to COVID-19 patients. The main secondary outcomes were all-cause mortality and median time of viral clearance.
Results: A total of 153 patients were enrolled and followed for 21 days. Among patients who took at least one dose of chloroquine or hydroxychloroquine (90.1% [138/153]), few clinical adverse events were reported and were mainly rash/pruritus, diarrhea, chest pain, and palpitations. No statistically significant increase in hepatic, renal, and hematological parameters or electrolyte disorders were reported. However, there was a significant increase in the QTc value without exceeding 500ms, especially in those who received chloroquine phosphate. Three adverse events of special interest classified as serious (known from chloroquine derivatives) were recorded namely pruritus, paresthesia, and drowsiness. One case of death occurred. The average onset of SARS-CoV-2 PCR negativity was estimated at 7.0 (95% CI: 5.0-10.0) days.
Conclusion: Hydroxychloroquine appeared to be well tolerated in treated COVID-19 patients in Burkina Faso. In the absence of a robust methodological approach that could generate a high level of scientific evidence, our results could at least contribute to guide health decisions that should be made based on different sources of scientific evidence including those from our study.
期刊介绍:
Therapeutics and Clinical Risk Management is an international, peer-reviewed journal of clinical therapeutics and risk management, focusing on concise rapid reporting of clinical studies in all therapeutic areas, outcomes, safety, and programs for the effective, safe, and sustained use of medicines, therapeutic and surgical interventions in all clinical areas.
The journal welcomes submissions covering original research, clinical and epidemiological studies, reviews, guidelines, expert opinion and commentary. The journal will consider case reports but only if they make a valuable and original contribution to the literature.
As of 18th March 2019, Therapeutics and Clinical Risk Management will no longer consider meta-analyses for publication.
The journal does not accept study protocols, animal-based or cell line-based studies.