The poor solubility of cyclosporine A (CsA) in water limits its oral absorption. We prepared CsA/ Soluplus/SDS complex, which can form CsA/Soluplus/SDS supersaturated micelles (CSS-SM) after hydration. Then, We further prepared CSS-SM osmotic pump tablets (CSS-SM-T). CSS-SM had a particle size of 156 nm, where in encapsulation efficiency and drug loading efficiency of CsA were 89.0% and 17.5%, respectively. CSS-SM-T achieved zero-level drug release in vitro. Pharmacokinetic data from Beagle dogs (all animal experiments were conducted under the guidelines approved by the Institutional Animal Care and Use Committee of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences) indicated that CsA in the ordinary osmotic pump tablets was hardly absorbed after orally administered; despite slightly lower bioavailability [relative bioavailability: (85.1 ± 47.4) %] than that of Sandimmum Neoral, CSS-SM-T displayed lower fluctuations in CsA plasma concentration and obvious sustained-release characteristics in vivo, implying lower toxicity. Therefore, CSS-SM-T provides a new research idea for the design and development of oral sustained- and controlled-release preparations of poorly water-soluble drugs.

OBJECTIVETo evaluate the follow-up efficacy and safety on slow transit constipation (STC) treated with individualized deep puncture at Tianshu (ST 25).

METHODSOne hundred and twenty-eight cases of STC were randomized into a deep puncture group (64 cases), a western medication group (31 cases) and a shallow puncture group (33 cases) at the ratio of 2:1:1. In the deep puncture group, electroacupuncture of deep puncture was applied to bilateral Tianshu (ST 25). The needle was inserted perpendicularly and slowly at the acupoint and went deeply till penetrating the peritoneum, about 20 to 65 mm in depth. In the western medication group, lactulose oral liquid was prescribed for oral administration. In the shallow puncture group, electroacupuncture of shallow puncture was done at bilateral Tianshu (ST 25). The needle was inserted perpendicularly and slowly, 5 to 8 mm in depth. The treatment lasted 4 weeks in the three groups and the follow-up visit of 12 weeks and 6 month after treatment was performed respectively. The weekly defecation frequency, patient's satisfaction and safety of deep puncture at Tianshu (ST 25) were assessed before and after treatment in each group.

RESULTSIn the deep puncture group, the weekly defecation frequency was (1.79 +/- 1.05) times/week before treatment and was (3.90 +/- 1.43) times/week after 4-week treatment. It was (3.49 +/- 1.46) times/week in 12-week follow-up visit after treatment and was (3.51 +/- 1.42) times/week in 6-month follow-up visit after treatment. In the deep puncture group, the improvements in weekly defecation frequency, patient's satisfaction and short-term efficacy were same as those in the western medication group and the shallow puncture group (all P > 0.05). The long-term efficacy in follow-up visit was better remarkably than that in the western medication group (P < 0.05, P < 0.01). Besides, the combined medication was reduced and no adverse reaction occurred.

CONCLUSIONThe individualized deep puncture at Tianshu (ST 25) is effective in the treatment of STC and achieves the satisfactory long-term efficacy. This therapy displays the good effective advantage and deserves to be promoted in clinical practice of acupuncture and moxibustion therapeutic program as compared with the first-tier line of medication, lactulose oral liquid, recommended at home and abroad, in terms of the evidence-based medicine.

Acupuncture Points ; Acupuncture Therapy ; Adult ; Aged ; Constipation ; physiopathology ; psychology ; therapy ; Defecation ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Patient Satisfaction ; Treatment Outcome ; Young Adult

OBJECTIVETo compare the clinical effects between electroacupuncture at Zusanli (ST 36) combined with intravenous drip of Granisetron and intravenous drip of Granisetron only for treatment of nausea and vomiting caused by the chemotherapy of the malignant tumor.

METHODSThe methods of multicentral, randomized controlled trial were used, the observation group (127 cases) was treated with electroacupuncture at Zusanli (ST 36) combined with intravenous drip of Granisetron, and the control group (119 cases) was treated with intravenous drip of Granisetron only.

RESULTSThe total effective rate of 90.5% in observation group was superior to that of 84.0% in control group (P < 0.01); the nausea and vomiting scores of two groups were obviously decreased after treatment (both P < 0.001), and the decreased degree of the observation group was superior to that of control group (P < 0.001).

CONCLUSIONElectroacupuncture at Zusanli (ST 36) can significantly alleviate the symptoms such as nausea and vomiting caused by the chemotherapy of the patients.

Acupuncture Points ; Adolescent ; Adult ; Aged ; Antineoplastic Agents ; adverse effects ; Electroacupuncture ; Female ; Humans ; Male ; Middle Aged ; Nausea ; etiology ; therapy ; Neoplasms ; complications ; drug therapy ; pathology ; Vomiting ; etiology ; therapy ; Young Adult