康辰藥業(603590.SH)：獲得金草片II期臨牀試驗總結報吿
格隆匯4月6日丨康辰藥業(603590.SH)公佈，公司購買的中藥創新藥金草片截止目前已經完成了治療盆腔炎性疾病後遺症慢性盆腔痛有效性和安全性的II期臨牀試驗，並獲得了《金草片II期臨牀試驗總結報吿》，根據研究情況，公司將順利開展金草片III期臨牀試驗。
金草片是從中藥筋骨草全草中提取的有效部位製劑製成的口服中藥片劑，主要成分為“總環烯醚萜苷”。筋骨草藥材收載於中國藥典2020年版，其性苦、寒，具有清熱解毒涼血消腫的功效。
本試驗採取多中心、隨機、雙盲、劑量平行對照、安慰劑對照的試驗設計。考慮到臨牀上盆腔炎性疾病後遺症慢性盆腔痛的治療以疼痛症狀的緩解為主要目標，因此，本試驗選擇視覺模擬評分(VAS)量表作為慢性盆腔痛的主要療效評價指標。本試驗分為三組：高劑量組(600mg/天)，低劑量組(300mg/天)，和安慰劑組。每組計劃各入組60例受試者，共180例。所有入組患者均接受每日給藥3次，連續給藥12周，月經期不停藥。
II期臨牀試驗的有效性結果顯示，金草片的鎮痛療效明顯優於安慰劑組，能明顯降低VAS評分，並顯著提高患者的疼痛消失率。在疼痛消失率方面，連續治療12周後，金草片高劑量組和低劑量組疼痛消失率為53.45%和43.33%，均明顯優於安慰劑組11.86%，並表現出統計學差異(p<0.0001)。其他療效評價指標(包括體徵McCormack量表評分、SF-12量表評分、中醫證候積分)均表現出一致的療效趨勢。
II期臨牀試驗的安全性結果顯示，筋骨草總環烯醚萜苷片安全性和耐受性良好，受試者依從性高，未觀察到潛在的安全性風險，其各項安全性指標的評價結果均與安慰劑相當。在治療相關不良事件方面，高劑量組、低劑量組的發生率分別為3.45%和1.67%，均低於安慰劑組的發生率(5.08%)。
基於金草片II期臨牀試驗結果，公司評估金草片治療盆腔炎性疾病後遺症慢性盆腔痛臨牀療效確切，且安全性和耐受性良好，具有明顯的臨牀開發價值和前景。
後續，公司擬向國家食品藥品監督管理局藥品審評中心(“CDE”)提交關鍵性III期臨牀試驗溝通交流會申請，進一步評價金草片治療盆腔炎性疾病後遺症慢性盆腔痛的有效性和安全性，為本品新藥註冊申請審查提供依據。
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