| Objectives：(1) To evaluate the protection of Naphthoquinephos Phate in the application ofmalaria prevention.(2) To evaluate the safety of Naphthoquinephos Phate in the application ofmalaria prevention.(3) To evaluate the compliance of Naphthoquinephos Phate in the application ofmalaria prevention.Methods:(1)4natural villages were surveyed with the malaria parasite carrying rate above10%, using village as a unit to survey the malaria parasite carrying rate, in Laiza cityof Kachin State in Myanmar.(2) The objects of this study were malarial microscopic examination negative,healthy and signed the informed consent voluntarily, with age between5to65yearsold. Then400people who were up to standard were divided into2groups randomly(drug group:200people and placebo group:200people). All the positive patients andcarriers were given regular treatments.(3) The adult dose was600mg，the dose of5~12years old was300mg and thedose of13~16years old was450mg (1time/each month with2months). There wereno differences in dose and methods between these two groups.(4) Follow-up were given to the individual in the first day and each week afterthe first medication, as well as, in the second and fourth week after the secondmedication, which included the whole body system physical examination and bloodsmear microscopic examination, with the purpose of providing the correct medicationfor the experimenters infected with plasmodium. In addition, they would have URT, BRT and blood biochemical test in the first day, the first week, the fourth week andthe eighth week after the first medication.(5) During the follow-up period, all the adverse events and cases infected withplasmodium were recorded and analyzed.Results:(1) The distribution of experimenters370of400healthy experimenters were evaluated at least one time aftermedication, accounting for92.5%(drug group:181, placebo group:189). Amongthem,309have taken medicine for two times, accounting for77.3%(drug group:156,placebo group:153).(2) The comparison results of two groups’ experimentersThe ages of370experimenters were from5to56years old. The average age ofthem was25.57±18.46(drug group:24.50±17.36, placebo group:26.63±19.56). Theaverage body temperatures of drug and placebo group were36.46±0.199and36.45±0.238, respectively. The numbers of female and male experimenters were215(58.1%) and155(41.9%). The number of sex proportion in drug group andplacebo group were female108(59.7%), male73(40.3%) and female107(56.6%),male (43.4%), respectively,(p=0.552＞0.05).129of370experimenters have malarialhistory before experiment two weeks, of which drug group was63and placebo groupwas66,(p=0.982＞0.05).(3) The protection of Naphthoquinephos PhateThe positive rate of malarial microscopic examination in drug group within60days was0.64%, however, in placebo group was12.5%,(P＜0.05). The protectiverate of drug group within30and60days were94.16%and94.88%, respectively.(4) The safety of Naphthoquinephos PhateThe adverse reactions in drug group and placebo group were15and14,(P=0.847＞0.05). Conclusions:(1) After they taking Naphthoquinephos Phate (one time per month with twomonths), the protective rate within60days was94.88%, which was similar to theMalalong introduced by USA recently. So, Naphthoquinephos Phate can provideprotective effect in malaria epidemic areas.(2) The lab abnormality rate of drug group and placebo group were7.5%(15/200)and7%(14/200) within60days. Furthermore, all the adverse events were mild andrecovered in one week after medication, demonstrating that Naphthoquinephos Phatecould provide a higher safety when be used in malaria epidemic areas.(3) During60days, in addition to some experimenters have not completed theentire observation due to the local war and other objective reasons, all theexperimenters in drug group would like to take medicine except one (1/156). |
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