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1.
钟向真 《中国优生与遗传杂志》2006,14(11):70-71,74
目的探讨三种不同方法治疗自身免疫型习惯性流产的临床效果。方法选取78例确诊为自身免疫异常引起的习惯性流产患者,分为4组,1为阿司匹林+泼尼松组(22例),2为阿司匹林+肝素组(18例),3为静丙组(20例),4为对照组(18例),不接受任何治疗,用卡方检验比较各组妊娠成功率。结果1、2、3组与对照组分别比较,差异均有统计学意义(P〈0.05),但3种治疗方法之间无显著差异(P〉0.05);1组出现了胎膜早破、妊娠期高血压疾病等妊娠合并症,2组出现了早产和消化道出血,但各组发生率无统计学差异(P〉0.05)。结论传统的激素、抗凝剂和被动免疫疗法均有一定疗效,但三者之间疗效无差异。 相似文献
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目的:探讨自拟壮骨方治疗绝经后骨质疏松症的疗效及作用机制。方法:将纳入研究的240例绝经后骨质疏松症患者随机分为2组,每组120例。治疗组采用口服自拟壮骨方治疗,对照组采用口服尼尔雌醇片治疗。比较2组患者的骨密度及血清中钙、磷、碱性磷酸酶、雌二醇的水平,同时比较2组患者治疗后的疼痛改善情况。结果:①骨密度。治疗前2组患者腰椎和股骨颈骨密度比较,组间差异均无统计学意义[(0.73±0.26)g·cm-2,(0.71±0.29)g·cm-2,t=3.296,P=0.110;(0.84±0.03)g· cm-2,(0.85±0.02)g·cm-2,t=3.114,P=0.201]。治疗组治疗前后腰椎骨密度的差值大于对照组[(0.20±0.15)g·cm-2,(0.18±0.12)g·cm-2,t=4.012,P=0.021];2组患者股骨颈骨密度的差值比较,差异无统计学意义[(0.60±0.24)g·cm-2,(0.16±0.14)g·cm-2,t=1.062,P=0.080]。②血生化指标。治疗前2组患者血清中钙、磷、碱性磷酸酶、雌二醇浓度比较,组间差异均无统计学意义[(2.24±0.16)mmol·L-1,(2.22±0.14)mmol·L-1,t =5.659,P=0.431;(1.19±0.21)mmol·L-1,(1.18±0.22)mmol·L-1,t =3.314,P=0.158;(109.50±13.41)U·L-1,(108.71±20.42)U·L-1,t =1.354,P=0.762;(40.86±18.26)pmol·L-1,(41.14±19.04)pmol·L-1,t=1.918,P=0.656]。治疗组血清中钙和磷浓度治疗前后的差值均大于对照组[(1.61±0.46)mmol·L-1,(0.31±0.25)mmol·L-1,t =5.618,P=0.000;(0.60±0.24)mmol·L-1,(0.30±0.14) mmol·L-1,t=7.012,P=0.000];碱性磷酸酶和雌二醇浓度治疗前后的差值与对照组比较,差异均无统计学意义[(20.21±12.16)U·L-1,(16.11±10.12)U·L-1,t=1.368,P=0.612;(19.26±10.23)pmol·L-1,(16.76±9.67)pmol· 相似文献
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《Journal of pharmaceutical sciences》2019,108(7):2207-2237
This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through consortia, enabling industry to supply key information to regulators in a transparent yet well-defined manner, and utilizing mutually understood risk-benefit analyses to produce drugs with appropriate safety, efficacy, and quality characteristics. 相似文献
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ObjectivesDose-finding trials are fundamental to develop novel drugs for children and adolescents with advanced cancer. It is crucial to maximise individual benefit, whilst ensuring adequate assessment of key study end-points. We assessed prognostic factors of survival in paediatric phase I trials, including two predictive scores validated in adult oncology: the Royal Marsden Hospital (RMH) and the MD Anderson Cancer Center (MDACC) scores.MethodsData of patients with solid tumours aged <18 years at enrolment in their first dose-finding trial between 2000 and 2014 at eight centres of the Innovative Therapies for Children with Cancer European consortium were collected. Survival distributions were compared using log-rank test and Cox regression analyses.ResultsOverall, 248 patients were evaluated: median age, 11.2 years (range 1.0–17.9); 46% had central nervous system (CNS) tumours and 54% extra-CNS tumours. Complete responses were observed in 2.1%, partial responses in 7.2% and stable disease in 25.9%. Median overall survival (OS) was 6.3 months (95% confidence interval, 5.2–7.4). Lansky/Karnofsky ≤80%, no school/work attendance, elevated creatinine and RMH score ≥1 correlated with worse OS in the multivariate analysis. The RMH and MDACC scores correlated with OS in adolescents (12–17 years), p = 0.002, but not in children (2–11 years).ConclusionsPerformance status of 90–100% and school/work attendance at enrolment are strong indicators of longer OS in paediatric phase I trials. Adult predictive scores correlate with survival in adolescents. These findings provide a useful orientation about potential prognosis and could lead in the future to more paediatric-adapted eligibility criteria in early-phase trials. 相似文献
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Praise O. Iyiewuare Ian D. Coulter Margaret D. Whitley Patricia M. Herman 《Journal of manipulative and physiological therapeutics》2018,41(9):807-813
Objective
This paper describes a process for ensuring and documenting Health Insurance Portability and Accountability Act (HIPAA) compliance in clinical practice-based research.Methods
The Center of Excellence for Research in Complementary and Alternative Medicine was funded by National Center for Complementary and Integrative Health to develop the methods for researching the appropriateness of care in complementary and integrative health, which previously was known as complementary and alternative medicine. We recruited 125 participating chiropractic clinics for enrolling patients and gathering their data via the online surveys. Chiropractic clinics completed the following: (1) obtained the files of patients who provided prior consent (the prospective sample), (2) obtained the files of the patients selected randomly using specified randomization procedures (the retrospective sample), and (3) transferred all patient data to the RAND Corporation via an encrypted file.Results
Most of the doctors of chiropractic from clinical practices had no concerns about obtaining and transferring the files of patients who provided informed consent. However, some doctors were uneasy about allowing the researchers to access the randomly selected files of patients who had not provided prior authorization. This led us to develop a set of forms to provide clinics about HIPAA compliance.Conclusion
For this study, we provided clinics with information about the rules under HIPAA, demonstrated how the study complied with those rules, explained the logic behind the necessity for collecting files from both the prospective and retrospective samples, and, if requested, provided clinics with a confidentiality agreement signed by the study principal investigator and an organizational contracts representative. The process we developed may assist other complementary and integrative health researchers and practitioners in future studies. 相似文献10.