| Abstract|| |
Background: Tuberculosis (TB) is an infectious disease caused by a bacterium, Mycobacterium tuberculosis. The prevalence and the mortality due to tuberculosis are reducing in India, with an increasing number of suspects being examined and treated under Revised National Tuberculosis Control Program (RNTCP). Aim: The primary objective of this study was to describe the basic demographic, clinical characteristics, trends of various types of tuberculosis and program specified treatment protocols of patients registered for TB treatment in this single center attached to medical college hospital under RNTCP. Materials and Methods: This was a retrospective, record-based study of patients of all types of tuberculosis from January 1995 to December 2010 in all age groups, evaluated at K. S. Hegde Medical College and Hospital, Deralakatte, Mangalore, Karnataka, India. Results: A total of 1058 cases were registered and treated under Directly Observed Treatment Short-course (DOTS) during this period. Males (689, 65.12%) contributed to more number of cases than females (369, 34.88%). Of 1058 cases, 400 (37.81%) were found to be smear positive and among them 297 (74.25%) were males and 103 (25.75%) were females. Among 400 smear positive cases, 322 were new smear positive cases and 78 were Re-treatment Smear Positive cases. The Sputum Positive Ratio was ranging between 7.8% and 23% during the study period. 621 cases (58.7%) were classified as Pulmonary and 437 (41.3%) were classified as Extra Pulmonary. Among 621 Pulmonary cases, 221 (35.59%) were treated according to radiological criteria alone (X-ray positive alone). 778 cases received Cat-I treatment, 135 cases received Cat-II treatment, and 141 cases received Cat-III treatment. CXR positive+ EPTB cases contributed to 62.2% (n = 658) of total tuberculosis cases registered for treatment. Conclusion: High proportion of TB patients with EP-TB and its increasing trend along with higher reporting of sputum smear-negative PTB is a major concern for the health authorities in this area.
Keywords: Directly Observed Treatment Short-course, Extra-Pulmonary Tuberculosis, Revised national tuberculosis control program, Trends, Tuberculosis
|How to cite this article:|
Prakasha S R, Suresh G, D'sa IP, Kumar S G, Rao R, Shetty M. A study of clinical characteristics and trend of different types of tuberculosis in coastal South India. Ann Trop Med Public Health 2012;5:489-94
|How to cite this URL:|
Prakasha S R, Suresh G, D'sa IP, Kumar S G, Rao R, Shetty M. A study of clinical characteristics and trend of different types of tuberculosis in coastal South India. Ann Trop Med Public Health [serial online] 2012 [cited 2018 Aug 15];5:489-94. Available from: http://www.atmph.org/text.asp?2012/5/5/489/105141
| Introduction|| |
TB is an infectious disease caused by a Bacterium, Mycobacterium tuberculosis. The Government of India evolved a revised strategy and launched the Revised National Tuberculosis Control Program (RNTCP) based on DOTS strategy in the country in 1997. India is the highest TB burden country accounting for the one fifth (21%) of the global incidence.  TB mortality in the country as well as the prevalence of TB has reduced from 1990 to 2010 as per the WHO global TB report 2009 and 2010. 
The program-defined treatment success rate among new smear positive patients registered under RNTCP in 2007 to 2009 was 87%.  Suspect's examination has increased substantially from 397 per 100000 populations per annum to 642 per 100000 population over the last 10 years. TB mortality in the country has reduced from over 42/100,000 population in 1990 to 23/100,000 population in 2010 as per the WHO Global TB Report 2009.  The prevalence of TB in the country has reduced from 568/100,000 population in 1990 to 249/100,000 population by the year 2010 as per the WHO Global TB Report, 2010. 
It has been estimated though that the number of new patients detected with a positive smear for acid-fast bacilli (AFB) represents just over half of the existing cases. We conducted the present study to evaluate the clinical presentation of patients with pulmonary and extra pulmonary TB who were enrolled to receive DOTS treatment under RNTCP in this tertiary institute and medical college center in Karnataka. The primary objective of this study was to describe the basic demographic, clinical characteristics and program specified treatment protocols of patients registered for TB treatment in this single center attached to medical college hospital.
| Materials and Methods|| |
This was a retrospective, record-based study of patients of all types of tuberculosis, in all age groups, evaluated at K. S. Hegde Medical College and Hospital, Deralakatte, Mangalore, Karnataka, India. The patients were identified from the medical records starting from January 1995 to December 2010. DOTS were started in this institute from July 2004 and it is a routine practice to start ATT in all tuberculosis patients as per RNTCP protocol under DOTS. Being a tertiary center and referral institute, patients mainly from Dakshina Kannada district of Karnataka as well as neighboring districts of Kasaragod and Kannur of north Kerala were included in this study that accessed this institution for medical assistance. Different types of extra pulmonary tuberculosis and the number of patients in each of these subtypes were documented. Diagnosis was made primarily based on Sputum Smear Examination. X-rays play a secondary role in the standard diagnostic algorithm for pulmonary tuberculosis. Sputum Smear Microscopy using the Ziehl-Neelsen staining technique was used as the standard case-finding tool. Three sputum samples were collected over two days (as spot-morning/morning-spot) from patients with history of chest symptomatics to arrive at the diagnosis.
All patients registered for TB treatment under RNTCP from 1 st January 2005 to 31 st December 2010 in DOTS centre attached to K. S. Hegde Medical College and Hospital, Deralakatte, Mangalore.
We used a descriptive study design with retrospective review of existing program records. The sources of information were two RNTCP records namely, the TB register and treatment cards. The variables included: demographic (age and sex), clinical (disease classification, type of TB, site of extra pulmonary TB (EP-TB)) and treatment related (categorization and treatment regimens).
Ethical Issues: As this study was a record review of the data collected under RNTCP, approval was obtained from the Central TB Division, Ministry of Health and Family Welfare, Govt. of India.
| Definitions|| |
Under RNTCP, DOTS-course is the recommended strategy for treatment of TB. The case definitions, disease classification, treatment regimens and treatment outcome definitions used by RNTCP are in line with standard WHO definitions. Based on the nature/severity of the disease and the patients' exposure to previous anti-tubercular treatments, RNTCP classifies tuberculosis patients in to three treatment categories. Category I includes new sputum smear-positive, seriously ill sputum smear-negative, seriously ill extra-pulmonary and New Sputum Positive/Negative HIV Positive patients. Category II includes Sputum smear-positive Relapse, Sputum smear-positive Failure, and Sputum smear-positive Treatment after default and Sputum smear negative others. Category II includes new sputum smear-negative, not seriously ill and new extra-pulmonary, not seriously ill patients.
Diagnosis and standard case definitions used under Revised National Tuberculosis Control Program
Pulmonary TB, smear-positive: TB in a patient with at least two sputum smear examinations positive for AFB or one sputum smear examination positive for AFB along with radiological abnormalities consistent with active pulmonary TB. Since 1 st April, 2009, the number of specimen required for diagnosis of smear-positive pulmonary TB is two, with one of them being a morning sputum specimen. One specimen positive out of the two is enough to declare a patient as smear-positive TB.
Extra pulmonary TB: TB of any organ other than lungs, such as the pleura (TB pleurisy), peripheral lymph nodes, intestines, genitourinary tract, skin, joints and bones, meninges of the brain, etc. Diagnosis is based on culture-positive specimen from the extra-pulmonary site, histological, radiological, or strong clinical evidence consistent with active extra-pulmonary TB followed by decision of the treating doctor to treat with a full course of anti-TB therapy. A patient diagnosed with both pulmonary and extra-pulmonary TB is classified as pulmonary TB.
Pulmonary TB, smear-negative: TB in a patient with symptoms suggestive of TB with at least three sputum smear examinations negative for AFB and radiographic abnormalities consistent with active pulmonary TB as determined by the treating doctor followed by a decision to treat the patient with a full course of anti-tuberculosis treatment.
| Types of TB Cases:|| |
New: A TB patient who has never had treatment for TB or has taken anti-tuberculosis drugs for less than 1 month. A new case can be either sputum positive, sputum negative or extra-pulmonary.
Relapse: A TB patient who had been declared cured or whose treatment had been completed by a physician, but who reports back to the health service and is now found to be sputum smear-positive.
Failure: Any TB patient who is smear-positive at 5 months after starting treatment. Failure also includes a patient who was treated with the Category III regimen but who becomes smear-positive during treatment.
Others: A TB patient who do not fit into the above-mentioned types. Reasons for putting a patient in this type should be specified.
History of contact with a case of tuberculosis with a positive Mantoux test with or without other symptoms of tuberculosis was considered as a guideline for starting ATT in children <14 years.
Smear positive (S+ve) patients diagnosed
No. = No. of S+ve patients diagnosed
% = No. of S+ve patients diagnosed/no. of TB suspects examined × 100
The data was analyzed using SPSS version 12. Chi-square test was used to know if differences observed were statistically significant. " P" value of <0.05 was considered significant.
| Results|| |
The total number of tuberculosis cases registered for treatment has been increasing during the period of 2005 to 2010. A total of 1058 cases were registered and treated under DOTS during this period. Males (689, 65.12%) contributed to more number of cases than females (369, 34.88%) [Table 1]. The Sputum Positive Ratio was ranging between 7.8 and 23% during the study period [Table 2]. Since 2010, the sputum positive ratio is declining which is due to the increasing number of sputum examined for AFB in chest symptomatics. Of 1058 cases, 400 (37.81%) were found to be smear positive. Smear positive cases were also more among males (n = 297, 74.25%) than females (n = 103, 25.75%) [Table 3]. Among 400 smear positive cases, 322 were new smear positive cases and 78 were Re-treatment Smear Positive cases.
|Table 1: Basic Demographic and clinical Characteristics of TB patients (N = 1058)|
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|Table 2: Basic Demographic and clinical characteristics of TB patients (N=1058)|
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|Table 3: Age and sex distribution of new Sputum smear positive cases (N = 400)|
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Cases were classified according to the type of tuberculosis and the treatment regimen given. Among 1058 cases, 621(58.7%) were classified as Pulmonary and 437 (41.3%) were classified as Extra Pulmonary. Among 621 Pulmonary cases, 221 were treated according to radiological criteria alone (X-ray positive alone). Totally 437 patients were treated as Extra Pulmonary cases. From the year 2005 to 2010, there was a steady increase in the total number of Extra Pulmonary cases. Overall, the total number of different types of Extra Pulmonary cases included Lymph Node (n = 115, 26.32%), Pleural (n = 134, 30.67%), Abdomen (n = 42, 9.6%), CNS (n = 56, 12.81%), Bones and Joints (n = 44, 10.1%) and Others (n = 46, 10.53%) [Table 4]. 778 cases received Cat-I treatment, 135 cases received Cat-II treatment, and 141 cases received Cat-III treatment. Four cases were registered under Non-DOTS regimen [Table 5]. Among Re-treatment cases (Cat-II), the number of treatment failure, treatment after default and relapse cases were 11, 14, and 53 respectively. 57 cases were documented as Re treatment others.
| Discussion|| |
The study was done to know the demographic and clinical characteristics of various tuberculosis patients in this single center experience, wherein mainly patients from the neighboring three districts seek medical care. Such data are useful to understand the impact of the RNTCP control program and the trend of tuberculosis cases over the years as well. Firstly, overall males contributed to about two thirds of cases (65.12 %), and among sputum positive cases (both new and re treatment) males contributed to about three fourth (74.25%) of cases. Thus, both the total number of cases as well as the percentage of sputum positive cases was higher among males compared to females. In a study from the same region from 2003 to 2006, males contributed to 70% of the total new sputum positive TB cases.  This is probably due to the fact that males, who are usually working are being commonly exposed to the TB bacillus more than females. This may also be due to increased access to diagnostic (such as chest radiography, culture facilities etc) and treatment services among males compared to females. There also may be other independent factors like smoking, lifestyle, diabetes, occupation related health hazards etc. which are associated with increased susceptibility to tuberculosis in an individual. But, among CXR positive+ EP cases (n = 658), the difference between males and females is less with males contributing to 59.6 % of cases.
Second, among 400 smear positive cases, 78 (19.5%) were Re-treatment Smear Positive cases. The percentage of smear positive cases varies in different regions of India. ,, In the present study, nearly one out of five smear positive cases were re-treatment cases. But the sputum positive ratio has decreased in 2010 because of the increasing number of TB suspects being examined under RNTCP program. This is a positive trend in terms of increased public awareness as well as the awareness among treating doctors.
Thirdly, majority of the patients treated had EP-TB and sputum smear-negative PTB. CXR positive+ EPTB cases contributed to 62.2% of total tuberculosis cases registered for treatment. Overall 58.7% of cases were classified as pulmonary, and 41.3% cases were classified as Extra Pulmonary. The percentage of EPTB cases also varies in different regions, but was found to be high (48%) in a study conducted at AIIMS between 2001 to 2005.  In the present study, the percentage of extra pulmonary cases from 2005 to 2010 were 30.1%, 35.62%, 37.22%, 47.87%, 46.12%, 46.35% serially [Figure 1]. Thus, there is a gradual, but sustained increase in the number of extra pulmonary cases compared to pulmonary cases [Figure 2]. A similar trend was observed in Kolkata with an increase in the new EPTB cases during 2000 to 2005.  In a study of tuberculosis in pediatric age group, majority of the patients treated had EP-TB (63.3%) in the year 2008 in Delhi.  The probable explanation for the observations in the present study may be, being a tertiary center; more extra pulmonary cases are being diagnosed, which needs extra investigations and invasive procedures as well. Only 10.29% of tuberculosis cases (784/7620) belonged to EPTB group during 2003 to 2006 in entire Dakshina Kannada district.  Thus, the overall trend is an increase in the EPTB cases in a tertiary center, but still the total number of EPTB cases enrolled in the community is comparatively less. Sputum smear microscopy and chest radiography are the two available diagnostic tools under RNTCP, which can detect the pulmonary cases only. Additional efforts to further develop algorithms and criteria for diagnosis of extra pulmonary TB should be made and this may increase the total number of tuberculosis cases detected in the community as well as increase the number of cases enrolled and treated under the program by gaining the confidence of treating practitioners. This will also help many patients in developing countries who cannot access private health care. In the era of growing HIV epidemic, EPTB becomes more important as chances of developing EPTB in immunocompromised patients are higher than their immunocompetent counterparts.  In the present study, Pleural TB was the commonest type of EPTB (n = 134, 30.67%), closely followed by lymph node TB (115, 26.32%).
|Figure 1: Trend of the Extra-Pulmonary cases (No. and Percentage) over 2005-2010|
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135 cases (12.76%) received category II treatment and were classified as retreatment cases. Only 141 cases (13.33%) received category III treatment, showing that most treating doctors preferred a four drug combination during the intensive phase. The percentage of patients put on category III treatment in other parts is slightly higher. ,, However, with the new RNTCP guidelines since 1 st April, 2009, there are only two treatment categories, either a new case or a retreatment case. This is a significant positive step in terms of attracting more cases to the program, which may help in further reducing the number of retreatment cases in the future.
221 cases were treated with X-ray positivity alone, and the number (and the percentage among total TB cases) of such cases from 2005 to 2010 was 43(30.1%), 29(19.86%), 50(27.7%), 34(20.6%), 33(14.22%) and 32(16.67%) serially [Figure 3]. There was a considerable reduction in the number of cases treated by the chest X-ray positivity alone, especially since last 2-3 years. This may highlight the reduction in the so called over diagnosis by X-ray alone, which is a favorable sign. At the same time, it may also be due to the increasing availability and use of newer antibiotics which have anti-tubercular activity as well in chest symptomatics. It will have a negative impact in the early diagnosis of tuberculosis cases. Lastly, a steady increase was observed in the total number of cases enrolled under RNTCP since 2005 to 2010, except in 2008. This highlights the successful running of RNTCP programme in this DOTS center attached to a medical college hospital in this rural area of Karnataka.
The limitations of the study include the treatment outcomes are not studied in this study; since many such enrolled cases are transferred out to the neighboring districts of Karnataka as well as Kasaragod and Kannur of northern coastal Kerala. Since this is a hospital based study, the findings cannot be generalized to the community. But it gives valuable information which can be utilized by the health administrators for the changing trend of reporting of TB cases in a tertiary level heath care. The annual case detection rate was not calculated in this tertiary referral center, where mainly referred cases come for diagnosis and treatment, except a small proportion of cases from the neighboring locality.
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S Rama Prakasha
Department of General Medicine, K. S. Hegde Medical Academy, Deralakatte, Mangalore, Karnataka - 575 018
Source of Support: None, Conflict of Interest: None
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]