Botulinum toxin-A effects on pain, somatosensory and psychosocial features of patients with refractory masticatory myofascial pain: a randomized double-blind clinical trial.

The antinociceptive effect of BoNT-A have been well documented in animal studies; however, results of few but well-designed randomized placebo-controlled clinical trials about BoNT-A efficacy in masticatory myofascial pain (MFP) are inconsistent. Therefore, the present randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy of BoNT-A in patients with refractory MFP. Twenty-eight patients with pain reduction of less than 30% despite conservative treatment and with an average pain intensity of > 50 mm on the visual analogue scale (VAS) participated. Patients were randomly assigned to receive a total of 80 U of BoNT-A or saline solution (SS) injected into the masseter and anterior temporalis muscles. Pain intensity (VAS), quantitative sensory testing (QST), conditioned pain modulation (CPM), and psychosocial status were examined. Follow-up was performed at 1 and 6 months. For repeated-measure comparisons between evaluation times, Friedman test with Bonferroni correction was used for pain and somatosensory variables and the Wilcoxon test for the psychosocial variables. The Mann-Whitney test was used for all comparisons between groups. The BoNT-A group had a significant decrease in pain intensity at follow-ups compared with the SS group (p < 0.001). QST assessment revealed higher pressure pain threshold values in the masseter muscle for BoNT-A group compared to SS (p < 0.03) at all follow-ups. No differences were found for mechanical pain threshold and wind-up ratio values (p > 0.05) in the entire study. The BoNT-A group presented the most efficient CPM effect (p < 0.03) only at the 1 month follow-up in the masseter muscle. There was a significant time effect for BoNT-A in all psychosocial variables (p < 0.05) and a drug effect in the Central Sensitization Inventory (p < 0.01), Pittsburgh Sleep Quality Index (p < 0.004), and Healthy Survey 36 (p < 0.05) at 6 months follow-up. The study demonstrates that a single injection-session of BoNT-A has positive effects on the hall pain spectrum of patients with refractory masticatory myofascial pain.

Dry needling in active or latent trigger point in patients with neck pain: a randomized clinical trial.

The purpose was to determine the efficacy of deep dry needling (DDN) applied on an active myofascial trigger point (MTrP) versus a latent-MTrP versus a non-MTrP location, on pain reduction and cervical disability, in patients with chronic neck pain. A randomized, double-blind clinical trial design was used. A sample of 65 patients was divided into non-MTrP-DDN, active-MTrP-DDN and latent-MTrP-DDN groups. The visual analog scale (VAS), reproduction of the patient's pain, number of local twitch responses, pressure pain threshold (PPT) and Neck Disability Index (NDI) were assessed before, during and after the intervention and up to 1 month post-intervention. The active-MTrP-DDN-group reduced pain intensity more than non-MTrP-DDN-group after a week and a month (P < 0.01), as well as showing the greatest improvement in tibialis muscle PPT. The treatment of both Active and Latent MTrPs was associated with the reproduction of the patient's pain. The application of DDN on an active-MTrP in the upper trapezius muscle shows greater improvements in pain intensity after 1 week and 1 month post-intervention, compared to DDN applied in latent-MTrPs or outside of MTrPs in patients with neck pain.

Efficacy of Aidi Injection and Brucea javanica Oil Emulsion Injection in Rectal Cancer during CapeOX Adjuvant Chemotherapy.

BACKGROUND: Adjuvant chemotherapy with CapeOX regimen is widely used in resected rectal cancer, which brings benefits to patients. But drug-related toxicities are severe during this process; thus, survival outcomes may potentially be affected. This study explored the efficacy of two Chinese herbal injections, Aidi injection (ADI) and Brucea javanica oil emulsion injection (BJOEI), as adjuvant drugs in CapeOX adjuvant chemotherapy on rectal cancer patients. METHODS: A total of 240 cases were enrolled in this retrospective study. 80 cases received CapeOX with ADI (the ADI group), 80 cases received CapeOX with BJOEI (the BJOEI group), and the rest 80 cases received CapeOX alone (the control group). After four cycles' chemotherapy, adverse reactions (ADRs) and quality of life (QOL) were analyzed. Then, patients received follow-up for at least one year, and the endpoint was disease-free survival (DFS). RESULTS: All patients completed at least four cycles' adjuvant chemotherapy. The incidence of leukopenia and thrombocytopenia was significantly lower in the ADI group; the incidence of nausea was significantly lower in the BJOEI group; the incidence of hand-foot syndrome was significantly lower in both the ADI group and BJOEI group. Significant difference was found in the control group regarding the Karnofsky Performance Status (KPS) scores prior and posttreatment. No difference was found among three groups regarding one-year DFS. CONCLUSION: As adjuvant drugs for rectal cancer during CapeOX chemotherapy, ADI shows advantages in decreasing leukopenia and thrombocytopenia, while BJOEI results better in remitting nausea. Both two CHIs had positive impacts on decreasing hand-foot syndrome and the maintenance of patients' QOL. It is worthy of further study and promotion for CHIs.

Efficacy and safety of traditional Chinese medicine injections combined with FOLFOX4 regimen for gastric cancer: A protocol for systematic review and network meta-analysis.

BACKGROUND: Traditional Chinese medicine injections (TCMJs) combined with FOLFOX4 regimen could achieve favorable effects in the treatment of gastric cancer. However, the efficacy and safety of different TCMJs combined with FOLFOX4 in the treatment of gastric cancer have not been fully clarified. Due to the fact that there are as many as 10 kinds of TCMJs, how to choose an appropriate TCMJ has become an urgent clinical problem. The objective of this network meta-analysis is to explore the optimal options among different TCMJs for gastric cancer. METHODS: PubMed, Web of Science, Scopus, Cochrane Library, Embase, China Scientific Journal Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang Data were searched to identify randomized controlled trials which focused on TCMJs combined with FOLFOX4 against gastric cancer from its inception to September 2021. Subsequently, 2 researchers will be independently responsible for literature screening, data extraction, and assessment of their quality. Standard pair-wise and Bayesian network meta-analysis will be performed to compare the efficacy and safety of different TCMJs combined with FOLFOX4 regimen via Stata 14.0 and WinBUGS1.4 software. RESULTS: The results of this meta-analysis will be submitted to a peer-reviewed journal for publication. CONCLUSIONS: The conclusion of this systematic review will provide evidence for selecting an optimal TCMJ combined with FOLFOX4 for patients with gastric cancer.

Xuesaitong injection treating acute myocardial infarction: A systematic review and meta-analysis.

BACKGROUND: Although the incidence of acute myocardial infarction (AMI) is decreasing, the mortality in AMI patients remains substantial. Traditional Chinese medicine has shown its role in the prevention and management of AMI. The purpose of this study is to evaluate the clinical efficacy of Xuesaitong injection (XST) for the treatment of AMI by a meta-analysis. METHODS: A literature search was performed in 5 medical databases up to June 1, 2020. Randomized controlled trials involving XST combined with conventional treatment versus conventional treatment were included. A meta-analysis of clinical efficacy, left ventricular function and other objective parameters was performed to evaluate the effects of XST on AMI. RESULTS: Five randomized controlled trials involving 539 participants were eventually included. Meta-analysis showed that the combination of XST and conventional treatment could achieve significantly better effect on improving clinical efficacy (risk ratio: 1.09 [1.01, 1.17]; P = .04), left ventricular ejection fraction (mean difference [MD]: 3.18 [1.69, 4.67]; P < .0001), hypersensitive C-reactive protein (MD: -2.58 [-5.04, -0.12]; P = .04), interleukin 6 (MD: -26.00 [-38.85, -13.16]; P < .0001), cardiac troponin T (MD: -15.85 [-18.09, -13.61]; P < .00001) and creatine kinase myocardial isoenzyme (MD: -73.06 [-79.74, -66.37]; P < .00001). CONCLUSION: XST combined with conventional treatment can achieve better efficacy on clinical performance and some of the AMI related parameters. However the interpretation of the results should be cautious, due to the relatively low quality of included trials. More rigorously designed, large-scaled, randomized controlled trials are warranted to support its clinical use in the future.

A novel biodegradable injectable chitosan hydrogel for overcoming postoperative trauma and combating multiple tumors.

Wound bacterial infections and tumor recurrence are the main reasons for the poor prognosis after primary tumor resection. Here, we fabricated a novel therapeutic nanocomposite using chitosan (CS) hydrogel combined with black phosphate nanosheets (BPNSs) and in situ grown copper nanoparticles (CuNPs). The obtained hydrogel (CS@BPNSs@CuNPs), possessing a remarkable temperature-sensitive spongy-like state, offered 24.98 % blood clotting index. The released BPNSs@CuNPs could produce reactive oxygen species (ROS) to kill infected invasive bacteria (98.1 %) and inhibit local residual tumor cell regeneration (11.3 %). Moreover, by coupling the photothermal properties of BPNSs, the BPNSs@CuNPs showed 19.6 % penetration rate to cross the blood tumor barrier (BTB) for treating brain tumors. The hydrogel platform was further combined with aPD-L1-based immunotherapy to employ its synergetic therapeutic effect in the prevention of tumors. The in vivo studies showed that biodegradable hydrogel could hold a great potential as a novel strategy for improving postoperative therapy and multi-tumor treatments.

Intraoperative local injection of uterosacral ligaments with ropivacaine during uterine surgery: A systematic review and meta-analysis of randomized controlled trials.

AIM: To perform a systematic review and meta-analysis of all randomized controlled trials that examined the efficacy of intraoperative local injection of the uterosacral ligaments with ropivacaine on postoperative pain and opioids consumption in patients undergoing uterine surgery for hysterectomy/myomectomy. METHODS: PubMed, Scopus, Web of Science and Cochrane Library databases were screened from inception to September 5th, 2020. We appraised the risk of bias using the Cochrane's risk of bias tool. Resting postoperative pain scores and cumulative consumption of postoperative opioids were regarded as continuous data, analyzed using the inverse variance method and reported as standardized mean difference (SMD) and weighted mean difference (MD), respectively, with 95 % confidence intervals (95 % CIs). RESULTS: Five studies met the inclusion criteria comprising 230 patients (117 and 113 patients received ropivacaine and placebo, respectively). The studies had an overall low risk of bias. Resting postoperative pain scores were not significantly different between both groups at 2 h (SMD = -0.30, 95 % CI [-0.70, 0.11], p = 0.15), 12 h (SMD = 0.04, 95 % CI [-0.26, 0.37], p = 0.81) and 24 h (SMD = -0.06, 95 % CI [-0.32, 0.20], p = 0.68). However, the ropivacaine group had significantly reduced cumulative opioid consumption during the first 24 h postoperatively (MD = -9.07, 95 % CI [-14.47, -3.66], p = 0.001). CONCLUSION: Intraoperative local infiltration of uterosacral ligaments with ropivacaine is technically feasible and significantly reduces postoperative opioid consumption in women undergoing gynecologic surgery of the uterus.

Gene therapy via canalostomy approach preserves auditory and vestibular functions in a mouse model of Jervell and Lange-Nielsen syndrome type 2.

Mutations in voltage-gated potassium channel KCNE1 cause Jervell and Lange-Nielsen syndrome type 2 (JLNS2), resulting in congenital deafness and vestibular dysfunction. We conducted gene therapy by injecting viral vectors using the canalostomy approach in Kcne1-/- mice to treat both the hearing and vestibular symptoms. Results showed early treatment prevented collapse of the Reissner's membrane and vestibular wall, retained the normal size of the semicircular canals, and prevented the degeneration of inner ear cells. In a dose-dependent manner, the treatment preserved auditory (16 out of 20 mice) and vestibular (20/20) functions in mice treated with the high-dosage for at least five months. In the low-dosage group, a subgroup of mice (13/20) showed improvements only in the vestibular functions. Results supported that highly efficient transduction is one of the key factors for achieving the efficacy and maintaining the long-term therapeutic effect. Secondary outcomes of treatment included improved birth and litter survival rates. Our results demonstrated that gene therapy via the canalostomy approach, which has been considered to be one of the more feasible delivery methods for human inner ear gene therapy, preserved auditory and vestibular functions in a dose-dependent manner in a mouse model of JLNS2.

Efficacy of Nonoperative Treatments for Lateral Epicondylitis: A Systematic Review and Meta-Analysis.

BACKGROUND: Lateral epicondylitis is a common overuse injury affecting approximately 1 to 3 percent of the population. Although symptoms may disappear spontaneously within 1 year, the clinical guidelines for conservative treatment are not clear. The authors' objective was to examine the outcomes of nonsurgical treatments for lateral epicondylitis through a meta-analysis and provide a treatment recommendation using the available evidence. METHODS: The authors searched the PubMed, EMBASE, Scopus, and Web of Science databases to identify primary research articles studying conservative treatments (electrophysiotherapy, physical therapy, and injections) for lateral epicondylitis. The authors included randomized controlled trials published in peer-reviewed journals. Data related to outcomes (pain, grip strength, Patient-Rated Tennis Elbow Evaluation score, and Disabilities of the Arm, Shoulder and Hand score) and complications were extracted. RESULTS: Fifty-eight randomized controlled trials were included in the meta-analysis. Electrophysiotherapy was effective in improving pain [mean difference, -10.0 (95 percent CI, -13.8 to -6.1)], Patient-Rated Tennis Elbow Evaluation score [mean difference, -10.7 (95 percent CI, -16.3 to -5.0)], and Disabilities of the Arm, Shoulder and Hand score [mean difference, -11.9 (95 percent CI, -15.8 to -7.9)]; and physical therapy improved pain [mean difference, -6.0 (95 percent CI, -9.7 to -2.3)] and Patient-Rated Tennis Elbow Evaluation scores [mean difference, -7.5 (95 percent CI, -11.8 to -3.2)] compared to placebo. Injections did not improve any outcome measures. Patients who received electrophysiotherapy and injections reported higher adverse effects than physical therapy patients. CONCLUSIONS: Patients who received electrophysiotherapy and physical therapy reported statistically and clinically improved scores in pain and function compared to placebo. Injections may put patients at higher risk for adverse effects compared to other conservative treatments. When managing lateral epicondylitis conservatively, electrophysiotherapy and physical therapy should be prioritized before other interventions. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

The Benefit of Perineural Injection Treatment with Dextrose for Treatment of Chondromalacia Patella in Participants Receiving Home Physical Therapy: A Pilot Randomized Clinical Trial.

Introduction: Chondromalacia patella is the degeneration of articular cartilage on the posterior facet of the patella and may indicate the onset of osteoarthritis. Conservative management is the main treatment option, and surgical intervention is considered the last option in a small percentage of patients. Perineural Injection Treatment (PIT) is a recently developed treatment option that is directed adjacent to the peripheral nerves that are the source of pathology causing neurogenic inflammation and pain. Objective: The objective of this study was to evaluate the efficacy of PIT combined with a home physical therapy program in patients with a diagnosis of chondromalacia patella compared with a control group receiving physical therapy only. Methods: Two patient groups were involved in this randomized clinical trial. The first received PIT combined with physical therapy (PIT + PT group) and the second was managed with physical therapy alone (PT group). Both groups were indicated to follow a 6-week home therapy plan afterward. The Western Ontario and McMaster Osteoarthritis Index was used to assess the patients at baseline and 6 months after therapy interventions. Results: Fifty patients (38 women and 12 men, median age 54.7 ± 14.8 years) were included; sex distribution and age did not differ between groups. Both groups had chondromalacia grade II or III, but the degree of gonarthrosis did not differ significantly between groups. The PIT + PT group outperformed PT group for pain (7.3 ± 3.5 vs. 3.2 ± 2.9 points; p < 0.010), stiffness (3 ± 1.69 vs. 1.6 ± 1.5 points; p < 0.010), and functional capacity (23.2 ± 10.7 vs. 11.1 ± 8.9 points; p < 0.010). Conclusions: Compared with physical therapy alone, PIT plus physical therapy reduced pain and stiffness and restored functional capacity. ClinicalTrials.gov Register Number #NCT03515720.

A comparison of the effects of acupoint injection combined with hyaluronic acid versus isolated hyaluronic acid for knee osteoarthritis: A protocol for systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Knee osteoarthritis (KOA) is a kind of degenerative osteoarthropathy, which causes joint pain and limited mobility, seriously affects the quality of life of the patient. Traditional Chinese Medicine acupuncture and moxibustion has been widely used to treat KOA, and acupoint injection is 1 of the acupuncture treatment methods. The purpose of this work is to evaluate the effectiveness of Acupoint injection combined with Hyaluronic Acid injection compared with isolated Hyaluronic Acid injection for KOA. METHODS: We will search articles in 7 electronic databases including Chinese National Knowledge Infrastructure, Wanfang Data, Chinese Scientific Journals Database, Chinese databases SinoMed, PubMed, Embase, and Cochrane Library databases. All the publications, with no time restrictions, will be searched without any restriction of language and status, the time from the establishment of the database to October 2020. Two reviewers will independently assess the quality of the selected studies, NoteExpress and Excel software will be used to extract data, and the content will be stored in an electronic chart. Different researchers will separately screen the titles and abstracts of records acquired potential eligibility which comes from the electronic databases. Full-text screening and data extraction will be conducted afterward independently. Statistical analysis will be conducted using RevMan 5.4 software. RESULTS: This study will evaluate the efficacy and safety of Acupoint injection combined with Hyaluronic Acid injection compared with isolated Hyaluronic Acid injection in the treatment of KOA, to provide high-quality, evidence-based clinical recommendations. TRIAL REGISTRATION NUMBER: INPLASY2020100058 CONCLUSION:: This study will provide reliable evidence on whether Acupoint injection combined with Hyaluronic Acid injection compared with isolated Hyaluronic Acid injection is more effective in treating KOA.

The efficacy and safety of acupoint injection for diabetic gastroparesis: A protocol for systematic review and meta-analysis.

BACKGROUND: Diabetic gastroparesis (DGP) is one of the common complications of diabetes. Accumulated evidences have shown that acupoint injection is beneficial for the clinical treatment of diabetic gastroparesis. However, there is currently no systematic review to assess this therapy. This program aims to evaluate the effectiveness and safety of this therapy for the patients with DGP. METHODS AND ANALYSIS: Literature search will be conducted via following electronic bibliographic databases from inception to Aug 2020: the Cochrane Library, PubMed, MEDLINE, Web of Science, EMBASE, Springer, China National Knowledge Infrastructure (CNKI), China Biology Medicine (CBM), Chinese Scientific Journal Database (VIP), Wan-Fang Database. All randomized controlled trials published in English or Chinese related to acupoint injection for DGP will be included. The primary outcome is the total effective rate. The secondary outcomes are the change of motilin and gastrin levels before and after the treatment. Two researchers will be responsible for the selection of study, extraction of data, and assessment of study quality independently. RevMan V5.3 Software will be used for assessing the risk of bias and synthesizing data. RESULTS: This study will provide a high-quality synthesis of current available evidence for the treatment of DGP with this therapy clinically. CONCLUSION: The conclusions of our study will provide new evidence to judge whether acupoint injection is an effective intervention for patients suffered from DGP. OSF REGISTRATION NUMBER:: osf.io/ms58j.

Effect of shenfu injection on microcirculation in shock patients: A protocol for systematic review and meta-analysis.

BACKGROUND: Shock is a major public health problem worldwide. At present, the morbidity and mortality of shock patients are relatively high. Vasomotor dysfunction is 1 of the key pathological aspects of shock. Shenfu injection has been widely used for the treatment of shock in China. Pharmacological studies have suggested that Shenfu injection can reduce peripheral circulation resistance and improve microcirculation. The purpose of this study is to evaluate the effect and safety of Shenfu injection on the microcirculation of patients with shock. METHODS: This review summarizes and meta-analyzes randomized controlled trials of Shenfu injection for the treatment of shock.Searched the following electronic databases: PubMed, Cochrane Library, Embase, CNKI, VIP and Wanfang Data. The Cochrane risk assessment tool was used to evaluate the methodological quality of randomized controlled trials. All tests are analyzed according to the standards of the Cochrane Handbook. Review Manager 5.3, R-3.5.1 software and Grading of Recommendations Assessment, Development, and Evaluation pro GDT web solution are used for data synthesis and analysis. RESULTS: This review focuses on the effects of Shenfu injection on the microcirculation of shock patients (blood lactic acid level, arteriovenous oxygen saturation, arteriovenous carbon dioxide partial pressure difference, sublingual microcirculation), 28-day mortality, 28-day ICU hospitalization and adverse reaction rate. CONCLUSION: This review provides a clear basis for evaluating the impact of Shenfu injection on the microcirculation of shock patients, as well as the effectiveness and safety of the treatment.

Pain during pars plana vitrectomy following sub-Tenon versus peribulbar anesthesia: A randomized trial.

PURPOSE: To compare pain during pars plana vitrectomy (PPV) following topical lidocaine jelly and sub-Tenon anesthesia versus peribulbar anesthesia. METHODS: Prospective, single-center, randomized study. Patients scheduled for PPV for macular hole (MH) or epiretinal membrane (ERM) at the Retina and Vitreous Section of the Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo were randomly assigned to one of two groups in a 1:1 allocation ratio. Patients assigned to Group ST received topical anesthesia with 2% lidocaine jelly followed by sub-Tenon anesthesia with 2-4 ml of 1% ropivacaine. Patients assigned to PB received peribulbar anesthesia with 4-6 ml of 1% ropivacaine. After PPV, patients in both groups were asked to rate the level of pain they felt during the entire procedure (including anesthesia administration and PPV) by pointing at a 0-100 Visual Analogue Pain Scale (VAS). Data regarding demographics, patient characteristics and surgical features were also collected. RESULTS: Fifty-four patients were enrolled in the study (26 in Group ST and 28 in Group PB). Baseline characteristics, including age, gender, and presence of comorbidities, were similar in both groups. The surgery performed was PPV alone in 10 and 14 patients in the ST and PB groups, respectively, and combined phacoemulsification and PPV in 16 and 14 patients in the ST and PB groups, respectively (p = 0.39, Pearson). Surgery duration (mean ± SD minutes) was similar in the two groups (62 ± 12 for ST and 70 ± 20 for PB, p = 0.09, t-Test). No patients needed supplemental topical or intravenous anesthesia during surgery. No sight- or life-threatening complication was observed in either group. VAS score was significantly lower in the ST compared to the PB group (median (interquartile range) was 1 (2.25-0) in the ST group compared to 11.5 (29.75-5) in the PB group, p< 0.0001, Wilcoxon). CONCLUSION: In this study of patients who underwent PPV for MH or ERM, topical followed by sub-Tenon anesthesia was more effective in controlling pain during the whole vitrectomy procedure than peribulbar anesthesia. Compared to peribulbar anesthesia which is administered with a sharp needle, sub-Tenon anesthesia administered with a blunt cannula may be associated with a reduced risk of such adverse events as globe perforation, retrobulbar hemorrhage, and inadvertent injection of anesthesia into the optic nerve sheath.

Efficacy and safety of traditional Chinese medicine injections in the treatment of acute myocardial infarction: A protocol for systematic review and network meta-analysis.

BACKGROUND: As one of the common cardiovascular diseases, acute myocardial infarction (AMI) is characterized by a high mortality rate, frequent complications, and a serious threat to human health and quality of life. Traditional Chinese medicine injection (TCMI) has been used clinically to treat AMI; however, there is no uniform standard for clinical treatment of AMI. The purpose of this study is to evaluate the efficacy and safety of different TCMI by using systematic review and network meta-analysis. METHODS: According to the strategy, the authors will retrieve both 4 Chinese databases and 3 English databases by June 30, 2020. After a series of screening, randomized controlled trials will be included related to TCMI for AMI. Two researchers will use Aggregate Data Drug Information System and STATA 15.0 to analyze the data. Finally, the evidence grade of the results will be evaluated. RESULTS: This study will provide a reliable evidence for the selection of TCMI therapies for AMI. CONCLUSION: The results of this study will provide references for evaluating the influence of different TCMI therapies for AMI, and provide decision-making references for clinical research. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/FYGBT.

Effect of sodium cantharidinate/vitamin B6 injection on survival, liver function, immune function, and quality of life in patients with hepatocellular carcinoma: Protocol for a meta-analysis.

BACKGROUND: Sodium cantharidinate/vitamin B6 (SC/VB6) injection, a famous insect-derived traditional Chinese medicine preparation, has been widely applied as a promising adjunctive drug for hepatocellular carcinoma (HCC). However, its exact clinical efficacy and safety is still not well investigated. In this study, we aimed to summarize the efficacy of SC/VB6 injection on survival, liver function, immune function, and quality of life (QoL) in patients with HCC through the meta-analysis. METHODS: All available randomized controlled trials (RCTs) and high-quality prospective cohort studies that investigated the efficacy and safety of SC/VB6 for patients with HCC were searched from ten electronic databases including PubMed, Google Scholar, Cochrane Library, Excerpt Medica Database (Embase), Medline, Web of Science (WOS), Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), China Scientific Journal Database (CSJ), and Wanfang Database. Papers in Chinese or English published from January 2000 to July 2020 will be included without any restrictions.Study selection and data extraction will be performed independently by 2 researchers. The clinical outcomes including overall survival (OS), QoL, liver function, immune function, and adverse events, were systematically evaluated. Review Manager 5.3 and Stata 14.0 were used for data analysis, and the quality of the clinical trials was also evaluated. RESULTS: The results of this study will be published in a peer-reviewed journal, and provide a helpful evidence for clinicians to formulate the best postoperative adjuvant treatment strategy for HCC patients. CONCLUSION: Our study will draw an objective conclusion of the efficacy of SC/VB6 on survival, liver function, immune function, and QoL in patients with HCC. INPLASY REGISTRATION NUMBER: INPLASY202070121.

An integrative review on facilitators and barriers in delivering and managing injectable therapies in chronic conditions: A part of the ACNAP project 'injectable medicines among patients with cardiovascular conditions'.

INTRODUCTION: Although preventive health and therapeutics have benefited from advances in drug development and device innovation, translating these evidence-based treatments into real-world practice remains challenging. AIM: The current integrative review aims to identify facilitators and barriers and perceptions in delivering and managing injectable therapies from patient perspectives. METHODS: An integrative review was conducted in the databases of PubMed, CINAHL, PsycINFO and Cochrane. Keywords were used "Injectable therapy", "IV therapy", "SC therapy", "long term injectable therapies", "self-administered injectable therapy", "patients", "caregivers", "family", "carers", "facilitators", "barriers", "perspectives", "needs", "expectations", "chronic disease", "cardiovascular disease" linked with the words "OR" and "AND". The search was limited from January 2000 to July 2019. Inclusion and exclusion criteria were used. RESULTS: Twenty studies were identified from the literature search. Studies followed qualitative, quantitative methodology and mixed methods. Facilitators included: health improvement, prevention of disease complications, taking control of their disease, effectiveness of the medication and convenience in management. Barriers included: fear of needles, insulin will cause harm, poor perception of the benefits of injectable therapies on their quality of life, inconvenience in self-management, social stigma, impact on daily living, financial barriers, lack of education. Perceptions included: 'treatment of last resort', 'life becomes less flexible', 'injectables were punishment/restriction', 'personal failure of self-management'. CONCLUSION: Evidence shows how to create effective communication and shared decision-making relationships to provide best possible care to patients who need injectable therapy and support for self-management. Future research might help guide response to the fears and barriers of the patients using patients' perspectives.

Xiaoaiping injection as adjunct therapy for patients with advanced esophageal carcinoma: A protocol for a systematic review and meta-analysis.

BACKGROUND: Esophageal carcinoma (EC) is one of the worst malignant digestive neoplasms with a strong tendency of invasion and metastasis. Despite the improvement of diagnostic and therapeutic methods in the past decades, the prognosis of EC remains unsatisfactory. Xiaoaiping injection (XAPI), a famous traditional Chinese herbal medicine, has been widely applied as a promising adjunctive drug for EC. However, the exact effects and safety of XAPI have yet to be systematically investigated. We aimed to summarize the efficacy and safety of XAPI for the treatment of advanced EC through the meta-analysis, in order to provide scientific reference for the design of future clinical trials. METHODS: Relevant randomized controlled trials (RCTs) were searched from Cochrane Library, PubMed, Google Scholar, Web of Science, Excerpt Medica Database, Medline, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, China Scientific Journal Database and Wanfang Database. Papers in English or Chinese published from January 2000 to May 2020 will be included without any restrictions.Study selection and data extraction will be performed independently by 2 investigators. The clinical outcomes including overall response rate, complete response rate, overall survival, Disease-free survival, quality of life, immune function and adverse events, were systematically evaluated. Review Manager 5.3 and Stata 14.0 were used for data analysis, and the quality of the studies was also evaluated. RESULTS: The results of this study will be published in a peer-reviewed journal, and provide more evidence-based guidance in clinical practice. CONCLUSION: Our study will draw an objective conclusion of the effects of XAPI combined with conventional treatment for advanced EC and provide a helpful evidence for clinicians to formulate the best postoperative adjuvant treatment strategy for EC patients. INPLASY REGISTRATION NUMBER: INPLASY202050094.

Volume and Infusion Rate Dynamics of Intraparenchymal Central Nervous System Infusion in a Large Animal Model.

Thalamic infusion of adeno-associated viral (AAV) vectors has been shown to have therapeutic effects in neuronopathic lysosomal storage diseases. Preclinical studies in sheep model of Tay-Sachs disease demonstrated that bilateral thalamic injections of AAV gene therapy are required for maximal benefit. Translation of thalamic injection to patients carries risks in that (1) it has never been done in humans, and (2) dosing scale-up based on brain weight from animals to humans requires injection of larger volumes. To increase the safety margin of this infusion, a flexible cannula was selected to enable simultaneous bilateral thalamic infusion in infants while monitoring by imaging and/or to enable awake infusions for injection of large volumes at low infusion rates. In this study, we tested various infusion volumes (200-800 µL) and rates (0.5-5 µL/min) to determine the maximum tolerated combination of injection parameters. Animals were followed for ∼1 month postinjection with magnetic resonance imaging (MRI) performed at 14 and 28 days. T1-weighted MRI was used to quantify thalamic damage followed by histopathological assessment of the brain. Trends in data show that infusion volumes of 800 µL (2 × the volume required in sheep based on thalamic size) resulted in larger lesions than lower volumes, where the long infusion times (between 13 and 26 h) could have contributed to the generation of larger lesions. The target volume (400 µL, projected to be sufficient to cover most of the sheep thalamus) created the smallest lesion size. Cannula placement alone did result in damage, but this is likely associated with an inherent limitation of its use in a small brain due to the length of the distal rigid portion and lack of stable fixation. An injection rate of 5 µL/min at a volume ∼1/3 of the thalamus (400-600 µL) appears to be well tolerated in sheep both clinically and histopathologically.