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Objective:To explore the safety and efficacy of radiofrequency in the treatment of overactive bladder(OAB).Methods:A prospective, multicenter, non-randomized controlled trial was conducted. Eligible patients were divided into test group and control group in Zhejiang Provincial People’Hospital, The First Affiliated Hospital of Wenzhou Medical University, and Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine from March 2019 to June 2020. Inclusion criteria: patients diagnosed with OAB, and bladder capacity>100ml. Exclusion criteria: pregnant and lactating women; patients with secondary OAB symptoms such as urinary tract obstruction; patients with uncontrolled urinary tract infection within 1 week; patients in stable stage by using other treatment methods; patients implanted with any nerve stimulator, cardiac pacemaker or implantable defibrillator; patients with malignant tumors, serious cardiovascular, cerebrovascular diseases, renal insufficiency or received BTX treatment in recent 12 months. The patients were allocated to test group and the control group in a ratio of 2∶1 according to the time sequence of the visit. The patients in the test group were treated with radiofrequency treatment. After entering the group, they were treated for 4 times at the 1st, 2nd, 7th and 8th week respectively. In the control group, the energy was turned off during the radiofrequency treatment. The patients were followed-up every week until the end of the 12th week. The treatment success rate [the average frequency of urination in 24 h was reduced more than 50% from the baseline or returned to the normal (≤8 times/day) or the average frequency of urgent urination in 24 h was reduced more than 50% from the baseline], the frequency of urination, urgent urination and nocturnal urination before and after treatment, the residual urine volume of the bladder, the quality of life (QOL) score and the occurrence of catheter related adverse events in two groups were compared.Results:114 patients were enrolled in the study, including 76 patients in the test group and 38 patients in the control group. There were no significant differences in the age [(44.2±12.8) vs. (41.7 ± 12.1) years old], male female ratio (13/63 vs. 4/34), average course of disease [2.0(1.2, 5.0) vs. 2.0 (1.0, 4.0) years], the frequency of urination[12.8 (10.6, 16.8) vs. 12.8 (10.3, 17.0) times], urgency urination [11.8(9.3, 15.8) vs. 11.8 (9.0, 17.0) times], nocturia [2.7 (1.3, 3.7) vs. 2.3(0.7, 3.3) times], residual urine volume of bladder [12.0 (3.0, 28.0) vs. 14.0 (3.7, 20.0) ml ] and the QOL score [5.0(4.0, 5.0) vs. 4.0(4.0, 5.0)]before the treatment between the two groups ( P>0.05). The treatment success rate in the test group was 76.3% (58/76), while 26.3% (10/38) in the control group, with a statistically significant difference ( P<0.01). There were significant differences between the test group and control group in the frequency of urination [9.7 (7.7, 12.0) vs. 12.9 (9.6, 15.7) times], urgent urination [7.3 (5.0, 10.0) vs. 11.7 (7.3, 15.3) times], nocturia [1.3 (0.7, 2.0) vs. 1.7 (1.0, 3.0) times] and the QOL score of the patients[3.0(1.0, 3.0) vs. 4.0(3.0, 4.5)]after the treatment(all P<0.05). The frequency of urination, urgency urination, nocturia, the residual urine volume and the QOL score in the test group were significantly improved ( P<0.05) after the treatment.The frequency of urination, nocturia, residual urine volume and the QOL score in the control group were improved ( P<0.05) after the treatment. 13 (11.4%) patients had catheter related adverse events. In the test group and the control group, there were 7 cases of macroscopic hemorrhage caused by the placement of instruments (5/76 vs. 2/38), 5 cases of acute urinary tract infection within 3 days (3/76 vs. 2/38), and 1 case of instrument breakage (catheter breakage) (0/76 vs. 1/38). There were no significant differences in the adverse events between the two groups ( P> 0.05). Conclusions:Radiofrequency treatment of OAB can effectively improve the symptoms of patients, improve the QOL of patients, and has low incidence of adverse events, with good efficacy and safety.
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Objective:To assess the efficacy and safety of 100 units of botulinum toxin A (BTX-A) intradetrusor injection in patients with overactive bladder.Methods:From April 2016 to December 2018, 17 tertiary hospitals were selected to participate in this prospective, multicenter, randomized, double-blind, placebo-controlled study. Two phases of study were conducted: the primary phase and the extended phase. This study enrolled patients aged 18 to 75 years who had been inadequately managed by anticholinergic therapy (insufficient efficacy or intolerable side effects) and had spontaneous voiding with overactive bladder. Exclusion criteria included patients with severe cardiac, renal and hepatic disorders, patients with previous botulinum toxin treatment for 6 months or allergic to BTX-A, patients with urinary tract infections, patients with urinary stones, urinary tract tumors, diabetes mellitus, and bleeding tendency. Eligible patients were randomly assigned to BTX-A group and placebo control group in a ratio of 2∶1. Two groups of patients received 20 intradetrusor injections of BTX-A 100U or placebo at the depth of the submucosal muscle layer respectively under cystoscope, including 5 injections at the base of the bladder, 3 injections to the bladder triangle, 5 injections each to the left and right walls and 2 injections to the top, sparing the bladder neck. As a placebo control group, patients received same volume of placebo containing no BTX-A and only adjuvant freeze-dried preparations for injection with the same method. A combination of gelatin, sucrose, and dextran served as adjuvants. Average micturition times per 24 hours, urinary incontinence (UI) episodes per day, average micturition volume per day, OAB symptom score(OABSS), and quality of life (QOL) score were recorded at baseline and the 2nd, 6th and 12th week after treatment. The primary efficacy endpoint was the change from baseline in the average micturition times per 24 hours at the 6th week after treatment. The secondary efficacy endpoints included the change from baseline in the average micturition times per 24 hours at 2nd and 12th week, as well as the change from baseline in the OABSS, QOL score, average frequency of urgency and UI episodes per day, urgency score, average micturition volume per day at 2nd, 6th and 12th week after treatment. Patients were followed for 12 weeks to assess adverse events (AEs). After assessed at week 12, if the micturition times has decreased less than 50% compared to baseline and the patient is willing to receive retreatment, then patients could enter the extended trial phase. In that phase, patients in both groups were injected with 100 units BTX-A from 12th week onwards and then followed up the same indicators for 12 weeks.Results:216 patients were enrolled in this trial (144 cases in the BTX-A group and 72 cases in the placebo control group). Baseline characteristics such as age (47.75±14.20 in the BTX-A group and 46.39±15.55 in the control group), sex (25 male/117 female in the BTX-A group and 10/61 in the control group), and disease duration (0.51 years in the BTX-A group and 0.60 years in the control group) were balanced between the two groups( P>0.05). A marked reduction from baseline in average micturition times per 24 hours was observed in all treatment groups at the 6th week and the reduction of the two groups was statistically different ( P<0.001 and P=0.008 respectively). Compared with the baseline, the average micturition times per 24 hours at the 6th week decreased from baseline by 2.40(0.70, 4.60)times for the BTX-A group and 0.70(-1.00, 3.30) times for the placebo control group respectively, and the difference between the two groups was considered to be statistically significant ( P=0.003). The change rates of average micturition times per 24 hours from baseline at the 6th week of the two groups were (16±22)% and (8±25)% respectively, and the difference between the two groups was statistically significant ( P=0.014). Compared with the baseline, the average micturition times per 24 hours at 2nd and 12th week decreased by 2.00(0.00, 4.00)and 3.30(0.60, 5.03)for the BTX-A group, 1.00(-1.00, 3.00)and 1.70(-1.45, 3.85)for the placebo control group respectively. The difference between two groups was considered to be statistically significant ( P=0.038 and P=0.012); the changes of average urgency times per day for the BTX-A group and the control group at the 2nd, 6th and 12th week were 2.00(0.00, 4.30)and 2.40(0.30, 5.00), 3.00(0.30, 5.70)and 0.70(-1.30, 2.70), 0.70(-1.30, 3.00) and 1.35(-1.15, 3.50), respectively. There were significant differences between two groups at the 2nd, 6th and 12th week, ( P=0.010, P=0.003 and P=0.025, respectively). The OABSS of the BTX-A group and the control group at the 6th week decreased by 1.00(0.00, 4.00)and 0.50(-1.00, 2.00) compared with the baseline, and the difference between the two groups was statistically significant ( P=0.003). 47 cases of BTX-A group and 34 cases of placebo control group entered the extended trial phase, and 40 and 28 cases completed the extended trial phase, respectively. The average micturition volume per 24 hours changed by -16.60(-41.60, -0.60)ml and -6.40(-22.40, 13.30)ml, (-35.67±54.41)ml and(-1.76±48.69)ml, (-36.14±41.51)ml and (-9.28±44.59)ml, (-35.85±43.35)ml and(-10.41±40.29)ml for two groups at the 12th, 14th, 18th and 24th week, and the difference between two groups was statistically significant at each follow-up time ( P=0.01, 0.006, 0.012 and 0.016, respectively). There was no significant difference in other parameters( P>0.05). However, adverse reactions after intradetrusor injection included increased residual urine volume (27 in the BTX-A group and 3 in the control group), dysuria (21 in the BTX-A group and 6 in the control group), urinary infection (19 in the BTX-A group and 6 in the control group), bladder neck obstruction (3 in the BTX-A group and 0 in the control group), hematuria (3 in the BTX-A group and 1 in the control group), elevated alanine aminotransferase (3 in the BTX-A group and 0 in the control group), etc. During the follow-up period, there was no significant difference in the other adverse events between two groups except the increase of residual urine volume( P<0.05). In the primary trial phase, among the 27 cases with increased residual urine volume in BTA group, only 1 case (3.70%) with PVR more than 300 ml; the PVR of 3 patients in the placebo group was less than 100 ml. The increase of residual urine volume caused by the injection could be improved or disappeared with the passage of time. Conclusions:Intradetrusor injection of Chinese BTX-A improved the average micturition times per 24 hours, the average daily urgent micturition times, OABSS, and average micturition volume per time, and reduced the adverse effects in patients with overactive bladder.Chinese BTX-A at dose of 100U demonstrated durable efficacy and safety in the management of overactive bladder.
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Objective:To explore the relationships between the gut microbiota in patients with cervical and endometrial cancers and the severity of radiation enteritis they suffered during radiotherapy.Methods:Feces samples were collected from 37 patients with cervical or endometrial cancer who received radical radiotherapy (RR) and postoperative radiotherapy (PR). Symptoms were recorded according to the grades of diarrhea and proctitis stated in CTCAE 5.0. The grade of symptoms was considered a high grade (HG) in the case of ≥ 2 and a low grade (LG). The 16S rRNA sequencing technology was used for DNA analysis of the samples.Results:The α diversity of gut microbiota was significantly higher in patients with LG symptoms (LG group) than that in patients with HG symptoms (HG group, P<0.05) and the β diversity also differed between the two groups (stress<0.2) before radiotherapy. Meanwhile, the Ruminococcus gnavus was significantly higher in the HG group than that in the LG group before radiotherapy ( P<0.05), and thus it may serve as a biomarker for the prediction of the severity of radiation enteritis in the patients before radiotherapy. The gut microbiota in the LG and HG groups showed different changes after three weeks of radiotherapy. In addition, RR patients showed higher gut microbiota diversity and less severe radiation enteritis than PR patients. Meanwhile, Faecalibacterium prausnitzii was significantly higher in RR patients than that in PR patients before radiotherapy ( P<0.05), which may correlate negatively with radiation toxicity. Conclusions:The characteristics of gut microbiota in patients with cervical and endometrial cancers were closely related to the severity of radiation enteritis they suffered during radiotherapy. Furthermore, prior treatment such as surgery might reduce radiation tolerance of the patients.
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China has started to accept the overseas clinical trial data about drug and medical devices, and the data in accordance with the requirements can be used to register in China. To do this work well, we should consider four key dimensions: data acceptance principle, data quality and reliability, data evaluation usability and data international difference. Among them, the authenticity, integrity, accuracy and traceability of data are the main factors to determine the quality reliability of data. Receiving data from overseas clinical trials about drug and medical devices will be conducive to the establishment of international mutual recognition system for clinical trial data, and to enhance the importance of data management in domestic clinical trials, and to promote the formation of quality management system on clinical trial data.
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In order to strengthen the integration of reform system and build a comprehensive integration of openness and innovation, the medical device registrar system has become the institutional choice to promote the reform of the medical approval system and the innovation and development of the industry. The system allows scientific researchers, R&D institutions and enterprises to become applicants for medical device registration and to consign the production of samples and products, thus realizing the separation of market license and production license, and breaking the binding relationship between registration and production in current regulations. The medical device registrar system has laid a theoretical foundation for remolding the management system of medical devices, and has also made practical exploration for improving the reform of the medical devices supervision system, so it has important theoretical and practical significance.
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Device Approval , Industry , Licensure , RegistriesABSTRACT
Objective To investigate the clinical features of cerebral venous sinus thrombosis (CVST)in patients with malignancy as well as its underlying pathogenesis. Methods The clinical data, including clinical presentation, laboratory results, neurological images were retrospectively reviewed in hospital patients with active malignant tumor and cerebral venous thrombosis from January 2006 to December 2016. Results Among the 586 CVST patients, 24 patients (4.10%) were with malignant tumor. Among these 24 patients, there were 8 males and 16 females with an average age of (39.88 ± 21.71) years old. Four patients (16.67%) had the risk factors of cerebral venous sinus thrombosis, while the other 20 patients(83.33%)had not any such risk factors.At the symptom onset of CVST, 22 patients(91.67%) had headache and focal neurological deficit, such as limbs weakness and numbness. The common substyles of malignant tumor were lung cancer (33.33%), breast cancer (29.17%)and acute lymphocytic leukemia(20.83%).Most patients(58.33%)were found to have cerebral metastasis.22 patients (91.67%) had elevated plasma D-dimmer level, and 19 patients (79.17%) had elevated plasma cancer biochemical marker levels.Conclusions Cancer-related CVST had the features including lacking conventional risk factors, elevated plasma D-dimmer and cancer biochemical marker levels.Cerebral metastasis and hypercoagulable state may be responsible for the pathogenesis of CVST.
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Objective To study the clinical features and possible pathogenesis of acute ischemic stroke in renal cell cancer patients. Methods The clinical data from in-hospital patients with renal cell cancer who developed acute ischemic stroke were collected, including the patients with renal cell cancer who developed acute ischemic stroke during anti-cancer therapies and those patients with acute ischemic stroke who were firstly diagnosed to have renal cell cancer during anti-stroke therapies between January 2003 and December 2015. Results A total of 2516 patients with renal cell cancer were screened, and there were 36 patients (1.43%) with acute ischemic stroke. Out of the 36 patients, there were 29 men (80.56%) and 7 women (19.44%). Their age ranged from 45 to 68 years, with a average age of (65.11 ± 14.77) years. Eight patients (22.22%) had some conventional cardiovascular risk factors, while the other 28 patients (77.78%) had no such risk factors. Magnetic resonance imaging (MRI) scans at the acute stage of ischemic stroke were carried out for all these patients. Based on the diffusion weighted imaging (DWI) of MRI, 8 patients (22.22%) had single lesion and 28 patients (77.78%) had multiple lesions in different arterial territories in their brains. The pathological types of renal cell cancer were:suprarenal epithelioma (18 patients, 50.00%), papillary cell carcinoma (12 patients, 33.33%) and chromophobe renal cell carcinoma (6 patients, 16.67%). Metastases were found 10 patients (27.78%) out of the 36 patients. Blood biochemical examination showed that 28 patients had elevated plasma D-dimer level, 22 patients had elevated plasma cancer antigen (CA)125 level, and 17 patients had elevated plasma carcinoembryonic antigen (CEA) levels. Conclusions It is suggested that the renal cell cancer associated stroke is characterized by lacking of traditional risk factors and having multiple lesions in brain;and that the elevated plasma D-dimer, CA125 and CEA levels may lead to hypercoagulable state and lead to ischemic stroke eventually .
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The license management of medical devices is an important part of production supervision, but there are some contradictions and confusion in the relevant legislation. The right way of resolve the plight is to distinguish correctly license application on the medical devices production for the first time, license change and license continuity, and then make the appropriate regulatory requirements.
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China , Durable Medical Equipment , LicensureABSTRACT
Objective To master the epidemic situation and control effect of schistosomiasis in Yugan County,Jiangxi Prov-ince. Methods The data of the schistosomiasis prevalence in human and cattle as well as Oncomelania hupensis snail status were collected and the change trends were analyzed in Yugan County from 2008 to 2012. Results The schistosome infection rates of residents in Yugan County have declined every year since 2008,and currently,the prevalence of schistosomiasis was at a low lev-el. No acute schistosomiasis case was found during the past 5 years. In 2012,the infection rate of bovine was above 1%in 88 en-demic villages,and the area with schistosome infected snails was 10 hm2. Conclusion In order to achieve the goal of schistosomi-asis transmission control in the whole county in 2015,the comprehensive control measures based on infection source control should be strengthened.
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Risk management penetrate the entire process of medical device regulation, and it is also very necessary for medical devices in use. Based on the analyzing of the status of risk management for medical devices, this paper discusses the principal, participants and entry point of risk management for medical devices.
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Device Approval , Equipment Safety , Equipment and Supplies , Risk ManagementABSTRACT
The full implementation of GMP for medical devices, which is an important step to improve quality management system of medical devices production, will have a positive impact on the quality management system of medical device. It will improve and promote the development of quality management system for medical device, by updating the idea and rebuilding the frame and optimizing the contents.
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China , Equipment and Supplies , Reference Standards , Quality ControlABSTRACT
Objective To explore the myogenic basis of the increased excitability and contractile activity in detrusor instability (DI) and investigate the differences of spontaneous contractions by ryanodine receptor (RyR) channels regulation in sarcoplasmic reticulum (SR) between DI and normal bladder muscle and of the RyR channels protein expression. Methods DI model was confirmed by filling cystometry from rats that underwent partial bladder outlet obstruction (BOO) about 8 weeks ago. Muscle strips were dissected from fresh bladder under microscope and the isometric tension in DI and normal strips were detected. The contractions were recorded in these strips exposed to some agents. SR microsome protein was obtained from DI and normal bladder muscle preparations and was used for Western blot analysis to determinate RyR channels expression. Results Treated with RyR channels blocker ryanodine , the contractile frequence significantly increased in normal strips, but not in DI muscle. Western blot analysis showed that RyR channels expression in DI muscle was significantly less than that in normal preparations. Conclusion RyR channels act a negative role in spontaneous contractile activity and the presumed mechanism may involve in Ca 2+ release of RyR channels which causes activation of Ca 2+ -dependent K + channels to decrease contractility. But this crosstalk mechanism is weaken in DI muscle, which provides a chance for spontaneous contractile overactivity.