Benralizumab efficacy and safety in severe asthma: A randomized trial in Asia.

BACKGROUND: Benralizumab is indicated as add-on therapy in patients with uncontrolled, severe eosinophilic asthma; it has not yet been evaluated in a large Asian population with asthma in a clinical trial. OBJECTIVE: To evaluate the efficacy and safety of benralizumab in patients with severe asthma in Asia. METHODS: MIRACLE (NCT03186209) was a randomized, Phase 3 study in China, South Korea, and the Philippines. Patients aged 12-75 years with severe asthma receiving medium-to-high-dose inhaled corticosteroid/long-acting ß2-agonists, stratified (2:1) by baseline blood eosinophil count (bEOS) (≥300/µL; <300/µL), were randomized (1:1) to benralizumab 30 mg or placebo. Endpoints included annual asthma exacerbation rate (AAER; primary endpoint), change from baseline at Week 48 in pre-bronchodilator (BD) forced expiratory volume in 1 second (pre-BD FEV1) and total asthma symptom score (TASS). Safety was evaluated ≤ Week 56. RESULTS: Of 695 patients randomized, 473 had baseline bEOS ≥300/µL (benralizumab n = 236; placebo n = 237). In this population, benralizumab significantly reduced AAER by 74% (rate ratio 0.26 [95% CI 0.19, 0.36], p < 0.0001) and significantly improved pre-BD FEV1 (least squares difference [LSD] 0.25 L [95% CI 0.17, 0.34], p < 0.0001) and TASS (LSD -0.25 [-0.45, -0.05], p = 0.0126) versus placebo. In patients with baseline bEOS <300/µL, there were numerical improvements in AAER, pre-BD FEV1, and TASS with benralizumab versus placebo. The frequency of adverse events was similar for benralizumab (76%) and placebo (80%) in the overall population. CONCLUSIONS: MIRACLE data reinforces the efficacy and safety of benralizumab for severe eosinophilic asthma in an Asian population, consistent with the global Phase 3 results.

Wuzi Yanzong prescription from Traditional Chinese Medicine for male infertility: a narrative review.

Wuzi Yanzong prescription (WYP), as a classical prescription for male infertility with kidney essence deficiency, is composed of Gouqizi (), Tusizi (), Wuweizi (), Fupenzi () and Cheqianzi (). It has been used for hundreds of years in the treatment of male infertility, known as "the first prescription of ancient and modern seeds", with convincing clinical evidence. At present, more than 100 chemical compounds have been isolated from WYP, including polysaccharide, fatty acids, flavonoids, phenylpropanoids, organic acids, alkaloids, terpenoids, etc. Pharmacological and clinical studies show that WYP has an obvious effect on reproductive system diseases, especially male infertility, which has a very wide application prospect. It also has effects on the nervous system, inhibiting liver injury, lowering blood sugar and blood lipid, anti-aging, improving immunity, resisting hypoxia and fatigue effects. This study reviewed the chemical constituents, quality control, pharmacology, and clinical application of WYP. There is no doubt about the clinical value of WYP, but its quality control system is not perfect, pharmacological mechanism is not fully explained, and clinical applications need to be reevaluated. Therefore, the follow-up researches should proceed from the theory of Traditional Chinese Medicine (TCM) and clinical applications, further explain the theoretical connotation, reveal the mechanism of action, and provide the basis for the secondary development of classic famous prescriptions. In addition, WYP is mostly used in combination with western medicines besides being used alone. Whether it can improve the efficacy and reduce side effects will also be a meaningful research direction in the future.