Table of Content

30 December 2015, Volume 4 Issue 4

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Original Articles

Adverse reactions of anti-tuberculosis drugs in major high-risk patients

DENG Guo-fang, SUN Li-zhen, TANG Yi-min,ZHANG Pei-ze, ZHAN Sen-lin, CHEN Tao,YE Tao-sheng

Journal of Tuberculosis and Lung Health. 2015, 4(4):  215-218.  doi:10.3969/j.issn.2095-3755.2015.04.002

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Objective We analyzed the adverse drug reactions in patients with tuberculosis for providing re-ferences to prevent and deal with the adverse drug reactions in high-risk patients.Methods We retrospectively analyzed 8492 patients with tuberculosis of Third people’s Hospital of Shenzhen from January 2011 to December 2014. All data were from the in-patient medical record room and the out-patient electronic medical record database. According to the annual review of tuberculosis treatment in 2014, 8492 patients were divided into general group (6689 cases) and high-risk group (1803 cases). The high-risk group was divided into three subgroups with diabetes (732 cases), AIDS (267 cases) and CHB (697 cases) differently. The major adverse reactions of anti-tuberculosis drugs in all groups were recorded. And the data were entered into the SPSS 19.0 software suite and analyzed using Chi-square test.Results The overall adverse drug reaction rate was 13.9% (929/6689) in general patients and 26.4% (476/1803) in high-risk patients. The difference between the two groups was statistically significant (χ²=33.785, P<0.0001). The severe adverse drug reaction rate was 1.1% (73/6689) in general patients and 6.4% (116/1803) in high-risk patients. There was no statistically significant difference between the two groups (χ²=6.012,P=0.198). In high-risk subgroup, the adverse drug reaction rate was 24.7% (181/732) in patients with diabetes mellitus; 36.3% (97/267) in patients with AIDS and 28.4% (198/697) in patients with chronic hepatitis B. There was no statistically significant difference between the subgroups (χ²=17.30,P=0.068).Conclusion Adverse drug reactions are more common seen in high-risk patients than in general patients, we should pay more attention to the prevention and treatment of high-risk patients.

Adverse drug reactions of chemotherapy and treatment in patients with multidrug resistant tuberculosis

KUANG Hao-bin, TAN Shou-yong, XIE Yu-hong, WANG Min, ZHANG Hong, YUAN Yuan, LI Yan, QIN Hong-juan, FENG Zhi-yu, YE Jin-quan

Journal of Tuberculosis and Lung Health. 2015, 4(4):  219-222.  doi:10.3969/j.issn.2095-3755.2015.04.003

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Objective To explore adverse drug reactions (ADR) of chemotherapy and treatment in patients with multidrug resistant tuberculosis (MDR-TB).Methods We analyzed retrospectively 96 patients enrolled MDR-TB project of Global fund and completed treatment in Guangzhou chest hospital from November 2008 to July 2013. The chemotherapy regimen was 6 Km(Am)-Z-Lfx(Ofx)-PAS(Cs)-Pto/18Z-Lfx(Ofx)-PAS(Cs)-Pto. The data including general condition, regimen, ADR and treatment were analyzed.Results There were 83 cases (86.5%,83/96) suffered from ADR in 96 patients who completed the course of treatment. The occurrence rate of ADR for the cases of cure and failure were 87.1% (54/62) and 85.3% (29/34) without statistical significance (χ²=0.06, P=0.806), respectively. In 0-1st month, 2nd-6th month of treatment, the incidences of ADR were 40.7% (22/54) and 46.3% (25/54) among patients who cured; 34.5% (10/29) and 55.2% (16/29) among patients who were failure, respectively. There was no statistical difference (χ²=0.31, P=0.577 and χ²=0.60,P=0.441).The common ADRs were nausea/vomiting (50.0%, 48/96), arthralgia (25.0%, 23/96), dizziness and headache (13.5%,13/96), and hepatitis (15.6%,15/96). The ADRs caused by Cfz,Pto,PAS,Clr,Lfx,Km,Z were common, and the incidence of these drugs were 100% (7/7), 48.7% (39/80),48.4% (31/64),47.1% (8/17), 28.5% (20/70), 28.3% (17/60), and 26.2% (22/84). 107 cases (69.5%) needed to stop relative drugs and then replaced with other drugs.Conclusion The occurrence rate of ADR of the chemotherapy for MDR-TB are relatively higher and vary. It needs to adopt correct strategy and standardized treatment.

Study on adverse drug reactions of interventional and non-interventional therapy for pulmonary tuberculosis

HUANG Yi-huan, CHEN Wei-sheng, CHEN Zhen-qiang

Journal of Tuberculosis and Lung Health. 2015, 4(4):  223-227.  doi:10.3969/j.issn.2095-3755.2015.04.004

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Objective To evaluate the clinical significance of interventional therapy for pulmonary tuberculosis (PTB) through monitoring the occurrence of the adverse drug reactions of the therapy.Methods 286 PTB patients who were over the age of 14 and had no dysfunction in liver, kidney, heart and eyes, hospitalized in the Third People’s Hospital of Shantou from Jan. 1^st, 2014 to Jun. 30^th, 2015 were enrolled. The patients were divided into intervention group (167 cases) and non-intervention group (119 cases) according to their treatment methods after collecting the information of their medical records. The adverse reactions of these two groups were observed in the two-month therapy.Results The adverse reaction rate of the 286 patients was 35.3% (101/286). It was 37.7% (63/167) for the intervention group and 31.9% (38/119) for the non-intervention group respectively. There was no statistically significant difference between these two groups (χ²=1.02, P>0.05). Additionally, after comparing the adverse reaction rates of the patients with different gender (male: 27.5% (46/167) and 23.5% (28/119); female:10.2% (17/167) and 8.4% (10/119)), history of alcohol intake (yes: 9.0% (15/167) and 9.2% (11/119); no: 28.7% (48/167) and 22.7% (27/119)), history of diabetes (yes: 6.0% (10/167) and 4.2% (5/119); no: 31.7% (53/167) and 27.7% (33/119)) in the two groups, there was no statistically significant difference (χ²=0.00, 0.33 and 0.61, all P values >0.05). The adverse drug reaction rates of the intervention group treated for 1 week, 2 weeks and 3 weeks were 4.2% (7/167), 6.0% (10/167) and 6.6% (11/167) respectively while those in non-intervention group were 5.0% (6/119), 10.1% (12/119) and 6.7% (8/119), with no statistical significance (χ²=0.12,1.64 and 0.00, all P values >0.05). The incidence rates of hepatic dysfunction and light hepatic injury, moderate and more serious hepatic injury were 15.6% (26 cases) and 3.0% (5 cases) for the intervention group, while those were 10.1% (12 cases) and 5.0% (6 cases) for the control group. The incidence rate of moderate and more serious moderate hepatic injury was significantly lower that of hepatic dysfunction and light hepatic injury (χ²=16.27, P<0.01).Conclusion Clinical interventional therapy do not apparently increase the incidence of adverse drug reactions.

Analysis of adverse reactions of 200 new bacteriological positive pulmonary tuberculosis patients treated with first-line antituberculosis drugs

LIU Guo-biao, TAN Shou-yong, LIN Xiao-shan, GONG Fang,YANG Qiong

Journal of Tuberculosis and Lung Health. 2015, 4(4):  228-232.  doi:10.3969/j.issn.2095-3755.2015.04.005

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Objective To understand the adverse reactions caused by first-line antituberculosis (anti-TB) drugs in new bacteriological positive pulmonary tuberculosis (PTB) patients.Methods Adverse reactions of 200 cases of new bacteriological positive PTB patients diagnosed and treated in Yuexiu TB Control Institute from September 2012 to April 2013 were analyzed. The cases were divided into adverse reactions group and no adverse reactions group, abnormal liver function group and normal liver function group. The differences between the two groups were analyzed.Results There were 127 cases with adverse reaction, and the incidence rate was 63.5% (127/200), abnormal liver function appeared in 50 cases, and the incidence rate was 25% (50/200). There were 111 cases with the adverse reaction appeared in 2 months of the treatment. Positive rate of hepatitis B surface antigen in abnormal liver function group was 18.0% (9/50), and that in normal liver function group was 8.0% (12/150), and the difference was statistically significant (χ²＝3.99, P=0.046). 173 cases were cured, and the cure rate was 86.5% (173/200).Conclusion The incidence rate of adverse reaction caused by anti-TB drugs is higher, while the impact on treatment regimen and treatment effect is small.

Study on adverse reactions of 1200 children on tuberculosis preventive treatment

WEI Xiao-hui, JIN Xiao-wei, DUAN Hai-xia, JIN Hong-jian

Journal of Tuberculosis and Lung Health. 2015, 4(4):  233-238.  doi:10.3969/j.issn.2095-3755.2015.04.006

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Objective To study the adverse reactions of 1200 children aged between 6-15 years old on rifapentine (L) and isoniazid (H) for TB preventive treatment.Methods A total of 1200 cases of children aged 6-15 at Xinmi from 2012—2014, whose tuberculin test were strongly positive, were selected. To observe the adverse reaction through the blood and liver function tests before and 1, 2 and 3 months after the treatment onset.Results (1) The adverse reaction incidence rate was 7.0% (84/120) in the first month, for boys and girls respectively 7.2% (44/614) and 6.8% (40/586), no significant difference (χ²=0.05, P>0.05). Among them 1.2% (14/1200) of gastrointestinal reactions, 2.8% (33/1200) of hepatic dysfunction, 3.1% (37/1200) of decreased white blood cell. (2) The adverse reaction incidence rate was 7.1% (34/482) in the second month, for boys and girls respectively 7.5% (19/254) and 6.6% (15/228), no significant difference (χ²=0.15, P>0.05). Among them 0.6% (3/482) of gastrointestinal reactions, 2.5% (12/482) of hepatic dysfunction, 3.9% (19/482) of decreased white blood cell. (3) The adverse reaction incidence rate was 6.2% (27/439) in the third month, for boys and girls respectively 7.2% (16/228) and 5.2％ (11/211), no significant difference (χ²=0.62, P>0.05). Among them 1.4% (6/439) of hepatic dysfunction, 4.8% (21/439) of decreased white blood cell. (4) The average monthly incidence of adverse reactions was 6.8％ (145/2121), 7.2% (79/1096) and 6.4% (66/1025) respectively for boys and girls, no significant difference (χ²=0.49, P>0.05). (5) Adverse reaction incidence in children aged 6－15 years old in turn was 11.6% (13/112), 9.1% (17/187), 7.2% (11/152), 5.4% (7/129), 6.7% (8/119), 3.3% (3/92), 7.1% (10/141), 7.1% (8/112), 5.7% (3/53) and 3.9% (4/103) respectively, there was no statistically significant difference in the incidence of adverse reactions by age (χ²=7.86, P>0.05).Conclusion The adverse reaction incidence rate of L+H regimen for preventive treatment for children aged between 6－15 years old are in normal level, but we need to perform periodic liver function and blood test during treatment so as to avoid severe reaction.

Clinical analysis on allergic skin rash caused by antituberculosis drugs of fixed-dose combination in 32 cases

HAN Na, LI Zhan-ying, TIAN Yan-qing

Journal of Tuberculosis and Lung Health. 2015, 4(4):  239-241.  doi:10.3969/j.issn.2095-3755.2015.04.007

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Objective To analyze the clinical diagnosis and treatment of allergic skin rash caused by the antituberculosis drugs of fixed-dose combination (FDC), and to guide the clinical practice.Methods We analyzed retrospectively clinical data of allergic skin rash, including basic information, clinical manifestations, diagnosis and treatment, from 32 cases treated with antituberculosis drugs of FDC in organization for tuberculosis prevention during May 2005 to July 2015. The type of allergic drug and clinical features were summarized.Results This group of antituberculosis drug of FDC induced allergic rash was mainly measles-like (37.5%, 12/32) or urticaria-like (31.5%, 10/32). Time to allergy medication taken was from 2 weeks to 1 months, of which 1 to 3 weeks was common. The rate of allergic skin rash caused by FDC was ethambutol (37.5%, 12/32), pyrazinamide (21.87%, 7/32), isoniazid (12.50%, 4/32) and rifampicin (3.12%, 1/32). All patients with allergic skin rash were cure after stopping the medicine and clinical symptomatic treatment.Conclusion The main types of allergic skin rash caused by antituberculosis drugs of FDC are the measles-like and urticaria-like. Early determination of the type of allergic skin rash caused by FDC and treatment in time will get the better prognosis.

Clinical analysis of the adverse drug reactions in 40 retreatment pulmonary tuberculosis patients

ZHANG Yun-ling, KAN Xiao-hong

Journal of Tuberculosis and Lung Health. 2015, 4(4):  242-246.  doi:10.3969/j.issn.2095-3755.2015.04.008

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Objective To investigate the characteristics of anti-tuberculosis drug induced adverse drug reactions (ADR) of retreatment pulmonary tuberculosis patients and the effect to therapy, and to encourage more attention be paid to the anti-tuberculosis drug induced ADR.Methods All 40 patients who conformed to the criteria of the research of retreatment pulmonary tuberculosis treatment of “Eleventh Five Year Plan” National Science and Technology major projects were enrolled from July, 2009 to December, 2011, the occurrence and results of ADR under close supervision through the whole course were analyzed.Results The ADR incidence rate of 40 retreatment pulmonary tuberculosis patients was 97.5% (39/40). Among those results, the highest incidence was hyperuricacidemia (85.00% (34/40)), others in sequences were the blood system damage (70.00% (28/40)) and liver function damage (40.00% (16/40)). The occurrence rates of ADR for once, twice, three times and four times were 2.50% (1/40), 40.00% (16/40), 30.00% (12/40) and 22.50% (9/40). The mild ADR incidence rate was 77.27% (85/110), the medium ADR incidence was 22.73% (25/110) and the severe ADR incidence rate was 0.00% (0/110). 50.91% (56/110) of ADR did not need special treatment, 36.36% (40/110) of ADR just needed symptomatic treatment and discontinuation was not required,11.82% (13/110) of ADR required discontinuation of anti-tuberculosis drug and needed symptomatic treatment, and only 0.91% (1/110) ADR patients could not tolerate the treatment of primary programs and dropped out.Conclusion The ADR incidence rate of retreatment pulmonary tuberculosis chemotherapy and occurrence frequency are higher, which decrease the patients’ compliance during treatment and bring difficulties to tuberculosis control. It must attract the clinical high attention to detect, diagnose, and manage ADR timely to ensure the patients complete treatment.

Analysis of adverse drug reactions of Cycloserine in the treatment of patients with multi-drug resistant pulmonary tuberculosis

CHENG Wu,TAN Shou-yong, LI Yan,KUANG Hao-bin

Journal of Tuberculosis and Lung Health. 2015, 4(4):  247-249.  doi:10.3969/j.issn.2095-3755.2015.04.009

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Objective To observe the adverse reactions of Cycloserine in the treatment of patients with multi-drug resistant pulmonary tuberculosis, and provide the basis for clinical safe medication.Methods To review the use of Cycloserine in the treatment of patients with multi-drug resistant pulmonary tuberculosis in our hospital, summarize the types of adverse reactions, the occurrence time and the processing results. The total number of patients was 61,and the number of patients with multi-drug resistant pulmonary tuberculosis treated with Cycloserine was 50 cases. The patients were aged between 18 and 78 years old, and the median age was 42.5 years.Results Up to 84.0% (42/50) of patients can complete the 24-months treatment course. Adverse reactions occurred in 8 cases, most of them occurred in the nervous and mental aspects. The incidence rate of adverse reactions was 16.0% (8/50), and the 8 patients discontinued the use of Cycloserine after the adverse reactions occur with the discontinuation rate of 16.0%. Those adverse reactions were all relieved after stopping the drug.Conclusion Cycloserine is a relatively safe drug for the treatment of multi-drug resistant tuberculosis. But in the course of using Cycloserine, need to be alert to the nervous and mental symptoms.

The analysis of Multidrug-resistant tuberculosis and Mycobacterium strain distribution in Bin Zhou region of Shandong

CHEN Zi-fang,WANG Feng-qing,WANG Jian,LAO Hai-li,SUN Ben-hai,CHEN Qi

Journal of Tuberculosis and Lung Health. 2015, 4(4):  250-253.  doi:10.3969/j.issn.2095-3755.2015.04.010

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Objective To explore multidrug resistance tuberculosis and Mycobacterium Strain distribution in Bin Zhou region.Methods Two thousand and eighty-three culture positive cases from outpatient and hospitalized tuberculosis patients between January 2013 and March 2015 were collected, among them, 1765 cases of the initial treatment, 318 cases of the re-treatment.Patients were divided into 5 age groups, 216 cases in 18－ age group,309 cases in 31－ age group, 593 cases in 41－ age group, 434 cases in 51- age group, 531 cases in more than 60 age group. Two thousand and eighty-three cases were conducted identification of multidrug detection and Mycobacterium species identification by Gene chip.Results Two thousand and sixteen strains were Mycobacterium tuberculosis in 2083 Mycobacterium by Gene chip, accounting for 96.8%. The total resistance rate was 3.6% (73/2016). The rate of multi-drug resistance in the initial treatment patients was 1.6% (27/1698) and that in re-treatment patients was 14.5% (46/318); there were 13 multidrug resistance cases in 18－ age group,8 cases in 31－ age group, 12 cases in 41－ age group, 29 cases in 51－ age group, 11 cases in more than 60 age group. a total of 40 cases were more than 51 years old, accounting for 54.8% (40/73). Sixty-seven cases non-Mycobacterium tuberculosis were detected in 2083 Mycobacterium, accounting for 3.2%, among them, 29 strains of Intracellular Mycobacterium, accounting for 43.3%.Conclusion The multidrug resistant rate of tuberculosis in Bin Zhou region was lower than the national average, and the non mycobacterium tuberculosis disease incidence rate was low, mainly intracellular mycobacteria infection.

Qualitative analysis on job burnout of tuberculosis control and prevention medical staff in the center for disease control and prevention at basic level in two cities of Yunnan Province

LI Ling,XU Lin

Journal of Tuberculosis and Lung Health. 2015, 4(4):  254-257.  doi:10.3969/j.issn.2095-3755.2015.04.011

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Objective To acquire the job burnout situation of the anti-tuberculosis (anti-TB) medical staff in the center for disease control and prevention (CDC) at basic level, and to further analyze the reasons and explore the solution for preventing and remitting job burnout among anti-TB medical staff preliminarily.Methods All 26 anti-TB medical staff who worked in county CDC in two cities of Yunnan province (including clinical doctors, project managers, radiologists, and laboratory staff) accepted the individual interviews referring to job burnout.Results 85% (2/26) anti-TB medical staff showed strong sense of job burnout, and 69% (18/26) expected to leave anti-TB positions. The main reasons were as following: high working pressure, high risk of occupational exposure, low income, the misunderstanding and prejudice resulted from lacking of awareness of TB and insufficient leadership attention.Conclusion Job burnout phenomena among basic level anti-TB medical staff are relatively common, and the degree of burnout is severe. We should improve the working environment and mental health from policy, system, organization, human resource configuration to prevent and reduce the occurrence of burnout.