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[摘要]
【目的】评价健脾和胃膏贴脐联合四逆和胃安神汤加减治疗肝胃不和型2型糖尿病胃轻瘫(DGP)伴焦虑状态的临床疗 效。【方法】将100例肝胃不和型DGP伴焦虑状态患者随机分为治疗组和对照组,每组各50例。对照组给予枸橼酸莫沙必利 片口服治疗,治疗组给予健脾和胃膏贴脐联合四逆和胃安神汤加减的中药颗粒剂治疗,疗程为4周。观察2组患者治疗前后 中医证候评分、胃轻瘫症状严重指数(GCSI)评分、汉密尔顿焦虑量表(HAMA)评分、胃排空时间、空腹血糖(FBG)、餐后2 h 血糖(2hPG)、糖化血红蛋白(HbA1c)、血浆胃动素(MOT)、胃泌素(GAS)及血清肿瘤坏死因子α(TNF-α)、白细胞介素6 (IL-6)水平的变化情况,并评价2组患者的临床疗效和安全性。【结果】(1)脱落情况:研究过程中,治疗组有4例患者脱落, 对照组有3例患者脱落,最终共有93例患者纳入疗效统计,其中治疗组46例,对照组47例。(2)治疗4周后,治疗组的总有 效率为95.65%(44/46),对照组为76.60%(36/47);组间比较(χ2检验),治疗组的疗效明显优于对照组(P<0.01)。(3)治疗 后,2组患者的各项中医证候评分(包括脘腹痞闷不舒、情绪抑郁或急躁易怒、纳差)和胃轻瘫主要症状指数(GCSI)评分均较 治疗前降低(P<0.05)、胃排空时间均较治疗前缩短(P<0.05),且治疗组对各项中医证候评分和GCSI评分的降低作用及对 胃排空时间的缩短作用均明显优于对照组(P<0.01)。(4)治疗后,2组患者的血浆MOT、GAS水平均较治疗前升高(P< 0.05),且治疗组的升高作用均明显优于对照组(P<0.01)。(5)治疗后,2组患者的糖代谢指标FBG、2hPG、HbA1c水平均较 治疗前降低(P<0.05),但2组治疗后的各项糖代谢指标比较,差异均无统计学意义(P>0.05)。(6)治疗后,2组患者的血清 TNF-α、IL-6水平均较治疗前降低(P<0.05),且治疗组的降低作用均明显优于对照组(P<0.05)。(7)治疗后,2组患者的 广州中医药大学学报 Journal of Guangzhou University of Traditional Chinese Medicine 2024年3月第41卷第3期 March 2024,Vol. 41,No. 3 589 HAMA 总评分及其精神性焦虑因子、躯体性焦虑因子评分均较治疗前降低(P<0.05),且治疗组的降低作用均明显优于对照 组(P<0.05)。(8)治疗期间,2组患者均未出现明显不良反应,具有较高的安全性。【结论】健脾和胃膏贴脐联合四逆和胃安 神汤加减治疗肝胃不和型DGP伴焦虑状态患者疗效确切,能有效缓解患者临床症状,增强患者胃动力,抑制炎症因子的发 生,改善患者焦虑情绪,提高患者生活质量。
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[Abstract]
Objective To evaluate the clinical efficacy of navel application of Jianpi Hewei Adhesive Plaster combined with oral use of modified Sini Hewei Anshen Decoction in treating diabetic gastroparesis (DGP) accompanied by anxiety of liver-stomach disharmony type in type 2 diabetes patients. Methods One hundred patients with DGP accompanied by anxiety of liver- stomach disharmony type were randomly divided into a treatment group and a control group, with 50 patients in each group. The control group was given oral use of Mosapride Citrate Tablets orally,and the treatment group was given navel application of Jianpi Hewei Adhesive Plaster combined with oral use of modified Sini Hewei Anshen Decoction. The course of treatment for the two groups covered 4 weeks. The two groups were observed in the changes of the traditional Chinese medicine(TCM)syndrome scores,Gastroparesis Cardinal Symptom Index(GCSI)scores,Hamilton Anxiety Scale(HAMA)scores,gastric emptying time,and levels of fasting blood glucose(FBG),2-hour postprandial blood glucose(2hPG),glycated hemoglobin(HbA1c),plasma motilin(MOT),gastrin(GAS),and serum tumor necrosis factor alpha(TNF-α) and interleukin 6(IL-6)before and after the treatment. After treatment,the clinical efficacy and safety of the two groups were evaluated. Results(1)During the trial,4 patients in the treatment group and 3 patients in the control group fell off,and eventually a total of 93 patients were included for the efficacy statistics,including 46 patients in the treatment group and 47 patients in the control group.(2)After 4 weeks of treatment,the total effective rate of the treatment group was 95.65%(44/46)and that of the control group was 76.60%(36/47). The intergroup comparison(tested by chi-square test)showed that the therapeutic effect of the treatment group was significantly superior to that of the control group(P<0.01).(3)After treatment, the TCM syndrome scores(including epigastric and abdominal congestion, depression or irritability, and poor appetite)and GCSI scores in the two groups were decreased compared with those before treatment (P<0.05) and the gastric emptying time was shortened compared with that before treatment(P<0.05), and the effect of the treatment group on decreasing TCM syndrome scores and GCSI scores and on shortening the gastric emptying time were significantly superior to that of the control group(P<0.01).(4)After treatment,the plasma MOT and GAS levels of the two groups were increased compared with those before treatment(P<0.05), and the increase in the treatment group was significantly superior to that in the control group(P<0.01).(5)After treatment,the levels of glucose metabolism indicators of FBG, 2hPG, and HbA1c in the two groups were decreased compared with those before treatment (P<0.05),but the differences of all glucose metabolism indicators between the two groups after treatment were 590 广州中医药大学学报 2024年第41卷 糖尿病胃轻瘫(diabetic gastroparesis,DGP)是 老年2型糖尿病(type 2 diabetes mellitus,T2DM)的 一种慢性并发症,因自主神经病变和胃肠激素分 泌异常,导致血糖升高而引起的功能性消化性疾 病,以胃动力障碍和胃排空延迟为特征,临床症 状常见早饱、餐后饱、恶心、呕吐、腹胀等,但 不伴有胃机械梗阻[1-3]。流行病学调查显示,国内 2型糖尿病患者中,有30%的人患有胃轻瘫[4];有 糖尿病病史的患者中,DGP病程超过5年的约占 50%[5]。目前,现代医学主要采用莫沙必利等促胃 肠动力药物治疗,但这类药物治疗效果一般,停 药后容易复发[6],病情反复导致患者出现焦虑状 态。据相关研究[7]显示,DGP患者大多伴有焦虑状 态,而当合用抗焦虑药物(如黛力新)时会影响胃 轻瘫疗效,二者难以兼顾。 中医方面,根据DGP 的临床表现,可将其归 属于“消渴”兼“痞满”类疾病,是在“消渴” 基础上并发“痞满”,因此,二者病机相互关联。 消渴病机多样,但最终都导致中焦脾胃受损。针 对肝胃不和型DGP伴焦虑状态的患者,其病机主 要是肝气郁结、横逆犯胃,一方面肝木克土而致 脾土损伤,另一方面木郁于里则情志不舒,故常 伴有焦躁不安等状态,给患者的身心健康和生活 质量造成严重的影响。本课题组的周军怀教授认 为,针对肝胃不和型DGP伴焦虑状态患者,既要 疏肝和胃,又要顾护患者精神情志,可以采用 “内外合治”“肝脾胃同治”的方法,运用院内制 剂健脾和胃膏贴脐联合四逆和胃安神汤加减治 疗,临床常可取得较好的疗效。基于此,本研究 采用随机对照方法,以100例肝胃不和型DGP伴焦 虑状态患者为研究对象,旨在探讨健脾和胃膏贴 脐联合四逆和胃安神汤加减治疗DGP伴焦虑状态 患者的临床疗效。现将研究结果报道如下。 1 对象与方法 1. 1 研究对象及分组选取2021年12月至2022年 12月期间在海南省三亚市中医院中医全科、脾胃 科、老年病科门诊及住院部接受治疗的肝胃不和 型DGP伴焦虑状态患者,共100例。按照就诊顺序 编号,采用SPSS 26.0 统计软件生成随机编号,把 患者随机分成治疗组和对照组,每组各50例。本 研究符合医学伦理学要求并通过海南省三亚市中 医院医学伦理委员会的审核批准(伦理审批号: 2023009)。 1. 2 诊断标准 1. 2. 1 西医诊断标准DGP 相关诊断标准参照 《中国2型糖尿病防治指南(2017年版)》[8]和《胃轻 瘫临床管理指南》[9]制定:① 2型糖尿病(T2DM)病 程不少于5年;②已出现消化道症状,如恶心,嗳 气,厌食,反复打嗝,餐后上腹部胀满或早饱 等;③胃排空缓慢:X线钡餐的检查显示,在胃中 残留的钡餐经过4 h后仍然存在。 1. 2. 2 中医辨证标准参照《糖尿病胃肠病中医 诊疗标准》[10]中肝胃不和型的辨证标准。主症:脘 not statistically significant(P>0.05).(6)After treatment,the serum TNF-α and IL-6 levels in the two groups were decreased compared with those before treatment(P<0.05), and the decrease in the treatment group was significantly superior to that in the control group(P<0.05).(7)After treatment,the total HAMA scores and the scores of mental anxiety factor and somatic anxiety factor of HAMA in the two groups were decreased compared with those before treatment(P<0.05),and the effect on lowering the scores in the treatment group was significantly superior to that in the control group(P<0.05).(8)During the treatment period,no significant adverse reactions occurred in the two groups of patients, which has high safety. Conclusion Navel application of Jianpi Hewei Adhesive Plaster combined with oral use of modified Sini Hewei Anshen Decoction exerts certain efficacy in treating DGP accompanied by anxiety of liver-stomach disharmony type. The therapy is effective on relieving clinical symptoms,enhancing gastric motility,inhibiting inflammatory response,and improving anxiety emotion and the quality of life of the patients.
[中图分类号]
R259.872
[基金项目]
三亚市高校及医疗机构专项科技计划项目(编号:2021GXYL08)