Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Male ; Double-Blind Method ; Drugs, Chinese Herbal/therapeutic use* ; Tic Disorders/drug therapy* ; Treatment Outcome

BACKGROUND: Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease. OBJECTIVE: This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m MAIN OUTCOME MEASURES: The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment. RESULTS: A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group. CONCLUSION: SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone. TRIAL REGISTRATION NUMBER NCT02063100 on ClinicalTrials.gov.

Purpose: The purpose of this study was to compare the survival and toxicities in cervical esophageal squamous cell carcinoma (CESCC) treated by concurrent chemoradiothrapy with either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) techniques. Materials and Methods: A total of 112 consecutive CESCC patients were retrospectively reviewed. 3D-CRT and IMRT groups had been analyzed by propensity score matching method, with sex, age, Karnofsky performance status, induction chemotherapy, and tumor stage well matched. The Kaplan-Meier method and Cox proportional hazards model were used for overall survival (OS) and progression-free survival (PFS). Toxicities were compared between two groups by Fisher exact test. Results: With a median follow-up time of 34.9 months, the 3-year OS (p=0.927) and PFS (p=0.859) rate was 49.6% and 45.8% in 3D-CRT group, compared with 54.4% and 42.8% in IMRT group. The rates of grade ≥ 3 esophagitis, grade ≥ 2 pneumonitis, esophageal stricture, and hemorrhage were comparable between two groups, while the rate of tracheostomy dependence was much higher in IMRT group than 3D-CRT group (14.3% vs.1.8%, p=0.032). Radiotherapy technique (hazard ratio [HR], 0.09; 95% confidence interval [CI], 0.01 to 0.79) and pretreatment hoarseness (HR, 0.12; 95% CI 0.02 to 0.70) were independently prognostic of tracheostomy dependence. Conclusion No survival benefits had been observed while comparing IMRT versus 3D-CRT in CESCC patients. IMRT with fraction dose escalation and pretreatment hoarseness were considered to be associated with a higher risk for tracheostomy dependence. Radiation dose escalation beyond 60 Gy should be taken into account carefully when using IMRT with hypofractionated regimen.

Objective To observed the clinical effect of long-term sacral nerve stimulation on anal rectal pain after lumbar surgery.Methods A total of 18 cases with functional anorectal pain (FARP) after lumbar surgery in our hospital from April 2015 to March 2018were selected, of whom 3 cases refuse to accept the treatment, the other 15 cases received sacral nerve electrical stimulation.The Pittsburgh Sleep Quality Index (PSQI) and simplified MPQ pain questionnaire were used to evaluate the clinical effect in preoperative and postoperative1 week, 1 month, 3 months, 6 months, 9 months and 1 year respectively.Results Fifteen cases of permanent sacral nerve stimulation before and after , The MPQ scale and PSQI of 15 patients with implantation of permanent sacral nerve stimulation in postoperative 1 week were better than those before implantation , the differences were significant( P＜ 0. 05) . In the MPQ scale , the PPI and PRI at 6 months after operation was better than those before implantation , the difference was statistically significant ( P ＜ O. 01 ) ; PSQI and V AS score after 2 months were better than those before implantation , the difference were statistically significant( P ＜ 0.01) , meanwhile in 1-year of follow-up , the PSQI and VAS score continued to decline , but the change was not obvious. Conclusion Long-term sacral nerve electrical stimulation in the treatment of lumbar anorectal pain has a good clinical effect , which can improve patients ' quality of life.

OBJECTIVE: To evaluate the clinicopathologic features and potential prognostic predictors of locally recurrent renal cell carcinoma patients after initial surgery. METHODS: Authors retrospectively analyzed data extracted from 81 patients who were treated for postoperative locally recurrence of renal cell carcinoma from January 2006 to June 2016 in the Department of Urology, Peking University First Hospital. Postoperative locally recurrence of renal cell carcinoma was defined as disease recurring in the remnant kidney, renal fossa, adjacent abdomen, ipsilateral adrenal and retroperitoneal lymph nodes. RESULTS: In the study, 81 patients were finally included, of whom 43 were initially treated in our hospital and 38 were initially treat in other centers. Partial nephrectomy (PN) was performed for 38 cases (26 in our hospital and 12 in other hospitals) as initial treatment and radical nephrectomy (RN) was conducted for the remnant 43 cases (17 in our hospital and 26 in other hospitals). Overall median recurrence time was 26 months (range: 3-164 months), in which 26 months (range: 3-55 months) for PN cases and 30 months (range: 4-164 months) for RN cases (P=0.009). Sixty-nine patients had single site recurrence, including remnant kidney (n=29), renal fossa (n=20), abdomen (n=4), ipsilateral lymph nodes (n=5), ipsilateral adrenal (n=11), while 12 patients had multiple sites recurrence. Seventy-eight patients were managed by complete surgical resection, while three patients were managed by radiofrequency ablation. Postoperative pathological diagnoses included clear cell carcinoma (n=72), papillary renal cell carcinoma (n=8, 7 cases with type 1, 1 case with type 2) and Xp11 translocation/TFE3 gene fusion renal cell carcinoma (n=1). Complete pathologic information of the initial surgery could be extracted from 43 patients who were initially treated in our hospital. Seventeen patients with initial radical nephrectomy were staged as T1a (n=4), T1b (n=2), T2a (n=1), T3a (n=8), and T3b (n=2). Twenty-six patients with initial partial nephrectomy were staged as T1a (n=18), T1b (n=7), and T3a (n=1). For PN cohort, the patients with T1a stage disease had longer median recurrence time than those with beyond T1a stage disease, and the difference was significant (29 months vs. 18 months, P=0.041). At the end of the follow-up, 58 patients were alive, 4 died and 19 lost the follow-up. Overall, 3-year and 5-year disease free survival rates were 81.9%, and 53.6%, respectively. CONCLUSION The present research reported a large-scale single central experience of locally recurrent renal cell carcinoma. The recurrence time of the PN group is shorter than that of the RN group. For patients after PN surgery, median recurrence time is longer for patients with T1a stage tumor when compared with those with stage beyond T1a. Patients can obtain relative long-term survival after complete secondary surgery resection.
Carcinoma, Renal Cell/surgery* ; Humans ; Kidney Neoplasms/surgery* ; Neoplasm Recurrence, Local ; Nephrectomy ; Prognosis ; Retrospective Studies ; Treatment Outcome

OBJECTIVE: To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles () for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction. METHODS: Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks (146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) after completion of the open-label treatment period. RESULTS: After the double-blind period, the median (interquartile range) changes in Scr were 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively (P=0.008), and the median changes in eGFRs were-0.2 (-4.3-2.7) and-2.21 (-5.7-0.8) mL•min•1.73 m, respectively (P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0 (-10.0-41.9) and 17.5 (-6.0-50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively (P=0.214), and the median changes in eGFRs were-2.3 (-6.4-1.9) and-3.7 (-7.5-1.1) mL•min•1.73 m, respectively (P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 mL•min•1.73 m per year. CONCLUSION Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function. (Trial registration No. ChiCTR-TRC-12002448).
Adult ; Disease Progression ; Double-Blind Method ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Follow-Up Studies ; Glomerular Filtration Rate ; drug effects ; Humans ; Kidney Diseases ; drug therapy ; physiopathology ; Male ; Middle Aged ; Outcome Assessment (Health Care)

Objective To investigate the effect of electroacupuncture on hypothalamic insulin receptor substrate 1 (IRS-1) in a rat model of type 2 diabetes mellitus (T2DM). Methods Sixty Wistar rats were randomized to a normal group (15 rats) and an observation group (45 rats). In the observation group, a rat model of T2DM was made by high-energy diet induction. After the model was successfully made 8 weeks later, the observation group was randomized to model making, treatment and blocker groups, 15 rats each. The treatment group received electroacupuncture and the blocker group, electroacupuncture plus intraventricular perfusion of phosphatidylinositol 3-hydroxyl kinase (PI3K) blocker. After 8 weeks of treatment, fasting plasma glucose (FPG) was measured using a glucometer, fasting insulin (Fins) was determined by ELISA, insulin resistance index (IRI) was calculated and IRS-1 expression was examined by SABC immunohistochemistry assay in every group of rats. Results FPG and Fins increased significantly (both P<0.01) and IRI and IRS-1 expression decreased significantly (P<0.01) in the model making group compared with the normal group. FPG and Fins decreased significantly (both P<0.01) and IRI and IRS-1 expression increased significantly (P<0.01) in the treatment group compared with the model making group. FPG and Fins decreased significantly (P<0.05, P<0.01) and IRI and IRS-1 expression increased significantly (P<0.01) in the treatment group compared with the blocker group. Conclusion Electroacupuncture can improve FPG, Fins and insulin sensitivity by regulating hypothalamic IRS-1 expression in T2DM rats.

Treatment of large bone defects caused by trauma, osteomyelitis, and tumors has been a major challenge in clinical. In the past, there have been many ways to repair and reconstruct the large bone defects. However, there is a long period of treatment, high technical requirement and complications such as ununion. After Masquelet reported the induced membrane technology in 2000, the technique was widely used in treatment of trauma, osteomyelitis, and large bone defects caused by tumors. It has been obtained good results. It has the advantages of short course, high healing rate, easy operation and easy to master. The induced membrane has unique structural characteristics and biological characteristics. There are many kinds of osteogenic factors that are included in the membrane, such as vascular endothelial growth factor, and morphogenetic protein-2, transforming growth factor-β1, etc. These osteogenic factors contribute to accelerate bone healing. With the development of induced membrane technology. The technology of Reamer Irrigator Aspirator technology, engineering tissue technology and internal fixation is used in clinic.It can provide bone source, promote bone defect reconstruction, improve long-term limb function and reduce complications.This paper retrospectively summarizes the experimental research and clinical progress of Masquelet technique in the treatment of large bone defects.

Adult ; China ; Databases, Factual ; Female ; Humans ; Male ; Middle Aged ; Pituitary Diseases ; classification ; epidemiology ; Registries ; Software

Objective To explore the effects of flavonoids of Rhizoma Drynariae on the formation of blood vessels in the induced membrane by Masquelet technique. Methods Seventy-two SD rats were randomly divided into 4 groups,namely model group,and high-,middle-and low-dose drug groups,18 rats in each group. Rat model of critical- sized femoral defect was built,and then polymethyl methacrylate (PMMA)bone cement spacer was inserted into the bone defect to induce the formation of membrane. From the first day after surgery , the rats in high-,middle-and low-dose drug groups were given gastric gavage of 0.44,0.22,0.11 g·kg-1·d-1 of Rhizoma Drynariae flavonoids, respectively, and the rats in the model group were given the same volume of normal saline. After 6-week medication,the pathologic features of bone cement- induced membrane were observed by Haematoxilin-Eosin(HE)staining,the contents of transforming growth factor(TGF)-β1 and vascular endothelial growth factor(VEGF)proteins in the induced membrane were tested by enzyme-linked immunosorbent assay (ELISA),and the mRNA levels of TGF-β1 and VEGF in the induced membrane were determined by real-time reverse transcription-quantitative polymerase chain reaction (RT-qPCR). Results More blood vessels in the induced membrane of the high-dose group were found than those of the other groups under the light microscope. The protein and mRNA expression levels of TGF-β1 and VEGF in the induced membrane of the 3 drug groups were much higher than those of the model group(P < 0.05). Except for the VEGF mRNA expression level, the changes of other indexes were dose-dependent. Conclusion Flavonoids of Rhizoma Drynariae are effective on enhancing the protein and mRNA expression levels of TGF-β1 and VEGF in the induced membrane, and can accelerate the vascularization,which promotes the reconstruction of bone defect.