Coura J R, de Abreu L L, Willcox H P, Petana W
Departamento de Medicina Preventiva, Universidade Federal do Rio de Janeiro.
Rev Soc Bras Med Trop. 1997 Mar-Apr;30(2):139-44. doi: 10.1590/s0037-86821997000200009.
A controlled clinical trial was carried out to evaluate the therapeutic efficacy and tolerance of nifurtimox and benznidazole in patients with chronic Chagas' disease. All patients had immunofluorescence and complement fixation reactions positives for T. cruzi antibodies and at least two xenodiagnoses positives in three performed before treatment, and they were submitted to clinical examinations, ECG and X-ray of the heart and esophagus. Of 77 patients studied, 27 were treated with nifurtimox and 26 with benznidazole in the dosage of 5 m/kg/day for 30 consecutive days, and 24 received a placebo in tablets similar to benznidazole. From the 77 patients, 64 (83.1%) accomplished the treatment: 23 (88.4%) with benznidazole, 19 (70.3%) with nifurtimox and 22 (91.6%) with placebo. The patients were evaluated, clinically, serologically and parasitologically (six xenodiagnoses within one year after treatment). The benznidazole group showed only 1.8% of positive xenodiagnoses post-treatment, the nifurtimox 9.6% and the placebo 34.3%. All serologic reactions continued positive and there were no clinical, ECG or X-ray changes one year after treatment.
开展了一项对照临床试验，以评估硝呋替莫和苯硝唑对慢性恰加斯病患者的治疗效果和耐受性。所有患者的克鲁斯锥虫抗体免疫荧光和补体结合反应均呈阳性，且在治疗前进行的三次异种诊断中至少有两次呈阳性，他们均接受了临床检查、心电图检查以及心脏和食管的X光检查。在研究的77例患者中，27例接受硝呋替莫治疗，26例接受苯硝唑治疗，剂量均为5mg/kg/天，连续30天，24例接受与苯硝唑外观相似的片剂安慰剂治疗。77例患者中，64例（83.1%）完成了治疗：23例（88.4%）接受苯硝唑治疗，19例（70.3%）接受硝呋替莫治疗，22例（91.6%）接受安慰剂治疗。对患者进行了临床、血清学和寄生虫学评估（治疗后一年内进行六次异种诊断）。苯硝唑组治疗后异种诊断阳性率仅为1.8%，硝呋替莫组为9.6%，安慰剂组为34.3%。所有血清学反应仍呈阳性，治疗后一年临床、心电图或X光检查均无变化。
