Objective To investigate the action of ulinastatin in protection of hepatic-renal function in patients with acute myocardial infarction (AMI) receiving emergency percutaneous coronary intervention (PCI). Methods 104 patients with acute myocardial infarction were randomly selected and divided into a study group (n = 55) and a control group (n = 49). The study group received intravenous ulinastatin of 300,000 units one hour before PCI, and 300,000 units daily for 3 days after the procedure; while the control group received the same amount of normal saline instead of ulinastatin before and after PCI. Levels of AST, ALT, and CRE were compared between the two groups and CCR was counted before and 72 hours after the procedure. Result Serum AST level was increased and CCR was decreased after PCI; and the change in the study group was lower than that in the control group (P < 0.05). ALT level was declined in the study group but was elevated in the control group after the procedure, with a significant difference between the two groups (P < 0.05). Conclusions Ulinastatin can protect hepatic-renal function in patients undergoing emergency PCI, lowering contrast-induced nephropathy and damage of liver and kidneys.

AIM: An effective and convenient method was established for HPLC fingerprints of Ciwujia Injection (Radix et Rhizoma seucaulis acanthopanacis senticost) which provided an approach for quality control in production. METHODS: Komasil-C_(18) column, phase A: 0.2% formic acid, phase B: 35% Acetonitrile, eluted with a gradient program and detected at 270 nm. The fingerprints of extraction from crude herbs, intermediate and finished product were compared. RESULTS: The fingerprint method for Ciwujia Injection was established. The similarity of 10 batches of Ciwujia Injection was not lower than 0.977. Obvious difference was carried on among the extraction from crude herbs, intermediate and finished product. CONCLUSION: This validated method is available for quality evaluation and quality control in Ciwujia Injection's production.

The traditional model Franz diffusion cell method has always been the “gold standard” for evaluating the permeability of transdermal drug delivery system （TDDS） drug. However， in the high throughput screening of a large number of drug molecules， it has the disadvantages of low efficiency， high cost， difficulty to obtain isolated skin，poor reliability and large workload. The emergence of parallel artificial membrane permeation assay （PAMPA） model provides reliable pre-prediction data for the evaluation of permeability of TDDS drug. PAMPA model has been widely used in the permeability screening research of TDDS drugs and their preparations such as analgesics， local anesthetics， antioxidants， antipyretics， analgesics and anti-inflammatory drugs， vitamins， cholinesterase inhibitors， active ingredients of natural products， and has the characteristics of high reliability， good selectivity， high efficiency， low cost and data stability. PAMPA model has greatly improved the high throughput screening efficiency of TDDS drug permeability. With the extensive application and gradual maturity of this model， it will become a new and effective evaluation method in addition to the traditional evaluation model.

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