OBJECTIVE: To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents. METHODS: This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs). RESULTS: This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed. CONCLUSION STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans ; Double-Blind Method ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Middle Aged ; Angina, Stable/physiopathology* ; Aged ; Syndrome ; Treatment Outcome ; Placebos ; Tablets

Objective To compare the subjective and objective outcomes of flexible ureterorenoscopy (F-URS) and extracorporeal shock wave lithotripsy (ESWL) for the treatment of inferior calyceal calculi between 10 to 20 mm. Method A retrospective analysis was performed for inferior calyceal calculi between 10 to 20 mm at our institution on a total of 112 patients treated with holmium laser lithotripsy or ESWL from September 2013 to September 2016. Retreatment rate, complications, stone clearance rate and subjective patient-reported outcomes were compared. Result Stone clearance rate was significantly higher in F-URS group compared with ESWL group (86.1% vs 61.8%, P < 0.05). Retreatment rate (44.7% vs 8.3%, P < 0.05) was higher in ESWL. There was no significant difference in complication (11.1% vs 7.9%, P > 0.05). Overall satisfaction score [(2.92 ± 1.24) vs (2.07 ± 1.35), P < 0.05] and voiding symptom score [(3.87 ± 0.64) vs (2.23 ± 0.73), P < 0.05)] were significantly higher in F-URS than ESWL. More patients in F-URS were willing to undergo the procedure again (83.3% vs 55.3%, P<0.05). Conclusion For the treatment of intermediate size inferior calyceal calculi,F-URS is superior to ESWL in terms of stone clearance rate, retreatment rate and subjective satisfaction.

Saponin frsom Cortex Albiziae (SCA) are extensively used in the clinical treatment of tumor and depression. However, SCA may cause several adverse effects, including reproductive toxicity. The present study was designed to assess the mechanism by which SCA cause reproductive toxicity in female mice. The general reproductive toxicity testing was accomplished in female Kunming mice. The animals were divided into four groups: three groups that were treated by oral gavage with 135, 270, and 540 mg·kg(-1)·d(-1) of SCA prepared in physiological saline, respectively, and one vehicle control group that was treated with physiological saline only. The gestational toxicity tests were conducted at 540 mg·kg(-1)·d(-1). The general reproductive toxicity results showed that the pregnancy rate of the SCA-treated group decreased with the pregnancy rate being decreased by 70% at 540 mg·kg(-1)·d(-1). SCA elicited maternal toxicity in the ovary and the uterus, but no fetal toxicity or teratogenicity was observed. The rates of implantation in the early, middle, and late pregnancy were all decreased, with stillbirths and maternal deaths being observed. Histopathological changes showed that SCA adversely affected the ovary and the uterus. In conclusion, SCA-induced reproductive toxicity in female mice is most likely caused by its damage to the ovary and the uterus.
Albizzia ; chemistry ; toxicity ; Animals ; Embryo Implantation ; drug effects ; Female ; Humans ; Mice ; Ovary ; drug effects ; Plant Extracts ; administration & dosage ; toxicity ; Pregnancy ; Reproduction ; drug effects ; Saponins ; administration & dosage ; toxicity ; Uterus ; drug effects

OBJECTIVETo evaluate the effect of the treatments of lumbar spinal stenosis by selective decompression of lumbar root canal and laminectomy.

METHODSFrom March 2007 to March 2011, 144 lumbar spinal stenosis patients were treated by selective decompression of lumbosacral root canal and laminectomy. All of these patients included 64 male and 80 female patients, age range 60-87 years, average (66 ± 5) years. Duration 6-72 months, average (12 ± 16) months. The patients were divided into 2 groups according to surgical procedure underwent: group A including 70 patients who were treated with selective decompression of lumbar root canal, group B including 74 patients who were treated with traditional laminectomy. Five time points were selected to assess clinical effect using Oswestry disability index (ODI) and Japanese Orthopaedic Association (JOA), which were pre-operation and 1 month, 6 months, 12 months and last follow-up. The data were analyzed through Wilcoxon matched-pairs signed-ranks test.

RESULTSAll operations were completed well without severe complications. The duration of follow-up was 12-55 months, average (31 ± 6) months. All patients' symptoms got improved or partial remission. The average pre- and post-operative scores of JOA in group A and B were from 14.0 ± 1.6 to 20.3 ± 1.7, from 13.6 ± 1.7 to 20.2 ± 2.0, respectively, there were significant statistical differences (Z = 2.41 and 2.23, P < 0.05). The average pre- and post-operative scores of ODI in group A and B were from 62% ± 4% to 28% ± 4%, from 63% ± 4% to 27% ± 3%, respectively, there were significant statistical differences (Z = 2.93 and 2.64, P < 0.05).

CONCLUSIONSPersonalized treatment programs should be established for elderly lumbar spinal stenosis according to stenosis location. Laminectomy is carried out with the stenosis in the central spinal canal; selective decompression of lumbosacral root canal is accepted with the stenosis in the nerve root canal without central stenosis.

Aged ; Decompression, Surgical ; Dental Pulp Cavity ; Humans ; Lumbar Vertebrae ; surgery ; Spinal Stenosis ; surgery ; Treatment Outcome

Objective To evaluate the effect of root canal taper and post on tooth stress distribution. Methods Three-dimensional finite element models of human mandibular first molar with root canals prepared with 35# K file, ProTaper and Profile were established. The tooth were restored with fiberresin, stainless steel and silver amalgam posts respectively. A vertical load on tooth occlusal surface was simulated. Marc software was used to analyze and calculate the stress distributions in the tooth restored with three kinds of different root canal posts, especially the in the cervical part and root. Results Different tapered root canals had no obvious influence on stress distribution in all three different posts. Stress distribution of stainless steel post located at the cervical and middle part of distal root, the highest Von-Mises stress was about 45 MPa. Stress distribution of silver amalgam post located at the orifice of root canal and pulp fundus, the highest Von-Mises stress was about 16 MPa. Stress distribution of fiber-resin post had no obvious stress concentration. Conclusions Fiber-resin post is the most ideal root canal post. Stainless steel post causes remarkable stress concentration in the root, which may raise the possibility of root fracture.

OBJECTIVEOtoacoustic emissions (OAE) and auditory brainstem responses (ABR) are tests widely used in neonatal hearing screening. This study aimed to investigate the differences and clinical value of distortion product otoacoustic emissions (DPOAE) and ABR in hearing screening of high-risk neonates admitted to a neonatal intensive care unit (NICU).

METHODSDPOAE and ABR were measured with the Smart-OAE analyser and the Smart-EP brain-stem electric response audiometry apparatus, respectively, in 600 high-risk neonates (1,200 ears). The testing results of DPOAE and ABR were compared.

RESULTSOf the 600 neonates (1,200 ears), the incidence of ABR abnormality (78.6%, 943/1,200) was remarkably higher than that of DPOAE abnormality (22.3%, 268/1,200). Two hundred and forty-one ears (20.8%) were negative and 252 (21%) were positive in both DPOAE and ABR tests. A total of 707 ears (58.9%) presented with a discordant result in DPOAE and ABR. The false positive and false negative rates of the DPOAE test were 6.0% (16/268) and 74.1% (691/932) respectively.

CONCLUSIONSIn high-risk neonates the diagnostic value of DPOAE for identification of hearing loss, when used alone, is limited. The ABR test appears to be more reliable for hearing screening in high-risk neonates. It is suggested that hearing screening for high-risk neonates should be conducted with ABR first, followed by OAE after failure on ABR.

Evoked Potentials, Auditory, Brain Stem ; physiology ; Female ; Hearing Tests ; methods ; Humans ; Infant, Newborn ; Intensive Care, Neonatal ; Male ; Neonatal Screening ; methods ; Otoacoustic Emissions, Spontaneous ; physiology

OBJECTIVETo evaluate the efficacy and safety of argon plasma coagulation (APC) in the treatment of large airway obstruction.

METHODSTotally 389 patients with treacheobronchial stenosis were treated with APC (ARCO3000 type) by bronchoscopy. The stenoses were caused by carcinomas (203 cases, 52.2%), metastatic tumors (67 cases, 17.2%), benign tumors (18 cases, 4.6%), granulomas (93 cases, 23.9%) and other lesions (8 cases, 2.1%). The rate of recanalization, relief of the symptoms, and complications were analyzed.

RESULTS1121 times of APC treatment were performed in the 389 patients. Complete recanalization was achieved in 138 cases (35.5%), partial in 143 (36.8%), mild in 55 (14.1%) and none in 53 (13.6%). The major complications included: super-ventricular tachycardia in 136 cases (34.9%), bleeding in 51 (13.1%), decrease in blood oxygen saturation in 48 (12.3%), asphyxia in 33 (8.5%), ventricular or super-ventricular arrhythmia in 24 (6.2%), short-term aggravation of airway obstruction in 18 (4.6%), and tracheal perforation in 3 (0.78%). All those complications were treated with various measures and no patient died of the complications during the procedure.

CONCLUSIONArgon plasma coagulation is effective and relatively safe in relieving the obstruction and dyspnea in patients with large airway obstruction caused by various reasons. However, for the patients with severe airway obstruction, argon plasma coagulation sometimes may cause severe or even lethal complications. Critical consideration of the indication, operators' skill and taking more precautions during the procedure are required to ensure the safety of argon plasma coagulation treatment.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Argon ; therapeutic use ; Bronchial Diseases ; etiology ; surgery ; Bronchial Neoplasms ; complications ; Bronchoscopy ; Constriction, Pathologic ; Electrocoagulation ; methods ; Female ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Tracheal Neoplasms ; complications ; Tracheal Stenosis ; etiology ; surgery ; Young Adult

OBJECTIVETo observe the efficacy and safety of Qianlieantong Tablets in the treatment of chronic prostatitis.

METHODSA multi-center, self-controlled open clinical trial was conducted. A total of 280 subjects with chronic prostatitis were enrolled and treated by Qianlieantong Tablets, 3 times a day, 5 tablets each time. Before and after 2 and 4 weeks after the administration, NIH-CPSI scores and white blood cell counts in the prostate secretion were recorded.

RESULTSOf the 273 subjects evaluated, the rates of excellence, effectiveness and ineffectiveness were 35.2% (n = 96), 47.6% (n = 130) and 17.2% (n = 47), respectively, with a total effectiveness rate of 82.8%. After 4 weeks'medication, the scores of the subjects on NIH-CPSI pain, voiding and quality of life and white blood cell counts in prostate secretion were significantly decreased compared with pre-treatment (P < 0.01). No adverse events or laboratory abnormality related to the medication were observed.

CONCLUSIONQianlieantong Tablets has a significant effect on chronic prostatitis with high safety, particularly indicated in chronic prostatitis with pelvic pain.

Adult ; Chronic Disease ; Drug Administration Schedule ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Prostatitis ; drug therapy ; Quality of Life ; Tablets ; Treatment Outcome

To study the chemical constituents of Fritillaria monanth Migo, the constituents were separated and purified by column chromatography on silica gel, and the structures were identified by NMR, MS spectral data. Six compounds were isolated and identified as ent-kauran-15-en-17-ol (I), entkauran-15-en-3alpha, 17-diol (II), fritillaziebinol (III), ent-kauran-16a, 17-diol (IV), ent-kauran-3alpha, 16alpha,17-triol (V), ent-16,17-epoxy-kauran-3alpha-ol (VI). All the compounds were isolated from this plant for the first time, and VI is named as ent-16,17-epoxy-kauran-3alpha-ol, which is a new compound.
Diterpenes, Kaurane ; chemistry ; isolation & purification ; Fritillaria ; chemistry ; Molecular Structure ; Plant Roots ; chemistry ; Plants, Medicinal ; chemistry

OBJECTIVETo evaluate the clinical effect of acellular dermal matrix allograft in repairing the oral mucosal defect of immediate implant.

METHODS51 cases underwent immediate implant surgery for 67 implants right after the teeth or roots extracted. The mucosal defect of implant areas were repaired by acellular dermal matrix. The basal membrane side of acellular dermal matrix was exposed to oral cavity, and another side was attached to the implant and alveolar crest surface. It was intercalated between mucosal flap and alveolar and fixed by iodoform pack or base plate. To understand condition of wound healing the patients were followed up from 4 months to 6 months after operation. The acellular dermal matrix closed wound and histological changes were observed. The implant was followed up months to 4 years.

RESULTSThe wounds were completely healed in 54 implant areas, partially healed in 11 implant areas, not healed 2 implant areas. histological examination wasn't differentiation between mucous epithelium and graft epithelium. None of 67 implants showed deterioration in the follow-up of one year. It was no obvious sign of immune rejection.

CONCLUSIONThe clinical result of acellular dermal matrix in repair the mucosal defect of immediate implant is good, the advantages are not to affect the integration bone with implant, less operation trauma, good esthetics results.

Adolescent ; Adult ; Aged ; Dental Implantation ; methods ; Dermis ; transplantation ; Female ; Humans ; Male ; Middle Aged ; Mouth Mucosa ; surgery ; Tissue Transplantation ; Transplantation, Homologous ; Transplants ; Wound Healing ; Young Adult