Characteristics of COVID-19 and possibilities of early causal therapy. Results of favipiravir use in clinical practice

This paper provides the results of a study evaluating the efficacy and safety of etiotropic therapy in patients hospitalized with SARS-CoV-2 infection. Objective. Тo evaluate the efficacy and safety of favipiravir (Areplivir) in patients with coronavirus disease 2019 (COVID-19) and compare it with recommended standard therapy. Patients and methods. Two hundred men and women aged between 18 and 80 years with COVID-19 were randomized into this study. The experimental group included patients who received favipiravir, whereas the control group comprised patients who received causal therapy in accordance with the latest version of the temporary methodical recommendations of the Ministry of Health of Russia ‘Prevention, diagnosis, and treatment of coronavirus infection (COVID-19).’ The efficacy and safety of therapy were evaluated by assessing clinical improvement using the WHO Ordinal Scale for Clinical Improvement, clinical and laboratory parameters, findings of chest computed tomography (CT), and elimination of SARS-CoV-2. We also analyzed the frequency and type of adverse events, need for invasive and non-invasive ventilation, and death rates. Results. Our analysis has demonstrated significant benefits of favipiravir over standard therapy in terms of the time to clinical improvement (in the experimental group it was 4 days shorter on average), time to recovery, frequency of recovery after 10 days (44% of patients from the experimental group and 10% of patients from the control group had no clinical signs of the disease at this time-point), and frequency of virus elimination by day 10 of therapy. Treatment with favipiravir was associated with a significant improvement in the lung condition (according to CT), normalization of laboratory parameters, and saturation level. Favipiravir has demonstrated a good safety profile similar to that of standard therapy. There was no difference in the frequency of adverse events between the experimental and control groups. Conclusion. The use of favipiravir for the treatment of SARS-CoV-2 infection reduced the time to clinical improvement by 4 days on average compared to standard therapy, ensured improvement of the lung condition (according to CT scans), and facilitated virus elimination in more than 90% of patients, thereby promoting faster recovery. Favipiravir had a good safety profile and was well tolerated by patients. This treatment regimen was shown to be effective, sufficient, and clinically reasonable to achieve good outcomes. Timely initiation of therapy with favipiravir (Areplivir) improves disease prognosis and reduces the global socioeconomic burden of the current pandemic. Key words: COVID-19, Areplivir, coronavirus, causal therapy, favipiravir

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Efficacy and safety of a monodisperse solid-in-oil-in-water emulsion in transcatheter arterial chemoembolization in a rabbit VX2 tumor model

10.1101/759316 ◽

2019 ◽

Author(s):

Daisuke Yasui ◽

Aya Yamane ◽

Hiroshi Itoh ◽

Masayuki Kobayashi ◽

Shin-ichiro Kumita

Keyword(s):

Adverse Events ◽

Transcatheter Arterial Chemoembolization ◽

Iodine Concentration ◽

Control Group ◽

Efficacy And Safety ◽

Water Emulsion ◽

Left Liver Lobe ◽

Vx2 Tumor ◽

Experimental Group ◽

Arterial Chemoembolization

AbstractTranscatheter arterial chemoembolization (TACE) is a standard treatment for unresectable hepatocellular carcinoma; however, it does not always result in tumor control. Nevertheless, treatment outcome can be improved with monodisperse emulsions of anticancer agents. In this study, the efficacy and safety of a monodisperse miriplatin-Lipiodol emulsion were evaluated in Japanese white rabbits. VX2 tumor was implanted into the left liver lobe of each rabbit. The animals were divided into control and experimental groups (of five animals each) and respectively administered a conventional miriplatin suspension or the emulsion via the left hepatic artery. Computed tomography (CT) was performed before, immediately after, and two days following TACE. All rabbits were sacrificed two days after the procedure. Each tumor was removed and cut in half for assessment of iodine concentration in one half by mass spectroscopy and evaluation of Lipiodol accumulation and adverse events in the other half. Mean Hounsfield unit (HU) values were measured using plain CT images taken before and after TACE. Iodine concentration was higher in the experimental group [1100 (750–1500) ppm] than in the control group [840 (660–1800) ppm]. Additionally, the HU value for the experimental group was higher than that for the control group immediately after [199.6 (134.0– 301.7) vs. 165.3 (131.4–280.5)] and two days after [114.2 (56.1–229.8) vs. 58.3 (42.9–132.5)] TACE. Cholecystitis was observed in one rabbit in the control group. Ischemic bile duct injury was not observed in any group. The results show that Lipiodol accumulation and retention in VX2 tumor may be improved by using a monodisperse emulsion. Moreover, no significant adverse events are associated with the use of the emulsion.

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Anerning Granule for Community Acquired Pneumonia: Protocol for Randomized, Double-Blind, Single-Dummy, Parallel Control of Placebo, Multicenter Clinical Trial

10.21203/rs.3.rs-32872/v1 ◽

2021 ◽

Author(s):

Menghua Sun ◽

Jian Lyu ◽

Yi-li Zhang ◽

Xu Wei ◽

Li-dan Zhang ◽

...

Keyword(s):

Adverse Events ◽

Community Acquired Pneumonia ◽

Clinical Treatment ◽

Secondary Outcome ◽

Control Group ◽

Efficacy And Safety ◽

Double Blind ◽

Ceftriaxone Sodium ◽

Parallel Control ◽

Experimental Group

Abstract Background: Community acquired pneumonia (CAP) in children is one of the common clinical diseases and infectious diseases threatening the health of the population. CAP has complicated causes, closely related to region, season, age, and primary disease. It is the most common cause of children being hospitalized and the first cause of death for children under 5 years old. At present, the clinical treatment is mainly antibiotics, but abuse and non-standard combination of antibiotics have led to increasing antibiotic resistance. Anerning Granules have the functions of clearing away heat and removing wind, reducing phlegm and relieving cough, and improving cough symptoms and lung signs. Thus, this study aims to evaluate the efficacy and safety of Anerning Granules (AEN) in the treatment of community-acquired pneumonia in children, and to explore whether AEN can reduce the use of antibiotics and have a good effect on the clinical treatment of CAP.Methods and analysis: this study, a randomized, double-blind, single-dummy, parallel control of placebo, multicenter clinical study will be established in 7 hospitals in the same period. A total of 216 patients with community-acquired pneumonia will be randomly allocated at a ratio of 2:1 to two groups: experimental group, control group. The experimental group receives Anerning Granules plus ceftriaxone sodium; the control group receives AEN placebo plus ceftriaxone sodium. Each group will be treated for ten days, and a stage effect evaluation will be conducted on the sixth day. The primary outcome is the end of antibiotics in frequency (DDDs) and effective rate. Secondary outcome measures of effectiveness are the full fever time, sore throat onset time, and safety assessment. Outcomes will be assessed at baseline and after treatment. In addition, adverse events will be monitored throughout the trial process and must be traced to be resolved.Discussion: This study protocol will provide the research data regarding the efficacy and safety of AEN for the treatment of community-acquired pneumonia in children. The first aim is to determine whether Anerning Granules can reduce the use of antibiotics; the second aim is to evaluate the effectiveness of Anerning Granules combined with ceftriaxone sodium in the treatment of children with community-acquired pneumonia. The third aim is to observe the safety of clinical application of Anerning Granules. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices of adverse events, which will provide reliable evidence for clinical treatment.Trial registration: Clinicaltrials.gov identifier: NCT03675178, registered on 16 September 2018.

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Methylprednisolone Pulses Plus Tacrolimus in Addition to Standard of Care vs. Standard of Care Alone in Patients With Severe COVID-19. A Randomized Controlled Trial

Frontiers in Medicine ◽

10.3389/fmed.2021.691712 ◽

2021 ◽

Vol 8 ◽

Author(s):

Xavier Solanich ◽

Arnau Antolí ◽

Gemma Rocamora-Blanch ◽

Núria Padullés ◽

Marta Fanlo-Maresma ◽

...

Keyword(s):

Adverse Events ◽

Experimental Treatment ◽

Standard Of Care ◽

Experimental Therapy ◽

Control Group ◽

Efficacy And Safety ◽

All Cause Mortality ◽

Secondary Outcomes ◽

Experimental Group ◽

Clinical Stability

Introduction: Severe lung injury is triggered by both the SARS-CoV-2 infection and the subsequent host-immune response in some COVID-19 patients.Methods: We conducted a randomized, single-center, open-label, phase II trial with the aim to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) vs. SoC alone, in hospitalized patients with severe COVID-19. The primary outcome was time to clinical stability within 56 days after randomization.Results: From April 1 to May 2, 2020, 55 patients were prospectively included for subsequent randomization; 27 were assigned to the experimental group and 28 to the control group. The experimental treatment was not associated with a difference in time to clinical stability (hazard ratio 0.73 [95% CI 0.39–1.37]) nor most secondary outcomes. Median methylprednisolone cumulative doses were significantly lower (360 mg [IQR 360–842] vs. 870 mg [IQR 364–1451]; p = 0.007), and administered for a shorter time (median of 4.00 days [3.00–17.5] vs. 18.5 days [3.00–53.2]; p = 0.011) in the experimental group than in the control group. Although not statistically significant, those receiving the experimental therapy showed a numerically lower all-cause mortality than those receiving SoC, especially at day 10 [2 (7.41%) vs. 5 (17.9%); OR 0.39 (95% CI 0.05–2.1); p = 0.282]. The total number of non-serious adverse events was 42 in each the two groups. Those receiving experimental treatment had a numerically higher rate of non-serious infectious adverse events [16 (38%) vs. 10 (24%)] and serious infectious adverse events [7 (35%) vs. 3 (23%)] than those receiving SoC.Conclusions: The combined use of methylprednisolone pulses plus tacrolimus, in addition to the SoC, did not significantly improve the time to clinical stability or other secondary outcomes compared with the SoC alone in severe COVID-19. Although not statistically significant, patients receiving the experimental therapy had numerically lower all-cause mortality than those receiving SoC, supporting recent non-randomized studies with calcineurin inhibitors. It is noteworthy that the present trial had a limited sample size and several other limitations. Therefore, further RCTs should be done to assess the efficacy and safety of tacrolimus to tackle the inflammatory stages of COVID-19.Clinical Trial Registration: Identifier [NCT04341038/EudraCT: 2020-001445-39].

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Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

Reviews on Recent Clinical Trials ◽

10.2174/1574887114666191105152404 ◽

2020 ◽

Vol 15 (1) ◽

pp. 34-47 ◽

Cited By ~ 1

Author(s):

Muhammed Rashid ◽

Madhan Ramesh ◽

K. Shamshavali ◽

Amit Dang ◽

Himanshu Patel ◽

...

Keyword(s):

Prostate Cancer ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Quality Assessment ◽

Cochrane Library ◽

Control Group ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

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Efficacy and Safety of Socheongryong-Tang Among Atopic Dermatitis Patients With Respiratory Disorders: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial

Frontiers in Pharmacology ◽

10.3389/fphar.2020.597885 ◽

2020 ◽

Vol 11 ◽

Author(s):

Ju Hyun Lee ◽

Eun Heui Jo ◽

Jee Youn Jung ◽

Young-Eun Kim ◽

Mi-Ju Son ◽

...

Keyword(s):

Clinical Trial ◽

Atopic Dermatitis ◽

Safety Evaluation ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Inflammatory Skin Disease ◽

Double Blinded ◽

Study Participants ◽

Experimental Group

Atopic dermatitis is a chronic inflammatory skin disease that affects the growth and development of children. The prevalence of atopic dermatitis has been continually increasing, and this has also been accompanied by rising socioeconomic costs. Interest has been growing in alternative medicine as a means of alleviating the burden of atopic dermatitis. This was a single-center, double-blinded, randomized, placebo-controlled investigator-led clinical trial including 60 atopic dermatitis patients. The participants were classified into an experimental group (30 persons) and a control group (30 persons), who were administered, respectively, socheongryong-tang or a placebo for 4 weeks. After 4 weeks of treatment, the participants visited the trial center again and assess their efficacy and safety. The researchers performed statistical comparisons of the changes in the SCORAD Index, amount and frequency of ointment use, and height and weight to assess the efficacy. To assess the safety, diagnostic tests and vital sign checks were performed at each visit, and the presence or absence of adverse events was observed. As a result, the frequency and the amount of steroid ointment application in both groups increased, but the experimental group showed less tendency (p = 0.081). Results of analyzing the children in the experimental group in relation to growth showed a significantly greater height growth than the control group (p < 0.05). In addition, all study participants did not show any remarkable abnormal signs in the safety evaluation. In conclusion, compared to the control group, the experimental group, who took socheongryong-tang showed a tendency to be less dependent on steroid ointment and statistically significant increase in height.

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Efficacy and safety of Nd:YAG laser vitreolysis for symptomatic vitreous floaters: A randomized controlled trial

European Journal of Ophthalmology ◽

10.1177/1120672120968762 ◽

2020 ◽

pp. 112067212096876

Author(s):

Gustavo D Ludwig ◽

Henrique Gemelli ◽

Guilherme M Nunes ◽

Pedro D Serracarbassa ◽

Márgara Zanotele

Keyword(s):

Adverse Events ◽

Contrast Sensitivity ◽

Nd:Yag Laser ◽

Visual Disturbance ◽

Control Group ◽

Efficacy And Safety ◽

Yag Laser ◽

Vitreous Floaters ◽

Significant Difference ◽

Laser Group

Background: Vitreous floaters are a common and inconvenient phenomena. This study aims to examine the efficacy and safety in treating vitreous floaters using Nd:YAG laser vitreolysis. Methods: In this prospective double-blinded randomized clinical trial 24 eyes of twenty-four patients were randomized into intervention with YAG laser vitreolysis and control groups. Primary outcomes were visual disturbance on a 10-point scale, qualitative changes in a 4-level scale, contrast sensitivity measured with the Pelli-Robson table and the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary results included objective change in vitreous opacities, best-corrected visual acuity (BCVA), variation in intraocular pressure (IOP) and other adverse events. Results: Twenty-one patients (21 eyes; 5 male, 16 female) were enrolled in this study (mean age 62 ± 7.9 years), three were lost during follow-up. In the YAG laser group, the 10-point visual disturbance score improved a mean of 4.7 points ( p < 0.001) compared to the control group that improved 2.1 ( p = 0.09). The YAG laser group reported greater subjectively symptomatic improvement (77%) than controls (25%). NEI VFQ-25 revealed improved general vision (75.8 versus 59.2; p = 0.037) and in mental health at 6 months (84.3 versus 70.3; p = 0.048). There was no significant difference in contrast sensitivity ( p = 0.848) and in IOP ( p = 0.505). No differences in adverse events between groups were identified. Conclusion: Vitreolysis with Nd:YAG laser improves visual results in patients with symptomatic vitreous floaters, without adverse events considered clinically relevant. Other trials with a larger number of participants are required to corroborate these results.

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Efficacy and Safety of Single-Agent Ruxolitinib Therapy for Myelofibrosis and Polycythemia Vera: A Meta-Analysis

Blood ◽

10.1182/blood.v126.23.1622.1622 ◽

2015 ◽

Vol 126 (23) ◽

pp. 1622-1622

Author(s):

Shijia Zhang ◽

Yucai Wang ◽

Larysa Sanchez ◽

Narjust Duma ◽

Victor Chang

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Polycythemia Vera ◽

Standard Therapy ◽

Meta Analysis ◽

Single Agent ◽

Efficacy And Safety ◽

Spleen Volume ◽

Peripheral Edema ◽

Pooled Data

Abstract Background: Ruxolitinib, a potent JAK1/JAK2 inhibitor, was approved by the FDA for the treatment of myelofibrosis (MF) and polycythemia vera (PV) in 2011 and 2014, respectively. The aim of this study was to evaluate the efficacy and safety data of single-agent ruxolitinib in patients with MF or PV through meta-analysis of reported clinical trials. Methods: PubMed and Web of Science databases were searched for clinical trials of ruxolitinib for the treatment of MF or PV through June 30th, 2015. Only clinical trials in which ruxolitinib was used as single-agent therapy for MF or PV were included in this meta-analysis. Pooled odds ratios (ORs) for proportion of patients with >= 35% reduction in spleen volume (primary outcome) and risk ratios (RRs) for dichotomous data with 95% confidence interval (CI) were analyzed using OpenMeta[Analyst] with a random effect model. Pooled ratios of adverse events of ruxolitinib therapy were also calculated. Results: Six clinical trials including 3 randomized controlled trials (RCTs) of 987 patients were identified and included in the analysis. Four studies were conducted in MF patients, and 2 studies in PV patients. Pooled data from the 3 RCTs (2 for MF and 1 for PV) showed that ruxolitinib, compared to placebo or standard therapy/best available therapy (BAT), significantly increased the proportion of patients with a reduction in spleen volume of 35% or more (OR = 79.55, 95% CI = 22.51-281.11, p < 0.001). Ruxolitinib improved the symptoms associated with MF or PV. Only the 2 RCTs for MF analyzed overall survival (OS), one of which showed OS benefit with ruxolitinib. Pooled data from all 6 trials showed that the most common hematologic adverse events were all grades anemia (71.8%) and thrombocytopenia (54.1%), regardless of whether or not they were deemed related to ruxolitinib therapy. Incidence of grades 3/4 anemia and thrombocytopenia was 30.2% and 15.3%, respectively, but rarely led to discontinuation of the drug. The most common non-hematologic adverse events were diarrhea (all grades = 18.1%, grades 3/4 = 1.1%), fatigue (all grades = 14.0%, grades 3/4 = 2.0%), peripheral edema (all grades = 12.0%, grades 3/4 = 0%), and dyspnea (all grades = 10.0%, grades 3/4 = 0.9%). Further analysis was conducted to evaluate the attributable risks of the adverse events using data from the 3 RCTs. Compared to placebo or standard therapy/BAT, ruxolitinib significantly increased the risk of developing all grades anemia (RR = 1.10, 95% CI = 1.03-1.17, p = 0.005), grades 3/4 anemia (RR = 1.87, 95% CI = 1.20-2.93, p = 0.006), all grades thrombocytopenia (RR = 2.04, 95% CI = 1.47-2.83, p < 0.001), but not grades 3/4 thrombocytopenia (RR = 2.04, 95% CI = 0.72-7.98, p = 0.153), all grades diarrhea (RR = 1.45, 95% CI = 0.96-2.20, p = 0.079), fatigue (RR = 0.865, 95% CI = 0.62-1.20, p = 0.382), peripheral edema (RR = 0.85, 95% CI = 0.61-1.18, p = 0.337), and dyspnea (RR = 1.25, 95% CI = 0.63-2.49, p = 0.520). Conclusions: Single-agent ruxolitinib therapy results in improvement of symptoms in MF or PV and significant reduction in spleen size compared to placebo or standard therapy/BAT. Anemia and thrombocytopenia were the most common hematologic adverse events, but rarely led to the discontinuation of therapy. Diarrhea, fatigue, peripheral edema and dyspnea were the most common non-hematologic adverse events, but not significant compared to placebo or standard therapy/BAT. Disclosures Chang: Johnson & Johnson: Other: Stock.

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Clinical efficacy and safety of silver nanoparticlebased disinfectant combined with piperacillin sodium and sulbactam sodium in the treatment of lower respiratory tract infection

Materials Express ◽

10.1166/mex.2020.1693 ◽

2020 ◽

Vol 10 (5) ◽

pp. 756-761

Author(s):

Xiaofei Li ◽

Lina Sheng ◽

Juncai Tu ◽

Lianqing Lou

Keyword(s):

Tract Infection ◽

Respiratory Tract ◽

Silver Nanoparticle ◽

Lower Respiratory Tract ◽

Respiratory Tract Infections ◽

Control Group ◽

Efficacy And Safety ◽

Lower Respiratory Tract Infections ◽

Tract Infections ◽

Experimental Group

This study evaluated the clinical efficacy and safety of piperacillin sulbactam in the treatment of lower respiratory tract infections, as well as the efficacy of silver nanoparticle-based disinfectant in equipment disinfection to reduce exogenous infection. From May 2018 to November 2018, 100 patients that had been diagnosed with a lower respiratory tract infection and hospitalized were divided into an experimental group and a control group. The experimental group was given piperacillin/sulbactam, and the control group was given mezlocillin/sulbactam, where 5.0 g was added to 100 mL of normal saline and administered via intravenous drip twice a day over a treatment course of 14 days. The cure rate of the experimental and control groups were 65.22% and 56.52% respectively. The efficacy rate was 91.30% and 91.30% respectively, with no significant difference between the two groups (P > 0.05). The results indicated that piperacillin/sulbactam is a safe, effective treatment for lower respiratory tract infections in elderly patients, the equipment was sterilized with silver nanoparticle-based disinfectant to reduce the incidence of adverse reactions and exogenous infections.

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Efficacy and safety of PEGylated recombinant human granulocyte stimulating factor in the prevention of neutropenia during concurrent chemoradiotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e18018 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e18018-e18018

Author(s):

Dongling Zou ◽

Qi Zhou ◽

Mingfang Guo

Keyword(s):

Cervical Cancer ◽

Concurrent Chemoradiotherapy ◽

Measurement Data ◽

Test Group ◽

Control Group ◽

Fisher Exact Test ◽

Combination Regimen ◽

Efficacy And Safety ◽

Grade 3 ◽

Experimental Group

e18018 Background: This randomized controlled prospective study aims to explore the efficacy and safety of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. Methods: Patients who met the eligibility criteria were divided into two groups according to the randomized principle of 2:1: the experimental group (patients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy) and the control group (patients did not use PEG-rhG-CSF for prevention and were given 5 ug / kg rhG-CSF when ANC < 1✕109). TP combination regimen was used for concurrent chemotherapy, specifically as follows: paclitaxel 150mg / m2 (day 1), cisplatin 35mg / m2 (day 1-2), repeated every three weeks. The PTV dose was 45 Gy in 1.8 Gy daily fractions, with five fractions per week. SPSS 25.0 software was used for statistical analysis of the data, t-test was used for measurement data, and χ2 test Fisher exact test was used for enumeration data. P < 0.05 was considered statistically significant. Results: As of September 2019, 30 patients were enrolled into this study, including 18 in the experimental group and 12 in the control group. One of the 18 patients in the test group (5.6%) had a Grade 3/4 neutropenia. Ten of the 12 patients in the control group (83.3%) developed Grade 3/4 neutropenia. The incidence of Grade 3/4 neutropenia in the two groups was statistically significant (P < 0.001, Table 1). The incidence of FN was 5.6% in the experimental group and 8.3% in the control group (P = 1.000). The incidence of delayed chemotherapy course was 11.1% in the experimental group and 58.3% in the control group (P = 0.013). The incidence of delayed chemotherapy course in the two groups was statistically significant (Table 1). As shown in Figure 4, the experimental group had a completion time of radiotherapy for 46.7 days, while the control group had 49.0 days (P = 0.278). Conclusions: Although the results of bone marrow function and overall survival are still to be obtained, it can be initially seen from the intermediate-term data that the use of PEG-rhG-CSF primary prevention reduced the granulocytopenia and the delay of the chemotherapy course during the concurrent chemoradiotherapy TP regimen for cervical cancer, which has the value of further completing this study. [Table: see text]

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Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.02149-17 ◽

2018 ◽

Vol 62 (4) ◽

Cited By ~ 5

Author(s):

Qingfeng Wang ◽

Yu Pang ◽

Wei Jing ◽

Yufeng Liu ◽

Na Wang ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Sputum Culture ◽

Successful Outcome ◽

Control Group ◽

Drug Resistant ◽

Sputum Culture Conversion ◽

Extensively Drug Resistant ◽

Experimental Group ◽

Culture Conversion

ABSTRACT We performed a multicenter, prospective, randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary endpoint was the time to sputum culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of “cure” and 1 (4.5%) “complete treatment,” for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were cured and 6 (22.2%) completed treatment by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between the CLO group and the control group. The average sputum culture conversion time for the experimental group was 19.7 months, which was not statistically different from that for the control group (20.3 months; P = 0.57). Of the 22 patients in the CLO group, 12 (54.5%) experienced adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% of patients (7/22 patients) in the CLO group versus 11.1% (3/27 patients) in the control group exhibiting this adverse event. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment. (This study is registered with the Chinese Clinical Trial Registry [ChiCTR, www.chictr.org.cn ] under identifier ChiCTR1800014800.)

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