Evaluation of individualized treatment of nonproliferative diabetic retinopathy: a multicenter, randomized, parallel-controlled study.

OBJECTIVE: To evaluate the differences in the efficacy of stationary treatment and individualized treatment for patients with nonproliferative diabetic retinopathy (NPDR). METHODS: This study was a randomized, controlled, multicenter clinical trial. Participants with NPDR were randomized into the stationary treatment group or the individualized treatment group. The stationary treatment group was given the basic treatment and Qiming granules, and the individualized treatment group was given the basic treatment, Qiming granules, and individualized Chinese herbal medicines over a 12-week period. The individualized therapeutic formula was also changed over time to adjust to the changes in the clinical presentation of the patient. We conducted observations of fundus retinal exudation and hemorrhage, visual acuity, Traditional Chinese Medicine symptom scores and other indicators. RESULTS: A total of 140 participants with NPDR were randomized into the stationary treatment group or the individualized treatment group, and 132 participants completed this study. Following the 12-week treatment, significant improvements in both primary and secondary outcomes were observed in the stationary and individualized treatment groups. No remarkable difference in the primary outcomes between the two groups was observed. However, there was a significant difference in the Traditional Chinese Medicine symptom scores (18 ± 7 vs 15 ± 6; P < 0.05). There were no severe adverse effects. CONCLUSION: Compared with stationary treatment, individualized treatment is more effective at relieving the Traditional Chinese Medicine symptoms and improving vision and fundus lesions at 12 weeks post treatment.

Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial.

BACKGROUND: Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. OBJECTIVE: To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. METHODS: This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. CONCLUSION: This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).

[Effects of Chinese Drugs Combined HAART on the Prognosis of AIDS Patients].

Objective To observe the effects of Chinese drugs (CD) combined highly active an- tiretroviral therapy (HAART) on the prognosis of acquired immune deficiency syndrome (AIDS) patients. Methods From October 2012 to October 2014, 437 AIDS patients in the treatment base of AIDS prevention and control pilot project, Yunnan Institute of Traditional Chinese Medicine and Materia Medica, were as- signed to stage IIA blank group (refusal to any Chinese medical treatment or Western medical treatment), stage IIA CD group (refusal to HAART, and treated by Fuzheng Kangdu Pill/Kang'ai Baosheng Pill alone), stage IIB Western medicine (WM) group (receiving HAART alone), stage IIB CD combined WM group (re- ceiving Fuzheng Kangdu Pill/Kang'ai Baosheng Pill based on syndrome typing + HAART), stage ll WM group (the same treatment as stage IIB WM group) , and stage Ill CD combined WM group (the same treat- ment as stage IIB CD combined WM group). The therapeutic course for all was 24 months. The mortality and morbidity of AIDS patients were observed. Results (1) The percentages of stage IIA patients and stage IIB patients were in a gradually decreasing tendency in each group, while the percentages of stage III (onset) patients and dead patients were in a gradually increasing tendency after 12- and 24-month treat- ment. However, there was no statistical difference among them (P >0. 05). (2) As for stage IIA patients, as compared with stage II A blank group, stage IIA patients occupied a higher percentage, stage IIB, stage III (onset) , and dead patients occupied a lower percentage in IIA CD group, but with no statistical difference among them (P>0.05). (3) As for stage IIB patients, as compared with stage IIB WM groups, stage IIA and II B patients occupied a higher percentage, but with no statistical difference (P >0.05). But dead pa- tients in stage III (onset) occupied an obviously lowered percentage in the CD combined WM group (P < 0.05). (4) As for stage III patients (onset) , as compared with stage lIA WM groups, stage IIA and IIB pa- tients occupied a higher percentage, and dead patients in stage III (onset) occupied an obviously lowered percentage in the CD combined CM group, but with no statistical difference (P>0.05). Conclusions The morbidity and mortality of AIDS patients were in a gradually increasing tendency regardless of any treat- ment, or what kind of treatment. CD combined WM (Fuzheng Kangdu Pill/Kang'ai Baosheng Pill + HAART) could significantly lower the percentage of dead stage IIB patients.

Effect of qiming granule on retinal blood circulation of diabetic retinopathy: a multicenter clinical trial.

OBJECTIVE: To objectively assess the effect of Qiming Granule in the treatment of diabetic retinopathy (DR) by fluorescence fundus angiography (FFA). METHODS: In a multi-center, randomized, parallel controlled clinical trial, patients with DR were randomly assigned to the control group (calcium dobesilate capsule) and the test group (Qiming Granule). Changes in the retinal blood circulation time were recorded by FFA after 3 months of medication. RESULTS: Significant reduction was observed in the retinal arterio-venous circulation time (AVCT) in both groups (P<0.01), the value was 7.635+/-3.149 s before treatment and 5.165 +/-3.382 s after treatment in the treated group, and 7.737+/-3.413 s and 5.313+/-3.472 s in the control group respectively. Qiming Granule also reduced the arm-to-retinal circulation time (ARCT, P<0.05). The value was 17.867+/-3.872 s before treatment and 15.643+/-4.648 s after treatment in the treated group, and 17.217+/-3.833 s and 16.312+/-3.613 s in the control group (P>0.05) respectively. The ARCT in the tested group was reduced, with a statistically significant difference post-medication (P<0.01). CONCLUSION: As a Chinese medicine complex prescription, Qiming Granule may alleviate retinal hypoxia and ischemia by increasing retinal blood flow and improving the blood circulation.

Simultaneous quantitation of aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine and benzoylhypaconine in human plasma by liquid chromatography-tandem mass spectrometry and pharmacokinetics evaluation of "SHEN-FU" injectable powder.

A rapid, specific and sensitive liquid chromatography-tandem mass spectrometry (LC/MS/MS) method was developed for simultaneous quantitation of six Aconitum alkaloids, i.e. aconitine (AC), mesaconitine (MA), hypaconitine (HA), benzoylaconine (BAC), benzoylmesaconine (BMA) and benzoylhypaconine (BHA) in human plasma collected from 18 healthy volunteers after intravenous drop infusion of "SHEN-FU" injectable powder in three different dosages. Lappaconitine was selected as the internal standard (IS). LC/MS/MS system coupled with an electrospray ionization (ESI) source was performed in multiple-reaction monitoring (MRM) mode. The transitions of the Aconitum alkaloids executed as following: m/z 646.3-->586.0 for AC; m/z 632.4-->573.1 for MA; m/z 616.2-->556.1 for HA; m/z 604.2-->104.8 for BAC; m/z 590.1-->104.8 for BMA; m/z 574.1-->104.8 for BHA; m/z 585.2-->161.8 for IS. Sample preparation was performed with solid-phase extraction (SPE) on a 1 mL HLB cartridge prior to analysis. The separation was applied on a Waters C(18) column (1.7 microm, 2.1 mm x 100 mm) and a gradient elution of methanol and 0.1% formic acid-water was used as mobile phase. The retention time was less than 4.5 min. The concentrations ranged from 0.1 to 1000 ng/mL for all six Aconitum alkaloids and showed a good linearity with the correlation coefficient (r(2)) >0.995. The validated method was employed to simultaneous quantitation and successfully used for the first time for the pharmacokinetic evaluation of the six Aconitum alkaloids after intravenous drop administration of "SHEN-FU" injectable powder in phase I clinical trial.

[Effects of electroacupuncture at different acupoints on FVEP in the rabbit with separated monocular optic nerve].

OBJECTIVE: To study the effect of acupuncture and moxibustion on the visual system and the mechanism. METHODS: Twenty-four rabbits were randomly divided into a "Hegu" (Ll 4) group and a "Taixi" (KI 3) group, 12 rabbits in each group. The rabbit model with separated monocular optic nerve was developed, cutting the link between the retina with the center, but do not injure the blood circulation in the retina. The effect of electroacupuncture on flicker vision evoked potential (FVEP) was investigated. RESULTS: When the optic nerve was cut off, the distal fibers of descending regulating the retina were cut off, the FVEP of the operative eye extinguished. Elctroacupuncture at "Hegu" (LI 4) and "Taixi" (KI 3) at various stages have stronger inhibiting action on the latent time and amplitudes of N1, P1, N2 of FVEP, marked by prolongation of the latent time of peak, and obvious decrease of the amplitude. And this inhibiting action has difference of acupoints. CONCLUSION: The distal fiber plays a certain role in the process of electroacupuncture influencing flicker electroretinogram (FERG) and FVEP, but the effect of acupuncture on FERG is induced through the distal fibers to influence the retina in a limited extent, but not through the central descending inhibition.