[IgG4-related diseases of retroperitoneum in urinary and male reproductive system: a clinicopathological analysis of eleven cases].

Objective: To analyze the clinicopathological features of IgG4-related diseases (RD) of retroperitoneum and the urinary and male reproductive system (IgG4-RUMR). Methods: A total of 11 IgG4-RUMR cases from January 2013 to March 2021 were retrospectively collected at Peking University Third Hospital and Shandong Provincial Hospital affiliated to Shandong First Medical University. The clinicopathologic features, laboratory and imaging findings were analyzed and scored according to the 2019 ACR/EULAR classification criteria for IgG4-RD. Results: The 11 patients (male:female is 9∶2; mean age 59 years, range from 44 to 83 years) were initially admitted to the Deparment of Urology/Kidney Transplantation (10 cases) and the Department of Oncology (1 case). All patients had urogenital disorders or imaging abnormalities. Three of the 11 patients had a history of IgG4-RD such as lacrimal gland engorgement, salivary gland engorgement and IgG4-associated pancreatitis. Abnormal retroperitoneal soft tissue and hydronephrosis were found in eight cases, while epididymal and spermatic cord masses were found in one case, simple renal mass in one case, and"benign prostatic hyperplasia"in one case. In the 10 patients tested for serum IgG4, the serum IgG4 level was 0.8-14.4 g/L. Histologically, all cases showed significant lymphoplasmacytic infiltration and storiform fibrosis, and some were accompanied by obliterative phlebitis. The number of IgG4 positive plasma cells was 12-155 per high-power field, and the IgG4/IgG ratio was 15%-77%. According to the 2019 ACR/EULAR IgG4-RD classification standard 11 cases scored 20-48 points, all of which met the diagnostic criteria of IgG4-RUMR. Therapeutically, the patient with a simple renal mass underwent partial nephrectomy. The patient with prostate lesion underwent transurethral resection of prostate and was initially diagnosed as nonspecific chronic prostatitis. Later, the patient was admitted again because of salivary gland swelling, and the pathologic diagnosis was amended. The patient with epididymal and spermatic cord masses participated in a clinical trial about retroperitoneal fibrosis. The remaining eight patients received symptomatic treatment such as adhesiolysis and stent placement. All the patients were subsequently treated with glucocorticoid/immunosuppressant and symptoms relieved. Conclusions: IgG4-RUMR is uncommon. In clinical practice, information from clinical, serologic, radiologic and pathologic evaluations must be integrated. IgG4-RUMR should be considered in the differential diagnosis of urinary and male reproductive diseases. The 2019 ACR/EULAR classification criteria for IgG4-RD, while relatively complex, are objective and practical in the diagnosis of IgG4-RUMR.

[Clinical effect of fractional carbon dioxide laser in the treatment of contracture scars].

Objective: To explore the clinical effect of the fractional carbon dioxide laser in the treatment of contracture scars. Methods: A retrospective before-after self-control study was conducted. From December 2016 to April 2021, 16 patients (7 males and 9 females, aged 3-49 years) with contracture scars causing impaired function of the adjacent joint were admitted to Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Eighteen joint scars of 16 patients were treated with fractional carbon dioxide laser every 2-3 months until the joint retained its normal range of motion or the effect plateaued. The treatment times of each patient were recorded. Before the first treatment and 6 months after the last treatment, the ranges of motion of the affected joint were measured in each patient, and the difference was calculated, meanwhile, the Vancouver Scar Scale (VSS) was used to evaluate the scar of each patient. In the treatment of 1 joint scar in each of 6 patients (totally 6 times of treatments), the ranges of motion of the affected joint before the current treatment, immediately after the treatment, and at the first follow-up after the treatment were documented, and the differences between the ranges before and immediately after the treatment as well as between the ranges before and at the first follow-up after the treatment were calculated. Adverse effects after the treatment in the treatment area were documented. At the last follow-up, a self-made questionnaire was used to collect the implementation status of the physical therapy and other scar management modalities during the treatment interval and follow-up period. Data were statistically analyzed with Wilcoxon rank sum test. Results: Eighteen joint scars in 16 patients received 2 (1, 3) times of fractional carbon dioxide laser treatment. The range of motion of the affected joint of 16 patients 6 months after the last treatment was 56.5 (39.0, 128.8)°, notably higher than 38.4 (22.9, 116.3)° before the first treatment (Z=-3.724, P<0.01), showing a remarkable improvement by 17.4 (8.0, 24.1)°. The vascular distribution, softness, and thickness scores, and total score in VSS scoring of scars of 16 patients 6 months after the last treatment were significantly lower than those before the first treatment (Z=-2.989, -3.762, -2.814, -3.739, P<0.01), with the most obvious improvement in softness. In 6 times of treatments, the range of motion of the affected joint immediately after treatment and at the first follow-up of (2.5±0.6) months after treatment were 156.2 (148.0, 164.2)° and 160.2 (156.7, 166.4)°, both notably higher than 151.4 (145.7, 155.3)° before treatment (Z=-2.201, -2.201, P<0.05), showing a remarkable improvement by 9.1 (4.4, 13.0)° and 13.1 (8.0, 15.7)°, respectively. No adverse effects such as blisters, infection, or hypertrophic scar formation were observed in the treatment area of 16 patients after treatment. Most patients adopted physical therapy, compression, silicone gel or sheets, and braces during the treatment interval and follow-up period. Conclusions: The fractional carbon dioxide laser can soften the scar and increase the range of motion of the affected joint, which is suitable for the clinical treatment of mild contracture scars.

Impact of different subspecies on disease progression in initially untreated patients with Mycobacterium avium complex lung disease.

OBJECTIVE: Disease progression is a strong indicator of treatment for Mycobacterium avium complex lung disease (MAC-LD). The impact of MAC subspecies on the risk of disease progression remains uncertain in MAC-LD patients. METHODS: In this cohort study, we included MAC-LD patients from 2013 to 2018 and classified them into M. intracellulare, M. avium, M. chimaera and other subspecies groups by genotype. We observed the disease progression of MAC-LD, indicated by antibiotic initiation and/or radiographic progression. We used Cox regression analysis to assess predictors for disease progression. RESULTS: Of 105 MAC isolates from unique MAC-LD patients, 35 (33%) were M. intracellulare, 41 (39%) M. avium, 16 (15%) M. chimaera and 13 (12%) other subspecies. After a mean follow-up time of 1.3 years, 56 (53%) patients developed disease progression: 71% (25/35), 54% (22/41), 31% (4/13) and 31% (5/16) in patients with M. intracellulare, M. avium, others and M. chimaera, respectively. The independent predictors for disease progression were M. chimaera subspecies (HR 0.356, 95% CI (0.134-0.943)), compared with the reference group of M. intracellulare, body mass index ≤20 kg/m2 (HR 1.788 (1.022-3.130)) and initial fibrocavitary pattern (HR 2.840 (1.190-6.777)) after adjustment for age, sex and sputum smear positivity. Among patients without fibrocavitary lesions (n = 94), the risk of disease progression significantly decreased in patients with other subspecies (HR 0.217 (0.050-0.945)) and remained low in those with M. chimaera (HR 0.352 (0.131-0.947)). CONCLUSIONS: Mycobacterium chimaera was not uncommon in this study; unlike M. intracellulare, it was negatively correlated with disease progression of MAC-LD, suggesting a role of MAC subspecies identification in prioritizing patients.

Expression and clinical significance of miR-193a-3p in invasive pituitary adenomas.

OBJECTIVE: Our study aimed to investigate miR-193a-3p expression and its clinical significance in pituitary adenomas (PAs). Moreover, the correlation between miR-193a-3p expression and the invasiveness of PAs was explored. PATIENTS AND METHODS: In this study, the relative expression levels of miR-193a-3p were detected via quantitative Real Time-Polymerase Chain Reaction (qRT-PCR). The correlations between miR-193a-3p and tumor size, clinical features, and prolactinomas postoperative prolactin (PRL) levels early remission were further analyzed. RESULTS: Compared with non-invasive PAs, there was a lower miR-193a-3p expression in invasive PAs. MiR-193a-3p expression had reverse relevance to tumor size. A higher risk of postoperative residual and recurrence was found in patients with downregulated miR-193a-3p. Prolactinomas patients with postoperative PRL levels early remission were at lower risk to relapse and patients with high-expression miR-193a-3p had a higher early remission rate, suggesting that miR-193a-3p was a significant prognostic factor for prolactinomas. CONCLUSIONS: MiR-193a-3p could have potential therapeutic value for invasive pituitary adenomas.

The impact of cancer development on the risk of mycobacterial diseases among rheumatoid arthritis patients.

Mycobacterial diseases are prevalent in cancer and rheumatoid arthritis (RA) patients, especially those receiving tumor necrosis factor-α inhibitor (TNFi). However, the impact of cancer development on the risk of mycobacterial diseases among RA patients is unknown. Data from the Taiwan National Health Insurance Research Database were used to conduct a retrospective study to assess the occurrence of mycobacterial diseases in RA patients developing cancer (cancer-positive), those using TNFi (TNFi-exposure), those with cancer and using TNFi (cancer-TNFi-comb), and those without cancer and not using TNFi (cancer-TNFi-free). Cancer and TNFi exposure were time-dependent, and independent risk factors of mycobacterial diseases were assessed by Cox regression. Among 1344 RA patients diagnosed during 2000-2013, 68 (5·1%) developed cancer before their end points. The incidence rates of mycobacterial diseases in the cancer-positive (n = 56), TNFi-exposure (n = 290), cancer-TNFi-comb (n = 12), and cancer-TNFi-free (n = 986) subgroups were 6·7, 2·0, 7·6, and 1·3 per 1000 person-years, respectively. As compared with the cancer-TNFi-free group, the risk for mycobacterial diseases increased for the TNFi-exposure group (adjusted HR = 3·6, 95% confidence interval (95% CI) 1·1-11·5, P = 0·032) and remained high for cancer-positive (adjusted HR = 14·6, 95% CI 3·3-63·7, P < 0·001) after adjustment. This study suggested that cancer development increased the risk of mycobacterial diseases in RA patients, and risk assessment for this subgroup should be considered.

Increased risk of incident osteoporosis and osteoporotic fracture in tuberculosis patients: a population-based study in a tuberculosis-endemic area.

The occurrence of osteoporosis in tuberculosis, a chronic infection, has rarely been evaluated. In this study, we found significantly higher incidence rates of osteoporosis (Adjusted hazard ratio (AHR) 1.82) and osteoporotic fracture (AHR 2.33) in tuberculosis patients than matched cohorts, which suggest that osteoporosis screening should be considered in tuberculosis patients' follow-up program. The aim of this study is to determine the occurrence of incident osteoporosis in patients who completed anti-tuberculosis (TB) treatment. INTRODUCTION: Chronic inflammatory disorders are associated with an increased risk of osteoporosis. Although TB is an infectious disease characterized by systemic inflammatory responses, the impact of active TB on incident osteoporosis is unclear. We used the Taiwan National Health Insurance Research Database to investigate the association between history of active TB and incident osteoporosis and osteoporotic fracture. METHODS: In this nationwide retrospective cohort study, active TB patients and their age- and sex-matched controls were identified from the National Health Insurance Research Database in Taiwan during 2000-2012. The occurrence of incident osteoporosis, osteoporotic fractures, and risk factors associated with osteoporosis among TB patients and matched controls were analyzed. RESULTS: We observed incident osteoporosis in 2.2% (n = 86) of the TB patients and in 1.1% (n = 162) of the matched controls. The incidence rate of osteoporosis was 4.31 and 1.80 per 1000 person-years, which was significantly higher in TB patients (p < 0.001). In multivariate analysis, TB was an independent risk factor for osteoporosis. The other independent factors associated with osteoporosis were older age, female sex, chronic obstructive pulmonary disease, asthma, and lower income. Moreover, we demonstrated that the occurrence of osteoporotic fracture was significantly higher in TB patients. CONCLUSIONS: Patients with a history of active TB have a higher incidence rate of osteoporosis and osteoporotic fracture.

Determinants of mortality in elderly patients with tuberculosis: a population-based follow-up study.

Elderly individuals with tuberculosis (TB) are more likely to have a non-specific clinical presentation of TB and high mortality. However, factors associated with mortality in elderly TB patients have not been extensively studied. This retrospective cohort study aimed to identify factors associated with death among elderly Taiwanese with TB. All elderly patients with TB from 2006 to 2014 in Taipei, Taiwan, were included in a study. Multiple logistic regression was used to identify the factors associated with death in elderly TB patients. The mean age of the 5011 patients was 79·7 years; 74·1% were men; 32·7% had mortality during the study follow-up period. After controlling for potential confounders, age ⩾75 years (reference: 65-74 years), male sex, end-stage renal disease (ESRD), malignancy, acid-fast bacilli-smear positivity, TB-culture positivity, pleural effusion on chest radiograph and notification by an ordinary ward or intensive care unit were associated with a higher risk of all-cause death; while high school, and university or higher education, cavity on chest radiograph and directly observed therapy were associated with a lower risk of all-cause death. This study found that the proportion of death among elderly patients with TB in Taipei, Taiwan, was high. To improve TB treatment outcomes, future control programmes should particularly target individuals with comorbidities (e.g. ESRD and malignancy) and those with a lower socio-economic status (e.g. not educated).

Increased risk of pulmonary tuberculosis in patients with gastroesophageal reflux disease.

BACKGROUND: Previous studies have suggested a close correlation between gastroesophageal reflux disease (GERD) and various respiratory disorders. However, the association between GERD and tuberculosis (TB) remains unexplored. METHODS: Using data retrieved from Taiwan's National Health Insurance Research Database from 2000 to 2009, this longitudinal nationwide cohort study included a total of 63,930 patients with GERD and controls matched by age, sex and comorbidities. Risk factors associated with the development of pulmonary TB (PTB) were investigated. RESULTS: Active PTB was documented in 65 (0.20%) patients with GERD and 41 (0.13%) matched cohorts within 1 year of GERD diagnosis. The incidence rate of PTB in the GERD group and the matched cohort was respectively 24.1 and 15.2 cases per 10,000 person-years. In multivariate analysis, GERD was an independent risk factor for PTB (adjusted HR 1.63, 95%CI 1.10-2.40, P = 0.015). Among patients with GERD, independent predictors for PTB included older age, male sex, chronic obstructive pulmonary disease, asthma and exposure to proton pump inhibitors (PPIs). CONCLUSION: Patients with GERD have a significantly increased risk of PTB within 1 year of GERD diagnosis. Exposure to PPIs is an independent predictor for PTB among patients with GERD.

Long-term risk of tuberculosis in haematopoietic stem cell transplant recipients: a 10-year nationwide study.

BACKGROUND: Tuberculosis (TB) is a serious problem for patients undergoing haematopoietic stem cell transplantation (HSCT) in TB-endemic areas; however, data on these patients are limited. METHODS: We obtained data on 2040 HSCT recipients from the Registry of Catastrophic Illness in Taiwan from 1997 to 2006. We also obtained data on age-, sex- and enrolment date-matched controls from the Longitudinal Health Insurance Database. The cumulative incidence of active TB in HSCT recipients and controls and risk factors for TB were analysed. RESULTS: Among 2040 HSCT recipients identified, 39 (1.9%) had newly diagnosed TB. The incidence rate was 688 per 100 000 person-years. The 10-year cumulative TB incidence was respectively 3.52% and 0.38% in HSCT recipients and controls (P < 0.001). HSCT was an independent risk factor for TB compared with matched controls. Among post-HSCT patients, independent risk factors for TB included age ⩾18 years and allogeneic recipients with graft-versus-host disease (GVHD). Post-HSCT patients with subsequent TB had a higher mortality rate than those without TB (P < 0.001). CONCLUSION: HSCT is associated with an increased risk of TB in endemic regions. Older age and development of chronic GVHD are independent predictors of late onset active TB in HSCT recipients.

Randomized clinical trial of endovenous microwave ablation combined with high ligation versus conventional surgery for varicose veins.

OBJECTIVE: To evaluate the efficacy of endovenous microwave ablation (EMA) in treatment of varicose veins (VVS). METHODS: The patients were randomly divided into EMA and high ligation and stripping (HLS) groups. Clinical outcomes and complications were assessed at 1, 3, 6, 12, and 24 months after surgery, and the effect on quality of life was also assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ) and Venous Clinical Severity Score (VCSS) respectively. RESULTS: EMA occluded VVS completely, with a shorter operative time, less bleeding and smaller incisions than the HLS procedure. In the EMA group, skin burns were found on 11 limbs (10.2%); sensory alteration and ecchymosis were less; and the recurrence rate of VVS was relatively lower compared with the HLS group. Both groups had significant improvement in VCSS and disease-specific quality of life (AVVQ) postoperatively. There was no significant difference in AVVQ and VCSS scores between the groups. CONCLUSION: EMA is an effective new technique for the treatment of VVS, and had a more satisfactory clinical outcome than HLS in the short term.

Gender differences in treatment outcomes of tuberculosis patients in Taiwan: a prospective observational study.

Gender disparities in tuberculosis (TB) cases are reported worldwide, and socio-cultural factors have been proposed as possible causes. To date, gender differences in treatment outcomes of TB patients remain controversial. In this prospective observational study, newly diagnosed, culture-proven TB patients from six hospitals in Taiwan were enrolled for analysis. Gender differences in demographic characteristics and treatment outcomes, including sputum conversion and on-treatment mortality, were analysed accordingly. From January 2007 through to December 2009, a total of 1059 patients were enrolled, including 819 (77.3%) males and 240 (22.7%) females. The ratio of male gender was around 50 ~ 60% in TB patients below 35 years and >80% for those older than 65 years. When compared with the female patients, the male patients were older, more likely to have the habit of smoking, chronic obstructive pulmonary disorder, malignancy and liver cirrhosis, and more likely to present with haemoptysis, body weight loss and pleural effusion. Regarding treatment outcomes, male gender is associated with a lower 2-month sputum culture conversion rate (78.8% vs. 89.3%, p 0.002) and higher on-treatment mortality (21.1% vs. 12.1%, p 0.002). Kaplan-Meier survival analysis demonstrated significantly higher mortality in the men (p 0.005). In multivariate analysis, male gender was an independent risk factor for 2-month sputum culture un-conversion (OR, 1.96; 95% CI, 1.12-3.41). Our findings suggest that male gender is associated with older age, more co-morbidities and worse treatment outcomes. Gender-specific strategies, including active case finding in elderly women and smoking cessation in male patients, are warranted to optimize TB management.

Role of 2-month sputum smears in predicting culture conversion in pulmonary tuberculosis.

Sputum smears and culture conversion are frequently used to evaluate treatment response in pulmonary tuberculosis patients. Limited data are available on the evaluation of the correlation between under-treatment sputum smear results and culture conversion. This prospective study included sputum culture-proven pulmonary tuberculosis patients at six hospitals in Taiwan. At least two sets of sputum were collected at the completion of 8 weeks of TB treatment. The sensitivities and specificities of 2-month sputum smears were estimated based on culture conversion status. A total of 371 patients were enrolled for analysis. Factors associated with culture conversion included having a smear positive before treatment, presence of a cavity on radiography, rifampicin resistance and usage of the DOTS (directly observed therapy, short course) strategy. The sensitivities of 2-month sputum smears for culture conversion among all patients, initially smear-positive patients and initially smear-negative patients were 64.3, 71.4 and 38%, respectively, and the specificities were 81.6, 69.9 and 92.8%, respectively. In patients who were 2-month sputum smear-positive, the 2-month culture conversion rate was 80% if the patients were under DOTS and without cavitary lesions in radiograms. The predictive value of 2-month sputum smears in culture conversion was limited and highly influenced by clinical factors in pulmonary tuberculosis patients.

Radiological presentation of pulmonary tuberculosis infected by the W-Beijing Mycobacterium tuberculosis strain.

SETTING: The W-Beijing strain of Mycobacterium tuberculosis is distributed globally, and is associated with high drug resistance rates in some areas. The effect of the W-Beijing strain on radiological features of pulmonary tuberculosis (PTB) remains unclear. OBJECTIVE: To compare the chest radiological presentation of PTB in patients infected with W-Beijing with that of patients infected with non-W-Beijing strains, and to explore factors affecting radiological patterns. DESIGN: Culture-proven PTB patients without previous anti-tuberculosis treatment were enrolled retrospectively. Chest radiographs were independently reviewed by two qualified chest physicians, and radiological presentation was classified into characteristic and unusual patterns. RESULTS: Of 233 patients studied, 123 (52.8%) were infected with the W-Beijing strain. Characteristic radiological patterns (91.1% vs. 76.4%, P = 0.002) and fibronodular lesions without cavity (57.7% vs. 43.6%, P = 0.032) were more common, while miliary lesions (0.0% vs. 3.8%, P = 0.048) were less frequent, in the W-Beijing group. After stepwise logistic regression analysis, the W-Beijing strain (P = 0.006) was found to be an independent factor for the characteristic radiological pattern for PTB. CONCLUSION: The characteristic radiological pattern for PTB was more common in patients infected with the W-Beijing strain. M. tuberculosis genotyping was an independent factor affecting the radiological presentation of pulmonary TB.

Outcome of antenatally diagnosed cardiac rhabdomyoma: case series and a meta-analysis.

OBJECTIVES: Rhabdomyoma, the most common primary fetal cardiac tumor, is often associated with tuberous sclerosis (TS). We aimed to evaluate outcome in cases diagnosed with fetal cardiac rhabdomyoma. METHODS: This study presents 11 cases with fetal cardiac rhabdomyoma. In addition, all relevant published cases of antenatally diagnosed cardiac rhabdomyoma since 1982 were identified from MEDLINE. We evaluated the following risk factors associated with clinical impact and perinatal outcome: family history of TS, gestational age at diagnosis, tumor size, site and number of tumors, tumor progression, and associated intracardiac and extracardiac anomalies. RESULTS: In this meta-analysis, 138 cases, including nine newly added by us, were categorized into Group A (107 live babies) and Group B (16 neonatal deaths and 15 intrauterine fetal deaths). Univariate analysis showed that large cardiac tumors (P < 0.0001), fetal dysrhythmia (P < 0.0001) and hydrops (P < 0.0001) were strong predictors of neonatal outcome. Tumor size >or= 20 mm (relative risk (RR), 20.6; 95% CI, 2.2-195.9; P = 0.009) and fetal dysrhythmia (RR, 13.6; 95% CI, 2.9-62.3; P = 0.001) were significantly associated with neonatal morbidity. TS, present in 85/133 (63.9%) cases, was significantly associated with multiple cardiac tumors (P < 0.0001) and family history of TS (P = 0.02). CONCLUSIONS: Large tumor size and hydrops are significantly associated with poor neonatal outcome, whereas family history of TS and multiple fetal cardiac tumors are associated with TS. Any sonographic detection of a fetal cardiac tumor should warrant further investigation for the possible presence of associated disorders.

Demonstration of a laser vorticity probe in turbulent boundary layers.

A laser-based probe for the nonintrusive measurement of velocity gradient and vorticity was demonstrated in turbulent boundary layers. Unlike most other optical methods, the current technique provides an estimate of the velocity gradient, without having to first measure velocity at multiple points. The measurement principle is based on the heterodyne of coherent light scattered from two adjacent particles. The beat frequency of the heterodyne is directly proportional to the velocity gradient. The probe is assembled from commercially available, inexpensive optical components. A laser Doppler velocimeter (LDV) processor is used to analyze the heterodyne signal. A component of vorticity is obtained by using two appropriately aligned velocity gradient probes. The optical probes developed were used in turbulent boundary layers to measure local, time-frozen velocity gradients partial differential u / partial differential y, partial differential v / partial differential x, and partial differential v / partial differential y, as well as the spanwise vorticity. The measurements were compared to those inferred from LDV measurements in the same facility and to data available in the literature.

Iatrogenic cardiovocal syndrome caused by transcatheter coil closure of patent ductus arteriosus.

UNLABELLED: Two infants developed hoarseness unexpectedly the day after transcatheter coil closure of a slender patent ductus arteriosus (PDA). The pathogenesis of this complication appears to be similar to that of the classic cardiovocal syndrome. During the intervention, the inappropriately implanted coil might have distorted the slender PDA, thereby causing angulation of the pliable PDA itself and precipitating impingement on the left recurrent laryngeal nerve. Fortunately, both infants recovered spontaneously from the hoarseness within several weeks. At present, the definite underlying neuropathology of this complication is unknown as we have not yet confirmed recovery of the left vocal cord movement by follow-up fibreoptic bronchoscopy. CONCLUSION: Iatrogenic cardiovocal syndrome could occur in infants after transcatheter coil closure of a slender PDA, using the currently popular 0.038-inch coil. A coil with a smaller diameter might prevent the occurrence of this syndrome.

Fixed-dose combination chemotherapy (Rifater/Rifinah) for active pulmonary tuberculosis in Taiwan: a two-year follow-up.

SETTING: Veterans General Hospital-Taipei, Taiwan. OBJECTIVE: To assess the efficacy and safety of a fixed-dose combination (FDC) of Rifater (RFT)/Rifinah (RFN) in the treatment of newly diagnosed smear-positive pulmonary tuberculosis. DESIGN: Patients were randomly assigned to two 6-month short-course chemotherapy regimens. One group of patients was treated with FDCs and another was given the four component drugs (INH, RMP, EMB and PZA) as separate formulations. RESULTS: The 105 patients enrolled in the study were divided into two treatment groups. Fifty-one patients who had completed treatment without interruption, 26 in the FDC group and 25 in the separate regimen, were eligible for analysis at the end of 2 years. Among the patients with a drug susceptibility test result available, four in the FDC group had bacilli resistant to pyrazinamide. In the separate regimen group, two patients had bacilli resistant to ethambutol and six had bacilli resistant to pyrazinamide. The two regimens were of similar effectiveness with regard to sputum conversion, compliance and radiological improvement. No patient with FDC treatment developed gastointestinal symptoms, visual disturbance or peripheral neuropathy (P < 0.05). However, FDC treatment resulted in drug-induced fever in one patient. One patient (3.8%) in the FDC group relapsed 5 months after completing treatment. CONCLUSION: This study suggests that the two regimens had similar effectiveness in the treatment of smear-positive pulmonary tuberculosis. However, the fewer adverse drug events among those patients treated with the FDC regimen suggests that it has a better safety profile.