Obvious Adverse Events Research Articles

A Case Series of Deep Transcranial Magnetic Stimulation Treatment for Patients with Obsessive-Compulsive Disorder in the Tokyo Metropolitan Area.

Obsessive-compulsive disorder (OCD) is a chronic illness in which patients do not achieve remission sufficiently with conventional medication. Deep repetitive transcranial magnetic stimulation (dTMS) for OCD neuromodulates the bilateral anterior cingulate cortex (ACC) and dorsal medial prefrontal cortex (mPFC), which are known to be impaired in OCD. While dTMS treatment for OCD has shown effective results overseas, TMS treatment for OCD has rarely been implemented in Japan, and its effectiveness is unknown. We conducted an FDA-approved dTMS protocol to 26 patients with OCD. In addition, individual exposure stimulation that elicited each patient’s obsessive thoughts was also combined during dTMS treatment. Before and after 30 sessions of TMS treatment, the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was used to assess changes in the severity of each patient’s obsessive-compulsive disorder. Response to dTMS treatment in patients with OCD was determined by whether the total score on the Y-BOCS after a course of treatment was reduced by 30% or more compared with the score at baseline. The percentage of responders in this case series following the 30 sessions of dTMS treatment was 53.9%. In addition, total Y-BOCS scores and scores on each item were significantly improved. The percent changes in total Y-BOCS scores did not differ between the sexes or between on- and off-medication patients. No obvious adverse events were observed in this case series. In line with the results of TMS studies for OCD patients reported overseas, dTMS treatment for Japanese patients with OCD may have a favorable therapeutic effect.

Efficacy and safety of abatacept for interstitial lung disease associated with antisynthetase syndrome: a case series.

This study investigated the efficacy and safety of abatacept (ABA) in interstitial lung disease (ILD) associated with antisynthetase syndrome (ASS). Eight patients were identified through retrospective analysis of the medical records of our centre. All patients fulfilled the Solomon criteria and had a disease complicated with ILD. Lung function, imaging, serum markers, clinical evaluation indicators of ILD, peripheral blood cell classification, cytokines, and prednisone doses were analysed. Seven of the eight patients were female. The mean age was 54.4 (standard deviation [SD] 6.0) years. Antibodies against Jo-1, PL-12, and PL-7 were present in three, three, and two patients respectively. At baseline, the mean diffusing lung capacity for carbon monoxide (DLCO) was 53.8% (SD 9.2%), the mean score of King's Brief Interstitial Lung Disease (KBILD) was 40.6 (SD 13.8), the median Krebs Von den Lungen-6 (KL-6) was 1612.5 (interquartile range [IQR] 1180.5-2431.5) U/ml. All patients experienced symptom alleviation after ABA therapy. The mean and median changes in DLCO percentage, KBILD, and KL-6 were 12.3% (p<0.05), 21.4 (p<0.01), and 174.5U/ml (p<0.01), respectively. No obvious adverse events related to ABA were observed during the treatment. Our study offers preliminary, but encouraging, clinical evidence in favour of ABA as a therapy for ASS-ILD. ABA demonstrated favourable effects on ILD and was well-tolerated. Well-designed randomised controlled studies are required to confirm the efficacy and safety of this strategy.

The Beneficial Effects of Hydrogen-Rich Saline Irrigation on Chronic Rhinitis: A Randomized, Double-Blind Clinical Trial

PurposeChronic rhinitis (CR) is a common chronic inflammation of the nasal mucosa. Nasal saline irrigation has been demonstrated to be an effective treatment for CR. In this study, we investigated the beneficial effects of hydrogen-rich saline irrigation as an anti-inflammatory irrigation therapy for CR and compared its effectiveness over saline irrigation. Hydrogen-rich saline (HRS) was investigated due to its antioxidant and anti-inflammatory properties.MethodsA total of 120 patients with CR were randomly divided into two groups, patients irrigated with HR (HRS group) and the control group irrigated with saline (NS group). A randomized, double-blind control study was performed. The main observation index in this study was the total score of nasal symptoms (TNSS). In addition, eosinophilic protein (ECP) of the nasal secretions, nasal nitric oxide (nNO) levels, and levels of regulatory T cells (Treg) and regulatory B cells (Breg) were also compared between the two groups. Furthermore, patients with allergic rhinitis (AR) and non-allergic rhinitis (NAR) were also evaluated based on serum-specific IgE positivity.ResultsAfter treatment, TNSS and nasal ECP in the two groups decreased significantly (P<0.05), with patients in the HRS group showing significantly lower levels compared to the NS group (P<0.05). There were no significant differences in Treg and Breg levels between the two groups. Subgroup analysis showed that TNSS in the AR-HRS group showed a more significant reduction compared to the AR-NS group (P<0.05); however, there were no significant differences for the other inflammatory biomarkers (P>0.05). ECP levels were reduced significantly in the NAR subgroup compared to NS irrigation (P<0.05). There were no obvious adverse events observed in patients during the entire treatment period.ConclusionCompared to saline irrigation, HRS nasal irrigation was found to improve CR clinical symptoms, especially in patients with AR. HRS could effectively be used for the clinical treatment of patients with CR.

Shexian Bupleurum Alleviates Insomnia and Improves Symptoms of Anxiety and Depression: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective: To observe the clinical efficacy of Shexian bupleurum on insomnia based on evaluation scales and polysomnogram (PSG). Methods: A total of 260 patients suffering from insomnia admitted to the outpatient department of Handan Central Hospital were included in a randomized, double blind, placebo-controlled trial. The patients were randomly divided into two groups: a control group (receiving placebo, n = 150), and an intervention group (receiving Shexian bupleurum treatment, n = 110). The clinical trial lasted for 4 weeks. The Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Patient Health Questionnaire (PHQ)-9, Generalized Anxiety Disorder (GAD)-7, 17 items of Hamilton Depression Scale (HAMD-17), and Hamilton Anxiety Scale (HAMA) were used to evaluate the patients at baseline as well as two weeks and four weeks after treatment; the Treatment Emergent Symptom Scale (TESS) was used to evaluate adverse reactions; polysomnography (PSG) was used to monitor and analyze their sleep characteristics at baseline and four weeks after treatment. Results: The PSQI, ISI, PHQ-9, HAMD-17, and HAMA scores of the intervention group significantly decreased compared to the control group, while the total sleep time, rapid eye movement sleep latency, stage 2 sleep, deep sleep, rapid eye movement sleep, and sleep efficiency of the intervention group significantly increased compared to the control group. The PHQ-9 score of the control group only decreased two weeks after treatment (p &lt; 0.05) compared to the intervention group. In addition, there were no obvious adverse events in both the intervention group and the control group. Conclusion: Shexian bupleurum not only improves sleep quality, but also relieves depression and anxiety in patients who suffer from insomnia.

Comparison of ciprofol (HSK3486) versus propofol for the induction of deep sedation during gastroscopy and colonoscopy procedures: A multi‐centre, non‐inferiority, randomized, controlled phase 3 clinical trial

Ciprofol is a propofol analogue with improved pharmacokinetic properties. A multi‐centre, non‐inferiority trial was conducted to compare the deep sedation properties of ciprofol and propofol with a non‐inferiority margin of 8% in patients undergoing gastroscopy and colonoscopy. In total, 289 patients were randomly allocated for surgery (259 colonoscopy and 30 gastroscopy) at a 1:1 ratio to be given intravenous injections of ciprofol (0.4 mg/kg) or propofol (1.5 mg/kg). The primary outcome was the success rate of colonoscopy defined as colonoscopy completion with no need for an alternative sedative or >5 ciprofol or propofol top up doses within any 15‐min time period. The success rate of colonoscopy was 100% in the ciprofol group vs. 99.2% in the propofol group (mean difference 0.8%, 95% CI: −2.2% to 4.2%). Except for the gastrointestinal lesions found during the gastroscopy and colonoscopy procedures, the occurrence rates of adverse drug reactions in the ciprofol and propofol groups were 31.3% and 62.8%, respectively (P < 0.001). Pain on injection was less common in the ciprofol group (4.9% vs. 52.4%, P < 0.001). The outcomes demonstrated that ciprofol was non‐inferior to propofol with regard to successful sedation for gastroscopy or colonoscopy procedures and no obvious important adverse events occurred.

The efficacy and safety of continuous intra-arterial infusion neoadjuvant chemotherapy with surgery for locally advanced gastric cancer: a preliminary pilot study.

Neoadjuvant chemotherapy (NAC) followed by R0 resection is regarded as a standard treatment strategy for locally advanced gastric cancer (GC); however, the response to systemic chemotherapy remains unsatisfactory. Continuous intra-arterial infusion chemotherapy (CAIC) is a new method, compared with systematic chemotherapy, it can deliver chemotherapy drugs more accurately, so as to achieve higher surgical conversion rate. This study aimed to explore the efficacy and safety of CAIC in locally advanced GC patients. In this retrospective pilot study, four patients with histologically confirmed locally advanced GC were identified from a tertiary hospital between May 2018 and December 2018. Clinic stage was belonged to T4N1-3M0 in all cases with potential probability for surgery. All cases received three cycles of NAC by CAIC with oxaliplatin (100 mg on day 1) plus oral S-1 (80 mg/m2/day twice daily for 14 days) (SOX). Contrast-enhanced computed tomography (CT) scans and pathological examinations were performed to evaluate chemotherapeutic response based on the tumor regression grade (TRG) and post-neoadjuvant pathological Tumor Node Metastasis (ypTNM) staging. All cases were regularly followed up with face-to-face interviews at outpatient, abdominal enhanced CT scan and serum tumor markers were be requested at 3-month intervals for up to 1 year postoperatively. The obstruction was significantly alleviated after three cycles of CAIC. Contrast-enhanced CT scans showed decreased tumor volume to some extent, along with lymph node shrinkage after treatment. Radical (R0) resection was achieved in all cases. Histopathological analysis showed tumor downstaging in three cases and upstaging in one case. The tumor response to treatment demonstrated TRG1a in one case, TRG1b in one case, and TRG2 in two cases, with an overall tumor regression rate of 100%. No obvious adverse events or perioperative complications were observed during or following treatment. All cases were alive without tumor recurrence or progression after the 1-year postoperative follow-up. Our study may shed light on super-selective CAIC as an effective method for improving the NAC response in locally advanced GC. Future studies with a larger sample sizes and long-term outcomes are required for a final conclusion.

Systematic review and Meta-analysis of efficacy and safety of Shuxuetong Injection in treatment of diabetic peripheral neuropathy

The present study evaluated the efficacy and safety of Shuxuetong Injection in the treatment of diabetic peripheral neuropathy(DPN). PubMed, Cochrane Library, EMbase, CNKI, VIP, SinoMed, and Wanfang were searched for randomized controlled trials(RCTs) of Shuxuetong Injection in the treatment of DPN from database inception to July 18, 2021. Literature screening was carried out according to the inclusion and exclusion criteria, and the required information was extracted. Cochrane risk-of-bias tool was used to evaluate the quality of the included trials, and RevMan 5.3 was used for Meta-analysis. Finally, six articles were included, involving 507 patients. The overall quality of included RCTs was not high. As revealed by Meta-analysis results, in terms of DPN score, one trial showed a significant difference in the experimental group before and after treatment, and the symptom of the experimental group was significantly improved compared with that in the control group after treatment. After treatment, a significant difference in DPN scores of the experimental group and the control group was observed(P&lt;0.05), and the symptom improvement of the experimental group was significantly better than that of the control group. In terms of sensory nerve conduction velocity(SCV), the experimental group was superior to the control group in improving conduction velocities(MD_(median SCV)=4.45, 95%CI[2.79, 6.10], P&lt;0.000 01; MD_(peroneal SCV)=6.70, 95%CI[5.64, 7.75], P&lt;0.000 01; MD_(posterior tibial SCV)=4.03, 95%CI[0.56, 7.49], P=0.02). In terms of motor nerve conduction velocity(MCV), compared with the conditions before treatment, the conduction velocities of median nerve, peroneal nerve, and posterior tibial nerve in both groups increased after treatment(P&lt;0.01). The experimental group was superior to the control group in improving MCV after treatment(P&lt;0.05). In terms of average blood glucose change, there is no statistical significance of the improvement of average blood glucose between experimental group and the control group(MD=-0.15, 95%CI[-0.82, 0.51], P=0.65). In terms of overall response rate, the curative effect of the experimental group in the treatment of DPN was superior to that of the control group(RR=1.23, 95%CI[1.11, 1.37], P=0.000 1). In terms of adverse events, no obvious adverse events were reported in the included RCTs. In light of existing data and indexes, the clinical efficacy of Shuxuetong Injection combined with western medicine in the treatment of DPN may be superior to that of conventional western medicine. It can improve the clinical symptoms, SCV, MCV, and average blood glucose of DPN, with good safety. However, existing clinical trials are few and the quality is low. It is recommended to further verify the above conclusions with internationally recognized outcome indicators.

The effect of anlotinib on unresectable differentiated thyroid cancer (T4): A retrospective study.

6096 Background: Though the majority of differentiated thyroid cancer (DTC) patients obtained a good prognosis after standardized therapy, approximately 15% of DTC patients will progress to unresectable disease. Part of locally advanced (T4) thyroid cancer patients with progressive invasion into vasculature/windpipe/esophagus lost the surgery opportunity because of difficult in achieving R0/R1 resection. The study aimed to evaluate the efficacy and safety of anlotinib in T4 PTC. Methods: Retrospectively included T4 papillary thyroid cancer (PTC) patients from West China Hospital of Sichuan University between Sep. 2020 and Feb. 2022. The patients were prescribed with Anlotinib (12 mg orally daily, two weeks on/one week off) at least two courses. The tumor response was defined by RECIST v. 1.1. The primary endpoint was objective response rate (ORR). Results: The study included 22 T4 PTC patients, including 8 patients with lung metastasis. The median age of patients was 59.2 years, 8/22 patients were male. The median follow-up was 5.5 months (2-13 months). Totally, the ORR was 68.2% (CR: 9.1%; PR: 59.1%), disease control rate (DCR) was 95.5% (SD: 27.3%), one patient progressed (PD). 8 patients with lung metastasis, the ORR was 75% (6/8). The average tumor shrinkage rate was 42.1%. And two female patients (T4aN1M1 and T4bN1M0 respectively) obtained CR. Additionally, one juvenile patient (14 y) also response to Anlotinib treatment with 55.2% tumor shrinkage, and no obvious AE was observed in this patient. Most adverse events (AEs) were grade 1 or 2. Common AEs of all grades were hypertension (68.2%), hypertriglyceridemia (36.4%), proteinuria (31.8%), and tended to discontinue when treatment ceased. Conclusions: Anlotinib demonstrated antitumor activity in the treatment of unresectable T4 PTC; Juvenile PTC patients also response to Anlotinib treatment; Anlotinib treatment was tolerable in T4 PTC patients.

Effects of Washed Fecal Bacteria Transplantation in Sleep Quality, Stool Features and Autism Symptomatology: A Chinese Preliminary Observational Study.

PurposeAutism spectrum disorder is a highly complex neurological and psychosocial disorder characterized by social dysfunction, severe reduction in speech, and a single stereotyped behavior. The treatment methods are currently limited, and children with autism generally suffer from constipation and sleep disorders. It is urgent to find an alternative psychotropic drug, given the drug dependence and adverse reactions that may occur with long-term medication.Patients and MethodsThis retrospective study included 49 children with autism at the first affiliated Hospital of Guangdong Pharmaceutical University, who received washed fecal microbiota transplantation (WMT) treatment between June 2019 and July 2021 and compared the sleep disorder scores between the constipation group, control group and blank group.ResultsSecond WMT could significantly improve the sleep disorder scores in the constipation group (p=0.026) and the decrease in sleep disturbance scale for children (SDSC) score was synchronized with the increase in Bristol stool form scale (BSFS) score. However, there was no significant difference between patients without constipation (p=0.54), and the behavior of autism improved in both groups.ConclusionWMT could relieve constipation and improve sleep disorders in children with autism, with no deterioration in stool morphology and sleep disorders in other children. Moreover, there were no obvious serious adverse clinical events after WMT.

Transcutaneous Electrical Acupoint Stimulation Improves Postoperative Cognitive Function in Senior Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial.

To evaluate the effectiveness and safety of transcutaneous electrical acupoint stimulation (TEAS) for improving postoperative cognitive function in senior patients undergoing video-assisted thoracoscopic surgical (VATS). From January to December 2020, 97 participants were randomly assigned to the TEAS group (49 cases) and the control group (48 cases) by a random number table. The patients in the TEAS group received TEAS, at the bilateral Neiguan (PC 6) and Zusanli (ST 36) acupoints. The control group received sham TEAS. The stimulation was started from 30 min before surgery until the end of the operation. The primary outcome was the incidence of pstoperative cognitive dysfunction (POCD), diagnosed based on the changes in the Mini-Mental Status Examination (MMSE) and Montreal Cognitive Assessment (MoCA) scores. The secondary outcomes were plasma levels of S100β protein and neuron-specific enolase (NSE). The incidence of POCD on day 1 and 3 after surgery in the TEAS group was significantly lower than that in the control group [day 1 after surgery: 28.3% (13/46) vs. 52.3% (23/44), P=0.028; day 3 after surgery: 21.7% (10/46) vs. 40.9% (18/44), P=0.043]. Compared with baseline, the MMSE and MoCA scores decreased to various extents in both groups. The MMSE scores on day 1, 3, and 5 after surgery and MoCA scores on day 1, 3, 5, and 7 after surgery in the TEAS group were higher than those in the control group (all P<0.05) in both groups. Compared with baseline, the plasma levels of S100β and NSE were significantly increased at 4, 8, 12, 24 h after surgery (all P<0.05). Compared with the control group, the plasma levels of S100β and NSE were lower in the TEAS group at 4, 8, 12, and 24 h after surgery (all P<0.05). No obvious adverse events were found during the trial. Application of TEAS in senior patients after VATS could reduce incidence of POCD and improve postoperative cognitive function.

Cerebral vasospasm after coil embolization for unruptured anterior communicating artery aneurysm: illustrative case.

BACKGROUNDCompared with several reports of cerebral vasospasm after clipping for unruptured cerebral aneurysm, only one study to date has reported cerebral vasospasm after coil embolization. Herein, the authors report a rare case of cerebral vasospasm after coil embolization for unruptured cerebral aneurysm.OBSERVATIONSA 58-year-old woman with an unruptured anterior communicating artery aneurysm was referred to our department. Stent-assisted coil embolization was performed for the aneurysm, and no obvious adverse events were observed on cerebral angiography obtained immediately after the operation. However, the patient developed mild headache and slight restlessness soon after the operation and new-onset disorientation, left hemispatial neglect, and left hemiplegia the day after the operation. Emergency brain magnetic resonance imaging and cerebral angiography indicated vasospasm in the right middle cerebral artery, and intra-arterial injection of fasudil hydrochloride hydrate was performed to dilate the middle cerebral artery. Blood flow in the middle cerebral artery immediately improved, and she was discharged without neurological deficits 8 days after the operation.LESSONSImmediate intervention is necessary to prevent cerebral infarction in patients with cerebral vasospasm, which may occur even after coil embolization for unruptured cerebral aneurysm.

The study of the effectiveness of CO2 fractional laser for dyspareunia in premenopausal women with vestibulodynia

ABSTRACT Introduction Among female sexual dysfunctions, a relatively large number of women with dyspareunia are encountered in clinical practice. However, there is no effective standard treatments in the absence of endocrine abnormalities. Objective The purpose of this study is to investigate the efficacy and safety of CO2 fractional laser for dyspareunia in premenopausal women with vestibulodynia. Methods From September 2019 to September 30, 2020, we enrolled the patients who were diagnosed with vestibular redness and vestibular pain but were not effective enough with symptomatic treatments or physical therapies. Patients with obvious atrophy findings were excluded. The patients received a CO2 fractional laser irradiation 3 times in total at 1-month interval. The equipment used was Smart Side Square. Irradiation was applied only to the vestibule and vulva, not to the vagina. Surface anesthesia was performed 10 to 20 minutes before laser irradiation. The irradiation output setting conformed to the basic setting, but it was adjusted at the discretion of the attending physician and the actual irradiation setting was recorded. The effect was evaluated using the VAS scale for vestibular pain. Results There were 20 patients aged 23 to 38 years (mean 28.7 years, median 28 years). Eighteen people completed the three times irradiation. The average VAS decreased from 8.5 before treatment to 5.1 after 3 treatments. No obvious adverse events were observed. Conclusions CO2 fractional lasers are effective for dyspareunia in premenopausal women with vestibular pain. Disclosure Work supported by industry: no.

Salvage focal brachytherapy in castration-resistant prostate cancer with neuroendocrine differentiation after radiation therapy.

IntroductionTreatment strategy for castration‐resistant prostate cancer with neuroendocrine differentiation after radiation therapy has not been established.Case presentationWe described a case of castration‐resistant prostate cancer with neuroendocrine differentiation after initial external beam radiotherapy followed by salvage androgen deprivation therapy. Magnetic resonance imaging detected recurrence of a suspicious lesion in the left lobe of the prostate, although the prostate‐specific antigen level was <0.2 ng/mL. Transperineal prostate saturation needle biopsy detected adenocarcinoma with neuroendocrine differentiation. The patient underwent salvage focal brachytherapy and had a prostate‐specific antigen progression‐free survival of 20 months with no obvious adverse events. No recurrence has been detected on magnetic resonance imaging for 18 months.ConclusionSalvage focal brachytherapy for prostate cancer after external beam radiotherapy can be one of the treatment strategies for local recurrence of castration‐resistant prostate cancer with neuroendocrine differentiation.

Protective effect of sacubitril/valsartan in patients with acute myocardial infarction: A meta-analysis.

To evaluate the effects and safety of sacubitril/valsartan in patients with acute myocardial infarction (AMI), a total of four databases, including PubMed, Cochrane Library, Embase and Web of Science, and the ClinicalTrials.gov website were searched. Using a combination of medical subject headings and entry terms, the final search was performed in July 2021. A manual search of cross-references from the original articles was also conducted. The meta-analysis was subsequently performed with Revman 5.3 software and a total of four studies comprising 586 patients were included. The results disclosed a significant reduction in major adverse cardiovascular and cerebrovascular events (MACCEs) [odds ratio (OR), 0.47; 95% confidence interval (CI), 0.30-0.73; P=0.0007], readmission (OR, 0.45; 95% CI, 0.29-0.71; P=0.0006), incidence of acute heart failure (AHF) (OR, 0.45; 95% CI, 0.28-0.71; P=0.0007) and N-terminal pro B-type natriuretic peptide [standardized mean difference (SMD), -0.88; 95% CI, -1.55-(-0.21); P=0.01] in the sacubitril/valsartan group compared with that in the control group, and a random effects model was used to pool these data. No significant differences were identified in the incidence of hypotension (OR, 2.91; 95% CI, 0.55-15.51; P=0.21), adverse events (OR, 2.19; 95% CI, 0.42-11.37; P=0.35), left ventricular ejection fraction (mean difference, 1.96; 95% CI, -0.84-4.76; P=0.17) or soluble suppression of tumorigenesis-2 (SMD, -0.45; 95% CI, -1.62-0.71; P=0.45) according to the random effects model. In conclusion, the present meta-analysis revealed that sacubitril/valsartan was able to effectively reduce the incidence of MACCEs, readmission and AHF in patients with AMI after revascularization without any obvious adverse events.

Trigeminal nerve stimulation for disorders of consciousness

According to previous case reports, trigeminal nerve stimulation (TNS) can be successfully used to wake a non-responsive unconscious patient. However, no studies have comprehensively investigated the effect of TNS on patients with disorders of consciousness (DOC). Therefore, the present study aimed to assess the safety and efficacy of TNS in DOC patients recruited at the First Affiliated Hospital of Nanchang University. We used Coma Recovery Scale-Revised (CRS-R) scores to assess patients at baseline and after 1–4 weeks of TNS. The patients were further followed up for 4 weeks after the last stimulation to evaluate the safety of the procedure. The participant group comprised 21 DOC patients with an acquired brain injury who were more than 3 months post-injury. The participants were 44.29 ± 12.55 years old and 5.52 ± 1.83 months post-DOC onset, and included 12 patients who were in a vegetative state or had unresponsive wakefulness syndrome and 9 patients who were in a minimally conscious state. Compared with CRS-R scores at baseline, those at weeks 4 and 8 showed no significant improvements in any of the DOC patients. Nonetheless, CRS-R scores improved throughout the study period in 8 out of the 21 DOC patients. Among those with improved scores, two patients in a minimally conscious state had improved CRS-R scores at week 4, while five had improved scores at 4 weeks later. Only one patient with vegetative state/unresponsive wakefulness syndrome had recovered to a minimally conscious state at week 4. Importantly, no obvious treatment-related adverse events were considered to be related to TNS. Taken together, these data provide early evidence that TNS may be an effective and safe approach for promoting the recovery of consciousness in patients with neurological disorders.

Efficacy and Safety of Mesenchymal Stem Cell Transplantation in the Treatment of Autoimmune Diseases (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Inflammatory Bowel Disease, Multiple Sclerosis, and Ankylosing Spondylitis): A Systematic Review and Meta-Analysis of Randomized Controlled Trial.

Objective To evaluate the efficacy and safety of mesenchymal stem cell (MSC) transplantation in the treatment of autoimmune diseases. Methods The Chinese and English databases were searched for clinical research on the treatment of autoimmune diseases with mesenchymal stem cells. The search time range is from a self-built database to October 1, 2021. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted data, and evaluated the bias of the included studies. RevMan 5.3 analysis software was used for meta-analysis. Results A total of 18 RCTs involving 5 autoimmune diseases were included. The 5 autoimmune disease were rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), inflammatory bowel disease, ankylosing spondylitis, and multiple sclerosis. For RA, the current randomized controlled trials (RCTs) still believe that stem cell transplantation may reduce disease activity, improve the clinical symptoms (such as DAS28), and the percentage of CD4+CD 25+Foxp3+Tregs in the response group increased and the percentage of CD4+IL-17A+Th17 cells decreased. The total clinical effective rate of RA is 54%. For SLE, the results showed that mesenchymal stem cell transplantation may improve SLEDAI [-2.18 (-3.62, -0.75), P = 0.003], urine protein [-0.93 (-1.04, -0.81), P < 0.00001], and complement C3 [0.31 (0.19, 0.42), P < 0.00001]. For inflammatory bowel disease, the results showed that mesenchymal stem cell transplantation may improve clinical efficacy [2.50 (1.07, 5.84), P = 0.03]. For ankylosing spondylitis, MSC treatment for 6 months may increase the total effective rate; reduce erythrocyte sedimentation rate, intercellular adhesion molecules, and serum TNF-α; and improve pain and activity. For multiple sclerosis, the current research results are still controversial, so more RCTs are needed to amend or confirm the conclusions. No obvious adverse events of mesenchymal stem cell transplantation were found in all RCTs. Conclusion MSCs have a certain effect on different autoimmune diseases, but more RCTs are needed to further modify or confirm the conclusion.

Effect of Chinese Patent Medicines on Ocular Fundus Signs and Vision in Calcium Dobesilate-Treated Persons With Non-Proliferative Diabetic Retinopathy: A Systematic Review and Meta-Analysis.

BackgroundDiabetic retinopathy (DR), one of the commonest microvascular complications in diabetic patients, is featured by a series of fundus lesions. Conventional Western medicine therapies for DR are always with modest treatment outcome. This paper is to assess the ocular fundus signs, vision and safety of Chinese patent medicines (CPMs) as an add-on treatment for DR.Method7 electronic databases were searched to determine eligible trials. Randomized controlled trials (RCTs) of non-proliferative diabetic retinopathy (NPDR) in which the intervention group received CPMs combined with calcium dobesilate (CD), and the control group received only CD were included for analysis. Two reviewers extracted the data independently. Results expressing as mean differences (MD) and relative risks (RR) were analyzed with a fixed-effects or random-effects models.Results19 RCTs involved 1568 participants with 1622 eyes met our inclusion criteria. The results suggested that compared with CD alone, CPMs plus CD for NPDR was superior at reducing the microaneurysm volume (MD -3.37; 95% confidence interval [CI], -3.59 to -3.14), microaneurysm counts (MD -2.29; 95%CI -2.97 to -1.61), hemorrhage area (MD -0.79; 95%CI -0.83 to -0.75), and macular thickness (MD -59.72; 95%CI -63.24 to -56.20). Participants in CPMs plus CD group also achieved a better vision. No obvious adverse events occurred.ConclusionCPMs as an add-on therapy for NPDR have additional benefits and be generally safe. This meta‐analysis demonstrated that CPMs combined with CD could improve retinal microaneurysm, hemorrhage, macular thickness, visual acuity, fasting blood glucose (FBG), and glycosylated hemoglobin (HbAlc) compared with CD alone. Further studies are needed to provide more conclusive evidence.Systematic Review RegistrationPROSPERO https://www.crd.york.ac.uk/prospero/, identifier CRD42021257999.

Clinical and Radiological Comparisons of Percutaneous Low-Power Laser Discectomy and Low-Temperature Plasma Radiofrequency Ablation for Cervical Radiculopathy: A Prospective, Multicenter, Cohort Study

BackgroundMinimally invasive techniques, such as percutaneous low-power laser discectomy (PLLD) and low-temperature plasma radiofrequency ablation (coblation) can be applied to treat degenerative cervical radiculopathy. However, less evidence supports the superiority of distinct minimally-invasive therapy. Our study aimed to evaluate the clinical and radiological characteristics of the PLLD and coblation for cervical radiculopathy.MethodsThis was a prospective, multicenter, cohort study (ChiCTR-ONC-17010356). The modified Macnab criteria was performed to assess the clinical improvement pre- and post-surgery. To evaluate the radiological effect, the Pfirrmann grading system and disk herniation index were applied with MRI.ResultsIn this study, 28 patients were enrolled in the coblation group and 30 patients in the PLLD group. The mean good-excellent rate at 3-month follow-up was 82.1% for PLLD group, and 66.7% for coblation group, respectively (p = 0.179). The PLLD group achieved higher good-excellent rate 6 and 12 months after discharge (92.9 vs. 70.0%, p = 0.026). Radiological data revealed that PLLD but not coblation treatment achieved significant reduction of disk herniation index (p < 0.0001). Coblation treatment did not change the Pfirrmann grades of cervical radiculopathy patients (n = 18), and 7 out of 17 (41.2%) patients achieved improvement after PLLD therapy. None obvious adverse event was observed in this study.ConclusionBoth PLLD and coblation are effective and safe option for patients with cervical radiculopathy. Better long-term clinical outcomes may be potentially associated with the improvement of disk degeneration after PLLD treatment.

The Effect and Safety of Iguratimod Combined With Methotrexate on Rheumatoid Arthritis: A Systematic Review and Meta-Analysis Based on a Randomized Controlled Trial.

Background: Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease with inflammatory synovitis. Iguratimod (IGU) combined with methotrexate (MTX) therapy may have better efficacy and safety. Methods: First, we searched randomized controlled trials (RCTs) of IGU + MTX in the treatment of RA through literature databases (such as PubMed, Corkland Library, CNKI, etc.) and then conducted RCT quality assessment and data extraction. Finally, we used RevMan 5.3 for meta-analysis, STATA 15.0 for publication bias assessment, and GRADE tool for the evidence quality assessment of primary outcomes. This systematic review and meta-analysis were registered in PROSPERO (CRD42021220780). Results: This systematic review and meta-analysis included 31 RCTs involving 2,776 patients. Compared with MTX alone, the ACR20, ACR50, and ACR70 of IGU + MTX are higher, while DAS28 is lower [ACR20: (RR 1.55, 95% CI 1.14–2.13, p = 0.006); ACR50: (RR 2.04, 95% CI 1.57–2.65, p < 0.00001); ACR70: (RR 2.19, 95% CI 1.44–3.34, p = 0.00003); DAS28: (weighted mean difference (WMD) −1.65, 95% CI −2.39 to −0.91, p < 0.0001)]. Compared with MTX + leflunomide, IGU + MTX has no significant difference in improving ACR20, ACR50, ACR70, but IGU + MTX improves DAS28 more significantly [ACR20: (RR 1.09, 95% CI 0.79–1.89, p = 0.59); ACR50: (RR 1.07, 95% CI 0.64–1.78, p = 0.81); ACR70: (RR 1.17, 95% CI 0.44–3.10, p = 0.76); DAS28: (WMD −0.40, 95% CI −0.42 to −0.38, p < 0.0001)]. Compared with the MTX + tripterygium subgroup and MTX-only subgroup, the incidence of adverse events of the IGU + MTX group is of no statistical significance [MTX only: (RR 0.99, 95% CI 0.87–1.13, p = 0.90); MTX + Tripterygium: (RR 0.73, 95% CI 0.29–1.85, p = 0.50)]. However, compared with MTX + leflunomide, the incidence of adverse events in the IGU + MTX group was lower (RR 0.74, 95% CI 0.62–0.88, p = 0.0009). The quality of ACR70 was high; the quality of adverse events and ACR50 test was moderate. Conclusion: Compared with conventional therapy, IGU + MTX may be a safer and more effective therapy for RA patients. When the intervention method is (IGU 25 mg Bid, MTX 10–25 mg once a week), and the intervention lasts for at least 12 weeks, the curative effect may be achieved without obvious adverse events.

Observation and analysis on clinical efficacy of Dachengqi decoction for acute pancreatitis

To observe the clinical efficacy of Dachengqi decoction combined with octreotide in the treatment of patients with acute pancreatitis (AP). From March 2018 to February 2021, a total of 68 patients with mild acute pancreatitis (MAP) and moderately severe acute pancreatitis (MSAP) admitted to Shanghai Traditional Chinese Medicine-Integrated Hospital were included, and they were randomly divided into western medicine treatment group and Dachengqi decoction group. The patients in the western medicine treatment group received conventional western medicine (octreotide+symptomatic treatment); in the Dachengqi decoction group, 100 mL of Dachengqi decoction was taken orally on the basis of conventional western medicine, twice a day; the observation time for both groups was 7 days. The levels of inflammation parameters [white blood cell count (WBC), interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP)] and serum amylase (Amy) before and after treatment of patients between the two groups, as well as the occurrence of clinical efficacy indicators and adverse reactions were compared. Among the 68 included patients, 4 were excluded because the specimen was not obtained or the patient gave up the treatment. A total of 64 patients were finally enrolled in the analysis, including 32 cases in the Dachengqi decoction group and 32 cases in the western medicine treatment group respectively. There was no statistically significant difference in inflammation parameters or serum Amy levels before treatment between the two groups. At 7 days of treatment, the inflammatory parameters and serum Amy levels of the two groups were significantly lower than those before treatment [western medicine treatment group: WBC (×109/L) was 5.94±2.08 vs. 11.81±3.66, IL-6 (ng/L) was 7.22 (5.72, 14.23) vs. 30.13 (15.77, 85.37), PCT (μg/L) was 0.068 (0.052, 0.128) vs. 0.290 (0.231, 0.428), CRP (mg/L) was 26.0 (18.3, 35.8) vs. 112.0 (62.0, 126.0), Amy (U/L) was 77 (57, 116) vs. 352 (162, 1 576); Dachengqi decoction group: WBC (×109/L) was 5.56±2.04 vs. 12.22±2.85, IL-6 (ng/L) was 5.70 (3.26, 11.06) was 50.30 (23.99, 88.32), PCT (μg/L) was 0.038 (0.028, 0.808) vs. 0.308 (0.129, 0.462), CRP (mg/L) was 11.0 (3.5, 24.0) vs. 150.0 (75.0. 193.0), Amy (U/L) was 78 (57, 104) vs. 447 (336, 718); all P < 0.05], and the levels of IL-6, PCT, and CRP decreased more significantly after treatment in the Dachengqi decoction group (all P < 0.05). The total clinical effective rate of patients in the Dachengqi decoction group was significantly higher than that of the western medicine treatment group [93.75% (30/32) vs. 71.88% (23/32), P < 0.05]. There was no obvious adverse event during the treatment and observation period in the two groups. Dachengqi decoction combined with octreotide therapy could improve the clinical efficacy of AP patients, and its mechanism might be related to reducing the level of inflammatory factors, thereby inhibiting the inflammatory response, and regulating the level of serum Amy.