ObjectivesTo systematically review the safety and effectiveness of uterine artery embolization (UAE), surgery and high intensity focused ultrasound (HIFU) in the treatment of uterine fibroids.MethodsPubMed, EMbase, The Cochrane Library, Web of Science, WanFang Data and CNKI databases were electronically searched to collect relevant studies on comparing the safety and effectiveness of UAE, surgery and HIFU in the treatment of uterine fibroids from January 2000 to August 2019. Two reviewers independently screened the literature, extracted the data and evaluated the risk of bias of included studies, network meta-analysis was performed by ADDIS 1.16.8 software and Stata 14.0 software.ResultsA total of 11 trials (22 references) involving 3469 patients were included. Compared with surgery, UAE and HIFU patients had higher quality of life (1-year follow-up) improvement, and UAE was higher than HIFU. Network meta-analysis showed that patients treated with HIFU had the lowest incidence of major complications within 1 year, followed by UAE, and surgery. Patients treated with HIFU and UAE had shorter hospitalization and quicker recovery time than surgery. The rate of further intervention after surgery treatment might be lower than that of UAE and HIFU.ConclusionsUAE has the highest quality of life improvement (1-year follow-up) for uterine fibroids. HIFU and UAE are safer with shorter hospital stays and quicker recovery time compared with surgery. However, both UAE and HIFU have the risk of re-treatment. However, limited by the number and quality of included studies, the above conclusions are needed to be verified by more high-quality studies.
To ensure the scientific and recognized evaluation of patient-centered clinical research outcomes, the drug development tool qualification certification website of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have disclosed the information of clinical outcome assessment (COA) submitted for certification, and encouraged the use of certified COA. This paper searched all COA and approval decisions on the website, analyzed the submitted information and certification status of COA, and interpreted the certification technology and process of COA, so as to provide references and suggestions for the development of patient-centered clinical research outcome evaluation.
Objective To investigate the clinical effect of high intensity focused ultrasound (HIFU) and uterine artery embolization (UAE) in the treatment of cesarean scar pregnancy (CSP). Methods A total of 152 patients with CSP diagnosed by B-type ultrasonography were enrolled prospectively in this study from June 2014 to May 2016 in Chengdu Women and Children’s Central Hospital and Suining Central Hospital. Six patients from Chengdu Women and Children’s Central Hospital and 84 from Suining Central Hospital for Volunteered HIFU treatment were regarded as observation group. The other 62 patients from Chengdu Women and Children’s Central Hospital were selected to accept UAE treatment voluntarily were designated as control group. The clinical efficacy and therapeutic safety of the two groups were compared after the treatment. Results Eighty-two patients (91.1%) in the observation group and 32 (51.6%) in the control group had a bleeding volume equal to 100 mL or lower during complete curettage of uterine cavity (P<0.05). The hospitalization expenses of the above two groups were respectively (25 126.51±1 473.49) and (32 928.42 ±1 579.35) yuan (P<0.05). The hospitalization time was (11.03±1.52) and (10.65±1.87) days respectively, and the difference was not statistically significant (P>0.05). There was no significant difference in the normal rate of human chorionic gonadotropin recovery between the observation group and the control group at 14 days after treatment (P>0.05). Eighty-seven patients (96.7%) in the observation group and 51 (82.3%) in the control group had their menstrual recovery to normal level at 2 months after treatment, and the difference was statistically significant (P<0.05). The incidence of postoperative complications was 1.1% and 6.4% in the observation group and the control group, respectively, and the difference was not statistically significant (P>0.05). Conclusions HIFU in the treatment of CSP is safe and effective. Compared with UAE, HIFU requires less cost with fewer complications, which is worth promoting.
ObjectiveTo compare the effectiveness of posterior and anterior psoas abscess debridement and local chemotherapy in abscess cavity combined with focus debridement, bone grafting, and fixation via posterior approach in treatment of thoracolumbar spinal tuberculosis, and explore the feasibility of psoas abscess debridement via posterior approach.MethodsBetween June 2012 and December 2015, the clinical data of 37 patients with thoracolumbar spine tuberculosis and psoas abscess were retrospectively analyzed. All the patients underwent posterior focus debridement, bone grafting, and internal fixation, and were divided into two groups according to different approaches to psoas abscess debridement. Twenty-one patients in group A underwent abscess debridement and local chemotherapy in abscess cavity via posterior approach; 16 patients in group B underwent abscess debridement and local chemotherapy in abscess cavity via anterior approach. No significant difference was found between two groups in gender, age, disease duration, involved segments, preoperative erythrocyte sedimentation rate (ESR), preoperative C-reactive protein (CRP), side of psoas abscess, maximum transverse diameter and sagittal diameter of psoas abscess, accompanying abscess, abscess cavity separation, preoperative Cobb angle of involved segments, preoperative American Spinal Injury Association (ASIA) classification (P>0.05). The operation time, intraoperative blood loss, hospitalization time, time of abscess absorption and bone fusion were recorded and compared between 2 groups. The change of pre- and post-operative involved segments Cobb angle was observed. Neurological function was assessed according to ASIA classification.ResultsExcept that the operation time of group B was significantly longer than that of group A (t=–2.985, P=0.005), there was no significant difference in intraoperative blood loss, hospitalization time, time of abscess absorption and bone fusion between 2 groups (P>0.05). All patients were followed up 18-47 months (mean, 31.1 months). No cerebrospinal ?uid leakage occurred intra- and post-operation. Four patients in group A underwent second-stage operation of abscess debridement and local chemotherapy in abscess cavity via anterior approach. All patients got abscess absorption, meanwhile ESR and CRP level normalized at last follow-up. The involved segments Cobb angle improved significantly when compared with preoperative values in both 2 groups (P<0.05); and there was no significant difference between 2 groups at last follow-up (P>0.05). Nine patients with spinal cord injury had significant neurological recovery at last follow-up (Z=–2.716, P=0.007).ConclusionPosterior focus debridement, bone grafting, and internal fixation combined with abscess debridement and local chemotherapy in abscess cavity is effective in treatment of thoracolumbar spinal tuberculosis, but in some cases anterior abscess debridement is still required.
In order to better incorporate patient input in clinical trials, the US Food and Drug Administration has included "patient-focused drug development" in the selection and development of clinical outcome assessments, and formulated a series of guidelines. Based on the third guiding principle, "Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments", this article summarizes the clinical outcome assessments from five aspects: concept, development process, scoring mechanism, interference factors and sensitivity, and introduces four different types of clinical outcome assessments, providing new ideas for "patient-focused drug development" efficacy evaluation in clinical trials.
Objective To analysis the safety of high-intensity focused ultrasound (HIFU) in the treatment of uterine fibroids and provide references for clinical practice and prevention of complications of gynecological diseases. Methods Databases including PubMed, The Cochrane Library (Issue 2, 2016), EMbase, CBM, CNKI, and VIP were searched to collect studies concerning the complications of HIFU for uterine fibroids from March 1st 2005 to February 15th 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by using R software. Results A total of twenty studies involving 2 405 patients were included. The results of meta-analysis showed that complications rate of gynecological system induced by HIFU was 6.63% (95%CI 3.58% to 12.28%); among them, the incidence of vaginal bleeding was 5.82% (95%CI 3.22% to 10.53%), and the incidence of abdominal pain was 10.02% (95%CI 4.77% to 21.05%). Conclusion The current evidence shows that there is a certain amount of complications of HIFU for uterine fibroids. Due to the limited quantity and quality of included studies, the above results are needed to be validated by more studies.
As subjects in drug clinical trials and participants in medical practice, patients can best understand their own conditions and needs. With this in mind, the FDA proposed "patient-centered drug discovery" and issued a set of guidelines to incorporate patient experiences, perspectives, needs, and preferences into the drug development and evaluation process. Guideline (2), methods for identifying important patient information, mainly describes methods and precautions for collecting and extracting patient experience data. This paper will focus on the characteristics, common methods and precautions of qualitative, quantitative and mixed research methods in the collection of patient experience data, in order to provide help for the comprehensive collection of patient experience data.
Epilepsy is a clinical syndrome characterized by recurrent epileptic seizures caused by various etiologies. Etiological diagnosis and localization of the epileptogenic focus are of great importance in the treatment of epilepsy. Positron emission tomography-computed tomography (PET-CT) technology plays a significant role in the etiological diagnosis and localization of the epileptogenic focus in epilepsy. It also guides the treatment of epilepsy, predicts the prognosis, and helps physicians intervene earlier and improve the quality of life of patients. With the continuous development of PET-CT technology, more hope and better treatment options will be provided for epilepsy patients. This article will review the guiding role of PET-CT technology in the diagnosis and treatment of epilepsy, providing insights into its application in etiological diagnosis, preoperative assessment of the condition, selection of treatment plans, and prognosis of epilepsy.
ObjectiveTo explore the effectiveness and safety of high-intensity focused ultrasound (HIFU) for bone tumors, so as to provide a reference for clinical decision. MethodsPubMed, EMbase, The Cochrane Library, CNKI and VIP databases were systematically searched for clinical effectiveness and safety studies of HIFU for bone tumors up to August 2014. Study selection, data extraction and quality assessment were applied independently by two reviewers, and then RevMan 5.1 software was used for conducting meta-analysis. If the data cannot be synthesized, the research outcome was described with a qualitative analysis. ResultsA total of 10 case series including 257 patients (157 males, 100 females) were included. The current evidence indicated that overall survival rates for all primary bone malignancy at 1-, 2-, 3- and 5-year were 89.8%, 72.3%, 60.5% and 50.5%, respectively. For the patients with clinical stage Ⅱb, the rates were 93.3%, 82.4%, 75% and 63.7%, respectively. For those with clinical stage Ⅲ, the rates were 79.2%, 42.2%, 21.1% and 15.8%, respectively. The local recurrence rate of HIFU for bone tumors was 7% to 9%, and recurrences at 1-, 2-, 3- and 5-year were 0%, 6.2%, 11.8% and 11.8%, respectively. The amputation rate was 2% to 7%. The adverse reaction rate was 27.2% (70/257), and among them the main was mild skin burn (21/257, 8.2%), followed by I degree burns (16/257, 6.2%), nerve damage (10/257, 3.9%) and fracture (6/257, 2.3%). ConclusionHIFU provide an alternative choice for patients with bone malignancy, with a certain effectiveness and safety. However, high-quality, large-scale randomized controlled trials or cohort studies which may focus on vary kinds of tumors, clinical stage and site of lesions are urgently needed, so that clinicians can use sufficient evidence for their clinical decision-making.
The patient, as the person who experiences the disease first-hand, has the most direct and accurate experience of the pain of the disease and the most accurate need for health products. Although there is a vast array of technological means to combat disease and maintain health, the human burden of disease has not been reduced and the health needs of patients have not been fully met. Therefore, "patient-focused drug development" is imperative. Gathering comprehensive information from patients through multiple channels and incorporating this information into the entire drug development process can help ensure that patients’ experiences, perspectives, needs and priorities are taken into account and valued. This article will introduce the concept, development process and the specific problems it faces in patient-focused drug development.