強骨寶治療馬來西亞膝骨關(guān)節(jié)炎患者的臨床研究
本文關(guān)鍵詞: 強骨寶 膝骨關(guān)節(jié)炎 臨床療效 安全性 出處:《中華中醫(yī)藥雜志》2017年07期 論文類型:期刊論文
【摘要】:目的:探討強骨寶在馬來西亞膝骨關(guān)節(jié)炎患者中的臨床應(yīng)用;評估強骨寶治療馬來西亞患者膝骨關(guān)節(jié)炎的療效;評價強骨寶對馬來西亞膝骨關(guān)節(jié)炎患者心肝腎功能的影響。方法:將60例入選的膝骨關(guān)節(jié)炎患者按照要求,通過口服途徑給藥,受試者每天服強骨寶兩次,每日1劑,每天服藥兩次,早、晚飯后30min各1次,400m L溫水沖服,需連續(xù)8周。每個受試者一共需要參加5次隨訪(包括:篩查即隨機訪問)。每次隨訪均記錄生命體征:心臟收縮壓、心臟舒張壓、心率;實驗室檢查:血液、尿液(生化全套、血常規(guī)、尿常規(guī)和類風(fēng)濕因子等);安全監(jiān)測指標(biāo):心電圖(ECG)檢查。12導(dǎo)聯(lián)心電圖測量在第1次的篩查和第6周末。隨訪8周后療效評估,生命體征和實驗室檢查觀測。結(jié)果:治療8周后,研究組自身對照分析,結(jié)果表明:患者關(guān)節(jié)疼痛、生活質(zhì)量在服藥后2周內(nèi)未發(fā)生明顯變化,4周內(nèi)關(guān)節(jié)腫脹未見明顯消退,4-8周內(nèi)關(guān)節(jié)疼痛、腫脹、僵硬、功能、生活質(zhì)量均得到逐步改善(P0.05);研究組治療后生命體征仍然保持在正常范圍內(nèi),無肝、腎功能異常;沒有患者表現(xiàn)出異常的心率、心臟收縮壓、心臟舒張壓和心電圖。結(jié)論:強骨寶治療膝骨關(guān)節(jié)炎療效確切;且無明顯不良反應(yīng),安全。強骨寶方對骨關(guān)節(jié)炎有一定治療效果,但為了更好地推廣應(yīng)用,證明其有效性,仍需擴大規(guī)模多中心進一步研究。
[Abstract]:Objective: to investigate the clinical application of Qianggu Bao in the treatment of knee osteoarthritis in Malaysia, and to evaluate the curative effect of Qianggu Bao on knee osteoarthritis in Malaysian patients. To evaluate the effect of Qianggu Bao on heart, liver and kidney function in patients with knee osteoarthritis in Malaysia. Methods: 60 selected patients with knee osteoarthritis were given oral administration of QG twice a day, once a day. Taking medicine twice a day, early, 30 minutes after supper, taking 400 mL warm water for 8 consecutive weeks. Each subject was followed up for 5 times (including screening and random visit. Vital signs: systolic blood pressure) were recorded at each follow-up. Heart diastolic blood pressure, heart rate; laboratory tests: blood, urine (biochemistry complete, blood routine, Urine routine and rheumatoid factors, safety monitoring indicators: ECG) examination. 12-lead electrocardiogram measurement during the first screening and at the 6th weekend. Evaluation of curative effect, vital signs and laboratory examination after 8 weeks follow-up. Results: after 8 weeks of treatment, The results of self-control analysis of the study group showed that there was no significant change in the quality of life in the patients with joint pain within 2 weeks after taking the drug. The swelling of the joints did not abate significantly within 4 weeks and 8 weeks after treatment, and the pain, swelling, stiffness and function of the joints were not abated significantly within 4 to 8 weeks. The quality of life was improved gradually (P 0.05); the vital signs of the study group remained within the normal range after treatment, without liver and kidney function abnormalities; no patients showed abnormal heart rate and systolic blood pressure. Conclusion: Qianggu Bao is effective in treating knee osteoarthritis with no obvious adverse reaction and safety. Qianggu Bao has some therapeutic effect on osteoarthritis, but in order to promote its application, it is effective. There is still a need to expand the scale of multi-center further research.
【作者單位】: 福建中醫(yī)藥大學(xué);
【基金】:福建省自然科學(xué)基金項目(No.2016J01380)~~
【分類號】:R274.9
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