PDF(Pubmed)
Abstract：
BACKGROUND: Hundreds of millions of doses of Praziquantel (PZQ) have been administered to persons with and without schistosomiasis living in schistosomiasis endemic settings, through the mass drug administration (MDA) strategy which started in the early 2000s. A recent publication suggested high risk of PZQ-related visual disorders, raising public health concerns. We aim to systematically synthesize evidence on the magnitude of PZQ-related visual disorders.
METHODS: We will search PubMed, Google Scholar, CINAHL, SCOPUS, CENTRAL and LILACS from 1977 (when the first human clinical trials on PZQ started) to 31st May 2024, with no language restrictions. The key search terms will include \"Praziquantel\", \"PZQ\", \"visual disorder\", \"adverse events\", \"side effects\", \"blurry vision\" and \"visual impairment\" together with alternative terms and synonyms. All the countries endemic for schistosomiasis will be included as search terms. We will also search HINARI, Africa Journals Online, Thesis Databases and Preprint Repositories. Where necessary, we will contact expert researchers working in the field of schistosomiasis, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), pharmaceutical industries, country-specific Food and Drug Authorities (FDAs) and the European Medicines Agency databases. We will search Conference Proceedings and reference lists of relevant studies for additional studies. At least two authors will independently select studies, extract data and assess risk of bias in the included studies. Any disagreements or discrepancies will be resolved through discussion between the reviewers. Heterogeneity will be explored graphically, and statistically using the I2-statistic. We will conduct random-effects meta-analysis when heterogeneity is appreciable, and express dichotomous outcomes (visual adverse events including excessive lacrimation, blurry vision and visual impairments) as risk ratio (RR) or Odds Ratio (OR) with their 95% confidence interval (CI). We will perform subgroup analysis to assess the impact of heterogeneity, and sensitivity analyses to test the robustness of the effect estimates. The overall level of evidence will be assessed using GRADE.
OBJECTIVE: The present review expects to identify and categorize visual disorders occurring after administration of PZQ, alone or in combination with other drugs. By synthesizing the data from multiple studies, the review aims to present a quantitative assessment of the risk or odds of experiencing a visual disorder in different populations after ingesting PZQ. The review will also generate insights into whether PZQ in combination with other drugs are associated with increased odds of visual disorders and whether the occurrence of visual disorders correlates with dosage or treatment duration. Policymakers, public health experts and stakeholders could rely on the review findings to deliver context-sensitive preventive chemotherapy programs by adjusting drug combinations or dosing schedules to reduce risk of visual adverse effects in populations treated with PZQ. The review aims to identify gaps in the current evidence regarding visual disorders following PZQ administration in schistosomiasis endemic settings which can serve as the basis for future research on important but unanswered questions.
UNASSIGNED: The findings of this study will be disseminated through stakeholder forums, conferences, and peer-review publications. The review protocol has been registered in the International Prospective Register for Systematic Reviews (PROSPERO)- CRD42023417963.
METHODS: We will search PubMed, Google Scholar, CINAHL, SCOPUS, CENTRAL and LILACS from 1977 (when the first human clinical trials on PZQ started) to 31st May 2024, with no language restrictions. The key search terms will include \"Praziquantel\", \"PZQ\", \"visual disorder\", \"adverse events\", \"side effects\", \"blurry vision\" and \"visual impairment\" together with alternative terms and synonyms. All the countries endemic for schistosomiasis will be included as search terms. We will also search HINARI, Africa Journals Online, Thesis Databases and Preprint Repositories. Where necessary, we will contact expert researchers working in the field of schistosomiasis, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), pharmaceutical industries, country-specific Food and Drug Authorities (FDAs) and the European Medicines Agency databases. We will search Conference Proceedings and reference lists of relevant studies for additional studies. At least two authors will independently select studies, extract data and assess risk of bias in the included studies. Any disagreements or discrepancies will be resolved through discussion between the reviewers. Heterogeneity will be explored graphically, and statistically using the I2-statistic. We will conduct random-effects meta-analysis when heterogeneity is appreciable, and express dichotomous outcomes (visual adverse events including excessive lacrimation, blurry vision and visual impairments) as risk ratio (RR) or Odds Ratio (OR) with their 95% confidence interval (CI). We will perform subgroup analysis to assess the impact of heterogeneity, and sensitivity analyses to test the robustness of the effect estimates. The overall level of evidence will be assessed using GRADE.
OBJECTIVE: The present review expects to identify and categorize visual disorders occurring after administration of PZQ, alone or in combination with other drugs. By synthesizing the data from multiple studies, the review aims to present a quantitative assessment of the risk or odds of experiencing a visual disorder in different populations after ingesting PZQ. The review will also generate insights into whether PZQ in combination with other drugs are associated with increased odds of visual disorders and whether the occurrence of visual disorders correlates with dosage or treatment duration. Policymakers, public health experts and stakeholders could rely on the review findings to deliver context-sensitive preventive chemotherapy programs by adjusting drug combinations or dosing schedules to reduce risk of visual adverse effects in populations treated with PZQ. The review aims to identify gaps in the current evidence regarding visual disorders following PZQ administration in schistosomiasis endemic settings which can serve as the basis for future research on important but unanswered questions.
UNASSIGNED: The findings of this study will be disseminated through stakeholder forums, conferences, and peer-review publications. The review protocol has been registered in the International Prospective Register for Systematic Reviews (PROSPERO)- CRD42023417963.
摘要：
背景：已经向生活在血吸虫病流行环境中的有和没有血吸虫病的人施用了数以亿计剂量的吡喹酮（PZQ），通过2000年代初开始的大规模药物管理(MDA)策略。最近的一份出版物表明，PZQ相关视觉障碍的风险很高，引发公众健康担忧。我们旨在系统地综合有关PZQ相关视觉障碍程度的证据。
方法：我们将搜索PubMed，谷歌学者，CINAHL,Scopus,CENTRAL和LILACS从1977年（在PZQ的第一个人体临床试验开始时）到2024年5月31日，没有语言限制。关键搜索词将包括\"Praziquantel\",\"PZQ\",“视觉障碍”，“不良事件”，“副作用”，“视力模糊”和“视力障碍”以及替代术语和同义词。所有血吸虫病流行国家都将作为搜索词包括在内。我们还将搜索HINARI,非洲在线期刊，论文数据库和预打印存储库。如有必要,我们将联系血吸虫病领域的专家研究人员，儿童基金会/开发计划署/世界银行/卫生组织热带病研究和训练特别方案，制药工业,特定国家的食品和药品管理局(FDAs)和欧洲药品管理局数据库。我们将搜索会议记录和相关研究的参考列表，以获得更多研究。至少有两位作者将独立选择研究，提取数据并评估纳入研究的偏倚风险。任何分歧或差异将通过审稿人之间的讨论解决。异质性将以图形方式进行探索，并使用I2统计量进行统计。当异质性明显时，我们将进行随机效应荟萃分析，并表示二分结果(视觉不良事件，包括过度流泪，视力模糊和视力障碍)作为风险比(RR)或赔率比(OR)及其95%置信区间(CI)。我们将进行亚组分析来评估异质性的影响，和敏感性分析，以检验效果估计的稳健性。证据的总体水平将使用等级进行评估。
目的：本综述期望对PZQ给药后发生的视觉障碍进行鉴定和分类，单独或与其他药物联合使用。通过综合多项研究的数据，本综述旨在对不同人群摄入PZQ后出现视觉障碍的风险或几率进行定量评估.该综述还将深入了解PZQ与其他药物联合使用是否与视觉障碍的几率增加有关，以及视觉障碍的发生是否与剂量或治疗持续时间相关。政策制定者，公共卫生专家和利益相关方可以依靠审查结果,通过调整药物组合或给药方案来实施情境敏感的预防性化疗方案,以降低接受PZQ治疗的人群的视觉不良反应风险.该综述旨在确定在血吸虫病流行环境中使用PZQ后有关视觉障碍的当前证据中的空白，这可以作为未来研究重要但未解决的问题的基础。
■这项研究的结果将通过利益相关者论坛传播，会议,和同行评审出版物。审查方案已在国际前瞻性系统审查登记册（PROSPERO）-CRD42023417963中注册。
方法：我们将搜索PubMed，谷歌学者，CINAHL,Scopus,CENTRAL和LILACS从1977年（在PZQ的第一个人体临床试验开始时）到2024年5月31日，没有语言限制。关键搜索词将包括\"Praziquantel\",\"PZQ\",“视觉障碍”，“不良事件”，“副作用”，“视力模糊”和“视力障碍”以及替代术语和同义词。所有血吸虫病流行国家都将作为搜索词包括在内。我们还将搜索HINARI,非洲在线期刊，论文数据库和预打印存储库。如有必要,我们将联系血吸虫病领域的专家研究人员，儿童基金会/开发计划署/世界银行/卫生组织热带病研究和训练特别方案，制药工业,特定国家的食品和药品管理局(FDAs)和欧洲药品管理局数据库。我们将搜索会议记录和相关研究的参考列表，以获得更多研究。至少有两位作者将独立选择研究，提取数据并评估纳入研究的偏倚风险。任何分歧或差异将通过审稿人之间的讨论解决。异质性将以图形方式进行探索，并使用I2统计量进行统计。当异质性明显时，我们将进行随机效应荟萃分析，并表示二分结果(视觉不良事件，包括过度流泪，视力模糊和视力障碍)作为风险比(RR)或赔率比(OR)及其95%置信区间(CI)。我们将进行亚组分析来评估异质性的影响，和敏感性分析，以检验效果估计的稳健性。证据的总体水平将使用等级进行评估。
目的：本综述期望对PZQ给药后发生的视觉障碍进行鉴定和分类，单独或与其他药物联合使用。通过综合多项研究的数据，本综述旨在对不同人群摄入PZQ后出现视觉障碍的风险或几率进行定量评估.该综述还将深入了解PZQ与其他药物联合使用是否与视觉障碍的几率增加有关，以及视觉障碍的发生是否与剂量或治疗持续时间相关。政策制定者，公共卫生专家和利益相关方可以依靠审查结果,通过调整药物组合或给药方案来实施情境敏感的预防性化疗方案,以降低接受PZQ治疗的人群的视觉不良反应风险.该综述旨在确定在血吸虫病流行环境中使用PZQ后有关视觉障碍的当前证据中的空白，这可以作为未来研究重要但未解决的问题的基础。
■这项研究的结果将通过利益相关者论坛传播，会议,和同行评审出版物。审查方案已在国际前瞻性系统审查登记册（PROSPERO）-CRD42023417963中注册。
