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OBJECTIVE To evaluate the cost-effectiveness of omalizumab in the treatment of severe allergic asthma from the perspective of healthcare providers in China. METHODS Based on the data from an international multicenter study of omalizumab in the treatment of severe allergic asthma， the Markov model was constructed according to the progression of severe allergic asthma， with a cycle of 4 weeks. Long-term health outcomes and costs of omalizumab combined with standard of care（SoC） regimen versus SoC regimen in the treatment of severe allergic asthma were simulated by using quality-adjusted life years （QALYs） and incremental cost-effectiveness ratio（ICER） as output indexes. One-way sensitivity analysis， probabilistic sensitivity analysis， and scenario analysis were performed to test the robustness of the results. RESULTS Compared with the SoC regimen， ICER for the omalizumab combined with SoC regimen was 107 723.05 yuan/QALY， which was less than the willingness-to-pay（WTP） threshold （268 074 yuan/QALY） calculated by three times per capita gross domestic product（GDP） in China in 2023. The one-way sensitivity analysis showed that the baseline serum level of immunoglobulin E had the greatest impact on the robustness of the model. The probabilistic sensitivity analysis showed that the omalizumab+SoC regimen had a 93.00% probability of being cost- effective. The scenario analysis showed that in the real world， the billing method of omalizumab based on specifications rather than actual usage may increase ICER. CONCLUSIONS Compared with the SoC regimen， the combination of omalizumab and SoC regimen for treating severe allergic asthma is cost-effective， with a WTP threshold of three times China’s per capita GDP
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In the field of ethics,issues related to brain-computer interface(BCI)technology mainly focus on physical and mental ethics,as well as social ethics,including personal privacy rights,whether a person is a person in the complete sense,the attribution of social responsibility.The population involved includes patients,doctors,and the whole social group in which patients live.In addition to analyzing physical and mental ethical risks,this paper also analyzed the potential ethical issues that may exist in the future large-scale application of BCI based on the current research status,mainly including the right of informed consent,privacy,and decision-making of physical and mental ethical risks,the responsibility attribution and fairness of social ethical risks,the responsibility ascription and equity of social ethical risk,and the question that whether the brain is the carrier of machine or the machine is the continuation of the brain in future ethical risks.Solutions have been proposed in the three levels of individual,system,and institution to provide governance recommendations for the future development of BCI.In addition,local data was obtained by collecting and summarizing relevant opinions through social research.Based on these,the future risks of BCI were introduced for the first time,and from the perspective of ethics,solutions to future problems were explored.
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【Objective】 To evaluate the efficacy of ultrasound-guided transperineal puncture and drainage in the treatment of pelvic lymphatic cyst. 【Methods】 A total of 26 patients with pelvic lymphocele who failed with conservative treatment received transperineal puncture and drainage guided by rectal ultrasound. 【Results】 All operations were successful without serious complications. The symptoms in 24 patients relieved within 48 hours after catheter drainage, and 2 patients had the catheter removed after continuous drainage for 3 weeks. Of the 26 patients, 19(73.1%) were cured and 7(26.9%) were relieved. The total effective rate was 100%. 【Conclusion】 Transperineal drainage guided by rectal ultrasound is a safe and effective treatment for pelvic lymphocele.
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Prostate biopsy is the gold standard for the diagnosis of prostate cancer. In order to reduce misdiagnosis and complications, the method of prostate biopsy has undergone tremendous changes, and is developing to be more accurate, safe and convenient. This article reviews the progress of clinical application of prostate biopsy.
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Objective:To investigate the efficacy of maintenance electroconvulsive therapy (MECT) combined with quetiapine treatment for manic episodes of bipolar disorder.Methods:A total of 103 patients with manic episodes of bipolar disorder received treatment in Kangci Hospital of Jiaxing from January 2019 to August 2020 and were included in this study. They were randomly divided into observation ( n = 46) and control groups ( n = 57). The observation group was given MECT combined with quetiapine treatment and the control group was treated with magnesium valproate sustained-release tablets combined with quetiapine. All patients received 4 weeks of treatment. Clinical efficacy, total hospital cost, drug cost during hospitalization, drug proportion, adverse reactions, and scores of the Bech-Rafaelsdn Mania Rating Scale and the Wisconsin Card Sorting Test pre- and post-treatment were compared between the two groups. Results:After 4 weeks of treatment, total response rate was significantly higher in the observation group than in the control group [76.09% (35/46) vs. 56.14% (32/57), χ2 = 4.45, P < 0.05]. In the observation group, total hospital cost, drug cost during hospitalization, and drug proportion were (16074.52 ± 1019.81) yuan, (1374.52 ± 619.81) yuan, and 8.70% respectively, which were not significantly different from those in the control group [(15618.14 ± 1550.34) yuan, (1261.14 ± 750.34) yuan, 10.53%, t = 1.71, 0.82, χ2 = 0.09, all P > 0.05]. After 4 weeks of treatment, Bech-Rafaelsdn Mania Rating score was significantly lower in the observation group than in the control group [(7.36 ± 3.04) points vs. (10.23 ± 2.37) points, t = 5.38, P < 0.001]. The number of wrong responses and the number of perseverative errors in the Wisconsin Card Sorting Test in the observation group were (40.45 ± 3.61) counts and (9.56 ± 1.39) counts, respectively, which were significantly lower than those in the control group [(48.59 ± 4.51) counts, (12.08 ± 1.25) counts, t = 10.17, 9.56, both P < 0.001]. The number of perseverative errors in the Wisconsin Card Sorting Test was significantly higher in the observation group than in the control group [(33.85 ± 2.50) counts vs. (29.71 ± 2.14) counts, t = 8.90, P < 0.001]. There was no significant difference in total incidence of adverse reactions between observation and control groups (21.74% vs. 22.81%, χ2 = 0.01, P > 0.05). Conclusion:MECT combined with quetiapine treatment is highly effective on the manic episodes of bipolar disorder. The combined therapy is worthy of clinical application.
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【Objective】 To investigate the current situation concerning volume control of red blood cells in additive solution produced by blood service in Chongqing, and to lay a foundation for promoting the homogenization of preparation process of red blood cells in additive solution. 【Methods】 A questionnaire was designed to investigate the factors related to the preparation of red blood cells in additive solution. The questionnaire was sent by Chongqing Association of Blood Transfusion via E-mail to 18 blood services in the city, and the collected data was sorted, revised and analyzed by research team. 【Results】 A total of 18 blood services(including 1 blood center + 1 sub-center, 6 central blood stations and 11 central blood banks) returned the questionnaires. The results showed that there were differences among blood services across Chongqing, regarding the centrifugal parameters during preparation, the operation mode and monitoring situation of the capacity control during preparation, and the formulation of the capacity standard of red blood cells in additive solution etc. 【Conclusion】 The preparation process of red blood cells in additive solution, produced by Chongqing blood services, should be further standardized, and the capacity control method of this product in Chongqing should be gradually unified to achieve regional homogeneity and to ensure blood safety.
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@#An HPLC-DAD wavelength switching method(240 nm, 280 nm, 316 nm, 403 nm)was developed for simultaneous determination of seven index components: hydroxysafflor yellow A, paeoniflorin, ferulic acid, salvianolic acid B, kaempferol, formononetin and tanshinone IIA in Naoxintong capsule. The qualities of different batches of Naoxintong capsules were evaluated by statistical analysis. Seven index components in 20 batches of Naoxintong capsules were simultaneously determined by HPLC wavelength switching method with Capcell PAK C18 MG II column(250 mm × 4. 6 mm, 5. 0 μm). The mobile phase consisted of methanol-acetonitrile(25 ∶75, A)-0. 1% formic acid aqueous solution(B)with a gradient elution program and a flow rate of 1. 0 mL/min, and the column temperature was 30 °C. The results were analyzed by statistical analysis to evaluate the differences in the quality of Naoxintong capsules. Results showed that the seven active components were well separated and showed good linearity hydroxysafflor yellow A(403 nm)2. 30- 11. 50 mg/L(r=0. 999 2), paeoniflorin(240 nm)8. 81- 44. 05 mg/L(r=0. 999 6), ferulic acid(316 nm)1. 22- 6. 10 mg/L(r=0. 999 6), salvianolic acid B(280 nm)11. 61- 58. 05 mg/L(r=0. 999 4), kaempferol(403 nm)1. 16-5. 80 mg/L(r=0. 999 4), formononetin(240 nm)0. 12- 0. 60 mg/L(r=0. 999 5)and tanshinone IIA(280 nm)2. 28- 11. 40 mg/L(r=0. 999 5). The precision was good and RSD was less than 2. 0%, The repeatability was good and RSD was less than 2. 0%. The stability was good in 24 h. The average recoveries were between 97. 35%- 101. 02% and RSD was less than 2. 0%. The contents of target components in Naoxintong capsules, hydroxysafflor yellow A was 0. 213- 0. 369 mg/g, paeoniflorin was 1. 535- 3. 217 mg/g, ferulic acid was 0. 153- 0. 236 mg/g, salvianolic acid B was 2. 563- 3. 271 mg/g, kaempferol was 0. 103- 0. 181 mg/g, formononetin was 0. 022- 0. 028 mg/g, and tanshinone IIA was 0. 466- 0. 698 mg/g. HPLC wavelength change and gradient elution method was established for simultaneous determination of seven index components in Naoxintong capsule. The method is accurate, sensitive, reliable, and repeatable, and can be used for the quality control of Naoxintong capsule.
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Objective@#To investigate the molecular-cytogenetic characterization and impact on tyrosine kinase inhibitors (TKIs) therapy in chronic phase of chronic myeloid leukemia (CML-CP) patients with variant Ph chromosome (vPh).@*Methods@#The clinical data of 32 patients with vPh chromosomes were collected and compared with 703 patients with typical Ph chromosome in newly diagnosed CML-CP who were on first-line imatinib (IM) and with BCR-ABL transcript of P210.@*Results@#There was no significant difference in demographic and hematological characteristics between vPh and classic Ph patients. 3(9.4%) of the 32 vPh cases were simple variant translocations. Among the remaining 29 cases with complex variant translocations, 28 cases (87.5%) involved 3 chromosomes, and only 1 (3.1%) involved 4 chromosomes. Except for 8, 15, 18, X, and Y chromosomes, the other chromosomes were involved. The frequency of chromosome 12q(15.5%) and 1p (12.1%) were higher involved. The most common FISH signal pattern was 2G2R1Y (74.1%), followed by 1G1R2F (14.8%), 2G1R1Y (3.7%), 1G2R1Y (3.7%), 1G1R1Y (3.7%). The comparison of complete cytogenetic response (CCyR) (P=0.269), major molecular response (MMR) (P=0.391) were carried out between simple and complex mechanisms, without difference. Compared with the classic Ph, the patients with vPh had higher IM primary resistance rate (χ2=3.978, P=0.046), especially primary hematological resistance (χ2=7.870, P=0.005), but the difference of CCyR (χ2=0.192, P=0.661), MMR (χ2=0.822, P=0.365), EFS (χ2=0.509, P=0.476), OS (χ2=3.485, P=0.062) were not statistically significant, and multivariate analysis showed that the presence of vPh did not affect OS (RR=0.692, 95%CI 0.393-1.765, P=0.658)、EFS (RR=0.893, 95%CI 0.347-2.132, P=0.126) and PFS (RR=1.176, 95%CI 0.643-2.682, P=0.703).@*Conclusion@#CML-CP patients with vPh and classic Ph had similar demographic and hematological characteristics. Except for 22q11, 9q34, the frequency of chromosome 12q and 1p were higher involved. The most common FISH signal pattern was 2G2R1Y, and different mechanisms had no impact on TKIs therapy. Compared with cases with classic Ph chromosomes, the patients with vPh chromosomes had higher risk of IM primary resistance, especially primary hematological resistance, which can obtain deeper molecular response quickly after changing to second-generation TKIs and didn’t affect long-term outcomes and OS.
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Objective To evaluate the dosimetry accuracy and clinical efficacy of 125I radioactive seed implantation using coplanar template (CPT) in the treatment of metastatic or recurrent chest wall tumor.Methods Thirty-one patients with metastasis or recurrence of chest wall tumor,who had been diagnosed with pathology between July 2005 and July 2015,were retrospectively studied.All patients underwent CPT-assisted 125I radioactive seed implantation.Brachytherapy radiation treatment planning system (BTPS) was used to make preoperative plans,and the prescribed dose (PD) was 110 Gy.CPT was used to assist CT guided 125I radioactive seeds implantation.Dose evaluation was performed immediately after implantation.The difference of dose parameters was compared between preoperation and postoperation,including Dg0,D100,V90,V100 and the numbers of seeds.Postoperative chest CT was conducted regularly to assess the treatment efficacy based on the response evaluation criteria in solid tumors (RECIST Version 1.1).The patients were followed up till July 2016.Results All patients went through implantation procedure successfully and there was no significant statistical difference between preoperative and postoperative dose parameters (P ＞ 0.05).The conformal index (CI) was 0.951 ± 0.13,external index(EI) was 6.5％ ±0.9％.Six months after implantation,CR,PR,SD and PD were 25.8％ (8/31),51.6％ (16/31),6.5％ (2/31) and 16.1％ (5/31),respectively.The effective rate was 77.4％,and local control rate was 83.9％ (26/31).Skin pigmentation occurred in 13 patients during the follow-up period,without any special treatment.Conclusions The auxiliary of CPT in the treatment of metastatic or recurrent chest wall tumor under the guiding of CT could achieve quality control,safety and effectiveness.
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Objective To compare the planned radiation dose and the actual dose received after 125I radioactive seeds implantation supported by coplanar template (CPT) in lung cancer patients with mediastinal node metastases 4R,and to evaluate the clinical efficacy.Methods Totally 32 patients with lung cancer with mediastinal lymph node metastases 4R who had been diagnosed via cellular pathology studies were selected from January 2008 to December 2014.The mediastinal lymph node metastases were treated by CPT-assisted 125I radioactive seed implantation.Digital imaging and communications in medicine (DICOM) data were acquired by chest CT scan before implantation,brachytherapy radiation treatment planning system (BTPS) was introduced to carry out the plan,and the prescribed dose(PD) was 120 Gy.CPT was used to control the precision of needle penetration and implantation of radioactive seeds.Computer tomography (CT) was used to ensure the correct position of needles and radioactive seeds.Dose evaluation was performed immediately after implantation and was compared with planned dose using paired t-test.The 6-months postoperative chest CT was conducted to evaluate treatment efficacy according to response evaluation criteria in solid tumors(RECIST Version 1.1).Results All patients went through implantation procedure successfully.Dose evaluation after implantation was as followed.The average dose received (231.9 ±29.6)Gy,the dose received by 90％ of the target(D90) (150.8 ± 16.6) Gy,the dose received by 100％ of the target(D100) (100.4 ± 12.6)Gy,the volume of 100％PD covering the target(V100)(94.1 ± 2.6) ％,the volume of 200％ PD covering the target(V200) (33.0 ± 5.7) ％,the conformal index (CI) 0.75 ±0.06,the external index(EI) (22.7 ± 5.8)％,the average dose received by the superior vena cava (19.3 ± 7.2)Gy,and the average dose received by aorta (12.1 ± 5.1)Gy.Efficacy was followed for 6 months after implantation and the effective rate was 84.37％.There was no serious complications (such as radioactive lung injury,major vascular injury,bleeding,and et al.) occurred in follow-up period.Conclusions CPT assisted CT guided 125I radioactive seed imnplantation in treating mediastinal node metastases 4R can achieve preoperative BTPS,minimize major vascular or organ injury.It is an accurate,effective and safe treatment approach and may be of great value to standardize the procedure of radioactive seed implantation in mediastinal metastases.