Shamkuwar Chetna Ashok, Meshram Sushant Hiraman, Mahakalkar Sunil M
Department of Pharmacology, Government Medical College, Chandrapur, Maharashtra, India.
Department of Respiratory Medicine, B.J. Medical College, Pune, Maharashtra, India.
Adv Biomed Res. 2017 Mar 28;6:37. doi: 10.4103/2277-9175.203162. eCollection 2017.
The estimated incidence and prevalence of tuberculosis in India are 2.1 and 2.6 million cases respectively. Immunotherapy may shorten tuberculosis treatments and improve the immunity of individuals as well. Hence we study the efficacy of levamisole (LVM) (immunomodulator) as an adjuvant to chemotherapy of pulmonary tuberculosis patients.
A randomized, double-blind, placebo-controlled clinical trial was conducted for 21 months in newly diagnosed sputum positive pulmonary tuberculosis patients. Patients were subjected initially to clinical examination, sputum acid-fast bacilli smear and culture, tuberculin skin test and weight record. During follow-up, above investigations were repeated. Sixty-five patients were randomly assigned into two groups to receive either tab LVM 100 mg once in a day or matching placebo, orally as a single dose, thrice a week, for 2 months with short-course antituberculosis chemotherapy.
Sputum negativity at 1 week was observed in 11 (44%) patients in LVM group whereas only 3 (12%) in placebo group. All the patients 25 (100%) in LVM group were sputum negative compared to 14 (56%) in placebo group by the end of 3 weeks. In LVM group, 24 (96%) and 11 (44%) patients in placebo group show radiological improvement at 2 months. A direct correlation existed between quantum of immune response and weight gain with LVM. LVM rendered all anergic patients to positive tuberculin reactors. In LVM group, patients with initial Mantoux ≥20 mm and advanced cavitary disease, there was decrease in tuberculin reaction size.
Adjuvant immunomodulation with levamisole has the potential of shortening the total duration of antitubercular therapy.
印度结核病的估计发病率和患病率分别为210万例和260万例。免疫疗法可能会缩短结核病治疗时间，并提高个体免疫力。因此，我们研究左旋咪唑（LVM）（免疫调节剂）作为肺结核患者化疗辅助药物的疗效。
对新诊断的痰涂片阳性肺结核患者进行了为期21个月的随机、双盲、安慰剂对照临床试验。患者最初接受临床检查、痰抗酸杆菌涂片和培养、结核菌素皮肤试验及体重记录。随访期间，重复上述检查。65例患者被随机分为两组，分别接受每日1次口服100mg LVM片或匹配的安慰剂，单剂量，每周3次，为期2个月，并进行短程抗结核化疗。
LVM组11例（44%）患者在1周时痰转阴，而安慰剂组仅3例（12%）。到3周结束时，LVM组所有25例（100%）患者痰转阴，而安慰剂组为14例（56%）。在LVM组，24例（96%）患者在2个月时影像学改善，安慰剂组为11例（44%）。免疫反应量与LVM导致的体重增加之间存在直接相关性。LVM使所有无反应患者转变为结核菌素反应阳性者。在LVM组，初始结核菌素试验≥20mm及有空洞形成的进展期疾病患者，结核菌素反应大小减小。
左旋咪唑辅助免疫调节有缩短抗结核治疗总疗程的潜力。
