Xu Jing, Guo Jia-gang, Wu Xiao-hua, Zeng Xiao-jun, Yang Wei-ping, Yang Guang-bin, Zheng Jiang, Zhou Xiao-nong
National Institute of Parasitic Disease, Chinese Center for Disease Control and Prevention, Shanghai 200025, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2009 Aug;43(8):718-22.
To understand the adverse and curative effects of film coated praziquantel for treatment of schistosomiasis japonica.
A questionnaire survey was conducted among 6 to 65 years old inhabitants from epidemic areas of schistosomiasis japonica in Jiangxi, Anhui and Hubei provinces, while indirect haemagglutination assay (IHA) was also administrated. The Serological positives were tested by Kato-Katz technique. A total of 509 habitats of serological positives and healthy persons were given praziquantel. 460 targets with no relative symptoms were followed up for adverse effect of drugs in one month and efficacy evaluation of praziquantel was carried out in 104 parasitological positives 3 months post-treatment.
The 84.7% (144/170) individuals thought film coated tablets were no smell or only with little smell while 92.9%(315/339) targets in control group fell that tablets smelled bad. The total side effect rates of film coated praziquantel group and control group in 1-2 hours post-treatment were 20.30% (27/133) and 83.18% (272/327) respectively. There was significantly different between two groups (chi(2) = 164.316, P < 0.05). The adverse effect rates of film coated praziquantel group in neuromuscular system, digestive system and cardiovascular system were 15.79% (21/133), 9.77% (13/133), 2.26% (3/133) individually which were significantly lower than those of control groups with 81.65% (267/327), 49.24% (161/327), 12.84% (42/327) in corresponding systems (chi(2)(neuromuscular system) = 175.188, chi(2)(digestive system) = 62.601, chi(2)(cardiovascular system) = 12.010, P < 0.05). And the adverse effect rate of allergic reaction of film coated group was no significant difference with control group (2.26%(3/133) versus 0.92% (3/327), chi(2) = 1.315, P = 0.235). One day after treatment, the adverse effect rate of film coated tablets of praziquantel decreased to 3.01% (4/133), significantly lower than that of control group (P < 0.05). There was no significant difference after 2 weeks treatment while the adverse effect rates decreased to 0.75%(1/133), 0.61% (2/327) in film coated praziquantel group and control group respectively (chi(2) = 0.029, P = 0.642). The curative rates 3 months post treatment were 84.91% (45/51) in film coated tablets of praziquantel group and 82.35% (42/53) in control group without significant difference (chi(2) = 1.536, P = 0.215).
The smell and adverse effects of film coated tablets of praziquantel were decreased significantly and its efficacy for treatment of schistosomiasis japonica was equal to the control tablets. The film coated tablets of praziquantel might be applied in field widely after a further verification.
了解吡喹酮薄膜包衣片治疗日本血吸虫病的不良反应及疗效。
对江西、安徽和湖北三省日本血吸虫病流行区6至65岁居民进行问卷调查，同时进行间接血凝试验（IHA）。血清学阳性者采用加藤厚涂片法检测。共对509例血清学阳性者和健康者的栖息地给予吡喹酮。对460例无相关症状的对象随访1个月观察药物不良反应，并对104例寄生虫学阳性者在治疗后3个月进行吡喹酮疗效评价。
84.7%（144/170）的人认为薄膜包衣片无气味或气味很小，而对照组92.9%（315/339）的对象认为片剂气味难闻。吡喹酮薄膜包衣片组和对照组治疗后1至2小时的总副作用发生率分别为20.30%（27/133）和83.18%（272/327）。两组间差异有统计学意义（χ² = 164.316，P < 0.05）。吡喹酮薄膜包衣片组在神经肌肉系统、消化系统和心血管系统的不良反应发生率分别为15.79%（21/133）、9.77%（13/133）、2.26%（3/133），均显著低于对照组相应系统的81.65%（267/327）（χ²(神经肌肉系统) = 175.188）、49.24%（161/327）（χ²(消化系统) = 62.601）、12.84%（42/327）（χ²(心血管系统) = 12.010），P < 0.。吡喹酮薄膜包衣片组过敏反应的不良反应发生率与对照组无显著差异（2.26%（3/133）对0.92%（3/327），χ² = 1.315，P = 0.235）。治疗1天后，吡喹酮薄膜包衣片的不良反应发生率降至3.01%（4/133），显著低于对照组（P < 0.05）。治疗2周后差异无统计学意义，吡喹酮薄膜包衣片组和对照组的不良反应发生率分别降至0.75%（1/133）、0.61%（2/327）（χ² = 0.029，P = 0.642）。治疗后3个月吡喹酮薄膜包衣片组的治愈率为84.91%（45/51），对照组为82.35%（42/53），差异无统计学意义（χ² = 1.536，P = 0.215）。
吡喹酮薄膜包衣片的气味和不良反应明显降低，其治疗日本血吸虫病的疗效与对照片剂相当。吡喹酮薄膜包衣片经进一步验证后可在现场广泛应用。
