Department of Microbiology and Parasitology, University of Buea, P.O. Box 63, Buea, Cameroon.
Research Foundation in Tropical Diseases and Environment, P.O. Box 474, Buea, Cameroon.
Trans R Soc Trop Med Hyg. 2020 Dec 16;114(12):954-961. doi: 10.1093/trstmh/traa146.
Prior to carrying out clinical trials, it is important to assess the health status of the study participants to be able to interpret subsequent changes that may be related to the effects of the treatments during the follow-up of patients. This study presents the clinical, haematological and biochemical profiles of podoconiosis patients prior to their involvement in the PodoLEDoxy clinical trial.
All lower limb lymphoedema patients visiting the centre were screened and a podoconiosis diagnosis was based on clinical manifestation and detailed medical history. Patients who satisfied the eligibility criteria were enrolled in the study and their demographic data, vital signs and medical history were collected followed by biochemical and haematological examinations.
Of the 222 participants enrolled in the study, 55.4% and 41.4% had either stage 3 or 2 podoconiosis as their highest stages, respectively. On physical examination, gastritis (46%) and poor vision (2.7%) were the most prevalent health issues identified. The majority of haematological and biochemical values were within the normal range except for mean platelet volume (47.7%), plateletcrit (58.1%), platelet distribution width (66.2%), mean corpuscular volume (67.6%) and red cell distribution width-standard deviation (79.3%), where >40% of the study participants had values out of the normal.
The clinical, haematological and biochemical profiles of the study participants were largely within the normal range except for certain haematological parameters that might be worth investigating.
在开展临床试验之前,评估研究参与者的健康状况非常重要,以便能够解释患者随访过程中可能与治疗效果相关的后续变化。本研究介绍了 PodoLEDoxy 临床试验前 podoconiosis 患者的临床、血液学和生化特征。
所有下肢淋巴水肿患者均接受筛查,根据临床表现和详细病史诊断 podoconiosis。符合入选标准的患者被纳入研究,并收集其人口统计学数据、生命体征和病史,随后进行生化和血液学检查。
在纳入研究的 222 名参与者中,分别有 55.4%和 41.4%的患者最高分期为 3 期或 2 期 podoconiosis。体格检查发现,最常见的健康问题是胃炎(46%)和视力不佳(2.7%)。除了平均血小板体积(47.7%)、血小板比容(58.1%)、血小板分布宽度(66.2%)、平均红细胞体积(67.6%)和红细胞分布宽度标准差(79.3%)外,大多数血液学和生化值均在正常范围内,研究参与者中有>40%的这些参数值不在正常范围内。
除了某些可能值得研究的血液学参数外,研究参与者的临床、血液学和生化特征在很大程度上处于正常范围内。