[Treatment of postprandial discomfort syndrome in the elderly: a multi-centered prospective randomized controlled clinical study].

Objective: To evaluate the efficacy and safety of Oryz-Aspergillus enzyme and pancreatin tablets (Combizym(®)) in the treatment of postprandial distress syndrome (PDS) in the elderly, compared with gastrointestinal motility drugs. Methods: A prospective randomized controlled trial was designed and registered in the China Clinical Trials Registry (ChiCTR-IPR-16008185). The elderly patients with PDS were randomly divided into three groups, including Mosapride group with Mosapride citrate tablets 5 mg 3 times per day for 2 weeks; Combizym(®) group with Combizym tablets 244 mg 3 times per day for 2 weeks; combined treatment group with both drugs and same doses for 2 weeks. The modified Nepean dyspepsia index (NDSI) score, discomfort intensity score and PDS score were calculated on patients before treatment, at the end of first and second week of treatment, as well as 4 weeks after treatment finished, respectively. Adverse effects were evaluated. Results: A total of 323 patients from 16 tertiary hospitals in China were enrolled in this study. Among them, 105 patients were in Mosapride group, 109 in Combizym(®) group and 109 in combined treatment group. There were 148 males (45.8%) and 175 females (54.2%) with median age 71.4±9.0 years (60-100 years). Baseline characteristics of three groups were comparable. After treatment, the NDSI scores in three groups all decreased significantly (P<0.001), while they were similar between groups (P>0.05). The discomfort intensity score and PDS score in three groups showed a significant reduction after treatment (P<0.001), especially in the combined treatment group. Compared with Mosapride group, the scores in Combizym(®) group decreased significantly after one or two weeks [discomfort intensity score: after one week, 4.0(2.5, 8.0) vs. 6.0(3.0, 10.0); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 6.0); all P<0.05. PDS score: after one week, 6.0(3.0, 9.0) vs. 7.0(3.5, 10.5); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 7.0); all P<0.05]. The efficacy rate in all patients after first week of treatment was over 15.0%. The efficacy rates after two weeks were 55.2%, 68.8% and 73.4% in Mosapride group, Combizym(®) group and combined treatment group, respectively. After two week treatment, the efficacy rates in Combizym(®) group (P=0.041) and combined group (P=0.006) were higher than that of Mosapride group. The recurrence rate of Mosapride group was 9.5%, which was significantly higher than that of Combizym(®) group (1.8%, P<0.05) and combined treatment group (1.8%, P<0.05). There were no serious adverse effects in the three groups. Conclusions: The efficacy of Oryz-Aspergillus enzyme and pancreatin tablets is comparable with that of Mosapride in elderly PDS patients, with fewer adverse effects and low recurrence rate. Combination regimen indicates better efficacy than that of Oryz-Aspergillus enzyme and pancreatin tablets or Mosapride alone.

[Normal values for solid state high resolution anorectal manometry in healthy adult volunteers].

Objective: To explore the normal values for two-dimension solid state high resolution anorectal manometry (HRAM) in healthy adult volunteers. Methods: The healthy adult volunteers were recruited by advertisement and underwent solid state HRAM in the left lateral position. Anorectal pressures and rectal sensation were recorded and analyzed. Results: (1) A total of 126 Chinese healthy adult volunteers (male: 50 cases (39.7%); age: (37.5±14.2) years old ) were recruited in this study. (2) Mean anal resting pressure (MERP) was (71.8±17.3) mmHg (1 mmHg=0.133 kPa). Maximum anal resting pressure (MARP) was (79.3±17.8) mmHg, Maximum anal squeeze pressure (MSP) was (178.7±52.8) mmHg. Anal high pressure zone (HPZ) length was (3.4±0.6) cm. During simulated evacuation, residual anal pressure (RAP) was (63.8±20.5) mmHg, and anal relaxation rate (ARR) was (37.0±11.5)%. Rectal threshold volume for first sensation (FST), desire to defecate (DDT), urgency to defecate (UDT) and maximum discomfort (MDT) was (47.4±10.0) ml, (84.5±18.2) ml, (125.8±28.5) ml, and (175.5±36.1) ml, respectively. (3) Compared with female subjects, male subjects had higher MSP[(211.0±50.7) mmHg vs (157.5±42.5) mmHg], RAP[(71.6±18.1) mmHg vs (58.8±20.5) mmHg]and rectal MDT[(187.0±36.4) mmHg vs (168.0±34.1)mmHg], but lower ARR[(32.1±8.0)% vs (40.2±12.3)%], all P<0.01. (4) MERP, MARP, MSP and rectal MDT were higher in young group (≤40 years old), all P<0.05. Conclusions: These observations provide normal values for two-dimension solid state HRAM, which have significant difference between genders and different age groups.