Do the diminishing efficacy and increasing toxicity of sodium stibogluconate in the treatment of visceral leishmaniasis in Bihar, India, justify its continued use as a first-line drug? An observational study of 80 cases
Do the diminishing efficacy and increasing toxicity of sodium stibogluconate in the treatment of visceral leishmaniasis in Bihar, India, justify its continued use as a first-line drug? An observational study of 80 cases
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DOI：
10.1080/00034989859258
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发表时间：
1998-07-01
影响因子：
--
通讯作者：
Roy, RK
中科院分区：
文献类型：
--
作者：
Thakur, CP;Sinha, GP;Roy, RK
在印度比哈尔邦，80例经寄生虫学确诊的内脏利什曼病（黑热病）病例接受每日20 mg葡萄糖酸锑钠/kg治疗30天，以评估该30天方案的当前疗效和毒性。48例（60%）患者获得临床和寄生虫学治愈。然而，26例（33%）患者对第一个疗程无应答（原发性无应答），2例在初始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天因心脏毒性（室上性心动过速），另1例在第24天因严重食欲不振）。所有30例用葡萄糖酸锑钠不能完全治愈的患者都成功地用阿替霉素B治疗。许多患者由于葡萄糖酸锑钠治疗而发生心电图改变。32例（40%）患者出现T波高度降低，7例（9%）患者出现T波倒置（明尼苏达代码5-1，5-2），3例（4%）患者出现ST段抬高（明尼苏达代码4-1），6例（8%）患者出现QT间期延长（与基线结果相比），2例（3%）患者出现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（粗房颤），4例患者（5%）发生室性心动过速、室颤、尖端扭转型室性心动过速和多灶性室性异位，死于心脏毒性。轻微的副作用，如注射部位疼痛（2例），食欲轻度减退（12例），口腔金属味（6例），关节疼痛（2例），也observed.It的结论是，葡萄糖酸锑钠在研究领域的疗效下降，多年来，其毒性增加。需要一种更有效、更安全、更便宜的替代药物作为黑热病的一线治疗。
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of treatment (primary unresponsiveness), two relapsed after initial clinical and parasitological cure, and two were withdrawn from the study (one on day 6 of treatment because of cardiotoxicity in the form of supraventricular tachycardia and the other on day 24 because of severe loss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.