Background:Endometriosis is an estrogen-dependent,progesterone-resistant gynecological disorder,with dysmenorrhea being the most common manifestation.Objective:This study evaluates the efficacy and safety of the Tibet...Background:Endometriosis is an estrogen-dependent,progesterone-resistant gynecological disorder,with dysmenorrhea being the most common manifestation.Objective:This study evaluates the efficacy and safety of the Tibetan herbal medication Honghua Ruyi Pill(HHRY)in managing endometriosis-related dysmenorrhea.Design,setting,participants and interventions:This is a multi-center,randomized,placebo-controlled,double-blinded clinical trial conducted in seven hospitals in China from July 2021 to January 2023.A total of 164 patients with endometriosis and moderate or severe dysmenorrhea(visual analog scale[VAS]score≥4)were assigned to the treatment or placebo group in a 1:1 ratio by block randomization.Patients received HHRY or placebo twice a day for three consecutive menstrual cycles(MCs)and were followed up for three MCs after stopping the medication.Main outcome measures:Primary outcomes were VAS score of the maximum(VASmax)of dysmenorrhea,endometriosis health profile-5(EHP-5)score,and 5-level EuroQoL 5-dimension version(EQ-5D-5L)score.Secondary outcomes were VASmaxof non-menstrual pelvic pain,days of leave taken,emergent use of nonsteroidal anti-inflammatory drugs(NSAIDs)and changes in uterine,cyst and nodule sizes.Safety profiles were assessed based on adverse events,vital signs,serology markers,urinalysis,and liver and kidney function indicators.Results:VASmaxof dysmenorrhea,EHP-5 score,EQ-5D-5 L score,and VASmaxof non-menstrual pelvic pain were significantly lower in the HHRY group compared to the placebo group at the final follow-up(3.00 vs 5.50,P0.999),but the number of patients who had taken time off was significantly different(5.00 vs 14.00,P=0.028).Sonographic evaluations indicated no significant change in uterine size(P=0.183)but showed a significant reduction in cyst size(2.09 cm vs 0.20 cm,P=0.027,sum of 3 diameters of cysts)and nodule size(0.70 cm vs 0.00 cm,P<0.001,maximum nodule diameter).Safety analysis showed no significant difference in the incidence of adverse events between groups(18.85%vs 28.05%,P=0.059).Conclusion:HHRY can improve dysmenorrhea,chronic pelvic pain,and quality of life in patients with endometriosis.It has a good overall safety profile,and a 3-month treatment can maintain its effects for at least 3 months after the last dose.HHRY may be considered as a new therapeutic option for treating endometriosis-related dysmenorrhea.展开更多
BACKGROUND During the perioperative period, the characteristic therapy of traditional Chinese medicine is effective in improving postoperative rehabilitation. In large-scale hospitals practicing traditional Chinese me...BACKGROUND During the perioperative period, the characteristic therapy of traditional Chinese medicine is effective in improving postoperative rehabilitation. In large-scale hospitals practicing traditional Chinese medicine, there is accumulating experience related to the promotion of fast recovery in the perioperative period.AIM To evaluate the efficacy and safety of Yikou-Sizi powder hot compress on Shenque acupuncture point combined with rapid rehabilitation technique.METHODS This prospective, multicenter, randomized, controlled study included two groups: Treatment group and control group. The patients in the treatment group and control group received Yikou-Sizi powder hot compress on Shenque acupuncture point combined with rapid rehabilitation technique and routine treatment, respectively. Clinical observation regarding postoperative recovery of gastrointestinal function was performed, including the times to first passage of flatus, first defecation, and first normal bowel sounds. The comparison between groups was conducted through descriptive analysis, χ~2, t, F, and rank-sum tests.RESULTS There was a statistically significant difference in the time to postoperative first defecation between the treatment and control group(87.16 ± 32.09 vs 109.79 ±40.25 h, respectively;P 0.05). The hospitalization expenses for the two groups of patients were 62283.45 ±12413.90 and 62059.42 ± 11350.51 yuan, respectively. Although the cost of hospitalization was decreased in the control group, the difference was not statistically significant(P > 0.05). This clinical trial was safe without reports of any adverse reaction or event.CONCLUSION The rapid rehabilitation technique with integrated traditional Chinese and Western medicine promotes the recovery of postoperative gastrointestinal function and is significantly better than standard approach for patients after colorectal surgery.展开更多
Purpose: The aim of this study is to develop and validate a scale for perioperative recovery with integrative medicine. Methods: The procedures for developing the scale included a review of both modern and ancient lit...Purpose: The aim of this study is to develop and validate a scale for perioperative recovery with integrative medicine. Methods: The procedures for developing the scale included a review of both modern and ancient literature, other perioperative scales or questionnaire references, an expert consultation, and interviews with patients and surgeons following standard procedures. Primary face and content validity were assessed through a small-scale patient survey of 50 patients. A final evaluation based on the patient survey was conducted among 354 patients (age range 16-75) from the same hospital. This included testing the perioperative recovery scale for integrative medicine (PRSIM) for scaling properties, reliability, validity and responsiveness. Results: The PRSIM, a 20-item scale, was modified from an initial version transcript which included 122 items. The 20 items in the PRSIM covered five domains: direct influence, indirect influence, activity, mental function and general health perceptions. Five factors extracted from an exploratory factor analysis demonstrated a desirable model fit. A confirmatory factor analysis further indicated that the PRSIM had a good fit with the same sample. A data analysis of the PRSIM with 349 patients showed that it had good internal consistency (α> 0.7), test-retest reliability (ICC > 0.4) and split half reliability (α= 0.66). Conclusions: The PRSIM can serve as a valuable instrument for assessing patient perioperative recovery in integrative medicine. It is acceptable for patients in the perioperative period undergoing treatment by either Chinese or integrative medicine, and has good psychometric properties. Registration number: ChiCTR-TRC-09000527.展开更多
AIM To investigate the effects of Xiangbin prescription(XBP), a Chinese herbal concoction, on gastrointestinal motility.METHODS Forty healthy volunteers were recruited for this randomized controlled trial of XBP. Antr...AIM To investigate the effects of Xiangbin prescription(XBP), a Chinese herbal concoction, on gastrointestinal motility.METHODS Forty healthy volunteers were recruited for this randomized controlled trial of XBP. Antroduodenojejunal manometry was used to monitor gastrointestinal motility in these subjects. After the subjects had fasted for at least 12 h, XBP(n = 30) or placebo(n = 10) was orally administrated and gastrointestinal motility was recorded for 4 h. Plasma motilin and ghrelin were measured by enzyme-linked immunosorbent assay.RESULTS Oral administration of XBP significantly increased the amplitude of duodenal contractions [19.5(13.0-26.7) vs 16.9(12.3-23.9), P < 0.05], jejunal contractions [18.3(15.3-25.0) vs 15.4(11.7-23.9), P < 0.01], and the motility index of duodenal contractions [522.0(146.0-139.0) vs 281.0(76.5-1006.0), P < 0.01] in phase Ⅱ of the migratory motor complex(MMC), which subsequently initiated the MMC cycle [74.0(30.0-118.0) vs 116.5(24.0-219.0), P < 0.05], shortened the duration of phase I of the MMC [42.0(0.0-90.0) vs 111.5(42.0-171.0), P < 0.01], and lengthened the duration of phase Ⅱ of the MMC [120(21-240) vs 58(16-170), P < 0.01] compared to the duration before XBP administration. There were significant differences in the amplitude of jejunal contractions [19.8(14.0-30.0) vs 18.0(13.0-28.5), P < 0.05], the motility index of duodenal contractions [236.0(115.0-306.0) vs 195.0(109.0-310.0), P < 0.05], and jejunal contractions [214.0(95.0-403.0) vs 178.0(55.0-304.0), P < 0.01] in phase Ⅲ of the MMC. Oral administration of XBP greatly increased plasma motilin(57.69 ± 9.03 vs 49.38 ± 8.63, P < 0.01) and ghrelin(279.20 ± 104.31 vs 238.73 ± 115.59, P < 0.01) concentrations compared to concentrations after oral administration of the placebo.CONCLUSION XBP can stimulate duodenal and jejunal motility and increase the concentrations of plasma motilin and ghrelin. The clinical applicability of XBP in treating GDIM deserves investigation.展开更多
BACKGROUND Interdigestive migrating motor complexes(MMC)produce periodic contractions in the gastrointestinal tract,but the exact mechanism of action still remains unclear.Intramuscular interstitial cells of Cajal(ICC...BACKGROUND Interdigestive migrating motor complexes(MMC)produce periodic contractions in the gastrointestinal tract,but the exact mechanism of action still remains unclear.Intramuscular interstitial cells of Cajal(ICC-IM)participate in gastrointestinal hormone and neuromodulation,but the correlation between ICCIM and MMC is also unclear.We found that xiangbinfang granules(XBF)mediated the phase III contraction of MMC.Here,the effects of XBF on gastric antrum motility in W/Wv mice and the effects of ICC-IM on gastric antrum MMC are reported.AIM To observe the effects of ICC-IM on gastric antrum motility and to establish the mechanism of XBF in promoting gastric antrum motility.METHODS The density of c-kit-positive ICC myenteric plexus(ICC-MP)and ICC-IM in the antral muscularis of W/Wv and wild-type(WT)mice was examined by confocal microscopy.The effects of XBF on gastric antrum slow waves in W/Wv and WT mice were recorded by intracellular amplification recording.Micro-strain-gauge force transducers were implanted into the gastric antrum to monitor the MMC and the effect of XBF on gastric antrum motility in conscious W/Wv and WT mice.RESULTS In the gastric antrum of W/Wv mice,c-kit immunoreactivity was significantly reduced,and no ICC-IM network was observed.Spontaneous rhythmic slow waves also appeared in the antrum of W/Wv mice,but the amplitude of the antrum slow wave decreased significantly in W/Wv mice(22.62±2.23 mV vs 2.92±0.52 mV,P<0.0001).MMCs were found in 7 of the 8 WT mice but no complete MMC cycle was found in W/Wv mice.The contractile frequency and amplitude index of the gastric antrum were significantly increased in conscious WT compared to W/Wv mice(frequency,3.53±0.18 cpm vs 1.28±0.12 cpm;amplitude index,23014.26±1798.65 mV·20 min vs 3782.16±407.13 mV·20 min;P<0.0001).XBF depolarized smooth muscle cells of the gastric antrum in WT and W/Wv mice in a dose-dependent manner.Similarly,the gastric antrum motility in WT mice was significantly increased after treatment with XBF 5 mg(P<0.05).Atropine(0.1 mg/kg)blocked the enhancement of XBF in WT and W/Wv mice completely,while tetrodotoxin(0.05 mg/kg)partially inhibited the enhancement by XBF.CONCLUSION ICC-IM participates in the regulation of gastric antrum MMC in mice.XBF induces MMC III-like contractions that enhance gastric antrum motility via ICCIM in mice.展开更多
Objective:To explore the effectiveness and safety about the treatment of Caesarean Scar Pregnancy combined hysteroscopic surgery with extopic pregnancy Ⅱ decoction and methotrexate(MTX).Methods: A total of 80 cases o...Objective:To explore the effectiveness and safety about the treatment of Caesarean Scar Pregnancy combined hysteroscopic surgery with extopic pregnancy Ⅱ decoction and methotrexate(MTX).Methods: A total of 80 cases of CSP patients admitted by our hospital from January 2014 to March 2017 were selected as the subjects. According to the treatment way, the patients were divided into experimental group (n=40) and control group (n=40). The control group was given MTX 50 mg/m2, IM once;and the experimental group was given extopic pregnancy Ⅱ decoction on the basis of the treatment given to the control group;the 8th day hysteroscopic surgery. Routine treatment was given after surgery. Experimental group continued to take extopic pregnancy Ⅱ decoction until monitoring the serum beta-hcg level drops below normal. The general information and curative effect, HCG levels before and after 4, 7 and 11d of treatment;mass diameter before and after 11 d of treatment, menstruation recovery time and the incidence of adverse reactions in 2 groups were observed.Results:After hysteroscopic surgery pretreatment with extopic pregnancy Ⅱ decoction and MTX, HCG levels after 4, 7 and 11d were significantly lower than before, it gradually reduced by time prolonged, and research group was lower than control group, the differences were statistically significant. After treatment with different drugs, the size of pregnancy package in the observation group was significantly smaller than that in the control group. Compared with the control group, the he package block size, beta HCG time and vaginal bleeding time were significantly reduced.Conclusion: It has significant clinical effect of hysteroscopic surgery combined with ectopic pregnancy Ⅱ and MTX in the treatment of CSP. It has worthy of clinical promotion to control the amount of blood, avoid intrauterine adhesion caused by uterine artery embolization and infection et al and reduce burden of the physical and economic of patients.展开更多
基金supported by the High-level Traditional Chinese Medicine Key Subjects Construction Project of National Administration of Traditional Chinese Medicine—Evidence-based Traditional Chinese Medicine(No.zyyzdxk-2023249)the Basic Research Funding of Beijing University of Chinese Medicine。
摘要Background:Endometriosis is an estrogen-dependent,progesterone-resistant gynecological disorder,with dysmenorrhea being the most common manifestation.Objective:This study evaluates the efficacy and safety of the Tibetan herbal medication Honghua Ruyi Pill(HHRY)in managing endometriosis-related dysmenorrhea.Design,setting,participants and interventions:This is a multi-center,randomized,placebo-controlled,double-blinded clinical trial conducted in seven hospitals in China from July 2021 to January 2023.A total of 164 patients with endometriosis and moderate or severe dysmenorrhea(visual analog scale[VAS]score≥4)were assigned to the treatment or placebo group in a 1:1 ratio by block randomization.Patients received HHRY or placebo twice a day for three consecutive menstrual cycles(MCs)and were followed up for three MCs after stopping the medication.Main outcome measures:Primary outcomes were VAS score of the maximum(VASmax)of dysmenorrhea,endometriosis health profile-5(EHP-5)score,and 5-level EuroQoL 5-dimension version(EQ-5D-5L)score.Secondary outcomes were VASmaxof non-menstrual pelvic pain,days of leave taken,emergent use of nonsteroidal anti-inflammatory drugs(NSAIDs)and changes in uterine,cyst and nodule sizes.Safety profiles were assessed based on adverse events,vital signs,serology markers,urinalysis,and liver and kidney function indicators.Results:VASmaxof dysmenorrhea,EHP-5 score,EQ-5D-5 L score,and VASmaxof non-menstrual pelvic pain were significantly lower in the HHRY group compared to the placebo group at the final follow-up(3.00 vs 5.50,P0.999),but the number of patients who had taken time off was significantly different(5.00 vs 14.00,P=0.028).Sonographic evaluations indicated no significant change in uterine size(P=0.183)but showed a significant reduction in cyst size(2.09 cm vs 0.20 cm,P=0.027,sum of 3 diameters of cysts)and nodule size(0.70 cm vs 0.00 cm,P<0.001,maximum nodule diameter).Safety analysis showed no significant difference in the incidence of adverse events between groups(18.85%vs 28.05%,P=0.059).Conclusion:HHRY can improve dysmenorrhea,chronic pelvic pain,and quality of life in patients with endometriosis.It has a good overall safety profile,and a 3-month treatment can maintain its effects for at least 3 months after the last dose.HHRY may be considered as a new therapeutic option for treating endometriosis-related dysmenorrhea.
基金Supported by Guangdong Provincial Department of Science and Technology,No.2014A020212278。
摘要BACKGROUND During the perioperative period, the characteristic therapy of traditional Chinese medicine is effective in improving postoperative rehabilitation. In large-scale hospitals practicing traditional Chinese medicine, there is accumulating experience related to the promotion of fast recovery in the perioperative period.AIM To evaluate the efficacy and safety of Yikou-Sizi powder hot compress on Shenque acupuncture point combined with rapid rehabilitation technique.METHODS This prospective, multicenter, randomized, controlled study included two groups: Treatment group and control group. The patients in the treatment group and control group received Yikou-Sizi powder hot compress on Shenque acupuncture point combined with rapid rehabilitation technique and routine treatment, respectively. Clinical observation regarding postoperative recovery of gastrointestinal function was performed, including the times to first passage of flatus, first defecation, and first normal bowel sounds. The comparison between groups was conducted through descriptive analysis, χ~2, t, F, and rank-sum tests.RESULTS There was a statistically significant difference in the time to postoperative first defecation between the treatment and control group(87.16 ± 32.09 vs 109.79 ±40.25 h, respectively;P 0.05). The hospitalization expenses for the two groups of patients were 62283.45 ±12413.90 and 62059.42 ± 11350.51 yuan, respectively. Although the cost of hospitalization was decreased in the control group, the difference was not statistically significant(P > 0.05). This clinical trial was safe without reports of any adverse reaction or event.CONCLUSION The rapid rehabilitation technique with integrated traditional Chinese and Western medicine promotes the recovery of postoperative gastrointestinal function and is significantly better than standard approach for patients after colorectal surgery.
摘要Purpose: The aim of this study is to develop and validate a scale for perioperative recovery with integrative medicine. Methods: The procedures for developing the scale included a review of both modern and ancient literature, other perioperative scales or questionnaire references, an expert consultation, and interviews with patients and surgeons following standard procedures. Primary face and content validity were assessed through a small-scale patient survey of 50 patients. A final evaluation based on the patient survey was conducted among 354 patients (age range 16-75) from the same hospital. This included testing the perioperative recovery scale for integrative medicine (PRSIM) for scaling properties, reliability, validity and responsiveness. Results: The PRSIM, a 20-item scale, was modified from an initial version transcript which included 122 items. The 20 items in the PRSIM covered five domains: direct influence, indirect influence, activity, mental function and general health perceptions. Five factors extracted from an exploratory factor analysis demonstrated a desirable model fit. A confirmatory factor analysis further indicated that the PRSIM had a good fit with the same sample. A data analysis of the PRSIM with 349 patients showed that it had good internal consistency (α> 0.7), test-retest reliability (ICC > 0.4) and split half reliability (α= 0.66). Conclusions: The PRSIM can serve as a valuable instrument for assessing patient perioperative recovery in integrative medicine. It is acceptable for patients in the perioperative period undergoing treatment by either Chinese or integrative medicine, and has good psychometric properties. Registration number: ChiCTR-TRC-09000527.
基金Supported by Guangdong Provincial Department of Science and Technology,No.[2013]173
摘要AIM To investigate the effects of Xiangbin prescription(XBP), a Chinese herbal concoction, on gastrointestinal motility.METHODS Forty healthy volunteers were recruited for this randomized controlled trial of XBP. Antroduodenojejunal manometry was used to monitor gastrointestinal motility in these subjects. After the subjects had fasted for at least 12 h, XBP(n = 30) or placebo(n = 10) was orally administrated and gastrointestinal motility was recorded for 4 h. Plasma motilin and ghrelin were measured by enzyme-linked immunosorbent assay.RESULTS Oral administration of XBP significantly increased the amplitude of duodenal contractions [19.5(13.0-26.7) vs 16.9(12.3-23.9), P < 0.05], jejunal contractions [18.3(15.3-25.0) vs 15.4(11.7-23.9), P < 0.01], and the motility index of duodenal contractions [522.0(146.0-139.0) vs 281.0(76.5-1006.0), P < 0.01] in phase Ⅱ of the migratory motor complex(MMC), which subsequently initiated the MMC cycle [74.0(30.0-118.0) vs 116.5(24.0-219.0), P < 0.05], shortened the duration of phase I of the MMC [42.0(0.0-90.0) vs 111.5(42.0-171.0), P < 0.01], and lengthened the duration of phase Ⅱ of the MMC [120(21-240) vs 58(16-170), P < 0.01] compared to the duration before XBP administration. There were significant differences in the amplitude of jejunal contractions [19.8(14.0-30.0) vs 18.0(13.0-28.5), P < 0.05], the motility index of duodenal contractions [236.0(115.0-306.0) vs 195.0(109.0-310.0), P < 0.05], and jejunal contractions [214.0(95.0-403.0) vs 178.0(55.0-304.0), P < 0.01] in phase Ⅲ of the MMC. Oral administration of XBP greatly increased plasma motilin(57.69 ± 9.03 vs 49.38 ± 8.63, P < 0.01) and ghrelin(279.20 ± 104.31 vs 238.73 ± 115.59, P < 0.01) concentrations compared to concentrations after oral administration of the placebo.CONCLUSION XBP can stimulate duodenal and jejunal motility and increase the concentrations of plasma motilin and ghrelin. The clinical applicability of XBP in treating GDIM deserves investigation.
摘要BACKGROUND Interdigestive migrating motor complexes(MMC)produce periodic contractions in the gastrointestinal tract,but the exact mechanism of action still remains unclear.Intramuscular interstitial cells of Cajal(ICC-IM)participate in gastrointestinal hormone and neuromodulation,but the correlation between ICCIM and MMC is also unclear.We found that xiangbinfang granules(XBF)mediated the phase III contraction of MMC.Here,the effects of XBF on gastric antrum motility in W/Wv mice and the effects of ICC-IM on gastric antrum MMC are reported.AIM To observe the effects of ICC-IM on gastric antrum motility and to establish the mechanism of XBF in promoting gastric antrum motility.METHODS The density of c-kit-positive ICC myenteric plexus(ICC-MP)and ICC-IM in the antral muscularis of W/Wv and wild-type(WT)mice was examined by confocal microscopy.The effects of XBF on gastric antrum slow waves in W/Wv and WT mice were recorded by intracellular amplification recording.Micro-strain-gauge force transducers were implanted into the gastric antrum to monitor the MMC and the effect of XBF on gastric antrum motility in conscious W/Wv and WT mice.RESULTS In the gastric antrum of W/Wv mice,c-kit immunoreactivity was significantly reduced,and no ICC-IM network was observed.Spontaneous rhythmic slow waves also appeared in the antrum of W/Wv mice,but the amplitude of the antrum slow wave decreased significantly in W/Wv mice(22.62±2.23 mV vs 2.92±0.52 mV,P<0.0001).MMCs were found in 7 of the 8 WT mice but no complete MMC cycle was found in W/Wv mice.The contractile frequency and amplitude index of the gastric antrum were significantly increased in conscious WT compared to W/Wv mice(frequency,3.53±0.18 cpm vs 1.28±0.12 cpm;amplitude index,23014.26±1798.65 mV·20 min vs 3782.16±407.13 mV·20 min;P<0.0001).XBF depolarized smooth muscle cells of the gastric antrum in WT and W/Wv mice in a dose-dependent manner.Similarly,the gastric antrum motility in WT mice was significantly increased after treatment with XBF 5 mg(P<0.05).Atropine(0.1 mg/kg)blocked the enhancement of XBF in WT and W/Wv mice completely,while tetrodotoxin(0.05 mg/kg)partially inhibited the enhancement by XBF.CONCLUSION ICC-IM participates in the regulation of gastric antrum MMC in mice.XBF induces MMC III-like contractions that enhance gastric antrum motility via ICCIM in mice.
摘要Objective:To explore the effectiveness and safety about the treatment of Caesarean Scar Pregnancy combined hysteroscopic surgery with extopic pregnancy Ⅱ decoction and methotrexate(MTX).Methods: A total of 80 cases of CSP patients admitted by our hospital from January 2014 to March 2017 were selected as the subjects. According to the treatment way, the patients were divided into experimental group (n=40) and control group (n=40). The control group was given MTX 50 mg/m2, IM once;and the experimental group was given extopic pregnancy Ⅱ decoction on the basis of the treatment given to the control group;the 8th day hysteroscopic surgery. Routine treatment was given after surgery. Experimental group continued to take extopic pregnancy Ⅱ decoction until monitoring the serum beta-hcg level drops below normal. The general information and curative effect, HCG levels before and after 4, 7 and 11d of treatment;mass diameter before and after 11 d of treatment, menstruation recovery time and the incidence of adverse reactions in 2 groups were observed.Results:After hysteroscopic surgery pretreatment with extopic pregnancy Ⅱ decoction and MTX, HCG levels after 4, 7 and 11d were significantly lower than before, it gradually reduced by time prolonged, and research group was lower than control group, the differences were statistically significant. After treatment with different drugs, the size of pregnancy package in the observation group was significantly smaller than that in the control group. Compared with the control group, the he package block size, beta HCG time and vaginal bleeding time were significantly reduced.Conclusion: It has significant clinical effect of hysteroscopic surgery combined with ectopic pregnancy Ⅱ and MTX in the treatment of CSP. It has worthy of clinical promotion to control the amount of blood, avoid intrauterine adhesion caused by uterine artery embolization and infection et al and reduce burden of the physical and economic of patients.