张忠良, 费霖莉, 冷燕奎. 加味二至丸辅助改善肩袖损伤伴绝经后骨质疏松症患者术后疗效的临床研究. 2025. biomedRxiv.202512.00073
加味二至丸辅助改善肩袖损伤伴绝经后骨质疏松症患者术后疗效的临床研究
通讯作者: 张忠良, zzl187712@163.com
DOI:10.12201/bmr.202512.00073
Clinical Study on Modified Erzhi Wan in Assisting the Improvement of Postoperative Efficacy in Patients with Rotator Cuff Tear Complicated by PMOP
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摘要:目的 观察加味二至丸辅助改善慢性肩袖损伤伴绝经后骨质疏松症(PMOP)患者术后疗效的有效性及安全性。方法 本研究纳入2024年6月至2025年3月在我院住院接受关节镜下肩袖修补术的慢性肩袖损伤伴PMOP患者,共纳入68例,根据数字表法分为观察组与对照组,每组各34例。对照组术后常规口服碳酸钙D3片及阿法骨化醇软胶囊抗骨质疏松治疗,观察组在对照组基础上服用加味二至丸,两组术后共干预12周。于术前、术后12周记录中医症候评分、疼痛视觉模拟评分(VAS)、美国肩肘外科医生协会评分(ASES)、健康调查简表评分(SF-36)、肱骨大结节骨密度(BMD),术后1周及术后12周记录超声下观察结果,并记录服药过程中的不良反应。结果 两组患者均完成了12周的随访。术前两组间中医症候评分、VAS评分、ASES评分、SF-36评分、肱骨大结节BMD比较差异无统计学意义(P>0.05),术后1周两组间超声下观察结果比较差异无统计学意义(P>0.05)。术后12周,观察组中医症候评分及VAS评分低于对照组,ASES评分及SF-36评分高于对照组,差异均具有统计学意义(P<0.05);两组间肱骨大结节BMD比较差异无统计学意义(P>0.05)。术后12周,观察组Sugaya分级优于对照组,肩峰下积液少于对照组,冈上肌腱滑动距离比高于对照组,差异均有统计学意义(P<0.05)。结论 加味二至丸辅助治疗慢性肩袖损伤伴PMOP患者肩袖修补术后,可有效减轻局部炎症反应,降低患者的疼痛程度,改善活动功能及生活质量,且安全性良好。
Abstract: Objective To observe the efficacy and safety of modified Erzhi Wan in adjuvantly improving the postoperative outcomes of patients with chronic rotator cuff injury complicated by PMOP. Methods This study enrolled 68 patients with chronic rotator cuff injury complicated by PMOP who were hospitalized in our hospital and underwent arthroscopic rotator cuff repair between June 2024 and March 2025. The patients were divided into an observation group and a control group using a random number table method, with 34 cases in each group. The control group received conventional oral administration of Calcium Carbonate D3 Tablets and Alfacalcidol Soft Capsules for anti-osteoporosis treatment after surgery. The observation group was given modified Erzhi Wan on the basis of the treatment received by the control group. Both groups received intervention for 12 weeks after surgery. TCM syndrome score, VAS score, ASES score, SF-36 score, and BMD of the greater tuberosity of the humerus were recorded before surgery and at 12 weeks after surgery. Ultrasonic observation results were documented at 1 week and 12 weeks after surgery, and adverse reactions during the medication period were also recorded. Results Both groups of patients completed a 12-week follow-up. Before surgery, there were no statistically significant differences between the two groups in terms of TCM score, VAS score, ASES score, SF-36 score, and BMD of the greater tuberosity of the humerus(P>0.05). One week after surgery, there was no statistically significant difference in the ultrasound observation results between the two groups (P>0.05). At 12 weeks after surgery, the TCM score and VAS score of the observation group werelowerthan those of the control group, while the ASES score and SF-36 score werehigherthan those of the control group; all these differences were statistically significant (P<0.05). There was no statistically significant difference in the BMD of the greater tuberosity of the humerus between the two groups (P>0.05). TheSugaya classificationof the observation group was better than that of the control group, thesubacromial effusionwas less than that of the control group, and thesliding distance ratio of the supraspinatus tendonwas higher than that of the control group; all these differences were statistically significant (P<0.05). Conclusion When used as an adjuvant therapy for patients with chronic rotator cuff injury complicated by PMOP after rotator cuff repair surgery, modified Erzhi Wan can effectively alleviate local inflammatory responses, reduce the patients pain level, improve motor function and quality of life, with good safety.
Key words: Erzhi Wan; Rotator Cuff Injury; PMOP; Ultrasound; Bone Mineral Density提交时间:2025-12-28
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序号 提交日期 编号 操作 1 2025-11-16 10.12201/bmr.202512.00073V1
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