Thakur C P, Sinha G P, Pandey A K, Kumar N, Kumar P, Hassan S M, Narain S, Roy R K
Kala-azar Research Centre, Patna, Bihar, India.
Ann Trop Med Parasitol. 1998 Jul;92(5):561-9. doi: 10.1080/00034989859258.
Eighty parasitologically confirmed cases of visceral leishmaniasis (kala-azar) in Bihar, India, were treated daily with 20 mg sodium stibogluconate/kg for 30 days, to assess the current efficacy and toxicity of this 30-day regimen. Clinical and parasitological cure was obtained in 48 (60%) of the patients. However, 26 (33%) patients did not respond to the first course of treatment (primary unresponsiveness), two relapsed after initial clinical and parasitological cure, and two were withdrawn from the study (one on day 6 of treatment because of cardiotoxicity in the form of supraventricular tachycardia and the other on day 24 because of severe loss of appetite). All 30 patients who were not entirely cured with sodium stibogluconate were successfully treated with amphotericin B. Electrocardiographic changes occurred in many of the patients as the result of treatment with sodium stibogluconate. Diminution in the height of the T wave was seen in 32 (40%), inversion of the T wave (Minnesota code 5-1, 5-2) in seven (9%), elevation of the ST segment (Minnesota code 4-1) in three (4%), prolonged QT interval (compared with baseline findings) in six (8%), and diminution in the height of the P, R and T waves in two (3%). Cardiac arrhythmia occurred in five patients (6%), supraventricular arrhythmia (coarse atrial fibrillation) occurred in one patient and ventricular tachycardia, ventricular fibrillation, torsade de pointes and multifocal ventricular ectopics occurred in the four patients (5%) who died of cardiotoxicity. Minor side-effects, such as pain at the site of injection (two cases), mild diminution in appetite (12 cases), metallic taste in mouth (six cases), and joint pain (two cases), were also observed. It was concluded that the efficacy of sodium stibogluconate in the study area has declined over the years and that its toxicity has increased. A more efficacious, safer and cheaper, alternative drug is required as the first line of treatment of kala-azar.
在印度比哈尔邦，对80例经寄生虫学确诊的内脏利什曼病（黑热病）患者，每日给予20mg葡萄糖酸锑钠/千克体重，持续治疗30天，以评估这一30天治疗方案目前的疗效和毒性。48例（60%）患者实现了临床和寄生虫学治愈。然而，26例（33%）患者对首个疗程治疗无反应（原发性无反应），2例在最初临床和寄生虫学治愈后复发，2例退出研究（1例在治疗第6天因室上性心动过速形式的心脏毒性退出，另1例在治疗第24天因严重食欲不振退出）。所有30例未被葡萄糖酸锑钠完全治愈的患者均成功接受了两性霉素B治疗。许多患者因葡萄糖酸锑钠治疗出现了心电图变化。32例（40%）出现T波高度降低，7例（9%）出现T波倒置（明尼苏达编码5 - 1、5 - 2），3例（4%）出现ST段抬高（明尼苏达编码4 - 1），6例（8%）QT间期延长（与基线结果相比），2例（3%）P、R和T波高度降低。5例患者（6%）发生心律失常，1例患者发生室上性心律失常（粗颤型心房颤动），4例因心脏毒性死亡的患者（5%）发生室性心动过速、心室颤动、尖端扭转型室速和多灶性室性早搏。还观察到一些轻微副作用，如注射部位疼痛（2例）、轻度食欲不振（12例）、口中金属味（6例）和关节疼痛（2例）。得出的结论是，多年来研究地区葡萄糖酸锑钠的疗效有所下降，其毒性有所增加。需要一种更有效、更安全且更便宜的替代药物作为黑热病的一线治疗药物。
