How Should Functionally Equivalent Drugs be Reimbursed?

Statutory reimbursement agencies as well as private insurers throughout member states of the Organization for Economic Cooperation and Development (OECD) reimburse the cost of medicines on the basis of criteria that include robust clinical evidence, budget impact analysis, and incremental cost effectiveness. The Centers for Medicare and Medicaid Services (CMS) in the US are no exception to this rule and are, in principle, seeking to maximize benefit for their Medicare enrollees, whilst ensuring reasonable drug outlays for the small number of drugs that they reimburse. This paper provides a retrospective analysis of the way two functionally equivalent drugs are treated for reimbursement purposes by the CMS; the period under consideration was 2001–3. The two drugs, epoetin-α and darbepoetin-α, are used for the treatment of anemia in renal failure and in patients receiving chemotherapy. By reviewing the publicly available pharmacological and clinical data of epoetin-α and darbepoetin-α, the paper confirms the two drugs’ functional equivalence, despite their structural differences. The implications of dose conversion ratios and costs to Medicare are subsequently explored. It is argued that the issue of dose equivalence between epoetin-α and darbepoetin-α has significant implications for patients, practitioners, and payors. A payor’s perspective is adopted in this respect, whereby clinical evidence and pricing data are used simultaneously. Based on the clinical evidence, a dose conversion ratio for epoetin-α:darbepoetin-α is established, which achieves a comparable clinical effect for the two drugs and this is set to be <254IU:1μg. The incremental costs to Medicare are calculated subsequently. The Average Wholesale Price and the Outpatient Prospective Payment System rule that Medicare uses to reimburse providers are used and suggest that treatment of cancer patients with chemotherapy-related anemia with epoetin-α would save Medicare an estimated $US600 million each year. Patients would also benefit significantly in terms of lower co-payments for epoetin-α. The evidence is supportive of the decision made by the CMS to reimburse the two drugs at the rate reflecting the achievement of comparable clinical effects and therefore reducing the pass-through payments for darbepoetin-α to zero for the 2002–3 fiscal year.     

经腹及经阴道B超监测卵泡发育的评估

应用经腹及经阴道B超对68名不孕症妇女,139个月经周期进行卵泡发育及排卵监测。卵泡检出率TAUS为90.6％,TVUS为98.0％,显著高于前者,P<0.05。成熟卵泡特征影象(卵丘等)在TVUS显象率较高。TVUS监测卵泡发育更实用可靠。     

乳腺良恶性病变的磁共振T2*W首过灌注成像与血管生成相关性研究

Objective： To study the diagnostic value of T2^＊-weighted first-pass perfusion imaging in breast tumors. Methods： We analyzed the magnetic resonance imaging （MRI） information along with the pathological and immunohistochemistry results. Magnetic resonance imaging was performed in 28 patients with breast tumor. The time to signal intensity curves were generated according to the T2^＊-weighted first-pass perfusion imaging. The curve＇s maximal signal intensity drop rate and maximal signal intensity decrease time were analyzed and compared with the pathological diagnoses after surgery. Results： Malignant breast lesions showed higher maximal signal intensity drop rate （44.69% ± 17.07 vs. 17.22% ±7.49, P 〈 0.001） than benign lesions, but there was no significant difference of maximal signal decrease time between those two lesions （23.94 s ± 4.92 vs. 20.02 s ± 6.83, P 〉 0.05）. Conclusion： The T2^＊-weighted first-pass perfusion imaging has enough sensitivity and specificity in breast tumor diagnosis.     

Survey of psychiatric disorders in a Taiwanese village population six months after a major earthquake.

BACKGROUND AND PURPOSE: The catastrophic Chi-Chi earthquake of September 21, 1999 in Taiwan provided a unique opportunity to study the disaster's psychiatric impact on survivors. This study assessed the development of psychiatric disorders among residents in a Taiwanese village near the epicenter of the earthquake within 6 months of the disaster. METHODS: A total of 442 of the 602 actual living residents of Tong-Chi village who were over 16 years of age and were present in the community at the time of the earthquake were included in this population survey. Subjects were interviewed by psychiatrists using the Mini-International Neuropsychiatric Interview and questionnaires to collect demographic information and risk factors for psychiatric disorders 4 to 6 months after the earthquake. RESULTS: The prevalence rates were 9.5% for current major depression, 2.8% for past major depressive episode, and 7.9% for post-traumatic stress disorder (PTSD). Females had significantly higher rates of most psychiatric disorders. After controlling for covariates, the significant risk factors for PTSD were female gender and having sought medical service after the earthquake. Significant risk factors for major depressive episode were divorced/widowed status, education level equal to or below primary school, and prominent house damage. CONCLUSION: This population survey of earthquake disaster survivors found an increased prevalence of psychiatric disorders after exposure to a catastrophic earthquake. These results highlight the need for prompt therapeutic attention to residents of earthquake disaster areas after the event.     

Anterior mediastinal immature teratoma with precocious puberty in a child with Klinefelter syndrome.

ABSTRACT: Klinefelter syndrome occurs in approximately 1 in 1000 males. A 4-year-old boy presented with precocious puberty and an anterior mediastinal mass. Serum alpha-fetoprotein and human chorionic gonadotropin levels were mildly increased. Computed tomography revealed a germ cell tumor (GCT) of the mediastinum. Complete resection of the tumor was performed. Histologic analysis revealed an immature teratoma. Males with Klinefelter syndrome develop GCTs at a rate 50 times higher than unaffected males. This case report calls attention to the need to rule out Klinefelter syndrome in boys who present with precocious puberty and a mediastinal GCT.     

核磁共振法测定非离子表面活性剂 HLB 值的研究 2.几种混合体系 HLB 值的测定与计算

本文应用核磁共振法(NMR)测定了几种混合体系的 HLB 值与混合体系中各组分的 HLB 值。实验结果表明,混合体系中各组分在核磁共振图谱中的积分曲线高度也具有加和性。混合体系的 HLB 值是体系中各组分 HLB 值的加权平均值。因此,对混合体系的 HLB 值可以应用 NMR 法直接测定,也可应用 NMR 法测定各组分的 HLB值,通过计算求得,计算值与实测值完全一致。     

Preload-induced curvilinearity of left ventricular end-systolic pressure-volume relations. Effects on derived indexes in closed-chest dogs

End-systolic pressure-volume relations (ESPVRs) were analyzed in 10 closed-chest autonomically blocked dogs before and after volume loading that restored end-diastolic volume to its value measured in the control conscious state. Dogs had been previously instrumented with a left ventricular pressure micromanometer and ultrasonic crystals for measurements of major, anteroposterior, and septum-free wall diameters. Left ventricular volume was calculated with an ellipsoidal model in the left ventricular cavity. ESPVRs obtained during caval occlusion after volume loading were curvilinear as shown by the division of the relation into two parts. The initial part of the relation had a significantly smaller ESPVR slope (Ees, 12.0 +/- 1.8 mm Hg/ml) and ESPVR volume-axis intercept (Vd, - 3.5 +/- 0.8 ml) than the final part of the relation (19.5 +/- 3.1 mm Hg/ml and 0.0 +/- 0.6 ml, respectively, p less than 0.01). The end-diastolic volume-peak dP/dt relation showed a similar curvilinearity when end-diastolic volumes were larger than 1.5-1.7 times the minimal end-diastolic volume reached during caval occlusion. ESPVRs were not different during aortic constriction and caval occlusion when end-diastolic volume was small. In contrast, with large end-diastolic volumes, Ees and Vd were significantly smaller during caval occlusion than during aortic constriction. The final part of ESPVR (with small end-diastolic volume) had the same slope and intercept as that during aortic constriction. We conclude that preload produces a curvilinearity of ESPVR that significantly modifies derived indexes when the range of preload changes is large.     

中药熏洗治疗膝关节骨性关节炎的Meta分析

为运用循证医学方法对中药熏洗治疗膝骨性关节炎（OA）的临床疗效及安全性进行系统评价和Meta分析。全面收集了中药熏洗治疗OA的文献资料。在严格质量评价基础上，对研究结果进行定性分析。合并各篇优、良为阳性结果，中、差为阴性结果。利用RevMan4．1软件对多个研究结果的总体疗效进行固定效应模型的Meta分析，并进行敏感性分析。用漏斗图表示发表性偏倚。结果显示，中药熏洗治疗OA的效应值OR=2．68.95％可信区间为[1．82，3．95]；敏感性分析显示效应值稳定；漏斗图图形不对称；无中药熏洗不良反应的报道。表明中药熏洗治疗OA有一定的疗效，由于漏斗图提示存在发表性偏倚，加上现有临床研究存在的方法学问题，现在的研究结论有一定的局限性，欲得出公认的结论，尚有待进行设计严谨的多中心、随机对照试验。