Jawahar M S, Sivasubramanian S, Vijayan V K, Ramakrishnan C V, Paramasivan C N, Selvakumar V, Paul S, Tripathy S P, Prabhakar R
Tuberculosis Research Centre, Madras, India.
BMJ. 1990;301(6748):359-62. doi: 10.1136/bmj.301.6748.359.
To assess the efficacy of a short course chemotherapy regimen for treating tuberculosis of the lymph nodes in children.
Open, collaborative, outpatient clinical trial.
Outpatient department of the Tuberculosis Research Centre, paediatric surgery departments of the Institute of Child Health and Hospital for Children and the Government Stanley Hospital, Madras, South India.
Children aged 1-12 years with extensive, multiple site, superficial tuberculous lymphadenitis confirmed by biopsy (histopathology or culture).
Patients were treated with a fully supervised intermittent chemotherapy regimen consisting of streptomycin, rifampicin, isoniazid, and pyrazinamide three times a week for two months followed by streptomycin and isoniazid twice a week for four months on an outpatient basis. Surgery was limited to biopsy of nodes for diagnosis and assessment.
Response to chemotherapy was assessed by regression of lymph nodes and healing of sinuses and abscesses during treatment and follow up. Compliance with treatment and frequency of adverse reactions were also estimated.
197 Patients were admitted to the study and 168 into the analysis. The regimen was well tolerated and compliance was good with 101 (60%) patients receiving the prescribed chemotherapy within 15 days of the stipulated period of six months. Those whose chemotherapy extended beyond that period received the same total number of doses. Clinical response was favourable in most patients at the end of treatment. Sinuses and abscesses healed rapidly. Residual lymphadenopathy (exceeding 10 mm diameter) was present in 50 (30%) patients at the end of treatment; these nodes were biopsied. Fresh nodes, increase in size of nodes, and sinuses and abscesses occurred both during treatment and follow up. After 36 months of follow up after treatment only 5 (3%) patients required retreatment for tuberculosis.
Tuberculous lymphadenitis in children can be successfully treated with a short course chemotherapy regimen of six months.
评估短程化疗方案治疗儿童淋巴结结核的疗效。
开放性、协作性门诊临床试验。
印度南部马德拉斯结核病研究中心门诊部、儿童健康与儿童医院以及政府斯坦利医院的小儿外科。
年龄在1至12岁,经活检(组织病理学或培养)确诊为广泛、多部位、浅表结核性淋巴结炎的儿童。
患者接受全程监督的间歇化疗方案,即链霉素、利福平、异烟肼和吡嗪酰胺每周三次,持续两个月,随后链霉素和异烟肼每周两次,持续四个月,均为门诊治疗。手术仅限于对淋巴结进行活检以用于诊断和评估。
通过治疗和随访期间淋巴结的消退以及窦道和脓肿的愈合来评估化疗反应。还评估了治疗依从性和不良反应发生率。
197名患者纳入研究,168名进入分析。该方案耐受性良好,依从性良好,101名(60%)患者在规定的六个月期限内15天内接受了规定的化疗。化疗超出该期限的患者接受的总剂量相同。大多数患者在治疗结束时临床反应良好。窦道和脓肿迅速愈合。治疗结束时,50名(30%)患者存在残留淋巴结病(直径超过10毫米);对这些淋巴结进行了活检。在治疗和随访期间均出现了新的淋巴结、淋巴结肿大以及窦道和脓肿。治疗后随访36个月,只有5名(3%)患者因结核病需要再次治疗。
儿童结核性淋巴结炎可通过六个月的短程化疗方案成功治疗。