Phase II trial of sunitinib as adjuvant therapy after stereotactic radiosurgery in patients with 1–3 newly diagnosed brain metastases

Journal of Neuro-Oncology - Patients with 1–3 brain metastases (BM) often receive sterotactic radiosurgery (SRS) without whole brain radiotherapy (WBRT). SRS without WBRT carries a high rate...     

归芍地黄丸中山茱萸的定性定量方法研究

摘 要 目的： 建立归芍地黄丸中山茱萸的定性和定量测定方法。方法: 采用TLC对归芍地黄丸中山茱萸进行定性鉴别,并采用HPLC测定山茱萸中莫诺苷、 马钱苷的含量。结果: TLC色谱斑点清晰,分离度好,专属性强;莫诺苷对照品在0.010～2.620 μg范围内线性关系良好（r=0.999 9）,平均回收率为102.75％,RSD为1.40％（n=6）。马钱苷对照品在0.009～2.170 μg范围内线性关系良好（r=0.999 9）,平均回收率为103.59%,RSD为1.10%（n=6）。结论:本方法准确、简单、可行,重复性好,可有效控制该制剂中山茱萸的质量。     

Pilot study of transepithelial， very high fluence accelerated corneal collagen cross-linking in primary keratoconus

Objective Evaluate the safety and effectiveness of transepithelial, very high fluence accelerated corneal collagen cross-linking （A-CXL） in primary keratoconus. Methods Self-control study. Thirteen primary keratoconus eyes of 13 patients were treated with transepthelial, very high fluence A-CXL with a UVA intensity of 45 mW/cm2, an irradiation time of 2 min 40 s, and a total energy of 7.2 J/cm2. Routine ophthalmologic examination, UCVA, BCVA, refractive error, corneal keratometry, anterior and posterior elevation （AE and PE）, index of vertical asymmetry （IVA）, minimum corneal thickness （CT）, compensated intraocular pressure （IOPcc）, endothelial cell density （ECD） were evaluated pre-operatively and 7-day, 1-month, 3-month, 6-month, 12-month post-operatively. Results The UCVA （F=6.111, P＜0.01） and BCVA （F=9.734, P＜0.01） showed a statistically significant improvement by 12-month post-operatively. The decrease in spherical lens （F=5.871, P＜0.05）, steeper K-value （F=19.651, P＜0.05）, Kmax （F=3.253, P＜0.05）, AE （F=23.958, P＜0.01）, PE （F=20.832, P＜0.01） and IVA （F=4.068, P＜0.05） were statistically significant. CT （F=4.180, P＞0.05）, ECD （F=1.812, P＞0.05） and IOPcc （F=0.332, P＞0.05） were without significant change. Conclusion Transepithelial, very high fluence A-CXL is safe and effective in treating primary keratoconus.     

Assessing the benefit–risk of new treatments using generalised pairwise comparisons: the case of erlotinib in pancreatic cancer

Background:

Efficacy and safety are the two considerations when characterising the effects of a new therapy. We sought to apply an innovative method of assessing the benefit–risk balance using data from a completed randomised controlled trial that compared erlotinib vs placebo added to gemcitabine in patients with advanced pancreatic cancer (NCIC CTG PA.3).

Methods:

We applied generalised pairwise comparisons with several prioritised outcome measures (e.g., one or more benefit outcomes and one or more risk outcomes). Here, the first priority outcome was overall survival (OS) time. Differences in OS that exceeded 2 months were considered clinically meaningful. The second priority outcome was toxicity. The overall treatment effect was quantified using the proportion in favour of erlotinib, which can be interpreted as the net proportion of patients who have a better overall outcome with erlotinib as compared with placebo. Sensitivity analyses were performed.

Results:

In this trial 569 patients were randomly assigned in a 1 : 1 ratio to receive gemcitabine plus either erlotinib or a matched placebo. Overall, the method indicated no statistically significant overall treatment effect in favour of erlotinib; if anything, the point estimate of the net proportion leaned in favour of the placebo group (overall proportion in favour of erlotinib=−3.6%, 95% CI, −14.2– 7.1% P=0.51). The net proportion was never in favour of the erlotinib group throughout all sensitivity analyses.

Conclusions:

Generalised pairwise comparisons make it possible to assess the benefit–risk balance of new treatments using a single statistical test for any number of prioritised outcomes. The benefit–risk assessment was not in favour of adding erlotinib to gemcitabine for the treatment of patients with advanced pancreatic cancer.