Opio Christopher Kenneth, Kazibwe Francis, Kabatereine Narcis B, Rejani Lalitha, Ocama Ponsiano
Makerere University College of Health Sciences, P. O. Box 7072, Kampala, Uganda.
Public Health Department, Bishop Stuart University, P. O. Box 9, Mbarara, Uganda.
Drugs Real World Outcomes. 2021 Jun;8(2):153-162. doi: 10.1007/s40801-020-00222-7. Epub 2020 Dec 26.
There is a general consensus that widespread use of praziquantel in populations where schistosomiasis is endemic prevents development of hepatic schistosomiasis and its complications. However, a few studies have reported discordant findings linking praziquantel to the occurrence of upper gastrointestinal bleeding (UGIB) in some patients with hepatic schistosomiasis and varices.
We explored if there was any causal association between recent praziquantel use (rPZQ) and upper gastrointestinal bleeding in hepatic schistosomiasis in rural Africa.
A quasi-experimental, retrospective case-controlled study was performed. It involved adult patients with past or acute UGIB, varices, periportal fibrosis, and/or cirrhosis. Cases had acute variceal bleeding while controls did not. The outcome was the frequency of lifetime episodes of UGIB and exposure was rPZQ (received praziquantel in the last 11 months from the date of enrollment). The data analysis included 2 × 2 tables, logistic regression, and propensity-score matching. Odds ratios (ORs), average treatment effects (ATEs), and their 95% confidence intervals (CIs) were used for inference.
Over 6 weeks, we enrolled 19 cases with 92 lifetime episodes of UGIB, and 66 controls with 192 lifetime episodes of UGIB. Cases were more likely to experience UGIB than controls following rPZQ (92% vs. 62%; OR 7.6; 95% CI 3.4-17). Factors predictive of more lifetime episodes of UGIB at multivariable analysis included rPZQ (adjusted OR 13; 95% CI 2.9-53), relative leukocytosis (adjusted OR 26; 95% CI 7.6-89), large varices (adjusted OR 5.0; 95% CI 1.7-15), a family member with hepatosplenic schistosomiasis (adjusted OR 19; 95% CI 7.4-51), advanced periportal fibrosis (adjusted OR 8.0; 95% CI 2.6-22), ascites (adjusted OR 14; 95% CI 4.3-47), and jaundice (adjusted OR 32; 95% CI 7.8-128). While the ATE following rPZQ among the treated was 0.40 (95% CI 0.33-0.48).
Our findings suggest the presence of a plausible causal association between recent praziquantel use and increased frequency of UGIB in our study population.
人们普遍认为，在血吸虫病流行地区广泛使用吡喹酮可预防肝血吸虫病及其并发症的发生。然而，一些研究报告了不一致的结果，将吡喹酮与一些肝血吸虫病和静脉曲张患者上消化道出血（UGIB）的发生联系起来。
我们探讨了近期使用吡喹酮（rPZQ）与非洲农村地区肝血吸虫病患者上消化道出血之间是否存在因果关系。
进行了一项准实验性回顾性病例对照研究。研究对象为患有既往或急性UGIB、静脉曲张、门静脉周围纤维化和/或肝硬化的成年患者。病例组发生急性静脉曲张出血，而对照组未发生。观察指标是UGIB终生发作的频率，暴露因素是rPZQ（从入组日期起的最后11个月内接受过吡喹酮治疗）。数据分析包括2×2列联表、逻辑回归和倾向得分匹配。采用比值比（OR）、平均治疗效果（ATE）及其95%置信区间（CI）进行推断。
在6周内，我们纳入了19例患者，其UGIB终生发作92次，以及66例对照，其UGIB终生发作192次。在接受rPZQ治疗后，病例组比对照组更易发生UGIB（92%对62%；OR 7.6；95%CI 3.4-17）。多变量分析中预测UGIB终生发作次数更多的因素包括rPZQ（调整后OR 13；95%CI 2.9-53）、相对白细胞增多（调整后OR 26；95%CI 7.6-89）、大静脉曲张（调整后OR 5.0；95%CI 1.7-15）、有肝脾血吸虫病家族史（调整后OR 19；9
