Objective To compare the efficacy and safety between hypofractionated radiotherapy(HyRt)and conventional radiotherapy after breast-conserving surgery.Methods This study was a single-center,prospective,randomized controlled study.Eighty-three patients with pTis-T2N0M0 breast cancer admitted to Tangshan People's Hospital from May 2017 to May 2019 were included.The patients received breast-conserving surgery+sentinel lymph node biopsy(SLNB).After surgery,they were treated with intensity modulated radiation therapy(IMRT).According to random table method,patients were divided into HyRt group(n=41)and conventional radiotherapy group(n=42).The dose of organs at risk,treatment efficacy,treatment failure modes,and radiotherapy related adverse reactions were analyzed in the two groups.The radiotherapy-related adverse reactions were evaluated according to NCI CTC AE Version 3.0,including radiation dermatitis,radiation pneumonia,breast/skin fibrosis,pulmonary fibrosis,etc.Results Eighty-three patients with breast cancer were included,with a median age of 44(26-67)years.There was no statistically significant difference in clinical parameters such as age(P=0.443),TNM stage(P=0.335),molecular typing(P=0.333),degree of differentiation(P=0.617),and pathological type(P=0.127)between the two groups of patients.Compared with conventional radiotherapy group,the V5(25.6％vs.33.8％,P=0.015),V20(13.3％vs.17.2％,P=0.042),and the mean radiation dose(MLD;7.4 Gy vs.10.4 Gy,P=0.020)of the affected lung of HyRt group significantly decreased.Only 3 patients in this study experienced distant metastasis,and no regional lymph node metastasis or local recurrence was observed.There was no significant difference in PFS rate at 2 years between HyRt group and conventional radiotherapy group(94.4％vs.85.2％,P=0.818).Compared with conventional radiotherapy group,the incidence of≥grade Ⅱ irradiation dermatitis in HyRt group was significantly reduced(2.4％vs.21.4％,P=0.015).There was no difference in the incidence of grade Ⅰ breast/skin fibrosis(19.5％vs.14.3％,P=0.570)between the two groups,and no grade Ⅲ radiotherapy-related side effects were observed in the two groups.Conclusions Compared with conventional radiotherapy with simultaneously integrated boosting-intensity modulated radiotherapy,the patients who received HyRt after breast-conserving surgery for early-stage breast cancer have good tolerance and low incidence of adverse reactions.HyRt can be used as the first option of radiation therapy.

Objective To construct a three-dimensional statistical shape model of the pelvis and analyze the individual variation and gender differences of the three-dimensional shape of the pelvis.Methods We collected CT data from 201 Chinese individuals and used deep learning to automatically reconstruct three-dimensional models of the pelvis.Through three-dimensional model registration,dense correspondence mesh mapping,and the use of statistical shape modelling(SSM)and principal component(PC)analysis method,we extracted models of variations(MoV)of pelvic shape changes and statistically compared the shape MoV between males and females.Results We analysed the top 10 principal components of shape variations,which accounted for 86.1％of the total variability.Among them,PC01,PC02,and PC04 showed significant differences between genders(P＜0.001),accounting for a total variability of 60.1％.PC08 and PC 10 demonstrated pelvic asymmetry,accounting for a total variability of 3.8％.Conclusion We constructed a three-dimensional statistical shape model of the pelvis in Chinese individuals,revealing the morphological variation and sex differences of Chinese pelvis.

The application of new-generation information technologies such as big data, the internet of things(IoT), and cloud computing in the traditional Chinese medicine(TCM)manufacturing industry is gradually deepening, driving the intelligent transformation and upgrading of the TCM industry. At the current stage, there are challenges in understanding the extraction process and its mechanisms in TCM. Online detection technology faces difficulties in making breakthroughs, and data throughout the entire production process is scattered, lacking valuable mining and utilization, which significantly hinders the intelligent upgrading of the TCM industry. Applying data-driven technologies in the process of TCM extraction can enhance the understanding of the extraction process, achieve precise control, and effectively improve the quality of TCM products. This article analyzed the technological bottlenecks in the production process of TCM extraction, summarized commonly used data-driven algorithms in the research and production control of extraction processes, and reviewed the progress in the application of data-driven technologies in the following five aspects: mechanism analysis of the extraction process, process development and optimization, online detection, process control, and production management. This article is expected to provide references for optimizing the extraction process and intelligent production of TCM.
Medicine, Chinese Traditional ; Drugs, Chinese Herbal ; Quality Control ; Big Data ; Algorithms

ObjectiveTo investigate the clinical efficacy and safety of Huanshao Capsules (HSC) in the treatment of oligoasthenospermia with spleen and kidney asthenia.

METHODSThis randomized, open, multicentered, positive drug controlled clinical trial included 200 cases of oligoasthenospermia with spleen and kidney asthenia, which were assigned to a trial and a control group of equal number to be treated with HSC at the dose of 3 capsules tid and Wuziyanzong Pills at 6 g bid, respectively, both for 12 weeks. We compared the semen volume, sperm concentration, sperm count, sperm motility and percentage of progressively motile sperm (PMS) as the main therapeutic indicators as well as the pregnancy rate as the secondary therapeutic indicator between the two groups of patients before and at 4, 8 and 12 weeks after medication.

RESULTSTotally, 190 of the patients completed the clinical observation, 96 in the trial and 94 in the control group. Compared with the baseline, the patients of the trial group showed significant time-dependent increases at 4, 8 and 12 weeks after medication in the mean sperm concentration (14.78 vs 15.33, 20.98 and 28.78 ×10⁶/ml, P < 0.05), percentage of grade a sperm (12.17% vs 15.05%, 21.17% and 26.97%, P < 0.05), PMS (24.78% vs 28.97%, 37.23% and 47.67%, P < 0.05), and sperm viability (38.64% vs 44.18%, 51.67% and 60.45%, P < 0.05). The pregnancy rate was significantly higher in the trial than in the control group 29.17% vs 18.09%, P < 0.05).

CONCLUSIONSHuanshao Capsules can improve the semen quality and pregnancy rate in the treatment of oligoasthenospermia patients with spleen and kidney asthenia, and therefore deserves a wide clinical application.

Capsules ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Oligospermia ; drug therapy ; Pregnancy ; Pregnancy Rate ; Semen Analysis ; Sperm Count ; Sperm Motility ; Spermatozoa ; Treatment Outcome

OBJECTIVE: To investigate the clinical effectiveness of polytheretherketone (PEEK) cages assisted anterior cervical discetomy and fusion (ACDF) to treat cervical spondylosis with sympathetic symptoms. METHODS: Retrospective analysis was undertaken for 39 patients who were diagnosed as cervical spondylosis with sympathetic symptoms and underwent ACDF with PEEK cages. Radiographs obtained before surgery, after surgery, and at the final follow-up were assessed for quality of fusion. The following criteria were used for assessing radiographic success of fusion: (1) endplate obliterated with no lucent lines; (2) obliteration of disc space by bony trabeculae; (3) less than 2°of intervertebral motion or 2 mm of motion between the spinous processes at the operated segment on flexion-extension lateral radiographs. The sympathetic symptoms including vertigo, headache, tinnitus, nausea and vomiting, heart throb, hypomnesia and gastroenterological discomfort were scored by 20-point system preoperatively, 2 months postoperatively and at the final follow-up. The recovery rate and clinical satisfaction rate were also evaluated. Surgical complications were also assessed. RESULTS: They were followed up for at least one year. The mean follow-up was 15.6 months. Radiographs of the cervical spine at the last follow-up revealed a solid fusion with no signs of a pseudoarthrosis in 36 cases. In two patients delayed union and bony fusion were achieved at the end of 9 and 11 months. Pseudoarthosis was found in 1 case but the patient had no symptoms. The score of sympathetic symptoms before surgery, 2 months after surgery and at the final follow-up were 8.4±1.0,2.2±0.3,and 2.4±0.3, respectively. There were 22 excellent cases, 15 good cases, 1 fair case and 1 bad case in terms of RR. Good to excellent results were attained in 95% of theses patients. The sympathetic symptoms improved in all the patients and the score was significantly improved after surgery. There was one patient who had cerebral spinal fluid leakage but he recovered one week after surgery. Two patients felt a mild swallowing discomfort, but it disappeared within one month after surgery. Subcutaneous hematoma occurred in one patient due to obstructed drainage. It was cleared two days after surgery. CONCLUSION Cervical spondylosis patients with sympathetic symptoms may be managed successfully with ACDF using PEEK cages. Successful clinical results regarding symptom improvement and general satisfaction with the surgical procedure depend not only on obtaining successful decompression and radiographic fusion but also on patient selection.
Cervical Vertebrae/surgery* ; Decompression, Surgical ; Diskectomy ; Humans ; Male ; Nausea ; Neurosurgical Procedures ; Radiography ; Retrospective Studies ; Spinal Fusion ; Spondylosis/surgery* ; Treatment Outcome ; Vomiting

OBJECTIVETo investigate the effects of Bushen Huoxue Fang (BSHX) on the apoptosis of epithelial cells in the prostatic ductal system of rats with benign prostatic hyperplasia (BPH) and its possible action mechanism.

METHODSOne hundred 3- month-old male Wistar rats were randomly divided into four groups of equal number (control, castrated, BPH model, and BSHX). BPH models were made by subcutaneous injection of testosterone following castration; the rats in the BSHX group were treated intragastrically with BSHX at 2.34 g/ml after modeling, while those in the other two groups with equal volume of saline, all for 37 days. On the 38th day, all the rats were sacrificed and their prostates harvested for detection of the distribution of TGF-beta1 and alpha-actin and the count of positive cells in the prostatic ductal system by immunohistochemical staining. The apoptosis rate of epithelial cells in the prostatic ductal system was determined by TUNEL assay.

RESULTSThe expression of TGF-beta1 was significantly increased in the rats of the BSHX group as compared with the BPH models in both the proximal prostatic duct ([15.28 +/- 4.30]% vs [36.42 +/- 8.10]%, P < 0.01) and the distal prostatic duct ([4.42 +/- 2.07]% vs [8.71 +/- 2.28 ]%, P < 0.05), while the expression of alpha-actin in the proximal duct was remarkably higher in the BSHX-treated rats than in the models ([28.14 +/- 7.43]% vs [18.28 +/- 4.07]%, P < 0.01), but lower than in the control animals ([33.57 +/- 6.85]%, P < 0.05). Compared with the control group, the BPH models and BSHX-treated rats both exhibited markedly decreased apoptosis of epithelial cells in the proximal prostatic duct ([39.42 +/- 9.20]% vs [3.86 +/- 1.34]%, P < 0.01, and [31.14 +/- 5.64]%, P < 0.01) and distal prostatic duct ([17.60 +/- 4.86]% vs [3.07 +/- 1.14]%, P < 0.01, and [12.37 +/- 2.25]%, P < 0.05). The apoptosis rate of epithelial cells in the prostatic ductal system was significantly higher in the BSHX-treated rats than in the BPH models (P < 0.01).

CONCLUSIONBy upregulating the expression of TGF-beta, BSHX can suppress the reduction of smooth muscle cells in the proximal prostatic duct, promote the apoptosis of prostatic epithelial cells, and thus effectively inhibit benign prostatic hyperplasia.

Actins ; metabolism ; Animals ; Apoptosis ; drug effects ; Disease Models, Animal ; Drugs, Chinese Herbal ; pharmacology ; Epithelial Cells ; drug effects ; pathology ; Male ; Prostatic Hyperplasia ; drug therapy ; metabolism ; pathology ; Rats ; Rats, Wistar ; Transforming Growth Factor beta1 ; metabolism

BACKGROUNDAcute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.

METHODSA randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients (n = 178; ≥ 18 years of age) with acute gouty attack (< 48 hours) were treated for 5 days with etoricoxib (120 mg/d; n = 89) or indometacin (75 mg twice daily; n = 89). The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2 - 5. Secondary end points included investigator assessments of tenderness and swelling, patient/ investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events (AEs).

RESULTSEtoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2 - 5 was 0.03 (95% confidence interval (CI) -0.19 to 0.25; P = 0.6364), which fell within the prespecified comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most (73.7%) were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related). Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group (n = 31) was less than the indometacin group (n = 34).

CONCLUSIONSEtoricoxib (120 mg once daily) is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin (75 mg twice daily).

Adult ; Aged ; Arthritis, Gouty ; drug therapy ; Cyclooxygenase Inhibitors ; adverse effects ; therapeutic use ; Double-Blind Method ; Female ; Humans ; Indomethacin ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Pyridines ; adverse effects ; therapeutic use ; Sulfones ; adverse effects ; therapeutic use

OBJECTIVETo evaluate the effect of FLAMIGEL (hydrogel dressing) on the repair of residual burn wound.

METHODSSixty burn patients with residual wounds hospitalized in 6 burn units from November 2011 to May 2012 were enrolled in the multi-center, randomized, and self-control clinical trial. Two residual wounds of each patient were divided into groups T (treated with FLAMIGEL) and C (treated with iodophor gauze) according to the random number table. On post treatment day (PTD) 7 and 14, wound healing rate was calculated, with the number of completely healed wound counted. The degree of pain patient felt during dressing change was evaluated using the visual analogue scale (VAS). The mean numbers of wounds with score equal to zero, more than zero and less than or equal to 3, more than 3 and less than or equal to 6, more than 6 and less than or equal to 10 were recorded respectively. Wound secretion or exudate samples were collected for bacterial culture, and the side effect was observed. Data were processed with repeated measure analysis of variance, t test, chi-square test, and nonparametric rank sum test.

RESULTSWound healing rate of groups T, C on PTD 7 was respectively (67 ± 24)%, (45 ± 25)%, and it was respectively (92 ± 16)%, (72 ± 23)% on PTD 14. There was statistically significant difference in wound healing rate on PTD 7, 14 between group T and group C (F = 32.388, P < 0.01). Ten wounds in group T and four wounds in group C were healed completely on PTD 7, with no significant difference between them (χ(2) = 0, P > 0.05). Forty-two wounds in group T and seven wounds in group C healed completely on PTD 14, with statistically significant difference between them (χ(2) = 42.254, P < 0.01). Patients in group T felt mild pain during dressing change for 37 wounds, with VAS score higher than zero and lower than or equal to 3. Evident pain was observed in patients of group C during dressing change for 43 wounds, and it scored higher than 3 and less than or equal to 6 by VAS evaluation. There was statistically significant difference in mean number of wounds with different grade of VAS score between group T and group C (Z = -4.638, P < 0.01). Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae, E. coli, Baumanii, and Staphylococcus epidermidis were all detected in both groups, but there was no statistical difference between group T and group C (χ(2) = 0.051, P > 0.05). No side effect was observed in either of the two groups during the whole trial.

CONCLUSIONSFLAMIGEL can accelerate the healing of residual burn wounds and obviously relieve painful sensation during dressing change.

Adolescent ; Adult ; Aged ; Bandages ; Burns ; therapy ; Female ; Humans ; Hydrogels ; Male ; Middle Aged ; Young Adult

Objective To obtain recombinant human anti-HBsAg genetic engineering antibodies from volunteer-derived antibody phage library.Methods A combinatorial human Fab library against HBsAg was constructed with antibody genes harvested from peripheral blood of HBsAb + volunteers after HBsAg booster immunization.The library was panned with phage display and selected by purified HBsAg.After that the selected antibodies were converted to full human IgG antibody with recombinant baculovirus/insect cell system and mammal cell system.Results 20 different human Fab antibodies specific for HBsAg were obtained by ELISA and determination of subtype and subclass of antibodies after gene sequencing.Six specific anti-HBsAg human Fab antibodies were converted to full human IgG antibody.Competitive ELISA showed three of the six full human IgG antibodies had different epitopes against HBsAg.Conclusion Three monoclonal antibodies with different epitopes against HBsAg were panned and obtained successfully and laid the foundation for the therapeutic antibodies and new vaccines.

OBJECTIVETo investigate the therapeutic effect of free tissue flap anastomosed with reverse descendant branch of lateral femoral circumflex artery for severe soft tissue defect at leg.

METHODSThe severe soft tissue defect at leg, without any vessels for anastomosis of free tissue flap, was reconstructed with free tissue flap, which was anastomosed with proximal end of descendant branch of lateral femoral circumflex artery and great saphenous vein. From Oct. 2004 to Dec. 2009, 36 cases were treated with 15 cases of latissimus dorsi musculocutaneous flaps, 12 cases of anterolateral femoral flaps, and 9 cases of thoracoumbilicus flaps.

RESULTSAll the 36 free flaps survived completely. The patients were followed up for 6 months to 2.5 years with good cosmetic results.

CONCLUSIONSIt is effective and practical to repair the severe soft tissue defects at legs with the reverse descendant branch of lateral femoral circumflex artery to carry the free flaps.

Adult ; Female ; Femoral Artery ; surgery ; Follow-Up Studies ; Free Tissue Flaps ; Humans ; Leg Injuries ; surgery ; Male ; Middle Aged ; Skin Transplantation ; methods ; Soft Tissue Injuries ; surgery ; Thigh ; surgery ; Treatment Outcome ; Young Adult