Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial

被引：116

作者：

Sharma, Surendra K. ^{[1
]}

Katoch, Kiran ^{[2
]}

Sarin, Rohit ^{[3
]}

Balambal, Raman ^{[4
]}

Jain, Nirmal Kumar ^{[5
]}

Patel, Naresh ^{[6
]}

Murthy, Kolluri J. R. ^{[7
]}

Singla, Neeta ^{[3
]}

Saha, P. K. ^{[1
]}

Khanna, Ashwani ^{[1
]}

Singh, Urvashi ^{[1
]}

Kumar, Sanjiv ^{[1
]}

Sengupta, A. ^{[1
,14
]}

Banavaliker, J. N. ^{[1
,8
]}

Chauhan, D. S. ^{[2
]}

Sachan, Shailendra ^{[2
]}

Wasim, Mohammad ^{[2
]}

Tripathi, Sanjay ^{[6
]}

Dutt, Nilesh ^{[6
]}

Jain, Nitin ^{[5
]}

Joshi, Nalin ^{[5
]}

Penmesta, Sita Ram Raju ^{[7
]}

Gaddam, Sumanlatha ^{[7
]}

Gupta, Sanjay ^{[9
]}

Khamar, Bakulesh ^{[10
]}

Dey, Bindu ^{[11
]}

Mitra, Dipendra K. ^{[1
]}

Arora, Sunil K. ^{[12
]}

Bhaskar, Sangeeta ^{[13
]}

Rani, Rajni ^{[13
,15
]}

机构：

[1] All India Inst Med Sci, New Delhi, India

[2] Natl JALMA Inst Leprosy & Other Mycobacterial Dis, Agra, Uttar Pradesh, India

[3] Natl Inst TB & Resp Dis, New Delhi, India

[4] Natl Inst Res TB ICMR, Madras, Tamil Nadu, India

[5] Hosp Chest Dis & TB, SMS Med Coll, Jaipur, Rajasthan, India

[6] NHL Municipal Med Coll, Ahmadabad, Gujarat, India

[7] Mahavir Hosp & Res Ctr, Hyderabad, Andhra Pradesh, India

[8] RBTB Hosp, New Delhi, India

[9] Catalyst Clin Serv Pvt Ltd, New Delhi, India

[10] Cadila Pharmaceut Ltd, Ahmadabad, India

[11] Dept Biotechnol, New Delhi, India

[12] Postgrad Inst Med Educ & Res, Chandigarh, India

[13] Natl Inst Immunol, New Delhi, India

[14] Chest Clin & Hosp, New Delhi, India

[15] CSIR, Inst Genom & Integrat Biol, Syst Biol Lab, New Delhi, India

来源：

SCIENTIFIC REPORTS | 2017年 / 7卷

关键词：

MULTIDRUG-RESISTANT TUBERCULOSIS; SPUTUM CULTURE CONVERSION; MULTIBACILLARY LEPROSY; HOUSEHOLD CONTACTS; CLINICAL-TRIALS; FOLLOW-UP; VACCINE; IMMUNOTHERAPY; CHEMOTHERAPY; CIPROFLOXACIN;

D O I：

10.1038/s41598-017-03514-1

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

Prolonged treatment of tuberculosis (TB) often leads to poor compliance, default and relapse, converting primary TB patients into category II TB (Cat IITB) cases, many of whom may convert to multidrug resistant TB (MDR-TB). We have evaluated the immunotherapeutic potential of Mycobacterium indicus pranii (MIP) as an adjunct to Anti-Tubercular Treatment (ATT) in Cat II pulmonary TB (PTB) patients in a prospective, randomized, double blind, placebo controlled, multicentric clinical trial. 890 sputum smear positive Cat II PTB patients were randomized to receive either six intra-dermal injections (2 + 4) of heat-killed MIP at a dose of 5 x 10(8) bacilli or placebo once in 2 weeks for 2 months. Sputum smear and culture examinations were performed at different time points. MIP was safe with no adverse effects. While sputum smear conversion did not show any statistically significant difference, significantly higher number of patients (67.1%) in the MIP group achieved sputum culture conversion at fourth week compared to the placebo (57%) group (p = 0.0002), suggesting a role of MIP in clearance of the bacilli. Since live bacteria are the major contributors for sustained incidence of TB, the potential of MIP in clearance of the bacilli has far reaching implications in controlling the spread of the disease.

引用

页数：11

共 41 条

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