摘要
目的探讨自行研制的口服消化道多维振动胶囊在人体应用的安全性和慢传输便秘(STC)改善的有效性。方法选择健康志愿者10例,其中男性5例,女性5例;年龄27~48岁,平均年龄38.00岁(标准差7.09岁);无器质性消化道狭窄、手术史。选择STC患者10例,其中男性3例,女性7例;年龄18~56岁,平均年龄36.70岁(标准差11.16岁);病程26~60个月,平均病程39.30个月(标准差9.60个月)。采用无线通信和机械振动技术研制的口服消化道多维振动胶囊,通过质检机构检测。健康志愿者和STC患者口服消化道多维振动胶囊,每例按规定方法依次口服14颗消化道多维振动胶囊。观察口服该胶囊的安全排出体外时间、大便Bristol评分、1周完全自主排便次数(CSBM);对STC患者在口服前后进行便秘Wexner评分,及时处理可能出现的任何不适。结果10例健康志愿者和10例STC患者均顺利通过6周的临床观察;口服的14颗消化道多维振动胶囊均自动顺利排出体外,健康志愿者口服前和口服2周、4周、6周大便Bristol评分分别为(3.40±0.84)分、(4.70±1.16)分、(3.80±0.63)分、(4.30±0.67)分;前7颗在体时间长于后7颗,口服2周、4周、6周CSBM分别为(11.00±2.00)次/周、(10.60±1.35)次/周、(10.60±0.97)次/周,均多于口服前的(6.90±1.19)次/周,但3个时间段间差异无统计学意义(P>0.05)。STC患者口服后7颗消化道多维振动胶囊在体时间明显少于前7颗,但仍长于健康志愿者;大便的Bristol评分随着治疗时间延长逐渐改善,6周后4例接近健康志愿者口服前水平,大便Bristol评分在口服前和口服2周、4周、6周时分别为(1.80±0.63)分、(2.00±0.67)分、(3.10±0.74)分、(3.90±0.74)分;CSBM也随着治疗时间延长有显著改善,口服前和口服2周、4周和6周的1周CSBM分别为(1.30±0.82)次/周.(2.70±0.95)次/周、(3.40±0.84)次/周、(4.90±1.37)次/周,呈逐渐增加,且各时间点之间差异均有统计学意义(P<0.05);STC患者口服前后的Wexner评分分别为(20.40±4.06)分、(13.90±1.85)分,差异有显著统计学意义(P=0.000)。结论口服消化道多维振动胶囊自主经过消化道排出,安全,可显著改善STC的症状,对于健康志愿者也有促进排便的作用。
Objective To investigate the safety of self-developed oral multi-dimensional vibration capsule in human application and its effectiveness of improving slow transit constipation(STC). Methods Ten healthy volunteers were enrolled as control group, which included 5 males and 5 females, aged 27-48 years old with mean age of 38.00 years old(standard deviation 7.09 years old), and without organic gastrointestinal stenosis and surgery history. Ten STC patients were set as study group, which included 3 males and 7 females, aged 18-56 years old with mean age of 36.70 years old(standard deviation11.16 years old), disease course was 26-60 months with mean course of 39.30 months(standard deviation 9.60 months). The oral digestive tract multi-dimensional vibration capsule was developed by wireless communication and mechanical vibration technique, and tested by quality inspection organization. Fourteen digestive tract multi-dimensional vibration capsules were swallowed in turn according to prescribed method. The safe excretion time, stool Bristol score and 1-week spontaneous defecation time(CSBM) were observed,Wexner score of constipation was performed for STC patients before and after study period, and any discomfort was promptly treated. Results All of the subjects successfully completed 6-week clinical observation;14 oral digestive tract multi-dimensional vibration capsules were automatically and smoothly excreted. In control group, stool Bristol score at pre-oral and 2-week, 4-week, 6-week post-oral were(3.40 ± 0.84) scores,(4.70 ± 1.16) scores,(3.80 ± 0.63) scores and(4.30 ± 0.67) scores, respectively. The in vivo time of the first 7 capsules was longer than that of the last 7 capsules, and CSBM for 2-week, 4-week, and 6-week were(11.00 ± 2.00) times/week,(10.60 ± 1.35) times/week, and(10.60 ± 0.97) times/week, respectively, which were longer than that of before oral administration[(6.90 ± 1.19) times/week],but the time differences of the three time periods were no significantly different( P > 0.05). The in vivo time of the last7 capsules in study group was significantly shorter than that of the first 7 capsules, but still longer than that in control group.The Bristol scores were gradually improved with prolongation of treatment time. After 6 week, the scores of 4 cases were closed to that of pre-oral level in control group, which were(1.80 ± 0.63) scores,(2.00 ± 0.67) scores,(3.10 ± 0.74) scores, and(3.90 ±0.74) scores at pre-oral and 2-week, 4-week, 6-week post-oral, respectively. CSBM was also improved significantly with prolonged treatment, CSBM per week of pre-oral and 2-week, 4-week, and 6-week was(1.30 ± 0.82) times/week,(2.70 ±0.95) times/week,(3.40 ± 0.84) times/week,(4.90 ± 1.37) times/week, respectively, which gradually increased, and the differences between time points were statistically significant(P < 0.05). The Wexner scores of STC patients before and after treatment were(20.40 ± 4.06) scores and(13.90 ± 1.85) scores, respectively, and the difference was statistically significant( P = 0.000).Conclusion It is demonstrated that oral digestive tract multi-dimensional vibration capsule is safe to be excreted, which can significantly improve symptoms of slow transit constipation and also shows the effect of promoting defecation in healthy volunteers.
作者
王永兵
杨建明
邓超明
赵凯
颜国正
王云峰
李刚
陈泽旭
WANG Yong-bing;YANG Jian-ming;DENG Chao-ming;ZHAO Kai;YAN Guo-zheng;WANG Yun-feng;LI Gang;CHEN Ze-xu(Department of General Surgery,Shanghai Padong New Area People's Hospital,Shanghai 200230,China;Shanghai 3D Biomedical Technology Co.,Ltd.,Shanghai 201114,China;Institute of Precise Engineering and Intelligent Microsystems,Shanghai Jiao Tong University,Shanghai 200230,China)
出处
《生物医学工程与临床》
CAS
2022年第3期284-289,共6页
Biomedical Engineering and Clinical Medicine
基金
上海市浦东卫生健康委重点学科建设项目(PWZxk2017-11)。
关键词
慢传输便秘(STC)
消化道多维振动胶囊
Bristol评分
自主排便
临床研究
slow transit constipation(STC)
digestive tract multi-dimensional vibration capsule
Bristol score
independent defecation
clinical research
