中药术后1号方治疗髋、膝关节置换术后气血亏虚肠燥证便秘的临床研究

Effect of Postoperative No.1 Recipe on Constipation of Patients with Qi and Blood Deficiency and Intestinal Dryness Syndrome after Hip and Knee Arthroplasty： A Clinical Trial

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DOI：10.7661/j.cjim.20221020. 213

中文关键词: 中药术后1号方髋、膝关节置换术后便秘临床研究

英文关键词:Postoperative No.1 Recipe postoperative of artificial joint replacement constipation clinical trial

基金项目:上海市卫生健康委员会上海市临床重点专科建设项目（No. shslczdzk04801）；人工膝关节置换术围手术期中西医结合快速康复

作者	单位
冉磊,肖涟波,解骏,沈军,赵翅,孟晓辉,徐博,王建业,施杞	1.上海中医药大学光华临床医学院（上海 201203） 2.上海中医药大学附属光华医院关节外科（上海 200052） 3.上海市中医药研究院中西医结合关节炎研究所（上海 200052） 4.上海中医药大学脊柱病研究所（上海 200003）

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中文摘要:

目的观察中药术后1号方治疗髋、膝关节置换术后气血亏虚肠燥证便秘的有效性及安全性。结果采用随机、单盲、平行对照设计，纳入2021年1—8月行髋、膝关节置换术后便秘患者120例，均来自上海中医药大学附属光华医院关节外科，按SPSS软件随机数法分为中药组（60例）与对照组（60例）。围术期按照关节置换术常规处理，术后第2天整体评估后进行药物干预，中药组给予术后1号方2袋（200 mL），每天2次；对照组给予果糖口服液15 mL，每天3次，均治疗3天，术后第9天评价中药通便疗效，评价指标包括治疗前后患者便秘主要症状评分、平均每周自发完全排便次数（SCBM）、便秘症状问卷（PAC-SYM）、中医证候评分和安全性指标，并判定主要症状疗效。结论最终纳入117例，中药组58例，对照组59例。与本组治疗前比较，中药组便秘主要症状平均得分、次要症状平均得分及中医证候评分均下降（P<0.05），SCBM明显增加（P<0.05）；对照组便秘主要症状平均得分升高（P<0.05），SCBM无明显改变（P>0.05），中医证候评分降低（P<0.05）。治疗后与对照组比较，中药组便秘主要症状平均得分、次要症状平均得分及中医证候评分均下降（P<0.05），SCBM增加（P<0.05）。中药组与对照组患者主要症状平均有效率分别为86.1%、78.2%，平均临床治愈率分别为43.9%、32.2%，两组比较差异均有统计学意义（χ2=15.736，P<0.001；χ2=5.304，P<0.05）。两组治疗前后肝、肾功能比较差异无统计学意义（P>0.05）。结论中药术后1号方可明显减少术后便秘症状，缓解胃肠道不适，改善术后生活质量，围手术期使用安全有效，可提高患者的有满意度和舒适度。中国临床试验注册中心注册（No.ChiCTR2100051629）。

英文摘要:

Objective To observe the efficacy and safety of Postoperative No.1 Recipe on constipation of patinets with qi and blood deficiency and intestinal dryness syndrome after hip and knee arthroplasty. Methods A randomized， single-blind， parallel controlled trail was performed. Totally 120 patients with constipation after hip and knee arthroplasty from the Department of Orthopedic Surgery， Guanghua Hospital affiliated to Shanghai University of Traditional Chinese Medicine from January 2021 to August 2021 were randomly assigned to the Chinese medicine （CM）group（60 cases） and the control group （60 cases） according to the SPSS software random number method. The perioperative period was treated according to the conventional treatment of joint replacement， and drug intervention was carried out after the overall evaluation at day 2 after operation. The CM group was given 2 package of Postoperative No.1 Recipe （200 mL）after operation， twice per day， while the control group was given fructose oral liquid 15 mL，three times per day. Both groups were treated for 3 days，and the laxative effect of CM was evaluated at day 9 after operation. The score of main symptoms of constipation，average number of spontaneous complete bowel movement per week（SCBM）， Patient?Assessment?of?Constipation Symptoms（PAC-SYM）， CM syndrome score and safety index were observed before and after treatment，thereby judging their efficacies. Results Finally，117 patients were enrolled，58 cases in the CM group and 59 cases in the control group. Compared with before treatment，the average scores of main symptoms，secondary symptoms and CM syndromes of constipation in the CM group decreased（P<0.05），and SCBM increased significantly（P<0.05）；In the control group，the average score of main symptoms of constipation increased （P<0.05），SCBM did not change significantly（P>0.05），and the score of CM syndromes decreased（P<0.05）. After treatment，compared with the control group，the average score of the main symptoms，secondary symptoms and CM syndromes in the CM group decreased（P<0.05），while the SCBM increased（P<0.05）. The average effective rate of main symptoms in the CM group and the control group were 86.1% and 78.2%，respectively，and the average clinical cure rate was 43.9% and 32.2%, respectively. There was statistical difference between the two groups （χ2=15.736，P<0.001；χ2=5.304，P<0.05）. There was no significant difference in liver and renal function between the two groups before and after treatment（P>0.05）. Conclusion Postoperative No.1 Recipe can significantly reduce postoperative constipation symptoms， relieve gastrointestinal discomfort， improve postoperative quality of life， perioperative use is safe and effective， improve satisfaction and comfort of patient. Chinese Clinical Trial Registry（No. ChiCTR2100051629）.

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