scholarly journals COVID-19 Vaccine Does Not Increase the Risk of Disease Flare-Ups among Patients with Autoimmune and Immune-Mediated Diseases

2021 ◽  
Vol 11 (12) ◽  
pp. 1283
Author(s):  
Larisa Pinte ◽  
Florentina Negoi ◽  
Georgeta Daniela Ionescu ◽  
Simona Caraiola ◽  
Daniel Vasile Balaban ◽  
...  
Keyword(s):  
Vaccine Hesitancy ◽  
Control Group ◽  
Disease Flare ◽  
The Past ◽  
Immune Mediated ◽  
Increased Risk ◽  
Risk Of Disease ◽  
To Receive ◽  
Autoimmune Phenomena

Background: Reports describing post-vaccine autoimmune phenomena, in previously healthy individuals, increased the concerns regarding the risk of disease flare-ups in patients with immune diseases. We aimed to assess the potential risk of disease flare-up, after receiving the COVID-19 (Coronavirus disease 2019) vaccine, during a follow-up period of 6 months. Methods: We performed a prospective cohort study, enrolling the patients with autoimmune- and immune-mediated diseases who voluntarily completed our questionnaire, both online and during hospital evaluations. Based on their decision to receive the vaccine, the patients were divided into two groups (vaccinated and non-vaccinated). Participants who chose not to receive the vaccine served as a control group in terms of flare-ups. Results: A total of 623 patients, 416 vaccinated and 207 non-vaccinated, were included in the study during hospital evaluations (222/623) and after online (401/623) enrolment. There was no difference concerning the risk of flare-up between vaccinated and non-vaccinated patients (1.16, versus 1.72 flare-ups/100 patients-months, p = 0.245). The flare-ups were associated with having more than one immune disease, and with a previous flare-up during the past year. Conclusions: We did not find an increased risk of flare-up following COVID-19 vaccination in patients with autoimmune-/immune-mediated diseases, after a median follow-up of 5.9 months. According to our results, there should not be an obvious reason for vaccine hesitancy among this category of patients.

Effect of zoledronic acid on bone loss in postmenopausal women with early breast cancer treated with sequential tamoxifen and letrozole

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 599-599
Author(s):  
T. Safra ◽  
R. Bernstein Molho ◽  
I. Stephansky ◽  
N. Yaal-Hahoshen ◽  
M. Inbar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Bone Loss ◽  
Postmenopausal Women ◽  
Adjuvant Treatment ◽  
Control Group ◽  
T Score ◽  
Increased Risk ◽  
To Receive

599 Background: Adjuvant treatment with aromatase inhibitors (AIs) in postmenopausal women (PMW) with early breast cancer (EBC) can be associated with decreased bone mineral density (BMD) and increased risk of osteoporosis and fractures. Tamoxifen (TAM) has bone protective effect. BIG 1–98 recent, 71 months update suggests that sequential therapy of TAM and letrozole (LET) in either order, have similar efficacy to 5 years of LET. This study is designed to evaluate the efficacy and safety of zoledronic acid (ZA) in preventing AIs bone loss after 2.5 years of TAM. Methods: This is an open-label, randomized phase II study of PMW with hormone receptor positive EBC previously treated with TAM for the last 2.5 years (with BMD T score ≥ -2.5). Patients are randomly assigned to receive LET (2.5mg/ daily) ± ZA. Patients on treatment arm receive 4 mg IV ZA every 6 months for 2 years. All patients are being evaluated every 6 (0–36) months with blood chemistry and BMD test. All patients receive vitamin D and calcium supplement. A comparison between groups and between time points is performed by one-way ANOVA with repeated measures using the Mixed model. Results: Seventy four patients were screened. Median age was 58.9 years (46.5–83.6). All patients are alive, one had an ipsilateral recurrence. Seventy two patients were evaluable (2 were screening failure), 33 randomized to receive ZA and 39 to the control group. Median follow-up (FU) was 18.2 months (1–47). At this point in time a significant interaction between groups and time trend was found, in favor of ZA treated group in lumbar T score (p = 0.0055). While in the control group a significant decline in lumbar BMD was noticed (p = 0.008), in the treatment group BMD did not change over time (p = 0.2971). Adverse events with ZA were mild with some flue like syndrome. No serious renal adverse event or ONJ (osteonecrosis of jaw) cases were reported. ZA was safe and well tolerated. Conclusions: Sequential adjuvant treatment with TAM and AIs in PMW with EBC can be associated with decreased BMD and increased risk of osteoporosis. In our study, LET-induced bone loss increases with time. A significant benefit in BMD was seen when ZA was added to LET. A longer follow up is needed to evaluate the real magnitude of ZA protective effects. [Table: see text]

scholarly journals Efficacy of Mobile phone use on adherence to Nevirapine prophylaxis and retention in care among the HIV-exposed infants in prevention of mother to child transmission of HIV: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lilian M. N. Kebaya ◽  
Dalton Wamalwa ◽  
Nyambura Kariuki ◽  
Bashir Admani ◽  
Philip Ayieko ◽  
...  
Keyword(s):  
Mobile Phone ◽  
Infant Feeding ◽  
Retention In Care ◽  
Control Group ◽  
Hiv Exposed Infants ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Hiv Exposed ◽  
To Receive

Abstract Background HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity for improving care and promoting retention assessed by timely attendance of scheduled appointments for the mother-baby pairs and achievement of an HIV-free generation. The objective of this study was to compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care assessed by timely attendance of scheduled appointments over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control). Methods In this open label randomized controlled study, one hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 h of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat. Results At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks]. Conclusions These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants. Trial registration PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449

scholarly journals When can total knee arthroplasty be safely performed following prior arthroscopy?

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jin-Ning Ma ◽  
Xiao-Lin Li ◽  
Pan Liang ◽  
Sheng-Li Yu
Keyword(s):  
Total Knee Arthroplasty ◽  
Postoperative Complications ◽  
Knee Arthroplasty ◽  
Acl Injury ◽  
Control Group ◽  
Optimal Timing ◽  
Complication Rates ◽  
Increased Risk ◽  
Total Knee

Abstract Background The optimal timing to perform a total knee arthroplasty (TKA) after knee arthroscopy (KA) was controversial in the literature. We aimed to 1) explore the effect of prior KA on the subsequent TKA; 2) identify who were not suitable for TKA in patients with prior KA, and 3) determine the timing of TKA following prior KA. Methods We retrospectively reviewed 87 TKAs with prior KA and 174 controls using propensity score matching in our institution. The minimum follow-up was 2 years. Postoperative clinical outcomes were compared between groups. Kaplan-Meier curves were created with reoperation as an endpoint. Multivariate Cox proportional hazards regressions were performed to identify risk factors of severe complications in the KA group. The two-piecewise linear regression analysis was performed to examine the optimal timing of TKA following prior KA. Results The all-cause reoperation, revision, and complication rates of the KA group were significantly higher than those of the control group (p < 0.05). The survivorship of the KA group and control group was 92.0 and 99.4% at the 2-year follow-up (p = 0.002), respectively. Male (Hazards ratio [HR] = 3.2) and prior KA for anterior cruciate ligament (ACL) injury (HR = 4.4) were associated with postoperative complications in the KA group. There was a non-linear relationship between time from prior KA to TKA and postoperative complications with the turning point at 9.4 months. Conclusion Prior KA is associated with worse outcomes following subsequent TKA, especially male patients and those with prior KA for ACL injury. There is an increased risk of postoperative complications when TKA is performed within nine months of KA. Surgeons should keep these findings in mind when treating patients who are scheduled to undergo TKA with prior KA.

Adverse effects of prolonged hyperventilation in patients with severe head injury: a randomized clinical trial

1991 ◽  
Vol 75 (5) ◽  
pp. 731-739 ◽  
Author(s):  
J. Paul Muizelaar ◽  
Anthony Marmarou ◽  
John D. Ward ◽  
Hermes A. Kontos ◽  
Sung C. Choi ◽  
...  
Keyword(s):  
Cerebral Ischemia ◽  
Control Group ◽  
Content Type ◽  
Cerebral Vasoconstriction ◽  
Number Of Patients ◽  
Severity Of Injury ◽  
Head Injured ◽  
Injured Patients ◽  
To Receive

✓ There is still controversy over whether or not patients should be hyperventilated after traumatic brain injury, and a randomized trial has never been conducted. The theoretical advantages of hyperventilation are cerebral vasoconstriction for intracranial pressure (ICP) control and reversal of brain and cerebrospinal fluid (CSF) acidosis. Possible disadvantages include cerebral vasoconstriction to such an extent that cerebral ischemia ensues, and only a short-lived effect on CSF pH with a loss of HCO3− buffer from CSF. The latter disadvantage might be overcome by the addition of the buffer tromethamine (THAM), which has shown some promise in experimental and clinical use. Accordingly, a trial was performed with patients randomly assigned to receive normal ventilation (PaCO2 35 ± 2 mm Hg (mean ± standard deviation): control group), hyperventilation (PaCO2 25 ± 2 mm Hg: HV group), or hyperventilation plus THAM (PaCO2 25 ± 2 mm Hg: HV + THAM group). Stratification into subgroups of patients with motor scores of 1–3 and 4–5 took place. Outcome was assessed according to the Glasgow Outcome Scale at 3, 6, and 12 months. There were 41 patients in the control group, 36 in the HV group, and 36 in the HV + THAM group. The mean Glasgow Coma Scale score for each group was 5.7 ± 1.7, 5.6 ± 1.7, and 5.9 ± 1.7, respectively; this score and other indicators of severity of injury were not significantly different. A 100% follow-up review was obtained. At 3 and 6 months after injury the number of patients with a favorable outcome (good or moderately disabled) was significantly (p < 0.05) lower in the hyperventilated patients than in the control and HV + THAM groups. This occurred only in patients with a motor score of 4–5. At 12 months posttrauma this difference was not significant (p = 0.13). Biochemical data indicated that hyperventilation could not sustain alkalinization in the CSF, although THAM could. Accordingly, cerebral blood flow (CBF) was lower in the HV + THAM group than in the control and HV groups, but neither CBF nor arteriovenous difference of oxygen data indicated the occurrence of cerebral ischemia in any of the three groups. Although mean ICP could be kept well below 25 mm Hg in all three groups, the course of ICP was most stable in the HV + THAM group. It is concluded that prophylactic hyperventilation is deleterious in head-injured patients with motor scores of 4–5. When sustained hyperventilation becomes necessary for ICP control, its deleterious effect may be overcome by the addition of THAM.

Abstract MP86: The Joint Effect of Outdoor Recreational Activity and 25-Hydroxyvitamin D on Cardiovascular Mortality in THE NHANES III Population

Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Macarius Donneyong ◽  
Carlton A Hornung
Keyword(s):  
Elevated Risk ◽  
Physical Activities ◽  
Mortality Data ◽  
Nhanes Iii ◽  
Additive Interaction ◽  
Joint Effects ◽  
The Past ◽  
Increased Risk ◽  
Cvd Mortality

Purpose Recreational physical activity (PA) reduces the risk of cardiovascular disease (CVD) morbidity and mortality. Outdoor-based recreational physical activities (ORA) have been reported to be associated with elevated 25(OH)D levels. We investigate the joint effects of frequent ORA and 25(OH)D levels on the risk of CVD mortality and the modifying effects of 25(OH)D. Methods Our sample consisted of 13,031 nationally representative adults (20 - 90 years old) free from CVD and cancer at baseline in the NHANES III (1988 - 1994) linked mortality dataset with follow-up mortality data through 2006. CVD mortality was based on reported deaths with corresponding ICD-10 codes for CVD as underlying cause of death. ORA was defined as self-reported participation in recreational physical activities considered to have occurred outdoors in the past month. Time to CVD mortality was estimated from multivariable adjusted Cox proportional hazards (CPH) models. A joint effects model was used in estimating multiplicative and additive interaction between ORA and 25(OH)D. Results A crude unweighted CVD mortality rate of 7.4% (964/13,031) occurred during a median follow-up of 14.33 years. Frequency of ORA <5 in the past month (HR=1.38, 95%CI:1.09 - 1.75) and 25(OH)D <30 ng/mL (HR=1.28, 95%CI:1.01 - 1.60) were associated with increased risk of CVD mortality compared to ORA ≥5 and 25(OH)D ≥30 ng/mL respectively, in a multivariable adjusted CPH model. In the joint effects model, frequency of ORA <5 and 25(OH)D <30 ng/mL (HR=1.81, 95%CI:1.05 - 3.10) and frequency of ORA <5 and 25(OH)D ≥30 ng/mL (HR=1.33, 95%CI:1.02 - 1.73) were associated with elevated risk of CVD mortality compared to the joint effects of ORA ≥5 and 25(OH)D ≥30 ng/mL. The joint effects model indicated the presence of multiplicative interaction. The synergy index, 1.52 (95%CI:0.31 - 7.41) suggested presence of additive interaction even though not statistically significant. Conclusion Lower frequency of ORA and serum 25(OH)D levels were jointly associated with elevated risk of CVD mortality. Serum 25(OH)D modified the risk of CVD mortality associated with lower frequency of outdoor-based recreational activities.

Abstract 092: No Change in Peripartum Cardiomyopathy Outcomes or Risk Factors Over the Past Decade

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Nivedita Basu ◽  
Madeline Mahowald ◽  
Kris Kawamoto ◽  
Melinda Davis
Keyword(s):  
Risk Factors ◽  
Maternal Age ◽  
Care Center ◽  
Tertiary Care ◽  
Temporal Trends ◽  
Peripartum Cardiomyopathy ◽  
Icd Implantation ◽  
The Past ◽  
Increased Risk

Background: Few studies have evaluated temporal trends in outcomes and risk factors for peripartum cardiomyopathy (PPCM). Prior research using administrative data could only assess short-term in-hospital adverse events. It has also been hypothesized that the incidence of PPCM is rising due to advancing maternal age and increased risk factors. Therefore, we examined long-term outcomes and prognostic factors to determine if there has been any change over the past decade. Methods: Patients seen at a tertiary care center between 2000 and 2011 with a diagnosis of PPCM were identified by ICD9 code 674.5x and confirmed by manual chart review. Year of diagnosis, clinical and demographic variables, echocardiographic data, and outcomes including myocardial recovery (defined as EF>=55%), ICD placement, LVAD, transplant, and death were reviewed for follow-up through November 2016. Results: Of 60 patients, 31 (52%) were diagnosed recently (2006-2011) and 29 (48%) were diagnosed prior to 2006 (1996-2005). There were no significant differences in the recent group compared to the past group in initial EF (19% vs 22%), final EF (39% vs 39%), and final recovery status (52% vs 48%). Similarly, there were no differences in rates of ICD implantation, LVAD/transplant, mortality, and years of survival. There were no differences in age at diagnosis or in rates of hypertension, smoking, or diabetes. Few patients in either category underwent a subsequent pregnancy. Mean years of follow-up (through 2016) were longer for those diagnosed prior to 2006 (8.3 years vs 3.4 years, p<0.001). Conclusions: There has been no improvement in outcomes for patients diagnosed with PPCM in the past decade. Maternal age and risk factors do not appear to be increasing. Despite advances in heart failure treatment and increased awareness of PPCM, more research about the management and follow-up of young mothers with PPCM is needed.

scholarly journals Reversal of Prediabetes in Saudi Adults: Results from an 18 Month Lifestyle Intervention

Nutrients ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 804 ◽  
Author(s):  
Osama E. Amer ◽  
Shaun Sabico ◽  
Hanan A. Alfawaz ◽  
Naji Aljohani ◽  
Syed Danish Hussain ◽  
...  
Keyword(s):  
Lifestyle Intervention ◽  
Lifestyle Modification ◽  
Multicenter Trial ◽  
Lifestyle Changes ◽  
Control Group ◽  
Post Intervention ◽  
Exercise Behaviors ◽  
Diet And Exercise ◽  
To Receive

Aim: This 18 month intervention study aims to determine the efficacy of a lifestyle modification program on prediabetes reversal among Saudi adults. Methods: An 18 month randomized, multicenter trial was conducted among Saudis with prediabetes aged 25–60 recruited from King Salman Hospital and primary care centers in Riyadh, Saudi Arabia. A total of 180 consenting individuals were randomized (1:1) to receive either intensive lifestyle intervention (ILIG) or guidance (control group, CG). ILIG was provided with a personalized lifestyle counseling by nutritionists every 3 months to improve diet and exercise behaviors. CG was given booklets containing information on prediabetes and its prevention. Data from lifestyle assessments and laboratory measurements were analyzed at baseline and every 6 months. The primary outcome was the reversal rate of prediabetes. Results: 158 participants were analyzed (CG:85, ILIG:73) at the 12 month follow-up and 28 participants (CG:11 and ILIG:17) completed the entire 18 month study. Post-intervention, the cumulative incidence of prediabetes reversal in the ILIG was 38 participants (52.1%) which was significantly higher than CG with 26 participants (30.6%) (p = 0.02). Conclusion: A tailored lifestyle intervention is effective in reversing prediabetes, at least for a year, among Arab adults with prediabetes. The challenge of sustaining interest in adopting lifestyle changes for a longer duration should be addressed in this population.

Manganese and Lipoflavonoid Plus® to Treat Tinnitus: A Randomized Controlled Trial

2016 ◽  
Vol 27 (08) ◽  
pp. 661-668 ◽  
Author(s):  
Eveling Rojas-Roncancio ◽  
Richard Tyler ◽  
Hyung-Jin Jun ◽  
Tang-Chuan Wang ◽  
Haihong Ji ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Data Collection And Analysis ◽  
Loudness Match ◽  
Minimal Masking Level ◽  
Lost To Follow Up ◽  
To Receive

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus® to treat their tinnitus. Research Design: Randomized controlled trial. Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus® for 6 months, or Lipoflavonoid Plus® only (as the control). Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus® is an effective treatment for tinnitus.

scholarly journals Increased Risk of Temporomandibular Joint Disorder in Patients with Rheumatoid Arthritis: A Longitudinal Follow-Up Study

2020 ◽  
Vol 9 (9) ◽  
pp. 3005
Author(s):  
Soo-Hwan Byun ◽  
Chanyang Min ◽  
Hyo-Geun Choi ◽  
Seok-Jin Hong
Keyword(s):  
Rheumatoid Arthritis ◽  
Temporomandibular Disorder ◽  
Population Data ◽  
Control Group ◽  
Chi Square ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Increased Risk ◽  
Joint Disorder

We evaluated the incidence of temporomandibular disorder (TMD) in patients with rheumatoid arthritis (RA) and examined the association between TMD and RA, through longitudinal follow-up. Population data from the Korean National Health Insurance Service-Health Screening Cohort from 2002 to 2015 was used. From 514,866 subjects, 3122 with RA were matched with 12,488 controls in a 1:4 ratio. The crude and adjusted models (for obesity, smoking, alcohol consumption, blood pressure, blood glucose, total cholesterol, and Charlson Comorbidity Index scores) were calculated. Chi-square tests, Kaplan-Meier (KM) analysis, and two-tailed analyses were used for statistical analysis. Stratified Cox proportional hazard models were used to assess the hazard ratios (HR) and 95% confidence intervals (CI) for TMD in the RA group, compared to those in the control group. The adjusted HR for TMD in RA was 2.52 (95% CI = 1.70–3.74), compared to the control group. The results were consistent with the subgroup analyses, according to age and sex, except in men older than 60 years of age. KM analysis showed similar results. Hence, we found that patients with RA have a higher risk of TMD, and should be observed for symptoms of the initial stage of TMD to prevent the risk of aggravation.

Superiority of ProMACE-CytaBOM over ProMACE-MOPP in the treatment of advanced diffuse aggressive lymphoma: results of a prospective randomized trial.

1991 ◽  
Vol 9 (1) ◽  
pp. 25-38 ◽  
Author(s):  
D L Longo ◽  
V T DeVita ◽  
P L Duffey ◽  
M N Wesley ◽  
D C Ihde ◽  
...  
Keyword(s):  
Total Dose ◽  
Pneumocystis Carinii ◽  
Large Cell ◽  
Complete Response ◽  
Aggressive Lymphoma ◽  
Increased Risk ◽  
Aggressive Histology ◽  
To Receive ◽  
Related Mortality

One hundred ninety-three patients with stage II, III, or IV follicular large-cell, diffuse large-cell, diffuse mixed, immunoblastic, or diffuse small noncleaved-cell (non-Burkitt's) lymphoma were randomized to receive either cyclophosphamide 650 mg/m2 intravenously (IV), doxorubicin 25 mg/m2 IV, etoposide 120 mg/m2 IV on day 1, mechlorethamine 6 mg/m2 IV, vincristine 1.4 mg/m2 (no cap at 2 mg total dose) IV on day 8, prednisone 60 mg/m2 orally daily days 1 through 14, procarbazine 100 mg/m2 orally daily days 8 through 14, and methotrexate 500 mg/m2 IV on day 15 with leucovorin 50 mg/m2 orally every 6 hours for four doses beginning 24 hours after methotrexate with cycles repeated every 28 days (ProMACE-MOPP) or same day-1 treatment as ProMACE-MOPP plus cytarabine 300 mg/m2 IV, bleomycin 5 U/m2 IV, vincristine 1.4 mg/m2 (no cap at 2 mg total dose) IV, and methotrexate 120 mg/m2 IV on day 8, leucovorin 25 mg/m2 orally every 6 hours for four doses beginning 24 hours after methotrexate, and prednisone 60 mg/m2 orally daily days 1 through 14 with cycles repeated every 21 days (ProMACE-CytaBOM). Co-trimoxazole two double-strength tablets orally twice daily throughout the period of treatment was added to the ProMACE-CytaBOM regimen when an increased risk of Pneumocystis carinii pneumonia was found in the first 35 patients receiving this combination. Median follow-up is 5 years. Among the 99 patients treated with ProMACE-MOPP, 73 achieved a complete remission (CR) (74%), 30 complete responders have relapsed (41%), and 45 patients have died (45%), including two (2%) of treatment-related causes. Among the 94 patients treated with ProMACE-CytaBOM, 81 achieved a CR (86%), 22 complete responders have relapsed (27%), and 31 patients have died (33%). The complete response rate (P2 = .048) and survival (P2 = .046) were significantly higher for patients treated with ProMACE-CytaBOM. The mortality of ProMACE-CytaBOM treatment overall was six of 94 patients (6.4%). There was no treatment-related mortality among patients treated with prophylactic co-trimoxazole (n = 59). ProMACE-CytaBOM combination chemotherapy with co-trimoxazole prophylaxis is a safe and effective treatment for patients with aggressive histology malignant lymphoma and is superior to ProMACE-MOPP.

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