Objective:To analyze 3 123 cases of medical device adverse events(MDAE)and provide some suggestions for the MDAE monitoring.Method:By the retrospective case study,3 123 MDAE reports were analyzed in Hunan Province in 2007.Result:The reports mainly came from medical institutions and other drug-use units.Intrauterine devices (IUD),medical suture thread and orthopedic implants caused a higher proportion of adverse events.The quantities of MDAE reports were imbalanced in different regions.Conclusion:The MDAE monitoring should be promoted by propaganda and training in order to ensure the safe use of medical devices in public.

The paper quantizes symptom data through binary coding,divides 8 syndromes summed up by experts into excess and de-ficiency syndromes,values and quantizes them,and establishes the model for classification of excess and deficiency syndromes of colorec-tal cancer based on BP neural network and decision tree.The result shows that BP neural network classification model is more applicablefor the handling of the nonlinear mapping relation compared with decision tree classification model.

Objective To observe the therapeutic effects of arsenic trioxide combined with transcatheter arterial chemoembolization on treatment of primary liver cancer with pulmonary metastases.Methods Sixty patients were randomly divided into two groups:group A (treatment group,n =30) and group B (control group,n =30).Group A was received periodic transcatheter arterial chemoembolization (TACE) and 10 mg arsenic trioxide by intravenous infusion for 5 hours per day,3 days after TACE.Each cycle consisted of 14 days' administration,and repeated after 2 weeks.Each patient was received 3-4 successive cycles.Group B was received periodic TACE alone.Objective efficiency,benefit rate,quality of life and the correlates with metastatic tumor size and number in the both groups were recorded.Results The objective efficiency was 26.7％ (8/30),and the benefit rate was 60.0％ (18/30) in group A,while they were 0 and 16.7％ (5/30) in group B with significant statistics differences (x2 =7.067,P =0.008;x2 =11.915,P =0.001).The quality of life was improved in 4 patients and stable in 18 of group A,while no patient was improved and 13 were stable in group B (x2 =9.669,P =0.008).There was a significantly positive correlation between the tumor burden and therapeutic effect (Kendall r =-0.765,P ＜ 0.001 ;Spearman r =-0.821,P ＜ 0.001).Conclusion Arsenic trioxide combined TACE is an effective treatment method in treating primary liver cancer with pulmonary metastases.

Objective: To explore the mechanism of traditional Chinese medicine(TCM) combined with regular therapy in the treatment of pneumonia with systemic inflammatory response syndrome(SIRS) in(children).Methods: Sixty-four children with pneumonia including 51 cases with SIRS complication were(randomly) divided into three groups: treatment group(regular therapy+TCM,n=26),control group Ⅰ((regular)(therapy) only,n=25) and the control groups Ⅱ(13 pneumonia children without SIRS(receiving)(routine) treatment). The dynamic changes of tumor necrosis factor-?(TNF-?),interleukin-6(IL-6) and IL-8 were measured before and after treatment in all children.Serum Creactive protein(CRP) and total white blood cell(WBC) count were measured simultaneously.Clinical symptom and sign scores were(performed)(5 days) after treatment in children with pneumonia and SIRS complication.Results: Before(treatment),serum TNF-?,IL-6,IL-8 and CRP concentrations were significantly higher in treatment group and(control) group Ⅰ than(control) group Ⅱ(all P

Catheter Ablation ; methods ; Combined Modality Therapy ; methods ; Embolization, Therapeutic ; methods ; Humans ; Liver Neoplasms ; surgery

Malignant tumors are a major health problem in current society. With the improvement of people's living standards and the changes in diet structure， the development trend of gastrointestinal tumors in China is gradually similar to that in developed countries. The incidence and mortality of colorectal cancer （CRC） remain high in China. Although targeted therapy and immunotherapy have greatly improved the prognosis of patients in recent years， chemotherapy is still the main means in clinical practice. However， the adverse reactions of chemotherapy often seriously affect the quality of life of patients， and even lead to treatment interruption， thereby affecting the efficacy. Oral Chinese medicine shows unique advantages in enhancing efficiency and reducing toxicity in CRC patients during chemotherapy， but its poor drug experience not only makes it difficult for patients to take it consistently but also affects the popularization of Chinese medicine at this stage. Medicinal and edible herbs （MEHs） are an important part of Chinese medicine and they are mild， delicious， convenient， affordable， nutritious， and safe. Therefore， they may be more suitable for patients with CRC chemotherapy to adhere to treatment. However， their efficacy is often criticized by clinical practitioners. They are only used in the food and health products industry， and their role as Chinese medicines has not been fully utilized. This paper summarized the common traditional Chinese medicine （TCM） syndromes and treatment methods during CRC chemotherapy， sorted out the nature， flavor， meridian tropism， and efficacy of MEHs， and reviewed the modern pharmacological research results of MEHs by the method of literature statistics. This study finds that the nature， flavor， meridian tropism， and efficacy of MEHs are in good agreement with the common TCM syndromes and treatment methods during CRC chemotherapy. Moreover， many MEHs have the effects of resisting CRC and alleviating the adverse reactions of chemotherapy. Furthermore， the effectiveness and superior efficacy of MEHs in CRC chemotherapy are initially demonstrated from the theoretical level， but high-quality clinical evidence is still needed to support it. The present study discussed the efficiency-enhancing and toxicity-reducing effects and application advantages of MEHs in CRC patients during chemotherapy to provide references for the clinical promotion of MEHs.

Objective:To evaluate the efficacy of total laparoscopic surgery vs. open surgery for hilar cholangiocarcinoma. Methods:The clinical data of 45 patients undergoing laparoscopic radical resection of hilar cholangiocarcinoma and 42 patients by open surgery from Mar 2017 to Mar 2021 were retrospectively analyzed.Results:There was no significant difference in demographics, Bismuth classification and excision extension between the two groups (all P>0.05). The laparoscopic surgery used longer time ( t=-1.366, P<0.05). The intraoperative blood loss, number of lymph node dissection and postoperative hospital stay favored laparoscopic method( t=0.043, t=0.026, t=-1.852, P<0.05). R 0 radical resection rate，postoperative complications were also in favor of laparoscopic surgery ( χ2=3.216, χ2=2.566, all P<0.05). There was no significant difference in postoperative pathology and in hospital expenses (all P>0.05). The 1- and 3-year survival rate of the laparoscopic group was superior (all P<0.05). Conclusions:In spite of longer operational time，patients in laparoscopic hilar cholangiocarcinoma radical resection group have shorter postoperative in hospital stay and longer postoperative survival time.

OBJECTIVETo observe the effect difference betweendecoction combined with acupuncture at back-points and simpledecoction for chronic fatigue syndrome.

METHODSSixty patients were randomly assigned into an herbal group and a combination group, 30 cases in each one. Simpledecoction was used in the herbal group for continuous one month, one decoction a day. Based on that in the herbal group, 30 min acupuncture was used in the combination group at bilateral Xinshu (BL 15), Feishu (BL 13), Pishu (BL 20), Ganshu (BL 18) and Shenshu (BL 23), with acupoints according to syndrome differentiation. Acupuncture was given for 3 courses, 10 times as a course with 3 days between two courses, once a day. Fatigue status was evaluated before and after treatment by fatigue scale 14 (FS-14) and self-rating anxiety scale (SAS).

RESULTSThe FS-14 scores, including body fatigue scores, mental fatigue scores and total scores, and SAS scores after treatment were lower than those before treatment in the two groups (all<0.01), with better improvements in the combination group (all<0.01).

CONCLUSION decoction combined with acupuncture at back-points can improve chronic fatigue syndrome, which are better than simpledecoction.

Objective     To analyze the clinical information of COVID-19 patients of Shanghai National Exhibition and Convention Center cabin hospital, and to explore the medical management strategy to provide thoughtful suggestions for other cabin hospitals and governments as valuable references. Methods     The clinical data of 174 308 patients confirmed COVID-19 in Shanghai National Exhibition and Convention Center cabin hospital from April 9 to May 31, 2022 were retrospectively reviewed. There were 103 539 male and 70 769 female patients, with an average age of 41.50±15.30 years. Medical and nursing management strategy was summarized. Results     Among the 174 308 patients, 71.5% (124 630 patients) were asymptomatic. The vaccination rate of patients with COVID-19 in the cabin hospital was 76.5% (133 338 patients), and the majority of none vaccinated patients were children under the age of 10 years and the elderly over the age of 60 years, the vaccination rate of whom was only 25.0% (1 322 patients) and 63.9% (13 715 patients), respectively. In addition, the proportion of mild symptom type in the patients not vaccinated was significantly higher than that in the vaccinated patients (P≤0.01). The average hospitalization time of patients in cabin hospital was 7.39±0.53 days, which was 7.01±2.12 days for patients under 60 years and 8.21±0.82 days for patients over 60 years. The hospitalization time of elderly patients was significantly longer (P≤0.01), and the hospitalization time of elderly patients at age over 60 years without vaccination was 8.94±1.71 days, which was significantly longer than the average hospitalization time and the time of elderly patients vaccinated (P≤0.01). The number of patients combined with basic diseases was 27 864 (16.0%), of which cardiovascular diseases accounted for 81.3% (22 653 patients). A total of 2 085 patients were transferred and treated in designated hospitals. Conclusion     Large scale cabin hospitals are helpful to cut off the source of infection. Attention shall be paid to the sorting of admission and timely transfer to other hospital during the patients management. Most of the patients have a good prognosis after treatment. The vaccination of key population and community-based screening will be the next step of focus.

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone