Jiangsu Institute of Parasitic Diseases, Wuxi, Jiangsu, China.
Key Laboratory on Technology for Parasitic Disease Prevention and Control, Ministry of Health; Jiangsu Provincial Key Laboratory on the Molecular Biology of Parasites, Wuxi, Jiangsu, China.
PLoS Negl Trop Dis. 2019 Apr 10;13(4):e0007238. doi: 10.1371/journal.pntd.0007238. eCollection 2019 Apr.
In the roadmap on the neglected tropical diseases (NTD) the World Health Organization (WHO) aims at attaining at least 75% coverage of preventive chemotherapy in pre-school and school-age children by 2020. A randomized controlled trial was used to compare the effectiveness of praziquantel in treating Schistosoma haematobium in Africa using two different sources for the drug, Merck Limited Partnership (KgaA), Germany and Nanjing Pharmaceutical Factory (NPF), China.
More than 6,000 participants testing positive for S. haematobium infection were enrolled from three villages (shehias) situated in the northern, middle and southern part of Pemba Island, Zanzibar. Applying criteria of inclusion and exclusion, resulted in a study population of 152 people (84 males, 68 females). A randomized controlled trial was conducted assigning participants to either praziquantel from NPF or Merck KGaA. After one month, the cure rate of S. haematobium and adverse events were compared to evaluate effectiveness. The ratio of male to female, the ratio of light/high infection intensity, and the average value of age were calculated between the two drug manufacturers. Chi-squared test and T-test were used for consistency analysis.
Out of the total of 73 cases receiving praziquantel from NPF, the cure rate achieved was 97.3% (73/75), while the 74 cases receiving the drug from Merck KgaA reached a similar cure rate (96.1% or 74/77). There was no significant difference between the two outcomes (χ2 = 0.003, P = 0.956). Among the 75 patients treat, only one (a 16-years old female student), who had received the drug made in China had slight adverse reactions manifested as dizziness, headache and abdominal pain.
The efficacy of China-made praziquantel does not differ significantly from praziquantel made by Merck KGaA in Germany.
ClinicalTrials.gov, NCT03133832.
世界卫生组织（WHO）在被忽视的热带病（NTD）路线图中，旨在到 2020 年，使学前和学龄儿童预防性化疗的覆盖率至少达到 75%。本研究采用随机对照试验比较了德国默克有限责任合伙公司（Merck Limited Partnership，KgaA）和中国南京制药厂（Nanjing Pharmaceutical Factory，NPF）生产的吡喹酮治疗非洲曼氏血吸虫病的疗效。
在桑给巴尔奔巴岛北部、中部和南部的三个村庄（shehias），招募了 6000 多名曼氏血吸虫病感染阳性者。根据纳入和排除标准，研究人群为 152 人（男性 84 人，女性 68 人）。采用随机对照试验，将参与者分配到 NPF 或 Merck KGaA 生产的吡喹酮。一个月后，比较两种药物的血吸虫治愈率和不良反应，以评估疗效。计算两种药物制造商的男女比例、轻/重度感染强度比和年龄平均值。采用卡方检验和 T 检验进行一致性分析。
在接受 NPF 吡喹酮治疗的 73 例患者中，治愈率为 97.3%（73/75），而接受 Merck KGaA 吡喹酮治疗的 74 例患者治愈率相似（96.1%或 74/77）。两种结果之间无显著差异（χ2 = 0.003，P = 0.956）。在接受治疗的 75 名患者中，仅有一名（一名 16 岁的女学生）接受中国生产的药物后出现轻微不良反应，表现为头晕、头痛和腹痛。
中国生产的吡喹酮的疗效与德国默克 KGaA 生产的吡喹酮无显著差异。
ClinicalTrials.gov，NCT03133832。
