目的:观察自拟通下消炎方联合针灸治疗慢性胆囊炎(肝胆湿热证)的临床疗效。方法:将符合纳入标准的本病患者120例随机分为治疗A组、治疗B组、治疗C组和对照组,每组40例。对照组消炎利胆片治疗,治疗A组予以自拟通下消炎方,治疗B组予针灸,治疗C组予自拟通下消炎方联合针灸。治疗4周后观察4组疗效。结果:治疗效果:治疗4周后,治疗A组、治疗B组、治疗C组、对照组均有改善,P < 0.05(差异有统计学意义);治疗后治疗组C组优于治疗A组、治疗B组、治疗C组、对照组,P < 0.05;治疗后治疗C组优于治疗A组,P < 0.05;治疗后治疗A组优于治疗B组,P < 0.05;治疗后治疗C组优于治疗B组,P < 0.05。中医症候积分:治疗4周后,治疗后治疗A组、治疗B组、治疗C组、对照组均有改善,P < 0.05;治疗后治疗组C组优于治疗A组、治疗B组、治疗C组优于对照组,P < 0.05;治疗后治疗C组优于治疗A组,P < 0.05;治疗后治疗A组未见明显优于治疗B组,P > 0.05(差异无统计学意义);治疗后治疗C组优于治疗B组,P < 0.05。彩超影像疗效:治疗4周后,治疗后治疗A组、治疗B组、治疗C组、对照组均有改善,P < 0.05;治疗后治疗组C组优于治疗A组、治疗B组、治疗C组优于对照组,P < 0.05;治疗后治疗C组优于治疗A组,P < 0.05;治疗后治疗A组未见明显优于治疗B组,P > 0.05;治疗后治疗C组优于治疗B组,P < 0.05。结论: 自拟通下消炎方联合针灸治疗慢性胆囊炎(肝胆湿热型)可以改善患者症状,临床疗效高于单纯使用中药自拟通下消炎方、消炎利胆片、针灸,值得临床应用以及推广。 Objective: To observe the clinical efficacy of Tongxia Xiaoyan Recipe combined with acupuncture and moxibustion in the treatment of chronic cholecystitis (damp heat syndrome of liver and gallbladder). Method: 120 patients with this disease who met the inclusion criteria were randomly divided into treatment group A, treatment group B, treatment group C, and control group, with 40 cases in each group. The control group was treated with Xiaoyan Lidan Tablet, the treatment group A was given Tongxia Xiaoyan Prescription, the treatment group B was given acupuncture and mox-ibustion, and the treatment group C was given Tongxia Xiaoyan Prescription combined with acu-puncture and moxibustion. After 4 weeks of treatment, observe the therapeutic effects of 4 groups. Result: Treatment effect: After 4 weeks of treatment, treatment group A, treatment group B, treat-ment group C, and control group all improved, P < 0.05 (the difference was statistically significant); after treatment, the treatment group C was better than the treatment group A, B, C, and control groups, P < 0.05; After treatment, Group C was better than Group A, P < 0.05; after treatment, group A was better than group B in treatment, P < 0.05; after treatment, the treatment group C was better than the treatment group B, P < 0.05. Traditional Chinese Medicine Syndrome Score: After 4 weeks of treatment, the treatment groups A, B, C, and control showed improvement (P < 0.05); after treatment, the treatment group C was better than the treatment group A, B, and C, with P < 0.05; after treatment, Group C was better than Group A, P < 0.05; After treatment, group A showed no significant improvement compared to group B, P > 0.05 (no statistically significant difference); after treatment, the treatment group C was better than the treatment group B, P < 0.05. Evaluation of color Doppler ultrasound imaging efficacy: After 4 weeks of treatment, treatment group A, treat-ment group B, treatment group C, and control group all improved, P < 0.05; after treatment, the treatment group C was better than the treatment group A, B, and C, with P < 0.05; After treatment, Group C was better than Group A, P < 0.05; after treatment, group A showed no significant im-provement compared to group B, P > 0.05; after treatment, the treatment group C was better than the treatment group B, P < 0.05. Conclusion: The self-made Tongxia Xiaoyan Recipe combined with acupuncture and moxibustion can improve the symptoms of patients with chronic cholecystitis (hepatobiliary damp heat type), and its clinical efficacy is higher than that of the self-made Tongxia Xiaoyan Recipe, Xiaoyan Lidan Tablets, and acupuncture and moxibustion, which are worth clinical application and promotion.
目的:观察自拟通下消炎方联合针灸治疗慢性胆囊炎(肝胆湿热证)的临床疗效。方法:将符合纳入标准的本病患者120例随机分为治疗A组、治疗B组、治疗C组和对照组,每组40例。对照组消炎利胆片治疗,治疗A组予以自拟通下消炎方,治疗B组予针灸,治疗C组予自拟通下消炎方联合针灸。治疗4周后观察4组疗效。结果:治疗效果:治疗4周后,治疗A组、治疗B组、治疗C组、对照组均有改善,P < 0.05(差异有统计学意义);治疗后治疗组C组优于治疗A组、治疗B组、治疗C组、对照组,P < 0.05;治疗后治疗C组优于治疗A组,P < 0.05;治疗后治疗A组优于治疗B组,P < 0.05;治疗后治疗C组优于治疗B组,P < 0.05。中医症候积分:治疗4周后,治疗后治疗A组、治疗B组、治疗C组、对照组均有改善,P < 0.05;治疗后治疗组C组优于治疗A组、治疗B组、治疗C组优于对照组,P < 0.05;治疗后治疗C组优于治疗A组,P < 0.05;治疗后治疗A组未见明显优于治疗B组,P > 0.05(差异无统计学意义);治疗后治疗C组优于治疗B组,P < 0.05。彩超影像疗效:治疗4周后,治疗后治疗A组、治疗B组、治疗C组、对照组均有改善,P < 0.05;治疗后治疗组C组优于治疗A组、治疗B组、治疗C组优于对照组,P < 0.05;治疗后治疗C组优于治疗A组,P < 0.05;治疗后治疗A组未见明显优于治疗B组,P > 0.05;治疗后治疗C组优于治疗B组,P < 0.05。结论: 自拟通下消炎方联合针灸治疗慢性胆囊炎(肝胆湿热型)可以改善患者症状,临床疗效高于单纯使用中药自拟通下消炎方、消炎利胆片、针灸,值得临床应用以及推广。
自拟通下消炎方,针灸,慢性胆囊炎,肝胆湿热型,临床疗效
Xiaosheng Xu
Zhejiang Chinese Medical University, Hangzhou Zhejiang
Received: May 28th, 2023; accepted: Jun. 22nd, 2023; published: Jun. 30th, 2023
Objective: To observe the clinical efficacy of Tongxia Xiaoyan Recipe combined with acupuncture and moxibustion in the treatment of chronic cholecystitis (damp heat syndrome of liver and gallbladder). Method: 120 patients with this disease who met the inclusion criteria were randomly divided into treatment group A, treatment group B, treatment group C, and control group, with 40 cases in each group. The control group was treated with Xiaoyan Lidan Tablet, the treatment group A was given Tongxia Xiaoyan Prescription, the treatment group B was given acupuncture and moxibustion, and the treatment group C was given Tongxia Xiaoyan Prescription combined with acupuncture and moxibustion. After 4 weeks of treatment, observe the therapeutic effects of 4 groups. Result: Treatment effect: After 4 weeks of treatment, treatment group A, treatment group B, treatment group C, and control group all improved, P < 0.05 (the difference was statistically significant); after treatment, the treatment group C was better than the treatment group A, B, C, and control groups, P < 0.05; After treatment, Group C was better than Group A, P < 0.05; after treatment, group A was better than group B in treatment, P < 0.05; after treatment, the treatment group C was better than the treatment group B, P < 0.05. Traditional Chinese Medicine Syndrome Score: After 4 weeks of treatment, the treatment groups A, B, C, and control showed improvement (P < 0.05); after treatment, the treatment group C was better than the treatment group A, B, and C, with P < 0.05; after treatment, Group C was better than Group A, P < 0.05; After treatment, group A showed no significant improvement compared to group B, P > 0.05 (no statistically significant difference); after treatment, the treatment group C was better than the treatment group B, P < 0.05. Evaluation of color Doppler ultrasound imaging efficacy: After 4 weeks of treatment, treatment group A, treatment group B, treatment group C, and control group all improved, P < 0.05; after treatment, the treatment group C was better than the treatment group A, B, and C, with P < 0.05; After treatment, Group C was better than Group A, P < 0.05; after treatment, group A showed no significant improvement compared to group B, P > 0.05; after treatment, the treatment group C was better than the treatment group B, P < 0.05. Conclusion: The self-made Tongxia Xiaoyan Recipe combined with acupuncture and moxibustion can improve the symptoms of patients with chronic cholecystitis (hepatobiliary damp heat type), and its clinical efficacy is higher than that of the self-made Tongxia Xiaoyan Recipe, Xiaoyan Lidan Tablets, and acupuncture and moxibustion, which are worth clinical application and promotion.
Keywords:Self Formulated Tongxia Xiaoyan Formula, Acupuncture and Moxibustion, Chronic Cholecystitis, Liver and Gallbladder Dampness Heat Type, Clinical Efficacy
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慢性胆囊炎(Chronic Cholecystitis)是临床工作中比较常见的消化系统疾病,通常包括慢性结石性胆囊炎、慢性非结石性胆囊炎 [
选取自2022.07.01至2023.03.31浙江中医药大学附属温岭中医院普外科确诊为慢性胆囊炎患者120例(符合本研究纳入标准)。治疗组A组男20例,女20例,年龄(42.14 ± 4.16)岁。治疗B组男18例,女性22例,平均年龄(43.42 ± 5.13)岁;治疗C组男22例,女性18例,平均年龄(42.12 ± 4.23)岁;对照组男15例,女性25例,平均年龄(43.12 ± 5.06)岁;治疗组以及对照组的材料无明显差异,有可比性。差异无统计学意义(P > 0.05)。本次研究已通过我院伦理委员会批准,且取得患者知情同意书。
西医诊断标准:根据《中国慢性胆囊炎、胆囊结石内科诊疗共识意见》(2018年)制定 [
中医诊断标准:《中药新药临床研究指导原则》 [
1) 符合慢性胆囊炎西、中医证候诊断标准,中医证候总分>5分,胆囊同时伴有结石的患者,结石小于1 cm。2) 年龄在18~65岁之间。3) 1周来没有服用治疗慢性胆囊炎的中西医药物者。4) 签署知情同意书自愿参加本项研究者。
1) 急性坏疽性胆囊炎、急性梗阻性化脓性胆囊炎、急性单纯性或者化脓性胆囊炎、胆囊穿孔并发弥漫性腹膜炎。2) 合并肝、肾心、脑血管、造血系统等严重原发病,以及精神病患者。3) 不愿配合的治疗者或者失访者。
1) 对照组:消炎利胆片(广东嘉应制药股份有限公司,国药准字Z44022467),每次6片口服,每日3次,4周一个疗程。2) 治疗组:A组:予自拟通下消炎方:柴胡10 g、黄芩20 g、白芍20 g、枳壳20 g、姜半夏10 g、生大黄12 g (后下)、连翘30 g、蒲公英30 g、生薏苡仁20 g、延胡索20 g、郁金15 g、丹参15 g、当归10 g。煎服30分钟,煎取200 ml (由温岭市中医院中药房统一代煎包装,一日两次口服)。B组:予针灸。(肝俞、胆俞、阳凌泉、期门、胆囊穴、太冲),针刺手法:泻法,每次留针30分钟。治疗4周。C组:予自拟通下消炎方联合针灸治疗。3) 疗程:以上方案均以28天为一疗程,治疗一个疗程,并随访1个月。
1) 临床症状、体征的变化:评估2次。观察受试者首次服药前及服药4周后的临床症状和体征。参照《中药新药临床研究指导原则》(2002年版)。2) 彩超影像下胆囊的变化:分别测量2次(受试者首次服药前及服药4周后)。使用彩色超声诊断仪(规格型号:LOGIQ-E8)。3) 监测三大常规、肝、肾功能、心电图及药物不良反应。分别于治疗前以及治疗后记录;若是出现不良反应以及毒副作用,及时查找原因。
1) 疾病疗效判定标准:参照国家药品监督管理局制定发布的《中药新药临床研究指导原则》(2002年5月第1版)。痊愈:临床症状、体征完全消失,证候积分减少≥95%,胆囊彩超检查正常。显效:临床症状、体征基本消失,证候积分减少≥70%,胆囊彩超符合显效标准。有效:临床症状、体征大部分消失,证候积分减少≥30%,胆囊彩超达到有效标准。无效:临床症状、体征无明显改善,或加重,证候积分减少<30%,胆囊彩超无改善。注:计算公式(尼莫地平法)为:证候疗效 = [(治疗前积分 − 治疗后积分) ÷ 治疗前积分] × 100%
2) 症候疗效判定标准:中医证候积分标准:《中药新药临床研究指导原则》(2002年5月第1版)中慢性胆囊炎评级法拟定。
3) 主要检测指标疗效判定标准:彩超影像:《中国慢性胆囊炎、胆囊结石内科诊疗共识意见》 [
统计分析采用SPSS23.0统计软件进行处理。运用SPSS23.0统计学软件进行数据处理。计量资料以( x ¯ ± s )表示,组间比较用单因素方差分析,组间两两比较采用多个样本均数间的多重比较(LSD),组内比较用配对t检验。计数资料以频数表示,组间比较用χ2检验。P < 0.05为差异有统计学意义。
治疗4周后,治疗A组、治疗B组、治疗C组、对照组均有改善,P < 0.05差异有统计学意义;治疗后治疗组C组优于治疗A组、治疗B组、治疗C组、对照组,P < 0.05差异有统计学意义;治疗后治疗C组优于治疗A组,P < 0.05差异有统计学意义;治疗后治疗A组优于治疗B组,P < 0.05差异有统计学意义;治疗后治疗C组优于治疗B组,P < 0.05差异有统计学意义。见表1。
治疗4周后,治疗后治疗A组、治疗B组、治疗C组、对照组均有改善,P < 0.05差异有统计学意义;治疗后治疗组C组优于治疗A组、治疗B组、治疗C组优于对照组,P < 0.05差异有统计学意义;治疗后治疗C组优于治疗A组,P < 0.05差异有统计学意义;治疗后治疗A组未见明显优于治疗B组,P > 0.05差异无统计学意义;治疗后治疗C组优于治疗B组,P < 0.05差异有统计学意义。见表2。
组别 | 例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
---|---|---|---|---|---|---|
治疗组A | 40 | 15 | 9 | 10 | 6 | 85.0%a |
治疗组B | 40 | 8 | 11 | 12 | 9 | 77.5%ab |
治疗组C | 40 | 20 | 7 | 9 | 4 | 90.0%acd |
对照组 | 40 | 10 | 7 | 12 | 11 | 72.5% |
表1. 治疗效果对比
注:与本组治疗前比较,aP < 0.05;与治疗组A治疗后比较,bP < 0.05;与治疗组A治疗后比较,cP < 0.05;与治疗组B治疗后比较,dP < 0.05。
组别 | 例数 | 治疗前 | 治疗后 |
---|---|---|---|
治疗组A | 40 | 13.41 ± 4.12 | 7.10 ± 2.05a |
治疗组B | 40 | 13.56 ± 3.31 | 7.56 ± 3.09ab |
治疗组C | 40 | 14.01 ± 3.56 | 5.10 ± 2.35acd |
对照组 | 40 | 13.07 ± 4.41 | 9.53 ± 2.22 |
表2. 治疗前后中医症候积分对比
注:与本组治疗前比较,aP < 0.05;与治疗组A治疗后比较,bP > 0.05;与治疗组A治疗后比较,cP < 0.05;与治疗组B治疗后比较,dP < 0.05。
治疗4周后,治疗后治疗A组、治疗B组、治疗C组、对照组均有改善,P < 0.05差异有统计学意义;治疗后治疗组C组优于治疗A组、治疗B组、治疗C组优于对照组,P < 0.05差异有统计学意义;治疗后治疗C组优于治疗A组,P < 0.05差异有统计学意义;治疗后治疗A组未见明显优于治疗B组,P > 0.05差异无统计学意义;治疗后治疗C组优于治疗B组,P < 0.05差异有统计学意义。见表3。
组别 | 例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
---|---|---|---|---|---|---|
治疗组A | 40 | 1 | 2 | 14 | 23 | 42.5%a |
治疗组B | 40 | 1 | 1 | 17 | 21 | 47.5%ab |
治疗组C | 40 | 2 | 2 | 17 | 19 | 77.5%acd |
对照组 | 40 | 1 | 1 | 12 | 26 | 35.5% |
表3. 治疗前后彩超影像疗效评价对比
注:与本组治疗前比较,aP < 0.05;与治疗组A治疗后比较,bP > 0.05;与治疗组A治疗后比较,cP < 0.05;与治疗组B治疗后比较,dP < 0.05。
治疗4周后,根据安全性指标观测,结果显示4组在研究期间未出现不良反应及毒副作用。
慢性胆囊炎通常见于饮食不调、情志不遂、胆囊结石等,也可由于急性胆囊炎反复发作所致。临床可表现反复发作的右上腹胀痛、恶心呕吐、反酸、口干口苦、腹胀、暖气、进食油腻后疼痛加重等症状,常伴右上腹轻压痛以及叩击痛 [
自拟通下消炎方起源于东汉张仲景《伤寒杂病论》大柴胡汤 [
本课题通过临床症状和体征、彩超下胆囊的变化进行对比,发现自拟通下消炎方联合针灸治疗慢性胆囊炎(肝胆湿热型)对于改善慢性胆囊炎患者的生活质量有重大意义,优于单纯使用以及针灸,为中医药综合治疗慢性胆囊炎提供现代科学依据,为其治疗提供新的途径。
徐小盛. 自拟通下消炎方联合针灸治疗慢性胆囊炎(肝胆湿热型)的临床研究Clinical Study on Tongxia Xiaoyan Recipe Combined with Acupuncture and Moxibustion in Treating Chronic Cholecystitis (Liver Gallbladder Damp Heat Type)[J]. 医学诊断, 2023, 13(02): 187-193. https://doi.org/10.12677/MD.2023.132032